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经导管主动脉瓣植入术在亚洲的结果与挑战:一项系统评价和荟萃分析

Transcatheter Aortic Valve Implantation Outcomes and Challenges in Asia: A Systematic Review and Meta-Analysis.

作者信息

Rivera Frederick Berro, De Luna Deogracias Villa, Ansay Marie Francesca Mapua, Nguyen Ryan T, Flores Gabrielle Pagdilao, Magalong John Vincent, Cha Sung Whoy, Aparece John Paul, Gonzales Jacques Simon T, Salva Wailea Faye C, Mangubat Gerard Francis E, Mahilum Mer Lorraine P, Inohara Taku, Vijayaraghavan Krishnaswami, Collado Fareed Moses S, Latib Azeem

机构信息

Department of Medicine, Lincoln Medical Center, New York, NY 10451, USA.

Department of Internal Medicine, Danbury Hospital, Danbury, CT 06810, USA.

出版信息

Rev Cardiovasc Med. 2023 Mar 6;24(3):79. doi: 10.31083/j.rcm2403079. eCollection 2023 Mar.

Abstract

BACKGROUND

Aortic stenosis (AS) is the world's most prevalent heart valve disease. Transcatheter aortic valve replacement (TAVR) or Implantation (TAVI) is widely available yet adopting this procedure in Asia has been slow due to high device cost, the need for specific training programs, and the lack of specialized heart teams and dedicated infrastructures. The limited number of randomized controlled trials describing TAVI outcomes among the Asian population hampered the approval for medical reimbursements as well as acceptance among surgeons and operators in some Asian countries.

METHODS

A comprehensive medical literature search on TAVI and/or TAVR performed in Asian countries published between January 2015 and June 2022 was done through MEDLINE and manual searches of bibliographies. The full text of eligible articles was obtained and evaluated for final analysis. The event rates for key efficacy and safety outcomes were calculated using the data from the registries and randomized controlled trials.

RESULTS

A total of 15,297 patients were included from 20 eligible studies. The mean patient age was 82.88 9.94 years, with over half being females (62.01%). All but one study reported Society of Thoracic Surgeons (STS) scores averaging an intermediate risk score of 6.28 1.06%. The mean logistic European Systems for Cardiac Operations Risk Evaluation (EuroSCORE) was 14.85. The mean baseline transaortic gradient and mean aortic valve area were 50.93 3.70 mmHg and 0.64 0.07 , respectively. The mean procedural success rate was 95.28 1.51%. The weighted mean 30-day and 1-year all-cause mortality rate was 1.66 1.21% and 8.79 2.3%, respectively. The mean average for stroke was 1.98 1.49%. The acute kidney injury (AKI) rate was 6.88 5.71%. The overall major vascular complication rate was 2.58 2.54%; the overall major bleeding rate was 3.88 3.74%. Paravalvular aortic regurgitation rate was 15.07 9.58%. The overall rate of pacemaker insertion was 7.76 4.6%.

CONCLUSIONS

Compared to Americans and Europeans, Asian patients who underwent TAVI had lower all-cause mortality, bleeding, and vascular complications, however, had a higher rate of postprocedural aortic regurgitation. More studies with greater sample sizes are needed among Asian patients for a more robust comparison.

摘要

背景

主动脉瓣狭窄(AS)是全球最常见的心脏瓣膜疾病。经导管主动脉瓣置换术(TAVR)或植入术(TAVI)已广泛应用,但由于设备成本高、需要特定培训项目以及缺乏专业心脏团队和专用基础设施,该手术在亚洲的采用速度一直较慢。描述亚洲人群TAVI结果的随机对照试验数量有限,这阻碍了医疗报销的批准以及一些亚洲国家外科医生和操作人员的接受。

方法

通过MEDLINE以及对参考文献的人工检索,对2015年1月至2022年6月期间在亚洲国家发表的关于TAVI和/或TAVR的综合医学文献进行检索。获取符合条件文章的全文并进行评估以进行最终分析。使用来自登记处和随机对照试验的数据计算关键疗效和安全性结果的事件发生率。

结果

20项符合条件的研究共纳入15297例患者。患者平均年龄为82.88±9.94岁,超过一半为女性(62.01%)。除一项研究外,所有研究均报告胸外科医师协会(STS)评分平均为中度风险评分6.28±1.06%。逻辑欧洲心脏手术风险评估系统(EuroSCORE)的平均值为14.85。平均基线跨主动脉压差和平均主动脉瓣面积分别为50.93±3.70 mmHg和0.64±0.07 cm²。平均手术成功率为95.28±1.51%。加权平均30天和1年全因死亡率分别为1.66±1.21%和8.79±2.3%。中风的平均发生率为1.98±1.49%。急性肾损伤(AKI)发生率为6.88±5.71%。总体主要血管并发症发生率为2.58±2.54%;总体主要出血率为3.88±3.74%。瓣周主动脉瓣反流发生率为15.07±9.58%。起搏器植入的总体发生率为7.76±4.6%。

结论

与美国人和欧洲人相比,接受TAVI的亚洲患者全因死亡率、出血和血管并发症较低,但术后主动脉瓣反流发生率较高。需要在亚洲患者中进行更多样本量更大的研究,以进行更有力的比较。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/580d/11264028/b44947cc142c/2153-8174-24-3-079-g1.jpg

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