Chronic Mechanical Circulatory Support for Inotrope-Dependent Heart Failure Patients Who Are Not Transplant CandidatesResults of the INTrEPID Trial
Joseph G. Rogers, MD, FACC*,1,*,
Javed Butler, MD, FACC ,2,
Steven L. Lansman, MD, PhD ,
Alan Gass, MD, FACC ,
Peer M. Portner, PhD, FACC||,3,
Michael K. Pasque, MD#,4,
Richard N. Pierson, III, MD, FACC**,5 for the 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.
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Figure 1 INTrEPID Enrollment Criteria
Enrollment strategy for the INTrEPID trial. Eligible patients had severe left ventricular dysfunction for  6 months, New York Heart Association (NYHA) functional class IV symptoms for 3 months, and were required to fail 2 attempts at weaning from inotropic support separated by at least 7 days. EF = ejection fraction; LVAD = left ventricular assist device.
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Figure 2 Survival Analysis for LVAD and OMT Groups
Survival at 6 months and 12 months demonstrates an approximate 50% reduction in the risk of death at these time points. Kaplan-Meier survival curves are also shown. The X represents censoring at the time of transplantation. CI = confidence interval; LVAD = left ventricular assist device; OMT = optimal medical therapy.
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Figure 3 Adverse Event Rates
Adverse event rates (events/patient-month of follow-up) are shown for all statistically significant events, as well as those of clinical interest where significant differences were not demonstrated between LVAD and OMT. CVA = cerebrovascular accident (stroke); other abbreviations as in Figure 2.
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Figure 4 Rates of Adverse Neurologic Events
The risk of stroke was greatest during the first month following device implantation, then it decreased to <0.1 strokes/patient (pt)-month on the device. Two patients in the OMT group had neurologic events (1 CVA, 1 TIA). TIA = transient ischemic attack; other abbreviations as in Figures 2 and 3.
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Figure 5 NYHA Functional Class
At the last measurement of functional class, 85% of LVAD recipients were asymptomatic or had minimal heart failure symptoms. Abbreviations as in Figures 1 and 2.
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