Major Survival Benefit of LVAD Seen for Patients on Intravenous Inotropic Therapy
Lynne Warner Stevenson
Brigham and Women's Hospital
Boston, MA, USA

The landmark Randomized Evaluation of Mechanical Assistance for Treatment of Congestive Heart Failure (REMATCH) trial showed a 46% reduction in 2-year mortality vs. medical therapy in patients with end stage heart failure. This new analysis of the data shows that the major benefit of mechanical assistance is in patients sick enough to require intravenous inotropic therapy at baseline. There does not appear to be a benefit in patients who were less compromised at baseline.

The REMATCH trial was an evaluation of mechanical cardiac support devices for end stage heart failure patients not eligible for transplant.

Left ventricular assist devices have been very successful as bridges to cardiac transplantation. In REMATCH, investigators evaluated mortality over 2 years in patients with very advanced heart failure who received permanent implantation of the HeartMate (Thoratec Corp.). This intervention has been called "destination therapy."

The hypothesis of REMATCH was that this left ventricular assist device would reduce 2- year mortality by 33% vs. optimal medical management. The landmark results of REMATCH instead showed a larger benefit of a 46% reduction in mortality (2-year mortality of 28% vs. 10%).

Investigators must now determine which patients are most likely to benefit from mechanical assistance devices. In this recent analysis, they hypothesize that patients sick enough to require inotropic therapy would have the major survival benefit and meaningful quality of life improvements.

Investigators chose to look at the impact of inotropic therapy because they were used surprisingly frequently. At the time of randomization, an unexpectedly high number of patients (71%, or 91 out of 129) were on intravenous inotropic infusions.

These patients on intravenous inotropic support at baseline had clinical profiles worse than the other REMATCH subjects. This was illustrated by lower systolic blood pressure, more pronouncedly dysregulated sodium levels and higher intracardiac pressures.

For patients who received optimal medical management, there was a clear trend toward worse survival among patients on inotropic infusions at baseline (P = 0.11).

The benefit of the left ventricular assistance device was high in patients on inotropic drugs at baseline. Survival at 6 months was 58% for those who received the device, vs. 39% for those on medical therapy. By 1 year, survival was over twice as high (49% vs. 22%, P = 0.0016). By 2 years, survival was 24% for patients with devices, and all the medical therapy patients had died.

That obvious survival benefit contrasts with no significant difference in survival for device vs. medical therapy for in the patients not on inotropic therapy at baseline (P = 0.52). It does not appear that a less compromised population would have significantly improved survival on the device.

Quality of life analysis suggests favorable and meaningful improvements for all survivors among the REMATCH subjects on inotropic drugs at baseline. Improvements in domains of physical and emotional function were greater at 1 year vs. the few survivors on medical therapy.

The National Heart, Lung and Blood Institute and Thoratec Corp. jointly sponsored the REMATCH trial.


Reporter: Andrew Bowser