Krishnaswamy Amar, Abbas Amr E, Babaliaros Vasilis C, Greenbaum Adam B, Yadav Pradeep, Moussa Issam D, Reed Grant W, Laham Roger J, Morse Michael A, Rodriguez Evelio, Depta Jeremiah P, McCabe James M, Bapat Vinayak N, Thourani Vinod H, Kapadia Samir R, Kaneko Tsuyoshi
Cleveland Clinic, Cleveland, Ohio, USA.
Department of Cardiovascular Medicine, Corewell Health William Beaumont University Hospital, Royal Oak, Michigan, USA.
JACC Cardiovasc Interv. 2025 Aug 25;18(16):1989-2000. doi: 10.1016/j.jcin.2025.06.039.
Aortic valve-in-valve (AViV) replacement for is approved for patients with degenerated surgical valves at high or prohibitive surgical risk, mostly on the basis of small series with short-term follow-up.
The aim of this study was to analyze the outcomes of AViV therapy using contemporary balloon-expandable valves (BEVs) in a large series with mid-term outcomes.
BEV AViV patients (June 2015 to December 2023) in the Society for Thoracic Surgeons (STS)/American College of Cardiology TVT (Transcatheter Valve Therapy) Registry were propensity matched to native transcatheter aortic valve replacement (TAVR) patients. Primary analysis included death and stroke at 5 years. Comparisons were also made on the basis of STS score, BEV subtype, and stented vs stentless index surgical valve type.
In total, 14,474 AViV patients were matched to 385,556 TAVR patients (13,638 pairs). The mean age was 74 years, and the mean STS Predicted Risk of Mortality was 6.1%. Emergency cardiac surgery (0.2%) and bioprosthetic valve fracture (22%) were infrequent. Death (43.1% vs 55.2%; P < 0.001), stroke (10.5% vs 11.8%; P < 0.001), and their composite were lower for AViV compared with TAVR at 5 years with similar findings at each STS tertile. The SAPIEN 3 Ultra RESILIA device demonstrated lower discharge echo gradients for all sizes (20 mm, 19.4 mm Hg vs 23.8 mm Hg; 23 mm, 15.1 mm Hg vs 19.2 mm Hg; 26 mm, 12.1 mm Hg vs 15.1 mm Hg; and 29 mm, 8.6 mm Hg vs 12.1 mm Hg). There was no difference in death or stroke at 5 years for stentless vs stented surgical valves (42.9% vs 46.0%; P = 0.12).
This large, real-world analysis confirms the safety and durability of AViV compared with TAVR at all surgical risk levels at mid-term follow-up. Consideration may be given to broadening the indication for AViV.
经导管主动脉瓣置入术（AViV）已被批准用于外科手术瓣膜退化且手术风险高或手术风险不可接受的患者，这主要基于小样本且短期随访的研究。
本研究旨在分析在一个包含中期结果的大样本队列中，使用当代球囊扩张瓣膜（BEV）进行AViV治疗的结果。
将胸外科医师协会（STS）/美国心脏病学会经导管瓣膜治疗（TVT）注册研究中2015年6月至2023年12月期间接受BEV AViV治疗的患者，按倾向得分匹配至接受经导管主动脉瓣置换术（TAVR）的患者。主要分析包括5年时的死亡和卒中情况。还根据STS评分、BEV亚型以及带支架与无支架的外科瓣膜类型进行了比较。
总共14474例AViV患者与385556例TAVR患者进行了匹配（共13638对）。平均年龄为74岁，平均STS预测死亡风险为6.1%。急诊心脏手术（0.2%）和生物瓣膜破裂（22%）的发生率较低。5年时，AViV组的死亡（43.1%对55.2%；P<0.001）、卒中（10.5%对11.8%；P<0.001）及其复合终点均低于TAVR组，在每个STS三分位数中均有类似发现。SAPIEN 3 Ultra RESILIA装置在所有尺寸下均显示出较低的出院时超声心动图梯度（20mm，19.4mmHg对23.8mmHg；23mm，15.1mmHg对19.2mmHg；26mm，12.1mmHg对15.1mmHg；29mm，8.6mmHg对12.1mmHg）。无支架与带支架的外科瓣膜在5年时的死亡或卒中情况无差异（42.9%对46.0%；P = 0.12）。
这项大型的真实世界分析证实，在中期随访中，在所有手术风险水平下，AViV与TAVR相比具有安全性和耐久性。可考虑扩大AViV的适应证。
