HeartWare LVAD Achieves Success in Clinical Trial of End-Stage Heart Failure

Chicago—HeartWare (HeartWare International), an investigational left ventricular assist device (LVAD), was successful in treating patients with endstage heart failure as a bridge to transplantation, and it was noninferior compared with other commercially implantable LVADs, according to results of a latebreaking pivotal trial presented at the AHA meeting. Keith Aaronson, MD, University of Michigan in Ann Arbor, who presented these results, said: “ADVANCE [Evaluation of the HeartWare HVAD Left Ventricular Assist Device System for the Treatment of Advanced Heart Failure] is the largest bridge-to-transplant trial. We found the highest reported success ever in a bridge-to-transplant trial at 180 days, and the lowest percentage to reach transplant in 18 days.” “We observed marked improvement in 2 heart failure–specific and 2 generalized quality-of-life measures from initial patient baseline. HeartWare patients were able to walk 113 m farther in 6 minutes after surgery, and patients’ own assessments of quality of life more than doubled,” he commented. HeartWare is unique among LVADs in that it provides a continuous flow rather than a pulsatile flow; the device is designed to be frictionless and thus longer lasting than existing LVADs. The miniaturized implantable blood pump is placed directly in the pericardial space without need for a pocket. It avoids the need for abdominal surgery generally required for competing devices. The frictionless design optimizes flow, pump surface washing, and hemocompatibility. HeartWare was associated with a 92% success rate at 180 days after implantation in a prospective trial of 137 patients with end-stage heart failure (New York Heart Association Class IV, listed for cardiac transplantation). Success was the primary end point and was defined as survival on the originally implanted device, transplant, or device removal for ventricular recovery at 180 days. Need for replacement of the LVAD was defined as failure. There was no control group for success. Looking at outcomes in the HeartWare patients at 180 days, 92.0% had been transplanted or were alive, 62.8% were alive, 29.2% had transplant, 4.4% had device exchange, and 3.2% had died. The HeartWare LVAD demonstrated noninferiority to contemporary implanted, commercially available LVADs according to a historical comparison with 499 patients enrolled in INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support) who received a primary LVAD as a bridge to transplantation. Survival (transplant or alive) in HeartWare patients at 180 days was 93.9%; at 360 days, it was 90.6%. In the INTERMACS population, survival was 90.2% and 85.7%, respectively. At baseline, mean age was about 53 years in both the treatment group and INTERMACS patients. About 28% of the treatment group were female compared with 24% of the INTERMACS group. Eighty-two percent of the study patients were on 1 inotropic medication, and 11% were on 2 inotropic medications. Dr. Aaronson pointed out that the study was not randomized, and baseline characteristics between the study patients and those on INTERMACS may differ. He noted that it was difficult to collect data on functional capacity and quality of life for some critically ill patients enrolled in the study, which may have led to an underestimation of the true benefits of the HeartWare device.