FDA Approves Left Ventricular Assist System for Severe Heart Failure Patients

The U.S. Food and Drug Administration today approved the HeartMate II, a continuous-flow, left ventricular assist system as a support for severe heart failure patients who are not acceptable candidates for heart transplantation.

The HeartMate II is already FDA-approved for use in patients awaiting further, perhaps more complex treatment, such as transplants.

Heart assist devices are surgically implanted mechanical pumps that help the heart's ventricle pump blood to the rest of the body. HeartMate II consists of a small, lightweight blood pump implanted in a patient’s chest just below the heart. An electrical cable that powers the blood pump passes through the patient’s skin to an external controller worn around the patient’s waist.

A physician designates the pump’s speed based upon clinical need. The device is designed to sound an alarm upon malfunction or other potentially drastic changes that could impact the pump’s operation.

“The approval of HeartMate II provides an option for heart failure patients who cannot receive a transplant,” said Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health. “Its smaller size and mobility should allow more patients, including women and men of smaller stature, access to treatment.”

In a randomized clinical study of 200 participants at 38 centers, 46 percent of 134 participants with the HeartMate II were still living after two years with no disabling stroke or need for a reoperation for device replacement or repair compared with 11 percent of 66 participants in the control group. In addition, data collected in a separate registry of smaller stature women and men indicated that the device worked well in this specific population.

As a condition of the FDA’s approval, the company will conduct a post-approval study to further evaluate the device’s performance. The data will be recorded in the Interagency Registry of Mechanical Assisted Circulatory Support (INTERMACS) and made available when the post-approval study is concluded. The INTERMACS is a clinical outcomes registry managed by the FDA, the National Heart, Lung and Blood Institute at the National Institutes of Health, the Centers for Medicare & Medicaid Services and participating hospitals and companies.

HeartMate II is manufactured by Thoratec Corp. based in Pleasanton, Calif.

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Kidney Transplant Survival can be Long-Term for People with HIV

A Johns Hopkins study finds that HIV-positive kidney transplant recipients could have the same one-year survival rates for themselves and their donor organs as those without HIV, provided certain risk factors for transplant failure are recognized and tightly managed.

“Kidney transplantation is a viable and necessary option for HIV-positive patients with chronic kidney disease, especially since kidney disease is taking such a large toll on this group,” says Jayme Locke, M.D., a resident in the Department of Surgery at Johns Hopkins University School of Medicine, and lead researcher of the study described in the January issue of the Archives of Surgery.

Traditionally, HIV patients were not considered transplant candidates because survival rates after transplantation were thought to be greatly compromised by the disease, which cripples the body’s immune system. Transplant patients also take drugs that suppress their immune systems in order to prevent organ rejection, a regimen thought to further threaten their already fragile immune systems.

Locke says their study results are in part a reflection of newer antiretroviral therapies that have reduced HIV death rates by 80 percent. Indeed, people with HIV now die like most other people, of chronic diseases, rather than from the opportunistic infections that once took a grave toll. Kidney disease, for example, accounts for more than 10 percent of HIV-related deaths.

For the study, Locke and her team looked at the one-year kidney survival rates and one-year patient survival rates of 36,492 HIV-negative and 100 HIV-positive kidney transplant recipients listed on the United Organ Sharing Network (UNOS) list who received transplants between January 2004 and June 2006. They excluded those under 18 and anyone who had multi-organ transplantation.

The chances of survival were the same in both groups. However, kidney survival rates in these two groups showed that HIV-negative recipients had a 94.6 percent survival rate, compared to 87.9 percent in people with HIV. (People can survive on dialysis even if their transplanted kidney fails.)

However, when the investigators broke down the results into subgroups, they learned that some of the kidneys transplanted into HIV-positive recipients were relatively late getting to full function. This so-called delayed graft function (DGF) reduced kidney survival by 30 percent. When this group was removed from the rate comparison, both HIV-positive and HIV-negative groups had equal kidney and patient survival rates, says Locke.

According to Locke, this is significant because DGF can be avoided by controlling certain negative risk factors such as advanced organ donor age, deceased-donor kidneys (vs. live-donor kidneys) and long cold ischemic times (the time the kidney is without blood flow before transplant).

Other researchers who contributed to this study from Johns Hopkins University School of Medicine include Robert Montgomery, M.D., Ph.D.; Daniel S. Warren, Ph.D.; and Dorry Segev, M.D., of the Department of Surgery; and Aruna Subramanian, M.D., of the Department of Medicine.

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