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(Circulation. 2004;110:975-981.)
© 2004 American Heart Association, Inc.
Original Articles |
From Brigham and Womens Hospital, Boston, Mass (L.W.S.); Department of Medicine, University of Minnesota, Minneapolis (L.W.M.); National Heart, Lung, and Blood Institute, Bethesda, Md (P.D.-N.); Columbia Presbyterian Medical Center, Heart Failure Center, New York, NY (D.D.A., D.M.); International Center for Health Outcomes and Innovation Research (InCHOIR), Columbia University, New York, NY (M.K.P., R.G.L.); IHC LDS Hospital Heart Failure Prevention and Treatment Program, Salt Lake City, Utah (D.G.R.); Heart Failure Treatment Program, University of Iowa Hospitals, Iowa City (R.M.O.); BryanLGH Heart Institute, Lincoln, Neb (S.K.K.); Midwest Heart Specialists, Edward Heart Hospital, Naperville, Ill (M.R.C.); and Wisconsin Heart and Vascular Clinics, Milwaukee (L.S.W.).
Correspondence to Lynne Warner Stevenson, MD, Brigham and Womens Hospital, 75 Francis St, Boston, MA 02115. E-mail lstevenson{at}partners.org
Received June 23, 2003; de novo received December 22, 2003; revision received April 15, 2004; accepted April 19, 2004.
Background Left ventricular assist devices (LVADs) have improved survival in patients with end-stage heart failure. Compared with previous trials, the Randomized Evaluation of Mechanical Assistance in Treatment of Chronic Heart Failure (REMATCH) trial enrolled patients with more advanced heart failure and high prevalence of intravenous inotropic therapy. This study analyzes, on a post hoc basis, outcomes in patients undergoing inotropic infusions at randomization.
Methods and Results Of 129 patients randomized, 91 were receiving intravenous inotropic therapy at randomization to LVAD or optimal medical management (OMM). Mean systolic pressure was 100 versus 107 mm Hg in those not receiving inotropes, serum sodium was 134 versus 137 mEq/L, and left ventricular ejection fraction was 17% for both groups. LVADs improved survival throughout follow-up for patients undergoing baseline inotropic infusions (P=0.0014); for the LVAD group versus the OMM group, respectively, 6-month survival was 60% versus 39%, 1-year survival rates were 49% versus 24%, and 2-year survival rates were 28% versus 11%. For 38 patients not undergoing inotropic infusions, 6-month survival was 61% for those with LVADs and 67% for those with OMM, whereas 1-year rates were 57% and 40%, respectively (P=0.55). Quality-of-life scores for survivors improved. Median days out of hospital for patients on inotropic therapy at randomization were 255 with LVAD and 105 with OMM.
Conclusions Despite severe compromise, patients undergoing inotropic infusions at randomization derived major LVAD survival benefit with improved quality of life. Patients not undergoing inotropic infusions had higher survival rates both with and without LVAD, but differences did not reach significance. Future studies should prespecify analyses of inotropic and other therapies to determine how disease severity and parallel medical treatment influence the benefits offered by mechanical circulatory support.
Key Words: heart failure transplantation heart-assist device
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