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Two-Year Outcomes in the Destination Therapy Post-FDA-Approval Study with a Continuous Flow Left Ventricular Assist Device: A Prospective Study Using the INTERMACS Registry

2013; Elsevier BV; Volume: 32; Issue: 4 Linguagem: Inglês

10.1016/j.healun.2013.01.003

1557-3117

Ulrich P. Jorde, S.S. Khushwaha, Antone Tatooles, Yoshifumi Naka, Geetha Bhat, James W. Long, Douglas Horstmanshof, Robert L. Kormos, Jeffrey J. Teuteberg, Mark S. Slaughter, Emma J. Birks, David J. Farrar, S.J. Park,

Heart Failure Treatment and Management

Purpose A post approval (PA) study for destination therapy (DT) was required by FDA to determine whether results with the HeartMate (HM) II Left Ventricular Assist Device (LVAD) in a commercial setting are comparable to results during the DT multicenter pivotal clinical trial conducted from 2005-2010. Methods and Materials The PA study was a prospective evaluation of the first 247 HM II patients identified pre-operatively as DT in the national INTERMACS registry. Patients were enrolled from Jan - Sep 2010 at 61 US centers and followed for two years. A historical comparison group included patients (n=133 at 34 centers) enrolled in the primary data cohort in the DT pivotal trial (TR) (NEJM 2009;361:2241-51). Survival rates and adverse events for PA were obtained in the INTERMACS registry. Results Baseline characteristics were similar for PA vs TR. PA patients were 45% INTERMACS profile 1-2, and 28% profile 3. Adverse events in the PA group were similar or lower than TR. The median length of stay after surgery was reduced by 6 days in PA vs TR. Kaplan Meier survival at 2 years was 62% (PA) vs 58% (TR). PA survival at 1 and 2 years was 82±5% and 69±6% for INTERMACS profiles 4-7 (n=63) vs 72±3% and 60±4% for profiles 1-3 (n=184). Conclusions Results in a commercial patient care setting for the DT population support the original findings from the pivotal clinical trial regarding the efficacy and risk profile of the HM II LVAD. These data suggest that dissemination of this technology post approval has been associated with continued excellent results. Baseline Characteristics Cohort Age≥70 % Male PCWP Albumin sCR Bilirubin Inotropes TR (n=133) 35% 80% 24±8 3.3±0.6 1.6±0.6 1.2±0.8 77% PA (n=247) 33% 83% 24±8 3.4±0.5 1.6±0.6 1.3±0.9 80% Adverse Events and Outcomes LOS 1 (d) Bleeding req surg Isc Stroke 2 Hem Stroke2 Device Infection 2 1 yr Surv 2 yr Surv TR 27 30% 0.06 0.07 0.48 68±4% 58±4% PA 21 11% 0.03 0.05 0.22 76±3% 62±3% 1 Length of stay 2 events/pt-yr