The NHLBI REVIVE-IT study

Understanding its discontinuation in the context of current left ventricular assist device therapy

on behalf of the REVIVE-IT Investigators

Research output: Contribution to journalEditorial

31 Citations (Scopus)

Abstract

The National Institutes of Health National Heart, Lung, and Blood Institute convened a working group in March 2008 to discuss how therapies for heart failure (HF) might be best advanced using clinical trials involving left ventricular assist devices (LVAD). This group opined that the field was ready for a trial to assess the use of long-term ventricular assist device therapy in patients who are less ill than patients currently eligible for destination therapy, which resulted in the Randomized Evaluation of VAD InterVEntion before Inotropic Therapy (REVIVE-IT) pilot study. The specific objective of REVIVE-IT was to compare LVAD therapy with optimal medical management in patients with less advanced HF than current LVAD indications to determine if wider application of permanent LVAD use to less ill patients would be associated with improved survival, quality of life, or functional capacity. REVIVE-IT represented an extraordinary effort to provide data from a randomized clinical trial to inform clinicians, scientists, industry, and regulatory agencies about the efficacy and safety of LVAD therapy in a population with less advanced HF. Despite significant support from the medical community, industry, and governmental agencies, REVIVE-IT failed to accomplish its goal. The reasons for its failure are instructive, and the lessons learned from the REVIVE-IT experience are likely to be relevant to any future study of LVAD therapy in a population with less advanced HF.

Original languageEnglish (US)
Pages (from-to)1277-1283
Number of pages7
JournalJournal of Heart and Lung Transplantation
Volume35
Issue number11
DOIs
StatePublished - Nov 1 2016

Fingerprint

National Heart, Lung, and Blood Institute (U.S.)
Heart-Assist Devices
Heart Failure
Therapeutics
Industry
National Institutes of Health (U.S.)
Population
Randomized Controlled Trials

Keywords

  • assisted circulation
  • clinical trials
  • heart failure
  • mechanical circulatory support
  • ventricular assist device

ASJC Scopus subject areas

  • Surgery
  • Pulmonary and Respiratory Medicine
  • Cardiology and Cardiovascular Medicine
  • Transplantation

Cite this

@article{4c78d83f1c1c40cca316e0a578a9ca5d,
title = "The NHLBI REVIVE-IT study: Understanding its discontinuation in the context of current left ventricular assist device therapy",
abstract = "The National Institutes of Health National Heart, Lung, and Blood Institute convened a working group in March 2008 to discuss how therapies for heart failure (HF) might be best advanced using clinical trials involving left ventricular assist devices (LVAD). This group opined that the field was ready for a trial to assess the use of long-term ventricular assist device therapy in patients who are less ill than patients currently eligible for destination therapy, which resulted in the Randomized Evaluation of VAD InterVEntion before Inotropic Therapy (REVIVE-IT) pilot study. The specific objective of REVIVE-IT was to compare LVAD therapy with optimal medical management in patients with less advanced HF than current LVAD indications to determine if wider application of permanent LVAD use to less ill patients would be associated with improved survival, quality of life, or functional capacity. REVIVE-IT represented an extraordinary effort to provide data from a randomized clinical trial to inform clinicians, scientists, industry, and regulatory agencies about the efficacy and safety of LVAD therapy in a population with less advanced HF. Despite significant support from the medical community, industry, and governmental agencies, REVIVE-IT failed to accomplish its goal. The reasons for its failure are instructive, and the lessons learned from the REVIVE-IT experience are likely to be relevant to any future study of LVAD therapy in a population with less advanced HF.",
keywords = "assisted circulation, clinical trials, heart failure, mechanical circulatory support, ventricular assist device",
author = "{on behalf of the REVIVE-IT Investigators} and Pagani, {Francis D.} and Aaronson, {Keith D.} and Robert Kormos and Mann, {Douglas L.} and Cathie Spino and Neal Jeffries and Taddei-Peters, {Wendy C.} and Mancini, {Donna M.} and McNamara, {Dennis M.} and Grady, {Kathleen L} and John Gorcsan and Ralph Petrucci and Anderson, {Allen Sawyer} and Glick, {Henry A.} and Acker, {Michael A.} and {Eduardo Rame}, J. and Goldstein, {Daniel J.} and Pamboukian, {Salpy V.} and Miller, {Marissa A.} and {Timothy Baldwin}, J.",
year = "2016",
month = "11",
day = "1",
doi = "10.1016/j.healun.2016.09.002",
language = "English (US)",
volume = "35",
pages = "1277--1283",
journal = "Journal of Heart and Lung Transplantation",
issn = "1053-2498",
publisher = "Elsevier USA",
number = "11",

}

The NHLBI REVIVE-IT study : Understanding its discontinuation in the context of current left ventricular assist device therapy. / on behalf of the REVIVE-IT Investigators.

