15 Cardiovascular Int new:International 4/9/09 09:07 Page 1

The international newspaper for cardiovascular specialists September 2009 Issue 15

Surgeon shortage New drugs steal predicted Page 4

the spotlight at the Kotseva: The EUROASPIRE ESC Congress surveys The hotline sessions at the European Society of Cardiology Congress 2009, held in Page 8 Barcelona, Spain, were dominated by the results of several new drug trials. The PLATO study compared the antiplatelet ticagrelor with clopidogrel. The RE-LY trial compared anticoagulant therapy using warfarin with dabigatran for the prevention of Blood test stroke in patients with non-valvular atrial fibrillation. Other studies included PRAGUE- predicts heart 7, on the use of abciximab in patients undergoing percutaneous coronary interven- tion, and PROTECT, which analysed the effects of rolofylline in heart failure patients. disease Page 12 THE PRESENTATION of the grelor instead of clopidogrel, sient ischaemic attack, recur- PLATO (A study of platelet for up to one year, led to 14 rent cardiac ischaemia, severe inhibition and patient out- fewer deaths, 11 fewer infarc- recurrent cardiac ischaemia, Paediatric comes) showed that ticagrelor tions, and eight fewer cases of and other thrombotic events. (Brilinta, AstraZeneca) stent thrombosis, without an “Ticagrelor is the first hypertension reduced the rate of cardiovas- increase in major bleeds. In antiplatelet therapy to achieve cular events (cardiovascular the PLATO study, the reduc- a significant reduction in car- clopidogrel in the incidence of the patient. Transient symp- guidelines death, myocardial infarction or tion in risk of cardiovascular diovascular mortality in acute major bleeding. When minor toms of dyspnoea were report- stroke) from 11.7% to 9.8% events appears early and the coronary syndrome patients bleeding was added, ticagrelor ed more often by patients on published compared to clopidogrel benefit over clopidogrel grows versus clopidogrel and perhaps showed a small increase in ticagrelor but only one in 100 Page 14 (Plavix) (p<0.001), without an with time. most importantly without an PLATO defined major plus ticagrelor treated patients over- increase in major bleeding. Ticagrelor demonstrated a increase in major bleeding,” minor bleeding versus clopido- all stopped taking study med- This efficacy endpoint was consistent benefit across multi- commented Lars Wallentin, grel. At continuous ECG moni- ication due to dyspnoea. driven by a significant reduc- ple secondary efficacy end- co-chair of the PLATO toring while in hospital, but not PLATO was a head-to-head Profile: tion in cardiovascular death points including cardiovascu- Executive Committee. at later follow-up in the outpa- outcomes study of ticagrelor and infarction with no differ- lar death and total mortality; Across all the important tient setting, pauses in the heart plus aspirin versus the active Alfred Bove ence in stroke. myocardial infarction; the patient subgroups (eg gender, rhythm were seen more fre- comparator, clopidogrel plus Pages 16 and 17 For every 1,000 patients composite of infarction, weight, history of quently with ticagrelor. aspirin, and was designed to admitted to the hospital stroke, and total mortality; and stroke/transient ischaemic However, such pauses were not establish whether ticagrelor because of an acute coronary a composite of cardiovascular attack) in PLATO, ticagrelor associated with any symptoms could achieve meaningful Use of aspirin syndrome event, use of tica- death, infarction, stroke, tran- showed no difference versus or clinical consequences for cardiovascular endpoints
2 in vascular stroke was 1.4% for percutaneous patients SYNTAX at two years: Comparable outcomes for intervention, compared to 2.8% for Page 22 surgery (p=0.03), while myocardial infarction was 5.9% and 3.3% stenting and bypass surgery in complex patients (p=0.01), respectively. The rate of TWO-YEAR DATA from the SYN- safety endpoint (all-cause death, everyday practice is 1.5. In addition, all-cause death was 6.2% for percuta- PLUS TAX clinical trial comparing percu- stroke and myocardial infarction). the study included 33% of patients neous intervention and 4.9% for sur- taneous coronary intervention (PCI) The patients in the SYNTAX trial – with >100mm stented length, 71% gery (p=0.24). Product News using the Taxus Express paclitaxel- all of whom have left main and/or with bi/trifurcations, 27% with Overall major adverse cardiovascu- Pages 24 and 26 eluting coronary stent (Boston three-vessel coronary disease – are a chronic total occlusions and 39% lar or cerebrovascular event rate, Scientific) to coronary artery bypass unique study group in the percuta- with left main disease. including all-cause death, stroke, graft surgery were announced at the neous coronary intervention field. In The results showed comparable infarction and repeat revascularisa- Clinical News European Society of Cardiology the SYNTAX trial, mean stent use safety profiles for the two treatment tion, was significantly higher for per- Pages 28 and 29 meeting in Barcelona, Spain. was 4.6 stents/patient, with one groups at two years, with a combined cutaneous coronary intervention The overall results demonstrated patient having 14 stents implanted. rate of all-cause death, stroke and (23.3% as compared to 16.4% for no statistically significant difference By contrast, the average number of infarction of 10.8% for percutaneous bypass, p=0.0002), driven largely by between percutaneous intervention stents implanted in a percutaneous intervention and 9.6% for bypass the anticipated higher rate of revascu- Events and bypass surgery in the composite coronary intervention patient in graft surgery (p=0.44). The rate of larisation in the percutaneous
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Other studies ble in both the elderly (aged 70 or older) was cut by 73%. The need for coronary New drugs steal and younger patient groups. revascularisation was also reduced with Elderly benefit in analysis of JUPITER Procoralan treatment, decreasing by 30% the spotlight at A new analysis from the JUPITER study Fewer heart attacks with Procoralan in all angina patients and 59% in those showed that Crestor (rosuvastatin calcium, New findings in patients with angina partic- with a heart rate ≥70 bpm. AstraZeneca) 20mg reduced the primary ipating in the BEAUTIFUL study show that the ESC Congress endpoint of major cardiovascular events there is a 42% reduction in heart attack Pitavastatin non-inferior to other statins 1
in ACS patients. 18,624 patients at 893 sites in (infarction, stroke, arterial revascularisation, with ivabradine (Procoralan). This benefit New phase III data demonstrated that 43 countries were sucessfully recruited. All hospitalisation for unstable was particularly marked in pitavastatin is non-inferior to atorvastatin patients were admitted to hospital because of angina, or death from cardio- patients with a resting heart and simvastatin at usual therapeutic doses acute coronary syndrome, one third with ST-ele- vascular causes) by 39%, com- rate ≥70bpm – Procoralan cut in patients with primary hypercholes- vation myocardial infarction and two thirds pared to placebo, in elderly the risk of hospitalisation for terolemia or combined dyslipidemia. LDL- without ST-elevation. Shortly after admission to patients with LDL-C less than heart attack by nearly three C target attainment data was similar when hospital, the patients started their long-term anti- 130mg/dL and elevated high- quarters and the rate of coro- comparing pitavastatin to first-line drugs platelet treatment with either ticagrelor (90mg sensitivity C-reactive protein. nary revascularisation by more atorvastatin and simvastatin, although twice daily) or clopidogrel (75mg daily) in a This analysis was conducted in than half. pitavastatin demonstrated significantly randomised, double-blind fashion for 6–12 5,695 patients aged 70 years or In this analysis, Procoralan higher LDL-C target attainment compared months. The PLATO study was led by the older. Additional results from reduced the primary endpoint to simvastatin in the lower dose study-arm Executive Committee co-chairs, Lars Wallentin, this analysis showed that – a combination of cardiovas- (pitavastatin 2mg vs. simvastatin 20mg) Sweden (Uppsala Clinical Research Center) and treatment with Crestor cular death, myocardial (p=0.047). Continued gradual increases in Robert Harrington, US (Duke Clinical Research reduced the combined risk of infarction and heart failure – HDL-C were observed over the long-term, Institute). cardiovascular death, heart attack and in all angina patients by 24% with an supported by data from a 52 week exten- The PLATO study was sponsored by stroke by nearly 40%, reduced the risk of improvement on all parameters. sion study. Pitavastatin also demonstrated AstraZeneca, which developed and manufac- heart attack by 45% and of stroke by 45%, Hospitalisations for fatal or non-fatal a favourable safety and tolerability profile tures ticagrelor (Brilinta). and also reduced the need for hospitalisa- infarction were also reduced by 42% with to 52 weeks, the latter exemplified by a tion for arterial revascularisation or unsta- Procoralan. This benefit was even more low rate of discontinuations due to Reduced incidence of stroke in the RE-LY trial ble angina by 49%. Treatment effects, rel- striking in angina patients with a heart adverse events, which were comparable to Results from the RE-LY (Randomised ative to placebo, were generally compara- rate ≥70bpm, where the risk of infarction those with simvastatin or atorvastatin. Evaluation of Long-Term Anticoagulant Therapy, Warfarin, compared with Dabigatran) study were presented for the first time at the abciximab (a IIb/IIIa GP inhibitor) improves (p=0.24). Fifteen patients (37.5%) died during day 60, and the proportion of subjects with per- ESC Congress and published online in the New outcome when compared with conventional hospitalisation in group A and 13 patients in sistent renal impairment. Enrolment was con- England Journal of Medicine. The primary selective administration. group B (32.5%) (p=0,82). Ejection fraction cluded in January 2009 and the main results objective of RE-LY was to assess the safety and This study, which is part of a series of ran- among survivors after 30 days was 44±11% (A) became available in June 2009. Of the total efficacy of the investigational oral direct throm- domised trials in cardiology and cardiac surgery vs. 41±12% (B) (p=0.205). Major bleeding sample, 677 patients received placebo and bin inhibitor, dabigatran etexilate (Boehringer performed in the Czech Republic, enrolled 80 occurred in 17.5% (A) vs. 7.5% (B) (p=0.310) 1,356 patients received rolofylline. Follow-up Ingelheim) against warfarin (titrated to INR 2.0 of these most critically ill patients but failed to and stroke in 2.5% (A) vs. 5% (B). No differ- was complete in all but one patient at 60 days to 3.0) for the prevention of stroke in patients show any benefit from the routine upfront ences were found in TIMI-flow and MBG after and four patients (0.2%) at 180 days. with non-valvular atrial fibrillation. administration of abciximab to all patients PCI. Treatment success was achieved by 40.6% The RE-LY study results have shown that (before coronary angiography) over a more con- patients on rolofylline, compared with 36.0% both doses of dabigatran etexilate were non- ventional selective use of abciximab during Effects of rollofylline in acute heart failure of patients on placebo, 21.8% of the patients inferior to warfarin on the primary endpoint of subsequent primary PCI. The PROTECT trial found no difference with were classified as treatment failure with rolo- reducing the incidence of stroke (including All 80 patients in this open-label multicentre rolofylline vs. placebo in acute heart failure fylline versus 19.8% with placebo, the remain- haemorrhagic) and systemic embolism (p < trial received standard antithrombotic and anti- patients. Although more rolofylline patients der being unchanged. There were no significant 0.001). Dabigatran etexilate 150mg BID was coagulant treatment (either during transport or than placebo patients experienced moderate or differences between the treatment groups in superior to warfarin in reducing the incidence directly at the catheterisation laboratory) and marked dyspnea improvement at 24 and 48 either secondary endpoint. Death or rehospitali- of stroke (including haemorrhagic) and sys- coronary angiography. Patients in the upfront hours from randomisation, this was counterbal- sation for cardiovascular or renal causes at day temic embolism by 34%, and there was no sig- treatment group (group A) received a bolus of anced by a lack of effect on persistent renal 60 occurred in 30.7% and 31.9% of rolofylline nificant difference in the rate of major bleeding abciximab immediately after randomisation fol- impairment. Lastly, the risk of important neu- and placebo patients. Persistent renal impair- for dabigatran 150mg BID compared to war- lowed by an infusion for 12 hours. PCI was per- rological events was increased in patients on ment occurred in 13.7% of placebo patients and farin. The rate of major bleeding with dabiga- formed immediately after coronary angiogra- rolofylline. 15% of rolofylline patients, respectively. tran etexilate 110mg BID (2.71%/year) was phy. Group B received standard therapy with PROTECT was aimed at the assessment of Moderate or marked better dyspnoea at both 24 20% lower compared to warfarin (p=0.003). optional abciximab administration during PCI the effects of rolofylline on symptoms, renal and 48 hours was observed in 52% of patients RE-LY was a global, phase III, randomised according to the interventional cardiologist. function, and short-term morbidity and mortali- in the rolofylline treated group versus 45.4% of trial of 18,113 patients enrolled in more than The study’s primary endpoint was a 30-day ty in 2,033 patients hospitalised for heart fail- patients in the placebo group. However, this 900 centres in 44 countries. combined outcome of death, reinfarction, ure within 24 hours with signs of fluid over- was partially counterbalanced by the higher stroke, and new renal failure. Secondary objec- load, impaired renal function and high BNP or rate of persistent renal impairment in the rolo- Abciximab during primary PCI tives were left ventricular ejection fraction NT-proBNP plasma levels. Patients were ran- fylline group. Registries have shown further therapeutic bene- assessed by echocardiography on day 30, major domised 2:1 to rolofylline 30mg/day, or place- Serious adverse events occurred in 13.8% of fit from the administration of glycoprotein (GP) bleeding complications, myocardial blush grade bo. Dyspnoea was assessed daily for the first rolofylline patients and 14.7% placebo patients IIb/IIIa inhibitors during percutaneous coronary after PCI, and TIMI-flow after PCI. seven days (or until discharge, if earlier) and and cardiac events occurred in 7.2% and 9.0%, intervention (PCI) in acute myocardial infarc- Results showed that PCI was technically suc- then at 14 days. respectively. The rate of central nervous system tion patients with cardiogenic shock. However, cessful in 90% of group A and 87.5% of group The primary endpoint was a three-category events was 1.5% in the rolofylline group versus there are no randomised data to support this B patients. Abciximab was used in 100% of ordered outcome of treatment success, patient 0.6% in placebo, including more patients expe- approach in these high-risk patients. The group A and 35% of group B. The primary end- unchanged, or treatment failure. Secondary riencing seizures, a known adverse effect of A1 PRAGUE-7 study was designed to determine point was reached in 17 group A patients endpoints were: time to death or rehospitalisa- receptor antagonists, and 16 (1.2%) vs 3 (0.5%) whether the routine upfront administration of (42.5%) and 11 group B patients (27.5%) tion for cardiovascular or renal causes through patients with strokes, respectively.

SYNTAX at two years: Comparable outcomes for stenting and bypass surgery in complex patients

1
coronary intervention bypass graft surgery, used to measure the com- anatomical complexity, group (17.4% as com- p=0.63) and moderate plexity of coronary artery which can be used in pared to 8.6% for coro- lesion complexity (22.8% disease based on nine combination with a nary artery bypass graft). and 16.4%, p=0.06). For anatomic criteria, includ- physician’s clinical judg- The trial results were patients in the upper ter- ing lesion frequency, ment to help determine also analysed based on cile – those with the most complexity and location. the best revascularisation the Syntax Score, which complex disease – there Higher Syntax Scores option. demonstrated no statisti- was a significant increase indicate patients with The Syntax Score and cally significant differ- in major adverse cardio- more complex disease Syntax Score website were ence in major adverse vascular or cerebrovascu- and increased treatment developed under the direc- cardiovascular or cere- lar event for percutaneous challenges. A Syntax tion of the SYNTAX trial brovascular events for intervention patients as Score website, steering committee, patients in the lower two compared to surgery www.syntaxscore.com, chaired by Patrick Serruys, terciles – those with low (28.2% as compared to was launched in May and and F W Mohr, and were lesion complexity (19.4% 15.4%, p=0.001). allows cardiologists and made possible by support for percutaneous inter- The Syntax Score is a cardiac surgeons to char- from Boston Scientific and vention and 17.4% for novel angiographic tool acterise a patient’s Cardialysis BV. Taxus Express

