Featured PapersRegistry Evaluation of Vital Information for VADs in Ambulatory Life (REVIVAL): Rationale, design, baseline characteristics, and inclusion criteria performance
Section snippets
Study population
Twenty-one implanting VAD centers screened 927 patients and enrolled 400 subjects with ambulatory advanced chronic systolic HF in a prospective, observational study between July 2015 and June 2016. (See Supplementary Figure S1 at www.jhltonline.org for CONSORT diagram). Entry criteria utilized only information collected during routine clinical care. Inclusion criteria were chosen with the goal of identifying a high risk but ambulatory, advanced, chronic systolic HF cohort receiving
Analysis cohort
Of 400 subjects enrolled in the study, 2 provided no follow-up information beyond enrollment, leaving 398 evaluable subjects. Data on 25 evaluable subjects whose follow-up did not extend through 1-year and who did not experience a primary outcome event were excluded from subsequent analyses. This included 4 who were lost to follow-up (median follow-up, 234 [186, 303] days), 15 who withdrew from the study (median follow-up, 165 [77, 238] days), and 6 who received UNOS status 2 transplants
Discussion
REVIVAL was designed as a prospective registry of ambulatory patients with advanced HF that would better define the clinical trajectory and relationship between baseline characteristics and outcomes of patients who might be considered for future studies of earlier VAD use. As such, a patient cohort generally considered not ill enough for LVAD or transplant, yet demonstrated here to be at substantial risk for death, urgent transplant, or durable MCS, was enrolled from advanced HF programs at
Disclosure statement
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),
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2022, Journal of Heart and Lung TransplantationCitation Excerpt :The REVIVAL registry contains information on 400 patients with advanced systolic HF from 21 US medical centers and has been previously described.17
Demise of HVAD: The only constant is change
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2022, Journal of Cardiac FailureCitation Excerpt :Patients were excluded if they had a significant noncardiac condition that would limit functional capacity or expected survival to less than 2 years, intravenous inotrope use, or chronic kidney disease with a creatinine of 3.0 mg/dL or greater, or were on dialysis. Detailed entry criteria and study design have previously been published.11 Patient demographic characteristics including age, sex, race, and current HF status, including INTERMACS profile, were captured at the time of enrollment.
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