Inside This Issue

Heart and Vascular Update Hybrid operating room, provides information to PRESORTED and VASCULAR healthcare providers on the latest FIRST CLASS MAIL a regional first in cardiovascular medicine and surgery U.S. POSTAGE at The Christ Hospital. PAID Stent technology takes CINCINNATI, OH Heart and Vascular Update PERMIT #5489 two steps forward Editorial Board 2139 Auburn Avenue | Cincinnati, Ohio 45219 Stent technology Dean J. Kereiakes, MD, FDA advisory panel: Medical Director spring 2013 The Christ Hospital Heart and Vascular Center Update MitraClip could serve as takes two steps forward Carl and Edyth Lindner Research Center an alternative treatment Ian Sarembock, MD, Executive Medical Director for reducing mitral Resorbable Absorb scaffold and flexible Absorb takes bioabsorbability to next level The Christ Hospital Heart and Vascular Service Line regurgitation For the past two decades, incremental improvements in stent Mike Keating Synergy stent expected to improve technology have improved outcomes for hundreds of thousands of President and CEO outcomes in people with coronary artery blockages. These devices have evolved Michael W. Schwebler from short, bare-metal mesh tubes that could be deployed only The Carl and Eydth Lindner Research Center at The Christ Hospital is Executive Director in the largest coronary vessels to a variety of thinner, longer stents The Christ Hospital Heart and Vascular Service Line leading two major clinical trials that will significantly advance stent coated with medications to reduce the risk of new blockages. technology for people with blocked coronary arteries. Heather Adkins While stents have dramatically reduced the need for open-chest Chief Strategy and Mission Officer National principal investigator in the multinational EVOLVE II clinical coronary bypass operations, the devices have had one limiting factor trial, Dean Kereiakes, MD, Medical Director, The Christ Hospital Heart Patty Thelen from the beginning: their use has required leaving a foreign metal Director of PR & Marketing and Vascular Center, leads _ number of sites in the evaluation of the object permanently implanted along the coronary arteries. Soon, that novel Synergy stent made by Boston Scientific, as well as _ number Emily Owens may change. of sites in the national ABSORB III trial to evaluate the Absorb BVS Manager, PR & Marketing stent made by Abbott. Both devices are approved in Europe but are The Lindner Research Center at The Christ Hospital is testing a Brian Riesenberg pending approval in the United States from the U.S. Food and Drug breakthrough stent, called Absorb, that represents the first fully Senior Consultant, PR & Marketing Administration (FDA). bioresorbable drug-eluting stent in the world. Two years after insertion, nothing remains of the stent except two tiny platinum dots Synergy offers more flexibility, used to track the original location of the device. bioabsorbable polymer The Absorb stent, made by Abbott, already is approved for sale in FDA advisory panel continued on back cover The first procedures to implant the novel Synergy bioabsorbable Europe and parts of Asia and South America. The ABSORB III clinical polymer drug-eluting stent as part of the EVOLVE II trial were trial will enroll about 2,250 patients, mostly in the United States, to • The EVEREST II study was the first to compare a catheter- (CRT). The study confirmed that mitral regurgitation can cause recently performed by Thomas Broderick, MD, and Joseph Choo, gather data required for U.S. FDA approval. Dr. Kereiakes is principal delivered device against conventional a poor response to CRT and it showed that treatment with the MD, interventional cardiologists at The Christ Hospital. investigator for this nationwide study. surgical therapy. Of the 279 patients enrolled, 184 received the MitraClip is safe, leads to substantial symptom improvement The Synergy stent, like many other stents, emits the drug The Absorb stent’s tubular scaffold is composed of polylactide, MitraClip and 95 had conventional surgery. After 30 days, 48 and can reverse ventricular remodeling. everolimus to prevent restenosis. The new stent stands out for a biocompatible material commonly used in dissolvable sutures percent of the surgical patients experienced a major adverse two reasons: It features an ultra-thin metal scaffold and a fully and other medical