In Memoriam: Participants Who Received Dabigatran Fect,” Write the Researchers in NEJM

April Issue

App 17 36 Uninterrupted dabigatran Martin Burke: Artificial intelligence outperforms warfarin in atrial Page 9 fibrillation ablation Thomas F Deering: Results from RE-CIRCUIT, the largest trial to compare the uninterrupted use of a non-vitamin K antagonist oral anticoagulant (NOAC) with uninterrupted use of warfarin in Profile the context of atrial fibrillation (AF) ablation, have shown that uninterrupted dabigatran Page 12 (Pradaxa, Boehringer Ingelheim) was associated with fewer bleeding complications than uninterrupted warfarin before, during and after AF treatment with ablation.

he findings offer evidence that major bleeding events with dabigatran Roberto Keegan: dabigatran is a safe and effec- may be related to the more specific The new LAHRS Ttive alternative to warfarin in mechanism of action (direct thrombin the context of AF ablation. The trial inhibition rather than a decrease in the Page 17 showed a 5.3% reduction in its pri- production of several coagulation fac- mary endpoint, major bleeding events tors) and shorter half-life of dabigatran during ablation or in the first two as compared with warfarin, as well as months after the procedure, with ma- the presence of normal levels of factor jor bleeds occurring in 1.6% of study VII and a stable anticoagulation ef- In memoriam: participants who received dabigatran fect,” write the researchers in NEJM. and 6.9% of patients on warfarin. With regards to secondary safety Mark E Josephson RE-CIRCUIT (Randomized evalu- and efficacy endpoints, there were ation of dabigatran etexilate compared no events of stroke, systemic embo- Mark E Josephson, a pioneer of clinical to warfarin in pulmonary vein abla- lism, or transient ischaemic attack cardiac electrophysiology (EP), passed tion: Assessment of an uninterrupted (TIA) in the dabigatran group and away at the age of 73 on 11 January 2017 periprocedural anticoagulation strat- Hugh Calkins only one event of TIA in the warfa- after a courageous battle with cancer. With egy) was presented by Hugh Calkins rin group from the time of ablation his passing, the EP community lost a great (Johns Hopkins Hospital, Baltimore, NEJM. However, the practice of until eight weeks after ablation. physician whose achievements will be USA) at the 2017 Scientific Session of switching anticoagulants “is cumber- The incidence of minor bleeding remembered for years to come. Andrew L the American College of Cardiology some” and sometimes “impractical” events was similar in the two groups Wit (Emeritus Professor of Pharmacology, (ACC; 17–19 March, Washington, for patients and physicians, they note. (18.6% of patients in the dabigatran Columbia University College of Physicians DC, USA) and simultaneously pub- RE-CIRCUIT is the largest trial group and 17% in the warfarin and Surgeons, New York, USA), a close lished in The New England Journal of to compare the uninterrupted use group). The composite incidence of professional colleague and friend of Medicine (NEJM). of NOACs to uninterrupted use of major bleeding events and throm- Josephson for over 40 years, writes this “I think it is great news for the warfarin in the context of AF abla- boembolic events, including stroke, tribute for Cardiac Rhythm News. field,” said Calkins. “There have been tion. This randomised, open-label, systemic embolism or TIA, was very few randomised studies focused multicentre, controlled study— lower in the dabigatran group than in ark E Joseph- on doing ablation procedures in fully funded by Boehringer Ingelheim— the warfarin group (1.6% vs. 7.2% son’s death is anticoagulated patients, and the use enrolled 704 patients scheduled for patients). No deaths were reported. Man extraordi- of NOACs has been increasing dra- ablation of paroxysmal or persistent Additionally, the authors noted nary loss to his family, matically. I expect these findings will AF at 104 sites in 11 countries and the availability of idarucizumab (ap- friends, colleagues and to encourage clinicians to quickly shift to randomly assigned patients to receive proved reversal agent for dabigatran) medicine and cardiology. doing this procedure with uninter- either dabigatran (150mg twice daily) as a “potential advantage of the His life was inextricably rupted use of NOACs.” or warfarin (target international periprocedural use of dabigatran”. intertwined with the Previous studies have shown normalised ratio, 2.0 to 3.0). Patients At ACC, Calkins said: “the avail- development of clinical the performance of AF ablation on started anticoagulant therapy four to ability of the specific reversal agent cardiac EP. Josephson was Mark E Josephson uninterrupted anticoagulation with a eight weeks before ablation and used idarucizumab, while not needed one of the pioneers of this (photo by Jan de Jonge) vitamin K antagonist (VKA)—such it continuously for up to eight weeks in any patient in this trial, further relatively new medical as warfarin—helps to minimise the after the procedure. The primary motivates the adoption of uninter- discipline which was born invention of the electrocar- risk of thromboembolic and bleeding endpoint was the incidence of major rupted dabigatran as the preferred in the 1960s. A recently diogram (ECG) in 1903, events, which are major complications bleeding events during and up to anticoagulation strategy in patients published book details his using deductive reasoning, of this procedure, commented Calkins. eight weeks after ablation and sec- undergoing AF ablation.” legacy and aptly identifies had established classifi- Data on the use of NOACs around the ondary endpoints included thrombo- Results of VENTURE AF the “Josephson School” cations of arrhythmias time of catheter ablation are limited. embolic and other bleeding events. (Cappato R et al. Eur Heart J of electrophysiologists according to sites of origin, “Most electrophysiologists have In total, the researchers analysed 2015;36(28):1805-11), the first trained by him, who will and hypothesised mecha- interrupted the dose of NOACs before data from 635 patients of the ablation prospective randomised trial of carry out his legacy.1 nisms.2 However, clinical catheter ablation, out of concern that set: 317 patients (mean age 59.1±10.4 uninterrupted rivaroxaban (Xarelto, When Josephson began EP was not born until the bleeding complications could lead to years; 72.6% male) received da- Bayer) and VKAs in patients with his electrophysiology 1960s when invention of worse outcomes in the presence of an bigatran and 318 patients (mean age non-valvular AF undergoing catheter training in the laboratory the electrode catheter ena- irreversible anticoagulant. High-risk 59.3±10.3; 77% male) received war- ablation, randomly assigned 248 of Anthony N Damato bled the heart to be electri- patients receiving NOACs often had farin. Dabigatran showed significant patients to either treatment and at the US Public Health cally stimulated directly their treatment changed over to VKAs improvement over warfarin for the showed the use of uninterrupted oral Service Hospital in Staten and electrical activity to periprocedurally, so that ablation could study’s primary endpoint, major bleed- rivaroxaban was feasible and event Island, USA, in 1971, be recorded from localised be performed with continuous anti- ing events, and was associated with rates were similar to those for unin- clinical EP was in its in- regions without thora- coagulation, and then were switched fewer periprocedural pericardial tam- terrupted VKA therapy. fancy. Brilliant minds over cotomy, in Amsterdam back to a NOAC, one or two months ponades and groin haematomas than Calkins has received lecture hono- five decades following the Continued on page 2 after ablation” write the authors in warfarin. “The mechanism of reducing raria from Boehringer Ingelheim. April Issue 2 Obituary 17 36

centred on the belief that an understanding of mechanisms is the foundation of future In memoriam: Mark E Josephson development of clinical cardiac EP. The Continued from page 1 treatment of patients should not be based and in Paris independently. In Amsterdam, only on published algorithms for the type of Dirk Durrer, Hein J Wellens and Reinier arrhythmia under consideration but should Schuilenburg showed that programmed pre- also involve an understanding of the basic mature stimuli using a specially designed electrophysiology. Those students who stimulator, applied to the atria or ventricles master these basics will be the ones who initiated tachycardia in patients with acces- will make innovative contributions and sory atrioventricular (AV) pathways.3 This devise new therapies in the future. To this was the origin of programmed electrical end he also wrote the “bible” of clinical stimulation (PES) to induce and terminate electrophysiology, Josephson’s Clinical tachycardias that were interpreted to be Andrew L Wit Mark Josephson teaching about Cardiac Electrophysiology, which is now in caused by reentrant excitation. Subsequent- complex arrhythmias, a course he gave its fifth edition.11 It is one man’s approach ly Wellens and his colleagues used PES and technique of endocardial catheter mapping with Hein J Wellens, sponsored by to the practice of clinical EP based on his intracardiac recordings to demonstrate that of VT.8 This approach led to recognition of Medtronic (photo by Rich Wawrzynski) many years of experience. It is extraordi- other supraventricular tachycardias as well the subendocardial origin of the majority of narily comprehensive. Another textbook as ventricular tachycardias could be induced these arrhythmias adjacent to aneurysms.8 became chief of cardiology. All in all, he focused more on basic electrophysiological and terminated by stimulation and were also What followed was the innovative surgical eventually co-authored over 50 publications mechanisms just went to press.12 likely caused by reentry..3,4 technique of subendocardial resection on this subject. In addition, he contributed I had a close personal and professional The Damato group then began using where a subendocardial layer of tissue to our current understanding of AV nodal relationship with Mark Josephson through- PES of the atria to define conduction and was stripped off from around an aneurysm reentrant tachycardia, atrial flutter and out our careers. I have worked with him in refractory properties of the components (along with resection of the aneurysm).9 fibrillation and ventricular fibrillation and the laboratory and the class room and have of the AV junction in normal and diseased Continuing these investigations, the defibrillation. He helped design and par- spent many hours with him at the dinner hearts. The Damato lab was one of the Josephson group described the properties ticipated in many major clinical trials that table over the past 40 years. He has been earliest laboratories in the USA that had a of the electrophysiological substrate for VT. have altered and improved clinical care of an important part of my life. I will miss major involvement in the development and Mapping during sinus rhythm, they showed patients with arrhythmias (references to all him greatly. growth of clinical EP owing to the pioneer- abnormal electrograms that provided mark- his studies can be found in reference 1). Continue reading special tributes for Mark ing development of the catheter technique ers for locating the reentrant circuits.10 Sub- Throughout his career, Josephson was E Josephson on pages 10 and 11. devoted to teaching and training the next for recording electrical activity from the sequent investigations defined the properties References His bundle by Benjamin J Scherlag in that of the circuits including their size and shape, generation of cardiac electrophysiologists. 1. Wellens HJ, et al. The Josephson School. A legacy of 5 important contributions to electrophysiology. Cardiotext 2016 laboratory. Josephson’s initial research the cause of slow conduction, the nature His nurturing of his fellows who became 2. Scherf D and Schott A. Extrasystoles and Allied with this group described the clinical EP of the excitable gap and localisation of the life-long friends, produced the second Arrhythmias. A William Heinemann Medical Book Publication 1 1973 of antiarrhythmic drugs, properties of the pathways using the 12 lead ECG. generation of clinical electrophysiologists 3. Wellens HJJ. Electrical stimulation of the heart in the study AV conduction system, and mechanisms This extraordinary output of new and that have made many important contribu- and treatment of tachyarrhythmias. Leiden: Stenfort Kroese 1971 1,6 of supraventricular tachycardia. Perhaps exciting information on the electrophysi- tions of their own to the growth of clinical 4. Wellens HJ et al. Electrical stimulation of the heart EP. They now have their own students (third in patients with ventricular tachycardia. Circulation more importantly, this is where he began to ology of VT in the late 1970s and 1980s 1972;46:216‒226 formulate his ideas about mechanisms and were eventually translated into innovative generation) entering the world of electro- 5. Scherlag BJ et al. Catheter technique for recording His bundle activity in man. Circulation 1969;39:13‒18 treatment of ventricular tachycardia (VT). therapeutic methodologies, which are now physiology. These generations insure that 6. Josephson ME et al. Effects of lidocaine on refractory After leaving this laboratory, Josephson widely used tools of clinical EP. These the Josephson School of Clinical Cardiac periods in man. Am Heart J 1972;84:778‒776 7. Josephson ME et al. Recurrent sustained ventricular went to the University of Pennsylvania in methodologies include PES to induce and Electrophysiology and Mark Josephson’s tachycardia. 1. Mechanisms. Circulation 1978;57:431‒440 1973 to join a fledgling cardiac EP group terminate VT, catheter mapping during legacy will be perpetuated.1 8. Josephson ME et al. Recurrent sustained ventricular tachycardia. 2. Endocardial mapping. Circulation and within a few years, was head of that sinus rhythm and VT to locate the sites of Josephson has also reached thousands of 1978;57:440‒7 9. Josephson ME et al. Endocardial Excision: A new group while still a cardiology fellow. It was reentrant circuits, entrainment techniques electrophysiologists through courses at both surgical technique for the treatment of recurrent ventricular at Penn in the mid to late 1970s that he be- to locate the critical isthmus of the circuits the beginning and advanced levels in the tachycardia. Circulation 1979;60:1430‒1439 10. Cassidy DM et al. Endocardial catheter mapping gan to publish his series of ground-breaking and catheter radiofrequency ablation at United States and Europe. These courses in patients in sinus rhythm: Relationship to underlying studies that has had a lasting influence on critical sites to prevent VT, replicating have been mostly taught with Wellens (Car- heart disease and ventricular arrhythmias. Circulation 1986;73:645‒652 clinical EP to the present day. Josephson the effects of the original subendocardial diovascular Research Institute, Maastricht, 11. Josephson ME. Josephson’s clinical cardiac and colleagues used systematic multi-site resection technique. The Netherlands) who as mentioned above, electrophysiology. Techniques and interpretations. Wolters Kluwer 2016 programmed stimulation to initiate and Josephson continued his studies on VT was one of the founding fathers of clinical 12. Wit AL, Wellens HJ and Josephson ME. Electrophysiological foundations of cardiac arrhythmias. terminate sustained VT resulting from after he moved to Beth Israel Hospital, EP. Many of the courses were mechanism- A bridge between basic mechanisms and clinical myocardial infarction7 and developed the Boston, USA, in 1992, where he eventually based. The philosophy of this approach is electrophysiology. Cardiotext (in Press)

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facebook.com/cardiacrhythmnews @CRN_publishing CRN App www.cardiacrhythmnews.com April Issue 17 36 Advertorial 3 CASE REPORTS CASE 1: Mapping a complex left CASE 2: Multiple morphologies ventricular substrate using EnSite of left atrial flutter sequentially Precision™ Cardiac Mapping mapped using EnSite Precision™ System Automated Mapping, Score Automated Mapping and Map, and AutoMark SparkleMap By Michael Kwasman, cardiac electrophysiologist, Providence By Rakesh Latchamsetty, cardiac electrophysiologist, University Sacred Heart Medical Center, Spokane, USA of Michigan Health Center, Ann Arbor, USA

