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经导管主动脉瓣置换术后人工瓣膜-患者不匹配:TRANSIT-PPM国际项目(针对退化性经导管主动脉瓣)

Prosthesis-patient mismatch following transcatheter aortic valve replacement for degenerated transcatheter aortic valves: the TRANSIT-PPM international project.

作者信息

Testa Luca, Casenghi Matteo, Criscione Enrico, Van Mieghem Nicolas M, Tchétché Didier, Asgar Anita W, De Backer Ole, Latib Azeem, Reimers Bernhard, Stefanini Giulio, Trani Carlo, Giannini Francesco, Bartorelli Antonio, Wojakowski Wojtek, Dabrowski Maciej, Jagielak Dariusz, Banning Adrian P, Kharbanda Rajesh, Moreno Raul, Schofer Joachim, Brinkmann Christina, van Royen Niels, Pinto Duane, Serra Antoni, Segev Amit, Giordano Arturo, Brambilla Nedy, Agnifili Mauro, Rubbio Antonio Popolo, Squillace Mattia, Oreglia Jacopo, Tanja Rudolph, McCabe James M, Abizaid Alexander, Voskuil Michiel, Teles Rui, Zoccai Giuseppe Biondi, Sondergaard Lars, Bedogni Francesco

机构信息

IRCCS Policlinico S. Donato, Milan, Italy.

Erasmus University Medical Center, Rotterdam, Netherlands.

出版信息

Front Cardiovasc Med. 2022 Jul 29;9:931207. doi: 10.3389/fcvm.2022.931207. eCollection 2022.

Abstract

BACKGROUND

A severe prosthesis-patient mismatch (PPM) is associated with adverse outcomes following transcatheter aortic valve replacement (TAVR) for aortic stenosis or a failed surgical bioprosthesis. The impact of severe PPM in patients undergoing TAV-in-TAVR is unknown.

AIM

We sought to investigate the incidence and 1-year outcomes of different grades of PPM in patients undergoing TAV-in-TAVR.

MATERIALS AND METHODS

The TRANSIT-PPM is an international registry, including cases of degenerated TAVR treated with a second TAVR. PPM severity, as well as in-hospital, 30-day, and 1-year outcomes were defined according to the Valve Academic Research Consortium-3 (VARC-3) criteria.

RESULTS

Among 28 centers, 155 patients were included. Severe PPM was found in 6.5% of patients, whereas moderate PPM was found in 14.2% of patients. The rate of severe PPM was higher in patients who underwent TAV-in-TAVR with a second supra-annular self-expanding (S-SE) TAVR (10%, = 0.04). Specifically, the rate of severe PPM was significantly higher among cases of a SE TAVR implanted into a balloon-expandable (BE) device (19%, = 0.003). At 1-year follow-up, the rate of all-cause mortality, and the rate of patients in the New York Heart Association (NYHA) class III/IV were significantly higher in the cohort of patients with severe PPM ( = 0.016 and = 0.0001, respectively). Almost all the patients with a severe PPM after the first TAVR had a failed < 23 mm BE transcatheter heart valve (THV): the treatment with an S-SE resolved the severe PPM in the majority of the cases.

CONCLUSION

After TAV-in-TAVR, in a fifth of the cases, a moderate or severe PPM occurred. A severe PPM is associated with an increased 1-year all-cause mortality.

CLINICAL TRIAL REGISTRATION

[https://clinicaltrials.gov], identifier [NCT04500964].

摘要

背景

严重的人工瓣膜与患者不匹配(PPM)与经导管主动脉瓣置换术(TAVR)治疗主动脉瓣狭窄或外科生物瓣膜失败后的不良结局相关。严重PPM在TAV-in-TAVR患者中的影响尚不清楚。

目的

我们试图研究TAV-in-TAVR患者不同等级PPM的发生率和1年结局。

材料与方法

TRANSIT-PPM是一项国际注册研究,包括接受二次TAVR治疗的退化性TAVR病例。PPM严重程度以及住院、30天和1年结局根据瓣膜学术研究联盟-3(VARC-3)标准定义。

结果

在28个中心中,纳入了155例患者。6.5%的患者发现有严重PPM,而14.2%的患者发现有中度PPM。在接受二次瓣环上自膨式(S-SE)TAVR进行TAV-in-TAVR的患者中,严重PPM的发生率更高(10%,P = 0.04)。具体而言,在球囊扩张式(BE)装置中植入自膨式(SE)TAVR的病例中,严重PPM的发生率显著更高(19%,P = 0.003)。在1年随访时,严重PPM患者队列中的全因死亡率和纽约心脏协会(NYHA)III/IV级患者的比例显著更高(分别为P = 0.016和P = 0.0001)。首次TAVR后几乎所有严重PPM患者的<23 mm BE经导管心脏瓣膜(THV)均失败:在大多数病例中,S-SE治疗解决了严重PPM问题。

结论

TAV-in-TAVR后,五分之一的病例出现中度或严重PPM。严重PPM与1年全因死亡率增加相关。

临床试验注册

[https://clinicaltrials.gov],标识符[NCT04500964]。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5d7f/9372302/92e891db719c/fcvm-09-931207-g001.jpg

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