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.

Volume 4 | Issue 18 | Through March 30, 2011 | Page 2

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The HeartWare device, while still experimental, already appears on track for FDA approval as a bridge for patients who would otherwise die while waiting for a heart transplant.

UCH patients on LVADs for bridge therapy rely on them for an average of 130 days, Brieke said.

HeartWare in December 2010 submitted its premarket approval information to the FDA for its completed bridge-to-transplant trial, which involved 140 patients at 30 centers, Taylor said. That means the device could be approved for bridge to transplant as soon as late 2011, Cannon said.

While it’s too early to know for sure, the HeartWare device’s absence of mechanical friction could lead to longer working life for the devices, Cannon said, although they are already built to last.

The HeartWare pumps up to 10 liters of blood per minute with an impeller (a propeller used to move fluid through a tube) held in place with magnetic force rather than mechanical bearings. The patient’s blood itself acts as a lubricant, according to the company.

Challenges persist. It’s still a serious surgery, though – six to eight hours on the operating table – and the patients are obviously very ill even before they undergo it. UCH’s first HeartWare patient survived surgery with a well-functioning pump only to break his neck in a fall and die in early March, Cannon said.

Ron McDougal has been doing well, his son Garret said, although after just two months, the elder McDougal is still rebuilding his strength after surgery. He’s off oxygen, Garret said, and he has his color back. But there are adjustments. The blood thinners mean nosebleeds can take hours to stanch. It’s a good thing Garret and his two sisters live a few minutes away, he said.

“I don’t think families fully understand how life-changing it is,” Garret McDougal said. “It’s great to get those extra years, but you have to have some dedicated family and support-group help to go through with it.”

That said, Garret added, the LVAD has been a good thing.

“It’s a great machine, and I think the whole family would make the same decision over and over again to do it,” he said. HeartWare left ventricular assist device (LVAD) recipient Ron McDougal,

center, with daughter Nora Urban and son Garret McDougal.

An artist’s rendering of the HeartWare device in the human body. (Courtesy HeartWare International, Inc.)

The HeartWare device is roughly the size of a golf ball. (Courtesy HeartWare International, Inc.)