implants. The drug eluted by the stent is fully event compared to 15 percent in the MitraClip group. A year Lindner Research Center Joins COAPT Trial bioabsorbable polymer coating that reduces the risks of irritation absorbed in about 90 days. The scaffold maintains its structural after surgery, 73 percent of the surgical group had achieved Despite a large volume of data from other clinical trials, more and inflammation. It also features a more flexible, fracture-resistant integrity for about six months while it helps prevent arterial recoil desirable reductions in regurgitation compared to 55 percent information about the MitraClip among high-risk surgical design that reduces the risk of rare, late-stage failures that can be and remodeling. The stent completely dissolves in 18 to 24 months, of the MitraClip group. After comparing symptoms, adverse patients is needed. The Lindner Clinical Research Center and the caused by the constant flexing of arteries as the heart beats. leaving behind a normally functioning blood vessel no longer events, quality of life, hospital length of stay and whether Heart and Vascular Center at The Christ Hospital Health Network “The Synergy stent has the smallest polymer load of any drug- irritated by the presence of a foreign object. patients needed nursing home or rehabilitation care, the study have joined 75 medical centers participating in the COAPT trial eluting stent. It also uses less metal and thinner struts, which Dr. Kereiakes and interventional cardiologists Charles Abbottsmith, concluded that the MitraClip was not as effective as traditional (Clinical Outcomes Assessment of the MitraClip Percutaneous enhance its flexibility and conformability,” Dr. Kereiakes says. “This MD, and Thomas Broderick, MD, implanted the first Absorb scaffolds surgery at fully stopping regurgitation, but the clip was superior Therapy for High Surgical Risk Patients). in safety, cost and quality of life measures. stent has the potential to become the dominant metal-platform in the U.S. clinical trial at The Christ Hospital. Worldwide, more than The study seeks patients with significant mitral regurgitation who stent in the U.S.” 3,000 people have received Absorb stents. • Another 133 high-risk patients have been enrolled in the have been adequately managed with heart failure medications, The Synergy stent received CE mark approval in October 2012. The “The Absorb scaffold represents a quantum step in the evolution REALISM clinical trial. So far for these patients, the MitraClip but are considered too high-risk for surgery. Participants will be EVOLVE II clinical trial is expected to enroll 2,000 patients at 160 sites of coronary angioplasty and stenting,” Dr. Kereiakes says. “The has demonstrated superior safety, durable reduction in mitral randomized in a 1:1 ratio to groups receiving the MitraClip device in 21 countries. Patients will be randomly assigned to receive either opportunity for the blood vessels to return to a more natural state is regurgitation, significant reduction in hospitalization for heart or continuing with medical therapy. The study will track mortality, the Promus Element Plus, also made by Boston Scientific, or the one of the unique features of Absorb. This may reduce risk for some failure and reduced mortality compared with predicted risk. stroke, kidney function, the need for or Synergy stent and will then be followed for 5 years. patients, particularly those who may require future interventions.” However, this study is not complete and data has not been permanent ventricular assist devices and other factors. Patients formally published. will be followed for up to 5 years. “The next major step beyond Synergy may be to eliminate the • Disclosures: Kereiakes is a principal investigator of the EVOLVE II trial and co-principal metal skeleton completely with an entirely bioabsorbable stent,” investigator of the ABSORB and DAPT trials, and is an executive steering committee • Meanwhile, the PERMIT-CARE study reports that the MitraClip For more information about the COAPT, Dr. Kereiakes says. member for the Tryton side branch stent system (Tryton Medical); he is a consultant may also help reduce poor results that some heart failure for Abbott Vascular, Boston Scientific, Medtronic and REVA Medical. patients experience after cardiac resynchronization therapy or other clinical trials call 513.585.1777.