In: Journal of Heart and Lung Transplantation, Vol. 35, No. 11, 01.11.2016, p. 1277-1283.

Research output: Contribution to journalEditorial

TY - JOUR

T1 - The NHLBI REVIVE-IT study

T2 - Understanding its discontinuation in the context of current left ventricular assist device therapy

AU - on behalf of the REVIVE-IT Investigators

AU - Pagani, Francis D.

AU - Aaronson, Keith D.

AU - Kormos, Robert

AU - Mann, Douglas L.

AU - Spino, Cathie

AU - Jeffries, Neal

AU - Taddei-Peters, Wendy C.

AU - Mancini, Donna M.

AU - McNamara, Dennis M.

AU - Grady, Kathleen L

AU - Gorcsan, John

AU - Petrucci, Ralph

AU - Anderson, Allen Sawyer

AU - Glick, Henry A.

AU - Acker, Michael A.

AU - Eduardo Rame, J.

AU - Goldstein, Daniel J.

AU - Pamboukian, Salpy V.

AU - Miller, Marissa A.

AU - Timothy Baldwin, J.

PY - 2016/11/1

Y1 - 2016/11/1

N2 - The National Institutes of Health National Heart, Lung, and Blood Institute convened a working group in March 2008 to discuss how therapies for heart failure (HF) might be best advanced using clinical trials involving left ventricular assist devices (LVAD). This group opined that the field was ready for a trial to assess the use of long-term ventricular assist device therapy in patients who are less ill than patients currently eligible for destination therapy, which resulted in the Randomized Evaluation of VAD InterVEntion before Inotropic Therapy (REVIVE-IT) pilot study. The specific objective of REVIVE-IT was to compare LVAD therapy with optimal medical management in patients with less advanced HF than current LVAD indications to determine if wider application of permanent LVAD use to less ill patients would be associated with improved survival, quality of life, or functional capacity. REVIVE-IT represented an extraordinary effort to provide data from a randomized clinical trial to inform clinicians, scientists, industry, and regulatory agencies about the efficacy and safety of LVAD therapy in a population with less advanced HF. Despite significant support from the medical community, industry, and governmental agencies, REVIVE-IT failed to accomplish its goal. The reasons for its failure are instructive, and the lessons learned from the REVIVE-IT experience are likely to be relevant to any future study of LVAD therapy in a population with less advanced HF.

AB - The National Institutes of Health National Heart, Lung, and Blood Institute convened a working group in March 2008 to discuss how therapies for heart failure (HF) might be best advanced using clinical trials involving left ventricular assist devices (LVAD). This group opined that the field was ready for a trial to assess the use of long-term ventricular assist device therapy in patients who are less ill than patients currently eligible for destination therapy, which resulted in the Randomized Evaluation of VAD InterVEntion before Inotropic Therapy (REVIVE-IT) pilot study. The specific objective of REVIVE-IT was to compare LVAD therapy with optimal medical management in patients with less advanced HF than current LVAD indications to determine if wider application of permanent LVAD use to less ill patients would be associated with improved survival, quality of life, or functional capacity. REVIVE-IT represented an extraordinary effort to provide data from a randomized clinical trial to inform clinicians, scientists, industry, and regulatory agencies about the efficacy and safety of LVAD therapy in a population with less advanced HF. Despite significant support from the medical community, industry, and governmental agencies, REVIVE-IT failed to accomplish its goal. The reasons for its failure are instructive, and the lessons learned from the REVIVE-IT experience are likely to be relevant to any future study of LVAD therapy in a population with less advanced HF.

KW - assisted circulation

KW - clinical trials

KW - heart failure

KW - mechanical circulatory support

KW - ventricular assist device

UR - http://www.scopus.com/inward/record.url?scp=84994474433&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84994474433&partnerID=8YFLogxK

U2 - 10.1016/j.healun.2016.09.002

DO - 10.1016/j.healun.2016.09.002

M3 - Editorial

VL - 35

SP - 1277

EP - 1283

JO - Journal of Heart and Lung Transplantation

JF - Journal of Heart and Lung Transplantation

SN - 1053-2498

IS - 11

ER -