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issue, the feeling is that univer- sities are producing far lesser cardiac surgeons than they Is predicted surgeon were 10 years ago.” High quality of care is needed shortage a wake-up Anthony Gershlick, consult- ant cardiologist, Glenfield Hospital NHS Trust, UK, said, “The issues raised are real. call in Europe? Rates of percutaneous coronary intervention to coronary artery A recent study has predicted that the United States will suffer a shortage of cardiotho- bypass grafting have increased in many parts of Europe and racic surgeons within the next 10 years. The study was led by Irving Kron, a thoracic vary from 4:1 in the UK to 8:1 surgeon from the University of Virginia, Charlottesville, US, and was prompted by the in Germany and France. There observation that fewer people were applying for cardiothoracic residency places are, undoubtedly, many patients who at one time would have KRON AND HIS colleagues role into cardiothoracic surgery undergone bypass who are now decided to approach the or if patients must delay appro- treated with percutenous inter- American Association for priate care because of a short- vention. The SYNTAX trial has Thoracic Surgery and the age of well-trained surgeons, helped us clarify the numbers Society of Thoracic Surgeons quality of care for patients will whom should still be referred to commission a study, based be diminished. for bypass. Approximately 25% on what they had observed, to Cardiovascular News asked of all patients requiring revas- predict the current and future a number of professionals to cularisation will have three ves- requirements for cardiotho- comment on the study and its sel disease; single and double racic surgeons. implications. vessel disease will be treated Given the increasing burden Michael Norell consultant with PCI. In SYNTAX about of cardiovascular disease and a interventional cardiologist and gery) study should provide years required for training but one-third (those with high growing and ageing popula- PCI Programme Director, The some reassurance to surgical also because of rapid develop- SYNTAX scores >32) are still tion, the investigators hypothe- Heart and Lung Centre, colleagues. Complex multives- ments in technology – we will candidates for surgery through sised that a shortage of cardio- Irving Kron Wolverhampton, UK, said, “In sel disease with a high Syntax increasingly see mechanical having better outcomes. So thoracic surgeons could have a basis of a projection of future the UK our more aggressive score requiring multiple stents devices for the treatment of 30% of 25% of all patients with serious impact in the future, supply and demand for cardio- approach to patients presenting is still likely to come into the heart failure (including the coronary artery disease needing causing patients to suffer. thoracic surgeons. with acute coronary syndromes surgical domain for the foresee- possibility of a totally revascularisation are still candi- Despite a rise in the use of new The results of the study pro- has resulted in older patients able future because of the implantable artificial heart) dates for surgery. Taking interventional technologies jected that, by 2025, the being considered for revascu- increased need for further over the next few years.” account of the likely expansion such as angioplasty, and a drop demand for cardiothoracic sur- larisation, along with their co- revascularisation in this group.” Although cardiothoracic sur- of transcatheter aortic valve in coronary artery bypass graft geons could increase by 46% if morbidities and increased sur- gery will have a place over the implantation, it is true that the (CABG) procedures, Kron and current healthcare use and gical risk. Scrutiny and Valve replacement impact next 10 to 15 years, the future need for cardiac surgeons will colleagues argue that surgical service delivery patterns con- publication of surgical out- Norell added that, in terms is not bright, said Bernardo fall and, if patients are receiv- intervention is often still need- tinue. However, the results comes prompted fears that sur- of valve disease, professionals Cortese, interventional cardiol- ing an equivalent less invasive ed after angioplasty.“Many also showed that supply is pro- geons might become risk are yet to see to what extent ogy, Cardiovascular procedure then this is appropri- people have recurrence, and a jected to decrease by 21% over averse, but recent UK data sug- transcatheter interventions will Department, Misericordia ate, after all, surgery for tuber- significant number of patients the same time period. gest that this might not be as replace traditional surgery. “It Hospital, Italy. “The shortage culosis, for gastric ulcers and still need coronary bypass and These findings led the inves- prevalent as initially thought. is probably too early to make of cardiac surgeons will be pro- tonsillectomy/adenoidectomy certainly other cardiac surgical tigators to conclude that the “As life expectancy increas- accurate predictions about gressive but not so fast. If it is have all fallen by the wayside.” operations”, Kron said. disparity between the projected es, patients initially managed future surgical manpower true that many interventional Gershlick said, however, The study was conducted future demand for, and supply percutaneously may still find needs but at the same time an cardiologists, helped by manu- that it is clear that there is through analysis of population, of, cardiothoracic surgeons their way to surgery eventually acceptance of the need for evo- facturers, are making great likely to be a continuing need physician office, hospital, and will lead to a shortage in the as either restenosis or native lution is necessary in all spe- progress for the treatment of for cardiac surgery and car- physician data sets to estimate US of cardiothoracic surgeons disease progression catches up cialties. Close surgical what only a few years ago was diac surgeons to provide the current patterns of healthcare within the next 10 years. with them. The results of the involvement in catheter-based a surgeon’s job, it is obvious same high quality of care as use and delivery. A simulation Furthermore, if non-board-cer- SYNTAX (Synergy between aortic and mitral procedures how the vast majority of they do currently. “To my model was used to form the tified physicians expand their PCI with Taxus and cardiac sur- will be valuable, as will their European or US hospitals will mind it is all about planning. application to other forms of need many years before using There should not be too many major vascular interventions. such high-level technologies. surgeons doing too few proce- The skills required to under- However, it is hard to predict dures nor too many. The prob- take surgical procedures are exactly what will happen. Italy lem is that it takes a great very different from those used performs the second highest many years to train a surgeon in the catheter lab, so changing number of interventional cardi- and this makes planning diffi- horses (as it were) is probably ology procedures in Europe, cult although cross practices the least practical option.” therefore I would say that Italy throughout Europe may make Leslie Hamilton, president, will face the same situation as this easier. Projecting num- Society for Cardiothoracic the US. In Italy we have too bers (conservatively) for the Surgery in Great Britain and many cath labs nowadays. I medium- and longer-term may Ireland, UK, said, “Manpower think they will not increase in be the best that can be done planning is notoriously diffi- number in the near future, but with resulting calculations, cult in a high-tech speciality they share a good average tech- perhaps suggesting a concen- like cardiac surgery, not only nology. Although I am not tration of surgeons in supra- Michael Norell Leslie Hamilton Bernardo Cortese because of the eight to 10 aware of any data around this regional centres.” “Coronary surgery is here to stay” MARK DE BELDER, presi- Several trials have been per- coronary surgery is here to although slowed, has not dent of the British formed to look at the relative stay. In the UK, we have not reached a plateau. We need to Cardiovascular Intervention pros and cons of each tech- seen a major drop in the rates encourage excellent trainees Society, UK, said, “A few nique and although we can do of coronary surgery. Moreover, to come into the intervention- years ago, there was a scare more with intervention that we as other commentators have al cardiology and cardiotho- among the cardiothoracic sur- could do in the past, any shift pointed out, there are many racic surgical specialties, but gical profession that they towards intervention has been other conditions requiring car- they must keep an eye on the would soon be out of business balanced by an increase in the diac surgery and innovations job prospects. Training for because of the rise in percuta- rate of investigation of patients will continue to fuel the need posts that will not exist will neous interventions. Some with coronary disease and a for surgical talents. lead to disappointment and have inappropriately pitted growing readiness to treat “Fear has been expressed we must try and avoid the Mark de Belder Anthony Gershlick coronary intervention against high-risk and elderly patients recently that we are over-pro- mismatch that occurred, for cardiac surgery whereas, in with both techniques. ducing interventional cardiol- example, in obstetrics and a specialty because of an ing, that is a more serious reality, both revascularisation Although new treatments will ogists in the UK, but the gynaecology a few years ago. erroneous forecast that the problem. Getting the balance techniques go hand-in-hand. emerge, the bottom line is that growth in clinical activity, But if trainees elect to avoid specialty is slowly disappear- right is a major challenge.”

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for those with heart disease. Hospital of South Manchester. The analysis – published by John Black, president of the Cardiac surgery sees the SCTS and Dendrite Royal College of Surgeons Clinical Systems – gives a said, “This new report proves complete breakdown of how that open reporting works if dramatic improvement since cardiac surgery is developing well funded and led by the cli- and highlights areas for future nicians. All branches of sur- improvement including gery are following the trail on mortality data publication unequal access to cardiac sur- reporting outcomes that car- gery across the UK. For exam- diac surgeons have blazed and Outcomes for adult cardiac patients have improved dramatically over the past five ple, while mortality rates this should spur those efforts years even as more elderly and high-risk patients are now being treated. These are across the board are improving on. All of medicine should the findings of a comprehensive new study of over 400,000 operations from the Ben Bridgewater there remains a persistent gap take note of the findings that Society for Cardiothoracic Surgery of Great Britain and Ireland published in July between the sexes with sur- full audit has not resulted in increased from less than vival rates significantly worse risk-averse behaviour.” THE RESULTS prompt the been considered too sick to patients were over 75 and 60% of cases to nearly 75%. for women than for men. Roger Boyle, Department Royal College of Surgeons of undergo an operation just five 5% over 80 years old. The
Re-do operations (for bleed- With mortality rates so low, of Health’s National Director England to urge all surgical years ago are now routinely average age of aortic valve ing or deep sternal wound surgeons are now looking at for Heart Disease and Stroke, specialties to follow the lead treated and doing well. replacement patients has infection) are rare and get- extending outcome reporting said: “We welcome this report as soon as possible. The report The findings provide com- increased from 61 in 1994 ting rarer. The re-do rate for to other areas which impact which shows that cardiac sur- Demonstrating Quality: The pelling evidence that, since to 68 in 2008. bleeding fell from 3.8 to on recovery time and quality- gery continues to lead the way Sixth National Adult Cardiac national publication of mortali-
More diabetic, high blood 3.2% between 2004 and of-life such as bleeding rates, in outcome measurement in Surgical Database Report, con- ty rates in cardiac surgery pressure and overweight or 2008 and for infection from post-operative stroke, kidney the UK. This report provides clusively proves wrong critics began in 2001, the quality of obese patients are having 0.8% to 0.6% over the same failure and the need to re-do invaluable information not who suggested that publishing care for patients has improved. cardiac surgery, all known period and the time between operations. just in terms of the numbers of mortality data would lead to
Mortality rates for coronary risk factors, yet overall first and second operations “One of the benefits we are people who have benefited but risk-averse behaviour from artery surgery have fallen by operation mortality rates is increasing, indicating that now seeing from public also tells us about improve- surgeons, with the most sick 21% and for isolated valves continue to fall. the grafts are lasting longer. reporting of outcomes is not ments in the effectiveness of and elderly patients being by a third. For elective sur-
Between 2001 and 2008
More than twice as many just about bringing poor per- treatment, patient safety and turned down for surgery for gery in the under-70s, mor- there has been a 50% people are now having aor- formers ‘into the pack’ but patient experience. I am par- fear of blotting statistics. In tality rate for coronary increase in the proportion of tic valve replacement and improving the performance of ticularly pleased that the evi- practice, the opposite has artery surgery is now less coronary surgery patients mitral valve operation. Both the pack as a whole. The very dence shows we are treating turned out to be true – the than 1%. who are diabetic. these procedures are more act of auditing services brings more people successfully in increase in reliable data has
The proportion of elderly
Between 2001 and 2008 the commonly required for about improvements as cen- older age. This report provides emboldened surgeons to take patients being seen for sur- proportion of coronary more elderly patients and tres learn from one another,” an example of how services on more complicated cases. gery has increased. One in patients with hypertension this increase reflects the said report author, Ben can put quality at the heart of More people who would have five coronary artery bypass (high blood pressure) has increasing life expectancy Bridgewater, University everything they do.

New treatment for management of LDL-C, Nearly half of statin-treated HDL-C and triglycerides is launched patients not currently TREDAPTIVE (nicotinic acid/laropiprant) 1000mg/20mg (two reaching LDL-C target tablets once daily maintenance dose), from Merck Sharp & Dhome, ALMOST HALF (48%) of statin- cardiovascular disease, achieved has been launched in the UK. It is treated patients are not meeting tar- through improved adherence, indicated for patients with combined get levels of LDL-C, according to lifestyle changes, or further drug mixed dyslipidaemia or primary the results of a new international intervention.” hypercholesterolaemia and should be study, conducted by Merck Sharp & In conjunction with the release of used in combination with a statin Dohme and presented at the the DYSIS data, MSD UK when the cholesterol lowering effect European Society of Cardiology announced findings from a UK-wide of statin monotherapy is inadequate, Congress in Barcelona, Spain. survey of over 2,000 people. or as monotherapy when statins are Additionally, nearly three-quarters According to the survey, the majority considered inappropriate or are not (73%) of the same patients had at of people (85%) in the UK now tolerated. Diet and other non-phar- least one lipid abnormality across know that cardiovascular disease is macological treatments, such as LDL-C, HDL-C and triglyceride the leading cause of death in the UK exercise and weight loss, should Marc Evans Ian Young levels. In a separate UK survey, and many are aware of LDL-C continue during therapy. results have also shown a need for (‘bad’ cholesterol) and HDL-C In clinical studies, 2,548 patients improving education of the public (‘good’ cholesterol) (71% and 59% have been randomised to treatment the drug reported no or mild flushing patients (10.2% vs. 22.2%, respec- around how to proactively manage respectively). Despite this wide with nicotinic acid/laropiprant (69%) versus 44% taking extended tively; p<0.001). their lipid levels. awareness, many did not know “how (1000mg/20mg or 2000mg/40mg) release nicotinic acid (ERN) Tredaptive contains 1000mg of The DYSlipidemia International to change” their LDL-C (57%) or for up to 52 weeks. In an efficacy (n=529). Tredaptive produced signif- nicotinic acid and 20mg of Study (DYSIS) was a large study HDL-C (74%). Furthermore, only study, treatment with the drug with icantly (p<0.001) lower percentages laropiprant in each tablet. The start- involving 22,000 statin-treated around one third (36%) had heard of or without a statin (n=696) has been of patients than ERN with moderate ing dose is one tablet once a day. patients, extending across 12 coun- triglycerides, with most (77%) think- shown to lower LDL-C levels by or greater flushing (31% versus After four weeks, it is recommended tries in Europe and Canada. 28 cen- ing triglycerides should be raised 18% and triglycerides by 26% and to 56%) and severe or greater flushing that patients be advanced to the tres were involved from the UK. rather than reduced and 90% not raise HDL-C levels by 20% (placebo (14% vs. 33%). Beyond week 6, maintenance dose of 2000mg/40mg The results showed that even in knowing how to change them. adjusted) for a 24-week period. patients in the ERN group continued taken as two tablets once daily. those patients reaching their LDL-C Marc Evans, consultant diabetolo- Marc Evans, consultant diabetolo- to experience a level of moderate, Ian Young, professor of medicine, target, 25% still had abnormal lev- gist at Llandough Hospital, UK, gist, Llandough, UK, commented severe or extreme flushing compara- Queen’s University Belfast, UK, els of triglycerides and/or HDL-C. commented: “DYSIS highlights that “Tredaptive can lower LDL-C and ble to that observed at week 6, while commented: “There is a wealth of Additionally, 38% of the study pop- a significant cardiovascular disease triglycerides levels and increase in the Tredaptive group, the flushing evidence supporting the benefit of ulation had elevated triglyceride risk can remain for some patients.” HDL-C levels by roughly 20%, ‘a signal gradually subsided to a level nicotinic acid on both atherosclero- levels, and 26% had HDL-C levels He continued: “A comprehensive rule of 20s’. Having a new treatment that approximated placebo. This sis and cardiovascular outcomes. below target. approach that addresses HDL-C and option that can address the wider reduction in flushing has led to However, its use has been limited by “Although statins have represent- triglycerides as well as LDL-C lev- lipid profile is welcomed and will be patients on Tredaptive being less its tolerability issues, which, along ed a considerable advancement in els may be beneficial in these cases. particularly useful for secondary pre- likely to discontinue treatment due with a complicated titration regime, cardiovascular disease prevention, This can be particularly important vention patients and those patients to flushing compared to ERN treated have been a barrier to achieving the DYSIS results indicate that cli- for patients who are at high risk of with dyslipidaemia at ‘high risk’.” optimum therapeutic doses in some nicians must continue to monitor cardiovascular disease such as sec- Nicotinic acid has been widely patients. The significant reduction in their patients’ lipid levels closely, ondary prevention patients, people recognised as an effective lipid- flushing with Tredaptive and its sim- including LDL-C, HDL-C and with diabetes and South Asian popu- modifying therapy for over 50 years, ple two step titration may help triglyceride levels,” said David lations. The UK survey of the gener- but its use has been limited due to a patients reach and continue with the Wood, lead UK investigator, al public also highlighted the need flushing side-effect. The laropiprant therapeutic maintenance dose of Imperial College London. He con- for educating people about the three component in Tredaptive is an anti- nicotinic acid, helping to give them tinued: “Many patients could bene- lipids – this is essential if we want flushing agent. During week 1, the the treatment's optimum benefit fit from additional management in the public to become engaged in majority of the 781 patients taking across the lipid profile.” order to further reduce their risk of their own health.”

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8 Cardiovascular News International Issue 15 September 2009 Clearer guidance on fat Experts to develop new prevention guidelines consumption is needed CARDIOVASCULAR DISEASE remains the commonest cause of dis- MANY PEOPLE are confused “The International Expert tributing significantly to reducing ability and death in the UK. about the health consequences of Meeting provided us with the the population risk of cardiovascu- Substantial progress has been made fats consumed, according to recent opportunity to draw from recent lar disease by making simple over the last few years in establish- reports published in the Annals of international scientific consensus dietary changes like exchanging ing evidence based guidelines and a Nutrition and Metabolism. and agree on guidelines for an opti- full-fat dairy products with low-fat National Framework for cardiovas- Fat is not usually considered by mal fat quality of the diet on the one choices, fatty meats with lean meats cular risk reduction. In particular, the many to be part of a healthy, bal- hand and an actionable approach to and fish, and the use of vegetable publication of the Joint British anced diet and many people do not disseminating recommendations on rather than saturated animal fats in Societies (JBS) first and seconds know that some fats are beneficial, the other,” said Ricardo Uauy, food preparation and food products. reports have established the impor- even essential. As a result, on the chairman of the International Expert They also recommended providing tance of making decisions based on whole, the quality of fats consumed Meeting in Barcelona and president people with important information global cardiovascular risk rather is not in line with current recom- of the International Union of on the nutrient content of food prod- than treating risk factors in isolation. mendations. To combat this, experts Nutritional Sciences. ucts on pack in a clear, usable, Up to date recommendations on suggest making simple dietary understandable way, including ener- cardiovascular risk management are changes, such as replacing full-fat gy content per portion size and fat being developed as part of the third dairy and meat products with quality, and using simple lan- JBS collaboration. These will take lean choices, and using guage when communicat- account of the results of important fats and oils of veg- ing with the public, and large scale trials, which indicate John Deanfield etable origin using consistent, benefit for both more aggressive and rather than of scientific and broader risk factor lowering. not only representatives of the key consuming fat of coherent language Decisions based on absolute cardio- professional societies but also those animal origin. when communi- vascular risk over 10 years often of the Department of Health and the The series of cating with health leads to treatment being started late National Institute for Health and papers include experts. in the evolution of arterial disease. Clinical Excellence (NICE). data presented by The emphasis on Furthermore, evidence is accumulat- According to Deanfield, this will 40 of the world’s clear and easy-to- ing that further benefit can be ensure an integrated approach, leaders in diet, nutri- follow guidance to the achieved through earlier interven- which can be rapidly translated into tion and health from 25 public was considered tion, in many cases. A major new clinical practice and these exciting countries. The meeting, enti- vital as was encouraging sci- development of the JBS3 recom- new proposals will be published in tled “Health Significance of Fat entists, healthcare professionals, mendations will therefore be the the next 18 months. Quality of the Diet”, which was governments, food industry, health provision of guidelines for lifetime “A greater focus on prevention held in Barcelona, Spain, earlier this authorities and media around the risk factor management, emphasis- should build upon the great strides year, examined existing recommen- The key output of the world to work together to make sure ing the importance of prevention. already made to reduce further the dations and guidelines on fats in International Expert Meeting was a that their advice is not only heard The JBS3 expert group, to be clinical impact of cardiovascular order to update the knowledge on statement which summarised the by the audience but also followed, chaired by John Deanfield, includes disease in the UK,” said Deanfield. health implications of the fat quality findings of the discussions and in helping people across the globe to of the diet; the role of high-quality which the experts with input from prevent chronic disease and to Previous reports fat sources in contributing to other stakeholders such as health achieve optimal health. Joint British recommendations on prevention of coronary heart achieving an optimal fat quality of and communication professionals The international event was the disease in clinical practice. British Cardiac Society, British the diet; consumer perception and and the food industry, called for first step of a global campaign to Hyperlipidaemia Association, British Hypertension Society, endorsed insights on fats and fatty acids in concerted actions at all levels to help consumers to make healthier by the British Diabetic Association: Heart 1998; 80 Suppl 2:S1-29. order to analyse what consumers guide consumers in making healthi- choices about their fat intake and actually know about fats and health, er choices with respect to the fat was followed by approximately 20 JBS 2: Joint British Societies’ guidelines on prevention of and current actual versus quality of the diet. The recommen- events worldwide where the mes- cardiovascular disease in clinical practice: Heart 2005; 91 Suppl (inter)national recommended intake dations included improving fat com- sages of the International Expert 5:v1-52. of fats and fatty acids. position of the diet and thereby con- Meeting were disseminated.