5 From the Medical Director Hybrid operating room FDA advisory panel: MitraClip could serve as an alternative treatment a regional first Dean Kereiakes MD Ian J Sarembock, Joseph K Choo, MD for reducing mitral regurgitation MB, ChB, MD $5 million project combines open-heart surgery and capabilities Dear Colleague, Introducing the latest advances in cardiac repair procedures to residents of Greater This issue of Heart and Vascular Update features some Cincinnati also requires a state-of-the-art operating room that allows cardiac surgeons of the latest advances in percutaneous catheter-based and interventional cardiologists to work shoulder-to-shoulder. cardiovascular interventions, from a novel catheter- Catheter-based device delivered clip that offers a new way to perform mitral That’s exactly what the new hybrid operating room (OR)/catheterization laboratory valve repair to a remarkable, resorbable that dissolves within 24 months. (cath lab) offers at The Christ Hospital Heart and Vascular Center. offers potential benefit As these technologies work their way through U.S. Opened in early January 2013 after a year in the making, the hybrid OR is completely clinical trials, most will likely become available for for those who cannot commercial (general) use within a few years to equipped for open-heart surgery while also providing state-of-the-art imaging improve outcomes for your patients. We at the Carl technologies usually found in a catheterization lab. Key components include a large and Edyth Lindner Research Center at The Christ space to accommodate interdisciplinary teams, X-ray, fluoroscopy, transesophageal have open-heart surgery Hospital are proud to have these technologies available now and to play a leading role in the echocardiogram capabilities and an array of ceiling-mounted imaging panels. research and development of these devices in the “You can do anything in this room, from surgically opening the chest to complex Figure 1: The cobalt chromium MitraClip implant with 2 arms U.S. and in our region. transcatheter valve or stent placements,” says Dean Kereiakes, Medical Director of and 2 grippers which are used to grasp the opposing free Over the past 25 years, our center has participated edges of the anterior and posterior mitral valve leaflets in in more than 1,200 clinical research trials, including The Christ Hospital Heart and Vascular Center. several first-in-man studies and dozens of first-in- order to improve their closing. the-U.S. experiences with leading-edge techniques. Having surgical capabilities in the same room as the cath lab support new and complex From this vantage point, the rapid evolution of procedures such as transcatheter aortic valve replacements. The new room allows interventional technology has been nothing less specialists to choose from three minimally invasive approaches – using a catheter via the than breathtaking. In the span of two decades, our The MitraClip system, made by Abbott Vascular, has been field has evolved from the development of balloon femoral artery, entering the heart through a small incision below the left breast, or via a approved for use in Europe since 2008, where more than 5,500 angioplasty to the introduction of the first bare-metal limited “mini sternotomy.” people have received the device. Clinical trials required for stents to the adoption of an array of drug-eluting stent platforms. The facility will accommodate teams that include cardio-thoracic surgeons, cardiologists, US Food and Drug Administration (FDA) approval are not yet In this issue, you will read about the new perfusionists, anesthesiologists and other support staff. Other procedures planned for the complete. However, an FDA advisory panel concluded in March Absorb stent from Abbott – the world’s first fully room include mitral valve repairs, abdominal aortic aneurysm repairs, ablations and other 2013 that the MitraClip offers potential benefit especially for bioresorbable drug-eluting stent. Amid the many procedures. patients who cannot tolerate open heart surgery. design improvements that have steadily made stents more effective, the Absorb stent represents the next The imaging technology in the hybrid OR includes the Philips Allura Xper FD 20 X-ray Interventional cardiologists at The Christ Hospital Heart and true quantum leap in this field. system, which provides extremely detailed visualization while keeping radiation dosing to Vascular Center have already performed some mitral valve repairs Meanwhile, catheter-based approaches are a minimum. The system also features Black Diamond video equipment that enables cases with the new device as part of the 75-center COAPT clinical becoming available for increasingly complex The world’s first catheter-based therapy