Sticchi Alessandro, Grassini Dario, Gallo Francesco, Benenati Stefano, Kim Won-Keun, Khokhar Arif A, Zeus Tobias, Toggweiler Stefan, Galea Roberto, De Marco Federico, Mangieri Antonio, Regazzoli Damiano, Reimers Bernhard, Nombela-Franco Luis, Barbanti Marco, Regueiro Ander, Piva Tommaso, Rodés-Cabau Josep, Porto Italo, Colombo Antonio, Giannini Francesco
Dipartimento di Patologia Chirurgica, Medica, Molecolare e dell'Area Critica, Lungarno Antonio Pacinotti, University of Pisa, 43, 56126 Pisa, Italy.
Department of Biomedical Sciences, Humanitas University, 20072 Milan, Italy.
J Clin Med. 2025 May 1;14(9):3144. doi: 10.3390/jcm14093144.
: Aortic stenosis (AS) is the most prevalent valvular heart disease in developed countries and imposes an increasing burden on aging populations. Although transcatheter aortic valve implantation (TAVI) has transformed the treatment of severe AS, current guidelines do not differentiate management based on gender. This study aimed to investigate gender-based differences in procedural complications and one-year clinical outcomes in patients treated with next-generation self-expandable TAVI devices. : This retrospective, multicenter international registry included 3862 consecutive patients who received either the ACURATE neo or Evolut R/Pro valve. Patients were stratified by gender; propensity score matching (PSM) adjusted for baseline differences. The primary endpoint was a composite of all-cause mortality or stroke at one year. Secondary endpoints included major vascular complications, major or life-threatening bleeding and acute kidney injury (AKI). : Of 3353 patients included (64.5% female), women were older (82.3 ± 5.6 vs. 81.1 ± 6.2 years, < 0.001) and had higher STS scores (5.2 ± 3.9 vs. 4.5 ± 3.4%, < 0.001). In the unmatched population, major vascular complications occurred in 7.7% of females versus 4.1% of males ( < 0.001), life-threatening bleeding in 2.8% vs. 1.4% ( = 0.016) and AKI in 8.5% vs. 5.7% ( = 0.009). After PSM, the primary endpoint was more frequent in females (9.4% vs. 6.0%, = 0.014), largely driven by stroke (2.8% vs. 1.2%, = 0.024), while overall mortality was similar (11.3% vs. 9.5%, = 0.264). : Despite comparable long-term survival, female patients undergoing TAVI with self-expandable valves experience higher rates of procedural complications, notably stroke and major vascular events. These findings underscore the need for tailored procedural strategies to improve outcomes in female patients.
主动脉瓣狭窄(AS)是发达国家最常见的心脏瓣膜病,给老龄化人口带来了日益沉重的负担。尽管经导管主动脉瓣植入术(TAVI)改变了严重AS的治疗方式,但目前的指南并未根据性别区分治疗管理。本研究旨在调查接受下一代自膨胀式TAVI装置治疗的患者在手术并发症和一年临床结局方面的性别差异。
这项回顾性、多中心国际注册研究纳入了3862例连续接受ACURATE neo或Evolut R/Pro瓣膜治疗的患者。患者按性别分层;倾向评分匹配(PSM)用于调整基线差异。主要终点是一年时全因死亡率或中风的复合终点。次要终点包括主要血管并发症、严重或危及生命的出血以及急性肾损伤(AKI)。
在纳入的3353例患者中(64.5%为女性),女性年龄更大(82.3±5.6岁对81.1±6.2岁,P<0.001),且STS评分更高(5.2±3.9%对4.5±3.4%,P<0.001)。在未匹配的人群中,主要血管并发症在7.7%的女性中发生,而在4.1%的男性中发生(P<0.001),危及生命的出血在2.8%的女性中发生,而在1.4%的男性中发生(P = 0.016),AKI在8.5%的女性中发生,而在5.7%的男性中发生(P = 0.009)。PSM后,主要终点在女性中更常见(9.4%对6.0%,P = 0.014),主要由中风驱动(2.8%对1.2%,P = 0.024),而总体死亡率相似(11.3%对9.5%,P = 0.264)。
尽管长期生存率相当,但接受自膨胀瓣膜TAVI治疗的女性患者手术并发症发生率更高,尤其是中风和主要血管事件。这些发现强调了需要制定针对性的手术策略以改善女性患者的结局。