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

https://doi.org/10.1016/j.healun.2019.09.008Get rights and content

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.

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),

References (15)

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