Case description Case description to generate high density maps of A male patient with a history of ischaemic A female under the age of 45 with complex left atrial arrhythmias that cardiomyopathy, myocardial infarction due a history of atrial fibrillation/atrial may arise post ablation. to occlusion of the circumflex, drug refrac- flutter and two prior pulmonary vein tory (amiodarone) ventricular tachycardia isolation procedures was studied Rx Only (VT), and a bi-ventricular implantable and mapped using the Abbott EnSite Brief Summary: Prior to using these cardioverter defibrillator (ICD) was mapped Precision™ Cardiac Mapping System devices, please review the Instructions using the Abbott EnSite Precision™ Cardiac Figure 1: High Density (3,698 points) which includes the new EnSite™ for Use for a complete listing of Mapping System. Because the patient was Peak-to-Peak Voltage map created with AutoMap module and SparkleMap indications, contraindications, pacemaker-dependent, bi-ventricular pacing duodecapolar mapping catheter feature. An Advisor™ FL circular warnings, precautions, potential was mapped via the EnSite™ AutoMap mapping catheter, Sensor Enabled™ adverse events and directions for use. module functionality using a steerable with a magnetic sensor was used duodecapolar mapping catheter with twenty to create a high resolution biatrial 1mm electrodes (2-2-2mm spacing). A model which was automatically high density (3,698 points) bipolar voltage field-scaled with magnetic coordinate substrate map was created (Figure 1). data. A left atrial flutter (cycle length The novel Last Deflection annotation 230ms) was induced with atrial extra- algorithm was used to detect late poten- stimulus pacing and mapped (Figure tials inside of the low-voltage substrate in Figure 2: Local activation timing (LAT) Map 1) with a high density Inquiry™ an aneurysmal region of the basal lateral using Last Deflection Annotation to display Electrophysiology Catheter, Inquiry™ left ventricle (Figure 2). late potentials in aneurysmal lateral wall AFocus II™ DL Catheter circular Electrograms with Fractionated signals mapping catheter with 20 evenly spaced Figure 1: Biatrial LAT map of LAFL1 (CL were automatically tagged using a bipolar electrodes. The novel AutoMap 230ms) and Inquiry™ Electrophysiology Fractionation Threshold of 4 (Figure 3). algorithm was used to acquire mapping Catheter, Inquiry™ AFocus II™ DL Three different morphologies of VT were data with user defined thresholds Catheter electrograms showing a either induced with ventricular extra-stimu- to filter data acquisition. For this posterior wall reentry lus pacing or occurred spontaneously. Local tachycardia, the AutoMap Thresholds Activation Timing (LAT) Mapping was were set as Score=62%, Cycle Length correlated with Score Mapping of pacemap- Tolerance=29ms, Speed Limit=10mm/s, ping data to identify entrance and exit sites Figure 3: Left ventricular (LV) Bipolar Peak- Signal-to-Noise rate=3, and Enhanced of the low voltage substrate with potential to-Peak Voltage map with Fractionated Noise Rejection “ON”. The SparkleMap channels of slow conduction (Figure 4). Signals marked with solid spheres display was used to dynamically depict Irrigated ablation was completed inside wavefront propagation superimposed the low voltage zone to homogenise the on top of the Local Activation Timing scar as well as around the border zone (LAT) Map, the Peak-to-Peak Voltage entrance and exit sites (Figure 5). Map, and the novel Fractionation Map. AutoMarks were used to display le- Ablation in the posterior wall Figure 2: LAT map of LAFL2 (CL sions and impedance drop was used as a converted the left atrial flutter (LAFL) 240ms) and Inquiry™ Electrophysiology colour metric (black >10ohms impedance into a second tachycardia (LAFL2 Catheter, Inquiry™ AFocus II™ Catheter drop, red=5‒10ohms impedance drop, CL=240ms). LAFL2 was mapped showing an anterior wall reentry below yellow=2‒5ohms impedance drop, and Figure 4: Score Map of pacemapping and determined to be an anterior wall the left atrial appendage gray <2ohms impedance drop). from distal ablation at exit site (94% scar-based reentry pivoting around the One morphology of VT was terminated match of VT1) base of the left atrial appendage (LAA) during irrigated ablation (Figure 6) and all (Figure 2). three morphologies were non-inducible Ablation between the base of the at the end of the procedure. Post-ablation appendage and the mitral annulus mapping via the duodecapolar catheter converted LAFL2 (240ms) into a third documented elimination of the conduction LAFL (LAFL3 CL=260ms), which was inside of the low voltage substrate. mapped to be a reentrant circuit along a line of block in the LAA/LSPV ridge Figure 3: LAT map of LAFL3 (CL 260ms) Summary (Figure 3). and Inquiry™ AFocus II™ Catheter This case highlights the flexibility and Figure 5: Comparison of Pre (left) and Ablation in the slow conduction showing a reentry in the LAA/LSPV Ridge advanced utility of this novel automated Post (right) Ablation Voltage Maps with zone at the base of the LAA ridge mapping system to generate high-density AutoMarks Lesions changed the rhythm again into a fourth maps of complex left ventricular substrates LAFL (LAFL4 CL=270ms). This was to facilitate a targeted substrate modification subsequently mapped to be an anterior ablation strategy. left atrial roof rotation. Ablation at the channel of slowest conduction along the Rx Only anterior roof terminated the tachycardia Brief Summary: Prior to using these devic- (Figure 4). es, please review the Instructions for Use for a complete listing of indications, contrain- Summary Figure 4: LAT map of LAFL4 (CL dications, warnings, precautions, potential Figure 6: Termination of VT3 during This case highlights the flexibility of 270ms) and termination during ablation adverse events and directions for use. radiofrequency (RF) ablation this novel automated mapping system of gap on anterior roof April Issue 4 ACC coverage 17 36 Real-world study supports the effectiveness of CardioMEMS HF system in reducing heart failure hospitalisations and cost of care A study of US Medicare patients undergoing pulmonary artery pressures sensor implantation, tell us about the circumstances outside of the clinical trial setting, has suggested that use of this strategy in clinical practice may be that preceded device implantation associated with reductions in heart failure hospitalisation similar to that seen in the clinical trials. and how those circumstances may have changed over time,” they note. he retrospective cohort study of ambulatory setting, rather than during a highlight in JACC. Additionally the authors argue that the Medicare patients receiving an heart failure hospitalisation. Patients in The CardioMEMS HF System greater involvement of the healthcare Timplantable pulmonary artery both the six and twelve month cohorts received US FDA approval in 2014 as team in the post-implantation period of pressure sensor (CardioMEMS HF, had a mean age of 71±11 years, 36% an approach to reducing heart failure CardioMEMS “may have produced a Abbott) presented by Akshay Desai, were women, and a large burden of hospitalisations in patients with chronic decreased heart failure hospitalisation (director of the Heart Failure Disease comorbid medical illness, including heart failure, NYHA Class III functional rate independent of the device-generated Management Program at Brigham and diabetes, hypertension, and chronic capacity, and a hospitalisation for pulmonary artery pressure data.” Women’s Hospital in Boston, USA) obstructive pulmonary disease. heart failure management in the year Finally, Krumholz and Dhruva call for at the 2017 Scientific Session of the Among the 1,114 patients in the six- prior to implantation. The device is “additional independent trials and more American College of Cardiology month cohort, there were 1,020 heart CE mark approved and has a class detailed observational studies to fill the (ACC; 17‒19 March, Washington, DC, failure hospitalisations in the six months IIb recommendation as a directed gaps in knowledge that remain.” USA), identified a 45% lower rate of before implantation, compared with 381 therapy management and monitoring In response to Krumholz and Dhruva’s heart failure hospitalisations during the heart failure hospitalisations, 139 deaths tool for heart failure patients in the editorial comments, Desai told Cardiac six months following device implant and 17 ventricular assist device implants 2016 European Society of Cardiology Rhythm News: “In this observational compared with the six-month period or cardiac transplants in the six months (ESC) guidelines for the diagnosis and analysis, it is not possible to definitively prior to device implantation, and a 34% after implantation (hazard ratio [HR] treatment of acute and chronic heart attribute the reductions in heart failure lower rate of heart failure hospitalisations 0.55; 95% confidence interval [CI]: 0.49 failure. hospitalisations seen during the post- at 12 months post-implant compared to to 0.61; p<0.001). Similar reductions In an accompanying editorial, Harlan implant interval to a beneficial effect of the 12 months prior to implant. These were noted in the subset of 480 patients Krumholz and Sanket Dhruva (Yale implantable haemodynamic monitoring. data are comparable to the 28% reduction with complete data available for 12 School of Medicine, New Haven, USA) As mentioned in the discussion of the in heart failure hospitalisations seen with months before and after implantation question the results of this CardioMEMS results in JACC, other enhancements longitudinal pulmonary artery pressure (HR: 0.66; 95% CI: 0.57 to 0.76; real-world study. They write: “This paper to clinical care in the post-implant monitoring compared to usual care in the p<0.001). responds to the great need for evidence period could have contributed to the randomised CHAMPION (CardioMEMS Reductions in heart failure about CardioMEMS, but unfortunately observed reduction in healthcare heart sensor allows monitoring of hospitalisations were associated with does not have the evidentiary strength utilisation. Nonetheless, these real- pressure to improve outcomes in New reductions in estimated costs associated to inform clinical decisions.” Amongst world data do provide support for the York Heart Association [NYHA] with heart failure care. The estimated their arguments they mention that the notion that the reductions in heart failure functional class III heart failure patients) reduction of $13,190 in comprehensive percentage of advanced heart failure hospitalisations seen with haemodynamic clinical trial that supported initial FDA heart failure costs at one year suggests patients who received the device is “quite monitoring in the randomised approval of this technology. a roughly two-year breakeven point to small”. “The study is observational and CHAMPION clinical trial may be The data were simultaneously recoup the initial device investment for the population that received the device is realisable in clinical practice for selected published with the oral presentation in this cohort. In the six-month data, Desai highly selected. During a period in which heart failure patients.” the Journal of the American College of et al reported a reduction of US$7,433 hundreds of thousands of Medicare Cardiology (JACC). per patient. “These results support the patients were hospitalised with heart The CardioMEMS HF System is an clinical effectiveness and potential failure, only 1,114 received the device,” implantable pulmonary artery pressure cost savings of using an implantable Krumholz and Dhruva write. They also sensor which allows clinicians remote, haemodynamic monitor to help with comment that claims data are good for longitudinal access to daily pulmonary heart failure management,” said Desai. information about health events such as artery pressure measurements to guide “Reducing heart failure hospitalisations heart failure hospitalisations, but “do adjustment of heart failure therapy. is an important goal for patients and not provide sufficient information about From 1,938 US Medicare patients who hospitals alike, and may help to improve patient characteristics and underwent pulmonary artery pressure long-term clinical outcomes and quality cannot sensor implantation from 1 June 2014 of life for our patients.” to 31 December 2015, there were 1,114 “These data, which are robust in who were continuously enrolled and competing risk models and in sensitivity had available data regarding healthcare analyses restricted to survivors utilisation for at least six months before as well as ambulatory implants, and after implantation, and 480 who provide real-world evidence in an had complete data for 12 months before unselected population supporting the CardioMEMS HF and after implantation. The majority incremental value of this approach to of implants (74.7%) occurred in the heart failure management,” Desai et al Pacemakers with Closed Loop Stimulation programming help to reduce recurrence of syncope Patients with refractory reflex vasovagal syncope who received a pacemaker programmed Now a door is open and we have a new possible with Closed Loop Stimulation (DDD-CLS, algorithm from Biotronik) had a seven-fold treatment for these patients,” he noted. reduction in fainting compared with patients in a placebo pacing group, according to Pacemakers with DDD-CLS detect contractions in results from the SPAIN study. the heart muscle that typically occur before an episode of syncope and release an electrical signal that calms he prospective, double-blind, randomised, session at the 2017 Scientific Session of the American the heart down, preventing sudden dips in heart rate placebo-controlled study met its primary College of Cardiology (ACC; 17–19 March, and blood pressure. Tendpoint of a significant reduction (≥50%) Washington, DC, USA). In the SPAIN trial, 54 patients aged 40 or older from in fainting episodes with DDD-CLS compared to Earlier small trials of DDD-CLS had shown 12 medical centres in Spain and Canada were enrolled. placebo pacing, noted study’s lead author Gonzalo mixed results in preventing fainting episodes, Baron All patients had experienced more than five episodes of syn- Baron Esquivias (Virgen del Rocio University Esquivias said. “This study is important because of cope in their lifetimes, with more than two in the past year. Hospital, Seville, Spain) at a late-breaking trial the lack of available treatments for recurrent syncope. Continued on page 8

April Issue 6 Lead extraction 17 36 Cardiac lead extractions safer in high-volume centres Cardiac lead extraction is safer in high-volume centres, according to the largest study of but is dependent on multiple patient factors and contemporary practice in Europe, published in the European Heart Journal. Extraction in a comorbidities that require an advanced and highly low-volume centre was associated with a double the risk of death while in hospital. skilled multidisciplinary team management that may only be facilitated in high-volume centres. In he European lead extraction controlled the event of cardiac major complications occurring registry (Electra) of transvenous lead after the procedure, patients may often be saved, if Textraction outcomes was conducted by the complications are recognised and treated promptly.” European Heart Rhythm Association (EHRA) of the She adds, “The Electra registry was not designed European Society of Cardiology (ESC) under the to define the minimum number of procedures needed EURObservational Research Programme (EORP). to reduce complications and increase success, but if “Indications for transvenous lead extraction are we extrapolate from the data it appears that centres expanding as lead extraction technology improves should perform at least 40 to 50 transvenous lead and extractors become increasingly skilled,” says extraction per year.” lead author Maria Grazia Bongiorni, director of The overall efficacy of transvenous lead extraction the Cardiology, Cardio Thoracic and Vascular was high, with 97% clinical and 96% complete Department at University Hospital, Pisa, Italy. “In radiological success rates. High-volume centres Europe, most centres have only recently started achieved radiological (96.2% vs. 93.4%) and clinical performing transvenous lead extraction and data are (97.3% vs. 94.3%) success more frequently than lacking on indications, techniques, success rates, low-volume centres. “The success of contemporary safety, and follow-up.” transvenous lead extraction is high, independent The Electra registry included 73 centres from from the technique used, but aggressive tools like 19 countries who enrolled 3,555 consecutive powered sheaths are less safe,” says Bongiorni. patients, of whom 3,510 underwent transvenous lead “Infection was the most common reason for extraction. The primary objective was to evaluate transvenous lead extraction (53% of cases), followed the acute and long-term safety of transvenous lead by lead malfunction.” extraction. Secondary objectives were to describe Procedure-related major complications and deaths the characteristics of patients, leads, indications, were more common in women (odds ratio [OR] 2.11), techniques, and outcomes. The complication rate in Maria Grazia Bongiorni and lead dwell time more than ten years (OR 3.54). low- and high-volume (30 or more transvenous lead Predictors of clinical failure included female gender extraction per year) centres was compared. High-volume centres had significantly lower overall (OR 1.81), three or more leads for extraction (OR Data were collected using a web-based system. in-hospital major complications (2.4% vs. 4.1%) and 2.47), and lead dwell time more than ten years (OR No specific protocol for the procedure, materials, deaths (1.2% vs. 2.5%) compared to low-volume 4). Bongiorni says, “Women have smaller and weaker techniques of extraction, or treatment after the centres. In a multivariable analysis, extraction in a blood vessels which are more vulnerable to damage. procedure was mandated during this observational low-volume centre was associated with a doubled risk When leads are in the body for a long time, the risk study. Patients were followed-up 12 months after of death from all causes during the hospital stay and a of fibrosis increases, the adhesions become tenacious, discharge to assess long-term safety and efficacy of doubled risk of clinical failure of the procedure. and the operator needs more energy to detach them transvenous lead extraction. Bongiorni says, “Patients who undergo transvenous from the veins which may cause complications.” The rate of in-hospital procedure-related major lead extraction in a low-volume centre are more She concludes, “Transvenous lead extraction is safe complications (the primary endpoint) was 1.7%, likely to die or have a major complication during and effective, with a low incidence of life-threatening including a mortality rate of 0.5%, with no significant the hospital stay. The outcome of transvenous lead complications. Outcomes may improve even further if differences between high- and low-volume centres. extraction is not confined to the procedure per se centres perform at least 40 to 50 procedures per year.” Registry shows positive results with new mechanical lead extraction device An Italian prospective multicentre registry with a requiring drainage. large study population has demonstrated the safety The authors note that initial and efficacy of a new hand-powered bidirectional single-centre experiences with rotational mechanical lead extraction sheath used in a limited number of patients chronically implanted leads for more than a year. have shown promising results with the new Evolution he study, led by Patrizio companion leads. This second mechanical extraction device. Mazzone (Ospedale San generation device has been “Our multicentre registry TRaffaele, Milan, Italy), designed to address this issue, with a larger study population Federico Migliore (University Mazzone et al note. confirmed and extended these of Padova, Padova, Italy) and Between September observations, demonstrating others evaluated the second 2013 and June 2016, 124 that the new Evolution device generation Evolution RL consecutive patients (84.7% Patrizio Mazzone Federico Migliore is an effective lead extraction mechanical extraction device male, mean age 65±14) tool with high success rates (Cook Medical). This sheath, underwent lead extraction at The authors comment that with the additional use of a with long-implanted leads,” the authors comment, “has four centres in Italy. In total, all of the leads were extracted snare. The overall clinical they write. “The efficacy of been fitted with a bidirectional 238 leads were removed, by via the subclavian approach. success rate was 100% and no this new extraction device is rotational mechanism and a using the new generation Ninety one leads were from complications related to the comparable with that of widely less aggressive tip, reducing Evolution RL device, due implantable cardioverter Evolution sheath were noted. used devices and techniques.” the risk of damage to leads, to cardiac device infection defibrillators (ICDs), 38 were The authors also highlight However, Mazzone et al vascular structures and (50.8%), lead malfunction right ventricular leads, 86 were that there were no deaths or suggest that larger-scale myocardial tissue.” (33.1%), upgrade (0.8%) and right atrial leads and 23 were major complications. Five randomised prospective A first generation of this for other reasons (15.3%). coronary sinus leads. minor complications occurred: studies are needed to verify device has a unidirectional The mean implant duration Mazzone et al report that one pericardial effusion not these findings and to compare rotational mechanism, which of the leads was 92.2±52.9 91.6% of the leads were requiring pericardiocentesis the clinical success, safety and may cause a phenomenon months. Sixty three leads had extracted completely with or surgical intervention, one cost effectiveness of different called “lead wrapping”, been implanted for more than the Evolution RL alone. This pneumothorax and three mechanical lead extraction especially in the presence of 10 years. success rate rose to 98.7% haematoma at the pocket techniques and laser systems. April Issue 17 36 Advertorial 7 Transvenous lead extraction is a safe procedure with low complication rates At present, transvenous lead extraction is a safe and successful procedure with a low complication rate. Its elective nature combined with experience, a multidisciplinary approach and the existence of rescue devices such as the Bridge Occlusion Balloon (Spectranetics) permit minimising the risk of major complications, including death, according to leading experts in the field Professor Charles Kennergren (Sahlgrenska University Hospital, Göteborg, Sweden) and Professor Christopher Aldo Rinaldi (Guy’s & St Thomas’ Hospitals, London, UK). Cardiac Rhythm News speaks in more detail about these topics with these two specialists who will also co- chair a Spectranetics Satellite Symposium on the subject at EHRA EUROPACE-CARDIOSTIM (18–21 June, Vienna, Austria).

