St. Francis Hospital
CARDIOVASCULARReport News for Physicians from St. Francis Hospital, The Heart Center®
Winter/Spring 2014
Roslyn, NY • A Member of Catholic Health Services of Long Island
TAVI:St. Francis Plays Pivotal Role in FDA Approval of Innovative Aortic Stenosis Treatment
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s the first hospital on Long Island to test Medtronic CoreValve, a minimally invasive, catheter-based heart device, St. Francis has helped to generate new findings that led the U.S. Food and Drug Administration to approve the device in January for those patients who are considered inoperable or extreme risk for traditional surgical aortic valve replacement. The Hospital has already performed nearly 170 of these procedures on patients with aortic valve stenosis who were too high-risk for conventional surgery or inoperable. Of that number, 22 cases were part of the extreme risk group that was the focus of the recently released results.The highly anticipated findings of the Medtronic CoreValve U.S. PivotalTrial showed that the life-saving technology was effective.This means that the FDA did not require an external panel for approving the device for extreme risk patients. CoreValve is part of the treatments on the horizon in the field of transcatheter aortic valve implantation, orTAVI. “The technology is revolutionary and allows us to treat patients who, prior to this, had no other option,” says Co-Principal Investigator George Petrossian, M.D., Director of Interventional Cardiovascular Procedures, who helped pioneer the procedure at St. Francis along with Newell Robinson, M.D., Chairman of Cardiothoracic andVascular Surgery. As the first site on Long Island to be approved for the CoreValve PivotalTrial, St.
Newell Robinson, M.D., Chairman of Cardiothoracic and Vascular Surgery, and George Petrossian, M.D., Director of Interventional Cardiovascular Procedures, helped pioneer the CoreValve procedure.
Francis began to enroll patients in 2011 for this major nationwide study for treating patients with aortic valve stenosis who were either high risk or inoperable. High risk is defined as an estimated surgical risk of 15 percent as determined by the Society for Thoracic Surgery Risk Score. Extreme Risk is defined as a surgical risk of mortality or irreversible morbidity of 50 percent or more. Protocols to use the procedure have expanded recently to include patients on Hemodialysis, Severe Mitral Regurgitation, or Low Gradient Aortic Stenosis, and, most recently,Valve inValve therapy for failed BioprostheticValves in Extreme Risk (inoperable) patients.Valve inValve therapy has some unique advantages, says Dr. Petrossian. St. Francis continues to participate in the SURTAVITrial, which evaluates Surgical Continued on page 2
Pioneering a New Treatment for Severe Arterial Calcification
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Richard Shlofmitz, M.D., Chairman of Cardiology, leading a Diamondback 360 training session for cardiologists from across the country. St. Francis was chosen to be one of two national training sites and will conduct training on a quarterly basis.
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New Clinical Trials at St. Francis Hospital Hospital Scores Another “A” in Safety Award SFH ReceivesU.S. News Ranking for Seventh Time New Additions to Cardiothoracic Surgical Team
Severe arterial calcification can be difficult to treat in patients with coronary artery disease. If not treated, restenosis can occur, and complications are more likely to increase. A device called the Diamondback 360® Coronary Orbital Atherectomy System, approved in October by the U.S. Food and Drug Administration, aims for a quicker, easier way to treat calcified arteries, says Richard M. Shlofmitz, M.D., Chairman, Department of Cardiology. St. Francis was one of the first hospitals in the country and the first on Long Island to use this new technology. “The Diamondback is a form of atherectomy that pulverizes the calcium and makes it easier to stent,” says Dr. Shlofmitz. The procedure takes much less time than older atherectomy devices. The ORBIT II trial tested the Diamondback in 443 patients and found it was safe and effective. The Diamondback will be used more frequently as cardiologists embrace an
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Mended Hearts for Two Russian Girls SFH Participates in Dissolving Stent Study
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Continued on page 2
Critical Care Units Receive Beacon Award St. Francis Extends Open Heart Surgery Program
Clinical Trials Recruiting Patients
U.S. News & World Report Ranks St. Francis One of the Top 10 Hospitals in the Nation for Cardiac Care
St. Francis physicians have been actively involved with trials relating to Medtronic CoreValve and related technology (see article on page 1). The following trials at St. Francis are currently recruiting patients:
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or the seventh year in a row, St. Francis Hospital,The Heart Center® has been recognized by U.S. News & World Report as one of the best hospitals in the nation. St. Francis ranked among the top 10 hospitals in the country for cardiology & heart surgery, ranking #8 nationwide – one of only two hospitals in the NY Metro area to make the top 10 in that specialty. It also rated among the best in the U.S. in seven other specialties: ear, nose & throat, gastroenterology & GI surgery, geriatrics, neurology & neurosurgery, and for the first time orthopedics, pulmonology, and urology. Once again, St. Francis was the topbe nationally ranked in seven other specialranked hospital on Long Island and the only ties is a reaffirmation of our mission of proLI hospital to be nationally ranked by U.S. viding excellence in patient care.” News in any of the 12 data-driven adult speSt. Francis was also recognized by U.S. cialties. The Hospital ranked fourth in New News as high performing regionally in York State and fifth in the NY Metro area. three specialties: cancer, diabetes & en“Congratulations to the physicians, nurses, and docrinology, and nephrology. staff at St. Francis Hospital for this outstanding According to U.S. News, “only about 15 percent achievement,” said Alan D. Guerci, M.D., President of hospitals are recognized for their high per& CEO of Catholic Health Services of Long Island formance as among their region’s best. Just 3 (CHS). “To be ranked among the top 10 hospitals in percent of all hospitals earn a national ranking in the country for cardiology and heart surgery and to any specialty.”
