Both quality of life and survival are improved in critically ill patients with congestive heart failure who receive a ventricular assist device, according to an article in the August 17th issue of Circulation. In the US, 500,000 to 800,000 patients have advanced heart failure, and yet fewer than 2,500 hearts are transplanted each year.

The left ventricular assist device is a newer treatment option. Although the devices were developed to act as a functional support until transplantation, they are now being studied as permanent therapy for patients who are ineligible for a transplant.

In the current study, a sub-analysis of the Randomized Evaluation of Mechanical Assistance of the Treatment of Congestive Heart Failure (REMATCH) trial, researchers investigated the outcomes of the sickest 129 patients enrolled in REMATCH (average age, 68 years). Of these people, 91 were ill enough to receive ongoing intravenous infusions of inotropic agents. Inotropic therapy is sometimes used as a temporary bridge to transplantation; in this case it was used to relieve symptoms in patients with end-stage heart failure. Sixty-eight patients received an assist device, and 61 patients were placed on optimal medical management.

“This is the sickest group of heart failure patients to ever enter a clinical trial. Most had frequent and oppressive breathing difficulties and lived a bed-bound or bed-to-chair existence,” said Lynne W. Stevenson, MD.

One year after the study began, 49 percent of patients who received an assist device were alive compared with 24 percent of those receiving optimal medical treatment. After two years, 28 percent of assist-device recipients were alive compared with only 11 percent of those on medical care alone. In contrast, of the 38 REMATCH patients not on inotropic therapy, 57 percent of those who received an assist device were alive after one year versus 40 percent of those who continued optimal medical treatment.

Survivors who received assist devices had significant improvements in their quality of life, becoming ambulatory and experiencing moderate rather than severe symptoms, according to Stevenson.

“The benefit of left ventricular assist device was most dramatic in the sickest people, those who will have the worst outcome without the device. But the overall outcome is best for less-ill patients who have not yet tipped over to certain mortality,” Stevenson said. “Our challenge is to find the patients who are sick enough to expect a large benefit, but to identify them before that tipping point, so they are treated early enough to have an optimal outcome.”

Previously, the REMATCH trial found that patients too ill to undergo heart transplant fared better if they received a pumping device rather than optimal treatment with medications. The device was already used as temporary “bridge” therapy for patients anticipating transplant within a few months. REMATCH was the first test of their value for the permanent treatment of patients who are not eligible for transplantation because they were too old or too sick.

“Although this subset analysis of patients on inotropic therapy in REMATCH is the only data we currently have available, it is limited by the small numbers and it must be considered exploratory but not definitive,” Stevenson said. “Furthermore, this study highlighted the limits of current knowledge about what is optimal medical management for very sick patients who do not receive left ventricular assist devices.”

To obtain further data on the outcome of patients receiving mechanical circulatory support, the National Heart, Lung, and Blood Institute (of the National Institutes of Health) is spearheading efforts to create a registry for recipients of left ventricular assist devices.