Tomás Benito-González, Rodrigo Estévez-Loureiro, Ignacio Iglesias-Gárriz, Javier Gualis, Armando Pérez de Prado, Carmen Garrote, Martin J Swaans, Jan A S Van der Heyden, Ted Feldman, Cristina Giannini, David Alonso, Miguel Rodriguez-Santamarta, Mario Castaño, Felipe Fernández-Vázquez
{"title":"MitraClip®治疗二尖瓣返流患者的生存优势:一项荟萃分析","authors":"Tomás Benito-González, Rodrigo Estévez-Loureiro, Ignacio Iglesias-Gárriz, Javier Gualis, Armando Pérez de Prado, Carmen Garrote, Martin J Swaans, Jan A S Van der Heyden, Ted Feldman, Cristina Giannini, David Alonso, Miguel Rodriguez-Santamarta, Mario Castaño, Felipe Fernández-Vázquez","doi":"","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>The MitraClip® system is a percutaneous treatment for mitral regurgitation (MR) that has shown promising results in patients who are inoperable or at high risk for mitral surgery. Data on the efficacy of the system over optimal medical therapy, above all in patients with functional MR, are scarce. The study aim was to assess the effect of MitraClip on the survival of patients with moderate/severe or severe MR compared to medical therapy, using meta-analytical techniques.</p><p><strong>Methods: </strong>Independently, reviewers searched electronically for relevant articles based on predefined criteria and end-points. Only articles with a comparison between MitraClip and conservative therapy were included. Standard meta-analysis techniques were used. The primary outcomes were 30-day and one-year mortalities.</p><p><strong>Results: </strong>Five observational reports were included that enrolled a total of 1,271 patients: 720 patients underwent percutaneous mitral valve repair (PMVR) with the MitraClip device, and 551 were managed conservatively. A total of 49 all-cause mortality events was reported at 30 days: 3.05% (22/720) in the PMVR arm, and 4.90% (27/510) in the conservative group, with no significant differences in all-cause mortality (OR 0.64; 95% CI 0.36-1.14). A total of 269 all-cause mortality events at one year was reported: 15.14% (109/720) in the PMVR arm, and 29.04% (160/551) in the conservative group. A significant difference favoring PMVR with the MitraClip system over medical therapy alone was observed (OR 0.44; 95% CI 0.30-0.64, p <0.0001). Neither significance between study heterogeneity (p = 0.18) nor publication bias was detected (p = 0.3).</p><p><strong>Conclusions: </strong>PMVR with the MitraClip system may be associated with an improvement in one-year survival compared to stand-alone medical management.</p>","PeriodicalId":50184,"journal":{"name":"Journal of Heart Valve Disease","volume":"26 6","pages":"651-658"},"PeriodicalIF":0.0000,"publicationDate":"2017-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Survival Advantage of MitraClip® Over Medical Treatment in Patients with Mitral Regurgitation: A Meta-Analysis.\",\"authors\":\"Tomás Benito-González, Rodrigo Estévez-Loureiro, Ignacio Iglesias-Gárriz, Javier Gualis, Armando Pérez de Prado, Carmen Garrote, Martin J Swaans, Jan A S Van der Heyden, Ted Feldman, Cristina Giannini, David Alonso, Miguel Rodriguez-Santamarta, Mario Castaño, Felipe Fernández-Vázquez\",\"doi\":\"\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>The MitraClip® system is a percutaneous treatment for mitral regurgitation (MR) that has shown promising results in patients who are inoperable or at high risk for mitral surgery. Data on the efficacy of the system over optimal medical therapy, above all in patients with functional MR, are scarce. The study aim was to assess the effect of MitraClip on the survival of patients with moderate/severe or severe MR compared to medical therapy, using meta-analytical techniques.</p><p><strong>Methods: </strong>Independently, reviewers searched electronically for relevant articles based on predefined criteria and end-points. Only articles with a comparison between MitraClip and conservative therapy were included. Standard meta-analysis techniques were used. The primary outcomes were 30-day and one-year mortalities.