Abstract
Purpose The DuraHeart pump is a continuous flow LVAD with centrifugal design utilizing active magnetic levitation for impellor positioning and passive magnetic coupling of motor and impellor. We report the outcomes of the US multicenter, prospective, single arm observational study in patients listed for transplantation. Methods and Materials The primary composite endpoint was the comparison of the proportion of patients alive on support and remaining listed for heart transplantation, transplanted or explanted and without device replacement at 180 days. A sample size of 140 subjects provided a > 80% power to test the hypothesis that treatment with the DuraHeart I (DH) LVAD was noninferior. The performance measure was established by historical outcomes. Results A total of 63 patients were enrolled in the study and implanted with the DH LVAD. The study was halted due to inadequate enrollment. At 6 months 82% of patients remained alive on support or transplanted (57% of patients remained on support, 25% received a transplant, 14% died, and 3% underwent device explant). Survival on LVAD support was 79% at 6 months. Major adverse events included pump failure (3 patients), ischemic stroke (7 patients), hemorrhagic stroke (2 patients) and device-related infection (percutaneous lead 13 patients/pump pocket 2 patients). There were no hemolysis events or occurrences of internal pump thrombus formation (50 pumps inspected with no evidence of pump thrombus). GI bleeding occurred in 6 patients. Conclusions The study failed to meet enrollment goals because of the considerably larger size of this pump. The interim results did demonstrate satisfactory outcomes at 6 months and validated the design of a centrifugal pump with full magnetic levitation with respect to hemocompatability. This was the first US trial of a full magnetic levitation pump and supports the notion that future designs with these concepts could potentially lead improved long-term outcomes with reduced AEs.
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