Surgical management of patients in the REMATCH trial.

The donor shortage makes cardiac transplantation a less than ideal treatment for end-stage heart failure. The utility of the left ventricular assist device (LVAD) as a permanent form of circulatory support has recently been established in the REMATCH (Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive Heart Failure) trial. In this report, we describe the surgical management of LVAD patients in REMATCH and their short-term outcomes. Between 1998 and 2001, 129 patients with end-stage heart failure, who were excluded from consideration for transplantation, were enrolled in the REMATCH clinical trial. Patients were randomized to two treatment arms: optimal medical management or HeartMate vented electric LVAD implantation. The primary end point of the study was death from any cause. Secondary end points included the incidence of serious adverse events, the duration of hospitalization, quality of life, and functional status. Sixty-eight patients received an LVAD, 55 (81%) of whom survived for longer than 1 month. The median intensive care unit and hospital lengths of stay (LOS) for those that survived at least 1 month were 15 and 34 days, respectively. Sixty-seven (99%) patients had a serious adverse event. The rates of perioperative bleeding, late bleeding, right heart failure, and sepsis were 0.42, 0.53, 0.15, and 0.53 events/patient-year, respectively. Factors predictive of a longer LOS for the implant hospitalization included sepsis, age, and late bleeding (p < 0.0001). The patients' New York Heart Association functional class improved significantly at 1 month compared with base line (p < 0.001). Functional class improved in LVAD-supported patients despite a high adverse event rate. Most adverse events occurred within 30 days of device implantation. Sepsis, age, and late bleeding were the major determinants of LOS.

RCT Entities:   Population Interventions Outcomes