Patent Foramen Ovale, Or PFO

Home , Foramen ovale (heart)

The latest news an d best prac tices from S anger Heart & Vascular Institute P Cardiologist Adult FASE FACC, Patel, Sanjay Cardiologist Interventional FACC Downey, William persiststhroughout life ...” thispotential interatrial communication “Inabout one-fourth of the population, atent Foramen MD, R. The E. MD,

A 32-ye life—thepatent foramen ovale, or PFO. communicationpersists throughout population,this potential interatrial However,in about one-fourth of the acomplete partition between the atria. people,these layers then fuse, creating primumand secundum. In most ofoverlapping layers of the septae pressurecloses a flap valve consisting shiftto lower right than left atrial pulmonarycirculation. At birth, the theleft atrium, thereby bypassing forshunting blood from the right to foramenovale is a physiologic conduit congenit A bemanaged? patentforamen ovale. How should she normalheart with the exception of a echocardiogramshowed a structurally neckwas normal. A transesophageal resonanceangiography of the brain and infarctin the left frontal lobe. Magnetic imagingdemonstrated a small acute ofthe brain with diffusion-weighted palpitationsor cardiac disease. An MRI migraineheadache, thromboembolism, episode.She had no prior history of 15minutes. She has never had a similar ache.The aphasia resolved fully within noweakness, sensory deficit or head thephone. She was fully alert and had becameaphasic while speaking on Duringfetal development, the a r-old wom a l condition l a n

suddenly

- O

www.sangerheart.org uponstanding. More commonly, right producessubstantial arterial orthodeoxia,a rare syndrome, it thromboembolicevents. In platypnea- ischemicstrokes and other arterial implicatedin the pathogenesis of some arebenign. PFO has clearly been symptom.However, not all PFOs PFOwill never have an associated veinthrombosis (DVT). Though most isthat the stroke is preceded by deep thentravel to the brain. acrossa PFO into the left atrium and causedby small emboli that travel thatmany cryptogenic strokes are observation,researchers hypothesize transitacross the PFO. Based on this demonstrateda large thrombus in acutestroke, echocardiography has contributory.In a few patients with Insome of these, the PFO is clearly twicethat of the general population. ofPFO is about 40 to 50 percent, cryptogenicstroke, the prevalence unexplained.Among patients with evaluation,about 16 percent remain strokeeach year. Even after extensive inthe United States suffer from C decompressionillness in scuba divers. ofPFO to migraine headaches and datasuggest a potential contribution ofpulmonary hypertension. Some canpotentiate hypoxemia in the setting toleft atrial shunting through a PFO vale ryptogenic stroke ryptogenic Thevast majority of people with Apresumption of this hypothesis Three-quartersof a million people C ontinued on page 6 hypoxemia

winter 2010-11/Vol. 1/issue 4 1/issue 2010-11/Vol. winter W I Further to see the archived and live CM the “Charlotte Ñ Ñ Ñ Ñ complete details. C third-party distribution. Please see information will not be used for located on our home page. Your and fill out the short sign-up form e-mail, visit a copy of I presentations available. www.sangerheart.org for noted presentations. Visit Free CM f you’re interested in receiving maging Ins Sanger s HS ho

i S 3D and 4D SH L gn up t

NE etter from the President marketing privacy policy for urgical H i V de ... de ave I W! FR

R E A The Sanger evolutionizing Cardiac credit is now available wards www.sangerheart.org L R O ung Cancer epor o ptions for Patients AHE E EE

