TY - JOUR
T1 - Registry Evaluation of Vital Information for VADs in Ambulatory Life (REVIVAL)
T2 - Rationale, design, baseline characteristics, and inclusion criteria performance
AU - for the REVIVAL Investigators
AU - Aaronson, Keith D.
AU - Stewart, Garrick C.
AU - Pagani, Francis D.
AU - Stevenson, Lynne W.
AU - Palardy, Maryse
AU - McNamara, Dennis M.
AU - Mancini, Donna M.
AU - Grady, Kathleen
AU - Gorcsan, John
AU - Kormos, Robert
AU - Jeffries, Neal
AU - Taddei-Peters, Wendy C.
AU - Richards, Blair
AU - Khalatbari, Shokoufeh
AU - Spino, Cathie
AU - Baldwin, J. Timothy
AU - Mann, Douglas L.
N1 - Funding Information:
Supported by funding from the National Institutes of Health; National Heart, Lung, and Blood Institute (NHLBI Contract Number HHSN268201100026C); and the National Center for Advancing Translational Sciences (NCATS Grant Number UL1TR002240) for the Michigan Institute for Clinical and Health Research (MICHR). The views expressed in this manuscript are those of the authors and do not necessarily represent the views of the National Heart, Lung, and Blood Institute; the National Institutes of Health; the Food and Drug Administration; or the US Department of Health and Human Services.
Funding Information:
Keith Aaronson: Related to the submitted work: NIH/NHLBI (contract). Outside the submitted work: Medtronic (research support and consultant [Independent Physician Quality Panel member]), Abbott (research support), Procyrion (Medical Advisory Board), NuPulseCV (consultant), Bioventrix (research support), Amgen (research support) Francis D. Pagani: Fineheart (Scientific Advisory Board) Kathleen Grady: Related to the submitted work: NIH/NHLBI (grant) Outside the submitted work: NIH/NHLBI (grant), NIH/NIA (grant), NIH/NINR (grant), ISHLT (non-financial support and Board of Directors), AHA (non-financial support) and HFSA non-financial support) John Gorcsan: Outside the submitted work: EBR Systems (grants), V-Wave (grant), GE (grant) The remaining authors have no conflicts of interest to disclose. Supported by funding from the National Institutes of Health ; National Heart, Lung, and Blood Institute (NHLBI Contract Number HHSN268201100026C); and the National Center for Advancing Translational Sciences (NCATS Grant Number UL1TR002240) for the Michigan Institute for Clinical and Health Research (MICHR). The views expressed in this manuscript are those of the authors and do not necessarily represent the views of the National Heart, Lung, and Blood Institute; the National Institutes of Health; the Food and Drug Administration; or the US Department of Health and Human Services.
Publisher Copyright:
© 2019 International Society for Heart and Lung Transplantation
PY - 2020/1
Y1 - 2020/1
N2 - INTRODUCTION: Improved understanding of the clinical course of ambulatory advanced chronic systolic heart failure may improve the provision of appropriate care and is central to the design of clinical trials in this population. METHODS: Twenty-one implanting ventricular assist device (VAD) centers enrolled 400 subjects in the Registry Evaluation of Vital Information for VADs in Ambulatory Life (REVIVAL), a prospective, observational study in ambulatory, chronic, advanced systolic heart failure, designed to identify a cohort with an approximately 25% 1-year risk of the primary composite outcome of death, urgent transplant, or durable mechanical circulatory support. Inclusion criteria utilized only information collected during routine clinical care. Exclusion criteria identified patients with contraindications to VAD. Study inclusion required at least 1 of 10 high-risk criteria derived from established hospitalization and non-hospitalization markers of increased mortality risk. We evaluated the test performance characteristics of the high-risk criteria. RESULTS: Data on 373 subjects evaluable for the primary composite outcome at the 1-year visit are presented. Baseline data were consistent with a less advanced cohort than Medical Arm for Mechanically Assisted Circulatory Support or Risk Assessment (MedaMACS) and Comparative Effectiveness of Left Ventricular Assist Device and Medical Management in Ambulatory Heart Failure Patients (ROADMAP). Freedom from the primary composite outcome was 75.9%. Non-hospitalization inclusion criteria identified 89% of patients with events. CONCLUSIONS: Using routinely obtained clinical information for enrollment, REVIVAL successfully recruited an ambulatory chronic systolic heart failure cohort with an approximately 25% annual risk of the primary composite outcome. Information from this registry will be relevant to the planning of future trials of earlier VAD use and of other interventions in this population.
AB - INTRODUCTION: Improved understanding of the clinical course of ambulatory advanced chronic systolic heart failure may improve the provision of appropriate care and is central to the design of clinical trials in this population. METHODS: Twenty-one implanting ventricular assist device (VAD) centers enrolled 400 subjects in the Registry Evaluation of Vital Information for VADs in Ambulatory Life (REVIVAL), a prospective, observational study in ambulatory, chronic, advanced systolic heart failure, designed to identify a cohort with an approximately 25% 1-year risk of the primary composite outcome of death, urgent transplant, or durable mechanical circulatory support. Inclusion criteria utilized only information collected during routine clinical care. Exclusion criteria identified patients with contraindications to VAD. Study inclusion required at least 1 of 10 high-risk criteria derived from established hospitalization and non-hospitalization markers of increased mortality risk. We evaluated the test performance characteristics of the high-risk criteria. RESULTS: Data on 373 subjects evaluable for the primary composite outcome at the 1-year visit are presented. Baseline data were consistent with a less advanced cohort than Medical Arm for Mechanically Assisted Circulatory Support or Risk Assessment (MedaMACS) and Comparative Effectiveness of Left Ventricular Assist Device and Medical Management in Ambulatory Heart Failure Patients (ROADMAP). Freedom from the primary composite outcome was 75.9%. Non-hospitalization inclusion criteria identified 89% of patients with events. CONCLUSIONS: Using routinely obtained clinical information for enrollment, REVIVAL successfully recruited an ambulatory chronic systolic heart failure cohort with an approximately 25% annual risk of the primary composite outcome. Information from this registry will be relevant to the planning of future trials of earlier VAD use and of other interventions in this population.
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U2 - 10.1016/j.healun.2019.09.008
DO - 10.1016/j.healun.2019.09.008
M3 - Article
C2 - 31679943
AN - SCOPUS:85074508232
SN - 1053-2498
VL - 39
SP - 7
EP - 15
JO - Journal of Heart and Lung Transplantation
JF - Journal of Heart and Lung Transplantation
IS - 1
ER -