July 11, 2013

HeartWare ventricular assist system for bridge to transplant: Combined results of the bridge to transplant and continued access protocol trial.


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The pivotal ADVANCE Clinical Trial was a multicenter clinical trial to evaluate the
HeartWare HVAD System for BTT in patients with advanced heart failure in the United States. This publication reports the analysis of combined data from the 140 BTT patients plus 192 patients from the continued access protocol (CAP) who were monitored to outcome or who completed 6 months of followup. The majority of implants occured in Intermacs 2 and 3 patients. 180 day survival was 91%, rivalling or superior to outcomes of other commercially available devices. A shift also occurred in the median time in therapeutic INR range (2.0–3.0) from 35% to 46%. The annualized rate of pump exchange for suspected thrombus dropped from 0.063to 0.027, a level 55% less than the rate before the anticoagulation protocol adjustment.

Cardiac Transplantation

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