Santarpino Giuseppe, Lorusso Roberto, Concistrè Giovanni, Castillo Josè Cuenca, Argano Vincenzo, Royse Alistair, Nobre Angelo Lucas, Parrino Patrick, Bisleri Gianluigi, Baghai Max, Fischlein Theodor, Troise Giovanni, Mastrogiovanni Generoso, Fontaine Raphael, Pacini Davide, Minniti Giuseppe, Pappalardo Aniello, Hughes George Chad, Noirhomme Philippe, Grimaud Jean-Philippe, Scherner Maximilian, Muñoz Ignacio, Asimakopoulos George, Walker Antony, Zakova Daniela, Torella Michele, Vigano Giorgio, Connolly Mark, Dinges Christian, Corbi Pierre, Salvador Loris, Rinaldi Mauro, Maroto Luis, Heimansohn David, Ramlawi Basel, Glauber Mattia, D'Agnano Jlenia, Cosco Valeria, D'Anna Veronica, Solinas Marco
Department of Clinical and Experimental Medicine, Magna Graecia University, Catanzaro, Italy.
Department of Cardiac Surgery, Città di Lecce Hospital, GVM Care & Research, Lecce, Italy.
J Cardiothorac Surg. 2025 Jul 25;20(1):313. doi: 10.1186/s13019-025-03558-9.
The treatment of aortic valve disease in small annuli remains a debated topic in terms of prosthetic choice - biological or mechanical - and risk of patient prosthesis mismatch.
The clinical data of the 241 patients who received a small size sutureless prosthesis from the Sorin Universal REgistry on Aortic Valve Replacement (SURE-AVR) (NCT02679404) were analysed at 30 days and at follow-up. The mean age was 75.5 ± 7.8 years (89.2% female); the mean Society of Thoracic Surgeons (STS) score was 4.2 ± 3.2%, and the preoperative NYHA class II or III score was 83.8%. A minimally invasive approach was performed in 52.7% of patients; concomitant procedures were performed in 27.8% of patients. Similar aortic clamping and cardiopulmonary bypass times were observed in the overall isolated cohort and the isolated minimally invasive cohort. The mean intensive care unit (ICU) stay was 2.4 ± 2.0 days and the total length of stay was 10.3 ± 6.1 days.
Three deaths were recorded at 30 days (1.2%), 2 for noncardiac causes. One patient experienced a myocardial infarction (0.4%) and 2 a nondisabling stroke (0.8%). 2 patients showed intraprosthetic leakage ≥ 2 and one patient para-prosthetic leakage ≥ 2; of these, one patient required reoperation with prosthesis removal. 4.1% of patients required a pacemaker implant. At a maximum follow-up of 8.1 years, 10 cardiovascular deaths, 4 valve related reinterventions (3 structural valve deterioration (SVD) requiring TAVI Valve-in-Valve, 1 endocarditis) occurred.
With their good clinical outcomes, sutureless prostheses represent a good alternative for patients with small annuli, who are at high risk for annular enlargement and anticoagulant therapy.
Study number 587/2015.
在小瓣环主动脉瓣疾病的治疗中，就人工瓣膜的选择（生物瓣或机械瓣）以及患者-人工瓣膜不匹配的风险而言，仍是一个存在争议的话题。
对索林通用主动脉瓣置换注册研究（SURE-AVR）（NCT02679404）中接受小尺寸无缝合人工瓣膜的241例患者的临床数据进行了30天及随访分析。平均年龄为75.5±7.8岁（89.2%为女性）；胸外科医师协会（STS）平均评分为4.2±3.2%，术前纽约心脏协会（NYHA）II级或III级评分占83.8%。52.7%的患者采用了微创方法；27.8%的患者进行了同期手术。在整个单纯队列和单纯微创队列中观察到相似的主动脉阻断和体外循环时间。平均重症监护病房（ICU）住院时间为2.4±2.0天，总住院时间为10.3±6.1天。
30天时记录到3例死亡（1.2%），2例为非心脏原因。1例患者发生心肌梗死（0.4%），2例发生非致残性卒中（0.8%）。2例患者出现人工瓣膜内漏≥2级，1例患者出现人工瓣膜旁漏≥2级；其中1例患者需要移除人工瓣膜再次手术。4.1%的患者需要植入起搏器。在最长8.1年的随访中，发生了10例心血管死亡，4例瓣膜相关再次干预（3例因结构性瓣膜退变（SVD）需要经导管主动脉瓣置入术（TAVI）瓣中瓣治疗，1例因心内膜炎）。
无缝合人工瓣膜具有良好的临床结果，对于瓣环扩大和抗凝治疗风险高的小瓣环患者来说是一个很好的选择。
研究编号587/2015。