RELAX-AHF A multicenter, randomized, double-blind, placebo-controlled phase IIIb study to evaluate the efficacy, safety and tolerability of Serelaxin when added to standard therapy in acute heart failure patients. CRLX030A2301. This study is evaluating the molecule relaxin compared with placebo to determine safety and efficacy for hospitalized patients with acute heart failure. It builds on previous research that found relaxin provided greater relief of dyspnea in acute heart failure compared with placebo. Effects of liothyronine sodium (cytomel or T3) on patients with dilated cardiomyopathy and chronic congestive heart failure: A pilot study. This initial trial evaluates the use of the active form of thyroid hormone in congestive heart failure patients with low circulating thyroid hormone.
New Additions to the St. Francis Cardiothoracic Surgical Team
Please call (516) 562-6790 for more information about any of these trials.
St. Francis Hospital Receives Another ‘A’ in Nationwide Safety Test For the fourth time, St. Francis Hospital has received an ‘A’ on a national safety score that rates hospitals on the quality of their care. The letter-based rating system was devised byThe Leapfrog Group, a nonprofit organization that ranks hospitals nationwide. St. Francis was one of only four hospitals on Long Island to “ace” the test and was joined by one other CHS hospital, St. Catherine of Siena, which also received a grade ‘A’ score. “Patient safety is always a number one priority for us here at St. Francis and we believe consumers should have easy access to quality information so they can make educated choices about picking the best hospital for their care,” says Jack Soterakis, M.D., SVP of Medical Affairs & Medical Director. The rankings, which come out every six months, rely on data from Leapfrog’s own ratings as well as outside sources including the Centers for Medicare and Medicaid Services and the Joint Commission. Grades range from “A” to “F” based on 28 safety indicators. More than 2,600 hospitals were surveyed on how well they prevented errors, infections, injuries, and drug mix-ups and once again St. Francis was among the top.
St. Francis Hospital Cardiovascular Report Winter/Spring 2014
The Cardiothoracic Surgery Group at St. Francis Hospital, which includes Newell Robinson, M.D., Chairman, Cardiovascular Surgery Service at Catholic Health Services of Long Island and Chairman of CarEdward Lundy, M.D. diothoracic and Vascular Surgery at St. Francis Hospital; Christopher L. La Mendola, M.D., Chairman, Cardiothoracic Surgery, Good Samaritan Hospital; Lawrence H. Durban, M.D., Director, Thoracic Surgery, St. Francis Hospital; and Neil Bercow, M.D., welcomes Edward Lundy, M.D., and Maksim Rovensky, D.O., to their practice. Dr. Lundy is the
former Chief of the Active International Cardiovascular Institute at Good Samaritan Hospital in Suffern, New York. He was also chief of the section of Cardiac Surgery and Director of the Cardiovascular Maksim Rovensky, D.O. Intensive Care Unit. During his seven years at Good Samaritan Hospital, he and his program were awarded 11 five star HealthGrade Ratings and two HealthGrade Awards for his surgical results. Dr. Rovensky is an attending cardiothoracic surgeon in the St. Francis Hospital Open Heart Surgery Program at Good Samaritan Hospital.
TAVI Continued from page 1
“This is an opportunity for us as cardiologists and cardiac surgeons to come together on the same playing field,” says Dr. Robinson. “It’s been fascinating to me as a surgeon where in the past, cardiologists and interventionalists have operated in silos, so to speak. In this case, the two groups are working together. It’s a win-win for everyone, especially patients.”
