Registry Evaluation of Vital Information for VADs in Ambulatory Life (REVIVAL): Rationale, design, baseline characteristics, and inclusion criteria performance

Abstract

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.

Keywords: mechanical circulatory support; outcomes; prognosis; risk factors; systolic heart failure.

Figure 1

Kaplan-Meier curve. Curve shows the estimate for the primary combined outcome and competing outcome curves displaying the cumulative incidence function estimates for death, UNOS 1A or 1B transplant, or durable MCS implantation. MCS, mechanical circulatory support; UNOS, United Network of Organ Sharing.

Figure 2

Timing of primary combined outcome events that were identified (true positives) by each study inclusion criteria and selected additional criteria through the 12-month study visit. 6MW, 6-minute walk; BNP, B-type natriuretic peptide; HFSS, Heart Failure Survival Score; Hosp, hospitalization; NT-proBNP, N-terminal prohormone of B-type natriuretic peptide; SHFM, Seattle Heart Failure Model; UNOS, United Network of Organ Sharing; VCO₂, carbon dioxide production; VE, ventilation; VO₂, oxygen consumption.