Giannini Cristina, Capodanno Davide, Toth Gabor G, Windecker Stephan, Schüpke Stefanie, Blackman Daniel J, Noble Stéphane, Eltchaninoff Hélène, Fiorina Claudia, Chieffo Alaide, Bartorelli Antonio L, Schmidt Albrecht, De Backer Ole, Gilard Martine, Curtis Elizabeth, L'Official Guillaume, Donal Erwan, Laroche Cécile, Prendergast Bernard, Petronio Anna Sonia, The European Valve Durability Tavi Registry Investigators On Behalf
Cardiothoracic and Vascular Department, Azienda Ospedaliero-Universitaria Pisana, Pisa, Italy.
Division of Cardiology, Azienda Ospedaliero Universitaria Policlinico "G. Rodolico-San Marco", Catania, Italy.
EuroIntervention. 2025 May 16;21(10):537-549. doi: 10.4244/EIJ-D-24-00662.
Valve durability is a key consideration as the patient population eligible for transcatheter aortic valve implantation (TAVI) expands to include lower-risk and younger individuals who are expected to live many years after the procedure.
This registry aimed to assess the incidence of long-term structural valve deterioration (SVD) beyond 5 years post-TAVI.
Consecutive living patients who underwent TAVI up until 2014 using any commercially available transcatheter heart valve (THV) at 22 participant centres were enrolled in the European Valve Durability TAVI Registry. All patients underwent comprehensive echocardiographic assessments (61% were evaluated independently by a central core laboratory) within 6 months of enrolment and at least 5 years post-TAVI; SVD was defined according to Valve Academic Research Consortium 3 definitions.
A total of 597 patients (aged 79.6±7.1 years at the time of TAVI; 47.2% male, mean Society of Thoracic Surgeons score 5.0%) were included. At a median of 6.1 years of follow-up (interquartile range 5.2-7.3 years), the crude incidence of moderate/severe SVD was 9.5% (n=57; moderate: 6.2%, n=37; severe: 3.4%, n=20). Predictors of SVD identified by Cox regression analysis were use of an intra-annular THV (hazard ratio [HR] 38.44, 95% confidence interval [CI]: 10.8-136.3; p<0.001), a small THV size (HR 4.82, 95% CI: 2.42-9.60; p<0.001) and moderate/severe postprocedural paravalvular leak (HR 3.64, 95% CI: 1.59-8.32; p=0.002).
The incidence of moderate/severe SVD during long-term follow-up after TAVI is low, with severe SVD being even rarer than moderate SVD. SVD occurs more frequently in patients treated with older-generation intra-annular valves and in those with small-sized THVs.
随着适合经导管主动脉瓣植入术(TAVI)的患者群体扩大到包括低风险和年轻个体,这些个体预计在手术后能存活多年,瓣膜耐久性成为关键考量因素。
本注册研究旨在评估TAVI术后5年以上长期结构性瓣膜退变(SVD)的发生率。
在22个参与中心,纳入截至2014年使用任何市售经导管心脏瓣膜(THV)接受TAVI的连续存活患者,纳入欧洲瓣膜耐久性TAVI注册研究。所有患者在入组后6个月内及TAVI术后至少5年接受全面超声心动图评估(61%由中央核心实验室独立评估);SVD根据瓣膜学术研究联盟3的定义确定。
共纳入597例患者(TAVI时年龄79.6±7.1岁;47.2%为男性,胸外科医师协会平均评分5.0%)。在中位随访6.1年(四分位间距5.2 - 7.3年)时,中/重度SVD的粗发生率为9.5%(n = 57;中度:6.2%,n = 37;重度:3.4%,n = 20)。Cox回归分析确定的SVD预测因素为使用瓣环内THV(风险比[HR] 38.44,95%置信区间[CI]:10.8 - 136.3;p < 0.001)、THV尺寸小(HR 4.82,95% CI:2.42 - 9.60;p < 0.001)和术后中/重度瓣周漏(HR 3.64,95% CI:1.59 - 8.32;p = 0.002)。
TAVI术后长期随访期间中/重度SVD的发生率较低,重度SVD比中度SVD更罕见。SVD在接受较老式瓣环内瓣膜治疗的患者和THV尺寸小的患者中更频繁发生。