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新一代经股动脉自膨胀式和球囊扩张式经导管心脏瓣膜的比较。

Comparison of latest generation transfemoral self-expandable and balloon-expandable transcatheter heart valves.

作者信息

Schaefer Andreas, Linder Matthias, Seiffert Moritz, Schoen Gerhard, Deuschl Florian, Schofer Niklas, Schneeberger Yvonne, Blankenberg Stefan, Reichenspurner Hermann, Schaefer Ulrich, Conradi Lenard

机构信息

Department of Cardiovascular Surgery, University Heart Center Hamburg, Hamburg, Germany.

Department of General and Interventional Cardiology, University Heart Center Hamburg, Hamburg, Germany.

出版信息

Interact Cardiovasc Thorac Surg. 2017 Dec 1;25(6):905-911. doi: 10.1093/icvts/ivx194.

Abstract

OBJECTIVES

We herein aimed to compare acute 30-day outcomes of latest-generation self-expandable and balloon-expandable transcatheter heart valves.

METHODS

From 2012 through 2016, 104 consecutive patients (study group, 69.2% female, 81.7 ± 5.5 years, logEuroSCORE I 15.9 ± 9.3%) received transfemoral transcatheter aortic valve implantation using the Symetis ACURATE neo® transcatheter heart valve. A control group of patients after transfemoral transcatheter aortic valve implantation with the Edwards Sapien 3™ transcatheter heart valve was retrieved from our database and matched to the study group. Data were retrospectively analysed according to updated Valve Academic Research Consortium definitions.

RESULTS

Device success was 94.2% (98 of 104) and 98.1% (102 of 104) in study and control groups, respectively (P = 0.157). All-cause 30-day mortality was 3.9 (4 of 104) vs 0.9% (1 of 104) (P = 0.317). Resultant transvalvular peak/mean gradients and effective orifice area were 14.2 ± 5.7 vs 22.6 ± 6.8 mmHg (P < 0.001)/7.3 ± 2.8 vs 11.8 ± 3.5 mmHg (P < 0.001) and 2.0 ± 0.4 vs 1.7 ± 0.4 cm2 (P = 0.063). Paravalvular leakage ≥moderate was observed in 4.8% (5 of 104) and 1.9% (2 of 104) (P = 0.257). Rate of permanent pacemaker implantation was 10.6% (11 of 104) vs 16.4% (17 of 104) (P = 0.239).

CONCLUSIONS

Next-generation self-expandable transcatheter heart valves preserve superiority in terms of post-interventional haemodynamics without presenting former drawbacks: rate of postoperative permanent pacemaker implantation and severity of residual paravalvular leakage were similar to balloon-expandable transcatheter heart valves.

摘要

目的

我们旨在比较最新一代自膨胀式和球囊扩张式经导管心脏瓣膜的30天急性预后。

方法

2012年至2016年,连续104例患者(研究组,女性占69.2%,年龄81.7±5.5岁,欧洲心脏手术风险评估系统I级评分为15.9±9.3%)接受了经股动脉使用Symetis ACURATE neo®经导管心脏瓣膜进行的经导管主动脉瓣植入术。从我们的数据库中检索出接受经股动脉使用Edwards Sapien 3™经导管心脏瓣膜进行经导管主动脉瓣植入术的对照组患者,并与研究组进行匹配。根据更新后的瓣膜学术研究联盟定义对数据进行回顾性分析。

结果

研究组和对照组的器械成功率分别为94.2%(104例中的98例)和98.1%(104例中的102例)(P = 0.157)。30天全因死亡率分别为3.9%(104例中的4例)和0.9%(104例中的1例)(P = 0.317)。由此产生的跨瓣峰值/平均压差和有效瓣口面积分别为14.2±5.7与22.6±6.8 mmHg(P < 0.001)/7.3±2.8与11.8±3.5 mmHg(P < 0.001)以及2.0±0.4与1.7±0.4 cm²(P = 0.063)。中重度及以上瓣周漏在研究组和对照组中的发生率分别为4.8%(104例中的5例)和1.9%(104例中的2例)(P = 0.257)。永久起搏器植入率分别为10.6%(104例中的11例)和16.4%(104例中的17例)(P = 0.239)。

结论

新一代自膨胀式经导管心脏瓣膜在介入后血流动力学方面保持优势,且不存在以往的缺点:术后永久起搏器植入率和残余瓣周漏的严重程度与球囊扩张式经导管心脏瓣膜相似。

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