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经导管主动脉瓣置换术治疗退行性经导管主动脉瓣:TRANSIT 国际项目。

Transcatheter Aortic Valve Replacement for Degenerated Transcatheter Aortic Valves: The TRANSIT International Project.

机构信息

IRCCS Policlinico S. Donato, Milan, Italy (L.T., M.A., N.B., A.P.R., M.C., F.D.M., G.B., F.B.).

Erasmus University Medical Center, Rotterdam, the Netherlands (N.M.V.M.).

出版信息

Circ Cardiovasc Interv. 2021 Jun;14(6):e010440. doi: 10.1161/CIRCINTERVENTIONS.120.010440. Epub 2021 Jun 7.

Abstract

BACKGROUND

Transcatheter aortic valve replacement (TAVR) has determined a paradigm shift in the treatment of patients with severe aortic stenosis. However, the durability of bioprostheses is still a matter of concern, and little is known about the management of degenerated TAV. We sought to evaluate the outcomes of patients with a degenerated TAV treated by means of a second TAVR.

METHODS

The TRANSIT is an international registry that included cases of degenerated TAVR from 28 centers. Among around 40 000 patients treated with TAVR in the participating centers, 172 underwent a second TAVR: 57 (33%) for a mainly stenotic degenerated TAV, 97 (56%) for a mainly regurgitant TAV, and 18 (11%) for a combined degeneration. Overall, the rate of New York Heart Association class III/IV at presentation was 73.5%.

RESULTS

Valve Academic Research Consortium 2 device success rate was 79%, as a consequence of residual gradient (14%) or regurgitation (7%). At 1 month, the overall mortality rate was 2.9%, while rates of new hospitalization and New York Heart Association class III/IV were 3.6% and 7%, respectively, without significant difference across the groups. At 1 year, the overall mortality rate was 10%, while rates of new hospitalization and New York Heart Association class III/IV were 7.6% and 5.8%, respectively, without significant difference across the groups. No cases of valve thrombosis were recorded.

CONCLUSIONS

Selected patients with a degenerated TAV may be safely and successfully treated by means of a second TAVR. This finding is of crucial importance for the adoption of the TAVR technology in a lower risk and younger population.

REGISTRATION

URL: https://www.clinicaltrials.gov; Unique identifier: NCT04500964.

摘要

背景

经导管主动脉瓣置换术(TAVR)在治疗严重主动脉瓣狭窄患者方面带来了治疗模式的转变。然而,生物瓣的耐久性仍然是一个令人关注的问题,对于退行性 TAV 的处理知之甚少。我们旨在评估接受二次 TAVR 治疗的退行性 TAV 患者的结局。

方法

TRANSIT 是一项国际注册研究,纳入了 28 个中心的退行性 TAV 病例。在参与中心接受 TAVR 治疗的约 40000 例患者中,有 172 例接受了二次 TAVR:57 例(33%)为主要狭窄性退行性 TAV,97 例(56%)为主要反流性 TAV,18 例(11%)为混合性退行性 TAV。总体而言,就诊时纽约心脏协会心功能 III/IV 级的比例为 73.5%。

结果

Valve Academic Research Consortium 2 器械成功率为 79%,原因是残余梯度(14%)或反流(7%)。1 个月时,总死亡率为 2.9%,而新发住院率和纽约心脏协会心功能 III/IV 级的比例分别为 3.6%和 7%,各组之间无显著差异。1 年时,总死亡率为 10%,而新发住院率和纽约心脏协会心功能 III/IV 级的比例分别为 7.6%和 5.8%,各组之间无显著差异。未记录到瓣膜血栓形成。

结论

选择合适的退行性 TAV 患者可安全、成功地接受二次 TAVR 治疗。这一发现对于在风险较低和年龄较轻的人群中采用 TAVR 技术具有至关重要的意义。

登记

网址:https://www.clinicaltrials.gov;唯一标识符:NCT04500964。

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