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经股动脉导管主动脉瓣置换术中极简方法的安全性和有效性:来自优化经导管瓣膜介入-经导管主动脉瓣植入术(OCEAN-TAVI)注册研究的见解

Safety and efficacy of minimalist approach in transfemoral transcatheter aortic valve replacement: insights from the Optimized transCathEter vAlvular interventioN-Transcatheter Aortic Valve Implantation (OCEAN-TAVI) registry.

作者信息

Hosoba Soh, Yamamoto Masanori, Shioda Kayoko, Sago Mitsuru, Koyama Yutaka, Shimura Tetsuro, Kagase Ai, Tada Norio, Naganuma Toru, Araki Motoharu, Yamanaka Futoshi, Shirai Shinichi, Watanabe Yusuke, Hayashida Kentaro

机构信息

Department of cardiovascular surgery, Toyohashi Heart Center, Toyohashi, Japan.

Department of cardiology, Toyohashi Heart Center, Toyohashi, Japan.

出版信息

Interact Cardiovasc Thorac Surg. 2018 Mar 1;26(3):420-424. doi: 10.1093/icvts/ivx355.

DOI:10.1093/icvts/ivx355
PMID:29096029
Abstract

OBJECTIVES

Favourable results have been reported for monitored anaesthesia care that includes local anaesthesia and conscious sedation [minimalist approach (MA)] for transfemoral transcatheter aortic valve replacement (TAVR). However, the efficacy of MA is still controversial in Japan. We describe our experience from a Japanese multicentre registry.

METHODS

Between October 2013 and April 2016, 1215 consecutive Japanese patients with symptomatic, severe aortic stenosis undergoing TAVR with self-expandable or balloon-expandable valves were prospectively included in the Optimized transCathEter vAlvular intervention-Transcatheter Aortic Valve Implantation (OCEAN-TAVI) registry. Of these patients, we retrospectively reviewed 921 consecutive patients who underwent elective transfemoral-TAVR. We evaluated the perioperative results of MA-TAVR and non-minimalist approach (NMA) TAVR using propensity score matching analysis.

RESULTS

A total of 118 patients underwent MA-TAVR, and 802 patients underwent NMA-TAVR [median age 84 vs 85 years, P = 0.25; Society of Thoracic Surgeons (STS) score 7.6 vs 6.4, P = 0.01]. One hundred eighteen matched pairs were compared after propensity score matching. In-hospital mortality and stroke/transient ischaemic attack were not significantly different between the MA-TAVR and the NMA-TAVR groups (2.5% vs 0.8%, P = 0.3; 1.7% vs 0.8%, P = 0.6, respectively). Major or life-threatening bleeding and the transfusion rate were significantly lower in the MA-TAVR group (3.4% vs 17%, P = 0.003; 6.8% vs 29%, P = 0.0002, respectively). The total intensive care unit days and length of hospital stay were significantly lower in the MA-TAVR group (P ≤ 0.0002).

CONCLUSIONS

MA-TAVR has similar results to NMA-TAVR in terms of mortality and stroke in this Japanese multicentre registry. Shorter procedure time and hospital stays were seen in the MA-TAVR group. MA-TAVR is as safe and effective as NMA-TAVR.

摘要

目的

对于经股动脉经导管主动脉瓣置换术(TAVR),采用包括局部麻醉和清醒镇静的监护麻醉管理[极简方法(MA)]已报告有良好结果。然而,在日本,MA的疗效仍存在争议。我们描述了来自日本多中心注册研究的经验。

方法

在2013年10月至2016年4月期间,1215例有症状、严重主动脉瓣狭窄且连续接受自膨胀或球囊膨胀瓣膜TAVR的日本患者被前瞻性纳入优化经导管瓣膜介入-经导管主动脉瓣植入(OCEAN-TAVI)注册研究。在这些患者中,我们回顾性分析了921例连续接受择期经股动脉-TAVR的患者。我们使用倾向评分匹配分析评估了MA-TAVR和非极简方法(NMA)TAVR的围手术期结果。

结果

共有118例患者接受了MA-TAVR,802例患者接受了NMA-TAVR[中位年龄84岁对85岁,P = 0.25;胸外科医师协会(STS)评分7.6对6.4,P = 0.01]。倾向评分匹配后比较了118对匹配病例。MA-TAVR组和NMA-TAVR组的院内死亡率和卒中/短暂性脑缺血发作无显著差异(分别为2.5%对0.8%,P = 0.3;1.7%对0.8%,P = 0.6)。MA-TAVR组的严重或危及生命的出血及输血率显著更低(分别为3.4%对17%,P = 0.003;6.8%对29%,P = 0.0002)。MA-TAVR组的重症监护病房总天数和住院时间显著更短(P≤0.0002)。

结论

在这个日本多中心注册研究中,MA-TAVR在死亡率和卒中方面与NMA-TAVR有相似结果。MA-TAVR组的手术时间和住院时间更短。MA-TAVR与NMA-TAVR一样安全有效。

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