Re chocardiography: O C Connect” logo c t N e v R and click on i eport LI ve i a e- NE The via CM

m E a

E il

Innovations in Sanger Heart & Vascular Institute Awards Cardiovascular Ñ Aetna Institutes of Ñ B. Hadley Wilson, MD, Care Quality Cardiac Rhythm presented a lecture at a recent recently designated Carolinas Transcatheter Cardiovascular Medical Center (CMC) as an Therapeutics meeting entitled I can’t believe this is the fourth issue of “Institute of Quality” hospital “Enhancing Outcomes in The Sanger Report. This will conclude our first year based upon an evaluation of Acute Myocardial Infarction: of publication and complete Volume 1. This issue the clinical performance and The Systems Approach.” features three clinical articles. overall value of the facility. Dr. Wilson also co-authored Continuing our focus on adult and congenital CMC is now listed as a a paper entitled “Improved heart disease, members of our adult cardiology team, participating facility in the Late Clinical Safety with William E. Downey, MD, and Sanjay R. Patel, MD, Aetna Institutes of Quality Zotarolimus-Eluting Stents spotlight a condition known as patent foramen ovale Cardiac Rhythm online Compared with Paclitaxel- (PFO). They review the high prevalence of PFO and provider directory. Eluting Stents in Patients the potential medical complications associated with it. with De Novo Coronary They outline the current therapeutic options available Ñ Sangeev Gulati, MD, Lesions: Three Year Follow- to patients, including the risks and benefits of PFO recently presented two up from the ENDEAVOR IV closure. abstracts at the Heart Failure Trial,” which was published Geoffrey A. Rose, MD, director of Sanger Heart Society of America meeting in the Journal of the American & Vascular Institute’s (SHVI’s) Cardiac Ultrasound in San Diego: “Relationship College of Cardiology: Laboratory, details the evolution of echocardiography Between Intrathoracic Cardiovascular Interventions. from single plane M-mode to now 3D and 4D imaging. Impedence, BNP and He also details the utility of these advanced images in 6-Minute Hall Walk” and Ñ John Symanski, MD, preoperative assessment of patients and intraoperative “Timecourse of Weight and had a letter published assessment of surgical success. Intrathoracic Impedence in The American Journal Mark K. Reames Sr., MD, a member of the Changes During Volume of Cardiology entitled Department of Cardiothoracic and Vascular Surgery, Overload.” Dr. Gulati spe- “The Coronary Collier.” reviews the history of surgery for lung cancer and cializes in adult cardiology thoracoscopy. He also reviews the experience with and heart transplantation Ñ Francis Robicsek, MD, and video-assisted thoracic surgery for lung cancer, which for Sanger Heart & Vascular Michael Rinaldi, MD, has become the treatment of choice for patients with Institute (SHVI) at CMC in represented SHVI at the resectable primary lung cancer at SHVI. Charlotte. South Atlantic Cardiovascular We continue to innovate with better diagnostic Society meeting presenting tools and less-invasive and improved methods to cases related to avoidance manage both lung and heart disease. I hope you of litigation and STEMI, enjoy reading this issue of The Sanger Report. respectively.

Sincerely, Ñ Congratulations to Rohit Mehta, MD, who was selected as a Fellow of the Heart Rhythm Society. Thinkstock

Paul G. Colavita, MD, FACC 11

President © 20 Sanger Heart & Vascular Institute Trophy image

The Sanger Report n www.sangerheart.org 3D and 4D Echocardiography: Further Revolutionizing Cardiac Imaging Geoffrey A. Rose, MD, FACC, FASE Director, Cardiac Ultrasound Laboratory

Since its introduction, the short of revolutionary. However, the “The ability to obtain use of cardiac ultrasound (also known shortcomings inherent in using a one- as echocardiography) has consistently images with this degree dimensional modality to evaluate a 3D advanced the care for patients with of anatomic detail has object (i.e., the beating heart) were readily cardiovascular disease. In the 1950s, further transformed apparent. The cycle of innovation began. Dr. Inge Edler recognized that high assessment of patients Two-dimensional echo was the result frequency sound waves—at the with mitral valve disease.” of those innovative efforts. Figure 2 time a new technology harnessed to demonstrates an example of MVP using identify structural defects in the steel 2D echo; this is the same patient as of ships—could be applied to study in Figure 1. In the 2D image, cardiac cardiac motion in real time. From A changing technology structure is represented in a manner more this key insight, a cycle of technical Displaying a single ultrasound scan- intuitive than its M-mode counterpart. and clinical innovation emerged. As line over time created the first echo The image is easier for the clinician to newer imaging data were integrated images. This was known as M-mode comprehend, thus leading to greater into clinical decision-making, these imaging (with “M” signifying motion), and understanding of the nature of the now more complicated decision it provided the first noninvasive means underlying disorder. In the case of MVP, pathways spurred development of more to identify MVP (see Figure 1) as well as such insights from 2D imaging led to pio- sophisticated imaging techniques. The many other cardiac conditions. Although neering efforts to repair damaged valves, incremental information thus gained in quite simple by today’s standards, rather than replacing such valves with a turn served to further advance those M-mode echo nevertheless represented prosthesis. This noninvasive technology clinical care algorithms. This concept a true breakthrough. It became possible enabled clinicians to obtain information can be illustrated by reviewing how to validate and quantify those clinical about a patient’s heart without use of mitral valve prolapse (MVP), a common impressions formulated from the history radiation and at the bedside, which cardiac condition, has been approached and physical examination (soft data) by an propelled its broader clinical application. over time, leading to its contemporary external frame of reference (hard data). evaluation using 3D and 4D techniques. For clinical medicine, this was nothing Continued on page 8