ecently published results from Balloon can provide at least 30 minutes of the largest prospective registry on acceptable haemostasis. Rtransvenous lead extraction, Elec- US FDA and CE mark approved in 2016, tra (European lead extraction controlled the Bridge Occlusion Balloon has been registry), conducted by the European successfully used in more than 20 patients Heart Rhythm Association (EHRA), have in USA and Europe. Dr Rinaldi comments demonstrated the safety and efficacy of that at the beginning of lead extraction the current practice of transvenous lead ex- procedures he now inserts a guidewire via traction with complete clinical and radio- the femoral vein with the Balloon ready to logical success rates of 96.7% and 95.7%, open if needed. “We have not had to use the respectively, and a 1.7% procedure-related Dr Charles Kennergren Dr Christopher Aldo Rinaldi balloon since it was introduced,” he notes. major complication rate with 0.5% mortal- Dr Kennergren reports having used the ity.1 Dr Kennergren, who is co-chairman Dr Kennergren comments: “The Electra tion has occurred,” notes Dr Kennergren. device successfully in two cases. In USA, of the registry and a physician with over data tell us that experience is important. Perforations in the superior vena cava Boyle TA et al2 recently published four 25 years of experience in lead extraction Even though we do not have a critical (SVC) are rare, occurring in less than 0.5% successful cases in HeartRhythm. “These involving more than 1,500 procedures, number of how many procedures per year procedures; however, when they happen, four cases demonstrate that endovascular says that data from this study indicates or per operator you should perform to perhaps are “the most catastrophic in lead occlusion balloons made specifically for that a substantial percentage of in-hospital reach a level where a complication rate is extraction procedures with a mortality lead extraction can dramatically strengthen mortality was related to preoperative pa- acceptable; what we know is if a centre is risk of approximately 50%,” comments a team’s response to vascular injuries,” tient conditions—mostly infections—and doing less than 30 procedures per year, the Dr Kennergren, who was involved in the Boyle TA et al conclude. not to the extraction procedure. complication rate is higher than if a centre development of the Bridge Occlusion Dr Kennergren also notes that “not all is doing more than 30 procedures per year Balloon. Join the discussion on “Increased indicated patients are being referred for [Electra showed a 2.4% in all cause in- The Bridge Occlusion Balloon, a safety of lead extraction” at the lead extraction” and that a major hurdle hospital major complications and deaths in specifically designed rescue device for Spectranetics Satellite Symposium at explaining this issue refers to the assump- high-volume centres (≥30 procedures per lead extraction procedures and unique in EHRA-EUROPACE CARDIOSTIM on tion that this is a dangerous procedure. year) compared to 4.1% in low-volume the market, aims to reduce mortality by Monday 19 June from 12.45–13.45. centres (<30 procedures per year)].” “This impression is there because refer- providing fast temporary occlusion of the References ring physicians compare adverse events Dr Rinaldi adds: “If you perform a large SVC, maintaining control and transition to 1. Bongiorni MG et al, European Heart Journal 2017, https://doi.org/10.1093/eurheartj/ehx080 of lead extraction with adverse events number of lead extractions your complica- surgery when a perforation occurs. Spec- 2. Boyle TA et al, HeartRhythm 2016, https://dx.doi. for other cardiac implantable electronic tions are probably going to be lower than tranetics states that the Bridge Occlusion org/10.1016/j.hrthm.2016.12.028 device (CIED) procedures, where com- if you are in a centre where there is less plication rate is very low and mortality is experience and you perform only a small almost absent,” he notes. “Lead extrac- number of lead extractions.” Therefore, tion procedures are something completely in case of limited experience or in doubt different, they could be a high-risk proce- of treating a difficult patient “referring to dure even if complication rate is low and a more experienced centre always makes in some instances mortality can be diffi- sense,” notes Dr Kennergren. cult to avoid.” However, “lead extraction “With lead extraction you always compares favourably with other similar have to assess each case individually and invasive procedures such as ablation and determine whether the benefits of lead percutaneous coronary intervention (PCI) extraction outweigh the risks,” comments from a risk complication perspective,” he Dr Rinaldi. “Historically most lead extrac- comments. tions have been performed due to infection Dr Rinaldi, a physician with nearly 19 and in such cases you have a Class I years of experience in lead extraction with indication to remove the lead. However, approximately 1,000 cases performed at his the Electra study also showed that there is institution and co-author of the Electra reg- a trend for a greater number of procedures istry, comments that high success rates and where the underlying indication is not low complication rates in lead extraction infection with nearly a 50/50 split in terms are directly impacted by preparation and of non-infected lead removals.” Dr Rinaldi experience and team-working in a multidis- noted that this is something the Heart ciplinary setting: “You need to be aware of Rhythm Society may need to look at when the patient’s comorbidities and ensure you revising the guidelines for lead extraction. have the right environment to reduce the risks. You also need to have the availability Bridge Occlusion Balloon—a of expert surgical back-up in the case of novel tool to prevent complications. Working in a multidiscipli- mortality in lead extraction nary setting with surgeons, microbiology, Safety precautions such as appropriate imaging specialists and electrophysiologists and imminent surgical back-up and tools increases the chance of procedural success.” such as the Bridge Occlusion Balloon are probably “the most important factors for The relevance of experience preventing mortality when a complica- Emphasising on the importance of experience, Dr Kennergren and Dr Rinaldi refer to data from Electra which found that lead extraction was associated with a higher success rate with lower all cause complication and mortality rates in high-volume centres compared with low-volume centres. Bridge Occlusion Balloon April Issue 8 Syncope 17 36 First guideline for evaluating and managing syncope released in USA The American College of Cardiology (ACC), the American Heart Association (AHA) and the Heart Rhythm Society (HRS) have recently released the first US guideline on the evaluation and management of patients with syncope.

he 2017 ACC/AHA/HRS Guideline for the Evaluation and TManagement of Syncope has been published online in the journals Circulation and HeartRhythm. Cardiac Rhythm News speaks to recommended for athletes with syncope Win-Kuang Shen (Mayo Clinic College I am not sure why we have not developed benefit). Routine cardiac imaging is and phenotype-positive hypertrophic of Medicine, Phoenix, USA), chair of a guideline earlier. I think it is because not useful in the evaluation of patients cardiomyopathy, CPVT, LQTS1, the guideline writing committee, about syncope is a symptom, not a specific with syncope unless cardiac aetiology or arrhythmogenic right ventricular key details of this guideline, which is disease/condition. As such, there have is suspected based on an initial cardiomyopathy before evaluation by a aimed to: been general reviews on the topic from evaluation including history, physical specialist (class III: harm). Define syncope as a symptom, the American College of Physicians and examination, or ECG (class III: no Referral for autonomic evaluation with different causes, in different other general and specialty societies; there benefit). Routine neurological imaging can be useful in selected patients with populations and circumstances. have been scientific statements on syncope and electroencephography are not syncope and known or suspected Provide guidance and related to sudden cardiac death, but not a recommended in the routine evaluation neurodegenerative disease (class IIa); recommendations on the evaluation comprehensive guideline on syncope. of patients with syncope in the absence referral to a specialist with expertise and management of patients with This is the first ACC/AHA/HRS of focal neurologic findings (class III: in adult congenital heart disease can suspected syncope in the context of formal guideline on syncope. no benefit). be beneficial in selected patients with different clinical settings, specific Vasovagal syncope is the most this disease and syncope (IIa). For the causes, or selected circumstances. What specialties were involved common cause of syncope. assessment and management of older Identify key areas in which writing this guideline? Effectiveness of drug therapy adults with syncope, a comprehensive knowledge is lacking to foster future The writing committee included is modest. Patient education is approach in collaboration with an expert collaborative research opportunities representatives from the ACC, AHA, recommended on the diagnosis and in geriatric care can be beneficial (IIa). and efforts. HRS, American Academy of Neurology, prognosis (class I). American College of Emergency Betablocker therapy, in the absence According to the guideline, Why was it relevant to develop Physicians, and Society for Academic of contraindications, is indicated as what knowledge gaps are a guideline on the evaluation Emergency Medicine, including a first-line therapy in patients with present in the evaluation and management of patients cardiologists, electrophysiologists, a long QT syndrome (LQTS) and and management of patients with syncope? neurologist, an emergency physician, and suspected arrhythmic syncope (class I). presenting with syncope? Syncope occurs in thousands of patients a paediatric cardiologist. Implantable cardioverter defibrillator The section 12 of the syncope guideline every day. One third to half of the US (ICD) implantation is reasonable in contains the description of several areas population have had syncope at some point What are the key patients with LQTS and suspected which require investigation. in their lifetime. Additionally, syncope is recommendations from the arrhythmic syncope on betablocker To highlight a few, now we have a symptom that can be associated with document? therapy or intolerant to betablocker provided a definition of syncope and other many different conditions, some of them Amongst the most relevant therapy (class IIa). associated conditions, and we can better benign; however, it is critically important to recommendations the guideline addresses: Dual-chamber pacing might be determine the types and epidemiology of exclude any serious causes. A detailed history and physical reasonable in a select population of syncope in different populations. We will Because syncope is very common and examination should be performed in patients over 40 years of age with need focused data on risk stratification and can affect many patients, this guideline patients with syncope (class I). recurrent vasovagal syncope and clinical outcomes divided according to will provide guidance to healthcare In the initial evaluation of patients prolonged spontaneous pauses (class the underlying disease. New monitoring providers to conduct efficient and effective with syncope, a resting 12-lead IIb). Betablockers are not beneficial technology is rapidly evolving. The role of evaluation and management for this large electrocardiogram (ECG) is useful in paediatric patients with vasovagal these devices needs to be determined by patient population. (class I). syncope (class III: no benefit). randomised clinical trials. Hospital evaluation and treatment is Electrophysiologic study is reasonable Furthermore, there are uncommon Given the importance of recommended for patients presenting in patients with moderate or severe conditions associated with syncope with syncope, could you explain with syncope who have a serious atherosclerotic coronary heart disease increased risk of sudden death. We need to why a guideline in this area medical condition potentially relevant to and unexplained syncope (class IIa). identify how to best evaluate these patients. has not been developed earlier the cause of syncope identified during Cardiovascular assessment by a care Finally, we need further investigation in the USA? initial evaluation (class I). provider experienced in treating athletes in specific populations—the young, The European Society of Cardiology Routine and comprehensive laboratory with syncope is recommended prior to the older, athletes, etc—in order to (ESC) released syncope guidelines in testing is not useful in the evaluation resuming competitive sports (class I). improve efficiency and effectiveness of 2001, 2004 and 2009. of patients with syncope (class III: no Participation in competitive sports is not evaluation and treatment.

Pacemakers with Closed Loop Stimulation programming help to reduce recurrence of syncope Continued from page 4 switched. Patients and their doctors were blinded at all estimated time to a first fainting episode was longer among To be eligible, participants had to have normal results on times to their group assignment. patients receiving DDD-CLS––29 months compared with an electrocardiogram, echocardiogram, 24-hour Holter test, After two years, 46 patients completed the trial. The just over nine months for patients receiving DDI, a statisti- carotid sinus massage and orthostatic test. They also had to patients’ average age was 56, and 48% of them were cally significant difference. show a drop in blood pressure and heart rate. men. During the trial, four patients experienced syncope Limitations of the study are its small size and short dura- All participants were implanted with a pacemaker. The while receiving DDD-CLS pacing, compared with 21 tion of follow-up (two years), Baron-Esquivias said. researchers randomly assigned half to receive DDD-CLS patients who fainted during DDI pacing, a statistically Baron-Esquivias, who currently uses DDD-CLS pacing pacing for 12 months and the other half to receive pacing significant difference. to treat patients with recurrent syncope in his own prac- in DDI mode, which does not respond to the contrac- Among patients initially assigned to DDD-CLS, 72.2% tice, said that if these findings are confirmed by larger, tions in the heart that precede syncope and, therefore, saw a reduction of more than 50% in syncope episodes ongoing studies, such as the ongoing BioSync CLS trial functioned in the SPAIN trial as a placebo group. After within the first year, but fainting recurred after they crossed sponsored by Biotronik, he expects that international 12 months, the two groups were switched so that the over to the DDI group. Patients who crossed over to DDD- guidelines will be changed to recommend DDD-CLS patients who had received DDD-CLS during the first year CLS after a year of placebo pacing saw a reduction of more pacing in these patients. received DDI for the next 12 months, and vice versa. If than 50% in syncope episodes during the second year. Nine The trial was funded by the Investigation Agency of the a patient in either group had more than three episodes patients who initially received DDI pacing met the criterion Spanish Society of Cardiology, which received an unre- of syncope in one month, their pacing assignment was for early crossover to DDD-CLS during the first year. The stricted grant from Biotronik Spain. April Issue 17 36 Updates 9 Modular cardiovascular device communication: A step towards artificial intelligence to treat cardiovascular disease independent modules of therapy through conductive radiof- anti-tachycardia pacing to terminate re-entrant VT from requency communication in order to advance more tolerable an S-ICD sensing device to an LCP treating device. In the bradycardia and anti-tachycardia pacing with an S-ICD. future, bidirectional communication will expand the concept MARTIN Currently, the combination of the LCP and S-ICD requires of modular devices (both therapeutic and diagnostic) to be device-device communication allowing delivery of ap- added only when it will benefit the patient’s individual clini- BURKE propriately timed sensing and pacing by using the individual cal needs rather than have all the features available but never strengths of both devices. Tapping into these strengths allows utilised. The next stage of cardiac implantable electronic for less re-engineering of either device to accomplish the device therapy is modular. COMMENT & ANALYSIS need. The strength of the first generation LCP is pacing The work performed so far is only the beginning. Add- without a lead. The strength of the S-ICD is sensing and ing no or minimal vascular modules in steps can limit the he implantable cardioverter defibrillator (ICD) is a treating successfully ventricular tachy-arrhythmias (VT) patients’ exposure to mechanical breakdown and chronic well-established therapy for the prevention of sudden from the subcutaneous space. The ability to communicate in indwelling vascular lead infections. It allows for simplifi- Tcardiac death. However, it is still associated with a near field body network is the key feature to leverage their cation and tailored device therapy to patients of all ages. complications over time to the patient, leading to re-opera- working together with the least amount of energy resource. Additionally, modular device therapy that uses medical body tion rates of 15.5% at six years.1 Many of the re-operation Importantly, creating communication at least unidirectional networks will also usher in the age of artificial intelligence rates are due to the in-dwelling lead(s) consequent to (S-ICD to LCP) poses a question, will combining the two where the S-ICD can act as the “mothership” of energy mechanical breakdown and infection. Infection-related com- devices’ functions through radiofrequency conductive resource and clinical decision making. The S-ICD as an plications associated with cardiac devices have particularly signals during VT sensed events lead to disruptions in the implant platform will be the main information intake module high mortality rates at one year.2 The long-term weakness main function of each individual device? In other words, processing the electrocardiographic, haemodynamic and of cardiac lead systems has made a compelling case for the what are the costs of combination if successful? Our research genetic signals communicated from cleverly placed modules entirely subcutaneous ICD (S-ICD, Boston Scientific). Still, in acute and chronic animal studies suggests high success of to indicate the timing and type of therapy that will have the a considered weakness of the S-ICD is its inability to pace communication with little risk to the patient, the function of best outcome for patients living with dynamic and life- the myocardium for extremes of bradycardia or tachycardia; either device or the successful treatment of VT. threatening cardiovascular disease. Medical body networks have been predominantly wide writes Martin C Burke (Chicago, USA). References: The S-ICD does have a transthoracic pacing function area (ie. hospital telemetry) since their inception. The typical 1. Ranasinghe I et al. Circulation 2014; 130:A20158 2. Tarakji KG et al. Europace 2014; 16:1490–5 between the shocking coils post-shock that paces at a rate of issue with Wi-Fi or wide area networks is the high energy 3. Tjong FV et al. Europace 2016; 18(11):1740–1747 50ppm for 30 seconds. The utility of this function is minor resources needed. Progressive improvements, in near field 4. Fang G, Orgun MA, Shankaran R, Dutkiewicz E, Zheng G. Truthful Channel Sharing for Self- Coexistence of Overlapping Medical Body Area Networks. given the patient selection for the S-ICD and the pain related communication and processor speed, now allow for low 5. Burke MC et al. Acute and chronic performance of communicating leadless anti- to its use. Advancing the S-ICD therapy as a platform for the energy use to provide inductive and conductive delivery tachycardia pacemaker and subcutaneous implantable cardioverter defibrillator. Heart Rhythm Congress 2016; Birmingham, UK future will require clever painless pacing modalities among to imbedded materials in the body.4 The LCP and S-ICD other monitors that can provide bradycardia and tachycardia modules are near field devices in the body. We have dem- Martin C Burke is chief scientific officer, CorVita Science therapy with minimal invasion of the vasculature. As a start, onstrated successful unidirectional communication 98% of Foundation, Chicago, USA. His research on this subject combining the leadless cardiac pacemaker (LCP) with the the time between an S-ICD and an LCP with as little as two is supported by a grant from Boston Scientific. He is a S-ICD seems iteratively natural.l.3 We continue to explore conductive impulses at two volts in a near field across the consultant for Boston Scientific and receives honoraria for the feasibility and functionality of combining these two chest.5 This type of communication allows for commanded speaking on behalf of the S-ICD