three surveys (20%, 21% and 18%, respec- 20.1% and 28%. The use of cardioprotective tively) despite increasing availability of new medication increased across all classes: Secondary prevention of and effective treatments to help patients stop aspirin or platelet-active drugs 81%, 84%, smoking. The prevalence of obesity (BMI and 93%; betablockers 56%, 69% and 86% ; ≥30kg/m2) continued to increase dramatically ACE inhibitors/AT2 receptor blockers 31%, cardiovascular disease in Europe: between the first and third survey (25%, 33% 49% and 74%, and lipid-lowering drugs 32%, and 38% respectively), with a corresponding 63% and 89%. Prescribing pills is not sufficient increase in central obesity. These adverse Yet it is clear from these time trends that trends in body weight and distribution, drug therapies are simply not sufficient. reflecting the same trends in the general pop- Preventive cardiology care needs a systematic, ulation, contribute to a worsening of other comprehensive, multidisciplinary approach, risk factors such as raised blood pressure, which addresses lifestyle and risk factor man- KORNELIA KOTSEVA dyslipidaemia and diabetes. agement by cardiologists, other specialists, Blood pressure management showed no general practitioners, nurses and other allied improvement with nearly three fifths (58%, health professionals, and a health care system 58% and 61%) of patients still having blood which invests in prevention. Saving people’s COMMENT & ANALYSIS pressure above the recommended target lives from acute heart attacks is not sufficient, (<140/90mmHg, <130/80mmHg in patients and an urgent investment in prevention is CARDIOVASCULAR DISEASE, of which The Netherlands and Slovenia. A total of with diabetes). This failure to improve man- needed to address the lifestyle causes of heart coronary heart disease is the most common, is 8,547 patients with coronary heart disease agement of blood pressure is despite the large disease. “To salvage the acutely ischaemic the major cause of death in adults in most were interviewed and examined at least six increase in prescriptions for anti-hypertensive myocardium without addressing the underly- European countries1. However, risk factor months after their coronary event or proce- medications. Therapeutic control of blood ing causes of the disease is futile; we need to management in patients with coronary heart dure. pressure remained unchanged, with only two invest in prevention.”2 disease in Europe is far from optimal. The The EUROASPIRE surveys give a unique fifths of patients on blood pressure lowering References results of EUROASPIRE (European Action European picture of preventive cardiology as medication achieving the blood pressure goal [1] Graham I, Atar D, Borch-Johnsen K, et al. European on Secondary Prevention through practiced by cardiologists, other specialists in the third survey. Guidelines on Cardiovascular Disease Prevention in Clinical Practice: Fourth Joint Task Force of the European Society of Intervention to Reduce Events) surveys, car- and primary care physicians looking after In contrast, the management of total cho- Cardiology and Other Societies on Cardiovascular Disease Prevention in Clinical Prevention in Clinical Practice. Eur J ried out by the European Society of patients with coronary disease. The compari- lesterol improved dramatically driven by the Cardiovasc Prev Rehabil 2007; 14 (Suppl 2): S1-S113. Cardiology in 1995–1996, 1999–2000 and son between the three surveys demonstrates a widespread use of statins. The prevalence of [2] Kotseva K, Wood D, De Backer G, De Bacquer D,Pyorala K, Keil U, on behalf of EUROASPIRE study Group 2006–2007, showed that integration of car- compelling need for more effective lifestyle elevated total cholesterol (≥4.5mmol/l) had Cardiovascular prevention guidelines - the clinical reality: a diovascular disease prevention into daily clin- management of coronary patients. Adverse decreased substantially: 95%, 77% and 46%. comparison of EUROASPIRE I, II and III surveys in 8 European countries. Lancet 2009; 372: 929-40 ical practice is inadequate2.EUROASPIREI, trends in smoking prevalence in younger However, nearly two fifths of patients on II, and III surveys were conducted in the women and the alarming increase in obesity, lipid-lowering medication in the third survey Kornelia Kotseva is a senior clinical research same geographical areas and hospitals in central obesity and diabetes are an increasing had not reached the total cholesterol goal. fellow, consultant cardiologist, Cardiovascular eight European countries – Czech Republic, cause for concern. The overall prevalence of The prevalence of self reported diabetes Medicine, National Heart & Lung Institute, Finland, France, Germany, Hungary, Italy, smoking was virtually unchanged over the mellitus increased across the surveys, 17.4%, Imperial College London, UK.

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10 Cardiovascular News International Issue 15 September 2009

Study shows high early Smaller catheters may be better readmission rates after PCI SMALLER CATHETERS may lead er likelihood of in-hospital myocar- A STUDY LED BY researchers 30-day mortality among readmit- to better outcomes, according to the dial infarction, death, and major from the Yale University School ted patients was higher than findings of a recent study led by P adverse cardiac events. of Medicine, New Haven, US, patients who were not readmitted Michael Grossman, University of Grossman and colleagues note that showed that one in every seven (3.6% vs. 0.6%; p< 0.001). The Michigan Hospitals and Health both the device industry and clinicians patients who undergo percuta- 30-day readmission rate of acute System, Ann Arbor, US. have shown an increasing preference neous coronary intervention (PCI) myocardial infarction (AMI) The association between guiding for smaller size catheters over the past is readmitted in hospital within 30 patients was significantly higher catheter size and complications of several years. Nevertheless, as shown days after the procedure. The than that of non-AMI patients percutaneous coronary intervention in the study, a sizeable number of results, published in the 1 (AMI 17.5%, non-AMI 13.6%, (PCI) in contemporary practice interventionalists still use larger size September issue of the Journal of p<0.001). Among all patients read- remains controversial. The study find- catheters “based on perceived better the American College of mitted within 30 days after the ings appear in the July issue of JACC: support and ease of use, and to provide Cardiology, also suggest that index percutaneous coronary inter- Cardiovascular Interventions. more options to treat complex or bifur- these patients are six times more vention, 27.5% had an associated During the study, data were collect- cation lesions and to use atheroablative likely to die. revascularisation procedure (PCI ed from 103,070 consecutive patients Michael Grossman devices,” they wrote. In addition, some The purpose of the study, led 25.8%, coronary artery bypass who underwent PCI at 21 institutions interventional textbooks recommend by Jeptha P Curtis, assistant pro- grafting 1.7%). The median read- in the Blue Cross Blue Shield of PCI for a restenotic lesion, while a larger guide catheters. fessor of Medicine, was to report mission rates varied across hospi- Michigan Cardiovascular Consortium larger percentage of 7F and 8F patients In contrast, the researchers con- on the all-cause readmission and tals, from 8.9% in the lowest between January 2001 and December had cardiogenic shock or received clude, “The data from this study sug- repeat revascularisation rates after decile to 22% in the highest decile. 2006. Outcomes were evaluated multivessel PCI compared with gest that the use of smaller guiding percutaneous coronary interven- “A substantial proportion of according to guide catheter size: 6F, patients in the 6F group. In unadjusted catheters during PCI is associated tion. The team conducted a retro- PCI patients are readmitted with- 7F, or 8F. data, rates of contrast induced with significantly better outcome, spective analysis of a cohort of in 30 days of discharge, and read- The data showed that procedures nephropathy (CIN) increased incre- including improved post-procedural Medicare fee-for-service admis- mission rates vary widely across using larger size guide catheters (7F mentally with catheter size (6F 3.39%, morbidity and reduced mortality.” sions associated with a percuta- hospitals,” the authors wrote. The and 8F) are associated with a broad 7F 4.38%, 8F 6.21%; p<0.0001 across “The key finding of this study”, neous coronary intervention in study concluded that readmis- array of adverse events – ranging groups). The same was true for vascu- Grossman said, “were that, compared 2005. Primary outcomes were 30- sions within 30 days of an index from renal dysfunction and vascular lar complications: 2.35%, 2.69%, and to smaller sized guide catheters, coro- day all-cause readmission rates percutaneous coronary interven- complications to myocardial infarc- 3.85%, in the 6F, 7F, and 8F groups, nary interventions performed with and 30-day readmission rates tion procedure were associated tions and in-hospital mortality – com- respectively (p<0.0001). Other in-hos- larger guide catheters were associated associated with a revascularisa- with a significantly higher 30- pared with those using smaller size pital outcomes, including infarction, with more post-procedure nephropa- tion procedure. day mortality rate, and more than catheters (6F). stroke, death, and major adverse car- thy, vascular complications, greater A total of 315,241 percutaneous one-quarter of such readmissions Overall, procedure volume diac events, followed the same pattern. drop in hemoglobin, and need for post- coronary intervention procedures resulted in a repeat revascularisa- decreased with increasing catheter After multivariable adjustment, 7F PCI transfusion and with greater performed at 1,108 hospitals were tion procedure. “These findings size: 6F: 64,335 PCI procedures; 7F: and 8F catheters were still associated adjusted incidence of post-PCI included in the analysis. The all- warrant further attention to deter- 32,676; and 8F: 6,059. More patients with increased risk of CIN and vascu- nephropathy requiring dialysis, infarc- cause 30-day readmission rate was mine whether these readmissions in the 7F group had acute or recent lar complications, while only 8F tion, bypass surgery, death and major 14.6%, and the all-cause 30-day are preventable,” the investiga- myocardial infarction or underwent catheters were associated with a high- adverse cardiac events. mortality rate was 1%. All-cause tors wrote.

(Drug-eluting?) Coronary stenting in Triple therapy (ASA, clopidogrel and VKAs) & major bleeding @ ≥12 months (average 9.3) 25 patients on chronic oral anticoagulation @ 30 days @ 6 months (average 6%) (average 13.3%) } 21 } ANDREA RUBBOLI 20 }

15 14.9 15 14 COMMENT & ANALYSIS 12.5 TRIPLE THERAPY OF ASPIRIN, clopidogrel eluting, stents is currently recommended in the and oral anticoagulation with vitamin K antago- light of the short (one month) need for clopido- 10 nists (VKA) is the most effective antithrombotic grel (and accordingly, triple) therapy. Certainly, treatment after percutaneous coronary interven- such strategy may prove much less than optimal 6.6 6.6 tion with stent implantation (PCI-S) to prevent in situations where the occurrence of restenosis 4.7 both stent thrombosis and thromboembolism is higher (ie, long lesions and/or small vessels, 5 relataed to the clinical condition for which diabetic patients, etc) or troublesome (ie, last 3.1 VKAs are indicated. Available data, however, remain vessel). The availability of drug-eluting 1.7 suggest that triple therapy is associated with a stents which allow a shorter duration of clopido- 0 relevant incidence of major bleeding, which may grel treatment therefore, is more than welcome. 0 Orford JL Lip GYH Rubboli Mattichak DeEugenio Mattichak Khurram Porter A Karjalainen Ruiz- Rogacka occur up to three to five times more frequently Optima (CID Vascular) is a polymer-free, et al & Karpha A et al. SJ et al. D et al. SJ et al. Z et al. et al. PP et al. Nodar JM R et al. than with dual antiplatelet treatment. Moreover, Carbofilm coated stent eluting Tacrolimus from (2004) M (2006) (2007) (2005) (2007) (2005) (2006) (2006) (2007) et (2008) (2008) an increasing incidence of major haemorrhages abluminal reservoirs, which has been widely has been reported as triple therapy prolongs: tested in patients with either stable or unstable Multicenter Registry with Antiplatelet Treatment two-six whereas an average 6% of major bleeding has coronary artery disease showing an excellent been observed at one month, as much as about safety and efficacy profile. Of note, post-hoc months (MATRIX) 10% has been reported at six and 12 months or analyses of the clinical studies carried out with Freedom from death-MI (%) Reported dual antiplatelet more (Figure 1). Since major haemorrhagic Optima showed the efficacy of a clopidogrel therapy complications after an acute coronary syndrome duration as short as two months, which had been Freedom from death-MI (%) 100% unfavourably impact on prognosis, meticulous carried out in about 30 to 50% of patients. The care needs to be paid in preventing such events. subsequent Multicenter registry with 95% 1 35% This is especially true after percutaneous coro- Antiplatelet Treatment two-sIX months 90% = 2m DAT nary intervention with stent implantation, when (MATRIX), in which more than 500 patients 85% 65% (even minor) bleeding may lead to premature were prospectively enrolled, confirmed the safe- > 2m DAT discontinuation of aspirin and/or clopidogrel, ty and efficacy of a two-month only dual 80% which in turn exposes patients to a potentially antiplatelet treatment regime (Figure 2). This 75% catastrophic event as stent thrombosis. Of note, device, which is now being tested in another 70% prophylactic administration of proton pump prospective, multicentre registry named = 2 months 65% inhibitors in the attempt to reduce the risk of Ongoing WARfarin and coronary STENTing > 2 months Acute, Sub-acute and late gastrointestinal bleeding appears not applicable (WAR-STENT)-Optima, where patients on 60% thrombosis 3 6 9 as a routine, because of the several recent reports chronic VKAs undergoing PCI-S are enrolled, 0 12 15 Acute Thrombosis 0.2% FUP (months) suggesting a negative interaction between these may prove the drug-eluting stent of choice in Sub-acute Thrombosis 0% agents and clopidogrel. this increasingly large and fragile patient subset. F-up = 2 Months Pts > 2 Months Pts Late Thrombosis 0% 30 days 97.71% (97.71 - 99.14) 171 99.69% (99.69 - 99.96) 324 Therefore, in patients on chronic VKAs Andrea Rubboli, Cardiac Catheterization 6 months 97.71% (97.71 - 99.14) 147 97.47% (97.47 - 98.73) 251 Interim analysis:12-month data presented at undergoing percutaneous coronary intervention Laboratory, Division of Cardiology, Ospedale 12 months 96.94% (96.94 - 98.73) 95 97.02% (97.02 - 98.45) 146 GISE08/TCT08/JIM09 the implantation of bare metal, rather than drug- Maggiore, Bologna, Italy

