Scotti Andrea, Baggio Sara, Pagnesi Matteo, Barbanti Marco, Adamo Marianna, Eitan Amnon, Estévez-Loureiro Rodrigo, Veulemans Verena, Toggweiler Stefan, Mylotte Darren, De Marco Federico, Giannini Francesco, Ferlini Marco, Naber Christoph K, Buono Andrea, Schofer Joachim, Rottbauer Wolfgang, Van Mieghem Nicolas M, Khogali Saib, Taramasso Maurizio, Pilgrim Thomas, Sinning Jan-Malte, Zweiker David, Montorfano Matteo, Van der Heyden Jan A S, Brugaletta Salvatore, Ielasi Alfonso, Hamm Christian W, Vanhaverbeke Maarten, Costa Giuliano, Massussi Mauro, Alarcón Robert, Zeus Tobias, Lunardi Mattia, Testa Luca, Di Ienno Luca, Lanzillo Giuseppe, Wolf Alexander, Maffeo Diego, Ziviello Francesca, Saccocci Matteo, Windecker Stephan, Sedaghat Alexander, Schmidt Albrecht, Brouwer Jorn, Regueiro Ander, Reimers Bernhard, Kim Won-Keun, Sondergaard Lars, Colombo Antonio, Mangieri Antonio, Latib Azeem
Montefiore-Einstein Center for Heart and Vascular Care, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY (A.S., A.L.).
Department of Biomedical Sciences, Humanitas University, Pieve Emanuele-Milan, Italy (S.B., B.R., A.C., A.M.).
Circ Cardiovasc Interv. 2023 Jan;16(1):e012538. doi: 10.1161/CIRCINTERVENTIONS.122.012538. Epub 2023 Jan 17.
In recent years, transcatheter aortic valve replacement (TAVR) techniques and technology have continuously improved. Data regarding the impact of these advancements on outcomes in large real-world settings are still limited. The aim of this study was to investigate temporal trends and assess contemporary outcomes after TAVR with Evolut PRO/PRO+ supra-annular self-expanding valves.
This study included patients enrolled in the multicenter NEOPRO (A Multicenter Comparison of Acurate NEO Versus Evolut PRO Transcatheter Heart Valves) and NEOPRO-2 (A Multicenter Comparison of ACURATE NEO2 Versus Evolut PRO/PRO+ Transcatheter Heart Valves 2) registries who underwent transfemoral TAVR with Evolut PRO/PRO+. Procedural dates (August 2017 through November 2021) were stratified in quartiles (Q) and used to investigate temporal trends in TAVR outcomes. Predischarge, 30-day Valve Academic Research Consortium-3 defined, and 1-year outcomes were evaluated.
In total, 1616 patients from 28 centers were included. Over time, patients had lower Society of Thoracic Surgeon-Predicted Risk of Mortality score (Q1-4, 4.1% [2.8-6.3%], 3.7% [2.6-5.3%], 3.3% [2.4-4.9%], 2.9% [2.2-4.3%]; <0.001) and more moderate or heavy valve calcification (Q1-4, 80%, 80%, 82%, 88%; =0.038). Overall Valve Academic Research Consortium-3 technical success was 94.1%, with 30-day and 1-year all-cause mortality of 2.4% and 10%, respectively. Throughout the study period, procedures were associated with higher rates of 30-day device success (Q1-4, 81.2%, 82.2%, 82.0%, 88.0%; Cochran-Armitage =0.023) and early safety (Q1-4, 66.8%, 67.5%, 74.0%, 77.6%; Cochran-Armitage <0.001), with fewer permanent pacemaker implantations (Q1-4: 15.3%, 20.0%, 12.1%, 11.6%; Cochran-Armitage =0.023) and residual mild or greater paravalvular leaks (Q1-4, 50.4%, 42.1%, 36.5%, 35.8%; Cochran-Armitage <0.001).
TAVR with Evolut PRO/PRO+ self-expanding valve is safe and effective. Despite the treatment of heavier calcified anatomies, procedural outcomes are improving over time with less need for pacemaker implantation and less significant paravalvular leaks.
近年来，经导管主动脉瓣置换术（TAVR）技术不断改进。关于这些进展对大型真实世界环境中治疗结果影响的数据仍然有限。本研究的目的是调查时间趋势，并评估使用Evolut PRO/PRO+超环自膨式瓣膜进行TAVR后的当代治疗结果。
本研究纳入了参加多中心NEOPRO（Acurate NEO与Evolut PRO经导管心脏瓣膜的多中心比较）和NEOPRO-2（ACURATE NEO2与Evolut PRO/PRO+经导管心脏瓣膜2的多中心比较）注册研究的患者，这些患者接受了经股动脉TAVR并使用Evolut PRO/PRO+。将手术日期（2017年8月至2021年11月）分为四分位数（Q），并用于研究TAVR治疗结果的时间趋势。评估出院前、30天瓣膜学术研究联盟-3定义的结果和1年结果。
总共纳入了来自28个中心的1616例患者。随着时间的推移，患者的胸外科医师预测死亡风险评分较低（第1-4四分位数，4.1%[2.8-6.3%]，3.7%[2.6-5.3%]，3.3%[2.4-4.9%]，2.9%[2.2-4.3%]；<0.001），且中重度瓣膜钙化更多（第1-4四分位数，80%，80%，82%，88%；=0.038）。总体瓣膜学术研究联盟-3技术成功率为94.1%，30天和1年全因死亡率分别为2.4%和10%。在整个研究期间，手术的30天装置成功率（第1-4四分位数，81.2%，82.2%，82.0%，88.0%； Cochr an-Armitage=0.023）和早期安全性（第1-4四分位数，66.8%，67.5%，74.0%，77.6%； Cochr an-Armitage<0.001）更高，永久性起搏器植入更少（第1-4四分位数：15.3%，20.0%，12.1%，11.6%； Cochr an-Armitage=0.023），残余轻度或更严重的瓣周漏更少（第1-4四分位数，50.4%，42.1%，36.5%，36.5%，35.8%； Cochr an-Armitage<0.001）。
使用Evolut PRO/PRO+自膨式瓣膜进行TAVR是安全有效的。尽管治疗的是钙化更严重的解剖结构，但随着时间的推移，手术结果不断改善，起搏器植入需求减少，瓣周漏也不那么严重。