ADVERTORIAL Physician-approved Quail Digital Wireless at London Bridge Hospital, said: Headsets improve communication in theatres “Quail Digital’s Headset System Tom Downes, chief executive officer (CEO) of Quail Digital Healthcare, explains has made a real difference to the how the company’s Wireless Headset technology is changing the way how standard of team communica- physicians communicate in operating theatres. tion during procedures. Excellent audio quality means that all clini- concentrate better and maintain noted that Quail Digital Healthcare cians have a clear understanding focus for longer if you and your Wireless Headsets reduced noise of progress within the lab, which team, in the operating room, the levels and staff stress in robotic Quail Digital Wireless Headset significantly boosts performance monitoring room and in ante- operating rooms measurably. and safety. The technology has rooms could communicate more Their clinical teams are ben- cantly. It is quieter and improves been a worthwhile investment and easily. The Quail Digital Health- efiting from far better operating concentration for the physician and its use in our EP labs is proving care Wireless Headset System is room communication by using the other team members.” highly beneficial.” providing the solution in operating Quail Digital Healthcare Wireless “The Headsets are very com- theatres worldwide. Headsets, primarily in the clinic’s fortable and hands-free, so very Quail Digital credentials robotic surgical suites. easy to use. My ability to com- in healthcare Tom Downes Quail Digital Headsets: Dr Ziv Tsafrir, a fellow in municate quickly and effectively Quail Digital Healthcare Wireless A physician-approved Minimally Invasive Gynecology with other members of the robotic Headsets are in hundreds of hospi- here will always be noise solution at Henry Ford and a Quail Digital team including: the table-side first tals and clinical institutions across in an operating theatre: phy- Top physicians praise the Quail Headset user said: “Using Quail assistant, the anaesthesiologist, Europe, USA and the Middle East. Tsicians giving instructions, Digital Healthcare Wireless Head- Digital’s Wireless Headsets during the perfusionist and nursing staff, Quail Digital is fully registered ambient noise from lighting, air- set System because it enables them robotic procedures certainly con- has led to increased efficacy and with System for Award Manage- conditioning systems and operating to accurately and calmly com- tributed to better patient outcomes patient safety in these complex ment (SAM) as an authorised US room equipment, conversation municate with their team in the lab by creating a calmer environment procedures,” he added. Federal Supplier to hospitals and between colleagues, talk-back to and monitoring room using digital for clinicians and staff.” At the London Bridge Hospital, agencies, and our Headsets have and from the monitoring room and lightweight headsets with excellent Dr Husam H Balkhy, associ- one of the UK’s largest private specific absorption rates (SARs) call-outs for roving team members. noise cancelling technology. ate professor and director of the healthcare facilities, Quail Digital safety test pass for Human Ex- But noise can be extraordinarily Research has shown that the Robotic and Minimally Invasive Healthcare Wireless Headsets posure to Electromagnetic Fields disruptive in operating rooms. As use of headsets in theatres ensures Cardiac Surgery program at are used in their electrophysiol- EN50360 and EN62311, Federal a physician you try to acclimatise better communication and a quieter University of Chicago Medicine, ogy (EP) labs where pacemak- Communications Commission to it, then realise that some of the and calmer environment. A paper Chicago, USA, said: “The addition ers, defibrillators, biventricular (FCC) and CE mark approval. stress you are experiencing, and from the Henry Ford Clinic in De- of the Quail Digital Headsets im- and resynchronisation therapy To find out more about Quail the miscommunication and dis- troit, USA, (Tsafrir Z et al, J Minim proves the working environment in devices are implanted. Neill Digital visit www.quaildigital.com. traction is due to noise. You could Invasive Gynecol 2015;22(6S):S8) the robotic operating room signifi- Townshend, electrophysiologist CAGE: 75J99 DUNS: 02427 April Issue 10 Obituary 17 36 Tributes for Mark E Josephson

Electrophysiologists such as David Callans, Eric Prystowsky, Jonathan Kalman and Peter Kowey and David Steinhaus and Julie Stephenson, both from Medtronic, pay tribute to Mark E Josephson.

David Callans, University of Pennsylvania, USA The world of electrophysiology has lost a genius founding father, and I lost a great friend. Mark Josephson died just before his 74th birthday. Oh, but how he lived! His extensive achievements and intellectual triumphs aside, what made Mark really amazing to the people who knew him was his expansive and often challenging personality. He was dedicated to make both himself as well as everyone he cared for as successful as they could possibly be, as a scientist, physician but especially as a human being. Although it took me a long time to understand, he was not interested in his disciples being as good as he was (thankfully, as this would have been impossible!), but was passionately concerned that they simply strive to be the best version of themselves. Around Mark, there was no avoiding this destiny though—halfhearted efforts were always called out in an aggressive but supportive way. One of my favourite memories characterising this attribute occurred during his last year at Penn. I was hanging out in his office when one of the cardiology fellows who was senior to me, and graduating that year walked in to sheepishly confess that he was “abandoning” an academic career and had taken a position in private practice. While he feared disappointing what he thought were Mark’s aspirations for him, Mark had actually been instrumental in getting him that position. He said: “I David Callans, Mark E Josephson and Bruce Hook want you to be the best doctor that you can possibly be, that is what I want for you.” sense of gratitude for his taking me on as a student, He shared a birthdate with another genius, Mozart, My relationship with Mark started during my enthusiastic but slow as I was, but Mark was offering who authored a quote that I feel personifies Mark: fellowship, way before I was even a little equipped so much more, even from the start. He was offering “Neither a lofty degree of intelligence nor to understand anything he was talking about. I would incredibly loyal friendship, an opportunity to share in imagination nor both together go into the making of a travel to his Gladwyne home for discussion about the his life, not just in his work. I was and continue to be genius. Love, love, love is the soul of genius.” nature of the ventricular tachycardia circuit (I so wish overwhelmed by this. Despite a profound sense of loss, his love, his ideas I had kept the diagrams he scribbled out on napkins At his funeral, his daughter Rachel said that Mark and his passion live on in all his dedicated disciples. during those talks) and the nature of life, both his made everyone around him feel like they were Mark’s and mine. I had not a chance to fully develop my best friend. He meant so much to so many. Eric Prystowsky, St Vincent Hospital, Indianapolis, USA It is an honour and privilege for me to pay tribute to Mark Josephson, a friend for many years and one of the pioneers of our field of clinical electrophysiology (EP). During the first decade or so of the new field of clinical EP, there were five key individuals who investigated and opened up the areas of research and clinical care for patients with arrhythmias: Hein Wellens and John Gallagher (my mentor) for Wolff-Parkinson-White Syndrome, Ken Rosen for atrioventricular node reentry, Michel Mirowski for the implantable cardioverter defibrillator (ICD) and Mark Josephson for ventricular tachycardia (VT). My training in clinical EP at Duke emphasised the EP laboratory and operating room diagnosis and treatment of supraventricular tachycardias, with little exposure to VT. As EP lab director at Indiana University my main focus became the study and treatment of ventricular tachycardia. I contacted Mark and asked if I could spend some time with him to learn how to map VT, which he graciously agreed to do. In fact, we spent almost the entire day together discussing his findings and observing him mapping the left ventricle. It was clear how much he loved to teach and I never forgot this act of kindness. Several years later I developed a course for fellows, taken from the model of Pick and Langendorf, on the interpretation of unknown intracardiac electrograms Mark E Josephson and Eric Prystowsky that Mark participated in for many years. The fellows April Issue 17 36 Obituary 11

important basic concepts. Second, an appreciation of history is important to our fellows and young colleagues. I think of Mark and his generation as a bridge. It was Mark, Ken Rosen, Hein Wellens, Jay Mason, Jeremy Ruskin, Bernard Lown, and many others who took early theories in EP and applied them to the clinical setting. Theirs was a tremendous accomplishment and should not be taken for granted because without their contributions, our discipline would look much different than the sophisticated clinical science it is today. And thirdly, and most importantly, literally thousands of patients would not have benefitted from so many of the life saving therapies that all of Mark’s hard work made possible. So thank you Mark. You will be missed.

David Steinhaus, medical director, Cardiac Rhythm and Heart Failure director, general manager, Heart Failure Medtronic and Julie Stephenson, Fellows Training and Jonathan Kalman Peter Kowey Transition, Cardiac Rhythm and Heart Failure Medtronic “loved him” and he did an outstanding job teaching high-risk patient population. I joined Toby Engel at One of Mark Josephson’s greatest passions was teaching these unknown tracings with me and the other faculty. the Medical College of Pennsylvania. We established cardiology and electrophysiology (EP) fellows. He Mark Josephson was a very bright light in the field a relationship with Michel Mirowski that led to the considered it his mission in life to teach future EPs of clinical EP, who will be remembered for his many implantation of the third implantable defibrillator the critical skill of thoroughly understanding the 12- contributions to the understanding and treatment of in the world at our site. While each of our centres lead electrocardiogram (ECG) in order to diagnose cardiac arrhythmias and his outstanding role as a pursued a different treatment paradigm for ventricular arrhythmias and plan for appropriate treatment. Together teacher and mentor. I already miss him. arrhythmia, we shared an interest in the mechanism by with his closest friend, Hein Wellens, he developed what which drugs exerted their electrophysiological effects quickly became a quintessential educational course called Jonathan Kalman, Royal Melbourne on tachycardia substrate. “How to approach complex arrhythmias.” Hospital, Melbourne, Australia The irony for all of us, of course, is that the This five-day, comprehensive course was most notable I first met Mark in person at an electrophysiology implantable defibrillator developed so quickly and for the interactive learning approach developed by Mark (EP) teaching session during my junior faculty year well that it eclipsed surgery and antiarrhythmic and Hein. The professors would take turns asking for at University of California San Francisco (UCSF) in drugs to become the paramount therapy for patients “volunteers” from among the participants. Brave fellows 1996 when he was a visiting lecturer. On that day I with significant ventricular arrhythmia. Surgery was would come to the front of the room and stand before a was (anxiously) prepared for the probing questions that effective but associated with too many complications huge 12-lead ECG projected onto the screen. Armed with Mark was renowned for and even though I acquitted to make it practical for large numbers of patients. a microphone and a giant pair of calipers, they would myself with a pass on a case of antidromic tachycardia And drugs had too many limitations to make them interpret the tracing guided by occasional questions and I received a lesson in his systematic and deductive reliable enough for sudden death protection, including comments from the professors. Mark and Hein were approach that has stayed with me throughout my career. proarrhythmia. very astute in assessing the individual knowledge of any Of course, I had met Mark many times before that in I do not believe that any of these developments volunteer and adjusted their guidance accordingly. the words of his monolithic textbook from which my could possibly have been anticipated when Mark and Mark and Hein established infamous rules of passion for EP began. In addition, I came to realise that I began our careers in Philadelphia. But despite many engagement for the course including: many of the electrophysiologic truisms that I learned fits and starts, it was Mark’s hard work, perseverance 1. No ties allowed. If a fellow wore a tie to the from one of my direct mentors, Michael Lesh, indeed and genius that laid the groundwork upon which programme, he ran the risk of having it cut off. had originated with Mark, Mike’s teacher and mentor. modern EP was built. The clinical application of 2. When looking for a volunteer, it was best for the In turn, I have had the opportunity to pass those “pearls” concepts such as the excitable gap, resetting, and fellows not to look down… Any sign of weakness on to the next EP generation. entrainment to name only a few, were made possible or uncertainty was a sure way of being “invited” to Mark never failed to emphasise that, even in the because of his early work in the EP lab and in the volunteer. era of computerised mapping and anatomically-based operating room. 3. Mark and Hein were always sensitive about giving ablation, the greatest and most rewarding challenges Remembering what Mark did for our field is everyone in the audience equal opportunity to volunteer in arrhythmia diagnosis still lay in the deductive worthwhile for three reasons. First, Mark was a tireless and on occasion would call for a “gender change.” reasoning of classical EP. With the aid of critically timed worker and an advocate for clinical EP. He deserves As anxiety-provoking as the course could be, all agreed stimuli interacting with reentrant circuits and some our thanks for helping to establish our wonderful it was an important rite of passage, opening their eyes well positioned catheters even the most complex of discipline. He correctly pointed out that EP procedures to the many details contained in an ECG they had never arrhythmias could be accurately described. This is one are no longer based on the precise knowledge of EP noticed or understood before. Many years later, most of the messages that reverberates across Mark’s work that was essential in the early days of our discipline, electrophysiologists can vividly recall the tracing they and throughout his teaching. and that our fellows are poorly trained to understand interpreted. Over the years since we first met, I have greatly The course thrived for 35 years with support from valued Mark’s friendship and the wisdom and the Medtronic Education teams in Europe and the intellectual integrity he has been prepared to share. His United States. An estimated 6,500 fellows across many genuine interest in my career and knowledge of my generations and geographies were trained during that work on each occasion that we met has been humbling. I time. Understanding the timeless value of this course am fortunate indeed to be able to count Mark Josephson and the unique, effective teaching styles of Mark and among my teachers and mentors. I am all the more Hein, footage from the course is being developed into an enriched for having counted him as a friend. interactive e-learning experience that attempts to honour and share their legacy with many more generations of Peter Kowey, Thomas Jefferson electrophysiologists to come. University, Philadelphia, USA Throughout Mark’s battle with cancer, he remained When I returned to Philadelphia in 1981 to begin my fiercely committed to the course, finding it especially first faculty job, Philadelphia was the centre of the therapeutic and energising. It was an honour to work with electrophysiology (EP) world. Mark Josephson and Mark and support him in the delivery of these courses. Len Horowitz had established a vanguard clinical EP Ultimately, thousands of electrophysiologists are smarter programme at Penn. They had begun an active surgery and safer in their work because of Mark’s passion for programme to map and remove foci of ventricular teaching. He was a great friend to us all and will be tachycardia, and were achieving good results in a greatly missed. April Issue 12 Interview 17 36 Profile Thomas F Deering

Thomas F Deering (Piedmont Heart Institute, Atlanta, USA) considers that the biggest challenge in electrophysiology (EP) is to “move from the volume to the value world of healthcare delivery” finding ways to improve lives in a “quality and cost-efficient manner”; an issue in which he is currently focusing research efforts. In this interview, he speaks about this and other research interests amongst other relevant aspects in his career and gives an overview of the highlights of this year’s Heart Rhythm Society Scientific Sessions as Programme Chair.