AVR versus CoreValve in Intermediate Risk patients (STS score between 4 and 10 percent) and opens this new treatment modality to a wider range of patients. The Hospital also has been using the FDA-approved Edwards SapienTAVI procedure. St. Francis has been chosen as a research site for the upcoming St. Jude Portico trial as well, which will randomize High Risk and Extreme Risk patients between the Portico valve and a commercially approvedTranscatheter HeartValve. The field ofTAVI enables St. Francis physicians to provide patients with a leading-edge, minimally invasive approach for aortic valve replacement.
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Pioneering a New Treatment Continued from page 1 easier-to-perform approach. In addition, as intravascular ultrasounds are used more often during angiograms, doctors will realize the number of patients with significant calcified disease who will benefit from this new treatment, says Dr. Shlofmitz.
Minimally Invasive Procedure to Treat VSD Gives Young Patients New Hope on children. Dr. Levchuck and St. Francis donated all of their medical services. During the four-hour procedures, which took place in the fall, Dr. Levchuck navigated through the arteries and veins with a transcatheter delivery system. “We placed half in the artery and half in the vein and connected them to establish an arterio-venous rail.The device slides right in there,” he says. One major difference with this approach is the recovery time. Open-heart surgery traditionally has a long recovery time; in these two cases, the girls were able to leave the hospital the next day. “I’ve been in pediatric cardiology for 20 years. When I was starting out in the early 1990s, we would operate on someone and they would have to sit still for a week or 10 days.When you look at this, the patients just went home two days later. It’s amazing,” he says. The girls also had remarkable post-op results, says Dr. Levchuck, who hears how they are now able to participate in ballet classes and sports like skiing and volleyball. “They were told they would never be able to do those things,” he says. “They came here with a seemingly terminal sentence and we were able to flip that switch,” he says. The transcatheter approach may be used more often at St. Francis as appropriate in children with congenital VSD or adults with post-infarction VSD, he says.
Heartfelt Moment: Sean Levchuck, M.D., Chairman of Pediatric Cardiology at St. Francis Hospital, receives token of thanks from two Russian girls who received life-saving cardiac procedure.
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wo children from Russia recently had their lives transformed by a new catheter-based treatment for ventricular septal defect (VSD).
The patients, Katya Lebedeva, 15, and Anastasia Bakhtiarova, 10, both from Russia, were born with VSDs. Although Lebedeva had open-heart surgery previously – the gold-standard treatment for VSD in the past – the surgery did not cure her congenital condition.
With help from the humanitarian organization, Russian Gift of Life USA, the two girls had their life-saving cardiac procedures performed at St. Francis by Sean G. Levchuck, M.D., Chairman of Pediatric Cardiology. Dr. Levchuck was the first surgeon on Long Island to perform this procedure
St. Francis Participates in Major Nationwide Study Evaluating Dissolving Stents Taking a page from the future, St. Francis is participating in a multihospital trial to evaluate the effectiveness of a coronary artery stent that dissolves over time. The trial, called ABSORB II Randomized Controlled Trial, assesses the Abbott Vascular ABSORB Everolimus Eluting Bioresorbable Vascular Scaffold System compared to Abbott’s Vascular XIENCE Everolimus Eluting Coronary Stent. The bioresorbable stent is made with the polylactide. The trial is in early stages, so it is too soon to say if the dissolvable stent will be more effective than traditional stents used currently, says Richard M. Shlofmitz, M.D., Chairman, Department of Cardiology. However, there are two reasons why the dissolving stent might prove over time to be more effective. “One, if you don’t have metal retained in the artery, theoretically, you may need less time to be on antiplatelet therapy,” he says. “Two, the vessel might react better if there is no metal in it, and there’s potentially less chance of scar tissue coming back over a five-year period.” Still, it remains to be seen if bioresorbable stents will become the gold standard. Currenty used drug-eluting stents have some advantages over the newer technology – for instance, they are easier to insert compared with bioresorbable stents, Dr. Shlofmitz says.
The trial is a prospective, randomized, active control, single blinded, parallel two-arm, multi-center clinical investigation. Final data completion for the study’s primary outcome measures is slated to take place in July 2015, and the full study should be complete in 2018, according to ClinicalTrials.gov.
