Exercise-based cardiac rehabilitation in patients with reduced left ventricular ejection fraction: The Cardiac Rehabilitation Outcome Study in Heart Failure (CROS-HF): A systematic review and meta-analysis

Q: What is the clinical evidence from this study?

Study design: Meta-Analysis. Population: Heart failure with reduced left ventricular ejection fraction (HFrEF, LVEF ≤40%) (n=4481). Intervention: Exercise-based cardiac rehabilitation (ebCR) vs. Usual care without structured or supervised exercise intervention. Primary outcome: All-cause mortality (HR 0.75, 95% CI 0.39-1.41).

Q: What does this research mean for the field?

Exercise-based cardiac rehabilitation does not significantly reduce mortality or hospitalization in patients with heart failure with reduced ejection fraction, but it improves exercise capacity and quality of life. Novelty: ClaimNovelty.SYNTHESIS. Consensus alignment: ConsensusAlignment.NEUTRAL.

Birna Bjarnason‐Wehrens; Roland Nebel; Katrin Jensen; Matthes Hackbusch; Maurizio Grilli; Stephan Gielen; Bernhard Schwaab; Bernhard Rauch

doi:10.1177/2047487319854140

June 8, 2019European Journal of Preventive CardiologyOpen Access

Exercise-based cardiac rehabilitation in patients with reduced left ventricular ejection fraction: The Cardiac Rehabilitation Outcome Study in Heart Failure (CROS-HF): A systematic review and meta-analysis

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Key result

Exercise-based cardiac rehabilitation fails to reduce all-cause mortality over control in HFrEF.

HR 0.75
95% CI 0.39-1.41
n=4,481

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Why the study?

In HFrEF patients, the effects of exercise-based cardiac rehabilitation on top of state-of-the-art medical and device therapy on mortality, hospitalization, exercise capacity, and quality of life were not well established.

Does exercise-based cardiac rehabilitation reduce all-cause mortality and hospitalization or improve exercise capacity and quality of life in patients with HFrEF (LVEF ≤40%) on contemporary guideline-directed medical therapy?

Key Points

To evaluate the impact of exercise-based cardiac rehabilitation added to modern medical therapy on mortality, hospitalization, exercise capacity, and quality of life in patients with heart failure and reduced left ventricular ejection fraction.
Systematic review and meta-analysis of 25 randomised controlled trials published in 1999 or later, encompassing 4,481 HFrEF patients with left ventricular ejection fraction ≤40%.
Included trials required structured exercise interventions with ≥90 minutes per week, ≥2 sessions per week, program duration ≥3 weeks, and post-randomization follow-up of ≥6 months.
The evidence base was dominated by the HF-ACTION trial, which contributed 52% of all analyzed patients.
No significant difference was detected for all-cause hospitalization at 12 months (RR 0.79, 95% CI 0.41-1.53, 4 studies) or heart failure hospitalization at 12 months (RR 0.59, 95% CI 0.12-2.91, 4 studies).
All included studies showed improved exercise capacity, and quality of life significantly improved on the Kansas City Cardiomyopathy Questionnaire at 6 months (mean difference 1.94, 95% CI 0.35-3.56, 2 studies), but not on the Minnesota Living with Heart Failure Questionnaire at ≥9 months (mean difference -4.19, 95% CI -10.51-2.12, 7 studies).

Study Design

Type

Meta-Analysis (n=4,481)

Blinding

Open-label

Multicenter

Yes

Structured PICO

Does exercise-based cardiac rehabilitation reduce all-cause mortality and hospitalization or improve exercise capacity and quality of life in patients with HFrEF (LVEF ≤40%) on contemporary guideline-directed medical therapy?

P

Population

4,481 adults with chronic HFrEF (LVEF ≤40%) across 25 RCTs published in 1999 or later on contemporary heart failure therapy, followed for 6 months to 10 years.

I

Intervention

Exercise-based cardiac rehabilitation (ebCR): structured and supervised continuous aerobic exercise training alone (21 studies) or combined with resistance training (10 studies), either as exercise-only CR (21 studies) or multicomponent CR (4 studies). Minimal requirements: ≥90 min/week, ≥2 sessions/week, for ≥3 weeks (observed range: 30-105 min/session, 2-7 sessions/week, for 4-54 weeks; total exercise volume 960-7800 min).

C

Comparator

Usual care control group not participating in any exercise-based rehabilitation programme or structured exercise intervention (supervised by general practitioners and/or resident cardiologists following local conventions; may participate in unstructured prevention programmes).

O

Outcome

All-cause mortality (evaluated via hazard ratio across follow-up of 30 months to 10 years, and relative risk at 6-month and 12-month follow-up)hard clinical

Main Result

Hazard Ratio: 0.75 (95% CI 0.39–1.41)

In HFrEF patients (LVEF ≤40%) receiving modern guideline-recommended medical and device therapy, exercise-based cardiac rehabilitation does not reduce mortality or hospitalization, but improves exercise capacity and quality of life.