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12 Cardiovascular News International Issue 15 September 2009 Blood test that measures omega-3 predicts heart disease A NEW BLOOD TEST, measuring Harris has published over 80 sci- the level of omega-3 fatty acids in entific articles on omega-3, includ- red blood cells, is now available as a ing his ground-breaking study, pub- consumer-friendly, “finger stick” test lished in Preventive Medicine (Vol. that can be used at home. While sci- 39, 2004) with co-author Clemens entists have long known of the bene- von Schacky, a cardiologist from fits of fish and fish oil for overall Munich, Germany, which first pro- heart health, over the past decade posed the Omega-3 Index as a car- research has proven that the omega-3 diovascular risk factor. fatty acids found in fish dramatically The Gene Smart Omega-3 Index reduce one’s risk for cardiovascular uses Harris’s proprietary HS-Omega- disease. Furthermore, recent research 3 Index methodology – the same indicates that omega-3 levels may be methodology used in the clinical among the best predictors of future studies that validated the correlation coronary heart disease, providing between the Omega-3 Index and much stronger correlations to the heart disease risk. The science behind risk of sudden cardiac death than tra- the Index has been tested and validat- ditional indicators, including HDL Floyd Chilton ed by data from numerous large-scale tis. This is of concern because maintained a ratio closer to 2:1. and LDL cholesterol. human clinical studies, including the omega-3s tend to be anti-inflamma- “The best news in all of this is The Gene Smart Omega-3 Index highly-regarded Physicians’ Health tory and cardioprotective, while con- that a low Omega-3 Index is an eas- measures the amount of eicosapen- measure omega-3 levels.” Study (PHS), which involved 14,916 suming too many omega-6 fats can ily modifiable risk factor,” added taenoic acid (EPA) and docosa- However, very recent studies sug- healthy male physicians. lead to an overproduction of inflam- Chilton. “By simply eating more hexaenoic acid (DHA) omega-3 fatty gest that individuals have varying “The strength of the association matory messengers. oily fish like salmon and albacore acids in red blood cell membranes capacities to metabolise omega-3s. between omega-3s and heart disease Chilton’s latest research in nutri- tuna, or taking a quality omega-3 and is expressed as the per cent of “So even if a person eats fish or is really quite remarkable,” said ent/gene interactions, published in supplement with the right levels of total fatty acids. The results of the takes fish oil supplements, they may Harris. “And the benefits of having the Journal of Biological Chemistry EPA and DHA, anyone can improve test are represented as a score that a not be getting enough,” Chilton a high Omega-3 Index, in the 8 to (5 June 2009), demonstrated that their Omega-3 Index score which significant body of research indicates added. “It is important to measure 10% range, speak for themselves. shifting ratios of omega-6 to omega- research suggests will reduce their may be an independent predictor of omega-3 levels within the body, so Individuals with a high Index have 3 from greater than 15:1 to less than risk of heart disease – the number heart disease – with a score of 4% or individuals can determine whether a decrease in the relative risk for 5:1 in humans can positively influ- one killer of men and women in this less indicating a high risk, and a their dietary intake of this important sudden cardiac death by as much as ence genes that provide protection country (US).” score of 8% or more indicating a rel- nutrient needs to be adjusted.” 90%.” against allergies and other inflam- The Gene Smart Omega-3 Index atively low risk. In introducing the Gene Smart In addition to measuring the matory diseases. According to test is now available through Gene “The research suggests that the Omega-3 Index, Gene Smart has amount of omega-3s in the blood- Chilton, the increased omega-6 fatty Smart Wellness at levels of omega-3 fatty acids should partnered with a pioneer of omega-3 stream, the new Gene Smart blood acids in the typical US diet is due in www.genesmart.com as a convenient, be routinely measured, especially in research and cardiovascular disease, test provides a measure of a person’s large part to the industrialisation of at-home “finger stick” kit which is vulnerable populations such as William S Harris, a professor in the omega-6 to omega-3 ratio. Leading our food supply and increased con- sent by the user to a lab for a compre- those at risk of cardiovascular and Department of Internal Medicine and experts believe that the marked shift sumption of omega-6 rich foods hensive analysis. Research suggests inflammatory diseases,” said Floyd Basic Biomedical Sciences at the in omega-6/omega-3 fatty acids in such as vegetable oils, salad oils, that the Gene Smart Omega-3 Index Chilton, a pioneer in inflammatory Sanford School of Medicine of the the Western diet over the past three margarine and fried foods. may be an independent risk factor disease and omega-3 research and a University of South Dakota and a co- generations has led to an overall Combined with a reduced consump- that is not influenced by other heart professor of physiology and phar- author on the American Heart increase in chronic whole body tion of omega-3 rich fish, this has disease risk factors like cholesterol or macology at Wake Forest Association’s (AHA) Scientific inflammation and a higher incidence resulted in omega-6/omega-3 ratios blood pressure. All risk factors, University School of Medicine. Advisory on Fish and Omega-3 Fatty of allergic and inflammatory disease often well in excess of 10:1. including the Omega-3 Index, should “This test is the most convenient, Acids published in Circulation (Vol. including cardiovascular disease, Anthropological evidence suggests be addressed as part of an overall affordable and effective way to 106:2002). asthma, allergies, diabetes and arthri- that our hunter-gatherer ancestors heart health risk reduction strategy. “No cause for concern in insulin drug trial” Heart disease risk may ACCUMULATING SAFETY years to date for a total expo- data from the large, interna- The ORIGIN trial sure of more than 50,000 per- come from little known tional ORIGIN trial have been The ORIGIN (Outcome Reduction with an Initial Glargine son-years. Data are collected reviewed by its independent Intervention) trial is sponsored by Sanofi-Aventis which related to all major serious type of cholesterol data monitoring committee, manufactures insulin glargine. The study involves health outcomes, including who have concluded that there patients from every continent and is co-ordinated by cancers. Accumulating data CHINESESCIENTISTS bat oxycholesterol’s effects. is no cause for concern regard- researchers at the Population Health Research Institute at are reviewed regularly by an presented one of the first “Total cholesterol, low- ing the use of insulin glargine McMaster University and Hamilton Health Sciences in Independent Data Monitoring studies suggesting that oxyc- density lipoprotein choles- (Lantus). Hamilton, Canada. The results are expected in 2011. Committee charged with holesterol may be the most terol (LDL), and the heart- This six-year study, which auditing the safety of the trial. serious cardiovascular health healthy high-density is lead by McMaster for concern. It also found no base analyses, it has generated In light of the questions raised threat of all. lipoprotein cholesterol University professors Hertzel reason to alter the design of questions about the safety of by the recent publication, this Health-conscious people (HDL) are still important Gerstein and Salim Yusuf of the study for safety reasons. glargine insulin. Such ques- committee of experts has know that high levels of health issues,” said study the Population Health “The ORIGIN investigators tions can best be answered by recently reviewed data related total cholesterol and LDL leader Zhen-Yu Chen, Research Institute, is deter- are reassured by the findings prospective, long-term follow- to cancers in both treatment cholesterol can increase the Chinese University of Hong mining whether insulin of the independent data com- up of large numbers of groups and has concluded that risk of heart attacks. Now Kong. “But the public should glargine and/or omega 3 fatty mittee,” said Gerstein. “We patients enrolled in ran- there is no cause for concern scientists are reporting that recognise that oxycholesterol acids can reduce cardiovascu- look forward to continuing domised trials of glargine ver- and no reason to alter the another form of cholesterol is also important and cannot lar events in 12,578 people this trial, which will provide sus other therapies.” design of the study for safety called oxycholesterol – vir- be ignored. Our work with elevated blood sugar lev- critical information regarding reasons. tually unknown to the public demonstrated that oxycholes- els from around the world. the effect of insulin glargine More than 12,500 patients The study is due to end in – may be the most serious terol boosts total cholesterol The data monitoring com- and omega 3 fatty acids on The ORIGIN trial ran- 2011, when detailed analyses threat. levels and promotes athero- mittee, headed by Rory important clinical outcomes.” domised more than 12,500 will be published. In the Scientists from China pre- sclerosis more than non-oxi- Collins, University of Oxford, Recently, the following people with dysglycemia to meantime, the data will con- sented one of the first studies dised cholesterol.” is auditing the trial for safety, statement about the concerns one injection of insulin tinue to be collected and on the cholesterol-boosting Fried and processed food, but did extra reviews recently was issued to the collaborating glargine per day versus usual audited for safety by this effects of oxycholesterol at particularly fast-food, con- after an article in Diabetologia researchers involved in the care. It is determining whether independent group. To main- the 238th National Meeting of tains high amounts of oxyc- in June suggested a connection study: “A recently published targeting normal fasting glu- tain a high-quality and unbi- the American Chemical holesterol. Avoiding these between use of insulin database analysis in cose levels with insulin ased study, researchers and Society. The researchers hope foods and eating a diet that glargine and cancer. Diabetologia suggested a link glargine reduces cardiovascu- the manufacturer of insulin their findings raise public is rich in antioxidants, such The committee reviewed between the use of glargine lar outcomes compared to glargine do not have access to awareness about oxycholes- as fresh fruits and vegeta- all data collected to date in insulin and cancer. Although standard management. data summarising outcomes terol, including foods with the bles, may help reduce its the two treatment groups and the results of this report were Participants have been fol- by treatment group until the highest levels of the substance levels in the body, the concluded there is no cause not confirmed in other data- lowed for an average of four study is over. and other foods that can com- researchers note.

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14 Cardiovascular News International Issue 15 September 2009 Pioneering research forms Death rate decreases following hospitalisation basis for first paediatric for heart attack A recent US study shows that, from 1995 to 2006, hospital 30-day hypertension guidelines death rates decreased significantly for patients hospitalised for a COMPREHENSIVE GUIDELINES myocardial infarction for the treatment and management FROM 1995 TO 2006, hospital 30- of hypertension in children and ado- day death rates decreased signifi- lescents have been published for the cantly for Medicare patients hospi- first time in the latest issue of the talised for a heart attack, as did the Journal of Hypertension. variation in the rate between hospi- Prepared by a task force estab- tals, according to a study in the 19 lished by the European Society of August 2009 issue of Journal of the Hypertension, the guidelines should American Medical Association. prove to be an invaluable source of “Over the last two decades, health information for physicians, nurses care professional, consumer, and and families. payer organizations have sought to “The necessity for the guidelines improve outcomes for patients hos- has become increasingly clear to pitalised with acute myocardial physicians in light of growing evi- infarction,” the authors wrote. dence that cases of mild hypertension However, little is known about from 14.6% to 10.1%. In contrast, in children and adolescents are much whether hospitals have been achiev- the 30-day mortality rate for all other more common than previously ing better short-term mortality rates conditions was 9% in 1995 and 8.6% thought. The progress made at patho- Empar Lurbe for infarction or if there has been a in 2006.” The risk-standardised mor- physiological and clinical research reduction in between-hospital varia- tality rate, which takes into account has made clear links between paedi- and adolescents. and makes recommendations for tion in short-term mortality rates, the differences in the types of atric hypertension and cardiovascular According to Lurbe, these guide- future research in the field. according to background informa- patients across hospitals and is cur- disease later in life, highlighting the lines primarily provide practical “The guidelines deal with medical tion in the article. rently being used by the Centers for need for improved cardiovascular strategies for diagnosing and treat- conditions in general and therefore Harlan M Krumholz, Yale Medicare and Medicaid Services to prevention strategies for pre-adult ing hypertension in children and their role must be educational and not University School of Medicine, New profile hospital performance, individuals,” said Empar Lurbe, adolescents. They include definition prescriptive or coercive for the man- Haven, US, and colleagues exam- decreased from 18.8% in 1995 to University of Valencia, Spain, who is and classification of hypertension; agement of individual patients who ined 30-day risk-standardised mor- 15.8% in 2006, and a reduction in head of the task force. “The publica- diagnostic evaluation; preventative may differ in their personal, medical tality rates for acute care hospitals in between-hospital differences in mor- tion of these guidelines will call measures; evidence for therapeutic and cultural characteristics, thus the US in the period between 1995 tality rates was also observed. attention to the burden of hyperten- management; therapeutic strategies requiring different decisions from the and 2006 for Medicare patients aged “Between 1995 and 2006, the sion in children and adolescents, and and approaches under special condi- average ones recommended by 65 years or older (average age 78), risk-standardised mortality rates for encourage public policy-makers to tions; treatment of associated risk guidelines. The new guidelines will who were hospitalised with myocar- patients admitted with infarction develop a global effort to improve factors; and screening for secondary prove vital in combating the growing dial infarction. The study included showed a marked and significant identification and treatment of high forms of hypertension. epidemic of cardiovascular disease in data on 3,195,672 discharges in decrease, as did between-hospital blood pressure among young people.” The importance of essential hyper- adults, by emphasising the need for 2,755,370 patients. The researchers variation. Although the cause of the The group has combined a consid- tension management in this age group preventative strategies to be imple- found that the all-cause and in-hospi- reduction cannot be determined erable amount of scientific data with is stressed and utility of out-of-office mented from an early age,” Lurbe tal death rates decreased over the with certainty, this finding may clinical experience in order to repre- blood pressure measurements in diag- said. “Action is required to address study period. They reported that “the reflect the success of the many indi- sent a consensus among specialists nosis, management and research is this problem in one of the most vul- 30-day mortality rate decreased from viduals and organisations dedicated involved in the detection and control pointed out. The task force suggests nerable and precious sectors of our 18.9% in 1995 to 16.1% in 2006, to improving care during this peri- of high blood pressure in children strategies for long-term follow-up, society: children and adolescents.” and in-hospital mortality decreased od,” the authors concluded.

TCT 2009 features groundbreaking trials in San Francisco THE TRANSCATHETER Cardiovascular ting patients first. Therapeutics (TCT) 2009 meeting will take A series of featured clinical trials will be The featured trials place at the Moscone Center, San Francisco, presented, in addition to late-breaking clinical US, on 21–25 September. This year’s TCT was trials. These featured trials represent ground- Clinical trials presented in the first session will focus on drug-eluting stents, and include: developed to reflect the advances and changes breaking research and will yield data and ZEST trial – Zotarolimus-eluting, sirolimus-eluting and paclitaxel-eluting stents in the field, while maintaining a long-standing insight that will further the field of interven- CEREA-DES trial – Corticosteroids in patients undergoing stent implantation commitment to the meeting’s core values, tional cardiology. STATINS PRE-PCI – A prospective randomised trial of statins prior to stent implantation in focusing on therapy innovation, trust in evi- The TCT Featured Clinical Trials will be patients with stable angina dence-based medicine, and dedication to put- presented on 24 September, 2–6pm. NEVO RES-ELUTION I QOL – A formal quality-of-life assessment from a prospective randomised trial of a novel sirolimus-eluting stent and a paclitaxel-eluting stent CILOTAX – A prospective, randomised, controlled trial of a stent eluting cilostazol and paclitaxel BIOFREEDOM – A prospective randomised trial of a polymer-free biolimus A9-eluting stent

Session 2 focuses on acute coronary syndrome therapies and novel imaging approaches. Clinical trials to be presented include: MISTRAL trial – Ambulance-initiated vs. cath lab-initiated intravenous abciximab in patients with STEMI COCKTAIL trial – Intracoronary abciximab infusion in patients with thrombotic lesions assessed by OCT NO REFLOW trial – Intracoronary vs. guide catheter infusion of nitrates vs. calcium channel blockers in patients with no reflow after primary PCI in STEMI OCTAMI trial – Zotarolimus-eluting and bare metal stents in STEMI assessed by OCT.

Finally, session 3 will focus on end-stage, structural heart and endovascular intervention: Follow-up from the Canadian Transcatheter Aortic Valve Implantation Program CROSS-CLI – A prospective multicentre registry of ultrasound-facilitated recanalisation of peripheral chronic total occlusions ARMOURA – Study of the Mo.Ma Proximal Cerebral Protection Device in high surgical risk subjects undergoing carotid artery stenting PROVASA trial – Intra-arterial progenitor cell transplantation of bone marrow mononuclear cells in patients with peripheral arterial occlusive disease ACT34-CMI – One-year results from a prospective, randomised, placebo-controlled phase II trial of CD34+ cells in patients with refractory angina.

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ProfileAlfred Bove

Alfred A Bove, emeritus professor of medicine, Temple University Medical School, Philadelphia, US, and president of the American College of Cardiology, spoke to Cardiovascular News International about his career, proudest moments and research.

When did you decide you wanted a career in medicine and cardiologists have been particularly rewarding. These two sites why did you choose cardiology as your specialty? have grown to be internationally recognised websites. It was while I was studying engineering in 1960 and realised that Cardiosource is the premier cardiology education site. Having cardiology involves electricity, physics, and hydraulics, which the opportunity to create the vision, and work with excellent are all favourites of engineers. editorial teams to build these sites has been a significant experience. We ultimately added a patient portal Who are the people who have influenced you? (cardiosmart.org) that has evolved into a significant source of Two important educators who influenced my career were Dr TM information for physicians and patients looking for authoritative Durant, who was chair of Medicine at Temple University cardiovascular health information. These three web sites Medical school during my student years, and Dr EH Wood, my represent the culmination of 15 years of design, development research mentor during my fellowship at the Mayo Clinic. and implementation that has fulfilled the original visions of an Dr Durant was a true clinician in the Osler tradition, where ACC web presence for all aspects of health care. listening to the patient, extracting a thorough history, and performing a complete examination was the underpinning of all Cardiology has undergone many changes over the years – medical care. This lesson has not been lost over the ensuing what do you think the most fundamental changes have years even though we have new diagnostic methods that some been? feel diminish the value of the clinical examination, and with our The last 40 years has been a great time to be in cardiology. current reimbursement system, there is a strong incentive to During this time, we witnessed the development of bypass avoid long-term care and engagement with patients. surgery, important new drugs have appeared for the treatment of Dr Wood at the Mayo Clinic strongly influenced my interest hypertension, arrhythmia, heart failure and coronary disease, in research. Dr Wood was a superb, internationally recognised interventional procedures to open narrowed coronary arteries investigator who was a major contributor to many innovative without surgery, implanted defibrillators, and a variety of diagnostic and therapeutic advances in the area of cardiovascular imaging systems that have reduced the risks of diagnostic medicine. Dr Wood expected his research fellows to be highly testing. All of these advances have reduced mortality from heart creative, innovate new technologies, and seek leadership roles in attacks from around 25% in the 1960s, to around 5% today. cardiovascular medicine and research. Many of his fellows went Having the opportunity to take part in these advances brings a on to lead highly successful careers in medicine. His laboratory sense of fulfillment to a cardiologist. was a centre for bioengineering applications in cardiology, and my engineering background fit perfectly into the research. In your opinion, what are the main trends in cardiology at the moment and what can we expect to see in the future? On a professional level, what have been your proudest At the moment, cardiology is focusing on less invasive therapy moments? for coronary disease, and valvular heart disease, implanted I have received awards for my research, including Honored devices for arrhythmias and heart failure. Professor Award at Temple University School of Medicine and I particularly look forward to the next 20 years in America’s Top Physician award three years in a row. I became cardiology. Advances in percutaneous techniques will president of the American College of Cardiology (ACC) this improve care for patient with valvular, coronary and year, and I have also received research awards. The realisation congenital heart abnormalities. Cellular and molecular that improving cardiovascular health for our country requires biology is beginning to show promise for treating heart some broader service commitments led me to participate in the disease, and prevention of cardiovascular disease has activities of the American College of Cardiology for nearly 30 become a dominant public goal. We will have more efficient years. I have been committed to education for my entire medical imaging modalities, electronic records connected nationally to career, and participated in many of the educational activities of avoid missing data and duplication of tests, and patients will the ACC as a faculty member, programme organiser, committee have their own part of the medical information system that will chair or member, and as the editor of the ACC Internet portals become their personal health record. Using these new tools to ACC.org and cardiosource.com. The efforts to establish ACC’s improve patient care promises an exciting time in cardiology web presence and build a robust educational site for for the foreseeable future.