Why did you choose to specialise in You have been highly involved in to resect his left ventricular aneurysm and ablate his VT. EP? research activities being participant in As a result of his prolonged hospitalisation, his daughter Career choices for physicians are often directed numerous research arrhythmia trials and actually got married in his cardiac care unit room by unanswered clinical problems, which challenge also as chief of the Arrhythmia Center of because he was too sick for discharge and she was going us to work in our teams to create solutions. As a Excellence of Piedmont Heart Institute; overseas with her fiancée, who was in the military. The young physician, when EP was in its early stages, could you tell us what are the current potential that I saw in this new field of EP hooked me I saw my mentors in this field characterised by a challenges undertaking research in EP? while the same case drove an intern colleague and friend passion for learning and innovation. The evolving The biggest present challenge is one that has been of mine into orthopaedics. techniques of defibrillator and ablation therapy around for a long time. We, as institutions and medical created an opportunity for us to move from the field societies, need to continue to innovate at multiple levels You have been an active member of of diagnostic medicine to the world of therapeutic (eg. develop new technologies to facilitate better clinical HRS since 1987; please tell us medicine where we could identify and then rectify a outcomes with lower risk; create proactive team-based what has been your most problem to improve and/or prolong life. Having the clinical management processes to ensure consistent and valuable benefit from it? chance to be involved in such an innovative specialty cost-effective treatment approaches, etc.) to improve I have had the chance to with smart, enthusiastic and energetic individuals was clinical advances in arrhythmic care globally. work with dedicated, very exciting. informed, and insightful Of the research you have seen lately, staff, physicians, allied Who are your mentors and what which piece do you think has had the professionals and influence have they had on your career? biggest clinical impact? basic/translational My father established a strong foundation by I do not believe that there is a single arrhythmic research science volunteer emphasising hard work; demanding a commitment to study or outcome that stands out to me as automatically professionals, who excellence; ensuring the importance of being humble or categorically representing the major advance in always put patient and taking great joy in seeing those around you our field in contrast to the multiple, evolutionary and succeed. I was then very fortunate to have a number sometimes revolutionary advances. EP research is an of great medical mentors with very different skill iterative process in which the basic scientists help sets. Dr Samuel Their, chief of Medicine during my us define underlying mechanisms; the translational medical school and early training years, instilled in my scientists help us bridge the gap from early cellular colleagues and me the need to always be on game and and animal research to human treatment processes question everything, not just to be critical, but to be the and the clinical scientists build upon that best one can. My first chief of Cardiology as a medical foundation to demonstrate the locus for clinical student and young physician, Dr Larry Cohen, was benefit then, thorough the guideline process, the classic “art and science” of medicine mentor, who clarify and define the role of these advances in always conducted himself with dignity and respect for our global arrhythmic community. patients and their families, colleagues, students and all members of the medical team. Dr Mark Estes, in his What are your current research classic quiet and supportive manner, made me always interests? want to strive for excellence and compassion while My current interests focus on two areas. First, understanding the importance of mentoring others as I given my role in Piedmont Heart, I consider matured in my career. myself very fortunate to be surrounded by and engaged with a collaborative group of What do you consider has been the colleagues in the EP field and in our other biggest development/challenge in EP? cardiovascular divisions (eg. heart failure, EP has moved from that of a diagnostic-only specialty structural heart, cardiothoracic surgery, general to one in which we can improve, if not always cure, cardiology, etc.) with whom we interact. This clinical arrhythmic outcomes. In my opinion, the collaborative effort enables us to combine our biggest challenge for our specialty, as we move from talents and interests to have a voice in study the volume to value world of healthcare delivery, is design and then be high-volume enrolees in a to ensure that we focus on finding ways to continue number of important pivotal trials across the amazing innovation of the past several decades the entire clinical perspective. so that we can improve lives in a quality and cost- Second, personally, I am very interested efficient manner. in outcomes research. As we move from the “volume to value” world we have What has been the biggest to find ways to continue innovation in disappointment—ie. something you a manner that identifies effectively the thought would be practice-changing but patients, who can benefit most from new was not? and evolving therapies, so that we continue I view shortcomings as “bumps in the road”, which to advance quality outcomes in a fiscally- provide us with an opportunity for improvement, rather sustainable manner. than as disappointments or failures. To specifically address your question, I believe that atrial fibrillation What has been your most (AF) ablation represents a very important clinical memorable case? development. However, despite incredible advances, As an intern I had a patient with I think that we need to continue to strive to develop heart failure and almost incessant methods to differentiate more effectively those monomorphic ischaemic ventricular patients, who will benefit significantly from this tachycardia (VT). This was in the early days therapy, from those who will not, while improving of VT ablation and device therapy. The EP techniques to lower procedural risk. and cardiothoracic surgery teams collaborated April Issue 17 36 Interview 13

Fact File

needs and societal goals first while working together dedicated to communicating this message to our as a team. It has been very inspirational members and involving them in this important effort. and enjoyable. We continue to have great interest in the Summits and Forums, the Late-Breaking Clinical Trials, As the Scientific Sessions Programme the Meet the Expert Sessions, the Live Cases, the chair and first vice president of HRS; Abstract and Poster Sessions, the Special Sessions could you tell us what the highlights of and the many Joint Sessions. this year’s Scientific Sessions are? For HRS 2017, we are aiming to bridge the This year we expanded upon our 2016 theme past to the future. Sessions have been designed of “Together we are” to “Together we can”. We to allow pioneers in the field to share their early are excited to have Hugh Evans, who has experiences; senior respected faculty, as mentors, emphasised global citizenry as a mechanism to impart their wisdom on the present state of the to advance humanitarian causes, as our art and new leaders to share their research and ideas plenary speaker. As a global society, on where we are going in the future. We hope that we have a number of sessions this approach will keep our meeting innovative and relevant to all attendees. As educational opportunities continue to evolve, for HRS 2017 we have made a concerted effort to increase interaction within our sessions; to foster multidisciplinary interaction and discussion; to Current leadership positions facilitate networking opportunities among colleagues 2016–2017 Scientific Sessions Programme and to increase awareness about the impact of chair and first vice president worldwide healthcare reform for medicine in general of Heart Rhythm Society and EP in particular. 2012– Chief Quality Office of Piedmont Heart Institute, Atlanta, USA What are the key milestones for HRS in 2011– Chief Centers of Excellence of the upcoming years? Piedmont Heart Institute, Atlanta, We must create a sustainable educational USA platform, which extends beyond our annual 2011– Chief Arrhythmia Center of meeting and, in collaboration with other Piedmont Heart Institute, Atlanta, organisations and societies, extends across USA the globe. As healthcare delivery continues to evolve, we must continue to find ways Past and present clinical to innovate and coordinate care delivery so appointments that we can achieve our vision of ending 1989– Attending Physician of Piedmont “death and suffering due to heart rhythm Hospital, Atlanta, USA disorders.” 1989–2000 Attending physician of Georgia Baptist Medical Center, Atlanta, If you had not been a medical USA doctor, what would you have 1986–1989 Attending physician of Yale New been? Haven Hospital, New Haven, USA I probably would have aimed either to be 1986–1989 Attending physician of Hospital of a college history or philosophy professor St Raphael, New Haven, USA or pursued a career as a linguist and lived abroad to experience and Medical Education learn from other people of different 1985–1986 Cardiac Electrophysiology and cultures. Permanent Pacing fellowship: Tufts New England Medical Center, Outside of medicine, Boston, USA what are your hobbies and 1983–1985 Cardiology fellowship: Boston interests? University Hospital, Boston I cherish my time with my fantastic City Hospital, Boston, USA wife and daughter. I have a variety 1981–1983 Internal Medicine Residency: Yale of eclectic interests. To paraphrase, New Haven Hospital, New Haven, I am a jack of many but a master of USA none. I like to balance my mind and 1980–1981 Internal Medicine Internship: Yale body. I read voraciously often while New Haven Hospital; New Haven, walking in my neighbourhood and in USA the woods on a variety of non-medical 1980 Medical School: Yale University, topics (please be assured that I do read and New Haven, USA, Cum Laude keep up on my medical reading) with a special (Class Day Award: Top 15% interest in general philosophy, history, philosophy of class) of science and, on the lighter side, historical novels. I love skiing and sailing but am not an expert in either. Journals reviewer My wife and I love to travel the globe, especially HeartRhythm, PACE, Journal of Interventional Europe, and share ideas with people from different Cardiac Electrophysiology, Circulation, American backgrounds than our own. Heart Journal April Issue 14 AF ablation 17 36 AF ablation associated with phrenic nerve injury: Is this complication now in our rear view mirror? injury, most recover nerve function within electromyography for direct monitoring of weeks and almost all by 12 months. In a diaphragmatic compound motor action po- large meta-analysis of 22 studies enrolling tentials during ablation. This technique has 1,308 patients undergoing cryoballoon ab- been reported to further reduce incidence of HUGH CALKINS lation, 4.7% had persistent phrenic nerve palsy.8–9 CMAPs are recorded using body paralysis after the ablation procedure but surface electrodes, oesophageal electrodes only 0.37% had paralysis lasting longer or a diagnostic catheter positioned in the than one year.6 As noted above, perma- hepatic vein. A decrease in the amplitude of COMMENT & ANALYSIS nent phrenic nerve injury resulting from the myopotential by 30% has been reported cryoballoon ablation had an incidence of in some studies to be more sensitive than Phrenic nerve injury is a well-established complication of all types of 0.3% in the recently completed Fire and abdominal palpation for predicting the atrial fibrillation (AF) ablation and is most common with balloon-based Ice trial. Studies have shown a higher risk subsequent reduction in diaphragmatic ex- approaches, writes Hugh Calkins (Baltimore, USA) for Cardiac Rhythm of phrenic nerve injury associated with the cursion and nerve injury.10 Energy delivery News. However, he notes, “with careful monitoring for phrenic nerve smaller 23mm balloon as compared with should be interrupted immediately at the injury during ablation the incidence of this complication has decreased the larger 28mm balloon with more proxi- first sign of phrenic nerve injury. In my dramatically to 0.3% or less.” In this commentary, Calkins details the mal energy application. There is no active experience, the CMAP approach is difficult strategies developed over the last years to prevent this complication. treatment known to facilitate phrenic to interpret and I have not found it terrible nerve healing but in symptomatic patients helpful. I have found it best to rely on pac- ver the past two decades catheter the cryoballoon group (2.7%). Permanent with permanent nerve injury diaphrag- ing of the phrenic nerve from the superior ablation of AF has emerged as a phrenic nerve injury, lasting 12 months or matic plication may improve dyspnoea vena cava while monitoring diaphragmatic Ocommonly performed, effective, longer, occurred in 0.3% of patients. and functional status. function with fluoroscopy or palpation. and generally safe treatment option for Phrenic nerve injury is an important The second most common scenario of In summary, phrenic nerve injury is a patients with AF. Despite the considerable complication of all types of AF abla- phrenic nerve injury is during electrical well-established complication of all types progress that has been made, it is impor- tion procedures and results from direct isolation of the superior vena cava using of AF ablation. Phrenic nerve injury is tant to recognise that AF catheter ablation thermal injury. The right phrenic nerve is point-by-point radiofrequency ablation. most common with balloon-based ap- remains an imperfect procedure. Unlike most commonly affected as it descends Very rarely, ablation at the roof of the left proaches including the cryoballoon. With catheter ablation of Wolff Parkinson White in close proximity to sites of ablation atrial appendage can result in left phrenic increased awareness of this complication syndrome, which is associated with a >97% in the superior vena cava and both right nerve damage. and careful monitoring for phrenic nerve rate of cure and a negligible risk of compli- superior and inferior pulmonary veins. A number of strategies have been injury during ablation the incidence of cations, the efficacy of AF catheter ablation Phrenic nerve injury is observed with all employed to prevent phrenic nerve injury. this complication has decreased drain optimal candidates lies somewhere in technologies for AF ablation including These include ensuring antral pulmo- matically to 0.3% or less. I have been the 60% to 80% range with a 1% to 3% radiofrequency, cryoablation, ultrasound, nary vein ablation, high-output pacing to fortunate to have no patients who experi- incidence of major complications. and laser ablation. Phrenic nerve paralysis establish whether the phrenic nerve can be enced permanent phrenic nerve paralysis The recently published multicentre can be asymptomatic or can cause dysp- captured from the proposed ablation site following cryoballoon ablation. Despite Fire and Ice trial provides up to date noea, tachypnoea, cough, hiccups, and before ablation, phrenic nerve mapping this, I will remain vigilant in hopes of information concerning the outcomes of thoracic pain. The diagnosis is suggested with anatomic tagging of its course using limiting the risk of this complication. At AF ablation.1 This study randomised over when newly elevated hemi-diaphragm electroanatomic mapping system, and the end of the day, phrenic nerve injury 700 patients to AF ablation using either with atelectasis of the ipsilateral lung monitoring of diaphragmatic excursion is in the rear view mirror—but not com- radiofrequency energy or the cryoballoon. base is observed on post-procedure chest with abdominal palpation, fluoroscopy pletely out of sight. radiograph. When suspected, diaphragm or intracardiac ultrasound while pacing The study revealed that the cryoballoon is References non-inferior to radiofrequency energy with excursion should be evaluated using the phrenic nerve from the superior vena 1. Calkins H et al. HeartRhythm 2007;4(6):816–61 7 2. Packer DL et al. J Am Coll Cardiol 2013;61(16):1713–23 respect to efficacy and overall safety. More fluoroscopy to confirm the diagnosis. cava or subclavian vein during ablation. 3. Guhl EN et al. J Cardiovasc Electrophysiol specifically, the primary efficacy endpoint The most common scenario in which It is now standard practice to pace the 2016;27(4):423–7 4. Metzner A et al. J Cardiovasc Electrophysiol (any atrial arrhythmias recurrence, use of phrenic nerve injury occurs is with cryobal- phrenic nerve from the superior vena cava 2014;25(5):466–70 antiarrhythmic drugs, or repeat ablation loon ablation and the incidence of transient or subclavian vein during cryoballoon or 5. Guiot A et al. J Cardiovasc Electrophysiol 2012;23(4):346‒51 1–5 at one year) was not different between the phrenic nerve injury is 3.5–11.2%. There laser balloon ablation—while palpating the 6. Andrade JG et al. HeartRhythm 2011;8(9):1444–51 7. Yong Ji S et al. J Cardiovasc Electrophysiol, cryoballoon and radiofrequency energy are various stages of phrenic nerve injury abdomen and/or fluoroscopic imaging to be 2013;24(10):1086–91 groups; neither was the primary safety ranging from detectable decrease in com- sure that diaphragmatic capture is present. 8. Franceschi F et al. HeartRhythm 2011;8(7):1068‒71 9. Miyazaki S et al. J Cardiovasc Electrophysiol 2015;26(6): endpoint. Based on the results of this and pound motor action potential (CMAP) be- If weakening or loss of diaphragmatic cap- 622‒8 other studies, the cryoballoon has become fore a reduction in diaphragmatic excursion ture is observed, energy application should 10. Mondesert B et al. Circ Arrhythm Electrophysiol 2014;7(4):605-11 a common alternative to radiofrequency is perceived to persistent paralysis. With be stopped immediately. Several other energy for AF ablation. Fire and Ice also cryoballoon ablation, most phrenic nerve strategies have been developed to monitor Hugh Calkins is director of the Cardiac showed that phrenic nerve injury was the injuries are transient and resolve within phrenic nerve function during cryoballoon Arrhythmia Service at Johns Hopkins most frequent adverse event reported in minutes. In patients with persistent nerve AF ablation. One of these is diaphragmatic Hospital, Baltimore, USA

