Amato Laura, Parmelli Elena, Vecchi Simona, Minozzi Silvia, Mitrova Zuzana, De Palma Rossana, Berti Elena, Davoli Marina
Dipartimento di Epidemiologia del Sistema Sanitario Regionale del Lazio.
Agenzia Sanitaria e Sociale, Regione Emilia-Romagna.
Recenti Prog Med. 2016 Jan;107(1):25-38. doi: 10.1701/2132.23102.
BACKGROUND: Aortic stenosis is the most common valve disease and transcatheter aortic valve replacement is considered as an alternative to surgical valve replacement or to medical treatment in inoperable or high-risk patients, but it is not suitable for all patients with severe aortic stenosis, taking into account also the high cost associated. OBJECTIVE: To evaluate the efficacy and safety of transcatheter aortic valve implantation (TAVI) for aortic stenosis via percutaneous, (transfemoral, or endovascular approach) or surgically (transapical, or transventricular) approach. RESULTS: The present review includes 10 randomized controlled trials (RCTs) and 29 observational studies. We combined the outcomes from the individual trials through meta-analysis where possible. We assessed the overall quality of the evidence for the primary outcome using the GRADE system. Regarding TAVI vs. standard surgery, there were no significant differences between TAVI and conventional surgery for mortality at 1 year or more, the frequency of stroke, and heart attack; for mortality at 30 days, no difference was observed in RCTs and the result was in favor of TAVI in observational studies. Another outcome in favor of TAVI was the frequency of major bleeding that was significantly lower in patients treated with TAVI. The quality of the evidence ranged from moderate to very low. Regarding TAVI vs. medical therapy, for the outcome death at 1 year or more, if we consider the RCTs, the results are favorable to TAVI, while in observational studies no significant differences were observed between the two interventions. In contrast, for the outcome mortality at 30 days, in RCTs no significant differences between the two interventions were observed, while the results were favorable to TAVI in observational studies. For the frequency of stroke in the single RCT that reported this outcome, it was significantly lower in patients treated with medical therapy, with no significant differences in the results of observational studies. The results related to the frequency of heart attack from observational studies are in favor of TAVI. The quality of the evidence ranged from low to very low. CONCLUSIONS: Candidates for TAVI are those patients for which conventional open-heart surgery is not recommended because of the risk due to advanced age or important comorbidities.
背景：主动脉瓣狭窄是最常见的瓣膜疾病，经导管主动脉瓣置换术被视为手术瓣膜置换或对无法手术或高危患者进行药物治疗的替代方法，但考虑到其相关的高成本，它并不适用于所有严重主动脉瓣狭窄患者。 目的：评估经皮（经股动脉或血管内途径）或手术（经心尖或经心室途径）进行经导管主动脉瓣植入术（TAVI）治疗主动脉瓣狭窄的疗效和安全性。 结果：本综述纳入了10项随机对照试验（RCT）和29项观察性研究。我们尽可能通过荟萃分析合并了各个试验的结果。我们使用GRADE系统评估了主要结局证据的总体质量。关于TAVI与标准手术，在1年及以上的死亡率、中风和心脏病发作频率方面，TAVI与传统手术之间无显著差异；在30天死亡率方面，RCT中未观察到差异，观察性研究的结果有利于TAVI。另一个有利于TAVI的结局是大出血频率，接受TAVI治疗的患者大出血频率显著更低。证据质量从中等到非常低不等。关于TAVI与药物治疗，对于1年及以上的死亡结局，如果考虑RCT，结果有利于TAVI，而在观察性研究中，两种干预措施之间未观察到显著差异。相比之下，对于30天死亡率结局，RCT中两种干预措施之间未观察到显著差异，而观察性研究的结果有利于TAVI。在报告该结局的单个RCT中，药物治疗患者的中风频率显著更低，观察性研究结果无显著差异。观察性研究中与心脏病发作频率相关的结果有利于TAVI。证据质量从低到非常低不等。 结论：TAVI的适用对象是那些因高龄或严重合并症风险而不建议进行传统心脏直视手术的患者。
Cochrane Database Syst Rev. 2017-12-22
Cochrane Database Syst Rev. 2020-1-9
Cochrane Database Syst Rev. 2020-10-19
Cochrane Database Syst Rev. 2021-4-19
Cochrane Database Syst Rev. 2017-5-26
Cochrane Database Syst Rev. 2017-4-10
Cochrane Database Syst Rev. 2022-11-17
Zotero 插件