</p><p><strong>Results: </strong>Five observational reports were included that enrolled a total of 1,271 patients: 720 patients underwent percutaneous mitral valve repair (PMVR) with the MitraClip device, and 551 were managed conservatively. A total of 49 all-cause mortality events was reported at 30 days: 3.05% (22/720) in the PMVR arm, and 4.90% (27/510) in the conservative group, with no significant differences in all-cause mortality (OR 0.64; 95% CI 0.36-1.14). A total of 269 all-cause mortality events at one year was reported: 15.14% (109/720) in the PMVR arm, and 29.04% (160/551) in the conservative group. A significant difference favoring PMVR with the MitraClip system over medical therapy alone was observed (OR 0.44; 95% CI 0.30-0.64, p <0.0001). 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引用次数: 0
摘要
背景:MitraClip®系统是一种经皮治疗二尖瓣反流(MR)的方法,在不能手术或高危二尖瓣手术的患者中显示出良好的效果。关于该系统优于最佳药物治疗(尤其是功能性MR患者)的疗效数据很少。该研究的目的是利用荟萃分析技术评估MitraClip对中度/重度或重度MR患者生存的影响,与药物治疗相比。方法:独立地,审稿人根据预定义的标准和终点以电子方式检索相关文章。仅纳入MitraClip与保守治疗比较的文章。采用标准荟萃分析技术。主要结局为30天和1年死亡率。结果:纳入5份观察性报告,共纳入1271例患者:720例患者采用MitraClip装置进行经皮二尖瓣修复(PMVR), 551例患者采用保守治疗。30天共报告了49例全因死亡事件:PMVR组为3.05%(22/720),保守组为4.90%(27/510),两组全因死亡率无显著差异(OR 0.64;95% ci 0.36-1.14)。一年内共报告269例全因死亡事件:PMVR组15.14%(109/720),保守组29.04%(160/551)。观察到PMVR与MitraClip系统相比单独药物治疗有显著差异(OR 0.44;结论:与独立医疗管理相比,MitraClip系统的PMVR可能与一年生存率的提高有关。
Survival Advantage of MitraClip® Over Medical Treatment in Patients with Mitral Regurgitation: A Meta-Analysis.
Background: The MitraClip® system is a percutaneous treatment for mitral regurgitation (MR) that has shown promising results in patients who are inoperable or at high risk for mitral surgery. Data on the efficacy of the system over optimal medical therapy, above all in patients with functional MR, are scarce. The study aim was to assess the effect of MitraClip on the survival of patients with moderate/severe or severe MR compared to medical therapy, using meta-analytical techniques.
Methods: Independently, reviewers searched electronically for relevant articles based on predefined criteria and end-points. Only articles with a comparison between MitraClip and conservative therapy were included. Standard meta-analysis techniques were used. The primary outcomes were 30-day and one-year mortalities.
Results: Five observational reports were included that enrolled a total of 1,271 patients: 720 patients underwent percutaneous mitral valve repair (PMVR) with the MitraClip device, and 551 were managed conservatively. A total of 49 all-cause mortality events was reported at 30 days: 3.05% (22/720) in the PMVR arm, and 4.90% (27/510) in the conservative group, with no significant differences in all-cause mortality (OR 0.64; 95% CI 0.36-1.14). A total of 269 all-cause mortality events at one year was reported: 15.14% (109/720) in the PMVR arm, and 29.04% (160/551) in the conservative group. A significant difference favoring PMVR with the MitraClip system over medical therapy alone was observed (OR 0.44; 95% CI 0.30-0.64, p <0.0001). Neither significance between study heterogeneity (p = 0.18) nor publication bias was detected (p = 0.3).
Conclusions: PMVR with the MitraClip system may be associated with an improvement in one-year survival compared to stand-alone medical management.
期刊介绍:
The Journal of Heart Valve Disease (ISSN 0966-8519) is the official journal of The Society for Heart Valve Disease. It is indexed/abstracted by Index Medicus, Medline, Medlar, PubMed, Science Citation Index, Scisearch, Research Alert, Biomedical Products, Current Contents/Clinical Medicine. It is issued bi-monthly in one indexed volume by ICR Publishers Ltd., Crispin House, 12A South Approach, Moor Park, Northwood HA6 2ET, United Kingdom. This paper meets the requirements of ANSI standard Z39.48-1992 (Permanence of Paper).