Di Muro Francesca Maria, Vogel Birgit, Sartori Samantha, Tchetche Didier, Feng Yihan, Petronio Anna Sonia, Mehilli Julinda, Bay Benjamin, Gitto Mauro, Lefevre Thierry, Presbitero Patrizia, Capranzano Piera, Oliva Angelo, Iadanza Alessandro, Sardella Gennaro, Van Mieghem Nicolas, Meliga Emanuele, Leone Pier Pasquale, Dumonteil Nicolas, Fraccaro Chiara, Trabattoni Daniela, Mikhail Ghada, Ferrer-Gracia Maria-Cruz, Naber Christoph, Sharma Samin K, Watanabe Yusuke, Morice Marie-Claude, Dangas George, Chieffo Alaide, Mehran Roxana
The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York, USA; Department of Experimental and Clinical Medicine, School of Human Health Sciences, Careggi University Hospital, University of Florence, Florence, Italy.
The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York, USA.
Am J Cardiol. 2025 Feb 1;236:56-63. doi: 10.1016/j.amjcard.2024.11.004. Epub 2024 Nov 8.
Limited evidence exists concerning the prognostic impact of baseline left ventricular ejection fraction (LVEF) on outcomes among women undergoing transcatheter aortic valve implantation (TAVI), which we aimed to investigate in the present analysis. Patients from the Women's International Transcatheter Aortic Valve Implantation (WIN-TAVI) registry were categorized according to baseline LVEF into 3 groups: reduced (LVEF ≤40%), mildly reduced (LVEF between 41% and 49%), and preserved (LVEF ≥50%) LVEF. The primary (Valve Academic Research Consortium 2 [VARC-2]) efficacy point was defined as a composite of mortality, stroke, myocardial infarction, hospitalization for valve-related symptoms or heart failure, or valve-related dysfunction at 1 year. The primary (VARC-2) safety end point included all-cause mortality, stroke, major vascular complication, life-threatening bleeding, stage 2 to 3 acute kidney injury, coronary artery obstruction requiring intervention, or valve-related dysfunction requiring repeated procedures. A Cox regression model was performed using the preserved LVEF group as the reference. Among the 944 patients included, 764 (80.9%) exhibited preserved, 80 (8.5%) had mildly reduced, and 100 (10.6%) had reduced LVEF. The 1-year incidence of VARC-2 efficacy end point was numerically higher in patients with reduced LVEF, albeit not resulting in a significant risk difference. Notably, reduced LVEF was associated with a higher risk of the 1-year VARC-2 safety end point, still significant after adjustment (28.0% vs 19.6%, Hazard Ratio 1.78, 95% Confidence Interval 1.12- 2.82, p = 0.014). These differences were primarily driven by trends toward increased rates of all-cause mortality, cardiovascular mortality, and major vascular complications. Clinical outcomes were similar between patients with mildly reduced and preserved LVEF. In conclusion, when performed in women with reduced LVEF, TAVI was associated with a worse (VARC-2) safety profile at 1-year follow-up. In contrast, patients with mildly reduced LVEF appeared to align more closely with outcomes observed in the preserved LVEF group than with the reduced LVEF group.
关于经导管主动脉瓣植入术（TAVI）女性患者中，基线左心室射血分数（LVEF）对预后的影响，现有证据有限，我们旨在通过本分析进行探究。来自国际女性经导管主动脉瓣植入术（WIN-TAVI）注册研究的患者，根据基线LVEF分为3组：LVEF降低组（LVEF≤40%）、轻度降低组（LVEF在41%至49%之间）和保留组（LVEF≥50%）。主要（瓣膜学术研究联盟2 [VARC-2]）疗效终点定义为1年时死亡、中风、心肌梗死、因瓣膜相关症状或心力衰竭住院、或瓣膜相关功能障碍的复合情况。主要（VARC-2）安全终点包括全因死亡、中风、主要血管并发症、危及生命的出血、2至3期急性肾损伤、需要干预的冠状动脉阻塞、或需要重复手术的瓣膜相关功能障碍。使用保留LVEF组作为参照进行Cox回归模型分析。在纳入的944例患者中，764例（80.9%）LVEF保留，80例（8.5%）轻度降低，100例（10.6%）降低。LVEF降低的患者中，VARC-2疗效终点的1年发生率在数值上更高，尽管未导致显著的风险差异。值得注意的是，LVEF降低与1年VARC-2安全终点的较高风险相关，调整后仍具有显著性（28.0%对19.6%，风险比1.78，95%置信区间1.12 - 2.82，p = 0.014）。这些差异主要由全因死亡率、心血管死亡率和主要血管并发症发生率上升的趋势驱动。LVEF轻度降低和保留的患者临床结局相似。总之，在LVEF降低的女性中进行TAVI时，1年随访时其（VARC-2）安全性较差。相比之下，LVEF轻度降低的患者似乎与LVEF保留组观察到的结局更为接近，而非与LVEF降低组。
