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经导管主动脉瓣置换术联合圣犹达医疗 Portico 瓣膜:首例人体应用经验。

Transcatheter aortic valve replacement with the St. Jude Medical Portico valve: first-in-human experience.

机构信息

St. Paul's Hospital, University of British Columbia, Vancouver, British Columbia, Canada.

出版信息

J Am Coll Cardiol. 2012 Aug 14;60(7):581-6. doi: 10.1016/j.jacc.2012.02.045. Epub 2012 May 30.

DOI:10.1016/j.jacc.2012.02.045
PMID:22657270
Abstract

OBJECTIVES

The purpose of this study was to demonstrate the feasibility and procedural outcomes with a new self-expanding and repositionable transcatheter heart valve.

BACKGROUND

Transcatheter aortic valve replacement is a viable option for selected patients with severe symptomatic aortic stenosis. However, suboptimal prosthesis positioning may contribute to paravalvular regurgitation, atrioventricular conduction block, and mitral or coronary compromise.

METHODS

The repositionable Portico valve (St. Jude Medical, Minneapolis, Minnesota) was implanted in 10 patients with severe aortic stenosis utilizing percutaneous femoral arterial access. Patients underwent transthoracic and transesophageal echocardiography and multidetector computed tomography before and after valve implantation. Clinical and echocardiographic follow-up was obtained at 30 days.

RESULTS

Device implantation was successful in all patients. Prosthesis recapture and repositioning was performed in 4 patients. Intermittent prosthetic leaflet dysfunction in 1 patient required implantation of a second transcatheter valve. There was 1 minor stroke. At 30-day follow-up, echocardiographic mean transaortic gradient was reduced from 44.9 ± 16.7 mm Hg to 10.9 ± 3.8 mm Hg (p < 0.001), and valve area increased from 0.6 ± 0.1 cm(2) to 1.3 ± 0.2 cm(2) (p < 0.001). Paravalvular regurgitation was mild or less in 9 patients (90%) and moderate in 1 patient (10%). There were no major strokes, major vascular complications, major bleeds, or deaths. No patient required pacemaker implantation. All patients were in New York Heart Association functional class II or less.

CONCLUSIONS

Transcatheter aortic valve replacement with the repositionable Portico transcatheter heart valve is feasible, with good short-term clinical and hemodynamic outcomes.

摘要

目的

本研究旨在展示一种新型自膨式可重定位经导管心脏瓣膜的可行性和程序结果。

背景

经导管主动脉瓣置换术是一种可行的选择,适用于有严重症状性主动脉瓣狭窄的选定患者。然而,假体定位不当可能导致瓣周漏、房室传导阻滞以及二尖瓣或冠状动脉受压。

方法

10 例严重主动脉瓣狭窄患者采用经皮股动脉入路植入可重定位的 Portico 瓣膜(明尼苏达州圣保罗市圣犹达医疗公司)。患者在植入瓣膜前后进行经胸和经食管超声心动图及多排螺旋 CT 检查。在 30 天时获得临床和超声心动图随访。

结果

所有患者均成功植入器械。4 例患者进行了瓣膜重回收和重定位。1 例患者出现间歇性瓣膜叶功能障碍,需植入第二枚经导管瓣膜。有 1 例轻微中风。在 30 天的随访中,经主动脉平均跨瓣梯度从 44.9 ± 16.7 mm Hg 降至 10.9 ± 3.8 mm Hg(p < 0.001),瓣口面积从 0.6 ± 0.1 cm²增加至 1.3 ± 0.2 cm²(p < 0.001)。9 例(90%)患者的瓣周漏为轻度或以下,1 例(10%)患者为中度。无重大中风、重大血管并发症、大出血或死亡。无患者需要植入起搏器。所有患者纽约心脏协会功能分级均为 II 级或以下。

结论

使用可重定位的 Portico 经导管心脏瓣膜进行经导管主动脉瓣置换术是可行的,具有良好的短期临床和血液动力学结果。

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