Figure 1 Figure 2

www.sangerheart.org n The Sanger Report Surgical Options for Patients Who Have Lung Cancer Mark K. Reames Sr., MD, FACS Cardiothoracic Surgeon

For decades, the surgical removal of early stage primary lung cancer has “Currently, approximately 5 percent of the lung made a substantial improvement in cancer programs in the United States and Europe patients’ long-term survival compared use VATS lobectomy as a significant treatment to other treatment modalities, including modality for lung cancer.” radiation and chemotherapy. To opti- mize a patient’s survival, surgeons must perform an anatomical resection to prevent clinically significant recurrence failure requiring reintubation, pneumo- popularized by Ralph J. Lewis, MD, of the tumor within the lobe of origin. nia and even death may be substantial. and Robert J. Caccavale, MD, with the Simple removal of the nodule and a Mortality associated with a thoracot- advancement of thoracoscopic stapling normal margin of lung parenchyma omy and lobectomy is approximately devices. (wedge resection), while useful in situa- 3 to 4 percent. The respiratory failure tions of pulmonary function inadequate rate requiring reintubation is between Improved survival to tolerate an entire pulmonary lobec- 10 and 15 percent. Currently, approximately 5 percent of tomy, creates an environment in which the lung cancer programs in the United local tumor recurrence may be as high Thoracoscopy States and Europe use VATS lobectomy as 20 percent. Therefore the recom- Fortunately, thoracoscopy or video- as a significant treatment modality for mended standard of surgical care for assisted thoracic surgery (VATS) has lung cancer. The data show that anatom- early stage lung cancer is pulmonary progressed to a point where lobectomy ical VATS resections have an improved lobectomy or pneumonectomy in the can be performed as a reasonable survival over that of anatomical resec- case of very proximal bronchogenic treatment for early stage lung cancer. tions done via thoracotomy. It’s impor- tumors. Thoracoscopy was developed tant to recognize, however, that in order by Swedish internist Hans Christian to achieve these results, true anatomical Thoracotomy Jacobaeus, MD, in 1910, to treat resections, which remove the entire Historically, these procedures have tuberculosis. It was used extensively parenchymal basin of the involved pul- been performed through a thoracotomy in Europe for the treatment of myco- monary lobe and thus require individual incision. This type of incision causes a bacterial infections. However, its use division of the bronchus, pulmonary vein great deal of trauma to the chest wall, diminished quite sharply with the and pulmonary arteries at their origins, secondary to division of the latissimus development of antituberculous drugs must be performed in order to achieve dorsi and serratus anterior muscles, and and antibiotic therapy in the 1950s. the lower rates of cancer recurrence retraction with or without resection of There was a resurgence of the that are seen with complete lobectomy. one of the ribs to achieve exposure to technique in the 1970s when the need This is in contradistinction to a generous the lung and its vascular and broncho- for pleural biopsy made the technique wedge resection, which includes mass genic structures. Thoracotomy creates more popular. More complex surgeries ligature or stapling of the pulmonary a great deal of patient discomfort, using the thoracoscope began around parenchyma, bronchus, arteries and vein making proper pulmonary toilet, includ- 2000, including anatomical lung cancer using more advanced stapling devices. ing coughing and deep breathing with resections as well as esophagogas- Wedge resection leaves pulmonary clearing of pulmonary secretions, quite trectomies. The thoracoscopic lobec- parenchyma and node-bearing tissue difficult in the postoperative period. In tomy was performed first by Robert behind, increasing the probability of these situations, the risk of respiratory J. McKenna Jr., MD, in 1996 and was cancer recurrence.

