Piayda Kerstin, Bauer Timm, Beckmann Andreas, Bekeredjian Raffi, Bleiziffer Sabine, Ensminger Stephan, Frerker Christian, Möllmann Helge, Walther Thomas, Balaban Ümniye, Herrmann Eva, Hamm Christian, Beyersdorf Friedhelm, Lichtenberg Artur, Zeus Tobias, Mehdiani Arash
Division of Cardiology, Pulmonology and Vascular Medicine.
Department of Cardiology, General Internal Medicine, Intensive Care, Sana Clinic Offenbach, Offenbach, Germany.
Am J Cardiol. 2022 Feb 1;164:111-117. doi: 10.1016/j.amjcard.2021.10.021. Epub 2021 Nov 26.
Patients presenting with severe aortic stenosis and large aortic annuli are challenging to treat because of the size limitations of available transcatheter heart valves. In this study, we aimed to determine clinical and hemodynamic outcomes in patients presenting with large aortic annuli who underwent transcatheter aortic valve implantation (TAVI). Patients from the German Aortic Valve Registry who underwent TAVI either with the Edwards Sapien (ES) or Medtronic CoreValve (MCV) systems from 2011 to 2017 were included. They were further stratified into a large (aortic annulus diameter 26 to 29 mm for ES; 26 to 30 mm for MCV) and extra-large (aortic annulus diameter >29 mm for ES; >30 mm for MCV) group and analyzed using propensity score adjustment. Extra-large was set beyond the sizing limitations according to the manufacturer's instructions for use. Patients in the large (n = 5,628) and extra-large (n = 509) groups were predominantly male (large: 92.6% vs extra-large: 91.9%). The 30-day mortality was comparable (large: 3.9% vs extra-large: 5.0%, p = 0.458). Procedure duration (large: 78.9 minutes ± 0.82 vs extra-large: 86.4 minutes ± 1.9, p <0.001) was longer in the extra-large group. Likewise, vascular complications (large: 6.2% vs extra-large: 12%, p = 0.002) and the need for a permanent pacemaker implantation (large: 18.8% vs extra-large: 26.0%, p = 0.027) were more often present in the extra-large group. Aortic regurgitation ≥II after valve implantation was numerically higher (large: 3.0% vs extra-large: 5.3%, p = 0.082) in patients with extra-large anatomy. In conclusion, patients with large and extra-large aortic annulus diameters who underwent TAVI have comparable 30-day mortality. Beyond the recommended annulus range, there is a higher risk for vascular complications and permanent pacemaker implantation.
由于现有经导管心脏瓣膜的尺寸限制，患有严重主动脉瓣狭窄和大主动脉瓣环的患者治疗具有挑战性。在本研究中，我们旨在确定接受经导管主动脉瓣植入术（TAVI）的大主动脉瓣环患者的临床和血流动力学结果。纳入了2011年至2017年在德国主动脉瓣注册中心接受使用爱德华兹Sapien（ES）或美敦力CoreValve（MCV）系统进行TAVI的患者。他们被进一步分为大（ES的主动脉瓣环直径为26至29mm；MCV的为26至30mm）和超大（ES的主动脉瓣环直径>29mm；MCV的>30mm）组，并使用倾向评分调整进行分析。超大组超出了制造商使用说明中的尺寸限制。大（n = 5628）和超大（n = 509）组患者主要为男性（大组：92.6% vs 超大组：91.9%）。30天死亡率相当（大组：3.9% vs 超大组：5.0%，p = 0.458）。超大组的手术时间更长（大组：78.9分钟±0.82 vs 超大组：86.4分钟±1.9，p <0.001）。同样，超大组血管并发症（大组：6.2% vs 超大组：12%，p = 0.002）和永久起搏器植入需求（大组：18.8% vs 超大组：26.0%，p = 0.027）更常见。超大解剖结构患者瓣膜植入后主动脉瓣反流≥II级在数值上更高（大组：3.0% vs 超大组：5.3%，p = 0.082）。总之，接受TAVI的大直径和超大直径主动脉瓣环患者30天死亡率相当。超出推荐的瓣环范围，血管并发症和永久起搏器植入风险更高。
