Willy Kevin, Ellermann Christian, Reinke Florian, Rath Benjamin, Wolfes Julian, Eckardt Lars, Doldi Florian, Wegner Felix K, Köbe Julia, Morina Nexhmedin
Department for Cardiology II: Electrophysiology, University Hospital Münster, 48149 Münster, Germany.
Department of Psychology, University of Münster, 48149 Münster, Germany.
J Cardiovasc Dev Dis. 2022 Aug 10;9(8):257. doi: 10.3390/jcdd9080257.
The implantation of cardiac devices significantly reduces morbidity and mortality in patients with cardiac arrhythmias. Arrhythmias as well as therapy delivered by the device may impact quality of life of patients concerned considerably. Therefore we aimed at conducting a systematic search and meta-analysis of trials examining the impact of the implantation of cardiac devices, namely implantable cardioverter-defibrillators (ICD), pacemakers and left-ventricular assist devices (LVAD) on quality of life. After pre-registering the trial with the PROSPERO database, we searched Medline, PsycINFO, Web of Science and the Cochrane databases for relevant publications. Study quality was assessed by two independent reviewers using standardized protocols. A total of 37 trials met our inclusion criteria. Of these, 31 trials were cohort trials while 6 trials used a randomized controlled design. We found large pre-post effect sizes for positive associations between quality of life and all types of devices. The effect sizes for LVAD, pacemaker and ICD patients were g = 1.64, g = 1.32 and g = 0.64, respectively. There was a lack of trials examining the effect of implantation on quality of life relative to control conditions. Trials assessing quality of life in patients with cardiac devices are still scarce. Yet, the existing data suggest beneficial effects of cardiac devices on quality of life. We recommend that clinical trials on cardiac devices routinely assess quality of life or other parameters of psychological well-being as a decisive study endpoint. Furthermore, improvements in psychological well-being should influence decisions about implantations of cardiac devices and be part of patient education and may impact shared decision-making.
心脏装置的植入显著降低了心律失常患者的发病率和死亡率。心律失常以及装置所提供的治疗可能会对相关患者的生活质量产生相当大的影响。因此,我们旨在对研究心脏装置(即可植入式心脏复律除颤器(ICD)、起搏器和左心室辅助装置(LVAD))植入对生活质量影响的试验进行系统检索和荟萃分析。在向PROSPERO数据库预先注册该试验后,我们在Medline、PsycINFO、科学网和Cochrane数据库中检索相关出版物。由两名独立评审员使用标准化方案评估研究质量。共有37项试验符合我们的纳入标准。其中,31项试验为队列试验,6项试验采用随机对照设计。我们发现生活质量与所有类型装置之间的正向关联存在较大的前后效应量。LVAD、起搏器和ICD患者的效应量分别为g = 1.64、g = 1.32和g = 0.64。缺乏相对于对照条件研究植入对生活质量影响的试验。评估心脏装置患者生活质量的试验仍然很少。然而,现有数据表明心脏装置对生活质量有有益影响。我们建议关于心脏装置的临床试验常规评估生活质量或心理健康的其他参数作为决定性的研究终点。此外,心理健康的改善应影响心脏装置植入的决策,并成为患者教育的一部分,且可能影响共同决策。