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Ann Thorac Surg 2003;75:S86-S92
© 2003 The Society of Thoracic Surgeons
a Department of Surgery, The University of Iowa, Iowa City, Iowa, USA
b Department of Surgery, Columbia University, New York, New York, USA
j Columbia University, New York, New York, USA
c Bryan LGH Heart Institute, Lincoln, Nebraska, USA
d Department of Surgery, Texas Heart Institute, Houston, Texas, USA
e Division of Cardiovascular Surgery, Brigham & Womens Hospital, Boston, Massachusetts, USA
f Section of Cardiac Surgery, University of Michigan, Ann Arbor, Michigan, USA
g Thoratec Corporation, Pleasanton, California, USA
h Department of Thoracic & CV Surgery and Transplantation, Ochsner Medical Foundation, New Orleans, Louisiana, USA
i Department of Cardiothoracic Surgery, Allegheny General Hospital, Pittsburgh, Pennsylvania, USA
k Department of Surgery, LDS Hospital, Salt Lake City, Utah, USA
* Address reprint requests to Dr Richenbacher, Division of Cardiothoracic Surgery, Department of Surgery, The University of Iowa Hospitals and Clinics, 200 Hawkins Drive, 1613B-JCP, Iowa City, IA 52242, USA.
e-mail: wayne-richenbacher{at}uiowa.edu
Published as part of the supplement on the Heart Failure & Circulatory Support Summit, Cleveland, OH, Aug 2225, 2002.
Abstract
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.
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