32 LEADING MEDICINE: ADVANCED ORGAN FAILURE MANAGEMENT AND TRANSPLANT
NATIONAL LEADERS IN LVAD RESEARCH the safety and efficacy of 96 patients implanted with the ReliantHeart HeartAssist5® VAD system compared to 96 patients implanted with either a Thoratec HeartMate II® LVAD or HeartWare HVAD® for left ventricular support while awaiting cardiac transplantation.” Houston Methodist is participating in Thoratec’s MOMENTUM 3 clinical trial, which will enroll more than 1,000 participants in up to 60 centers across the nation to evaluate the HeartMate 3 for use as long-term support for individuals who are not candidates for heart transplantation (known as destination therapy). The device will also be evaluated for short-term use in patients awaiting transplantation. “Houston Methodist is the first center in Texas to implant the HeartMate 3 device, which is the newest assist device out in trial,” Bruckner said.
Hany Samir, MD, center, Brian Bruckner, MD, right Houston Methodist’s left ventricular assist device (LVAD) program has distinction as one of the largest in the country. Under the wide umbrella of cardiovascular and transplant medicine, physicians and surgeons from both Houston Methodist J.C. Walter Jr. Transplant Center and Houston Methodist DeBakey Heart & Vascular Center work together to pursue the most current and advanced clinical trials in LVAD therapy. “We offer cutting-edge trials for several ventricular assist devices, such as HeartWare’s ENDURANCE Supplemental Trial,” said Brian Bruckner, MD, director of mechanical circulatory support at Houston Methodist. “We’re also doing the ReliantHeart’s HeartAssist device, a prospective, randomized, multicenter, clinical trial to evaluate
Recently, Houston Methodist was the largest enroller in Thoratec’s pivotal ROADMAP (Risk Assessment and Comparative Effectiveness of Left Ventricular Assist Device and Medical Management in Ambulatory Heart Failure Patients) trial. Led by Jerry Estep, MD, medical director of the heart transplant and LVAD program, the trial included 200 patients and compared the HeartMate II LVAD therapy with optimal medical management in ambulatory heart failure patients who were not dependent on intravenous inotropic support but met the FDA-approved indication for destination therapy. The primary endpoint measurement was a composite of survival with improvement in the Six Minute Walk Test distance from a baseline of ≥ 75 meters at 12 months. “This study gives us, for the first time, data that carefully allows us to weigh the benefits and risks of using current LVAD therapy in this patient population. This clarity of projected benefit versus risk allows us to tailor our treatment decision more accurately and appropriately,” Estep said. The study findings were published in the October 2015 issue of the Journal of the American College of Cardiology and Estep was the first author of the paper. The two-year follow-up study of patients is currently in progress. The VAD program at Houston Methodist has a rich history. The first assist device was implanted by Michael E. DeBakey, MD, in the 1960s. DeBakey continued to develop assist devices with George P. Noon, MD, also at Houston Methodist, and together they designed the first continuous flow pump, called the DeBakey VAD.