Limitations

Heterogeneity in study population, study design, and exercise-based cardiac rehabilitation interventions
Majority of included studies were small single-centre trials (25-216 participants), with the analysis dominated by the large HF-ACTION trial (52% of all patients)
High risk of performance bias as blinding of participants and staff was not possible due to the nature of the intervention
Six included studies enrolled only men, and nine trials had unbalanced baseline characteristics
Poor quality of reporting in some included studies and lack of adequate patient compliance (approx. 60% in HF-ACTION)
Evident heterogeneity in study populations, study designs, and exercise-based cardiac rehabilitation interventions
Most included trials were small single-center studies (21 of 25 studies), with overall sample dominated by the HF-ACTION trial (52% of patients)
Lack of blinding of participants and staff resulting in high risk of performance bias
Six studies included only men and nine studies had unbalanced baseline characteristics
Underpowered individual studies and lack of adequate patient compliance with prescribed training (approximately 60% in HF-ACTION)

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Implication

Reframes cardiac rehabilitation in HFrEF around functional and symptomatic benefits rather than survival; confirms mortality neutralizes alongside contemporary GDMT.

Abstract

BACKGROUND: In heart failure with reduced left ventricular ejection fraction (HFrEF) patients the effects of exercise-based cardiac rehabilitation on top of state-of-the-art pharmacological and device therapy on mortality, hospitalization, exercise capacity and quality-of-life are not well established. DESIGN: The design of this study involved a structured review and meta-analysis. METHODS: Evaluation of randomised controlled trials of exercise-based cardiac rehabilitation in HFrEF-patients with left ventricular ejection fraction ≤40% of any aetiology with a follow-up of ≥6 months published in 1999 or later. RESULTS: Out of 12,229 abstracts, 25 randomised controlled trials including 4481 HFrEF-patients were included in the final evaluation. Heterogeneity in study population, study design and exercise-based cardiac rehabilitation-intervention was evident. No significant difference in the effect of exercise-based cardiac rehabilitation on mortality compared to control-group was found (hazard ratio 0.75, 95% confidence interval 0.39-1.41, four studies; 12-months follow-up: relative risk 1.29, 95% confidence interval 0.66-2.49, eight studies; six-months follow-up: relative risk 0.91, 95% confidence interval 0.26-3.16, seven studies). In addition there was no significant difference between the groups with respect to 'hospitalization-for-any-reason' (12-months follow-up: relative risk 0.79, 95% confidence interval 0.41-1.53, four studies), or 'hospitalization-due-to-heart-failure' (12-months follow-up: relative risk 0.59, 95% confidence interval 0.12-2.91, four studies; six-months follow-up: relative risk 0.84, 95% confidence interval 0.07-9.71, three studies). All studies show improvement of exercise capacity. Participation in exercise-based cardiac rehabilitation significantly improved quality-of-life as evaluated with the Kansas City Cardiomyopathy Questionnaire: (six-months follow-up: mean difference 1.94, 95% confidence interval 0.35-3.56, two studies), but no significant results emerged for quality-of-life measured by the Minnesota Living with Heart Failure Questionnaire (nine-months or more follow-up: mean difference -4.19, 95% confidence interval -10.51-2.12, seven studies; six-months follow-up: mean difference -5.97, 95% confidence interval -16.17-4.23, four studies). CONCLUSION: No association between exercise-based cardiac rehabilitation and mortality or hospitalisation could be observed in HFrEF patients but exercise-based cardiac rehabilitation is likely to improve exercise capacity and quality of life.

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Cite This Study

Bjarnason‐Wehrens et al. (2019) conducted a meta-analysis in Heart failure with reduced left ventricular ejection fraction (HFrEF, LVEF ≤40%) (n=4,481). Exercise-based cardiac rehabilitation (ebCR) vs. Usual care without structured or supervised exercise intervention was evaluated on All-cause mortality (HR 0.75, 95% CI 0.39-1.41). Exercise-based cardiac rehabilitation did not significantly reduce all-cause mortality compared to control in HFrEF patients (HR 0.75, 95% CI 0.39-1.41), though it improved quality of life.

synapsesocial.com/papers/6a8439f17b4d6f59a47bfd53 https://doi.org/10.1177/2047487319854140

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Exercise-based cardiac rehabilitation in patients with reduced left ventricular ejection fraction: The Cardiac Rehabilitation Outcome Study in Heart Failure (CROS-HF): A systematic review and meta-analysis

Figures

Key Points

Study Design

Structured PICO

Main Result

Limitations

Ask about this paper

Implication

Abstract

Discussion

Cite This Study

Exercise-based cardiac rehabilitation in patients with reduced left ventricular ejection fraction: The Cardiac Rehabilitation Outcome Study in Heart Failure (CROS-HF): A systematic review and meta-analysis

Figures

Key Points

Study Design

Structured PICO

Main Result

Limitations

Ask about this paper

Implication

Abstract

Discussion

Cite This Study

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