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HMII
HeartMate II Destination Therapy Trial
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Trial evaluated continuous flow HeartMate II LVAD for reduction of adverse events and improvement in functional capacity in patients with end-stage HF.
Design: randomized, parallel
Patients: 200
Centers: 38
Countries: United States
RESULTS: The primary endpoint of survival free from disabling stroke and device failure requiring operation at two years occurred in 46% of patients with the continuous flow LVAD and 11% of patients with the pulsatile flow LVAD (P<0.001). The rate of disabling stroke was similar in both study arms (11% for continuous flow and 12% for pulsatile flow). Thirty-six percent of patients with the pulsatile flow LVAD needed surgery to repair or replace the pump compared with 10% of patients using the continuous flow LVAD. Six-minute walk distance was 327 m in the continuous flow group vs. 277 m in the pulsatile group.
Presented at AHA 2009.
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