Use of a Continuous-Flow Device in Patients Awaiting Heart Transplantation
Leslie W. Miller, M.D., Francis D. Pagani, M.D., Ph.D., Stuart D. Russell, M.D., Ranjit John, M.D., Andrew J. Boyle, M.D., Keith D. Aaronson, M.D., John V. Conte, M.D., Yoshifumi Naka, M.D., Donna Mancini, M.D., Reynolds M. Delgado, M.D., Thomas E. MacGillivray, M.D., David J. Farrar, Ph.D., O.H. Frazier, M.D., for the HeartMate II Clinical Investigators
Background The use of left ventricular assist devices is anaccepted therapy for patients with refractory heart failure,but current pulsatile volume-displacement devices have limitations(including large pump size and limited long-term mechanicaldurability) that have reduced widespread adoption of this technology.Continuous-flow pumps are newer types of left ventricular assistdevices developed to overcome some of these limitations.
Methods In a prospective, multicenter study without a concurrentcontrol group, 133 patients with end-stage heart failure whowere on a waiting list for heart transplantation underwent implantationof a continuous-flow pump. The principal outcomes were the proportionsof patients who, at 180 days, had undergone transplantation,had cardiac recovery, or had ongoing mechanical support whileremaining eligible for transplantation. We also assessed functionalstatus and quality of life.
Results The principal outcomes occurred in 100 patients (75%).The median duration of support was 126 days (range, 1 to 600).The survival rate during support was 75% at 6 months and 68%at 12 months. At 3 months, therapy was associated with significantimprovement in functional status (according to the New YorkHeart Association class and results of a 6-minute walk test)and in quality of life (according to the Minnesota Living withHeart Failure and Kansas City Cardiomyopathy questionnaires).Major adverse events included postoperative bleeding, stroke,right heart failure, and percutaneous lead infection. Pump thrombosisoccurred in two patients.
Conclusions A continuous-flow left ventricular assist devicecan provide effective hemodynamic support for a period of atleast 6 months in patients awaiting heart transplantation, withimproved functional status and quality of life. (ClinicalTrials.govnumber, NCT00121472
[ClinicalTrials.gov]
.)
Source Information
From the University of Minnesota, Minneapolis (L.W.M., R.J., A.J.B.); the University of Michigan, Ann Arbor (F.D.P., K.D.A.); Johns Hopkins Hospital, Baltimore (S.D.R., J.V.C.); Columbia University, New York (Y.N., D.M.); Texas Heart Institute, Houston (R.M.D., O.H.F.); Massachusetts General Hospital, Boston (T.E.M.); and Thoratec, Pleasanton, CA (D.J.F.). Drs. Miller and Pagani contributed equally to this article.
Address reprint requests to Dr. Miller at Washington Hospital Center, 110 Irving St. NW, Rm. 1F-1208, Washington, DC 20010-2975, or at leslie.w.miller{at}medstar.net.
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