Goetz Gregor, Wernly Bernhard, Wild Claudia
HTA Austria - Austrian Institute for Health Technology Assessment GmbH, Vienna, Austria.
Department of Health Care Management, Technical University Berlin, Germany.
Int J Cardiol Heart Vasc. 2023 Mar 28;45:101189. doi: 10.1016/j.ijcha.2023.101189. eCollection 2023 Apr.
To synthesise the available evidence of wearable cardioverter defibrillator (WCD) therapy as an add-on measure to optimal medical therapy (OMT) or as a replacement of hospital stay.
An update systematic review (SR) of comparative effectiveness and safety of WCD therapy was conducted. We included randomised controlled trials (RCT), prospective comparative studies and prospective uncontrolled studies with at least 100 patients. A narrative synthesis of the evidence was conducted.
One RCT ( = 2348) and further eleven observational studies ( = 5345) fulfilled our inclusion criteria. In the only available RCT, the use of the WCD was not statistically associated with a clinical benefit on arrhythmic mortality in post-myocardial infarction (MI) patients with an ejection fraction of ≤35%. The compliance with WCD therapy was low in the RCT and high in observational studies, with ten observational studies reporting on a daily wear time between 20 and 23.5 h. The range of percentage of patients receiving at least one appropriate shock was 1-4.8% and the rate of first shock success was reported to be 100% in three studies. Serious adverse events (SAEs) such as inappropriate shocks occurred rarely, with between 0% and 2% of patients being inappropriately shocked within ten observational studies. In one of the observational studies, two patients (2%) were allergic to nickel developing skin rash and false alarms occurred in 58 patients (57%) in this study. Another registry study ( = 448) reported milder AEs, such as dermatitis and pressure marks, occurring in 0.9% and 0.2% of enrolled patients, respectively.
The only available RCT failed to show superiority of add-on use of WCD in post MI patients. Observational evidence shows that the compliance with WCD is good, but the evidence is afflicted with selection bias and the inclusion of diverse mixed patient populations diluting the ability to draw indication-specific conclusions on the utility of the device. More comparative data is needed to justify continuing or expanding use of WCD therapy.
综合可穿戴式心脏复律除颤器（WCD）治疗作为优化药物治疗（OMT）的附加措施或替代住院治疗的现有证据。
对WCD治疗的比较有效性和安全性进行了更新的系统评价（SR）。我们纳入了随机对照试验（RCT）、前瞻性比较研究和至少有100例患者的前瞻性非对照研究。对证据进行了叙述性综合。
一项RCT（n = 2348）和另外11项观察性研究（n = 5345）符合我们的纳入标准。在唯一可用的RCT中，对于射血分数≤35%的心肌梗死（MI）后患者，使用WCD与心律失常死亡率的临床获益在统计学上无关联。RCT中WCD治疗的依从性较低，而观察性研究中依从性较高，有10项观察性研究报告每日佩戴时间在20至23.5小时之间。接受至少一次适当电击的患者百分比范围为1 - 4.8%，三项研究报告首次电击成功率为100%。严重不良事件（SAE）如不适当电击很少发生，在10项观察性研究中，0%至2%的患者受到不适当电击。在一项观察性研究中，两名患者（2%）对镍过敏出现皮疹，该研究中有58名患者（57%）出现误报。另一项注册研究（n = 448）报告，轻度不良事件如皮炎和压痕分别发生在0.9%和0.2%的入组患者中。
唯一可用的RCT未能显示在MI后患者中附加使用WCD的优越性。观察性证据表明WCD的依从性良好，但证据存在选择偏倚，且纳入了不同的混合患者群体，削弱了就该设备效用得出特定适应症结论的能力。需要更多的比较数据来证明继续或扩大使用WCD治疗的合理性。
