Journal article
The NHLBI REVIVE-IT study: Understanding its discontinuation in the context of current left ventricular assist device therapy
The Journal of heart and lung transplantation, v 35(11), pp 1277-1283
Nov 2016
PMID: 27836022
Featured in Collection : UN Sustainable Development Goals @ Drexel
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.
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Details
- Title
- The NHLBI REVIVE-IT study: Understanding its discontinuation in the context of current left ventricular assist device therapy
- Creators
- Francis D. Pagani - University of Michigan–Ann ArborKeith D. Aaronson - University of Michigan–Ann ArborRobert Kormos - University of Pittsburgh Medical CenterDouglas L. Mann - University of Washington in St. Louis, St. Louis, Missouri.Cathie Spino - University of Michigan–Ann ArborNeal Jeffries - National Heart Lung and Blood InstituteWendy C. Taddei-Peters - National Heart Lung and Blood InstituteDonna M. Mancini - Columbia UniversityDennis M. McNamara - University of Pittsburgh Medical CenterKathleen L. Grady - Midwestern UniversityJohn Gorcsan - University of Pittsburgh Medical CenterRalph Petrucci - Drexel UniversityAllen S. Anderson - Midwestern UniversityHenry A. Glick - Annenberg Public Policy CenterMichael A. Acker - Annenberg Public Policy CenterJ. Eduardo Rame - University of Pennsylvania, Philadelphia, PennsylvaniaDaniel J. Goldstein - Albert Einstein College of MedicineSalpy V. Pamboukian - University of Alabama at BirminghamMarissa A. Miller - National Heart Lung and Blood InstituteJ. Timothy Baldwin - National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Marylandon behalf of the REVIVE-IT Investigators
- Publication Details
- The Journal of heart and lung transplantation, v 35(11), pp 1277-1283
- Publisher
- Elsevier
- Resource Type
- Journal article
- Language
- English
- Academic Unit
- [Retired Faculty]
- Web of Science ID
- WOS:000388540700001
- Scopus ID
- 2-s2.0-84994474433
- Other Identifier
- 991019167999704721
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InCites Highlights
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- Collaboration types
- Domestic collaboration
- Web of Science research areas
- Cardiac & Cardiovascular Systems
- Respiratory System
- Surgery
- Transplantation