Dewidar Omar, Birnie David, Podinic Irina, Welch Vivian, Wells George A
School of Epidemiology and Public Health, University of Ottawa, 600 Peter Morand Crescent, Ottawa, Ontario, K1G 5Z3, Canada.
Bruyère Research Institute, University of Ottawa, 85 Primrose Ave, Ottawa, Ontario, K1R 6M1, Canada.
Syst Rev. 2021 Jul 23;10(1):210. doi: 10.1186/s13643-021-01746-x.
There is abundant evidence for sex differences in the diagnosis, implantation, and outcomes for cardiac resynchronization therapy (CRT) devices. Controversial data suggesting women are less likely to receive the device regardless of the greater benefit. The aim of this review is to assess sex differences in the implantation rate, clinical effectiveness, and safety of patients receiving CRT devices.
We will conduct a systematic literature search of MEDLINE, Embase, and Web of Science to identify cohort studies that meet our eligibility criteria. Title and full text screening will be conducted in duplicate independently. Eligible studies report clinical effectiveness or safety of patients receiving CRT device while providing sex-disaggregated data. Implantation rate will be extracted from the baseline characteristics tables of the studies. The effectiveness outcomes include the following: all-cause death, hospitalization, peak oxygen consumption (pVO), quality of life (QoL), 6-min walk test, NYHA class reduction, LVEF, and heart failure hospitalization. The complication outcomes include the following: contrast-induced nephropathy, pneumothorax, pocket-related hematoma, pericardial tamponade, phrenic nerve stimulation, device infection, death, pulmonary edema, electrical storm, cardiogenic shock, and hypotension requiring resuscitation. Description of included studies will be reported in detail and outcomes will be meta-analyzed and presented using forest plots when feasible. Risk of bias will be assessed using the Newcastle-Ottawa Scale (NOS) by two review authors independently. GRADE approach will be used to assess the certainty of evidence.
The aim of this review is to determine the presence of differences in CRT implantation between women and men as well as differences in clinical effectiveness and safety of CRT after device implantation. Results from this systematic review will provide important insights into sex differences in CRT devices that could contribute to the development of sex-specific recommendations and inform policy.
PROSPERO CRD42020204804.
有充分证据表明，心脏再同步治疗（CRT）设备在诊断、植入及治疗效果方面存在性别差异。有争议的数据表明，尽管女性可能从该设备中获益更多，但她们接受该设备治疗的可能性较小。本综述的目的是评估接受CRT设备治疗的患者在植入率、临床疗效和安全性方面的性别差异。
我们将对MEDLINE、Embase和Web of Science进行系统的文献检索，以确定符合我们纳入标准的队列研究。标题和全文筛选将由两名独立人员分别进行。符合条件的研究报告接受CRT设备治疗患者的临床疗效或安全性，并提供按性别分类的数据。植入率将从研究的基线特征表中提取。疗效指标包括：全因死亡、住院、峰值耗氧量（pVO）、生活质量（QoL）、6分钟步行试验、纽约心脏协会（NYHA）心功能分级改善、左心室射血分数（LVEF）和心力衰竭住院。并发症指标包括：造影剂肾病、气胸、囊袋相关血肿、心包填塞、膈神经刺激、设备感染、死亡、肺水肿、电风暴、心源性休克以及需要复苏的低血压。将详细报告纳入研究的描述，并在可行时使用森林图对结果进行荟萃分析和展示。将由两名综述作者独立使用纽卡斯尔-渥太华量表（NOS）评估偏倚风险。将采用GRADE方法评估证据的确定性。
本综述的目的是确定男女在CRT植入方面是否存在差异，以及设备植入后CRT在临床疗效和安全性方面的差异。该系统综述的结果将为CRT设备中的性别差异提供重要见解，这可能有助于制定针对性别的建议并为政策提供参考。
PROSPERO CRD42020204804
