退行性三尖瓣生物瓣与非三尖瓣生物瓣的主动脉瓣反流、主动脉瓣再次干预时间及死亡率

Aortic Regurgitation, Time to Aortic Valve Reintervention, and Mortality in Degenerated Trifecta Versus Non-Trifecta Bioprosthesis.

作者信息

Abbas Amr E, Madanat Luai, Khalili Houman, Mando Ramy, Kheyrbek Mazhed, Chandra Rohit, Niroula Shailesh, Hanson Ivan, Dixon Simon, Renard Brian, Bloomingdale Richard, Cami Elvis, Pridham Brittany, Altshuler Jeffrey, Kindzelski Bogdan, Fazzalari Franco, Shannon Francis, Vivacqua Alessandro

机构信息

Department of Cardiovascular Medicine. William Beaumont University Hospital, Corewell Health East, Michigan; Oakland University William Beaumont School of Medicine, Rochester, Michigan.

Department of Cardiovascular Medicine. William Beaumont University Hospital, Corewell Health East, Michigan.

出版信息

Am J Cardiol. 2024 Jun 1;220:49-55. doi: 10.1016/j.amjcard.2024.03.033. Epub 2024 Apr 4.

Abstract

On July 31, 2023, the Trifecta valve was withdrawn from the market after concerns regarding early (≤5 years) structural valve deterioration (SVD), mainly as aortic regurgitation (AR). Our aim was to determine the timing, mechanism, and impact of bioprosthetic SVD in patients who underwent redo aortic valve replacement (redo-AVR) with either redo-SAVR or valve-in-valve transcatheter aortic valve replacement (TAVR) using Trifecta versus other bioprosthetic valves. Patients who underwent redo-AVR for SVD at our institution were categorized into 2 groups based on the valve type: Trifecta versus non-Trifecta. Multivariate Cox proportional hazard model and Kaplan-Meier curves were used to compare mortality. A total of 171 patients were included; 58 (34%) had previous SAVR with a Trifecta valve and 113 (66%) with non-Trifecta valve. A total of 103 patients (60%) underwent valve-in-valve TAVR and 68 redo-SAVR (40%). The age, gender, and Society of Thoracic Surgeons score were similar between Trifecta and non-Trifecta groups. In patients with bioprosthetic valves requiring redo-AVR, Trifecta valves had an earlier onset of greater than moderate AR (4.5 vs 11.9 years, p <0.001) and earlier time to redo-AVR (5.5 vs 12 years, p <0.001). AR was more common as the mechanism of SVD in Trifecta versus non-Trifecta valves (55.2% vs 30.1%, p = 0.006). All-cause adjusted mortality from index SAVR was higher in the Trifecta than in non-Trifecta group (hazard ratio 4.1, 95% confidence interval 1.5 to 11.5, p = 0.007). In conclusion, compared with non-Trifecta valves, Trifecta valves exhibit early SVD primarily as AR and progress rapidly to significant SVD requiring redo-AVR. Mortality is significantly higher with Trifecta than in non-Trifecta valves, potentially impacting the results of SAVR versus TAVR studies.

摘要

2023年7月31日,在对早期(≤5年)结构性瓣膜退变(SVD),主要是主动脉瓣反流(AR)表示担忧后,Trifecta瓣膜退出市场。我们的目的是确定接受再次主动脉瓣置换术(redo-AVR),采用Trifecta瓣膜行再次外科主动脉瓣置换术(redo-SAVR)或经导管主动脉瓣置换术(TAVR)瓣中瓣植入的患者与接受其他生物瓣膜置换的患者相比,生物瓣膜SVD的发生时间、机制及影响。在我们机构因SVD接受redo-AVR的患者根据瓣膜类型分为两组:Trifecta瓣膜组和非Trifecta瓣膜组。采用多变量Cox比例风险模型和Kaplan-Meier曲线比较死亡率。共纳入171例患者;58例(34%)曾接受Trifecta瓣膜的SAVR,113例(66%)接受非Trifecta瓣膜置换。共103例患者(60%)接受瓣中瓣TAVR,68例接受redo-SAVR(40%)。Trifecta瓣膜组和非Trifecta瓣膜组的年龄、性别及胸外科医师协会评分相似。在需要redo-AVR的生物瓣膜患者中,Trifecta瓣膜出现大于中度AR的时间更早(分别为4.5年和11.9年,p<0.001),再次行AVR的时间也更早(分别为5.5年和12年,p<0.001)。与非Trifecta瓣膜相比AR更常见为Trifecta瓣膜SVD的机制(55.2%对30.1%,p=0.006)。Trifecta瓣膜组初次SAVR后的全因校正死亡率高于非Trifecta瓣膜组(风险比4.1,95%置信区间1.5至11.5,p=0.007)。总之,与非Trifecta瓣膜相比,Trifecta瓣膜主要表现为早期SVD并进展为严重SVD,需要redo-AVR。Trifecta瓣膜组的死亡率显著高于非Trifecta瓣膜组,这可能影响SAVR与TAVR研究的结果。

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