Nielsen Kim M, Zwisler Ann-Dorthe, Taylor Rod S, Svendsen Jesper H, Lindschou Jane, Anderson Lindsey, Jakobsen Janus C, Berg Selina K
Department of Cardiology, The Heart Centre, Copenhagen University Hospital, Rigshospitalet, Blegdamsvej 9, Copenhagen, Denmark, 2100.
Cochrane Database Syst Rev. 2019 Feb 12;2(2):CD011828. doi: 10.1002/14651858.CD011828.pub2.
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.
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.
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.
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.
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.
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 VO) 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 (I = 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.
预防心源性猝死的一种有效方法是使用植入式心脏复律除颤器（ICD）。尽管接受ICD装置可能带来降低死亡率的益处，但患者在接受ICD后出现的心理问题可能会对其健康相关生活质量产生负面影响，并导致再次入院率增加、医疗需求增加、生产力和就业收入损失以及发病率和死亡率上升。其他心脏病的证据表明，心脏康复应包括运动训练和心理教育干预；这种康复可能使ICD患者受益。先前关于心脏康复的系统评价排除了ICD患者。因此，进行了一项系统评价，以评估ICD植入后基于运动的干预方案的证据。
评估与对照组（无干预组、常规治疗组或无体育锻炼成分的另一康复方案组）相比，基于运动的心脏康复方案（单独的运动干预或与心理教育成分相结合）对成年ICD患者的益处和危害。
我们于2018年8月30日检索了Cochrane中心对照试验注册库（CENTRAL）、医学期刊数据库（MEDLINE）、荷兰医学文摘数据库（Embase）和其他四个数据库，并于2017年11月14日检索了三个试验注册库。我们还进行了参考文献核对、引文检索，并与研究作者联系以获取缺失数据。
如果随机对照试验（RCT）研究了基于运动的心脏康复干预与无干预、常规治疗或另一康复方案的比较，我们将其纳入。试验参与者为成年人（18岁及以上），无论ICD的类型或适应证如何，均接受过ICD治疗。
两位综述作者独立提取数据并评估偏倚风险。主要结局为全因死亡率、严重不良事件和健康相关生活质量。次要结局为运动能力、抗心动过速起搏、电击、非严重不良事件、就业或失业以及成本和成本效益。通过评估预定义的偏倚风险领域来评估系统误差（偏倚）风险。评估临床和统计异质性。使用固定效应模型和随机效应模型进行荟萃分析。我们使用GRADE方法评估证据质量。
我们确定了2004年至2017年发表的八项试验，共随机分配了1730名参与者，平均干预持续时间为12周。所有八项试验均被判定总体偏倚风险较高，效应估计值在干预结束时报告，随访时间为8至24周。七项试验报告了全因死亡率，但仅在一项试验中出现死亡，没有证据表明基于运动的心脏康复与对照组之间存在差异（风险比（RR）1.96，95%置信区间（CI）0.18至21.26；参与者 = 196；试验 = 1；证据质量：低）。也没有证据表明基于运动的心脏康复与对照组之间在严重不良事件方面存在差异（RR 1.05，95% CI 0.77至1.44；参与者 = 356；试验 = 2；证据质量：低）。由于健康相关生活质量结局报告的差异，无法汇总数据。然而，五项在干预结束时报告健康相关生活质量的试验，每项均显示基于运动的心脏康复与对照组之间几乎没有差异或无差异证据。对于次要结局，有证据表明干预结束时基于运动的心脏康复组的合并运动能力（峰值摄氧量）更高（平均差异（MD）0.91 mL/kg/min，95% CI 0.60至1.21；参与者 = 1485；试验 = 7；证据质量：极低），尽管有证据表明存在实质性统计异质性（I² = 78%）。没有证据表明在需要抗心动过速起搏的风险（RR 1.26，95% CI 0.84至1.90；参与者 = 356；试验 = 2；证据质量：中等）、适当电击（RR 0.56，95% CI 0.20至1.58；参与者 = 428；研究 = 3；证据质量：低）或不适当电击（RR 0.60，95% CI 0.10至3.51；参与者 = 160；研究 = 1；证据质量：中等）方面存在差异。
由于缺乏证据，我们无法明确评估基于运动的心脏康复对成年ICD患者全因死亡率、严重不良事件和健康相关生活质量的影响。然而，我们的研究结果确实提供了极低质量的证据，表明与无运动对照组相比，接受基于运动的心脏康复的患者运动能力更高。需要进一步进行高质量的随机试验，以评估基于运动的心脏康复对该人群全因死亡率、严重不良事件、健康相关生活质量、抗心动过速起搏和电击的影响。
