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Meta-Analysis
. 2019 Feb 12;2(2):CD011828.
doi: 10.1002/14651858.CD011828.pub2.

Exercise-based cardiac rehabilitation for adult patients with an implantable cardioverter defibrillator

Kim M Nielsen  1 , Ann-Dorthe Zwisler, Rod S Taylor, Jesper H Svendsen, Jane Lindschou, Lindsey Anderson, Janus C Jakobsen, Selina K Berg
Affiliations
Meta-Analysis

Exercise-based cardiac rehabilitation for adult patients with an implantable cardioverter defibrillator

Kim M Nielsen et al. Cochrane Database Syst Rev. .

Abstract

Background: An effective way of preventing sudden cardiac death is the use of an implantable cardioverter defibrillator (ICD). In spite of the potential mortality benefits of receiving an ICD device, psychological problems experienced by patients after receiving an ICD may negatively impact their health-related quality of life, and lead to increased readmission to hospital and healthcare needs, loss of productivity and employment earnings, and increased morbidity and mortality. Evidence from other heart conditions suggests that cardiac rehabilitation should consist of both exercise training and psychoeducational interventions; such rehabilitation may benefit patients with an ICD. Prior systematic reviews of cardiac rehabilitation have excluded participants with an ICD. A systematic review was therefore conducted to assess the evidence for the use of exercise-based intervention programmes following implantation of an ICD.

Objectives: To assess the benefits and harms of exercise-based cardiac rehabilitation programmes (exercise-based interventions alone or in combination with psychoeducational components) compared with control (group of no intervention, treatment as usual or another rehabilitation programme with no physical exercise element) in adults with an ICD.

Search methods: We searched CENTRAL, MEDLINE, Embase and four other databases on 30 August 2018 and three trials registers on 14 November 2017. We also undertook reference checking, citation searching and contacted study authors for missing data.

Selection criteria: We included randomised controlled trials (RCTs) if they investigated exercise-based cardiac rehabilitation interventions compared with no intervention, treatment as usual or another rehabilitation programme. The trial participants were adults (aged 18 years or older), who had been treated with an ICD regardless of type or indication.

Data collection and analysis: Two review authors independently extracted data and assessed risk of bias. The primary outcomes were all-cause mortality, serious adverse events and health-related quality of life. The secondary outcomes were exercise capacity, antitachycardia pacing, shock, non-serious adverse events, employment or loss of employment and costs and cost-effectiveness. Risk of systematic errors (bias) was assessed by evaluation of predefined bias risk domains. Clinical and statistical heterogeneity were assessed. Meta-analyses were undertaken using both fixed-effect and random-effects models. We used the GRADE approach to assess the quality of evidence.

Main results: We identified eight trials published from 2004 to 2017 randomising a total of 1730 participants, with mean intervention duration of 12 weeks. All eight trials were judged to be at overall high risk of bias and effect estimates are reported at the end of the intervention with a follow-up range of eight to 24 weeks.Seven trials reported all-cause mortality, but deaths only occurred in one trial with no evidence of a difference between exercise-based cardiac rehabilitation and control (risk ratio (RR) 1.96, 95% confidence interval (CI) 0.18 to 21.26; participants = 196; trials = 1; quality of evidence: low). There was also no evidence of a difference in serious adverse events between exercise-based cardiac rehabilitation and control (RR 1.05, 95% CI 0.77 to 1.44; participants = 356; trials = 2; quality of evidence: low). Due to the variation in reporting of health-related quality of life outcomes, it was not possible to pool data. However, the five trials reporting health-related quality of life at the end of the intervention, each showed little or no evidence of a difference between exercise-based cardiac rehabilitation and control.For secondary outcomes, there was evidence of a higher pooled exercise capacity (peak VO2) at the end of the intervention (mean difference (MD) 0.91 mL/kg/min, 95% CI 0.60 to 1.21; participants = 1485; trials = 7; quality of evidence: very low) favouring exercise-based cardiac rehabilitation, albeit there was evidence of substantial statistical heterogeneity (I2 = 78%). There was no evidence of a difference in the risk of requiring antitachycardia pacing (RR 1.26, 95% CI 0.84 to 1.90; participants = 356; trials = 2; quality of evidence: moderate), appropriate shock (RR 0.56, 95% CI 0.20 to 1.58; participants = 428; studies = 3; quality of evidence: low) or inappropriate shock (RR 0.60, 95% CI 0.10 to 3.51; participants = 160; studies = 1; quality of evidence: moderate).

