Andreas Ruck, Won-Keun Kim, Paolo Alberto Del Sole, Max Wagener, Angela McInerney, Magdi S Yacoub, Elfatih A Hasabo, Cagri Ayhan, Hesham Elzomor, Dina Neiroukh, Abdul Amir, Nawzad Saleh, Magnus Settergren, Rickard Lindler, Dinos Verouhis, Samuel Sossalla, Matthias Renker, Matteo Montorfano, Barbara Bellini, Xavier Carrillo Suarez, Victoria Vilalta Del Olmo, Federico De Marco, Matteo Biroli, Helge Mollmann, Eckel Clemens Enno, Giuseppe Tarantini, Tommaso Fabris, Alfonso Ielasi, Giuliano Costa, Marco Barbanti, Osama Soliman, Darren Mylotte
{"title":"使用 ACURATE neo2 对重度双尖瓣主动脉瓣狭窄进行 TAVI：Neo2 BAV 注册。","authors":"Andreas Ruck, Won-Keun Kim, Paolo Alberto Del Sole, Max Wagener, Angela McInerney, Magdi S Yacoub, Elfatih A Hasabo, Cagri Ayhan, Hesham Elzomor, Dina Neiroukh, Abdul Amir, Nawzad Saleh, Magnus Settergren, Rickard Lindler, Dinos Verouhis, Samuel Sossalla, Matthias Renker, Matteo Montorfano, Barbara Bellini, Xavier Carrillo Suarez, Victoria Vilalta Del Olmo, Federico De Marco, Matteo Biroli, Helge Mollmann, Eckel Clemens Enno, Giuseppe Tarantini, Tommaso Fabris, Alfonso Ielasi, Giuliano Costa, Marco Barbanti, Osama Soliman, Darren Mylotte","doi":"10.4244/EIJ-D-24-00869","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>The ACURATE neo2 is a contemporary transcatheter aortic valve implantation (TAVI) system approved for the treatment of severe aortic stenosis in Europe. The ACURATE neo2 has not been evaluated in bicuspid aortic valve (BAV) stenosis.</p><p><strong>Aims: </strong>We sought to evaluate the safety and efficacy of ACURATE neo2 in patients with BAV stenosis.</p><p><strong>Methods: </strong>We retrospectively analysed consecutive severe BAV stenosis patients undergoing TAVI with ACURATE neo2 at 10 European centres. Imaging data from preprocedural multislice computed tomography, pre- and postprocedural echocardiography, and procedural cinefluoroscopy were evaluated by a core laboratory. Valve Academic Research Consortium 3 (VARC-3)-defined 30-day procedure safety and efficacy were the primary endpoints. Adverse events were site-reported according to VARC-3 criteria.</p><p><strong>Results: </strong>Among 181 patients with BAV stenosis treated with the ACURATE neo2, the mean age was 77.5±7.2 years, 58.0% were female, and the Society of Thoracic Surgeons Predicted Risk of Mortality (STS-PROM) score was 2.3% (1.6-3.7%). Most procedures were transfemoral, and predilatation was performed in all cases. A second valve was required in 4 cases (2.2%). VARC-3-defined technical success was 95.6%. The primary endpoints of device success and early safety occurred in 90.6% and 82.3%, respectively. At 30 days, cardiovascular death occurred in 2.2% (N=4) and stroke in 1.6% (N=3). Core laboratory-adjudicated echocardiography reported an effective orifice area of 2.0 (1.7-2.5) cm<sup>2</sup> and a mean transvalvular gradient of 6.5 (4.6-9.0) mmHg. Half of all cases (51.2%) had no paravalvular leak, while moderate leak occurred in 4.3%. A new permanent pacemaker was required in 11 patients (6.5%).</p><p><strong>Conclusions: </strong>The ACURATE neo2 demonstrated favourable clinical outcomes and bioprosthetic valve performance at 30 days in selected patients with severe BAV stenosis.</p>","PeriodicalId":54378,"journal":{"name":"Eurointervention","volume":" ","pages":"e130-e139"},"PeriodicalIF":7.6000,"publicationDate":"2025-01-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11727691/pdf/","citationCount":"0","resultStr":"{\"title\":\"TAVI with the ACURATE neo2 in severe bicuspid aortic valve stenosis: the Neo2 BAV Registry.\",\"authors\":\"Andreas Ruck, Won-Keun Kim, Paolo Alberto Del Sole, Max Wagener, Angela McInerney, Magdi S Yacoub, Elfatih A Hasabo, Cagri Ayhan, Hesham Elzomor, Dina Neiroukh, Abdul Amir, Nawzad Saleh, Magnus Settergren, Rickard Lindler, Dinos Verouhis, Samuel Sossalla, Matthias Renker, Matteo Montorfano, Barbara Bellini, Xavier Carrillo Suarez, Victoria Vilalta Del Olmo, Federico De Marco, Matteo Biroli, Helge Mollmann, Eckel Clemens Enno, Giuseppe Tarantini, Tommaso Fabris, Alfonso Ielasi, Giuliano Costa, Marco Barbanti, Osama Soliman, Darren Mylotte\",\"doi\":\"10.4244/EIJ-D-24-00869\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>The ACURATE neo2 is a contemporary transcatheter aortic valve implantation (TAVI) system approved for the treatment of severe aortic stenosis in Europe. The ACURATE neo2 has not been evaluated in bicuspid aortic valve (BAV) stenosis.</p><p><strong>Aims: </strong>We sought to evaluate the safety and efficacy of ACURATE neo2 in patients with BAV stenosis.