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St. Francis Hospital Cardiovascular Report Winter/Spring 2014
NON-PROFIT ORG. U.S. POSTAGE PAID ROSLYN, NY PERMIT #15
St. Francis Hospital
CARDIOVASCULARReport ®
is published by St. Francis Hospital,The Heart Center . Questions or comments can be directed to St. Francis Hospital, Office of Development and Public Affairs, 100 PortWashington Blvd., Roslyn, NewYork 11576. (516) 705-6655. Copyright © 2014. All Rights Reserved. St. Francis Hospital is a member of Catholic Health Services of Long Island, the healthcare ministry of the Diocese of Rockville Centre. Jack Soterakis, M.D., Senior Vice President Medical Affairs/Medical Director Writers:Vanessa Caceres, Rosemary Gomez Contributing Photographer:William Baker Designer: Roger Gorman, Reiner Design
For physician referral, please call 1-888-HEARTNY
www.stfrancisheartcenter.com
(432-7869). For information about cardiovascular
Connect with St. Francis services at St. Francis Hospital, call (516) 562-6725.
Critical Care Units at St. Francis Receive Gold-Level Beacon Award for Excellence St. Francis is now the only hospital in New York State to hold three gold-level Beacon Awards from the American Association of Critical-Care Nurses (AACN). Its Cardiothoracic Intensive Care Unit (CTICU), Surgical Intensive Care Unit (SICU), and Medical Intensive Care Unit (MICU 2), have all received the coveted national honor. The award, which marks a significant milestone on the path to exceptional patient care and a healthy work environment, recognizes unit caregivers who successfully improve pa-
tient outcomes and align practices with AACN’s six standards for a healthy work environment. Units that achieve the top-tier, three-year designation meet national criteria consistent with Magnet Recognition, the Malcolm Baldrige National Quality Award, and the National Quality Healthcare Award. “St. Francis is now the proud recipient of three of the five gold-level Beacon Awards that have been conferred to hospitals in New York State,” says Ann Cella, Senior VP of Patient Care Services and CNO at St. Francis Hospital. “This latest recognition is a testament to the continued excellence we provide in nursing care.” AACN President Vicki Good, R.N., MSN, CENP,
applauds the commitment of the caregivers in the Critical Care Units at St. Francis Hospital for working together to meet and exceed the high standards set forth by the Beacon Award for Excellence. These dedicated healthcare professionals join other members of the exceptional community of nurses who set the standard for optimal patient care. “The Beacon Award for Excellence recognizes caregivers in stellar units whose consistent and systematic approach to evidence-based care optimizes patient outcomes. Units that receive this national recognition serve as a role model to others on their journey to excellent patient and family care,” she explains.
St. Francis Hospital Extends Its World-Class Open Heart Surgery Program to Good Samaritan Hospital St. Francis Hospital is bringing its nationally renowned cardiothoracic surgery program to another member of the CHS system, Good Samaritan Hospital in West Islip. The medical leadership of the program was recently announced and the surgeons began seeing patients at Cardiothoracic Surgery Associates, located at 1111 Montauk Highway, West Islip on December 1. Christopher La Mendola, M.D., has been appointed chairman of the Department of Cardiothoracic Surgery and director of the St. Francis Hospital Open Heart Surgery Program at Good Samaritan Hospital. In addition, Maksim Rovensky, D.O., joined the program as an atSt. Francis Hospital Cardiovascular Report Winter /Spring 2014
tending cardiothoracic surgeon. Dr. La Mendola earned his medical degree from Stony Brook University School of Medicine, where he was a member of the Alpha Omega Alpha Honor Medical Society. He completed his residency in general surgery and fellowship in thoracic surgery at New York University School of Medicine and in 1994 joined the Department of Cardiothoracic and Vascular Surgery at St. Francis Hospital, The Heart Center®. He is a fellow of the American College of Surgeons and the American College of Cardiology. La Mendola is also a member of the Society of Thoracic Surgeons, the New York Society for Thoracic Surgery and the Medical Society of the State of New York. He helped pioneer off-pump coronary bypass surgery and minimally invasive valve surgery and has been recognized by New York Magazine as one of the Best Doctors, by the Consumers’
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Research Council of America as one of the nation’s Top Surgeons, by Newsday as one of Long Island’s Top Doctors and by Castle Connolly as one of the New York Metro Area’s Top Doctors. He resides in Lloyd Harbor. Dr. Rovensky served as a clinical associate in the Department of Thoracic and Cardiovascular Surgery at the Cleveland Clinic Foundation. He earned his medical degree at the New York College of Osteopathic Medicine in Old Westbury. He completed his surgical residency at Maimonides Medical Center, Clinical Affiliate of Mount Sinai School of Medicine, in Brooklyn, where he served as a chief resident. He also completed a fellowship at Montefiore Medical Center, Albert Einstein College of Medicine, in the Bronx. He resides in Massapequa.