Primessnig Uwe, Wiedenhofer Julia M, Trippel Tobias D, Loddenkemper Carina M, Schrader Helene, Brand Anna, Spethmann Sebastian, Stangl Karl, Haghikia Arash, Landmesser Ulf, Boldt Leif-Hendrik, Blaschke Florian, Hindricks Gerhard, Sündermann Simon H, Grubitzsch Herko, Falk Volkmar, Dreger Henryk, Sherif Mohammad
Department of Cardiology, Angiology and Intensive Care Medicine, Deutsches Herzzentrum der Charité, Campus Virchow Klinikum, Berlin, Germany.
Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Charité-Universitätsmedizin Berlin, Berlin, Germany.
Front Cardiovasc Med. 2024 Jul 15;11:1400626. doi: 10.3389/fcvm.2024.1400626. eCollection 2024.
There is a lack of real-world data directly comparing different valve prostheses for transaortic valve replacement (TAVR). We aimed to compare early clinical outcomes at 30-days between the self-expandable Portico valve (Abbott) with the balloon-expandable Edwards Sapien 3 valve (Edwards Lifesciences) (ES3).
Out of 1,901 patients undergoing TAVR between January 2018 and December 2021, all patients who received either Portico valve or ES3 valve via transfemoral TAVR were matched using nearest-neighbor (1:1) propensity scoring. Primary endpoints were single safety endpoints and early safety composite endpoints defined by Valve Academic Research Consortium-2 (VARC-2) criteria. The secondary endpoint was to analyze risk predictors for new permanent pacemaker (PPM) implantation in TAVR.
Out of 661 complete cases, a total of 434 patients were successfully matched based on age, sex, Euro Score II and STS-score. In the matched cohort, 217 received either a Portico or valve and 217 received an ES3 valve. The VARC-2 early safety composite scores indicated a significantly greater overall 30-day safety risk in the Portico group at 9.2% ( = 20) compared to 3.7% ( = 8) in the ES3 group ( = 0.032). The requirement for new permanent pacemaker (PPM) implantation was also higher in the Portico group, at 21.2% ( = 46) vs. 13.4% ( = 29) in the ES3 group ( = 0.042). 30-day mortality was higher was 3.7% ( = 8) in Portico group compared to 0.9% in ES3 group ( = 0.11). Furthermore, implantation of the Portico valve was identified as a significant risk predictor for new PPM implantation, alongside higher age, preprocedural atrioventricular block (AVB) and longer total procedure duration.
This study shows significantly higher rates of early clinical complications for Portico valve prostheses compared to ES3. These findings should be especially taken into consideration when selecting valve prosthesis for high-risk patients.
目前缺乏直接比较不同经主动脉瓣置换术（TAVR）瓣膜假体的真实世界数据。我们旨在比较自膨胀式Portico瓣膜（雅培公司）与球囊扩张式爱德华兹Sapien 3瓣膜（爱德华兹生命科学公司）（ES3）在30天时的早期临床结果。
在2018年1月至2021年12月期间接受TAVR的1901例患者中，所有通过经股动脉TAVR接受Portico瓣膜或ES3瓣膜的患者均采用最近邻（1:1）倾向评分进行匹配。主要终点是由瓣膜学术研究联盟-2（VARC-2）标准定义的单一安全终点和早期安全复合终点。次要终点是分析TAVR中新永久性起搏器（PPM）植入的风险预测因素。
在661例完整病例中，基于年龄、性别、欧洲评分II和STS评分，共成功匹配了434例患者。在匹配队列中，217例接受了Portico瓣膜或其他瓣膜，217例接受了ES3瓣膜。VARC-2早期安全复合评分显示，Portico组30天总体安全风险显著更高，为9.2%（n = 20），而ES3组为3.7%（n = 8）（P = 0.032）。Portico组新永久性起搏器（PPM）植入的需求也更高，为21.2%（n = 46），而ES3组为13.4%（n = 29）（P = 0.042）。Portico组30天死亡率更高，为3.7%（n = 8），而ES3组为0.9%（P = 0.11）。此外，Portico瓣膜植入被确定为新PPM植入的一个重要风险预测因素，同时还有年龄较大、术前房室传导阻滞（AVB）和总手术时间较长。
本研究表明，与ES3相比，Portico瓣膜假体的早期临床并发症发生率显著更高。在为高危患者选择瓣膜假体时，应特别考虑这些发现。