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Fact File

Education and training 1962–1966 MD, Temple University School of Medicine, Philadelphia, US 1967–1970 PhD (Physiology/ Bioengineering), Philadelphia

Postgraduate training and fel- lowships l960–1966 Research assistant and summer research fellow, Temple University Medical School 1966–1967 Intern in internal medicine, Temple University Hospital 1967–1970 Postdoctoral fellow, Temple University Medical School 1969–1970 Resident in internal medicine, Temple University Tell us about the most memorable case you have ever Hospital treated? 1970–197l Research associate (with Earl H Wood), Mayo I have treated atrial fibrillation for several professional Graduate School of Medicine, Rochester, US athletes, and restored a normal life to patients with end-stage heart failure through heart transplantation. Military service From 1971 LCDR, CDR, CAPT, undersea medical officer, officer in What are your current areas of research? charge, head of Medical Department, director of med- Returning to the research laboratory after 18 years of ical services, executive officer, director of ancillary administering an academic cardiology programme, I found services, and retired as capt, USN in 1998. that there was a strong need for translating new clinical From 1987 US Navy professional school liaison officer for Temple knowledge into practical clinical care. The focus of my University School of Medicine current research is the patient. We are developing and testing Internet-based communication systems that are designed to Fellowships improve health literacy, and empower patients to participate 1967–1969 Postdoctoral Fellow, NIGMS, Temple University, in their healthcare. The disparity between healthcare related Department of Physiology to income and location are readily overcome using Internet- 1970–1971 Special Postdoctoral Fellow, NHLI, Mayo Graduate based communication, and we have been focusing our School of Medicine efforts on urban and rural underserved communities to 1975–1980 Established investigator of the American Heart improve heart failure care, reduce cardiovascular disease Association risk, and manage hypertension. Disparities in healthcare are multifactorial, and two important factors are health literacy Licensure and empowerment. With these two aspects overcome, Pennsylvania, Virginia, and Minnesota patient self-care will improve, and patients will become knowledgeable enough to seek care when it is appropriate. Board certification Oct 1971 American Board of Internal Medicine Outside of cardiology, what other interests do April 1984 Cardiovascular Disease Subspecialty you have? Jan 2000 Undersea and Hyperbaric Medicine I enjoy the specialty of Undersea and Hyperbaric Medicine. This specialty has brought me to many exotic locations Appointments around the world to teach diving medicine and dive in 1973–1977 Assistant professor of medicine, Department of unique waters of the world. This is an experience in another Medicine, Division of Cardiology, Temple University world of undersea creatures, increased pressure, thermal Medical School, Philadelphia stress, and exotic intoxications and poisonings that requires 1973–1977 Assistant professor of physiology, Department of special skill and knowledge. Supporting diving in our Navy Physiology, Temple University Health Sciences Center has also been quite rewarding. In 2010 we will hold our 36th 1977–1981 Associate professor of medicine, Department of consecutive continuing medical education program devoted Medicine, Temple University Medical School to diving and hyperbaric medicine. 1977–1981 Associate professor of physiology, Department of In my spare time i enjoy sport scuba diving, long-distance Physiology, Temple University Medical School running, website development, and mathematical modeling. 1978–1981 Adjunct associate professor of medicine and staff member, Institute for Environmental Medicine, What advice would you give to a young cardiologist? University of Pennsylvania, Philadelphia This is an exciting time in cardiology due to the therapy 1981–1986 Professor of medicine, Mayo Medical School, consult- advances that are now available or are soon to appear. The ant in cardiovascular disease, associate consultant in demand for cardiology services will increase as the baby physiology, Mayo Clinic, Rochester boomers retire, so there will be lots of research and clinical 1981 Professor of medicine, Department of Medicine, work to do. Temple University Medical School 1986–1999 Bernheimer Professor of Medicine, chief, Cardiology Section, Temple University School of Medicine 1998–2001 Associate dean, Practice Plan Affairs, Temple University School of Medicine 2001– Professor of Medicine (emeritus), Temple University 2005–2008 Chief, Cardiology Section, Temple University Hospital and administrative appointments from 1973

Consulting and editorial positions 1975–1985 Consultant to National Institute for Neurologic Diseases and Stroke for review of Stroke Center Programs 1998–2002 Executive editor, web site American College of Cardiology 2002–2007 Editor-in-chief, Cardiosource.com

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Reduced mortality risk Watchman: Alternative to with CRT-D in MADIT-CRT FINAL RESULTS from the ment for ICD patients. landmark MADIT-CRT trial, “The MADIT-CRT long-term warfarin therapy which were published by the Executive Committee antici- AN ARTICLE PUBLISHED sure of the left atrial 1,065 patient years of moni- New England Journal of pated that the benefit for the recently in The Lancet reports appendage and subsequent toring, there were 3.0 efficacy Medicine, were presented CRT-D therapy group would that patients with atrial fibril- discontinuation of warfarin events per 100 patient-years during a Hotline session at be dominated by a reduction lation at risk of stroke could and 244 patients followed in the device group. In the the annual European Society in heart failure events and the be offered percutaneous clo- long-term warfarin therapy. warfarin group there were 4.9. of Cardiology (ESC) data overwhelmingly confirm sure of the left atrial The percutaneous method This translates to a relative Congress in Barcelona, that,” said Moss. appendage instead of long- involved implantation of a reduction of 38%. On the Spain. “Furthermore, CRT-D therapy term warfarin therapy. The device (the Watchman) to other hand, serious safety Arthur Moss, professor of showed an equal benefit in findings are from the PRO- close off the left atrial events were more frequent in medicine at the University of both ischaemic and non- TECT AF study, led by David appendage. Effectiveness was the device group (7.4 events Rochester Medical Center ischaemic patients. The R Holmes, Mayo Clinic, determined through a com- per 100 patient-years) com- and principal investigator of MADIT-CRT data are com- Rochester, US. pared with the warfarin group the trial, presented the pelling and help bridge a clin- About 90% of atrial throm- (4.4 events per 100 patient- MADIT-CRT data. The pri- ical gap in our understanding bi in patients with non- years). The majority of mary endpoint showed that of heart failure in Class I and valvular atrial fibrilla- these safety events were Boston Scientific’s cardiac II patients.” tion are assumed to linked to the procedural David R Holmes resynchronisation therapy MADIT-CRT is the world’s initiate in the left atrial implant. defibrillators (CRT-Ds) were largest randomised study of appendage. The authors The authors wrote in A Kinsella, and W Oliver associated with a 34% rela- NYHA Class I and II examined in this ran- conclusion: “The efficacy Tobin, Adelaide and Meath tive reduction in the risk of patients, with more than domised study the effi- of percutaneous closure of Hospital, Dublin, incorporat- all-cause mortality or first 1,800 patients enrolled at 110 ciency and safety of per- the left atrial appendage ing the National Children’s heart failure event in asymp- centres in 14 countries. cutaneous closure of the with this device was non-infe- Hospital, Trinity College, tomatic and mild (NYHA left atrial appendage com- rior to that of warfarin therapy. Dublin, Ireland, remarked that Class I and II) heart failure pared with long-term war- Although there was a higher warfarin has its limitations. patients, when compared to farin therapy in patients with rate of adverse safety events in However, it is still the pre- standard implantable car- non-valvular atrial fibrillation the intervention group than the ferred treatment for patients dioverter defibrillators at risk for stroke. control group, events in the with non-valvular atrial fibril- (ICDs) (p=0.001). Patients eligible for the bined endpoint of all stroke intervention group were main- lation and who are suitable for In addition, MADIT-CRT study had a least one of fol- (ischaemic and haemorrhag- ly a result of periprocedural long-term oral anticoagula- data showed that CRT-D ther- lowing: previous stroke or ic), cardiovascular death, and complications. Closure of the tion. But they mention that apy reduces the relative risk transient ischaemic attack, systemic embolism. There left atrial appendage might additional research on the use of heart failure events by congestive heart failure, dia- were serious adverse events provide an alternative strategy of left atrial appendage occlu- 41% when compared to ICD betes, high blood pressure, or that were measured in the to chronic warfarin therapy for sion devices is necessary. This therapy (p< 0.001). Patients were 75 years or older. safety assessment. They stroke prophylaxis in patients particularly applies for treated with CRT-D therapy Overall, 707 patients were included major bleeding, peri- with non-valvular atrial fibril- patients unsuitable for long- showed an improvement of included in the assessment cardial effusion, and device lation.” term warfarin therapy. 11% in left ventricular ejec- and 463 were randomised in a embolisation. In an associated note, The study was funded by tion fraction after one year, 2:1 ratio to percutaneous clo- Results indicated that after Dominick J H McCabe, Justin Atritech. compared to a 3% improve-

performance of Reveal XT for automatic AF incorrect decisions regarding the administra- detection in a technical sense. It demonstrated tion of the optimal antithrombotic therapy. XPECT: Monitoring AF with that subcutaneous monitoring of AF is feasible Thus, a careful and reliable assessment of AF and can be accurately performed. The positive presence/absence, burden and episode duration results of this trial may have relevant clinical would considerably benefit any primary or a minimally invasive device implications. secondary stroke prevention strategy. Continuous monitoring can play an important Continuous monitoring of AF as a role even after the discontinuation of anticoag- superior method ulation therapy in confirmed AF free patients, JOHN CAMM The low reliability of symptoms to detect AF as anticoagulation can be restarted as soon as and measure its burden is well known and has clinically relevant relapses are detected, inde- been assessed in patients with and without pendently of symptoms. COMMENT & ANALYSIS implanted devices: the perception of AF may Continuous AF monitoring may also play a markedly differ among patients and many role in some patients without a history of AF, ATRIAL FIBRILLATION (AF) is associated The XPECT study (Reveal XT Performance patients can perceive AF-like symptoms in the such as patients with cryptogenic stroke. with substantial morbidity, which primarily Trial) is a prospective, multicentre trial, absence of arrhythmia. Recent scientific reports demonstrated the clin- involves troublesome symptoms, heart failure, designed to evaluate the performance of Given the unpredictable nature of the ical relevance of more intensive AF monitor- and thromboembolic events. Reveal XT (Medtronic), the first MRI episodes continuous monitoring of AF is likely ing in this patient population immediately after Results of any therapy applied are usually approved subcutaneous, leadless, insertable to be superior to any other intermittent method the event (Neurology 2008;71:1696–170. J judged by the absence of clinical symptoms cardiac monitor (ICM) featuring an automatic based on the ECG or symptoms. The low relia- Stroke Cerebrovasc Dis 2009; 18(3):185-189). and documentation of sinus rhythm on avail- AF detection algorithm. The first patient was bility of symptoms and intermittent monitoring Each time AF is detected, the patient can able ECG recordings. Routine office ECGs, enroled in September 2007 and the last patient to detect AF makes any decision about stop- immediately start the appropriate anticoagula- occasional 24-hour ambulatory ECG and enroled in July 2008. The first data were pre- ping/starting anticoagulation unsafe for the tion therapy with the objective of preventing a longer term ECG event recording are the stan- sented by Professor Hindricks (Heart Center patient. deleterious stroke recurrence. The high sensi- dard monitoring strategies. Leipzig, Germany) at the Heart Rhythm Inability to detect AF episodes and low reli- tivity for identifying patients with AF (96.1%) Whether such surveillance is sufficient to Society congress 2009 in Boston, US. ability to exclude AF, may lead to incorrect makes ICMs suitable for clinical practice gain reliable information concerning the sup- Patients who were likely to present paroxys- conclusions regarding the efficacy of the because the physician can rely on the ability of pression or cure of AF is debated. However, mal AF were selected. A dedicated external rhythm control strategy and, consequently, to the device to detect AF episodes. On the other when AF is deemed to have been completely Holter device stored a 46-hour ECG recording hand, the high NPV=97.4%, which allows suppressed or cured, physicians are tempted to of a signal that was provided by the Reveal XT patients without AF to be identified, is also stop anticoagulation in an effort to avoid the with related markers and two surface ECG Xpect study: The facts highly relevant in clinical practice, because the unnecessary risk of bleeding. The concern is leads. The surface ECG recordings were I Analysable Holter recordings: 206 col- physician can rely on the device. When no AF that asymptomatic and/or undetected recur- reviewed by a core-lab, against which the lected from 247 patients. episode has been stored the patient is really an rences of AF could expose patients to automatic arrhythmia classification of the I 71 contained core-lab-classified AF with AF-free patient. increased risk of ischaemic stroke and throm- Reveal XT was evaluated. an AF burden >1% (i.e. >14.5 min per Detailed information of stored ECGs and boembolic events. 24h). In all recordings, AF was detected analysis such as daily AF burden trend in Implantable loop recorders (ILR) are largely Major findings by the ICM (sensitivity=100%). Cardiac Compass Report are stored on the accepted in clinical practice for diagnosing The major findings of this study are that I There were 76 patients with at least one device and can made available by the physi- patients with unexplained syncope (Europace Reveal XT equipped with a dedicated AF AF episode, and the overall sensitivity to cian during a follow-up visit or via remote data 2009; 11:671–687. EHRA Position Paper). detection algorithm is not only sensitive for the identify patients with AF was 96.1%. access (CareLink, Medtronic). These technology of long term continuous detection of AF episodes, but also accurate for I The automatic algorithm of the device monitoring implemented with specific soft- the measurement of AF burden and above all was also effective in correctly classifying Professor John Camm is head of the Department of ware for automatic AF detection, is now avail- highly reliable for the exclusion of the pres- patients without AF, with a negative pre- Cardiac and Vascular Sciences and chairman of the able to monitor symptomatic and asympto- ence of AF. dictive value (NPV)=97.4%. Discipline of Cardiology at St George’s, University matic episodes of AF. The XPECT study evaluated the of London, UK.

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TON-TIMI 38, weighing the risk of major bleeding and the TAVI effective Effient is approved by the FDA reduction in cardiovascular events, found an overall ben- DAIICHISANKYO was associated with a sig- cardiovascular events in efit significantly favouring for high-risk AND ELI LILLY have nificantly higher risk of 13,608 acute coronary Effient compared with announced that the FDA serious bleeding events patients managed with PCI. Plavix. For every 1,000 patients has approved Effient compared with clopidogrel. The study showed that patients treated with Effient (prasugrel) tablets for the However, appropriate Effient taken with aspirin as compared with Plavix, “TRANSCATHETER aortic valve reduction of thrombotic patient selection may help had a 19% relative risk there were 23 fewer patients implantation (TAVI) represents an cardiovascular events reduce this risk.” reduction of the combined with heart attacks and six effective therapeutic alternative to (including stent throm- The risk of bleeding was endpoint of cardiovascular more with major bleeding conventional aortic valve replace- bosis) in patients with highest in Effient-treated death, non-fatal heart attack events. ment for patients who are at high acute coronary syn- patients who were either 75 or non-fatal stroke versus In addition, the results risk or have contraindications to dromes who are man- years of age or older, Plavix taken with aspirin. from a pharmacogenetic sub- surgery, and the combination of the aged with percutaneous weighed less than 132 This benefit was driven study of TRITON-TIMI 38 transfemoral and transapical coronary intervention pounds (60kg), or who had a predominantly by reduction patients, as well as several approaches further increases the (PCI). prior history of transient in heart attacks. The benefit early phase pharmacokinetic number of patients who can be Effient helps keep ischaemic attacks (TIA) or of Effient compared with studies, showed that the treated,” said Dominique Himbert, blood platelets from stroke. Effient is contraindi- Plavix was seen as early as active form of prasugrel Bichat Hospital in Paris, France, at sticking together to cated in patients with a histo- three days and continued does not appear to be affect- the European Society of Cardiology form clots. Taking ry of prior over the 15 months of the ed by genetic variations in Congress. Effient with aspirin after TIA/stroke. trial. In addition, there were common cytochrome P450 “Degenerative aortic stenosis PCI has been shown to It is gen- fewer stent-related clots (CYP) enzymes, including should be addressed with appropri- reduce the chances of erally not (known as stent thrombosis) CYP2C19. Because both ate resources to treat a larger num- having a cardiac event recom- in patients treated with Effient and Plavix are “pro- ber of elderly patients at high-risk and stent thrombo- mended in Effient compared with drugs”, they require CYP450 or with contraindications to con- sis among patients 75 Plavix (a relative risk enzymes to convert them to ventional cardiac surgery. These patients with acute years of age or reduction of their active drug form. interventions should be less inva- coronary syndromes. prasugrel significantly older, except for those in approximately 50%). Approximately 30% of sive than surgery, less influenced Effient should be initiated reduced the combined risk high-risk situations, such as The risk of non-coronary Caucasians and 60% of by patients’ comorbidities, and with a loading dose of 60mg of cardiovascular death, those with diabetes or a his- artery bypass graft related Asians have reduced func- allow shorter hospital stays and followed by a maintenance heart attack or stroke over tory of prior heart attack. bleeding, which included life- tion in the CYP2C19 gene. faster recovery,” Himbert said. dose of 10mg once daily. In the current standard of care, Daiichi Sankyo and Eli threatening and fatal bleed- Many drugs, including cer- The single-centre study reports addition, for those patients clopidogrel, across a wide Lilly co-developed Effient, ing, was significantly higher tain proton pump inhibitors the short and mid-term outcomes of who weigh less than 132 variety of patient types,” which was discovered by with Effient (2.2%) compared such as omeprazole, also 120 patients treated by TAVI. All of pounds (60kg), physicians said lead TRITON-TIMI 38 Daiichi Sankyo and its with Plavix (1.7%). When inhibit CYP2C19. As stated them suffered from a very severe should consider lowering the investigator Elliott Antman, Japanese research partner, compared with the overall in the Plavix prescribing and symptomatic aortic stenosis, maintenance dose to 5mg professor of Medicine at Ube Industries. treatment population, the risk information, studies have and multidisciplinary medicosurgi- once-daily. Patients taking Brigham and Women’s of major bleeding was high- shown that formation of cal consensus concluded that they Effient should also take Hospital (BWH) in Boston TRITON-TIMI 38 results est among those patients clopidogrel’s active metabo- had an unacceptably high operative 75mg to 325mg aspirin oral- and senior investigator with The approval was based treated with Effient who were lite may be affected by risk or contraindications to surgery. ly once-daily, according to the BWH TIMI Study on results from the pivotal either 75 years or older, had a patients with reduced An evaluation using echocardiog- their doctors’ instructions. Group. “Prasugrel is an phase III TRITON-TIMI 38 body weight less than 132 CYP2C19 function or by raphy, angiography and computed “The data from the TRI- important new option for clinical trial, which com- pounds, or had a prior history drugs that inhibit CYP2C19, tomography was used to define the TON-TIMI 38 phase III piv- patients with acute coronary pared Effient with Plavix of transient ischaemic including certain proton feasibility of TAVI, the approach otal trial provide compelling syndromes who are man- (clopidogrel bisulphate, attack/stroke. pump inhibitors such as (transfemoral or transapical) and the evidence that treatment with aged with PCI. Prasugrel Sanofi-aventis) in reducing An analysis from TRI- omeprazole. type of prosthesis: Edwards SAPI- EN THV (balloon expandable) or CoreValve Revalving System (self expandable). On average, patients Genetic variation associated with outcomes with use of clopidogrel were 81 years old, more than half of them had at least two severe comor- PATIENTS WITH A CERTAIN clopidogrel remains unexplained,” bidities, and their estimated opera- genetic variation who received the authors wrote. tive mortality was between 16% and clopidogrel had a decreased platelet In the sample of clopidogrel- 27%, according to the predictive response to treatment and among treated patients undergoing percuta- risk score used. The risk profile those who had percutaneous coro- neous coronary intervention, after tended to be even more severe in nary intervention had an increased one year of follow-up, carriers of the transapical group than in the risk of having a cardiovascular the CYP2C19*2 genotype were transfemoral. event in the following year than more likely (20.9% vs. 10%) to patients who did not have this vari- have a cardiovascular ischaemic Learning curve ant, according to a study in the 26 event or death compared with non- The prosthesis was successfully August issue of the Journal of the carriers. implanted in 96% of the cases. The American Medical Association. “CYP2C19 genotype may prove most frequent complications were “Dual antiplatelet therapy, includ- useful in helping clinicians choose vascular (10%), due to the large ing clopidogrel and aspirin, inhibits the most effective antiplatelet thera- diameters of the femoral sheaths, platelet function, preventing py and dose for a given individual. and heart blocks necessitating ischemic events and improving out- Those with the CYP2C19*2 geno- definitive cardiac pacing (9%). comes following acute coronary type may benefit more from an Strokes were rare (3%). Overall, syndromes and percutaneous coro- Clopidogrel molecule antiplatelet regimen that does not procedural mortality was 3%, and nary intervention,” the authors include clopidogrel, such as the 30-day mortality 9%, 8% in the wrote as background information in response. In the Pharmacogenomics of 227 patients undergoing percuta- third-generation thienopyridine pra- transfemoral group, and 11% in the the article. Clopidogrel therapy of Antiplatelet Intervention (PAPI) neous coronary intervention. sugrel, or ticagrelor and cangrelor. transapical group. At one year, improves outcomes by inhibiting Study (2006–2008), the researchers The researchers found that Like clopidogrel, these agents inhib- overall survival was 79%. There adenosine diphosphate (ADP)-stim- administered clopidogrel for seven platelet response to clopidogrel was it ADP-stimulated platelet aggrega- was no statistically significant dif- ulated platelet activation. However, days to 429 healthy Amish persons highly heritable. “Indeed, follow-up tion but are not as dependent on ference between the transfemoral variability in response to clopido- and measured platelet response. The genotyping indicated that the loss- CYP2C19 for activation. Genotype- (83%) and the transapical group grel is well established, with nonre- population in this study (Old Order of-function CYP2C19*2 variant directed decisions regarding which (69%). The most important predic- sponsiveness related to recurrent Amish) are a relatively homoge- was associated with clopidogrel antiplatelet agent to use in a specific tor of late mortality was related to ischemic events. Some research has neous group in which confounding response and could account for patient may also have an important the learning curve, involving the suggested that genetic variations variables, including medication most of the association signal economic impact if costs of equally patients’ selection process, the pro- may affect clopidogrel response, usage and lifestyle, are minimised. detected in the initial genome-wide efficacious medications differ great- cedural technique itself, and post- specifically the gene variant A genome-wide association study association study. The CYP2C19*2 ly. Whether CYP2C19*2 carriers operative care. One-year survival CYP2C19*2. was performed followed by geno- genotype accounts for approximate- may benefit from increased dosing was 60% in the first 25 patients, Alan R Shuldiner, University of typing the loss-of-function ly 12% of the variation in clopido- of clopidogrel is not yet known,” the compared to 85% in the last 95, Maryland School of Medicine, cytochrome P450 (CYP) 2C19*2 grel response. With age and sex, authors wrote. and this difference was statistically Baltimore, US, and colleagues per- variant. Findings in the PAPI Study approximately 22% of the variation “Prospective randomised clinical significant in uni- and multivariate formed a genome-wide association were extended by examining the in clopidogrel response can be trials will be necessary to determine analysis. Most important, 87% of study of ADP-stimulated platelet relation of CYP2C19*2 genotype to explained. Although substantial and the efficacy of CYP2C19 geno- the survivors returned to normal aggregation to identify genes asso- platelet function and cardiovascular highly significant, the majority of type–directed therapy in evidence- life, with no or only mild residual ciated with variation in clopidogrel outcomes in an independent sample the variation in platelet response to based clinical decision making.” symptoms.