Authors' conclusions: Due to a lack of evidence, we were unable to definitively assess the impact of exercise-based cardiac rehabilitation on all-cause mortality, serious adverse events and health-related quality of life in adults with an ICD. However, our findings do provide very low-quality evidence that patients following exercise-based cardiac rehabilitation experience a higher exercise capacity compared with the no exercise control. Further high-quality randomised trials are needed in order to assess the impact of exercise-based cardiac rehabilitation in this population on all-cause mortality, serious adverse events, health-related quality of life, antitachycardia pacing and shock.

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Conflict of interest statement

Selina K Berg1, Jane Lindschou2, Jesper H Svendsen3 and Ann‐Dorthe Zwisler4 are involved academic investigators in RCTs, investigating the effect of cardiac rehabilitation for people:

  1. with atrial fibrillation treated with radiofrequency ablation1, 2, 3, 4 (Risom 2017);

  2. treated for infective endocarditis1, 2, 4;

  3. after heart valve surgery1, 2, 4 (Sibilitz 2016);

  4. treated with ICD1, 3, 4 (Berg 2014).

Trial acronym: COPE‐ICD, CopenHeart and DanRehab. These trials are funded by the Danish government and by external funds. The funders have no influence on the research.

Rod Taylor is a co‐author on a number of current Cochrane Reviews of cardiac rehabilitation and co‐chief investigator of a research programme designing and evaluating a de novo home‐based rehabilitation intervention for patients with heart failure and their carers.

Lindsey Anderson is an author on a number of other Cochrane cardiac rehabilitation Reviews.

Janus C Jakobsen and Kim M Nielsen have no known conflicts of interest.