The Sanger Report n www.sangerheart.org Figure 1 Figure 2

Figure 3 Figure 4

Images

The images above detail a VATS lobectomy to treat a patient with lung cancer. Ñ Figure 1. Four small incisions are used for thoracoscopic access to the pleural space. Ñ Figure 2. Specially designed vascular stapling devices are used to anatomically resect the involved lobe. Ñ Figure 3. After detachment, the lobe of lung is placed into a sterile endoscopic bag. Ñ Figure 4. The specimen is removed from the chest cavity via one of the small incisions.

Physicians at Sanger Heart & 0.55 percent. Our respiratory failure average of 8 days with thoracotomy) Vascular Institute have extensive requiring reintubation rate is Ñ lower respiratory failure rates and mor- experience with pulmonary lobectomy 1.1 percent. tality rates (0.55 percent with thoracos- using VATS. We use a thoracoscopic In my opinion, thoracoscopic lobec- copy vs. 3 to 4 percent with thoracotomy) approach in more than 95 percent tomy versus thoracotomy is the treatment Ñ faster convalescence (4 to 5 weeks of patients who are considered to be of choice for patients with resectable with thoracoscopy vs. 2 to 3 months candidates for lung cancer resection. primary lung cancer. Some of the major with thoracotomy) Currently, we have performed 180 VATS benefits include: For more information, to refer a procedures in a three-and-a-half-year Ñ a shorter hospital stay (an average patient or for clinical questions, call period, achieving a mortality rate of of 3 days with thoracoscopy vs. an 877-999-SHVI (7484).

www.sangerheart.org n The Sanger Report Patent Foramen Ovale

Continued from page 1 recurrence without any therapy. Among factors increasing the risk of a recurrent 943 patients treated with aspirin or neurologic event include: patients with cryptogenic stroke don’t have warfarin after cryptogenic stroke in the Ñ larger PFOs an obvious venous thrombus, we may not presence of PFO, the annual risk of stroke Ñ spontaneous right-to-left shunting look hard enough. When venography was was 2 percent; death 0.9 percent; and Ñ prominent eustachian valves used to systematically investigate the legs transient ischemic attack (TIA) 2.2 percent.3 Ñ a hypercoagulable state of 42 patients with arterial embolism and In another study of 581 patients with It’s unclear whether warfarin has any PFO, DVT was found in 24 patients. In PFO and cryptogenic stroke, the risk therapeutic benefit over aspirin. Several 13 of these patients, DVT was found of recurrent stroke or TIA at four years studies have suggested trends toward only in the calf veins and would likely was 4 percent in patients with no PFO; benefit with warfarin, but no strong have been missed with conventional 2 percent in patients with PFO alone; conclusions can be drawn. investigation.1 In another study using MR and 15 percent in patients with PFO and Though no devices are currently venography, pelvic vein thrombi were atrial septal aneurysm.4 However, not approved for PFO closure in the United found in 20 percent of patients with all PFOs are the same. Some appear to States, percutaneous device closure of PFO cryptogenic stroke and PFO.2 cause a higher risk of first and subsequent has risen in prominence as an alternative to So what’s the risk of a recurrent stroke than others. In addition to the medical therapy after cryptogenic stroke. neurologic event, and how can we prominently increased risk conferred by The two most commonly used devices reduce it? No data exist on the risk of atrial septal aneurysm, other potential are the Amplatzer® cribriform and the Gore Helex™ septal occluders. These devices use a metallic scaffold to position fabric on both sides of the atrial septum to occlude the PFO. They are effective in closing the defect, with more than 95 percent of newer devices achieving complete closure. This can be done safely:

New England Journal of Medicine In a report of 1,970 closures, there were no strokes and TIA occurred in 0.2 percent; tamponade in 0.3 percent; and access-site problems in 1.5 percent.

