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经导管主动脉瓣置换术治疗退行性生物瓣外科瓣膜:全球瓣中瓣注册研究结果。

Transcatheter aortic valve replacement for degenerative bioprosthetic surgical valves: results from the global valve-in-valve registry.

机构信息

Washington Hospital Center, 110 Irving St NW, Suite 4B-1, Washington, DC 20010, USA.

出版信息

Circulation. 2012 Nov 6;126(19):2335-44. doi: 10.1161/CIRCULATIONAHA.112.104505. Epub 2012 Oct 10.

Abstract

BACKGROUND

Transcatheter aortic valve-in-valve implantation is an emerging therapeutic alternative for patients with a failed surgical bioprosthesis and may obviate the need for reoperation. We evaluated the clinical results of this technique using a large, worldwide registry.

METHODS AND RESULTS

The Global Valve-in-Valve Registry included 202 patients with degenerated bioprosthetic valves (aged 77.7±10.4 years; 52.5% men) from 38 cardiac centers. Bioprosthesis mode of failure was stenosis (n=85; 42%), regurgitation (n=68; 34%), or combined stenosis and regurgitation (n=49; 24%). Implanted devices included CoreValve (n=124) and Edwards SAPIEN (n=78). Procedural success was achieved in 93.1% of cases. Adverse procedural outcomes included initial device malposition in 15.3% of cases and ostial coronary obstruction in 3.5%. After the procedure, valve maximum/mean gradients were 28.4±14.1/15.9±8.6 mm Hg, and 95% of patients had ≤+1 degree of aortic regurgitation. At 30-day follow-up, all-cause mortality was 8.4%, and 84.1% of patients were at New York Heart Association functional class I/II. One-year follow-up was obtained in 87 patients, with 85.8% survival of treated patients.

CONCLUSIONS

The valve-in-valve procedure is clinically effective in the vast majority of patients with degenerated bioprosthetic valves. Safety and efficacy concerns include device malposition, ostial coronary obstruction, and high gradients after the procedure.

摘要

背景

经导管主动脉瓣中瓣植入术是一种治疗失败的外科生物瓣患者的新兴治疗选择,可能避免再次手术的需要。我们使用一个大型的全球注册研究评估了这项技术的临床结果。

方法和结果

全球瓣中瓣注册研究纳入了来自 38 个心脏中心的 202 名退行性生物瓣患者(年龄 77.7±10.4 岁;52.5%为男性)。生物瓣失效模式为狭窄(n=85;42%)、反流(n=68;34%)或狭窄和反流并存(n=49;24%)。植入的装置包括 CoreValve(n=124)和 Edwards SAPIEN(n=78)。93.1%的病例达到了手术成功。不良手术结果包括初始器械位置不当(15.3%)和开口冠状动脉阻塞(3.5%)。手术后,瓣膜最大/平均梯度为 28.4±14.1/15.9±8.6mmHg,95%的患者主动脉瓣反流程度为≤+1 度。30 天随访时,全因死亡率为 8.4%,95%的患者纽约心脏协会功能分级为 I/II 级。87 例患者获得了 1 年随访,治疗患者的生存率为 85.8%。

结论

在大多数退行性生物瓣患者中,瓣中瓣术具有临床疗效。安全性和有效性的关注点包括器械位置不当、开口冠状动脉阻塞和术后高梯度。

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