Thoratec HeartMate II Continuous-Flow LVAD Poses “Acceptable” Risks
This article was originally published in The Gray Sheet
Executive Summary
A new study of Thoratec's HeartMate II continuous-flow left-ventricular assist device supports the growing consensus that patient selection has a far greater influence than device selection on the mortality rate of LVAD patients
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A new study of Thoratec's HeartMate II continuous-flow left-ventricular assist device supports the growing consensus that patient selection has a far greater influence than device selection on the mortality rate of LVAD patients. Results of a 133-patient, single-arm trial of HeartMate II led by Leslie W. Miller, University of Minnesota, appear in the Aug. 30 New England Journal of Medicine. The trial results are part of Thoratec's PMA for HeartMate II as a bridge to transplant for patients with end-stage heart failure. FDA's Circulatory System Devices panel is expected to review the PMA this fall. All of the patients in the trial were on a heart transplant waiting list. The primary endpoint was the proportion of patients surviving at least 180 days on the device and either remaining transplant-eligible, receiving a transplant, or recovering and no longer needing a transplant. One hundred of the 133 patients reached the 180-day endpoint. The overall survival rate on the pump was 75% at six months and 68% at 12 months. The device was associated with significant improvements in patients' functional status and quality of life over the first three months. HeartMate II, which is smaller and potentially more durable than current pulsatile volume-displacement pumps, "showed an acceptable risk profile, as compared with that reported for a pulsatile-flow pump," Miller et al. conclude. Device-related adverse events, including bleeding, stroke and drive-line infection, were significantly less frequent with HeartMate II than in previous trials of pulsatile devices such as Thoratec's HeartMate XVE. However, "the persisting rate of death of 20% to 25% before transplantation seen in our study is similar to previous reports with other pumps and suggests that the selection of patients and the presence of adverse risk factors at the time of device implantation contribute more to adverse outcome than the device used," the authors conclude. The relative importance of patient selection versus device selection was also observed by the authors of a recent "destination therapy" trial of the HeartMate XVE (1 (Also see "Destination LVAD Success Depends On Patient Selection Study Shows" - Medtech Insight, 6 Aug, 2007.), p. 18). - Reed Miller ([email protected]) |