Image courtesy of the However, it’s far from clear that device closure reduces the risk of recurrent stroke. Observational studies have suggested some therapeutic benefit. Among 1,430 patients undergoing closure, the annual risk of recurrent stroke was 0.19 percent and TIA was 1.5 percent, compar- ing favorably with 2 percent for each with medical therapy.3 While these data are promising, they’re potentially confounded by placebo effects, selection bias and the absence of independently adjudicated outcomes. Results of the first randomized trial in the field were presented at the American Heart Association meeting in November. The CLOSURE-I trial randomized 909 patients with cryptogenic stroke

The Sanger Report n www.sangerheart.org Patent Foramen Ovale

or TIA in the setting of PFO to medical in patients undergoing PFO or atrial septal be contributory. Further studies should therapy (aspirin or warfarin) or PFO closure defect closure for cryptogenic stroke. In include an evaluation for hypercoagulability. using the STARFlex® device plus medical contrast, the only prospective randomized Transesophageal echocardiography therapy. Seventy-two percent of patients control trial, Migraine Intervention with should be done to assess for atrial septal were enrolled on the basis of a stroke. STARFlex Technology (MIST), found no aneurysm and atrial pathology and exclude Closure of the PFO did not reduce the pri- benefit of PFO device closure in patients other potential sources of cardioembolic mary endpoint of recurrent stroke or TIA who have migraines.6 Several industry- events. Therapy should include aspirin at 2 years with recurrent strokes occur- sponsored studies of PFO closure to treat with consideration given to three months ring in 3.1 percent of the closure patients migraine are ongoing. In the interim, cur- of warfarin, even if the hypercoagulability and 3.4 percent of the medically treated rent evidence doesn’t support closing PFOs evaluation is unrevealing. The optimal patients. Similarly, recurrent TIA occurred as a treatment for migraine. strategy for prevention of recurrent in 3.3 percent of the STARFlex patients neurologic events is unknown and requires and 4.6 percent of the medically treated Hypoxia syndromes completion of randomized control trials. patients. These results were substantially Usually, interatrial communications do Physicians should tell the patient that affected by device- and procedure-related not produce hypoxia because left atrial they don’t know whether the risks of closing events with three of the 12 strokes in the pressure is greater than right. However, her PFO outweigh the benefits. She should closure arm being directly related to the in the setting of pulmonary hypertension, be informed of the ongoing randomized procedure and another two being due to right atrial pressure may exceed left, trials of PFO closure and be offered the late atrial fibrillation that was likely due to driving some desaturated blood from the opportunity to participate. If she isn’t the device. venous system into the left atrium and interested in participating in one of the trials, Whether these data apply to other thereby exacerbating hypoxia. Usually, medical therapy should be recommended. closure devices isn’t known. Prior data this exacerbation is minimal. However, For more information or to schedule an has suggested a substantially higher occasionally it can be substantial and appointment, call 877-999-SHVI (7484) or incidence of device-related thrombus improved with PFO closure. visit www.sangerheart.org. with the STARFlex device than with the More rarely, hypoxia due to right to References: AMPLATZER and GORE HELEX devices. left interatrial shunting can occur despite 1. Stollberger C, Slany J, Schuster I, et al. The Thus, it’s not clear that this negative trial normal atrial pressures. The platypnea- prevalence of deep venous thrombosis in patients applies beyond this device. In an effort to orthodeoxia syndrome is dyspnea with suspected paradoxical embolism. Ann Int Med. clarify the field, three randomized trials are and arterial desaturation that occur in 1993;1199(6):461. ongoing: the upright position but improve with 2. Cramer S, et al. Increased pelvic vein thrombi in RESPECT (AMPLATZER PFO Occluder) recumbence. In this rare syndrome, cryptogenic stroke: Results of the paradoxical emboli PC-Trial (AMPLATZER PFO Occluder) some anatomic abnormality (commonly from large veins in ischemic stroke study. Stroke. REDUCE (GORE HELEX) a persistent eustachian valve) directs 2004;35:46–50. flow across the septum in a manner 3. Homma S, Sacco R. Patent foramen ovale and Migraine headaches that is exacerbated by standing. stroke. Circulation. 2005;112(7):1063-1072. Migraine headaches affect approxi- Physicians can diagnose this condition