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22 Cardiovascular News International Issue 15 September 2009

No evidence for the routine World’s first adult cardiac stem cell patient use of aspirin in people with receives infusion THE WORLD’S FIRST Anversa, of Harvard asymptomatic vascular events recipient of adult cardiac University and Brigham & stem cells to treat congestive Women's Hospital in Boston, The routine use of aspirin for the primary prevention of heart failure, Michael Jones, for processing and to grow vascular events in people with asymptomatic disease was infused on July 17 2009. cardiac stem cells from Jones’ This marks the world’s first tissue. cannot be supported, according to results from the phase-one FDA-approved Jones’ infusion procedure Aspirin for Asymptomatic Atherosclerosis (AAA) study clinical trial using adult car- was performed at Jewish diac stem cells to treat heart Hospital by Sohail Ikram, THE STUDY, presented in cular events is well established disease. The clinical trial is M.D., UofL Professor of the European Society of in patients with a clinical his- being conducted by a team of Medicine and Director and T Cardiology Congress 2009, in tory of arterial vascular dis- University of Louisville Chief of Invasive and Barcelona, Spain, is the first ease (secondary prevention); physicians at Jewish Interventional Cardiology at T placebo-controlled ran- however, evidence in primary Hospital. Jewish Hospital. domised trial designed to prevention is limited, with During the infusion proce- Study leader Roberto Bolli, p determine the effect of aspirin studies suggesting that any dure, Jones was directly Jewish Hospital Heart and in asymptomatic atherosclero- benefit of aspirin must be injected with his own cardiac Lung Institute Distinguished sis as reflected by a low ankle weighed against the risk of stem cells into heart scar tis- Chair in Cardiology and A brachial index (ABI). bleeding. The aim of the AAA sue using a minimally-inva- Director of UofL’s Institute Results found no statistical- trial was to determine the fatal or non-fatal coronary event of major bleeding sive cardiac catheterisation for Molecular Cardiology i ly significant difference in pri- effectiveness of aspirin in pre- event or stroke, or revascu- requiring admission to hospi- procedure, which reaches the said, “We continue to enroll mary endpoint events between venting events in people with larisation. There were two tal occurred in 34 (2%) of sub- heart through an artery in the patients in this first-of-its- U those subjects allocated to asymptomatic atherosclerosis secondary endpoints: all ini- jects in the aspirin group and leg. The 66-year-old, self- kind clinical trial. We hope to aspirin or placebo (HR 1.03, detected by ABI screening. tial vascular events defined 20 (1.2%) in the placebo employed man continues to help the heart regenerate its c 95% CI 0.84–1.27). The study recruited 28,980 as a composite of a primary group. recover following the outpa- own tissue and improve heart Joint first author Gerry men and women aged 50 to endpoint event or angina, Commenting on the results tient procedure. function.” Bolli is collaborat- Fowkes, Wolfson Unit for 75 years who were free of intermittent claudication or (and on the use ofABI as a Mark Slaughter, chief of the ing with a number of leaders D Prevention of Peripheral clinically evident cardiovas- transient ischaemic attack; screening method), Fowkes Division of Cardiothoracic in the field of cardiovascular Vascular Diseases, cular disease in central and all-cause mortality. said: “Although the AAA Surgery at UofL and director and stem cell medicine for r Edinburgh, UK, said: “It is Scotland; all were given an Results showed that 357 trial was not one of screening of the Heart Transplant and this clinical trial. possible that in the general ABI screening test. Those participants had a primary per se, the results would sug- Mechanical Assist Device The team will continue to D population, aspirin could pro- with a low ABI (3,350 sub- endpoint event (13.5 per 1,000 gest that using theABI as a Program at Jewish Hospital, evaluate Jones, as well as duce a smaller reduction in jects, ≤0.95 ABI) were person years, 95%CI tool to screen individuals performed coronary artery other patients who have M vascular events than this trial entered into the trial and ran- 12.2–15), 181 in the aspirin free of cardiovascular dis- bypass surgery on Jones on 23 enrolled in the clinical trial, was designed to detect, but it domised to once daily 100mg group and 176 in the placebo ease in the community is March 2009. Jones suffered for heart function and blood t is questionable whether such aspirin or placebo. group. A vascular event com- unlikely to be beneficial if from congestive heart failure flow. In addition, the heart’s an effect, together with Participants were followed- prising the secondary endpoint aspirin is the intervention to due to multiple blocked arter- overall size and the size of the aspirin related morbidity, up for a mean of 8.2 years occurred in 578 participants, be used in those found to be ies that had resulted in perma- scar tissue will be measured. U would justify the additional and outcomes ascertained by but again no statistically sig- at higher risk. Other more nent scarring of his heart mus- Since this is a phase-one resources and health care annual contact, general prac- nificant difference was found potent antiplatelets might be cle. During the procedure, clinical trial designed to test t requirements of an ABI titioner records, linkage to between the aspirin and place- considered, but only if Jones' cardiac stem cells were the treatment’s safety and screening programme.” discharges from Scottish bo groups (288 vs. 290 increased effectiveness in retrieved from a portion of his feasibility, all patients L The benefits of antiplatelet hospitals, and death notifica- events). All-cause mortality avoiding ischaemic events is own atrium, the upper cham- enrolled in the trial will therapy in the prevention of tion. The primary endpoint was similar in both groups not matched by increased ber of the heart. The tissue receive the cardiac stem cell e future cardio- and cerebrovas- was a composite of initial (176 vs. 186 deaths). An initial bleeding.” was then sent to Piero therapy. r d Telehealth reduces hospital admissions and promotes self-care e

Telehealth has been successful in improving care for patients with signs and to answer health-related a chronic heart failure (CHF), GPs at The Orchard Medical Centre in questions at a pre-set time each day, Bristol, UK, have reported reducing the need for patients to visit F the GP practice or hospital and pro- THE PRACTICE HAS successfully dramatic improvement in another moting patient self-care. m integrated telehealth into its CHF patient with severe heart failure who Tunstall’s RTX telehealth moni- service, to provide more preventa- has not had to use out-of-hours tors are used with medical devices tive support within the community health services in the 18 months including weighing scales, blood setting, keeping patients independ- since using the monitoring equip- pressure monitors, peak flow meters ent and out of emergency care, and ment, where previously she had and ECG monitors that connect via promoting greater self-management. been in and out of hospital four serial port, infrared or Bluetooth to Avoiding hospital admissions in this times in a nine-month period. collect and transmit the patient's vital way can reduce some of the burden Clearly from this example tele- signs and related health information. on secondary care providers, while health has the potential to reduce District nurses at the practice then providing a cost-effective model of costs, which is even more com- securely access the data to make care for the management of CHF. pelling when CHF is becoming an informed and timely decisions about The system has liberated valuable increasing burden in an ageing pop- find it difficult to visit the surgery. “Clinical contact with the district patient health and well-being, work- additional resources at the practice, ulation, and the annual cost to the Patients have found the solutions nursing team has actually increased ing closely with the doctors. and the GPs have reported reduced NHS is £600m. According to the easy to use, resulting in increased as a result with patients taking The positive results reported by hospital admissions for some of the British Heart Foundation, inpatient medication compliance and a result- greater interest and increased respon- The Orchard Medical Centre reflect CHF patients since deploying the care accounts for 60% of heart fail- ing improvement in quality of life. sibility for their condition. The reas- the growing acceptance of telehealth telehealth solutions. ure care; with average admissions According to Richard Berkley, surance of self-monitoring has also as a means of enabling Trusts to sup- In the case of one patient who had approaching two weeks, and so clinical lead on the telehealth project, helped to boost medication compli- port a greater number of patients, severe heart failure and a history of keeping patients out of hospital and “Telehealth keeps people where they ance, which in turn is thought to improving outcomes and making the poor medication compliance, the supporting them within the home want to be, and that’s at home with have helped to avoid unplanned best use of available resources. telehealth monitor enabled GPs to environment through telehealth has their family. Patient acceptance of emergency admissions and has The telehealth project was a joint view the direct link between poor the potential to deliver significant telehealth is high; daily monitoring helped to keep patients safe and well venture between NHS South medication compliance, weight gain resource and budgetary savings. has enabled more accurate titration of within the home environment.” Gloucestershire and South and low oxygen saturation. This was Telehealth has proven valuable in patient medication, and also gives The telehealth system was Gloucestershire Council community remedied with the aid of telehealth identifying trends such as change in patients valuable reassurance, keep- deployed from Tunstall Healthcare, care and housing department, and was as the patient could see for herself body weight at an early stage to ing them calm and reducing the risks who carried out remote health moni- funded by a technology grant from the importance of taking her med- enable early intervention, and also in of exacerbation and of hospital toring. Patients, in this case with the council together with three years ication. Telehealth also resulted in a providing support to patients who admission. CHF, are prompted to take their vital project support from Takeda UK.

BIBA Publishing 15 Cardiovascular Int new:International 4/9/09 09:09 Page 23

Interdisciplinary Leg Initiative 13–14 October 2009 Munich, Germany

under the auspices of the German Vascular Society

The rising rate of leg amputations The Interdisciplinary The magnitude of the problem - European Management Challenge perspectives Turning individual specialists into team A systematic diagnostic approach – The players ilegx wheel Wound Clinics versus Unravel the many different Diabetic Foot Clinics causes of leg/foottissue loss Reimbursement Challenges Differential diagnosis – the O ht er The advantages and right treatment strategy i c disadvantages of an m P r e s s a e h insurance led healthcare Definitive u r e c t e r i a l I s system Management – A r How to influence todayand tomorrow D i a b e t i c Leg/Foot Up-date on clinical Tissue Healthcare policy t i c Loss R e n a l trials L y m p h a A r t e r Patient Involvement D i i a l

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Register now www.ilegx.com 15 Cardiovascular Int new:International 4/9/09 09:09 Page 24

