The Cooper Heart Institute, under the direction of Perry J. Weinstock, MD, Head of the Division of Cardiovascular Disease, has recently added more clinical firsts to its already-impressive roster of achievements – testament not only to the cutting-edge cardiac expertise that resides here but also to the commitment Cooper has made to the infrastructure that supports it.
“A first-rate cardiac program requires a lot of resources,” says Michael Rosenbloom, MD, Co-Director of the Cooper Heart Institute and Head of the Division of Cardiothoracic Surgery, citing instrumentation, technology, specialized cardiac anesthesia and critical care, and support personnel. “And the hospital has gone all-in to provide them.”
This commitment has put the Cooper Heart Institute on the proverbial map as the region’s most comprehensive cardiac program, earning national recognition for its quality outcomes and attracting outstanding clinical talent.
As a result, a growing number of companies are partnering with Cooper on clinical trials that are helping to transform the practice of cardiac care – and offering hope to previously untreatable patient populations through innovative devices and surgical techniques like transcatheter aortic valve replacement (TAVR) – an area in which Cooper excels.
“We’re also known for our close relationship between cardiac surgery and cardiology,” Dr. Rosenbloom notes. “Everyone here realizes that working together not only serves patients best but it’s also the way to achieve our goal of getting new technology as soon as it’s available. Industry recognizes us for this collaboration, and it’s a real plus.”
In the past few months alone, Cooper Heart Institute has racked up an array of notable firsts – both within and outside clinical trials:
Cooper is one of only two sites in New Jersey participating in the COAPT Trial, a national clinical trial designed to study the safety and effectiveness of Abbott Vascular’s MitraClip® device in heart failure patients who have functional mitral regurgitation and are considered extremely high-risk for surgery (MitraClip currently is FDA-approved only for use in patients with degenerative mitral valve disease who are not surgical candidates).
“Cooper was selected as a study site because of our extensive experience in structural heart disease,” notes Sajjad A. Sabir, MD, Co-Director of the Structural Heart Disease Program in Cooper’s Division of Cardiovascular Disease. “We’re excited about this because there are a lot of patients with mitral valve regurgitation who have no other treatment option.”
Good Friday was a very good day for two Cooper patients who were the first in South Jersey to undergo implantation of the Medtronic CoreValve®, used to treat severe aortic stenosis in patients ineligible for open-heart surgery.
“The Edwards SAPIEN valve was initially FDA-approved for this extreme-risk patient population and Cooper was the first in New Jersey to offer it to patients; now it’s also commercially available for high-risk patients who are candidates for either surgery or TAVR,” explains Dr. Sabir. “The CoreValve is currently only for those patients who are at extreme risk for surgery, and we are the first and only institution in South Jersey to offer this new technology to our patients.”
Radiofrequency (RF) ablation is the standard treatment for paroxysmal AF when medications don’t work; however, its success rate is only about 70 percent, and approximately one-third of patients treated require more than one procedure. The RF energy is delivered one point at a time around the pulmonary veins via a catheter tip, so there can be gaps, and it’s time-consuming.
In 2012, the FDA approved another type of ablative therapy for AF, cryoablation (freezing). This treatment is also delivered via a catheter, but this technique uses a balloon that inflates within the heart, outside the origin of the pulmonary veins. “It’s more homogeneous and the entire vein can be isolated in just a few minutes,” says Andrea M. Russo, MD, Director of Electrophysiology and Arrhythmia Services, who performed the first procedure at Cooper earlier this year.
Certain patients may be better candidates for one form of therapy than another. In any case, both modalities are now available for patient care at Cooper.
“So we have an option for patients based on their anatomy and the type of atrial fibrillation they have,” Dr. Russo adds, noting that Cooper is the only facility in South Jersey to offer cryoablation. She’s hopeful this technology will reduce the recurrence rate and says, “The preliminary evidence is looking positive.”
Cooper is the only study site in the state for TRANSFORM, the first US clinical trial of a rapid deployment system for surgical aortic valve replacement procedures. The Edwards Lifesciences INTUITY valve system, which consists of a bovine pericardial heart valve and novel balloon-expandable frame, is designed to facilitate small-incision surgery and rapid valve deployment with the goal of enabling faster procedures.
“This new valve system enables us to cut up to an hour off the operation be- cause it doesn’t require the 15 to 18 pairs of sutures that other valves do,” says Dr. Rosenbloom, who is the principal investigator. “As a result, patients spend less time on bypass which means less risk and fewer complications,” he says. “It’s very exciting.”
In January, an 82-year-old female patient at Cooper underwent New Jersey’s first valve-in-valve procedure to replace her failing, surgically implanted bio- prosthetic aortic valve with a transcatheter valve – without open-heart surgery. Using transcatheter techniques, the new valve was placed inside the old surgically implanted valve and expanded by inflating a balloon, pushing the old valve out of the way.
“The entire procedure took less than an hour, the patient went home in less than 48 hours, and she is feeling dramatically better,” says Interventional Cardiologist Georges I. Kaddissi, MD, of Cardiovascular Associates of the Delaware Valley. “This procedure is a life-saving option for select patients with failed tissue valves who are not candidates for another open-heart surgery.”
Central sleep apnea, a type of sleep- disordered breathing, is associated with a higher rate of ventricular arrhythmias. The Cooper Heart Institute is participating in a safety and efficacy study to evaluate the Respicardia® remede® System, an implantable medical device designed to improve cardiovascular health by restoring a more normal breathing pattern during sleep.
Clinical Cardiologist John A. Andriulli, DO, Director of Cooper’s Arrhythmia Device Program, and the cath lab team performed the first remede® System implantation on January 30, 2014.
Cooper also participated in a national trial to evaluate the benefits of a first-of- its-kind drugeluting bioresorbable vascular scaffold for the treatment of coronary artery disease (ABSORB III). Abbott’s Absorb TM device works by restoring blood flow to the heart like a metallic stent, but then dissolves into the body, leaving behind a treated vessel that may resume more natural function and movement.
Interventional Cardiologist Andrew P. Zinn, MD, of Cardiovascular Associates of the Delaware Valley, inserted the first Absorb device into a patient earlier this year.
“Our relationship with industry builds on itself,” Dr. Rosenbloom says. “As we do well in clinical trials, it attracts more companies looking to launch their products.”
As a result, Cooper is able to offer more solutions to more patients – evidenced by the spate of recent firsts outlined here.
“There’s very little we can’t do,” he adds. “We can take the highest-risk cases and do well – and routine cases do even better.”