to treat mitral regurgitation has cardiac procedures. In recent years, we have to be broadcast live, both in-house and to medical centers across the country. trial. This study will add up to 420 patient experiences to the Figure 2: The top panel demonstrates advancement of the evaluated several groundbreaking techniques, moved a step closer to widespread availability in Greater Cincinnati. This collective evidence the FDA will use to consider approving the MitraClip into the left across the mitral valve to begin including catheter-based radiofrequency and device for general use in the US. therapies to control cardiac arrhythmias, less-invasive therapy could offer an alternative to open-heart techniques the grasping process. The bottom panel illustrates the leaflet transcatheter aortic valve replacements and other insertion assessment, which ensures that both leaflets of the interventions that once required open-heart surgery. to repair the most common form a cardiac valve malfunction. How the MitraClip system works mitral valve are fully inserted and secure into the MitraClip. This In this issue, you will read more about the intriguing MitraClip therapy is based on a surgical “edge-to-edge” repair creates a double orifice and a reduction in mitral regurgitation. MitraClip device, which continues this trend by offering a non-surgical option for mitral valve repair Mitral regurgitation occurs in approximately 6 percent of people For many years, treatment for mitral regurgitation has been pioneered by the Italian surgeon Ottavio Alfieri, MD. His in patients with mitral regurgitation – the most technique uses sutures to convert a leaking single mitral orifice aged 65 and older. Moderate to severe mitral regurgitation limited to open-heart surgery to repair or replace the faulty valve. Clinical trial results show promise common type of dysfunction. occurs in 15 to 30 percent of patients with heart failure, which However, many patients are considered too high risk to endure into a double orifice valve with a “bowtie” appearance that All these advances have the potential to add years accounts for approximately 500,000 of the 5.8 million Americans the procedure. Now, an alternative treatment with a lower risk decreases or eliminates regurgitation. The MitraClip device More than 1,000 patients in the US (including more than of good-quality life for our patients while reducing 500 high surgical risk patients) have received the MitraClip pain, speeding recovery and further minimizing with heart failure. profile and lower cost than open-heart surgery may offer patients mimics this repair. through multiple clinical trials. The results provide evidence complications. These novel therapies provide special improved quality of life. The steerable MitraClip delivery system is advanced under x-ray benefit to our more fragile and elderly patients who Detecting mitral regurgitation depends largely on its severity for significant clinical benefit with relatively low mortality risk. often are not good candidates for open-heart surgery. and the pace of onset. Sometimes doctors detect heart murmurs The MitraClip system may be one such solution. “This catheter- and ultrasound guidance to the point of regurgitation. The clip’s • The EVEREST I feasibility trial enrolled 52 patients who were We encourage you to share the news about these during routine examinations, which can indicate regurgitation. based approach may offer an improved option for people who arms and grippers, made of cobalt chromium, capture opposing exciting advances in coronary care with your In many cases, however, the valve problem goes unnoticed until have too many co-morbidities to safely receive open-heart free edges of the mitral valve leaflets. The device is gradually selected if they were candidates for mitral valve surgery. patients.. more traditional signs of heart failure emerge, such as shortness surgery,” says Dean Kereiakes, MD, Medical Director of The Christ tightened to create a bowtie-shaped double-orifice. (figure 1). A year later, two-thirds of patients continued to have a Sincerely, of breath, fatigue, lightheadedness, swollen feet or ankles or Hospital Heart and Vascular Center/ Lindner Research Center. The procedure is conducted in a catheterization laboratory with significant reduction in mitral regurgitation. This study also excessive urination. the patient under full anesthesia, but does not involve using a demonstrated that open-heart mitral valve surgery is not heart-lung machine. Recovery time is significantly shorter than precluded by prior treatment with the MitraClip, should Dean J. Kereiakes, M.D. an open-heart procedure. surgery become necessary. Medical Director, Heart and Vascular Center continued on back cover 2 3 4