Volume 4 | Issue 18 | Through March 30, 2011 Continued First patients have been enrolled, implanted with HeartWare device Tiny Heart Pump on Trial By Todd Neff LVAD revolutions. He has a better chance of holding on now than he would have a decade ago. The devices back in 2000 were big, clunky, pulsing pumps, “Model Ts versus today’s Ferraris,” as Cleveland put it. Then in came the HeartMate XVE, a pump the size of a personal pan pizza, and more recently the industry-standard HeartMate II, no larger than a small soda can. Cleveland and CU were part of the clinical trial that led to the HeartMate II’s approval for destination therapy. The HeartWare- funded trial, for which Medicare will help cover participant costs, is aiming to enroll 450 patients at as many as 50 centers patients by 2014. So far, 78 patients have been enrolled, according to HeartWare spokesman Christopher Taylor. Anne Cannon, RN, program manager for the Mechanical Circulatory Support Program, said the HeartWare pump promises to reduce the risk of infection, the most common complication for patients who receive LVADs. It’s also small enough for surgeons to implant completely within the pericardium, the sac that surrounds the heart, eliminating the need to create infection-prone “pump pockets” in the abdominal wall. It’s the size of a golf ball. It contains a magnetically levitated impeller. It’s keeping Ron McDougal alive. McDougal, 66, of Oberlin, Kan., on Jan. 19 became just the second patient at University of Colorado Hospital implanted with a HeartWare Left Ventricular Assist System. Cardiothoracic surgeon Joseph Cleveland, MD, did the surgery as part of a nationwide clinical trial testing the effectiveness of the tiny device, which does the job of pumping blood for patients with advanced heart failure and dim prospects for a heart transplant. The gentle name for it is “destination therapy.” Destination therapy patients “live with this pump for the rest of their lives,” said Andreas Brieke, MD, a UCH cardiologist specializing in heart failure. Brieke and Cleveland lead the University of Colorado School of Medicine’s Mechanical Circulatory Support Program, which has become a vital extension of the only advanced heart failure program in Colorado. McDougal is among 21 UCH patients who have since early 2010 received destination therapy with either the experimental HeartWare device or, more commonly, the FDA-approved mainstay HeartMate II, made by Thoratec Corporation of Pleasanton, Calif. McDougal’s cardiomyopathy (decline in heart-muscle function) had progressed to Class IV heart failure, rendering him unable to perform any physical activities without discomfort and risk of death. McDougal enrolled in the trial of the HeartWare device, which the Cardiac & Vascular Center had joined in September 2010. He had a two-in-three chance of being randomly assigned a HeartWare device, the latest in a decade-long progression of left ventricle assist devices (LVADs) that are getting better and better with time, Cleveland said. “With dad, there was really never any question about whether he wanted it or not,” said his son Garret McDougal. “He’s got grandkids and that’s all he has in mind anymore. He wasn’t ready to let go.” UCH cardiologist Andreas Brieke, MD, left, and cardiothoracic surgeon Joseph Cleveland, MD.