</p><p><strong>Methods: </strong>We retrospectively analysed consecutive severe BAV stenosis patients undergoing TAVI with ACURATE neo2 at 10 European centres. Imaging data from preprocedural multislice computed tomography, pre- and postprocedural echocardiography, and procedural cinefluoroscopy were evaluated by a core laboratory. Valve Academic Research Consortium 3 (VARC-3)-defined 30-day procedure safety and efficacy were the primary endpoints. Adverse events were site-reported according to VARC-3 criteria.</p><p><strong>Results: </strong>Among 181 patients with BAV stenosis treated with the ACURATE neo2, the mean age was 77.5±7.2 years, 58.0% were female, and the Society of Thoracic Surgeons Predicted Risk of Mortality (STS-PROM) score was 2.3% (1.6-3.7%). Most procedures were transfemoral, and predilatation was performed in all cases. A second valve was required in 4 cases (2.2%). VARC-3-defined technical success was 95.6%. The primary endpoints of device success and early safety occurred in 90.6% and 82.3%, respectively. At 30 days, cardiovascular death occurred in 2.2% (N=4) and stroke in 1.6% (N=3). Core laboratory-adjudicated echocardiography reported an effective orifice area of 2.0 (1.7-2.5) cm<sup>2</sup> and a mean transvalvular gradient of 6.5 (4.6-9.0) mmHg. Half of all cases (51.2%) had no paravalvular leak, while moderate leak occurred in 4.3%. A new permanent pacemaker was required in 11 patients (6.5%).</p><p><strong>Conclusions: </strong>The ACURATE neo2 demonstrated favourable clinical outcomes and bioprosthetic valve performance at 30 days in selected patients with severe BAV stenosis.</p>\",\"PeriodicalId\":54378,\"journal\":{\"name\":\"Eurointervention\",\"volume\":\" \",\"pages\":\"e130-e139\"},\"PeriodicalIF\":7.6000,\"publicationDate\":\"2025-01-20\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11727691/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Eurointervention\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.4244/EIJ-D-24-00869\",\"RegionNum\":1,\"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":"Eurointervention","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.4244/EIJ-D-24-00869","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"CARDIAC & CARDIOVASCULAR SYSTEMS","Score":null,"Total":0}
TAVI with the ACURATE neo2 in severe bicuspid aortic valve stenosis: the Neo2 BAV Registry.
Background: The ACURATE neo2 is a contemporary transcatheter aortic valve implantation (TAVI) system approved for the treatment of severe aortic stenosis in Europe. The ACURATE neo2 has not been evaluated in bicuspid aortic valve (BAV) stenosis.
Aims: We sought to evaluate the safety and efficacy of ACURATE neo2 in patients with BAV stenosis.
Methods: We retrospectively analysed consecutive severe BAV stenosis patients undergoing TAVI with ACURATE neo2 at 10 European centres. Imaging data from preprocedural multislice computed tomography, pre- and postprocedural echocardiography, and procedural cinefluoroscopy were evaluated by a core laboratory. Valve Academic Research Consortium 3 (VARC-3)-defined 30-day procedure safety and efficacy were the primary endpoints. Adverse events were site-reported according to VARC-3 criteria.
Results: Among 181 patients with BAV stenosis treated with the ACURATE neo2, the mean age was 77.5±7.2 years, 58.0% were female, and the Society of Thoracic Surgeons Predicted Risk of Mortality (STS-PROM) score was 2.3% (1.6-3.7%). Most procedures were transfemoral, and predilatation was performed in all cases. A second valve was required in 4 cases (2.2%). VARC-3-defined technical success was 95.6%. The primary endpoints of device success and early safety occurred in 90.6% and 82.3%, respectively. At 30 days, cardiovascular death occurred in 2.2% (N=4) and stroke in 1.6% (N=3). Core laboratory-adjudicated echocardiography reported an effective orifice area of 2.0 (1.7-2.5) cm2 and a mean transvalvular gradient of 6.5 (4.6-9.0) mmHg. Half of all cases (51.2%) had no paravalvular leak, while moderate leak occurred in 4.3%. A new permanent pacemaker was required in 11 patients (6.5%).
Conclusions: The ACURATE neo2 demonstrated favourable clinical outcomes and bioprosthetic valve performance at 30 days in selected patients with severe BAV stenosis.
期刊介绍：
EuroIntervention Journal is an international, English language, peer-reviewed journal whose aim is to create a community of high quality research and education in the field of percutaneous and surgical cardiovascular interventions.
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