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Triage of Ambulatory Patients With Advanced HF
Quick Takes
- In a cohort of patients with ambulatory advanced systolic heart failure on maximally tolerated guideline-directed medical therapies, death, urgent transplant, or ventricular assist device (VAD) implantation occurred in just over one-third of subjects at 2 years.
- Better risk stratification and treatments may further reduce deaths in the small though still significant group of patients (16%) who died at 2 years without an advanced therapy.
- For patients without a primary event, quality of life and functional capacity remained relatively stable through 2 years with few HF hospitalizations, arguing against earlier VAD implantation for healthier patients.
Study Questions:
What are 2-year clinical outcomes for ambulatory patients with advanced systolic heart failure (HF) on maximally tolerated evidence-based therapies?
Methods:
The REVIVAL (Registry Evaluation of Vital Information for VADs in Ambulatory Life) study was a prospective, observational study conducted between July 2015 and June 2016 at 21 advanced HF centers with active ventricular assist device (VAD) programs. REVIVAL enrolled ambulatory patients with New York Heart Association (NYHA) class II-IV symptoms, a left ventricular ejection fraction (LVEF) ≤35%, and an HF diagnosis for ≥12 months who received guideline-directed medical and device therapies as tolerated. Subjects had to have ≥1 high-risk feature for HF mortality. Subjects were followed for 2 years or until death, VAD, or heart transplant. Functional capacity and quality of life were assessed at regular study visits through 24 months. The primary outcome was the composite of urgent heart transplant, durable VAD, or death.
Results:
REVIVAL enrolled 400 subjects (mean age 60 years, 25% women, 25% self-identified Black). Mean LVEF was 21%, and 71% had NYHA class III or greater HF symptoms. Use of guideline-directed medical therapy (GDMT) was high with 96% prescribed a beta-blocker; 95% an angiotensin-converting enzyme inhibitor, angiotensin-receptor blocker, or angiotensin receptor/neprilysin inhibitor; and 70% a mineralocorticoid antagonist. Over 2 years, 37% of subjects experienced a primary outcome event (61 deaths, 57 VADs or total artificial hearts, and 23 urgent transplants). The majority of deaths were cardiac in nature (78.1%). For those subjects not experiencing an outcome event, the relative proportion who were Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) profile 7 increased. For the 175 patients alive and active in the registry at 2 years, 81% did not experience an HF hospitalization during the study period. Quality of life remained stable for 2-year survivors without a primary outcome event.
Conclusions:
Ambulatory patients with advanced systolic HF on maximally tolerated GDMT not selected for VAD or heart transplant had stable quality of life and few hospitalizations at 2 years. These findings do not support lowering the threshold for VAD implantation to less sick patients.
Perspective:
Identifying the optimal timing for VAD implantation or heart transplantation remains challenging. Premature heart transplantation or LVAD implantation exposes patients to potentially unnecessary complications. These risks, however, must be balanced against those of delaying therapies, during which time patients may experience clinical deterioration and poor outcomes. The current study employed rigorous inclusion criteria to select for a high-risk cohort of HF patients as evidenced by their low LVEF, impaired functional capacity, and elevated N-terminal pro–B-type natriuretic peptide levels. Despite this, use of guideline-directed medical and device therapies was robust.
At 2 years, over one-third of patients experienced a primary outcome event, driven predominantly by VAD and heart transplant, with 16% of patients dying by 2 years. For the 63% of subjects who did not experience the primary outcome at 2 years, quality of life remained stable with small though clinically significant declines in functional capacity. This challenges the belief that earlier VAD implantation would improve clinical outcomes when considering modern day VAD technology. Importantly, however, 16% of subjects died by 2 years without an advanced therapy. Whether these deaths could have been averted by earlier delivery of advanced therapies is unknown and an important limitation of the trial. Additionally, as noted by the authors, improvements in medical and device therapies since REVIVAL was launched may further improve clinical outcomes for patients managed medically.
Clinical Topics: Cardiac Surgery, Heart Failure and Cardiomyopathies, Cardiac Surgery and Heart Failure, Acute Heart Failure, Chronic Heart Failure, Mechanical Circulatory Support
Keywords: Heart-Assist Devices, Heart Failure, Systolic
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