Randomized Evaluation of Mechanical Assistance for Treatment of Congestive Heart Failure - REMATCH - Subanalysis

Description:

Further analysis of the REMATCH trial assessing the benefit from implanted left ventricular assist devices (LVAD) in patients on intravenous inotropic therapy. The REMATCH trial, supported by the National Heart, Lung and Blood Institute, was a multicenter study designed to evaluate the efficacy of long-term implantation of a specific LVAD device (Heartmate, Thoratec Corp.) compared with optimal medical management in end-stage heart failure patients who were not eligible for heart transplants.

Study Design

Study Design:

Patients Enrolled: 129
NYHA Class: Class IV
Mean Follow Up: 2 years

Patient Populations:

New York Heart Association class IV heart failure, ineligibility for heart transplant, and a history of standard medical treatment for 90 days.

Primary Endpoints:

Total mortality, quality of life.

Secondary Endpoints:

Adverse events; hospitalization; cost; cost-effectiveness.

Concomitant Medications:

Digoxin, diuretics, angiotensin-converting enzyme (ACE) inhibitors (unless contraindicated); beta-blockers, spironolactone at investigator discretion.

Principal Findings:

Previously reported REMATCH data showed a 46% reduction in mortality for LVAD patients compared to those receiving standard medical therapy alone. After 1 year, survival was 51% for LVAD patients versus 28% for medical therapy patients; at 2 years, survival was 28% and 10% respectively. The new data addresses a subgroup of REMATCH patients (n=129) with left ventricular ejection fractions <0.25, New York Heart Association class IV heart failure, ineligibility for heart transplant, and a history of standard medical treatment for 90 days. These patients were sicker at trial entry compared to those seen in other trials. A total of 91 of the 129 patients were undergoing treatment with intravenous inotropic agents at baseline. Overall, there was a clear trend toward worse survival rates among REMATCH patients receiving inotropic infusions at baseline. At 1 year, 49% of the LVAD patients receiving inotropic agents were alive, compared to only 22% of medical therapy patients. Investigators concluded that the major benefit of LVAD is in patients receiving inotropic agents at baseline. Use in a less sick population would not be expected to show equal benefit.

Interpretation:

Among end-stage heart failure patients who are treated with intravenous inotropic agents at baseline, implantation of an LVAD was associated with a 1 year survival benefit. This subgroup of higher risk patients may account for much of the benefit observed in the trial as a whole.

References:

Rose EA et al, The REMATCH trial: rationale, design, and end points. Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive Heart Failure. Ann Thorac Surg 1999; 67: 723-30. Rose EA et al, Long-term mechanical left ventricular assistance for end-stage heart failure. N Engl J Med 2001; 345: 1435-43.

Clinical Topics: Cardiac Surgery, Heart Failure and Cardiomyopathies, Invasive Cardiovascular Angiography and Intervention, Cardiac Surgery and Heart Failure, Acute Heart Failure, Heart Transplant, Mechanical Circulatory Support

Keywords: Heart-Assist Devices, Survival Rate, Heart Failure, Stroke Volume, Heart Transplantation


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