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使用Portico瓣膜进行经导管主动脉瓣植入术:一项多中心、真实世界注册研究的2年结果

Transcatheter Aortic Valve Implantation with the Portico Valve: 2-Year Outcomes of a Multicenter, Real-World Registry.

作者信息

Didagelos Matthaios, Ninios Vlasis, Kakderis Charalampos, Lakkas Lampros, Kouparanis Antonios, Nikas Dimitrios, Naka Katerina K, Rammos Aidonis, Zegkos Thomas, Kamperidis Vasileios, Ninios Ilias, Evangelou Sotirios, Tsalikakis Dimitrios G, Michalis Lampros, Ziakas Antonios

机构信息

1st Cardiology Department, AHEPA University General Hospital, 54636 Thessaloniki, Greece.

2nd Cardiology Department, Interbalkan Medical Center, 55535 Thessaloniki, Greece.

出版信息

Life (Basel). 2023 Aug 21;13(8):1785. doi: 10.3390/life13081785.

DOI:10.3390/life13081785
PMID:37629642
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10455265/
Abstract

INTRODUCTION

The self-expanding, resheathable, repositionable transcatheter aortic heart valve Portico is being used successfully for transcatheter aortic valve implantation procedures (TAVI) in patients with severe aortic stenosis. The aim of this study was to evaluate outcomes at 2 years after TAVI with the Portico valve.

METHODS

Multicenter registry of clinical, echocardiographic and survival data from consecutive patients treated with the Portico TAVI system (Abbott, Chicago, IL, USA) in three cath labs in Northern Greece and Epirus during 2017-2020. The primary end point was all-cause mortality at 24 months. Secondary end points included procedural outcomes (efficacy and safety) and echocardiographic measurements.

RESULTS

A total of 90 patients (81 ± 6 years, 50% females, mean age 81 ± 6 years) were included in the registry. The indication for implantation was severe, symptomatic aortic stenosis (NYHA III, IV) in eighty-two (91.1%) and degeneration of a prosthetic aortic valve in eight (8.9%) patients. All patients were categorized as high surgical risk (mean Logistic Euroscore 25.9 ± 10, Euroscore II 7.7 ± 4.4 and STS score 10.8 ± 8.9). The procedure was performed transfemorally in all patients, under general anesthesia in 95.6%, under TOE guidance in 21.1%, with native valve predilatation in 46.7%, and the "resheath" option was used in 31.1% of the cases. The implantation was successful in 97.8% and there was a need for a second valve in 2.2% of the cases. Complications included permanent pacemaker implantation (16.7%), access cite complications (15.6%), arrythmias (23.3%), paravalvular leak (moderate 7.8%, severe 1.1%), acute kidney injury (7.8%), no strokes and one death during the procedure. Aortic valve peak velocity, peak and mean pressure gradients, were significantly reduced after the procedure. All-cause mortality at 1, 12 and 24 months was 4.4%, 6.7% and 7.8%, respectively.

CONCLUSIONS

TAVI with the Portico system comprises an effective and safe solution for the management of severe, symptomatic aortic stenosis in high-risk surgical patients.

摘要

引言

自膨胀、可重新收纳、可重新定位的经导管主动脉心脏瓣膜Portico已成功应用于严重主动脉瓣狭窄患者的经导管主动脉瓣植入术(TAVI)。本研究的目的是评估使用Portico瓣膜进行TAVI术后2年的结果。

方法

对2017年至2020年期间在希腊北部和伊庇鲁斯的三个导管实验室接受Portico TAVI系统(美国伊利诺伊州芝加哥市雅培公司)治疗的连续患者的临床、超声心动图和生存数据进行多中心登记。主要终点是24个月时的全因死亡率。次要终点包括手术结果(有效性和安全性)和超声心动图测量。

结果

登记册共纳入90例患者(81±6岁,50%为女性,平均年龄81±6岁)。植入指征为82例(91.1%)严重、有症状的主动脉瓣狭窄(纽约心脏协会III级、IV级)和8例(8.9%)人工主动脉瓣退变。所有患者均被归类为高手术风险(平均逻辑欧洲评分25.9±10,欧洲评分II 7.7±4.4,胸外科医师协会评分10.8±8.9)。所有患者均经股动脉进行手术,95.6%在全身麻醉下进行,21.1%在经食管超声心动图引导下进行,46.7%进行了自体瓣膜预扩张,31.1%的病例使用了“重新收纳”选项。植入成功率为97.8%,2.2%的病例需要植入第二个瓣膜。并发症包括永久性起搏器植入(16.7%)、穿刺部位并发症(15.6%)、心律失常(23.3%)、瓣周漏(中度7.8%,重度1.1%)、急性肾损伤(7.8%),术中无中风和死亡病例。术后主动脉瓣峰值速度、峰值和平均压力梯度均显著降低。1个月、12个月和24个月时的全因死亡率分别为4.4%、6.7%和7.8%。

结论

使用Portico系统进行TAVI是治疗高风险手术患者严重、有症状主动脉瓣狭窄的一种有效且安全的解决方案。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f93d/10455265/b93bc48e9235/life-13-01785-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f93d/10455265/b93bc48e9235/life-13-01785-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f93d/10455265/b93bc48e9235/life-13-01785-g001.jpg

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本文引用的文献

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Self-expanding intra-annular versus commercially available transcatheter heart valves in high and extreme risk patients with severe aortic stenosis (PORTICO IDE): a randomised, controlled, non-inferiority trial.自膨式瓣中瓣与商业可用经导管心脏瓣膜在高危和极高危重度主动脉瓣狭窄患者(PORTICO IDE)中的应用:一项随机、对照、非劣效性试验。
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Transcatheter Aortic Valve Replacement With a Repositionable Self-Expanding Prosthesis: The PORTICO-I Trial 1-Year Outcomes.经导管主动脉瓣置换术联合可重定位自扩张假体:PORTICO-I 试验 1 年结果。
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Real-world procedural and 30-day outcome using the Portico transcatheter aortic valve prosthesis: A large single center cohort.使用 Portico 经导管主动脉瓣假体的真实世界程序和 30 天结果:一项大型单中心队列研究。
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