The study met its primary safety endpoint with no First-in-man study shows promising results with a multi- device or procedure-related serious adverse events at seven electrode radiofrequency balloon for paroxysmal AF treatment and 30 days. Successful pulmonary vein isolation was achieved with a 98% success rate, Daly told delegates. He Results of AF-FICIENT, the first-in-man study which seeks to evaluate the safety and also noted that the “procedural times were comparable to performance of the new Apama radiofrequency (RF) balloon catheter system (Apama Medical), other technologies” with an average balloon time of one have shown the device is safe and allows successful pulmonary vein isolation for paroxysmal hour and 39 minutes. After six-month follow-up, patients atrial fibrillation (AF) treatment. demonstrated 80% freedom from AF. In conclusion, Daly said, the Apama RF balloon his prospective, non-randomised, multicentre pilot Another RF balloon catheter, developed in Japan and catheter system is able to achieve successful pulmonary study was presented for the first time by Matthew known as the “hot balloon”, was previously studied, vein isolation with “quick ablation and without excessive TDaly (Christchurch Hospital, Christchurch, New Daly told Cardiac Rhythm News. “This balloon delivers catheter manipulations.” However, he noted, “this initial Zealand) at a late-breaking clinical trial session at the AF energy everywhere it touches; therefore, there is not experience warrants further clinical use.” Symposium (12‒14 January, Orlando, USA). much control to where the energy goes. Its developers When asked about what would be a possible advantage Daly explained that the Apama RF balloon catheter is an reported good initial results, but now it seems to have of this RF balloon catheter compared to cryoballoons, Daly over-the-wire 28mm balloon with 12 proximal and six distal faded,” he commented. told Cardiac Rhythm News: “The theoretical advantage of electrodes designed to map and ablate. The system also Daly reported the results from the first 18 patients this RF balloon catheter over cryoballoons is that it will has built-in cameras to provide real-time visualisation of treated with the new Apama technology at four centres in eventually be faster and the customisable geometry will electrode contact to the tissue during the entire procedure. New Zealand, Prague and Paraguay. avoid complications like phrenic nerve palsy.” April Issue 17 36 VT ablation 15 Multielectrode mapping may be more effective than point-by-point mapping for VT substrate ablation Results from the first randomised study comparing multielectrode mapping vs. conventional point-by-point mapping for ventricular tachycardia (VT) substrate ablation procedures have shown that a multielectrode mapping strategy allows better discrimination of local abnormal electrograms and conducting channels, which may be considered key elements for successful VT substrate ablation.

he study, recently published in Eu- PPM; ablation was guided by MEM. ropace by the Ventricular Arrhyth- The researchers identified that by using Tmia Research Group, Barcelona, MEM the far-field/late potential ratio was Spain, led by Antonio Berruezo (Hospital significantly lower compared to PPM Clinic and IDIBAPS, Barcelona, Spain), (0.58±04 vs. 1.64±1.1; p=0.01), which also found that ablation guided by multi- provided better discrimination of local electrode mapping was associated with a abnormal electrograms and conducting shorter radiofrequency time. channels. “Multielectrode catheters (such “Current VT substrate ablation strate- as PentaRay) with smaller electrode size gies aim to completely abolish abnormal and closer interelectrode distance may local electrograms identified within the provide a better resolution of intracardiac scar region. Therefore, substrate-based electrocardiograms than conventional approaches are highly dependent on ac- mapping catheters, allowing more accurate curate delineation of scar architecture and assessment of the activation sequence identification of abnormal local electro- within the conducting channels and better grams,” write the researchers. Point-by- identification of the conducting channels point electroanatomical mapping is the entrance,” the authors note. “conventional strategy” used to identify Results also showed that scar dechan- slow conducting channels that are ablation neling guided by MEM was associ- targets; however, this strategy is “time ated with a shorter radiofrequency time consuming and operator dependent” as it (median 12 vs. 22 minutes; p=0.023). This requires a very detailed and accurate elec- could be due to a “better identification troanatomical map, the authors comment. of appropriate ablation targets” with this Multipolar catheters with smaller elec- strategy, the researchers highlight. trodes and shorter interelectrode distances “It should be noted that the ablation “may facilitate” the detection of such areas technique used in this study (scar- of slow conduction, the researchers argue. dechanneling) aims for complete arrhythmic Therefore, they sought to compare mul- substrate elimination by selectively targeting tielectrode mapping using the PentaRay conducting channel entrances. Thus, the catheter (Biosense Webster) vs. conven- appropriate identification of ablation tional point-by-point mapping using the targets becomes a key point when using open irrigated 3.5mm tip Thermocool this ablation approach,” the Ventricular Navistar catheter (Biosense Webster) in a Arrhythmia Research Group write. first-of-its-kind randomised study. Amongst other results the researchers From September 2013 to Decem- found that substrate mapping time ber 2015, 20 consecutive patients was similar with MEM and PPM (95% male, 67.3±10.3 years old) with (19.7±7.9 minutes vs. 25±9.2 minutes; ischaemic heart disease undergoing p=0.222) and that there were not VT ablation were enrolled at Hospital differences in the number of late Clinic and IDIBAPS, Barcelona, Spain. potentials identified within the scar The patients were randomised into two by MEM vs. PPM (73±50 vs. 76±52 groups. In group A (10 patients), sub- late potentials per patient; p=0.965). strate mapping was performed first by They also found no differences in VT point-by-point mapping (PPM) and sec- inducibility after procedure. ond by multielectrode mapping (MEM), The researchers note that it remains ablation was guided by PPM. In group “unknown” whether these results could B (10 patients), substrate mapping was be reproduced in non-ischaemic patients performed first by MEM and second by and/or with other ablation approaches.

Ventricular Arrhythmia Research Group (from left to right): First row: José Ortiz, Elena Arbelo, Antonio Berruezo, Mario Cabrera. Second row: Francesca Vassanelli, David Soto, Mikel Martinez, Juan Acosta. Third row: Diego Penela, Markus Linhart April Issue 16 Left atrial appendage 17 36 Use of intracardiac echocardiography is a “viable option” for Amplatzer Amulet implantation Intracardiac echocardiograpy (ICE) facilitates a high The LAA closure rate at implant In conclusion, Schmidt implant success rate of the Amplatzer Amulet left was 100% with ICE and 99.8% said, “use of ICE for implant atrial appendage (LAA) occluder as well as high LAA with TEE. At three months, the procedure of the Amplatzer closure rate to prevent thromboembolism in non- LAA remained closed in 100% Amulet LAA occluder is a valvular atrial fibrillation (AF), according to data from of patients in the ICE group and viable option with high success a sub-analysis of the Amulet Observational study. in 98.8% of the patients in the rate as well as high LAA closure Device or procedure-related serious adverse event TEE group. rate. The device or procedure- rate was low. The rate of device or related serious adverse event procedure-related serious rate is low, giving patients with oris Schmidt adverse events and LAA adverse events within seven non-valvular AF an additional (Cardioangiologisches closure. days of implant was 3.8% option for stroke prevention.” BCentrum Bethanien, Schmidt noted that the (ICE patients=3.2%, TEE Regarding the relevance Frankfurt am Main, Germany) implanters in the study used patients=3.9%). The overall of studying the use of ICE in presented the results of this either ICE or TEE during the Boris Schmidt 30-day mortality rate was 0.4%, Amplatzer Amulet implant sub-analysis at a late-breaking implant procedure at their two of the deaths were device- procedures, Schmidt told clinical trial session at the AF discretion. In the Amulet at 61 clinical sites in Europe, or procedure-related. None of Cardiac Rhythm News that Symposium (12‒14 January, Observational study, Middle East, Asia, Australia and these deaths occurred in the ICE the use of ICE “may help Orlando, USA). a total of 1,088 South America. The procedure group. Cardiac perforation and to reduce the utilisation of This sub-analysis, patients was guided by TEE in 958 cardiorespiratory arrest were the human resources since an Schmidt told (75±8.5 patients (88.4%), by ICE in 126 causes of the deaths. additional echocardiography delegates, was years (11.6%) and four are unknown. Regarding serious adverse is no longer required.” aimed to compare of age, Nearly 83% of patients device effects including “The implanting physician transesophageal 35.5% were contraindicated to oral perforation, pericardial can do both, implant the echocardiography (TEE) female) anticoagulation and 64.9% had a effusion, cardiac tamponade, device and handle the ICE to ICE in Amplatzer were CHA2DS2-VASc score of ≥4. embolisation, thrombus on probe,” he added. Amulet LAA enrolled Schmidt reported a 99.2% device, stroke and vascular The Amplatzer Amulet LAA occluder implants between June implant success rate of the complications, 3.2% were occluder is CE mark approved, in terms of 2015 and Amulet Amplatzer occluder adjudicated to the ICE group but remains an investigational use, serious Amplatzer Amulet September 2016 with ICE and 98.4% with TEE. and 3.9% to the TEE group. device in USA. Occlutech left atrial appendage occluder shows high procedural success in first-in-man experience The first-in-man study exploring the safety, feasibility and neurological outcome with the a correct placement of the device. The researchers Occlutech left atrial appendage (LAA) occluder (Occlutech) has shown a 93% procedural found that one device was twisted but still stable with success rate and acceptable efficacy at three months for stroke prevention in patients with a complete occlusion of the LAA. Two patients had a atrial fibrillation (AF) and a HAS-BLED score ≥3. persistent leak of less than 3mm. At one month, two patients showed thrombus formation at the device and he study, published by Barbara Bellmann (Chari- were treated with warfarin. At three months, only one té – Universtätsmedizin Berlin, Berlin, Germany) patient of the two patients reported presented persistent Tand others in the Journal of Cardiovascular thrombus; however, the size of the thrombus became Electrophysiology also demonstrated no significant smaller. Both patients continued oral anticoagulation neurological deficits. treatment without signs of bleeding. Currently, there are two LAA closure systems avail- Twelve patients completed follow-up at 12 months. able in Europe: the Watchman LAA closure device All of them showed a correct placement of the device (Boston Scientific) and the Amplatzer Amulet LAA and none of the patients presented with a persistent leak occluder (Abbott). Watchman is the only device com- of <3mm or >3mm. The investigation of the thrombus mercially available in the USA. The Occlutech device is formation in the two patients reported earlier was still undergoing preliminary in-human investigation. outstanding at 12 months. The Occlutech device “adapts itself through its soft- Bellmann et al also reported that no patients devel- ness to the anatomy of the LAA,” write Bellmann et al. oped a clinically apparent stroke or died during three- Therefore, “it may be an option for patients with abso- and 12-month follow-up. lute contraindications for oral anticoagulation”. Addi- Neurological examinations were performed by tionally, the authors comment, the Occlutech Steereable neurological specialists in all patients within 24 hours Sheath has the flexibility to rotate 180 degrees to reach prior to and following LAA closure as well as one LAAs facilitating device implantation. The sheath is and three months after the procedure. The researchers used for transseptal puncture and a change to a delivery reported no significant neurological changes at any sheath is not necessary, which “could lead to a reduction of these time frames. The authors point out that silent of the procedure time and the prevention of complica- Barbara Bellmann cerebral lesions are often identified following interven- tions,” they note. tional cardiology procedures. “This is the first-in-man In this prospective study, 30 patients (mean age 74±8 was successfully implanted in 28 of the 30 patients study and we presented the first experience with the years, 19 male) were treated with the Occlutech device, enrolled (93%). Two patients had to receive another new Occlutech device, so it is a very pleasing result between 2012 and 2016, at the Klinikum Coburg in device (Amplatzer Amulet) due to their “shallow LAA that no significant neurological abnormalities occurred Coburg, Germany. All patients had an indication for oral anatomy”, Bellmann et al note. After device implanta- after the procedure,” they note. Although three-month anticoagulation and were either at a high risk of bleed- tion, 86% of the patients had sufficient LAA closure follow-up success of LAA with the Occlutech device ing or suffered from previous bleeding events—includ- without leakage confirmed by transesophageal echo- was high in this study and comparable to initial experi- ing cerebral and gastrointestinal bleeding. The mean cardiography. A leak less than 3mm was reported after ences with Watchman and Amplatzer, Bellmann et al

CHA2DS2-VASC and HAS-BLED scores were 4±1. implantation in four patients. suggest the confirmation of these results in a larger The authors comment that the Occlutech device After three-month follow-up, 27 patients showed randomised trial. April Issue 17 36 Societies 17 SOLAECE to become LAHRS At the last Latin American Society of Electrophysiology and Cardiac Stimulation (SOLAECE) Congress (Porto Alegre, Brazil, November 2016) the Executive Board of SOLAECE announced a new proposal to strengthen the positioning of the society into the global context of cardiac arrhythmias with a new legally constituted society to be named Latin American Heart Rhythm Society (LAHRS). Cardiac Rhythm News speaks to 2017‒2018 president of SOLAECE Roberto Keegan (Hospital Privado del Sur, Buenos Aires, Argentina) and 2017‒2018 vice president of SOLAECE Luis Carlos Sáenz (Fundación Cardioinfantil, Bogotá, Colombia) about this new proposal.

consensus documents. Another to express their ideas and of project of LAHRS also includes course all those who support this the creation of a magazine aimed initiative will be giving legitimacy to function as an official organ of to this new society. We are dissemination throughout the Latin working legally to ensure that all American territory, so that everyone those who participate and finally has the opportunity to make their support this initiative, signing the research or ideas known. Founding Act, can become part of LAHRS as founding members. The What is the biggest Founding Assembly will take place challenge facing LAHRS? at HRS 2017 (Chicago, USA) on We believe that the greatest Wednesday 10 May, McCormick challenge is to carry out the first Place, West Building Room 470 from step of the project, which is the legal 14.30‒17.30. formalisation of the society. Another great challenge will undoubtedly be Regarding the practice the interest of the Latin American of electrophysiology in community of electrophysiologists on Latin America, in which our society. areas have you seen major improvement? At the HRS Scientific We believe that the practice of Sessions 2017, LAHRS will electrophysiology in Latin America be hosting an inaugural has achieved important improvements assembly of this new over the last years. However, perhaps society; could you give us the greatest advance is in the area of Roberto Keegan Luis Carlos Sáenz details of this event? human resources with professionals It will be a Founding Assembly that of great academic and professional Could you give us the of SOLAECE 2015‒2016, and who will give everyone the opportunity level. reasons for giving legal for personal reasons had to decline status to SOLAECE? to assume the presidency for the The evolution of modern scientific current period. In the proposal we societies has created the urgent need defined three key objectives for to have a legally constituted Latin LAHRS: 1) to obtain institutional American society as the current consolidation giving it the legal SOLAECE has no legal status. Taking framework mentioned above; 2) to advantage of this need and taking obtain scientific and educational into account the global context of the consolidation promoting research, main scientific societies related to education and development of cardiac electrophysiology, we decided scientific knowledge in the field of to name it LAHRS. cardiac arrhythmias in Latin America. An example of this is the proposal To what extent will the to establish an annual LAHRS current composition of the congress; 3) finally, to enhance society change with this social commitment promoting new legal status? joint actions with other scientific Although it is the foundation of a new societies, governmental entities, non- society, it is actually the continuity governmental organisations, health of SOLAECE. In recent years, insurers, etc. These objectives will SOLAECE, under the presidencies of pursue the improvement of medical Drs Luis Aguinaga (Centro Privado de care and health of the population in Cardiología, Tucumán, Argentina) and Latin America. Guilherme Fenelon (Albert Einstein Jewish Hospital, São Paulo, Brazil), What are the benefits for has positioned itself in the world of Latin American members arrhythmias, in particular working with this new society? in partnership with societies such as There are many potential benefits the Heart Rhythm Society (HRS), the for LAHRS members. Amongst European Heart Rhythm Association those, belonging to a strong (EHRA) and the Asia Pacific Heart and consolidated society, which Rhythm Society (APHRS). works in partnership with the main international societies, gives What are the objectives of its members the opportunity to this brand new society? participate actively in important The objectives are defined in the global projects. One example is the proposal that we prepared together opportunity that more than 45 Latin with Dr William Uribe (San Vicente American physicians have had to Fundación Centros Especializados, participate as writing members or Medellín, Colombia) vice president reviewers in more than 20 global April Issue 18 Research 17 36

