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Physicians Update

 
Summer 2010

New Ventricular-Assist Device Extends Both Range and Hope for Heart-Failure Patients

07/15/2010

PU-Summer10-HeartMate II
Food and Drug Administration (FDA) approval in January of a small, easily implantable ventricular-assist device (VAD) for “destination therapy” — not merely as a bridge to transplantation — offers tens of thousands of the sickest heart-failure patients the potential for increased survival and a vastly improved functional status and quality of life.

The destination-therapy indication for the HeartMate II VAD means that an estimated 50,000–100,000 people in the United States who are unable to benefit from drug treatment and are not candidates for transplantation could be eligible for a VAD to restore proper blood flow. The HeartMate II had been approved since April 2008 only as a short-term therapy for patients awaiting a transplant.

“Until now, most VADs were approved for patients on the transplant list who needed the device to support their circulation and keep them alive until they could receive a heart,” says Richard Shemin, M.D., chief of cardiothoracic surgery at UCLA. A prior VAD approved for destination therapy was much larger, difficult to implant and not embraced by most patients, Dr. Shemin notes.

In addition to providing a long-term option for seriously ill heart-failure patients who are unable to receive transplantation, the new VAD doesn’t have the same level of restrictions on age and co-morbid conditions that often exclude patients from the transplant list. “Any patient who has persistent symptoms, limited functional status and poor quality of life despite maximal medical therapy can be referred for evaluation for destination VAD therapy,” says cardiologist Robb MacLellan, M.D., medical director of the UCLA Ventricular-Assist Device Program.

Drs. MacLellan and Shemin explain that the HeartMate II has many advantages over previous generations of VADs, including its smaller size, the ability to implant it completely inside the body and a longer-life battery pack that can run for up to 12 hours before needing to be recharged. “Patients with this device can now live comfortably outside the hospital, but still have enough battery power to go to a restaurant or sporting event,” Dr. Shemin says. “Complications are reduced, and the overall quality of life is markedly better than when you are tied to a 300- pound console with limited ability to go anywhere, as was often the case with the previous technologies.”

FDA approval came after publication of a study in the New England Journal of Medicine last fall comparing the continuous-flow HeartMate II device with first- and second-generation pulsatileflow devices, which are not only much larger but also are dependent on valves and plunger-type mechanisms. The newer VAD more than doubled the two-year survival rate for patients, with a lower rate of complications. Forty-six percent of the HeartMate II patients achieved the primary study endpoint of survival at two years while remaining free from disabling stroke or the need for a reoperation to replace or repair the pump.

With the new device, quality of life for patients with destination VAD therapy is now comparable to that of patients who have received a transplant, PU-Summer10-FDA approved HeartMate IIsays Dr. MacLellan, who notes that some who have received the VAD intending it to be a bridge to transplant have been so happy with the result that they decided to delay going back on the transplant list.

“Patients after transplant have to be on a number of medications to prevent rejection, and they may need regular heart biopsies,” notes Gregg C. Fonarow, M.D., director of the Ahmanson-UCLA Cardiomyopathy Center. “The potential disadvantages to the VAD relate to needing the battery pack and making sure the power for the device doesn’t ever run out. There are also risks of serious infections or blood clots forming, and of the pumps failing. But these risks have been greatly reduced in the newer devices.”

Because of the potential for thrombosis and emboli, patients take blood-thinning medications and are closely monitored with the help of a device they can use at home, Dr. MacLellan says. The vast majority of driveline infections that occur can be treated with oral antibiotics. Although there was a concern that end-organ function might be affected, by shifting from pulsatile to continuous flow as seen with the HeartMate II, the pivotal study showed no significant detriment.

Of the more than five million people in the United States who suffer from heart failure, it’s estimated that 50,000– 100,000 are part of the sickest group, unable to benefit from proven medications and unlikely to survive more than a year without one of two interventions: heart transplantation or a VAD. But because of the limited availability of donor hearts, only about 2,500 heart transplants are performed each year — and many patients would not be considered transplant candidates even if a heart were available.

“Many patients are ineligible because of age or other factors,” Dr. Shemin says. “They are either presensitized to antigens in the general population so that there can never be a match, or they have unusual blood types or other medical conditions that make them unsuitable. Having a new option for them is a major advance.”

For more information about the HeartMate II at UCLA, go to: www.uclahealth.org/heartmate





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