24 Cardiovascular News International Issue 15 September 2009 Product News

and a delivery system designed for greater part of the leading Vasoview endoscopic vessel is evidence that an elevated PRA poses a sig- Taxus Liberté long flexibility and enhanced deliverability. Xience harvesting portfolio of products from Maquet nificant risk to future organ transplant patients. Prime is now widely available in Europe and Cardiovascular, and will be sold separately as In these patients, an increased PRA can stent is approved in select countries throughout Asia-Pacific and well as in combination with other Vasoview decrease the number of possible donors for Latin America. products. subsequent organ transplants, and increase by the FDA “Abbott’s Xience Prime is an improve- “Vasovision is at the forefront of ergonomic time on transplant waiting lists. ment in design, deliverability and con- visualisation technology for endoscopic vessel In February 2008, the company received a Boston Scientific has announced formability, all of which can be dis- harvesting. It is exciting to know that Maquet 510(k) clearance from the FDA for its that it has received approval tinctly observed during coronary stent remains committed to innovation in cardiac CryoValve SG pulmonary human heart valve. from the FDA to market its procedures, in both everyday and complex surgery products,” said Thomas Langdon, CryoValve SG is indicated for the replacement Taxus Liberté long pacli- lesions,” said Antonio Bartorelli, director of Omaha Thoracic & Cardiovascular Surgery, of diseased, damaged, malformed, or malfunc- taxel-eluting coronary the Interventional Cardiology Department of Nebraska, US, director of cardiovascular sur- tioning native or prosthetic pulmonary valves. stent system, a next- the Centro Cardiologico Monzino, University gery at the Alegent Health Heart & Vascular The valve can be used in conjunction with right generation drug-elut- of Milan, Italy. “Xience Prime is designed to Institute in Omaha. ventricular outflow tract reconstruction proce- ing stent (DES) be easily deliverable even in complex cases dures, commonly performed in children with designed for long and very long lesions.” congenital heart defects. In addition, the valve lesions. Xience Prime utilises the same well-studied Enrolment in can be used for pulmonary valve replacement At 38mm, it is the Taxus drug and proven biocompatible polymer as during the Ross Procedure, an operation in longest available Liberté Abbott’s market-leading Xience V everolimus- the Trifecta trial which a patient's defective aortic valve is drug-eluting stent, eluting stent. Xience Prime is based upon the removed and replaced with his own pulmonary providing doctors an well-tested design used in the Multi-Link is completed valve. The CryoValve SG is then surgically option that can Vision family of stents, which is the most implanted in place of the removed native pul- reduce the number of widely used stent platform in the world – more St Jude Medical has announced that it has com- monary valve. stents used in more than 2 million of Abbott’s cobalt chromium pleted enrolment in its European clinical trial to complex cases, simplify- stents have been implanted worldwide. evaluate Trifecta, a stented pericardial tissue ing procedures and reduc- “Xience Prime leverages the superior out- heart valve. Panel recommends ing costs. It affords a more comes from the extensive body of clinical evi- The Trifecta clinical trial is a multicentre, efficient treatment option for dence from the SPIRIT family of clinical tri- prospective study, which enrolled 120 patients HDE approval of the estimated 8 to 10% of als, and offers design and delivery at six centres throughout Europe. The trial will patients with long lesions. The system properties that make it even evaluate the safety and efficacy of the Trifecta Medtronic valve device received CE mark approval in easier for a physician to appropri- as a replacement for the aortic valve. Efficacy 2007. ately reach and treat a will be determined by the valve’s haemodynam- The FDA’s Circulatory System Devices Panel “The Taxus Liberté long stent offers lesion,” said Patrick ic performance at 12 months, as measured by has unanimously recommended conditional physicians and patients distinct advantages Serruys, professor of echocardiography. approval of a Humanitarian Device compared to using two overlapping drug-elut- interventional car- Aortic valve replacement is typically indicat- Exemption (HDE) for the Melody tran- ing stents,” said Mark Turco, director of the diology at the ed for patients with aortic stenosis or aortic scatheter pulmonary valve, by Medtronic, for Center for Cardiac & Vascular Research at Thoraxcenter, regurgitation. An estimated 500,000 people the treatment of children and adults with con- Washington Adventist Hospital, Takoma Park, Erasmus University worldwide suffer from severe, symptomatic aor- genital heart disease. The FDA usually fol- US. “In the ATLAS Long Lesion Trial, the Hospital, Rotterdam, The tic stenosis, while approximately 170,000 lows the recommendations of its expert pan- 38mm Taxus Liberté stent significantly Netherlands. “The Xience Prime stent is patients worldwide undergo aortic tissue heart els. Devices approved under HDE are reduced myocardial infarction when compared designed to improve stent deliverability, mini- valve replacements annually. intended to serve patient populations of fewer to the Taxus Express stent, making the Taxus mize vessel injury and provide easy access to than 4,000 per year in the US. Liberté long stent an attractive option for inter- lesions in complex anatomy.” “This Melody valve is an enormous break- ventional cardiologists faced with long, chal- Xience Prime uses cobalt chromium tech- CryoLife receives through and an enormous relief for patients lenging lesions.” nology, and has one of the thinnest drug-elut- with congenital heart disease,” said paediatric The TAXUS ATLAS Long Lesion Trial ing stent struts available, while maintaining FDA clearance for cardiologist William E Hellenbrand, reported a significant 79% reduction in the rate strength to support the vessel. It provides NewYork‐Presbyterian Morgan Stanley of nine-month myocardial infarction for the excellent visibility under X-ray during the CryoPatch SG Children’s Hospital and professor of clinical Taxus Liberté long stent as compared to the stent implantation procedure. Xience Prime is medicine at Columbia University Medical Taxus Express stent control (1.3% vs. 6.3%, available in a broad size matrix, including CryoLife has announced that Center, US. “The device offers the potential to p=0.026). At two years, the composite measure Xience Prime SV for small vessels and Xience it has received 510(k) clear- break the cycle of open heart surgery after of cardiac death or myocardial infarction Prime LL for long lesions. ance from the FDA for its open heart surgery. If the FDA follows the showed a significant 63% reduction for the CryoPatch SG pulmonary advice of its expert panel, physicians and Taxus Liberté long stent compared to the human cardiac patch. patients will have a powerful new option for Taxus Express stent (3.5% vs. 9.4%, Maquet launches CryoPatch SG is processed these very sick and hard-to-treat patients.” p=0.0426). The rate of stent thrombosis at two with the company's proprietary The Melody transcatheter pulmonary valve years was 0% for the long stent and 0.8% for Vasovision SynerGraft technology is the first transcatheter heart valve to be Taxus Express. designed to remove Pulmonary approved for commercial use anywhere in the The Taxus Liberté series is now available in endoscopic system allogeneic donor cells Hemi-Artery Patch world and the first to be reviewed by an FDA 92 sizes, ranging from 2.25mm to 4mm in and cellular remnants panel. It received the CE mark in October diameter and from 8mm to 38mm in length. Maquet Cardiovascular has announced the from tissue without 2006, and has been approved for sale in introduction of the Vasovision endoscopic compromising the Canada since December 2006. To date, nearly visualisation system, a heads-up, goggle-based integrity of the under- 1,000 patients worldwide have benefited from. Abbott launches visual display that places the endoscope image lying collagen matrix. With the panel recommendation, the device is within the harvester’s natural field of vision CryoPatch SG is on track to become the first transcatheter heart the new Xience during endoscopic vessel harvesting (EVH) indicated for the valve of any kind to receive FDA approval for procedures. repair or reconstruc- Pulmonary Trunck Patch use in the US. Prime Worn as eyewear by the healthcare provider tion of the right ven- The panel has recommended conditions of retrieving the vein, the Vasovision system tricular outflow tract, which is a surgery com- approval which include a post-approval study, Abbott announced at the European Society of offers crisp, clear views of the harvesting tun- monly performed in children with congenital revision of the patient brochure and instructions Cardiology Congress, in Barcelona, Spain, the nel and can eliminate the strain associated with heart defects, such as Tetralogy of Fallot, for use, and implementation of a physician train- widespread availability of its next-generation poorly placed monitors or field of view chal- Truncus Arteriosus, and pulmonary atresia. ing and education programme. Xience Prime everolimus-eluting coronary lenges commonly found in today’s operating CryoPatch SG is distributed in three anatomic stent system for the treatment of coronary rooms. The system is lightweight, comfortable configurations: pulmonary hemi-artery, pul- artery disease. Xience Prime, which received and easy to use with fingertip adjustments for monary trunk, and pulmonary branch. CE mark in June, offers a novel stent design brightness and contrast. This new product is Implantation of the CryoPatch SG reduces the risk for induction of HLA class I and class II alloantibodies, based on Panel Reactive Antibody (PRA) measured at up to one year, compared to standard processed pulmonary car- diac tissues. Data have not been provided to evaluate the effect of reduced alloantibodies on the long-term durability, or long-term resistance to rejection by the patient, of the CryoPatch SG. Avoiding elevated PRA is important for patients receiving CryoPatch SG as some may ultimately require a heart transplant. While the Medtronic’s Melody Abbott’s Xience Prime link between immune response and allograft tissue performance is still being debated, there

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26 Cardiovascular News International Issue 15 September 2009 Product News

five new cardiovascular probes, Intima-media Health Canada Xience V Thickness (IMT) auto measurement and rou- tine assist, among other new upgrades. approves Abbott’s The ProSound Alpha 10 2009 Performance Upgrade features new pediatric and adult Xience V probes, along with Contrast Harmonic Echo (CHE) improvements. The ProSound Lab, Abbott has announced that it has received (also known as the DAS-RS1), ALOKA’s approval from Health Canada for the Xience V software application suite, will boast vector everolimus-eluting coronary stent system for flow mapping and 2D tissue tracking. These the treatment of coronary artery disease. new research applications are currently under According to Abbott, Xience V is the only validation. drug-eluting stent to have demonstrated superi- Shipments of the new ProSound Alpha 6, ority over the Taxus paclitaxel-eluting coro- will commence worldwide from October 2009. nary stent system (Boston Scientific) in the primary endpoints of two randomised, pivotal (phase III) clinical trials. Alvimedica “Xience V is an important next-generation treatment option combining impressive deliv- announces four erability with demonstrated efficacy and safe- ty,” said Guy Leclerc, interventional cardiolo- product launches gist and associate professor of research, Centre Hospitalier de l’Universite de Montreal. “With Alvimedica has announced that soon will strong, long-term data supporting it, Xience V launch four new cardiovascular products: is a welcome addition for treating patients with the Coracto rapamycin-eluting stent, the coronary artery disease.” Coraxel paclitaxel-eluting stent, the angio- The clinical program for Xience V graphic catheter Alvision, and the Alviguide studied patients in the US, Canada, Europe, guiding catheter. South Africa and Asia-Pacific, and According to the company, Coracto ensures demonstrated excellent long-term results and either the Edwards SAPIEN transcatheter heart parameters of lipid metabolism in special balance between the completely biodegrad- data on “real-world” patients from the valve or an Edwards surgical valve via open- patient populations, including the elderly, able polymer and the drug to be administered, SPIRIT family of trials. heart surgery. In the non-surgical, medical man- patients with diabetes and patients at higher car- which enables a controlled drug release pro- In long-term data from the SPIRIT III trial agement arm, patients considered to be non- diovascular risk. The overall safety and tolera- file and hence a timely clinical effect to the of 1,002 patients, Xience V continued to operative are randomized to receive either the bility of Livalo are consistent with other com- patient. Rapamycin, a macrocyclic lactone, is demonstrate positive clinical benefits for Edwards SAPIEN transcatheter heart valve or monly prescribed statins. a potent cytostatic inhibitor of smooth muscle patients out to two years. Xience V demon- appropriate medical therapy. Livalo is expected to launch in the US during cell proliferation. The PL GA which is used strated a 45% reduction in the risk of major The PARTNER trial is designed for patients Q1 of 2010 and will be available in three low as a polymer on the stent degrades completely adverse cardiac events compared to Taxus with severe aortic stenosis who are not good dosages (1mg, 2mg and 4mg). into its monomers, lactic acid and glycolic (7.3% for Xience V vs. 12.8% for Taxus) at candidates for surgery due to age or other con- Since its launch in Japan, South Korea, acid, after the drug is released eliminating the two years. Major adverse cardiac event is current health factors. Thailand and China, Livalo has been success- long term antiplatelet therapy. Constant defined as a composite of cardiac death, The Edwards SAPIEN transcatheter heart fully used in these countries to treat primary design used in Coracto provides high flexibil- myocardial infarction, or ischaemia-driven valve is manufactured by Edwards, which is hypercholesterolemia and combined dyslipi- ity and optimum radial strength. Clinical target lesion revascularisation for the SPIRIT also funding the study. demia, and has accumulated millions of patient- studies showed that Coracto performs very III trial. Xience V also demonstrated a low years of exposure. It is frequently prescribed in successfully in patients with the worst coro- rate of stent thrombosis between one and two these countries as first-line therapy for a broad nary lesions. years per Academic Research Consortium Pitavastatin is range of patients including the elderly, patients The Coraxel stent has a biocompatible dual definition of definite/probable stent thrombo- with diabetes and those whose treatment is coating layer composed of an athrombogenic sis (0.3% for Xience V vs. 1% for Taxus). approved for complicated by concurrent disease and con- coating as the base layer that provides perma- comitant medications. nent protection and promotes re-endotheliali- use in the US sation, and above a polymer matrix which is 100th heart totally biodegradable and incorporated with Kowa Pharmaceuticals has announced that the New ProSound paclitaxel. The controlled drug release mech- transcatheter valve FDA has approved Livalo (pitavastatin), a anism assures that 100% of the drug is potent HMG-CoA reductase inhibitor (statin), Alpha ultrasound released within 6–8 weeks. The use of this replacement for the primary treatment of hypercholes- system enables six months of dual antiplatelet terolemia and combined dyslipidemia. system launched therapy. Coraxel design provides high flexi- Over the last four years, heart specialists at “Livalo has a robust safety, efficacy and tol- bility to reach highly tortuous vessels and its NewYork-Presbyterian Hospital/Columbia erability profile and offers an attractive alterna- ALOKA Holding Europe AG launched at open cell design allows for easy side branch University Medical Center have implanted an tive for patients with primary hypercholes- the European Society of Cardiology congress access. Furthermore, Coraxel has thinner innovative aortic heart valve replacement using terolemia or combined dyslipidemia,” said in Barcelona, Spain, its new ProSound struts compared with the most contemporary a catheter-based approach that does not require Antonio M Gotto Jr, the Stephen and Suzanne Alpha 6, the next generation of compact drug-eluting stents. open-heart surgery in a total of 100 patients – Weiss Dean of Weill Medical College of color ultrasound systems. This new system Alvision, an angiographic catheter, has large the most of any US medical centre to date. Cornell University, New York, US. “Livalo has provides unprecedented performance in car- inner lumen size which assures outstanding The procedures were conducted as part of very positive attributes that will help continue to diovascular ultrasound, is fully upgradable flow rates, superior visualisation, ease of hand multiple clinical research studies of the fill current unmet needs in the statin market for and easy-to-use. injection and hence success even in difficult Edwards SAPIEN transcatheter heart valve. clinically complex patient populations, such as Building upon the proven technology of the lesions. With its special design and enhanced Currently ongoing is the PARTNER (Placement the elderly, patients with diabetes or patients high performance ProSound Alpha 10 and radiopacity, Alvision 4F angiographic catheter, of aortic transcatheter valves) trial, a phase III who take multiple medications for co-morbid Alpha 7, the ProSound Alpha 6 compact sys- which is less invasive due to smaller diameter, multicentre study led by national co-principal conditions.” tem addresses the cardiovascular ultrasound appears under the x-ray like a 5F or 6F investigators Martin Leon and Craig Smith and Livalo is a fully synthetic and highly potent needs of public and private hospitals and clin- catheters. Alvision angiographic catheter focused on the treatment of patients who are at statin engineered in Japan. Livalo differs from ics. The Alpha 6 high power processor allows incorporates an atraumatic tip that facilitates high risk or not suitable for open heart valve other, currently available statins in the US in a number of different imaging modes previ- crossing through the arteries, and with its replacement surgery. that it has a unique cyclopropyl group on the ously seen only in high end systems, without unique design, success in all angiography The SAPIEN heart valve, made of base structure. This cyclopropyl group con- compromise on image quality and color cases is achieved. bovine pericardial tissue leaflets tributes to a more effective inhibition of the Doppler sensitivity. Alviguide, a guiding catheter, has a large hand-sewn onto a metal HMG-CoA reductase enzyme to This latest addition to the ProSound Alpha non-tapered lumen, which downsizes without frame, is implanted inhibit cholesterol production, series has also been designed for ease of use. compromising the performance and hence via catheter-based and potentially affords greater Its compact, ergonomic design features a good visualisation during the procedure is methods. LDL-C clearance and reduc- large, programmable touch screen panel lay- achieved. A stiffer proximal shaft with softer The PARTNER tion of plasma cholesterol. out for quick access to frequently-used con- distal shaft allows exceptional pushability, trial is a prospective Importantly, pitavastatin is trols. The ProSound Alpha 6 is also designed smooth torque transition, and enhanced con- randomised study only minimally metabolised to be mobile and is economically and envi- trol. Back up support even in tortuous anatomy with two separate by the liver through the ronmentally friendly, with reduced power and difficult to reach lesions is maintained. treatment arms. In cytochrome P450 pathway, consumption. Proximal and distal ends have the same diame- the surgical arm, through which many other The ProSound Alpha 7 and the flagship ter with teflon coating which enhances pusha- patients are ran- medications are metabolised. model, the ProSound Alpha 10 are also to bility and deliverability. Optimum pushability, domised to receive In pivotal phase III trials, receive a number of upgrades, as part of the shape retention, kink resistance, torque control Livalo effectively reduced 2009 Performance Upgrades. The ProSound and deliverability are achieved with Alviguide Edwards’ SAPIEN valve LDL-C and improved other Alpha 7 2009 Performance Upgrade features guiding catheter.

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28 Cardiovascular News International Issue 15 September 2009 Clinical News

