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7年经导管主动脉瓣植入术的发展:一家大型市级医院2000例患者的前瞻性单中心注册研究结果(TAVIK注册研究)

Evolution of transcatheter aortic valve implantation over 7 years: results of a prospective single-centre registry of 2000 patients in a large municipal hospital (TAVIK Registry).

作者信息

Schymik Gerhard, Herzberger Valentin, Bergmann Jens, Bramlage Peter, Conzelmann Lars O, Würth Alexander, Luik Armin, Schröfel Holger, Tzamalis Panagiotis

机构信息

Department of Cardiology, Medical Clinic IV, Municipal Hospital Karlsruhe, Academic Teaching Hospital of the University of Freiburg, Karlsruhe, Germany.

Institute for Pharmacology and Preventive Medicine, Cloppenburg, Germany.

出版信息

BMJ Open. 2018 Oct 25;8(10):e022574. doi: 10.1136/bmjopen-2018-022574.

Abstract

OBJECTIVES

Use of transcatheter aortic valve implantation (TAVI) to treat severe aortic stenosis (AS) has gained popularity, accompanied by an evolution of patient and clinical factors. We aimed to characterise changes and evaluate their impact on outcomes.

SETTING

In this single-centre, German TAVIK registry patients undergoing TAVI between 2008 and 2015 were documented prospectively.

PARTICIPANTS/INTERVENTIONS: 2000 consecutive patients with AS undergoing TAVI were divided in four cohorts. 500 patients underwent TAVI in each of the following time bins: April 2008 to July 2010 (cohort I), July 2010 to April 2013 (cohort II), April 2012 to October 2013 (cohort III) and October 2013 to March 2015 (cohort IV).

RESULTS

The mean age was 81.8 years, without significant variation across cohorts. Compared with cohort I, prior MI (5.4%vs11.0%; p<0.001) and New York Heart Association class IV (10.0%vs3.6%; p<0.001) were less common in cohort IV. Across cohorts, there was a fall in EuroSCORE (24.3%-18.7%), frailty (48.4%-17.0%) and use of transapical access (43.6%-29.0%), while transfemoral access increased (56.4%-71.0%; p<0.001 for each). Periprocedurally, there was a fall in moderate/severe aortic regurgitation (3.2%-0.0%) and rate of unplanned cardiopulmonary bypass (4.0%-1.0%; both p<0.001). A similar trend applied to 30-day rate of major vascular complications (5.2%-1.8%; p=0.006), life-threatening bleeding (7.0%-3.0%; p<0.001) and cardiovascular mortality (4.4%-1.8%; p=0.020). One-year post-TAVI, mortality and stroke rates did not differ.

CONCLUSIONS

Evolution of TAVI between 2008 and 2015 saw a trend towards its usage in lower risk patients and rapid progression towards improved safety. Evaluation and refinement should now continue to further lessen stroke and pacemaker rates.

摘要

目的

经导管主动脉瓣植入术(TAVI)用于治疗严重主动脉瓣狭窄(AS)已日益普及,同时患者及临床因素也在不断演变。我们旨在描述这些变化并评估其对预后的影响。

背景

在这个德国单中心的TAVIK注册研究中,前瞻性记录了2008年至2015年间接受TAVI的患者。

参与者/干预措施:2000例连续接受TAVI的AS患者被分为四个队列。在以下每个时间段内有500例患者接受了TAVI:2008年4月至2010年7月(队列I)、2010年7月至2013年4月(队列II)、2012年4月至2013年10月(队列III)以及2013年10月至2015年3月(队列IV)。

结果

平均年龄为81.8岁,各队列间无显著差异。与队列I相比,队列IV中既往心肌梗死(MI)(5.4%对11.0%;p<0.001)和纽约心脏协会IV级(10.0%对3.6%;p<0.001)的情况较少见。在各队列中,欧洲心脏手术风险评估系统(EuroSCORE)评分下降(24.3% - 18.7%)、虚弱程度下降(48.4% - 17.0%)以及经心尖入路的使用减少(43.6% - 29.0%),而经股动脉入路增加(56.4% - 71.0%;每项p<0.001)。围手术期,中度/重度主动脉瓣反流减少(3.2% - 0.0%)以及非计划性体外循环率下降(4.0% - 1.0%;均p<0.001)。类似趋势也适用于30天主要血管并发症发生率(5.2% - 1.8%;p = 0.006)、危及生命的出血发生率(7.0% - 3.0%;p<0.001)以及心血管死亡率(4.4% - 1.8%;p = 0.020)。TAVI术后1年,死亡率和卒中率无差异。

结论

2008年至2015年间TAVI的发展呈现出在低风险患者中使用的趋势以及安全性快速改善的趋势。现在应继续进行评估和改进,以进一步降低卒中和起搏器使用率。

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