“Our aim with this study was to quantify the clinical improvements that we have experienced with complex arrhythmia ablations, specifically AF, since upgrading to the Niobe ES system,” says Antoine Da Costa, chief Clinical News of the EP Unit at CHU of Saint-Étienne. “We sought to evaluate procedure duration, as well as efficacy and ex- UK NICE recommends Boston Scientific vide insights into the use of edoxaban for uninterrupted tent of fluoroscopic exposure associated with the Niobe CRT-D devices using EnduraLife battery anticoagulation in patients undergoing catheter ablation, ES system compared to the Niobe II in patients requir- technology applying state-of-the-art treatment in accordance with ing AF ablation. Our results confirmed that the Niobe The UK’s National Institute for Health and Care Excel- the recent treatment guidelines. In this study, edoxaban ES system reduced procedure time and X-ray exposure lence (NICE) has issued medical technology guidance will be used with the approved dosage regimen for by a minimum of 30%, primarily due to the system’s recommending the use of Boston Scientific’s cardiac re- stroke prevention in AF.” enhanced responsiveness.” synchronisation therapy defibrillators (CRT-D) powered In the Saint-Étienne study, researchers compared by EnduraLife battery technology for treating patients Medtronic initiates global trial of Arctic data on 92 consecutive patients treated with the Niobe with heart failure. Front Advance cardiac cryoablation ES system to 92 consecutive patients treated using the In their evaluation, NICE—which provides evi- catheter Niobe II system for symptomatic drug-refractory atrial denced-based guidance to improve health and social Medtronic has enrolled the first participants in the STOP fibrillation. The percentage of circumferential pulmo- care in the UK’s National Health Service (NHS)—con- Persistent AF clinical trial. The trial will evaluate the nary vein isolation, as confirmed via spiral catheter cluded that the extended battery life observed with safety and effectiveness of a pulmonary vein isolation- recording during ablation, was 100%. Procedure time Boston Scientific EnduraLife-powered CRT-Ds is likely only strategy for treating patients with persistent atrial was significantly lower with the Niobe ES system than to reduce the number of avoidable replacement proce- fibrillation (AF), using the Arctic Front Advance cardiac the Niobe II system (1.9±0.4 vs. 2.7±1h, p<0.0001), as dures a patient may have to undergo, thereby offering cryoablation catheter. John Harding, Doylestown Hospi- was X-ray duration (12±4 vs. 15±7min, p=0.001). improved outcomes for patients and potential savings to tal in Doylestown, USA, treated the first patient enrolled The Electrophysiology Unit (EP) at CHU of Saint-Éti- the NHS in England of approximately £6 million in the in the trial. enne first implemented Stereotaxis technology in 2009 first five years. STOP Persistent AF is a prospective, multicentre, and installed a second Niobe system in 2015. They are The savings were calculated by modelling the costs single-arm clinical trial that will enrol up to 225 patients recognised as a national centre of excellence, consist- associated with early replacement procedures, such at 25 centres in the USA, Canada, Europe and Japan. ently ranked in the top five for interventional cardiology as a reduction in hospital admissions, bed days and Patients will be followed for 12 months after the initial in France, as well as a European centre of reference in procurement costs. Fewer replacement procedures also cryoballoon ablation procedure. the treatment of complex arrhythmias. equate to a reduction in associated costs accrued from “Gaining meaningful data from this trial will help post-operative complications and infections—both of further clinicians’ understanding of possible treatment CardioFocus HeartLight Excalibur which also have a measurable impact on morbidity options for patients with persistent AF,” says co-princi- balloon undergoes initial clinical and mortality. pal investigator Hugh Calkins, director of the Electro- evaluation “The NICE guidance reinforces the multi-faceted physiology Laboratory and Arrhythmia Service at the CardioFocus has announced the initial clinical importance of battery longevity in devices treating pa- Johns Hopkins Hospital in Baltimore, USA. “As AF evaluation of the HeartLight Excalibur balloon, a tients with heart failure and life-threatening ventricular progresses and episodes become more constant, patients’ next-generation technology designed for the treatment arrhythmias,” says Jay Wright, consultant cardiologist, quality of life diminishes while their risk of AF-related of atrial fibrillation. The device is undergoing an initial Liverpool Heart and Chest Hospital, Liverpool, UK. health effects, such as heart failure and stroke, increases. clinical evaluation in Europe as part of a broader “Additionally, the reduction in replacement procedures This trial could help us advance care for this hard-to- development programme that seeks to confirm its and potential savings identified treat population.” design objectives. within the guidance could offer Medtronic cryoballoon has been used in more than The Excalibur balloon, according to a company longer-term relief to NHS providers 250,000 cases worldwide. Currently, no ablation release, leverages the universal balloon design of the who have recently seen an increase catheters are approved for treating persistent AF in the HeartLight Endoscopic ablation system and introduces in the number of patients requiring USA. The Medtronic Arctic Front Advance cryoabla- an advanced feature set designed to optimise the speed further in-hospital treatment.” tion system is approved in the USA for the treatment and magnitude of target tissue contact during pulmonary The NICE medical technologies of drug-refractory, recurrent, symptomatic paroxysmal vein isolation procedures. advisory committee found that atrial fibrillation and in Europe for the treatment of “The HeartLight Excalibur balloon conforms ef- the evidence from 16 independ- atrial fibrillation. fectively to the range of anatomies that we encounter ent clinical and economic during pulmonary vein isolation procedures,” says Jan studies supported a case for Clinical study validates efficiencies of Petrů, head of the Electrophysiology Laboratory, Cardi- adoption and concluded that Stereotaxis Niobe ES system compared ology Department, Na Homolce Hospital, Prague, Czech EnduraLife-powered CRT-Ds to Niobe II system Republic. “It is also very responsive, which may result have a greater battery capacity in both better procedural efficiencies and potentially and longer battery life compared better patient outcomes. We are very pleased with the with other CRT-Ds reviewed. experience thus far.” In addition to a more compliant construction that First patient enrolled in Daiichi Sankyo’s enables adaptive vein conformance, the Excalibur ELIMINATE-AF edoxaban study balloon also incorporates proprietary Dynamic The first patient has been enrolled into Daiichi Sankyo’s Response technology. This feature is designed to ELIMINATE-AF study. The multinational, randomised make the balloon highly responsive to a range of user phase 3b study will explore the safety and efficacy of techniques and amounts of pressure applied, while the company’s oral, once-daily direct factor Xa-inhibitor optimising vein contact. The result is a design meant edoxaban (Lixiana/Savaysa) against a vitamin K antago- to maximise the engagement of the balloon with the nist in patients with atrial fibrillation (AF) undergoing pulmonary veins, while decreasing the time required to catheter ablation. complete ablation procedures. The study will investigate the incidence of the composite of all-cause death, stroke and major bleed- AtriCure names US principal ing. Approximately 560 patients will be enrolled in Niobe ES investigator for the CONVERGE IDE ELIMINATE-AF from 75 clinical sites across Europe, clinical trial Canada and Asia. Stereotaxis has reported results of a study conducted AtriCure has announced David B DeLurgio as the US prin- “Catheter ablation as a method of treating AF is more at Centre Hospitalier Universitaire (CHU) of Saint- cipal investigator for the CONVERGE IDE clinical trial. frequently performed in clinical practice due to its posi- Étienne, France, which validates the advantages of the DeLurgio is a cardiac electrophysiologist at Emory tive effect on AF-related symptoms and quality of life; Niobe ES magnetic navigation system over the Niobe II Healthcare in Atlanta, USA. He is director of Electro- however, it is associated with a significant thromboem- system in terms of procedure and fluoroscopy times for physiology at the Emory Heart and Vascular Center bolic risk during and shortly after the procedure,” says atrial fibrillation (AF) ablation procedures. The study at Emory St Joseph’s Hospital, a role he has served in Stefan Hohnloser, professor of Medicine and Cardiol- was published in the International Journal of Cardiol- since 2014. DeLurgio earned his medical degree from ogy, head, Department of Electrophysiology, Johann ogy and represents the first comparison study of Stere- the University of California Los Angeles School of Wolfgang Goethe University in Frankfurt, Germany, and otaxis’ latest generation remote magnetic navigation Medicine, and completed a fellowship in Cardiac Elec- principal study investigator. “ELIMINATE-AF will pro- system to its predecessor. Continued on page 20

April Issue 20 Research 17 36

set by your doctor, perhaps due to coronary artery disease, heart failure or other heart conditions—wrist-worn monitors are less accurate than the standard chest strap,” says Marc Gillinov, The Judith Dion Pyle chair in Heart Valve Clinical News Research, Thoracic and Cardiovascular Surgery at Cleve- land Clinic, and the study’s lead author. “We found these Continued from page 18 the higher rate of stroke in the HVAD group compared devices can equally over- and underestimate heart rate. to the control. In the ENDURANCE Supplemental trial, The error ranged from +/-34 beats per minute to +/-15 that gap closed and the stroke rates are comparable: beats per minute, depending on the type of activity.” there was no statistically significant difference between This single-centre study included 50 volunteers, mostly the HVAD and HeartMate II. We believe the narrow- Cleveland Clinic employees, who responded to internet ing of those rates was most likely due to blood pressure notices and flyers. They were 38 years old on average management,” says Carmelo Milano, co-principal inves- (±12 years), 43% female and generally healthy. Each tigator, and surgical director of cardiac transplantation participant was fitted with a continuous four-lead elec- and left ventricular assist device programmes for the trocardiogram, a chest monitor and an armband (Scosche Division of Cardiothoracic Surgery at Duke University Rhythm+). They were then randomly fitted with two of Medical Center in Durham, USA. four different wearable heart rate monitors (one on each Device exchange was not included in the primary wrist). The devices chosen for testing (Apple Watch, endpoint, but transient ischaemic attacks were. Fourteen- Fitbit Blaze, Garmin Forerunner 235, and TomTom Spark point-seven per cent of patients who received the HVAD Cardio) were based on their popularity and sales figures. system experienced a neurologic event within 12 months Researchers then recorded volunteers’ heart rates at rest of implantation, compared to 12.1% of patients in the and after light, moderate and vigorous exercise across control arm (p=0.14). Posthoc analysis revealed a rate of three types of activities, including the treadmill, station- disabling stroke or death of 18.8% at 12 months among ary bike and elliptical (with and without hand levers). David B DeLurgio patients receiving the HVAD system, compared to 21.6% Measurements on the wearable devices were compared to of patients receiving the control device. readings from the chest strap and electrocardiogram. Par- trophysiology at Emory University School of Medicine. Additional posthoc analyses comparing data from the ticipants exercised for a total of 18 minutes; one dropped He originally joined Emory Healthcare in 1996 and ENDURANCE Supplemental trial to data from the origi- off at the final stage due to fatigue. served as director of the Arrhythmia Center and Electro- nal ENDURANCE Destination Therapy trial show: The chest strap monitor closely matched readings physiology Lab at Emory University Hospital Midtown. The pre-specified blood pressure management protocol from the electrocardiogram, which is the gold stand- “I am honoured and humbled to be given this opportu- in the ENDURANCE Supplemental trial was effective ard for measuring the heart’s activity (level of agree- nity to serve as the national principal investigator for in reducing the mean arterial blood pressure by a clini- ment with electrocardiogram, rc=.996; 1 being perfect the CONVERGE trial,” says DeLurgio. “This landmark cally meaningful amount when compared to HVAD agreement); however, the wrist-worn devices were less study is critically important research in the field of car- patients from the original ENDURANCE trial (as well accurate on average (level of agreement with electrocar- diac electrophysiology. At Emory, we have adopted the as when compared to the control group in ENDUR- diogram, rc=.67-.92). While the watch-style heart rate Convergent approach and have experienced first-hand ANCE Supplemental). monitors may accurately report heart rate at rest, and the results of this therapy. Now, I am looking forward to A 24.7% reduction of overall stroke and transient most were acceptable on the treadmill, they were fairly taking a leadership role and partnering with other trial ischaemic attack incidence—and a 50% reduction in inaccurate while bicycling or using the elliptical. Of the sites to quickly enrol patients and complete the trial.” haemorrhagic strokes—in patients receiving support wrist-worn heart rate monitors, only the Apple Watch The CONVERGE IDE trial is a landmark prospective, from the HVAD system. provided accurate heart rate readings when participants randomised trial comparing the Convergent approach to switched to the elliptical trainer without arm levers; endocardial catheter ablation for patients with persis- Wrist-worn heart rate monitors less none gave correct measurements when they used arm tent or long-standing persistent atrial fibrillation. The accurate than standard chest strap levers. The wrist and forearm monitors also became less Convergent approach is a multidisciplinary therapy in accurate the more intense the activity levels, with the which a closed-chest epicardial ablation is performed exception of the Apple Watch. by a surgeon, and then complemented by an endocardial “Even though all these wrist-worn monitors work by catheter ablation performed by an electrophysiologist. In the same general principles, there is considerable vari- addition to the ongoing IDE trial, individual centre results ation among them,” Gillinov says. “Overall, they were have been published in numerous peer reviewed papers. most accurate when someone was using the treadmill at low intensity and worst when exercising on the elliptical Medtronic ENDURANCE Supplemental at high intensity.” trial of HVAD fails to meet primary What’s behind the discrepancies? Unlike the chest strap endpoint which, like the electrocardiogram, measures electrical Medtronic’s ENDURANCE Supplemental trial of the activity of the heart, wrist-worn monitors use optical company’s HVAD ventricular assist device has failed to sensing or light to measure blood flow. meet its primary endpoint of all neurological events at 12 “It is not measuring what the heart does, but rather months. However, secondary results have shown superior Researchers at Cleveland Clinic, Cleveland, USA, put [downstream] blood flow—basically the volume of blood results for patients treated with the system than those in five popular wrist-worn fitness trackers to the test to find in the tissue,” Gillinov says, adding that these devices control arm of the study, who had received the HeartMate out how accurately they gauge heart rate across several also introduce many more variables that can result in II (Thoratec). types of exercise and intensity levels. incorrect readings (eg. insufficient contact with the skin Results of Medtronic’s ENDURANCE Supplemental Based on their findings, the old-fashioned chest strap because of sweating or poor fit, skin pigmentation). trial were presented in a late-breaking clinical trial session monitor is best, particularly for people who need to keep The bottom line, Gillinov says, is that the wrist-worn of the 2017 International Society for Heart and Lung tabs on how quickly or slowly their heart is beating dur- devices do not provide the full picture; nor are they Transplantation scientific meeting (ISHLT; 5–8 April, San ing activity, according to the study team. The standard intended to be medical devices. Diego, USA). The study evaluated the company’s HVAD chest strap was the most accurate regardless of the inten- “We are just at the beginning of a revolution in system as a destination therapy for patients needing left sity of the workout or whether someone was using the personal management of health by virtue of wearable ventricular assist devices (LVAD) who received improved treadmill, elliptical or stationery bike. The results were physiological monitoring,” Gillinov says. “As people blood pressure management. The HVAD system is not presented at the 2017 Scientific Session of the American take more control of their health and record their own approved in the USA for destination therapy. College of Cardiology (ACC; 17–19 March, Washington, physiological data, they need to know how accurate it While the trial did not meet its primary endpoint, DC, USA). is; this is especially concerning for people with heart secondary results showed that 76.4% of patients receiving This study builds on earlier research by the same team conditions that can be exacerbated [with activity]. the HVAD system were alive on the originally implanted that assessed a different set of heart rate monitors and was Cardiologists can use these data and decide which device and free of disabling stroke, compared to 66.9% of limited only to walking or jogging on a treadmill. Heart monitor they would recommend and help educate patients patients in the control arm (non-inferiority p<0.0001; su- rate is often used as part of a formula to calculate how about their limitations.” periority p=0.0354). This prespecified secondary endpoint many calories are being burned during exercise. How- This study is limited due to its small size. Researchers analysis showed the HVAD system was superior to the ever, for people with heart problems, an accurate heart say larger studies are needed and should also evaluate control group (absolute difference 9.2%), as evaluated by rate reading is important. “If you need to know your heart how these devices perform in measuring heart rate in this composite endpoint. rate with accuracy when exercising—either because you people who have heart failure, diabetes, are recovering “In the ENDURANCE trial, we were concerned about are training for a marathon or have safe heart rate limits from heart attack or are obese. April Issue 17 36 Market watch 21