tinguished institutions in the nation to offer Clinical Research Institute is responsible for (p<0.001), a 46% reduction. Accumetrics this innovative technology to patients who the design, conduct and analysis of the overall
In the same population, the number of have no other treatment alternatives available study. patients requiring post-operative ventilation GRAVITAS trial to them,” said Anderson. “The implantation was reduced from 75.6% in the sternotomy marks the culmination of nearly three decades group to 50.3% in the Port Access group enrols 50% of of research and development and the technolo- HeartWare (p<0.001). Further, substantially fewer Port gy has finally reached the point where an arti- Access patients required prolonged ventila- the patients ficial heart has become a real option for end- International tion (defined by the Society of Thoracic stage heart failure patients. We believe this Surgeons as greater than 24 hours): 5.4% Accumetrics has announced that it has procedure is a significant step toward offering surpasses 50 compared to 11.8% with full sternotomy reached the halfway mark (1,600 patients) in new hope and a future to patients who may (p=0.039). the enrolment of its landmark clinical trial, still have more quality time with their family implants in the US
Trends in the mitral valve replacement data GRAVITAS (Gauging Responsiveness with a and loved ones.” supported the findings in the repair cohort, VerifyNow Assay Impact on Thrombosis and HeartWare International has announced that but due to a smaller patient population size Safety). HeartWare has surpassed 50 implants in the US (n=42), statistical significance was not The trial is specifically designed to demon- 2,000 Xience V under its ADVANCE clinical trial, marking an achieved for as many endpoints. One excep- strate the value of providing clinicians with important early enrolment milestone. The 50th tion was the 64% reduction in intensive care actionable information for patients who are patients may be implant was performed at the Texas Heart unit length of stay from 147 hours in the poor responders to clopidogrel (Plavix). The Institute in Houston by O H Frazier, a distin- sternotomy group to 53 hours in the Port multicentre, placebo controlled trial will deter- eligible to new trial guished surgeon, scientist, and academician Access group (p=0.016). mine whether tailored antiplatelet therapy for renowned for his research and development of Ryan and his co-authors conducted a retro- poor responders, identified based on the results Abbott has announced the expansion of the new cardiovascular surgical techniques and spective review of outcomes from matched of the company’s VerifyNow P2Y12 Test, company’s XIENCE V USA post-approval ventricular assist devices. “We are very pleased patient groups at a single centre undergoing reduces major cardiovascular adverse events study designed to evaluate the safety and with the early clinical results of this small mitral valve repair or replacement with either (heart attack, stent thrombosis) following per- effectiveness of the company’s Xience V pump. Its unique inflow cannula and small size a full sternotomy or the Port Access approach cutaneous coronary intervention (PCI). everolimus-eluting coronary stent system in a enable us to place the device without a surgical through a minithoracotomy (an average inci- Currently the trial is being conducted at more real-world clinical setting out to five years. pump pocket, which greatly reduces the risk of sion of 4.1cm in length). Patients who were than 70 sites in the US and Canada, with a The expansion allows for more than 2,000 serious infection. The improved pump simpli- not candidates for Port Access surgery, prima- total enrolment goal of approximately 2,800 patients from the XIENCE V USA trial to be fies implantation and allows for optimal func- rily due to their vasculature, were screened patients. eligible to cross over into the landmark Dual tion, even in difficult cases where the out. Data were extracted from the researcher- Anti-Platelet Therapy (DAPT) trial, an indus- myocardium is thin or the apex of the ventricle s’ STS-certified, audited database between try-wide collaboration with medical device and is difficult to access,” said Frazier. January 1996 and November 2008. First FDA- pharmaceutical companies. The ADVANCE trial is an FDA approved The full research has been accepted for pub- The first patient was enrolled into the IDE study designed to evaluate the lication later this year in the Journal of Heart approved AbioCor XIENCE V USA expansion by James HeartWare Ventricular Assist system as a Valve Disease. A similar analysis of aortic Hermiller, director, Cardiac Catheterization bridge to heart transplantation for patients valve replacement and repair procedures was implant performed Labs, The Care Group at St Vincent Hospital with end-stage heart failure. The primary end- conducted and is expected to be presented at in Indianapolis, US. Hermiller is a principal point of the trial is survival at 180-days post the Southern Thoracic Surgical Association Abiomed has announced the successful investigator of the XIENCE V USA trial along surgical implantation. Under the IDE, a total meeting in November 2009. implant of its AbioCor Total Replacement with Mitch Krucoff, director, Cardiovascular of 150 patients will be enrolled across a max- Heart, performed at Robert Wood Johnson Devices Unit, Duke Clinical Research Institute imum of 28 centres. Currently, 16 centres are University Hospital by Mark Anderson, associ- in Durham. enrolling patients. HeartWare expects the Sunshine Heart ate professor of surgery at UMDNJ-Robert The XIENCE V USA trial expansion allows number of active centres to expand steadily Wood Johnson Medical School and chief of for an additional 3,000 patients to be enrolled over coming months as the balance of the 28 implants first the section of cardiac surgery at both the med- into Abbott’s study, which was originally sites work through the steps required to begin ical school and Robert Wood Johnson designed to study 5,000 patients in the US. enrolling patients. female C-Pulse University Hospital. This is the first AbioCor The primary endpoint of XIENCE V USA is a implant since the completion of clinical trials measure of stent thrombosis every year out to patients in the US and Humanitarian Device Exemption (HDE) five years, as defined by the Dublin/Academic Improved approval from the FDA on 5 September 2006. Research Consortium. Sunshine Heart has announced that the Jewish The 76-year-old male patient was diagnosed The DAPT trial is an independent, large- outcomes with Hospital in Louisville, US, has completed with congestive, end-stage heart failure and scale study in size (20,000+patients) and scope implants of the company’s C-Pulse heart assist did not qualify for a heart transplant or other intended to determine the appropriate duration Port Access system in two female patients, ages 55 and 58, available therapies, making him eligible for the for dual antiplatelet therapy as well as the safe- respectively, under a clinical trial approved by AbioCor implant. More than one week after ty and effectiveness of DAPT to protect System the FDA. These procedures mark the first US the surgery, the patient is showing signs of a patients from stent thrombosis and major female patients treated with the C-Pulse heart strong and stable recovery. adverse cardiovascular and cerebrovascular Edwards Lifesciences has announced that assist system. “We are honoured to be among the few dis- events following the implantation of either a new research demonstrates that using its min- The C-Pulse system was implanted by Mark drug-eluting or bare metal stent. imally invasive Port Access System in mitral Slaughter, professor of surgery and chief of the The DAPT concept was devel- valve surgery significantly decreases the Division of Thoracic and Cardiovascular oped by a consortium of eight length of stay in hospitals and intensive care Surgery at the University of Louisville. companies (four major stent units, and improves other outcomes when “It is an honor to have completed the first manufacturers, includ- compared to conventional sternotomy. US implants of the C-Pulse heart assist sys- ing Abbott, and Results were presented at the Society for tem in female heart failure patients,” said four manufactur- Heart Valve Disease 5th Biennial Meeting in Slaughter. “C-Pulse is highly innovative and ers of Berlin, Germany. implanted with a simple, low-risk minimally antiplatelet “The data show statistically significant invasive surgical procedure. The device has medications) patient benefits, as well as the potential for the potential to offer a new therapy option for who came togeth- reducing hospital costs associated with lengthy the treatment of advanced heart failure.” er to address an stays and certain complications, when using the “We are excited to be a part of the C-Pulse FDA) request for this Port Access System in mitral valve surgery,” clinical trial in the US,” said Sumanth Prabhu, post-market study. The said the study’s lead author, William H Ryan, a professor of medicine and physiology and Harvard cardiac surgeon with Cardiopulmonary director of Heart Failure at the University of Research Science and Technology Institute, Louisville and co-principal investigator of the Dallas, US, Medical City Dallas Hospital, trial at Jewish Hospital. “The C-Pulse system Dallas, and the Heart Hospital Baylor, Plano. is a novel device that increases blood flow to “For mitral valve repair, Port Access surgery the body and to the heart muscle itself without demonstrated substantial reductions in hospital coming into direct contact with the blood. days, intensive care units stay, ventilation time Consequently, the risk of stroke and embolism and return to OR for post-op bleeding,” Ryan appears to be negligible and blood thinning continued. medication is not required.” Among the study’s statistically significant The 20 patient FDA-approved feasibility findings: clinical trial is being undertaken at six US
The 171 patients undergoing mitral valve medical institutions: Northwestern Memorial repair with the Port Access System had total Hospital, The Ohio State Medical Center, hospital stays approximately 1.5 days less Jewish Hospital, Hershey Medical Center of than sternotomy patients (p<0.001). In these the Pennsylvania State University, University AbioCor Total patients, intensive care unit stay was of Florida School of Medicine and University Replacement Heart reduced from 82 hours to 44 hours of Alabama/Birmingham Medical Center.

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Cardiovascular News International Issue 15 September 2009 29 Clinical News

2500U prior to endoscopic vein harvest was First new DeBakey associated with improved acute saphenous vein graft patency in patients undergoing off- heart assist device pump coronary artery bypass. Pre-heparinasa- tion was also linked to a significant reduction implanted by in the incidence and volume of residual clot strands within the vein. Heidelberg cardiac “In our experience, the impact of pre- heparinisation on surgical bleeding is minimal, surgeons making it a promising strategy that may improve patient outcomes with minimally A team of cardiac surgeons headed by invasive vein harvesting,” said lead investiga- Matthias Karck, director of the Department of tor Robert Poston, chief, Division of Cardiac Cardiac Surgery at Heidelberg University Surgery, Boston University, US. Hospital, Germany, was the first in the world HeartAssist The prospective study examined acute to implant the HeartAssist 5 ventricular assist patency rates in 460 patients that underwent device, the modern version of the DeBakey left ventricle and it works very quietly and off-pump coronary artery bypass using veins ventricular assist device. The device augments effectively with a high flow coefficient,” acquired through endoscopic vein harvest, the pumping function of the left ventricle in an explains Karck. Thus, patients are able to live comparing patients receiving no heparin prior especially effective, gentle and quiet manner. a nearly normal life at home. to harvest (n=306) to those who received one The pump weighs 92g and is made of titanium In Europe, the HeartAssist 5 has CE mark of three doses of heparin prior to the procedure and plastic. It pumps blood from the weakened for both adult and paediatric use. In the US, (n=181). A subset of the most recent 110 or failed left ventricle into the aorta. the HeartAssist 5, formerly DeBakey VAD patients underwent catheter-based infrared “Following the 3.5 hour surgery, the patient Child, is the only FDA-approved paediatric imaging (OCT) of the full tract of harvested is doing fine,” reports Karck. The 50-year-old Michael DeBakey ventricular assist device. A bridge-to-transplant saphenous vein in order to measure residual woman suffered from heart failure that could IDE clinical study is currently underway in the clot within the vein. Overall, vein graft paten- not be effectively treated with medication. Baylor College of Medicine in Houston, who US for adults. cy was 98.9% in patients treated with heparin Since a heart transplant was not an option due died in 2008 at the age of 99. The modern ver- compared to 95.2% in the controls (p<0.05). In to medical reasons, the implanted heart pump sion of the device, the HeartAssist 5, is manu- the subset of the most recent patients, 42% will now assist her heart permanently. factured by the US company MicroMed Heparin use prior receiving pre-heparinasation showed residual “The heart pump can also be used as a Cardiovascular. It is considered to be a fifth clot in the harvested vein compared with 85% bridge-to-transplant while the patient waits for generation ventricular assist device because it to endoscopic vein of patients that did not receive heparin a matching donor heart,” says Arjang can be implanted adjacent to the heart and has (p<0.05). Clot volume and the percentage of Ruhparwar, senior registrar in the Department an exclusive flow probe that provides direct, harvest improves the vein containing clot were also significantly of Cardiac Surgery in Heidelberg. When a accurate measurement of blood flow from the reduced with the use of heparin prior to endo- donor heart becomes available, the pump and left ventricle to the aorta. The new miniature graft patency scopic vein harvest. the diseased heart are both removed and device is light, easy-to-handle and can be mon- “The data are evidence that with pre- replaced by the new donor heart. itored and controlled externally. Maquet Cardiovascular has announced that heparinisation, endoscopic vein harvest can be The DeBakey ventricular assist device was “The new device has great advantages – at data presented at the annual meeting of the performed with excellent patency results in first developed in the 1990s in cooperation only 92g, it is the smallest and lightest International Society for Minimally Invasive patients who require coronary artery bypass with the NASA by Michael DeBakey, the approved ventricular assist device in Europe Cardiothoracic Surgery showed that adminis- grafting, reinforcing the efficacy of this proce- renowned American cardiac surgeon at the that can completely replace the function of the tration of a heparin bolus with doses as low as dure,” said Poston.

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Cardio West the Jervis patents. The ‘141 patent covers self- Father of the total artificial heart expanding medical devices using stress to restrain a metal alloy that will expand to its artificial heart original shape upon being released from a restraint, such as a sheath. For example, this is honoured invention allows doctors to locate and expand a medical device to repair holes in the heart, treat The life and accomplishments of Willem Johan aortic aneurysms, place stents within the periph- Kolff, the world’s most prolific inventor of eral vasculature or treat damaged or diseased artificial organs, was honored on 31 August heart valves via a less invasive, transcatheter during the Kolff Memorial Symposium in The heart valve procedure. The ‘957 patent, which Netherlands, where he was born. Kolff passed expired in 2004, covers a method of treatment away at the age of 97 on 11 February 2009. using shape memory alloys, such as nitinol, in Among Kolff’s many accomplishments accordance with the Jervis inventions. were the artificial kidney, heart-lung machine, artificial eye, artificial ear and arti- ficial arm. However, he was best known for GE Healthcare and his decades of work that culminated in the first human implant of a permanent total arti- TomTec announce ficial heart in 1982. “Over the years, there have been hundreds cooperation of total artificial heart designs,” said Steve Langford, SynCardia’s senior clinical support settled substantially all intellectual property liti- GE Healthcare and TomTec Imaging Systems specialist who started with the total artificial Medtronic and gation affecting the stent design and stent deliv- have entered into a formal strategic cooperation heart in 1983. “It is a true testament to Dr ery systems of its bare metal and drug-eluting contract to boost their excellence in echocardio- Kolff’s work that his total artificial heart has Abbott resolve stent franchise. As a result, Medtronic will now graphy. This new cooperation is designed to been implanted more than 800 times, and is the focus more resources on efforts to improve ensure a seamless integration of TomTec’s only one that is approved and in use world- patent disputes health care for patients with vascular disease. CardioArena program for analysis of 2D/3D/4D wide today.” data into GE Healthcare’s cardiology IT solu- At the symposium, Michiel Morshuis, senior Medtronic has announced global resolution of tions portfolio, Centricity Cardiology. physician and heart surgeon at the Heart & all outstanding intellectual property litigation Medtronic TomTec integrates its clinical application Diabetes Center NRW in Bad Oeynhausen, with Abbott. Terms of the agreement stipulate packages for the routine workflow, as well as Germany, presented on clinical experience that neither party will sue each other in the field favoured in dispute advanced 3D/4D applications. TomTec’s clini- with the modern version of Kolff’s total artifi- of coronary stent and stent delivery systems for cal application packages are available for the cial heart, the SynCardia temporary a period of at least 10 years, subject to certain with AGA Medical visualisation and quantification of the LV, RV CardioWest Total Artificial Heart. He also conditions. The agreement includes a US$400 and MV, vascular measurement and arterial introduced the 12-lb wearable discharge driver million settlement payment to be made to Medtronic has announced that a federal US dis- health and comprehensive 2D image review currently under development that is designed Abbott and also results in a US$42 million suc- trict court jury in San Francisco awarded it and measurements. Centricity Carddas and to power the total artificial heart outside the cess payment to evYsio Medical Devices, as US$57 million in past damages, finding that CA1000 is a successful combination of hospital. part of a Medtronic sublicense to Abbott of the AGA Medical’s manufacture, sale and use of its advanced clinical reporting functionalities and The Heart & Diabetes Center NRW has per- evYsio stent design technology. In connection Amplatzer Occluder and vascular plug product traditional DICOM viewing capabilities formed more than 130 implants of the total with the settlement, Medtronic expects to report lines infringed claims of two US patents owned enabled with the latest 3D clinical analysis artificial heart. The hospital also pioneered the in its first quarter financial results a special by Medtronic. The jury also ordered that AGA tools. GE Healthcare’s Centricity Cardiology development and use of the first portable driv- charge to be calculated in accordance with gen- pay Medtronic a royalty of 11% on future US solution received the 2008 Frost & Sullivan er to allow stable total artificial heart patients erally accepted accounting principles. sales of the infringing products through 2018. Product Line Leadership Award for offering a in Europe to enjoy a quality life at home while Following the resolution of these disputes The patents involved in this case are US comprehensive package to manage single and they wait for a matching donor heart. with Abbott, Medtronic has now resolved or Patent Nos. 6,306,141 and 5,067,957, known as multi-vendor cardiology environments.

Calendar Cardiovascular News International 21–25 September Pulmonary Rehabilitation) 17–21 October to Arrhythmias in Heart Conference Centre Editor: TCT 2009 – Transcatheter Annual Meeting 2009 23rd EACTS Annual Meeting Failure: From Basic Tel: 44 (0)1865 391836 Dr Kevin Fox Cardiovascular Therapeutics Pittsburgh, US – The European Association Principles to Treatment Fax: 44 (0)1865 391836 Publisher: San Francisco, US Tel: +1 (312) 321 5146 for Cardio-Thoracic Surgery Sophia Antipolis, France Email: [email protected] Stephen Greenhalgh The Moscone Center Email: [email protected] Vienna, Austria European Heart House We: www.bsh.org.uk Tel: 866 695 5498 (US and Web: www.aacvpr.org Tel: +44 (0)1753 832166 Tel: +33 (0)4 9294 7600 Managing Editor: Canada) Fax: +44 (0)1753 620407 Fax: +33 (0)4 9294 8646 30 November–1 December Marcio Brito, Tel: +1 514 228 3034 1–4 October Email: [email protected] Email: [email protected] Cardiologia&Arte 2009 [email protected] (international) ASNC 2009 – The 14th Web: www.eacts.org Web: www.escardio.org/EHRA Campus on Arrhythmias Editor: Fax: +1 514 228 3074 Annual Scientific Session of Milan, Italy Lisa Glass, Email: [email protected] the American Society of 18–21 October 3–4 November Sesto San Giovanni [email protected] Web: www.tctconference.com Nuclear Cardiology Heart Rhythm Congress – 3rd Indo-European Course on Tel: +39 0541 305836 Advertising: Minneapolis, US HRC 2009 Revascularisation Fax: +39 0541 305842 Sanna Eronen, 13–14 October Tel: +1 (301) 215 7575 Birmingham, UK Paris, France Email: [email protected] [email protected] Ilegx – Interdisciplinary Leg Fax: +1 (301) 215 7113 Hilton Birmingham George Pompidou Hospital Web: www.cardiologiaearte.org Design: Initiative Email: [email protected] Metropole Tel: +91 11 2987 1034 David Reekie Munich, Germany Web: www.asnc.org Tel: +44 (0)1789 451831/2 Fax: +91 11 2994 5827 9–12 December Holiday Inn Munich City Fax: +44 (0)1789 450682 Email: [email protected] Euroecho 2009 Layout: Centre 4–7 October Email: congress@ Web: www.indoeurocardiology Madrid, Spain Matt Hadfield Tel: +44 (0)20 7736 8788 Venice Arrhythmias 2009 heartrhythmcharity.org.uk course.com Tel: +33 (0)4 9294 7600 Fax: +44 (0)20 7736 8283 Fondazione Giorgio Cini, Web: www.heartrhythmcongress. Fax: +33 (0)4 9294 7601 Cardiovascular News Email: [email protected] Isola di San Giorgio Maggiori com 14–18 November Email: [email protected] International is published by Web: www.ilegx.com Venice, Italy AHA (American Heart Web: www.escardio.org/euroecho BIBA Publishing, a division of Tel: +39 0541 305822 20–23 October Association) Scientific BIBA Medical Ltd. 24–25 September E-mail: [email protected] 30th National Meeting of the Sessions 2009 14–16 January 2010 Head Office: Europe AF Web: www.venicearrhythmias.org Italian Society of Invasive Orlando, USA 15th Annual Boston Atrial BIBA Publishing Ltd, London Hilton Metropole Cardiology Tel: +1 (214) 570 5935 Fibrillation Symposium, 44 Burlington Road, Hotel, London, UK Bologna, Italy Fax: +1 (214) 706 5262 14–16 October Mechanisms and New Fulham, London SW6 4NX, UK Tel: +44 (0) 1455 552559 XI Congres Francophone de Palazzo della Cultura e dei Email: [email protected] Directions in Therapy Tel: +44 (0) 20 7736 8788 Email: eurpeaf@millbrook Cardiologie Interventionnelle Congressi Web: www.scientificsessions.org Boston, USA Fax:+44 (0) 20 7736 8283 conferences.co.uk Paris, France Tel: +39 055 50351 Seaport Hotel & Conference Web: www.europeaf.com Hotel Meridien Etoile Fax: +39 055 5001912 26–27 November Center, The World Trade Tel: +33 (0)1 4192 0120 Email: [email protected] 12th British Society for Heart Center Copyright ©: BIBA Medical Ltd. All rights 30 September–3 October Fax: +33 (0)1 4641 0521 Web: www.oic.it/gise2009 Failure Annual Autumn Tel: +1 (603) 897 5510 reserved. No part of this publication may be reproduced, stored in a retrieval system, AACVPR (American Email: [email protected] Meeting 2009 Fax: +1 (603) 578 9666 transmitted in any form or by any other Association of Web: www.congres-cfci.com 23–24 October London, UK Email: [email protected] means, electronic, mechanical, photocopy- Cardiovascular and Pharmacological Approach Queen Elizabeth II Web: www.afsymposium.com ing, recording or otherwise without prior per- mission in writing of the editor.

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