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在无现场心脏手术的医院进行经股动脉经导管主动脉瓣植入术(在家中进行经导管主动脉瓣置换术):一项多中心前瞻性干预研究。

Transfemoral Transcatheter Aortic Valve Implantation at Hospitals Without On-Site Cardiac Surgery (TAVI at Home): A Multicenter Prospective Interventional Study.

作者信息

Compagnone Miriam, Dall'Ara Gianni, Grotti Simone, Mambelli Greta, Fabbri Elisabetta, Savini Carlo, Balducelli Marco, Santarelli Andrea, Iorio Elia, Vaquerizo Beatriz, Marchese Alfredo, Tarantini Giuseppe, Saia Francesco, Zingaretti Chiara, Moretti Carolina, Cavazza Caterina, Vertogen Bernadette, Ottani Filippo, Rubboli Andrea, Nanni Oriana, Pizzi Carmine, Galvani Marcello, Tarantino Fabio Felice

机构信息

Interventional and Structural Cardiology Unit Forlì-Cesena, 47121 Forlì, Italy.

Department of Medical and Surgical Sciences-DIMEC-Alma Mater Studiorum, University of Bologna, 40138 Bologna, Italy.

出版信息

J Cardiovasc Dev Dis. 2025 Feb 10;12(2):63. doi: 10.3390/jcdd12020063.

Abstract

Transcatheter aortic valve implantation (TAVI) has become the standard of care for elderly patients with aortic stenosis. International guidelines recommend that TAVI should be performed only in centers with on-site cardiac surgery (CS). However, rapidly evolving TAVI technology and increasing operator expertise have significantly reduced peri-procedural complications, including those requiring rescue surgery, which occur in less than 0.5% of cases. Furthermore, only a minority of major complications are treated with CS, and the outcomes remain unfavorable. TAVI in centers without CS could represent a solution to reduce waiting times and ensure continuity of care for fragile patients. "TAVI at Home" is a single-arm prospective interventional study. According to sample size calculations based on literature data, the study aims to enroll a total of 200 patients, beginning with a run-in phase of 20 patients to establish safety. The primary endpoint is 30-day all-cause mortality. Secondary endpoints include technical success and the evaluation of single complications 30 days after the procedure. Hospitals without CS that are eligible to perform TAVI must have a high volume of coronary percutaneous interventions, operators with established TAVI experience, collaboration with vascular surgeons, and regular Heart Team meetings to ensure rigorous patient selection.

摘要

经导管主动脉瓣植入术(TAVI)已成为老年主动脉瓣狭窄患者的标准治疗方法。国际指南建议,TAVI仅应在具备现场心脏手术(CS)的中心进行。然而,快速发展的TAVI技术和操作人员专业水平的提高已显著降低围手术期并发症,包括需要抢救手术的并发症,其发生率不到0.5%。此外,只有少数主要并发症通过CS治疗,且结果仍然不理想。在没有CS的中心进行TAVI可能是减少等待时间并确保为脆弱患者提供连续护理的一种解决方案。“在家中进行TAVI”是一项单臂前瞻性干预研究。根据基于文献数据的样本量计算,该研究旨在总共招募200名患者,首先进行20名患者的导入期以确定安全性。主要终点是30天全因死亡率。次要终点包括技术成功以及术后30天对单一并发症的评估。有资格进行TAVI的无CS医院必须有大量的冠状动脉经皮介入治疗、有TAVI经验的操作人员、与血管外科医生的合作以及定期的心脏团队会议,以确保严格的患者选择。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4d81/11856494/84370b416f3e/jcdd-12-00063-g001.jpg

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