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CLINICAL RESEARCH: CLINICAL TRIALS

Chronic Mechanical Circulatory Support for Inotrope-Dependent Heart Failure Patients Who Are Not Transplant Candidates

Results of the INTrEPID Trial

Joseph G. Rogers, MD, FACC^_*,_*, Javed Butler, MD, FACC, Steven L. Lansman, MD, PhD, Alan Gass, MD, FACC, Peer M. Portner, PhD, FACC^||, Michael K. Pasque, MD^#, Richard N. Pierson, III, MD, FACC^_** INTrEPID Investigators

^_* Cardiovascular Medicine Division, Duke Clinical Research Institute, Duke University, Durham, North Carolina
Division of Cardiology, Emory University, Atlanta, Georgia
Division of Cardiothoracic Surgery, Westchester Medical Center, Valhalla, New York
Division of Cardiology, Beth Israel Medical Center, New York, New York
^|| Department of Cardiothoracic Surgery, Stanford University, Palo Alto, California
^# Division of Cardiothoracic Surgery, Washington University School of Medicine, St. Louis, Missouri
^_** Division of Cardiothoracic Surgery, University of Maryland Medical Center and Baltimore Veterans Administration Medical Center, Baltimore, Maryland

Manuscript received October 10, 2006; revised manuscript received March 22, 2007, accepted March 28, 2007.

^_* Reprint requests and correspondence: Dr. Joseph G. Rogers, Medical Director, Cardiac Transplant and Mechanical Circulatory Support Program, Box 3034, Duke University Medical Center, Durham, North Carolina 27710 (Email: joseph.rogers{at}duke.edu).

Objectives: This study evaluated the impact of left ventricular assist device (LVAD) support on survival and quality of life in inotrope-dependent heart failure patients ineligible for cardiac transplantation.

Background: The role for LVADs as a bridge to cardiac transplantation has been established, but data supporting their role as permanent therapy in nontransplant candidates are limited.

Methods: The INTrEPID (Investigation of Nontransplant-Eligible Patients Who Are Inotrope Dependent) trial was a prospective, nonrandomized clinical trial comparing LVAD with optimal medical therapy (OMT). Fifty-five patients with New York Heart Association functional class IV symptoms who failed weaning from inotropic support were offered a Novacor LVAD. Eighteen of these patients did not receive an LVAD owing to patient preference (n = 14) or unavailability of the device (n = 4) but consented to follow-up and constitute a contemporaneous control group.

Results: The LVAD and OMT patients were well matched for demographic and disease severity measures, except OMT patients had a lower mean serum sodium (128 mg/dl vs. 134 mg/dl; p = 0.001) and a higher mean blood urea nitrogen concentration (59 vs. 40; p = 0.02). The LVAD-treated patients had superior survival rates at 6 months (46% vs. 22%; p = 0.03) and 12 months (27% vs. 11%; p = 0.02). Adverse event rates were higher in the OMT group. Eighty-five percent of the LVAD-treated patients had minimal or no heart failure symptoms. Five LVAD patients and 1 OMT patient improved sufficiently while on therapy to qualify for cardiac transplantation.

Conclusions: Inotrope-dependent heart failure patients who are ineligible for transplantation have a high short-term mortality rate and derive a significant survival advantage from "destination" mechanical circulatory support.

Abbreviations and Acronyms   CVA = cerebrovascular accident   LVAD = left ventricular assist device   NYHA = New York Heart Association   OMT = optimal medical therapy   TIA = transient ischemic attack

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