mately 27 million people in the United by performing echocardiography on a tilt 4. Mas J, Arquizan C, Lamy C, et al. Recurrent States. Observational studies have dem- table and thereby demonstrating postural cerebrovascular events associated with patent foramen ovale, atrial septal aneurysm, or both. NEJM. onstrated PFO in about 50 percent of augmentation of an interatrial shunt in the 2001;345(24):1740–1746. patients who have migraines with aura.5 upright position. In these cases, closure of

This led to the theory that substances such the PFO or atrial septal defect is curative. 5. Cheng T, Anzola G, Magoni M, et al. Potential source as serotonin and micro-emboli bypass the of cerebral embolism in migraine with aura: A transcranial pulmonary circulation and reach the central So, how should we manage Doppler study. Neurology. 1999;53(9):2211. nervous system via the PFO. Several non- our patient? 6. Dowson A, Mullen M, Peatfield R, et al. Migraine randomized studies have suggested signifi- The patient has had a single Intervention with STARFlex Technology (MIST) trial. cant improvement in migraine frequency cryptogenic stroke in which the PFO may Circulation. 2008:117(11):1397–1404.

www.sangerheart.org n The Sanger Report recycle-logo_2options_v2.ai

The Sanger Report PRSRT STD 1001 Blythe Blvd. U.S. POSTAGE PAID Suite 300 Sanger Heart & The The Charlotte, NC 28203 Vascular Institute

Printed With Soy Ink Printed With Soy Ink

Please Recycle This Publication

Printed With Soy Ink Please Recycle This Publication

Nationally, the estimated rate 3D and 4D Figure 3 Echocardiography of mitral valve repair is less than 70 percent; higher rates of valve Continued from page 3 repair denote greater programmatic expertise. A superior In addition to providing exqui- diagnostic tool site but nevertheless qualitative Despite the advantage of 2D anatomic information, the capabil- imaging beyond that achieved by ity to derive detailed quantitative M-mode imaging, there remain 3D data has become available clinical questions that are only best (see Figure 4). Mitral leaflet height understood through examination of and length can be precisely mea- 3D images. (As mentioned, the heart sured, as well as sizing of the is a complex 3D object.) Consider annular dimensions. This provides mitral valve repair. Figure 3 dem- for greater operative planning, Figure 4 onstrates a 3D image of the mitral which promises to further shorten valve (same patient as in Figures 1 operative times and improve and 2). The mitral valve is presented repair results. from the surgical perspective, i.e., it’s oriented to correspond to the The future of imaging view of the valve that the surgeon Where do we go from here? has during open-heart surgery. 3D/4D echo techniques are just The ability to obtain images with beginning to enter the clinical arena this degree of anatomic detail has of day-to-day care. The ability of further transformed assessment of these approaches to provide quanti- patients with mitral valve disease. fiable data is just developing. Many At Sanger Heart & Vascular Institute other conditions, such as hypertro- (SHVI), preoperative determination phic cardiomyopathy (see Figure 5), Figure 5 of the feasibility of percutaneous or are best evaluated in the 3D/4D surgical repair using 3D echo and domain. But just as 2D imaging 4D echo (3D imaging in real time) supplanted our reliance on M-mode, has become our standard approach. it appears to be a matter of time The ability to have cardiologists before 3D/4D imaging moves to and surgeons “speak the same the forefront of noninvasive imaging. language” by having image data The Imaging Group at SHVI is displayed in an easily recognizable working to lead this advance. format has been a key driver of For more information about our our highly successful mitral surgical cardiac imaging services, call repair rate of more than 90 percent. 704-373-0212.