Ambulatory Advanced Heart Failure in Women: A Report From the REVIVAL Registry

Abstract

Objectives: This study sought to explore clinical characteristics and outcomes in women and men with ambulatory advanced heart failure (HF).

Background: Women have been underrepresented in studies of advanced HF and have an increased mortality on the transplant waiting list and early after mechanical circulatory support (MCS). An increased understanding of the differential burden of HF between women and men is required to inform the use of mechanical circulatory support in ambulatory advanced HF patients.

Methods: REVIVAL (Registry Evaluation for Vital Information on Ventricular Assist Devices in Ambulatory Life) is a prospective, observational study of 400 outpatients with chronic systolic HF, New York Heart Association functional class II to IV, and 1 additional high-risk feature. Clinical characteristics, quality of life, and functional capacity were compared between women and men, as was a primary composite endpoint of death, durable MCS, or urgent heart transplantation at 1 year.

Results: REVIVAL enrolled 99 women (25% of the cohort) who had similar age, ejection fraction, INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support) profiles, medication use, and willingness to consider MCS as the men enrolled; however, women reported significantly greater limitations in quality of life with respect to physical limitation, reduced 6-min walk distance, and more frequent symptoms of depression. Nevertheless, 1-year combined risk of death, durable MCS, or urgent transplantation did not differ between women and men (24% vs. 22%; p = 0.94).

Conclusions: This study represents the largest report to date of women with ambulatory advanced HF receiving contemporary therapies. Systematic elicitation of patient-reported outcome measures uncovered an added burden of HF in women and may be an appropriate target of augmented support and intervention.

Keywords: functional capacity; mechanical circulatory support; outcomes; quality of life; systolic heart failure; women.

Figure 1:. Competing Events Curves for Women and Men through One Year.

Women (n=99) are shown in Panel A, Men (n=301) in Panel B. Actuarial probability of patients being alive, dead, or receiving durable MCS or UNOS Status 1 transplant at 1 year are shown.

CENTRAL ILLUSTRATION:. Freedom from Primary Combined Outcome in Women and Men.

The primary composite outcome of interest was death, durable MCS, or urgent transplantation (TXP). The overall freedom for the combined outcome at one year was 76% for women and 78% for men (log-rank p=0.94), with a HR 0.98 (95% CI 0.61-1.58). GDMT, guideline directed medical therapy.