Manuel Pan, Rafael González-Manzanares, Sergio García Blas, Juan M Ruiz-Nodar, Elena Izaga Torralba, Alba Abril Molina, José M de la Torre-Hernández, Daniel Tébar, Ignacio Gallo, Claudio Rivadulla, Francisco Torres Saura, Antonio E Gómez Menchero, José F Díaz, Gabriela Veiga Fernández, Joaquín Vila-García, Marta Herrero Brocal, Raúl Moreno, Juan Sanchis, Soledad Ojeda
{"title":"新的扩张不足标准无法预测新氧瓣膜植入术后的结果:来自独立的多中心注册中心的结果。","authors":"Manuel Pan, Rafael González-Manzanares, Sergio García Blas, Juan M Ruiz-Nodar, Elena Izaga Torralba, Alba Abril Molina, José M de la Torre-Hernández, Daniel Tébar, Ignacio Gallo, Claudio Rivadulla, Francisco Torres Saura, Antonio E Gómez Menchero, José F Díaz, Gabriela Veiga Fernández, Joaquín Vila-García, Marta Herrero Brocal, Raúl Moreno, Juan Sanchis, Soledad Ojeda","doi":"10.1016/j.rec.2025.09.007","DOIUrl":null,"url":null,"abstract":"<p><strong>Introduction and objectives: </strong>Suboptimal outcomes with the ACURATE neo2 valve have been attributed to valve frame underexpansion, reported in approximately 20% of cases according to 3 recently proposed angiographic criteria. We aimed to validate these criteria in an independent registry with a 2-year follow-up.</p><p><strong>Methods: </strong>This registry included 696 patients with severe aortic stenosis treated with the ACURATE neo2 valve at 7 experienced centers. Underexpansion was defined as the presence of at least 1 of the 3 criteria; the boundary box method was also applied to assess postparallelism. The primary endpoint was a composite of all-cause mortality, stroke, or heart failure hospitalization at 2 years.</p><p><strong>Results: </strong>The mean age was 81 ± 5.8 years. Based on the 3-criteria method, underexpansion was identified in 154 patients (22%). There were no significant differences in the primary endpoint between the 2 groups. The cumulative incidence of the composite outcome was 13.7% vs 11.0% at 1 year and 21.0% vs 17.4% at 2 years for the underexpanded and expanded groups, respectively (P = .535). Similarly, no differences were observed with the boundary box method. On multivariable analysis, underexpansion was not independently associated with the primary endpoint (HR, 1.15; 95%CI, 0.73-1.80, P = .537). The only variables significantly associated with major adverse events at 2-years were atrial fibrillation, diabetes mellitus, and reduced glomerular filtration rate.</p><p><strong>Conclusions: </strong>The presence of at least 1 angiographic underexpansion criterion after ACURATE neo2 implantation did not predict adverse outcomes at follow-up.</p>","PeriodicalId":38430,"journal":{"name":"Revista española de cardiología (English ed.)","volume":" ","pages":""},"PeriodicalIF":4.9000,"publicationDate":"2025-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Failure of the new underexpansion criteria to predict outcomes after ACURATE neo2 valve implantation: results from an independent multicenter registry.\",\"authors\":\"Manuel Pan, Rafael González-Manzanares, Sergio García Blas, Juan M Ruiz-Nodar, Elena Izaga Torralba, Alba Abril Molina, José M de la Torre-Hernández, Daniel Tébar, Ignacio Gallo, Claudio Rivadulla, Francisco Torres Saura, Antonio E Gómez Menchero, José F Díaz, Gabriela Veiga Fernández, Joaquín Vila-García, Marta Herrero Brocal, Raúl Moreno, Juan Sanchis, Soledad Ojeda\",\"doi\":\"10.1016/j.rec.2025.09.007\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Introduction and objectives: </strong>Suboptimal outcomes with the ACURATE neo2 valve have been attributed to valve frame underexpansion, reported in approximately 20% of cases according to 3 recently proposed angiographic criteria. We aimed to validate these criteria in an independent registry with a 2-year follow-up.</p><p><strong>Methods: </strong>This registry included 696 patients with severe aortic stenosis treated with the ACURATE neo2 valve at 7 experienced centers. Underexpansion was defined as the presence of at least 1 of the 3 criteria; the boundary box method was also applied to assess postparallelism. The primary endpoint was a composite of all-cause mortality, stroke, or heart failure hospitalization at 2 years.</p><p><strong>Results: </strong>The mean age was 81 ± 5.8 years. Based on the 3-criteria method, underexpansion was identified in 154 patients (22%). There were no significant differences in the primary endpoint between the 2 groups. The cumulative incidence of the composite outcome was 13.7% vs 11.0% at 1 year and 21.0% vs 17.4% at 2 years for the underexpanded and expanded groups, respectively (P = .535). Similarly, no differences were observed with the boundary box method. On multivariable analysis, underexpansion was not independently associated with the primary endpoint (HR, 1.15; 95%CI, 0.73-1.80, P = .537). The only variables significantly associated with major adverse events at 2-years were atrial fibrillation, diabetes mellitus, and reduced glomerular filtration rate.</p><p><strong>Conclusions: </strong>The presence of at least 1 angiographic underexpansion criterion after ACURATE neo2 implantation did not predict adverse outcomes at follow-up.</p>\",\"PeriodicalId\":38430,\"journal\":{\"name\":\"Revista española de cardiología (English ed.)\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":4.9000,\"publicationDate\":\"2025-09-30\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Revista española de cardiología (English ed.)\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1016/j.rec.2025.09.007\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"CARDIAC & CARDIOVASCULAR SYSTEMS\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Revista española de cardiología (English ed.)","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1016/j.rec.2025.09.007","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"CARDIAC & CARDIOVASCULAR SYSTEMS","Score":null,"Total":0}
Failure of the new underexpansion criteria to predict outcomes after ACURATE neo2 valve implantation: results from an independent multicenter registry.
Introduction and objectives: Suboptimal outcomes with the ACURATE neo2 valve have been attributed to valve frame underexpansion, reported in approximately 20% of cases according to 3 recently proposed angiographic criteria. We aimed to validate these criteria in an independent registry with a 2-year follow-up.
Methods: This registry included 696 patients with severe aortic stenosis treated with the ACURATE neo2 valve at 7 experienced centers. Underexpansion was defined as the presence of at least 1 of the 3 criteria; the boundary box method was also applied to assess postparallelism. The primary endpoint was a composite of all-cause mortality, stroke, or heart failure hospitalization at 2 years.
Results: The mean age was 81 ± 5.8 years. Based on the 3-criteria method, underexpansion was identified in 154 patients (22%). There were no significant differences in the primary endpoint between the 2 groups. The cumulative incidence of the composite outcome was 13.7% vs 11.0% at 1 year and 21.0% vs 17.4% at 2 years for the underexpanded and expanded groups, respectively (P = .535). Similarly, no differences were observed with the boundary box method. On multivariable analysis, underexpansion was not independently associated with the primary endpoint (HR, 1.15; 95%CI, 0.73-1.80, P = .537). The only variables significantly associated with major adverse events at 2-years were atrial fibrillation, diabetes mellitus, and reduced glomerular filtration rate.
Conclusions: The presence of at least 1 angiographic underexpansion criterion after ACURATE neo2 implantation did not predict adverse outcomes at follow-up.