York City, USA, says. value (weighted formula) when the cath- The hospital approval process has eter is stable. begun for the trial to take place at Mount “Compared to my previous ablation Sinai, the Mayo Clinic, Houston Method- strategy, thanks to the new Carto Visitag Product News ist Hospital, Houston, USA and Pacific module with Ablation Index, I have Heart Institution, Santa Monica, USA. reduced my procedural time by 26% and Medtronic announces World Report’s list of “2016’s Biggest The clinical trial start date in the USA is radiofrequency ablation time by 36% in Medicare reimbursement for Achievements in Medicine.” scheduled for May 2017. paroxysmal atrial fibrillation ablation. Micra Transcatheter Pacing Primary results from the Medtronic “This study will confirm the safety of Furthermore, in my experience with the System Micra TPS Global Clinical Trial, the Sierra device for patient use, and will Ablation Index combined to an optimised published in November 2015 in The lay a solid foundation for future efforts workflow, the success rate at one year New England Journal of Medicine, to demonstrate that Sierra can prevent follow-up (single-procedure freedom of showed the Micra TPS was successfully stroke in atrial fibrillation patients and documented arrhythmia) is now up to implanted in 99.2% of patients by 94 eliminate the need to take blood thinners 92%,” says Mattias Duytschaever, Heart physicians around the world and that the for stroke prevention,” notes the lead Division Az Sint-Jan Hospital, Bruges, system met its safety and effectiveness study principal investigator, Sheldon Belgium. “I strongly believe that the endpoints at six months follow-up with Singh, Sunnybrook Health Sciences information the Ablation Index gives me wide margins. Long-term results from the Centre in Toronto, Canada. will further increase acute and long-term Micra Trial, published in November 2016 durability finally closing the gap to dura- in HeartRhythm, reinforced these data, Biosense Webster launches ble pulmonary vein isolation.” showing the risk of major complications Carto 3 system Carto Visitag Micra at 12 months for Micra patients was low module with Ablation Index Biotronik launches Edora at 4%, 48% lower than for patients with Biosense Webster has launched the Carto MR-conditional pacemakers Medtronic has announced that the traditional pacemakers (hazard ratio: Visitag module with Ablation Index, a US Centers for Medicare & Medicaid 0.52, 95% CI: 0.35-0.77, p=0.001). new technology providing visual indica- Services (CMS) has approved cover- tion based on the integration of power, age for the Micra Transcatheter Pacing US FDA grants contact force and time parameters to be System (TPS). This decision, effective Investigational Device displayed on the Carto 3 system. immediately, follows the approval of two Exemption to Aegis Medical The index was developed to simplify studies required to enable reimbursement for Sierra ligation system and standardise the workflow for ablating through Medicare’s policy of Coverage patients with paroxysmal atrial fibril- with Evidence Development (CED). lation and support electrophysiologists In January 2017, CMS issued a final using the Carto SmartTouch technology, Edora National Coverage Determination (NCD) in reproducing their own successful abla- that covered leadless pacemakers under tion strategy to achieve pulmonary vein Biotronik has launched the Edora range CED when used in accordance with isolation. of high-functioning, small-size pacemak- FDA-approved labelling in FDA-ap- The Carto Visitag module with Abla- ers and cardiac resynchronisation therapy proved studies that have been approved tion Index is intended to integrate power, pacemakers (CRT-Ps). by CMS, or under prospective, longitu- contact force and time into one single Continued on page 22 dinal studies approved by CMS. The two Sierra Micra studies approved by CMS are the Micra Post-Approval Study (PAS), which Aegis Medical Innovations has received was required by the FDA as a condi- Investigational Device Exemption ap- tion of approval of the device in April proval from the US FDA to initiate a 2016, and a new Micra CED Study, the clinical trial in the US for its Sierra liga- “Longitudinal coverage with evidence tion system. Aegis developed the Sierra development study on Micra leadless technology in partnership with the Mayo pacemakers,” which was developed by Clinic in Rochester, USA. Medtronic to address research questions According to a press release, Si- identified by CMS in the NCD. erra could—with additional clinical The Micra PAS Study will enrol a sub- research—prove to prevent stroke in set of Medicare Micra patients through a patients with atrial fibrillation. The Sierra traditional clinical research design, while procedure is designed to close off the left the Micra CED Study will encompass atrial appendage by placing a ligature all Medicare beneficiaries who receive around the base and cinching it down Micra under an innovative new ap- with a lock. Closing off the left atrial approach to CED, linking information from pendage from circulation prevents clots Medtronic’s device registration system from leaving the appendage, eliminating to Medicare health insurance claims and a potential source of future stroke. Ac- enrolment data. cording to the release, Sierra also has the “Since the Medicare coverage decision potential to reduce, and possibly elimi- was announced earlier this year, we have nate atrial fibrillation in some patients. been working closely with CMS to se- The clinical trial, called LASSO-AF, cure study approvals which will provide is an early feasibility study designed to additional evidence supporting the Micra assess the safety and procedural success of TPS,” says John Liddicoat, senior vice Sierra in closing off the left atrial append- president, Medtronic, and president of age using a minimally invasive, epicardial the Cardiac Rhythm and Heart Failure di- approach. Participants will be considered vision. “We are pleased that all Medicare for this trial if their doctors have deter- beneficiaries indicated for Micra accord- mined that they have atrial fibrillation, are ing to the FDA label are now covered by at increased risk for developing a stroke, the NCD and, as a result, have access to and are not ideal candidates for taking this innovative pacing technology.” anticoagulation drugs. Approved by the FDA in April 2016 “In contrast to vascular treatments, this for patients who need a single-chamber non-vascular approach does not implant a pacemaker, the Micra TPS is the first and device inside the heart that might migrate only leadless pacemaker approved for use or cause clots in the left atrial append- in the USA. The miniaturised device was age, thus potentially improving patient recently named at the top of US News & safety,” Vivek Reddy, Mount Sinai, New April Issue 22 Market watch 17 36

tailored to individual patients. This technology can help eliminate the effort, time and patient inconvenience commonly associated with conventional pre- and post- scan pacemaker reprogramming. Product News “A long-lasting and small wireless pacemaker that allows patients to undergo MRI scans is an important step Continued from page 21 cardiac monitors, experienced a forward in growing our available treatment options for The new devices are equipped with features designed 49% reduction in false detections patients,” says David Sandler, director of electrophysi- to improve patient safety, therapy and comfort. Moreo- with the Reveal LINQ ICM with ology at the Oklahoma Heart Institute, Tulsa, USA. ver, Edora pacemakers are significantly smaller and TruRhythm Detection when compared lighter than preceding models. to the Reveal LINQ ICM. US FDA approves Abbott’s FlexAbility “Biotronik’s new series of pacemakers fits well in the “Insertable cardiac monitors help Catheter, Sensor Enabled current age of smart technologies, with devices that are physicians find answers for patients at risk The FlexAbility Ablation Catheter, Sensor Enabled smaller, lighter and shorter while retaining longevity,” for cardiac arrhythmias to better manage is designed to improve the versatility and precision says Saravanan AL Krishinan, Hospital Sultanah Bahi- a range of patient populations,” says James during cardiac ablation procedures to treat atrial yah, Alor Setar, Malaysia. “What is more, the devices Allred, Cone Health Medical Group Heartcare, flutter. offer simplified magnetic resonance imaging (MRI) Greensboro, USA. “The enhancements with the The Sensor Enabled tool complements the access, which is often crucial for better patient care.” Reveal LINQ ICM with TruRhythm Detection EnSite Precision cardiac mapping system Edora pacemakers and CRT-Ps are MR-conditional make it smarter by streamlining device data review and expands Abbott’s cardiac mapping and feature the company’s award-winning MRI AutoDe- so physicians can make decisions more accurately and and ablation portfolio. tect functionality. This means that within a programma- quickly for patients.” The FlexAbility Ablation Catheter, ble window of up to 14 days, the device’s built-in sensor Reveal LINQ ICM with TruRhythm Detection, which Sensor Enabled is the first ablation is designed to detect an MRI environment, automatical- allows physicians to continuously and wirelessly catheter from Abbott that helps ly switch the system to MRI mode, and then automati- monitor a patient’s heartbeat for up to three FlexAbility Ablation collect both electrical current cally switch back to its standard mode once the scan is years, is approximately one-third the size of an Catheter, Sensor Enabled resistance (impedance) and complete. Since the device is only in MRI mode for the AAA battery (~1 cc). It is placed just beneath magnetic data to facilitate duration of the scan, the patient should receive optimal the skin through a small incision of less than 1cm in the detailed, accurate mapping as well as assist in the therapy for the maximum amount of time, according to upper left side of the chest, using a minimally invasive treatment of sites that trigger or sustain abnormal heart a company release. procedure, and its presence is often nearly undetect- rhythms. It also represents the second Sensor Enabled Devices in the Edora series also support Biotronik’s able to the naked eye once the incision has healed. The tool released by Abbott in USA for the use with the Home Monitoring service for remote long-term patient device communicates wirelessly with a patient bedside company’s EnSite Precision cardiac mapping system, care with a streamlined workflow. monitor that uploads device data to the Medtronic Care- which also includes the Advisor FL Circular Mapping Edora CRT-Ps are specifically tailored for individual- Link network; it is MR-Conditional, allowing patients to Catheter, Sensor Enabled. ised therapy through quadripolar technology for flexible undergo magnetic resonance imaging (MRI), if needed. When used with the EnSite Precision cardiac pacing in the left ventricle. mapping system, Sensor Enabled catheters, according US FDA approves expanded indication to a company release, allow physicians to create AliveCor releases first artificial for Medtronic Freezor Xtra cryoablation highly detailed 3D cardiac models with the heart’s intelligence-enabled platform for early catheter electrical activity overlaid on it. These models help atrial fibrillation detection The US Food and Drug Administration (FDA) has ap- the physicians identify the type of arrhythmia and the AliveCor has released the Kardia Pro, an industry-first proved Medtronic’s Freezor Xtra cryoablation catheter areas they should treat with the ablation catheter. artificial intelligence-enabled platform for doctors to for treating patients with atrioventricular nodal re-entrant The catheter is also compatible with Abbott’s monitor patients for the early detection of atrial fibrilla- tachycardia (AVNRT). The Freezor Xtra catheter is a flex- MediGuide Technology, which allows the physician to tion, in the USA. ible, single-use device used to freeze cardiac tissue and reduce the duration of live X-ray during a procedure. The company has also announced US$30 million in new block unnecessary electrical signals within the heart. “I am seeing an increasing number of patients with funding, led by Omron Healthcare and the Mayo Clinic. “The expanded indication for this catheter will complex cardiac arrhythmias, which has created a strong Vic Gundotra, AliveCor chief executive officer, says, allow more patients to benefit from a safe and effec- need for advanced tools that can meet the needs of those “Kardia Pro tracks important measures of physiology tive therapy that can prevent heart racing, and allow patients” says Jeffrey Winterfield, director, Ventricular like weight, activity and blood pressure, and, for the first them to get back to their normal activities,” says Peter Arrhythmia Service and associate professor of cardiac time, artificial intelligence technology is used to create Wells heart rhythm doctor at Baylor Heart and Vascular electrophysiology at the Medical University of South a personal heart profile for each user, enabling user Hospital, Dallas, USA, and principal investigator of the Carolina, USA. “Sensor Enabled catheters, along with identification.” ICY-AVNRT clinical trial. EnSite Precision cardiac mapping system, allow me “What I find so compelling about Kardia is how The expanded indication is supported by data from to quickly identify and treat the arrhythmia, giving me it empowers my patients, making them much more the Intracardiac Cryoablation for Atrioventricular Nodal the flexibility and accuracy I need to reach the most proactive in their own healthcare,” says Theodore Reentrant Tachycardia (ICY-AVNRT) clinical study, challenging locations in the heart to support effective Takata, cardiac electrophysiologist. “Reviewing which demonstrated safety and effectiveness of the outcomes and improve the lives of my patients.” data this quickly also lets me make important Freezor Xtra catheter for the treatment of patients medical decisions, accelerating the time to with AVNRT. With 397 enrolled patients in 34 Biotronik launches a new series of Ilivia diagnosis and avoiding unnecessary healthcare clinical trial sites across the USA and Canada, the CRT devices utilisation.” study found freedom from AVNRT at 92.6% at six Biotronik has announced the launch of a new series months post-procedure. All of the safety endpoints of cardiac resynchronisation therapy (CRT) devices FDA clears Reveal LINQ were met, with no primary safety events related to with several functionalities that allow physicians to Insertable Cardiac Monitor with the catheter. offer an all-inclusive and individualised solution for TruRhythm Detection optimised CRT. The US Food and Drug Administration US FDA approves Assurity MRI “Biotronik’s new CRT-Ds are equipped with numer- (FDA) has given 510(k) clearance to pacemaker ous features that address physicians’ concerns about Medtronic for its Reveal LINQ Insertable Abbott has announced US Food and Drug Admin- cardiac resynchronisation therapy,” says Christof Cardiac Monitor (ICM) with TruRhythm istration (FDA) approval for magnetic resonance Kolb, German Heart Center, Munich, Germany. “The Detection. (MR)-conditional labelling for both the Assurity energy-efficient MultiPole Pacing has great potential A company release states that the Reveal MRI pacemaker and the Tendril MRI pacing lead. to increase patients’ response to CRT and to sustain LINQ ICM with TruRhythm Detection of- Patients implanted with these low-voltage this in the long term.” fers exclusive algorithms that result in a 95% devices will have the ability to undergo full Biotronik states that the Ilivia series of CRT-Ds reduction in false bradycardia episodes and a body magnetic resonance imaging (MRI) scans, is specifically designed to address the 30–40% non- 47% reduction in false pause episodes when if required. With the approval, the company response rate to CRT without causing disproportionate compared with its predecessor, the Reveal LINQ states, the Assurity MRI pacemaker is now the additional battery drain. The system features MultiPole ICM. The device also features a self-learning world’s smallest, longest-lasting wireless MRI- Pacing (MPP) for sequential or simultaneous pacing in atrial fibrillation algorithm, which learns and compatible pacemaker. the left ventricle (LV) that is individually programma- adapts to a patient’s heart rhythm over time. The Assurity MRI pacemaker works with Ab- ble for an increased response rate. To further improve Atrial fibrillation episodes, which are most likely bott’s MRI Activator handheld device to trigger therapy success, this is complemented by a diverse to trigger false positives with insertable pre-programmed MRI settings appropriately portfolio of LV leads for different patient anatomies and April Issue 17 36 Market watch 23

and enhancing the patient experience.” According to a press release, Medtronic will employ a strategic rollout of the technology in the geographies where it is cleared. Medtronic acquired CardioInsight in 2015, Product News now part of the Medtronic Atrial Fibrillation Solutions business in the Cardiac Rhythm and Heart Failure division. target veins, including a newly launched Sentus QP lead released, non-invasive, cardiac electrical mapping sys- with alternative pole-spacing for short to medium veins. tem in the world, eliminating the invasive steps of this Abbott completes the acquisition of St The Ilivia CRT-D series also offers ProMRI and is clinical procedure. Jude Medical equipped with Biotronik’s award-winning MRI AutoDe- The CardioInsight system uses a 252-electrode sensor Abbott has now completed the acquisition of St Jude tect feature, which enables the device to automatically vest that is worn by the patient to pair body surface Medical. The Abbott press release announcing the com- recognise an MRI environment within a programmable electrical data with heart-torso anatomy. The technol- pletion of the acquisition said, “The transaction provides time window, and switch itself to and from MRI mode. ogy creates 3D electroanatomic maps of the heart by Abbott with expanded opportunities for future growth and This simplifies the process of MRI scans for both collecting electrocardiogram signals from the chest, is an important part of the company’s ongoing effort to patients and physicians and decreases the duration of and combining these signals with data from a computed develop a strong, diverse portfolio of devices, diagnostics, reduced therapy, offering increased patient safety. tomography scan of the heart. The vest technology con- nutritionals and branded generic pharmaceuticals.” tours to the patient’s body to allow for continuous and “Abbott has a strong track record of successfully US FDA clears CardioInsight non- simultaneous panoramic mapping of both atria or both integrating dozens of businesses on a global scale and invasive 3D mapping system ventricles, which cannot be achieved with current inva- accelerating growth,” says Miles D White, chairman Medtronic has received US Food and Drug Administra- sive methods. The 3D cardiac maps can be created by and chief executive officer of Abbott. “The addition of tion (FDA) 510(k) clearance for the CardioInsight non- capturing a single heartbeat, and enable rapid mapping St Jude Medical strengthens our global medical device invasive 3D mapping system. The CardioInsight system of these heart rhythms. The predecessor system has been leadership while offering innovative products to address is used to map a wide range of irregular heart rhythms used with more than 1,600 patients and is featured in more areas of care, in more physicians’ offices and in the upper and lower chambers of the heart providing more than 120 peer-reviewed journals and presentations. hospitals around the world.” electroanatomic 3D maps. “By offering this non-invasive approach, we are ef- Pursuant to the terms of the agreement, upon com- The system was first used commercially in the USA fectively streamlining the clinical procedure planning pletion of the acquisition St Jude Medical became a by Vivek Reddy, director of cardiac arrhythmia services process for clinicians, and making it easy for patients wholly-owned subsidiary of Abbott. As a result of the at the Mount Sinai Hospital and the Mount Sinai Health to receive precise mapping results from their providers completion of the acquisition, 4 January 2017 was the System, New York City, USA. right at their bedside,” says Reddy. “This system shifts last day of trading of St Jude Medical shares on the New The CardioInsight system is the first commercially mapping away from the EP lab, potentially saving time York Stock Exchange.

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