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机构每月经导管缘对缘修复术治疗重度二尖瓣反流的手术量影响:来自GIOTTO-VAT研究的证据。

Impact of Institutional Monthly Volume of Transcatheter Edge-to-Edge Repair Procedures for Significant Mitral Regurgitation: Evidence from the GIOTTO-VAT Study.

作者信息

Corcione Nicola, Ferraro Paolo, Finizio Filippo, Cimmino Michele, Albanese Michele, Morello Alberto, Biondi-Zoccai Giuseppe, Denti Paolo, Rubbio Antonio Popolo, Bedogni Francesco, Bartorelli Antonio L, Mongiardo Annalisa, Giordano Salvatore, De Felice Francesco, Adamo Marianna, Montorfano Matteo, Maisano Francesco, Tarantini Giuseppe, Giannini Francesco, Ronco Federico, Villa Emmanuel, Ferrario Maurizio, Fiocca Luigi, Castriota Fausto, Squeri Angelo, Pepe Martino, Tamburino Corrado, Giordano Arturo

机构信息

Unità Operativa di Interventistica Cardiovascolare, Pineta Grande Hospital, 81030 Castel Volturno, Italy.

Unità Operativa di Emodinamica, Santa Lucia Hospital, 80047 San Giuseppe Vesuviano, Italy.

出版信息

Medicina (Kaunas). 2025 May 16;61(5):904. doi: 10.3390/medicina61050904.

Abstract

: Mitral valve transcatheter edge-to-edge repair (TEER) is a widely adopted therapeutic approach for managing significant mitral regurgitation (MR) in high-risk surgical candidates. While procedural safety and efficacy have been demonstrated, the impact of institutional expertise on outcomes remains unclear. We aimed at evaluating whether the institutional monthly volume of TEER influences short- and long-term clinical results. : This analysis from the multicenter, prospective GIOTTO trial study evaluated the impact of institutional monthly volume on outcomes of TEER to remedy significant mitral regurgitation. Centers were stratified into tertiles based on monthly volumes (≤2.0 cases/month, 2.1-3.5 cases/month, >3.5 cases/month), and key clinical, echocardiographic, and procedural outcomes were analyzed. Statistical analysis was based on standard bivariate tests as well as unadjusted and multivariable adjusted Cox models. : A total of 2213 patients were included, stratified into tertiles based on institutional procedural volume: 645 (29.1%) patients in the first tertile, 947 (42.8%) patients in the second tertile, and 621 (28.1%) patients in the third tertile. Several baseline differences were found, with some features disfavoring less busy centers (e.g., functional class and surgical risk, both < 0.05), and others suggesting a worse risk profile in those treated in busier institutions (e.g., frailty and history of prior mitral valve intervention, both < 0.05). Procedural success rates were higher in busier centers ( < 0.001), and hospital stay was also shorter there ( < 0.001). Long-term follow-up (median 14 months) suggested worse outcomes in patients treated in less busy centers at unadjusted analysis (e.g., = 0.018 for death, = 0.015 for cardiac death, = 0.014 for death or hospitalization for heart failure, < 0.001 for cardiac death or hospitalization for heart failure), even if these associations proved no longer significant after multivariable adjustment, except for cardiac death or hospitalization for heart failure, which appeared significantly less common in the busiest centers ( < 0.05). Similar trends were observed when focusing on tertiles of overall center volume and when comparing for each center the first 50 cases with the following ones. : High institutional monthly volume of TEER mitral valve repair appears to correlate with an improved procedural success rate and shorter hospitalizations. Similarly favorable results were found for long-term rates of cardiac death or hospitalization for heart failure. These findings inform on the importance of operator experience and center expertise in achieving state-of-the-art results with TEER, while confirming the usefulness of the proctoring approach when naïve centers begin a TEER program.

摘要

二尖瓣经导管缘对缘修复术(TEER)是一种广泛应用于治疗高风险手术候选者严重二尖瓣反流(MR)的治疗方法。虽然手术安全性和有效性已得到证实,但机构专业水平对治疗结果的影响仍不明确。我们旨在评估机构每月TEER手术量是否会影响短期和长期临床结果。

这项来自多中心、前瞻性GIOTTO试验研究的分析评估了机构每月手术量对TEER治疗严重二尖瓣反流结果的影响。根据每月手术量(≤2.0例/月、2.1 - 3.5例/月、>3.5例/月)将中心分为三个三分位数组,并分析关键的临床、超声心动图和手术结果。统计分析基于标准双变量检验以及未调整和多变量调整的Cox模型。

共纳入2213例患者,根据机构手术量分层为三个三分位数组:第一三分位数组645例(29.1%)患者,第二三分位数组947例(42.8%)患者,第三三分位数组621例(28.1%)患者。发现了一些基线差异,一些特征对手术量较少的中心不利(如心功能分级和手术风险,均P<0.05),而其他一些特征表明在手术量较大机构接受治疗的患者风险状况更差(如虚弱和既往二尖瓣干预史,均P<0.05)。手术量较大的中心手术成功率更高(P<0.001),住院时间也更短(P<0.001)。长期随访(中位14个月)显示,在未调整分析中,手术量较少中心治疗的患者结果较差(如死亡P = 0.018,心源性死亡P = 0.015,因心力衰竭死亡或住院P = 0.014,因心力衰竭心源性死亡或住院P<0.001),即使在多变量调整后这些关联不再显著,但因心力衰竭心源性死亡或住院在手术量最大的中心明显较少见(P<0.05)。当关注中心总体手术量的三分位数组以及比较每个中心的前50例病例与后续病例时,观察到类似趋势。

机构每月高TEER二尖瓣修复手术量似乎与手术成功率提高和住院时间缩短相关。在心力衰竭心源性死亡或住院的长期发生率方面也发现了类似的有利结果。这些发现说明了术者经验和中心专业水平在通过TEER实现最佳治疗结果方面的重要性,同时证实了新手中心启动TEER项目时指导方法的有用性。

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