Figures

1
1
Study flow diagram.
2
2
Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
3
3
Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
4
4
Table: Serious adverse events at end of intervention.
5
5
Table: Serious adverse events at longest available follow‐up.
6
6
Summary of results on health related quality of life at end of intervention and at longest available follow‐up
1.1
1.1. Analysis
Comparison 1 Exercise‐based cardiac rehabilitation versus control at the end of the intervention, Outcome 1 All‐cause mortality.
1.2
1.2. Analysis
Comparison 1 Exercise‐based cardiac rehabilitation versus control at the end of the intervention, Outcome 2 Serious adverse events.
1.3
1.3. Analysis
Comparison 1 Exercise‐based cardiac rehabilitation versus control at the end of the intervention, Outcome 3 Exercise capacity (VO2 peak) (random‐effects model).
1.4
1.4. Analysis
Comparison 1 Exercise‐based cardiac rehabilitation versus control at the end of the intervention, Outcome 4 Exercise capacity (VO2 peak) (fixed‐effect model).
1.5
1.5. Analysis
Comparison 1 Exercise‐based cardiac rehabilitation versus control at the end of the intervention, Outcome 5 ICD, antitachycardia pacing.
1.6
1.6. Analysis
Comparison 1 Exercise‐based cardiac rehabilitation versus control at the end of the intervention, Outcome 6 ICD, appropriate shock.
1.7
1.7. Analysis
Comparison 1 Exercise‐based cardiac rehabilitation versus control at the end of the intervention, Outcome 7 ICD, inappropriate shock.
1.8
1.8. Analysis
Comparison 1 Exercise‐based cardiac rehabilitation versus control at the end of the intervention, Outcome 8 Non‐serious adverse events.
2.1
2.1. Analysis
Comparison 2 Exercise‐based cardiac rehabilitation versus control at the end of the intervention (best‐worst case meta‐analysis), Outcome 1 All‐cause mortality.
2.2
2.2. Analysis
Comparison 2 Exercise‐based cardiac rehabilitation versus control at the end of the intervention (best‐worst case meta‐analysis), Outcome 2 Serious adverse events.
3.1
3.1. Analysis
Comparison 3 Exercise‐based cardiac rehabilitation versus control at the end of the intervention (worst‐best case meta‐analysis), Outcome 1 All‐cause mortality (random‐effects model).
3.2
3.2. Analysis
Comparison 3 Exercise‐based cardiac rehabilitation versus control at the end of the intervention (worst‐best case meta‐analysis), Outcome 2 All‐cause mortality (fixed‐effect model).
3.3
3.3. Analysis
Comparison 3 Exercise‐based cardiac rehabilitation versus control at the end of the intervention (worst‐best case meta‐analysis), Outcome 3 All‐cause mortality.
3.4
3.4. Analysis
Comparison 3 Exercise‐based cardiac rehabilitation versus control at the end of the intervention (worst‐best case meta‐analysis), Outcome 4 Serious adverse events.
4.1
4.1. Analysis
Comparison 4 Exercise‐based cardiac rehabilitation versus control at longest follow‐up, Outcome 1 All‐cause mortality.
4.2
4.2. Analysis
Comparison 4 Exercise‐based cardiac rehabilitation versus control at longest follow‐up, Outcome 2 Serious adverse events (random‐effects model).
4.3
4.3. Analysis
Comparison 4 Exercise‐based cardiac rehabilitation versus control at longest follow‐up, Outcome 3 Serious adverse events (fixed‐effect model).
4.4
4.4. Analysis
Comparison 4 Exercise‐based cardiac rehabilitation versus control at longest follow‐up, Outcome 4 Exercise capacity (VO2 peak).
4.5
4.5. Analysis
Comparison 4 Exercise‐based cardiac rehabilitation versus control at longest follow‐up, Outcome 5 ICD, appropriate shock (random‐effects model).
4.6
4.6. Analysis
Comparison 4 Exercise‐based cardiac rehabilitation versus control at longest follow‐up, Outcome 6 ICD, appropriate shock (fixed‐effect model).
4.7
4.7. Analysis
Comparison 4 Exercise‐based cardiac rehabilitation versus control at longest follow‐up, Outcome 7 ICD, all shocks.
5.1
5.1. Analysis
Comparison 5 Exercise‐based cardiac rehabilitation versus control at longest follow‐up (best‐worst case meta‐analysis), Outcome 1 All‐cause mortality.
5.2
5.2. Analysis
Comparison 5 Exercise‐based cardiac rehabilitation versus control at longest follow‐up (best‐worst case meta‐analysis), Outcome 2 Serious adverse events.
6.1
6.1. Analysis
Comparison 6 Exercise‐based cardiac rehabilitation versus control at longest follow‐up (worst‐best case meta‐analysis), Outcome 1 All‐cause mortality.
6.2
6.2. Analysis
Comparison 6 Exercise‐based cardiac rehabilitation versus control at longest follow‐up (worst‐best case meta‐analysis), Outcome 2 Serious adverse events (random‐effects model).
6.3
6.3. Analysis
Comparison 6 Exercise‐based cardiac rehabilitation versus control at longest follow‐up (worst‐best case meta‐analysis), Outcome 3 Serious adverse events (fixed‐effect model).
7.1
7.1. Analysis
Comparison 7 Subgroup analysis, Outcome 1 All‐cause mortality: exercise intervention only compared to exercise intervention plus any other co‐intervention at longest follow‐up.
7.2
7.2. Analysis
Comparison 7 Subgroup analysis, Outcome 2 Serious adverse events: follow‐up.
7.3
7.3. Analysis
Comparison 7 Subgroup analysis, Outcome 3 Serious adverse events: exercise intervention only compared to exercise intervention plus any other co‐intervention at end of intervention.
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