Akash Jain, John Jose, Matteo Montorfano, Henrik Nissen, Pedro Martin, Ashok Seth, Kresimir Stambuk, Sengottuvelu Gunasekaran, Mussayev Abdurashid, Mario García-Gómez, Clara Fernandez-Cordón, Alberto Campo, Marcelo Rodriguez, Mathias D Jorgensen, Sofía Campillo, Manuel Carrasco-Moraleja, Alberto San Román, Ignacio J Amat-Santos
{"title":"自膨胀精确Neo-2和球囊膨胀Myval经导管心脏瓣膜4年随访比较。","authors":"Akash Jain, John Jose, Matteo Montorfano, Henrik Nissen, Pedro Martin, Ashok Seth, Kresimir Stambuk, Sengottuvelu Gunasekaran, Mussayev Abdurashid, Mario García-Gómez, Clara Fernandez-Cordón, Alberto Campo, Marcelo Rodriguez, Mathias D Jorgensen, Sofía Campillo, Manuel Carrasco-Moraleja, Alberto San Román, Ignacio J Amat-Santos","doi":"10.1002/ccd.70034","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Recently, Acurate neo2 (ACN2; Boston Scientific, US) and Sapien-3 series (Edwards Lifesciences, US) were compared in the IDE trial failing to demonstrate non-inferiority of ACN2. The Myval series (MyV), an alternative balloon-expandable device, demonstrated non-inferiority compared to Sapien-3 and Evolut (Medtronic, US) in the LANDMARK trial. However, no direct comparison exists between ACN2 and MyV.</p><p><strong>Aims: </strong>We aimed to compare mid-term clinical and hemodynamic outcomes of the ACN2 and MyV transcatheter heart valves.</p><p><strong>Methods: </strong>This multicenter retrospective analysis included patients implanted with ACN2 and MyV series devices. The primary objective was to assess 1-year mortality and stroke rates. Secondary outcomes included technical success, mortality, stroke, residual aortic regurgitation (AR), mean aortic gradients, and new permanent pacemaker implantation (PPI) rates up to 4 years. A matched comparison adjusting for clinical and anatomical characteristics was performed and echocardiograms were centrally analyzed.</p><p><strong>Results: </strong>A total of 545 patients (ACN2: 144; MyV: 401) from nine institutions were included. Matched technical success rates were 87.6% and 94.4%, p = 0.180 (90.3% for ACN2 and 97% for MyV; p < 0.001 in unmatched). In-hospital matched PPI rates were 10.1% for ACN2 and 9% for MyV. At 4 years, matched residual ≥ moderate AR rates were similar (ACN2: 15.8% vs. MyV: 21.1%, p = 0.706), though ACN2 showed better mean aortic gradients (9.2 ± 4.2 vs. 13.1 ± 5.4, p = 0.001) and effective orifice area. Unmatched mortality + stroke rates were comparable but lower for ACN2 after matching (3.4% vs. 15.7%, p = 0.005). Importantly, cardiovascular mortality (3.4% for ACN2 and 5.6% for MyV, p = 0.720) and valve-related deaths were comparable.</p><p><strong>Conclusion: </strong>ACN2 showed superior long-term hemodynamics and lower matched 4-year mortality and stroke rates, though cardiovascular mortality and valve-related deaths were comparable.</p>","PeriodicalId":520583,"journal":{"name":"Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions","volume":" ","pages":""},"PeriodicalIF":0.0000,"publicationDate":"2025-07-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Comparison of Self-Expandable Acurate Neo-2 and Balloon-Expandable Myval Transcatheter Heart Valves at 4-Year Follow-Up.\",\"authors\":\"Akash Jain, John Jose, Matteo Montorfano, Henrik Nissen, Pedro Martin, Ashok Seth, Kresimir Stambuk, Sengottuvelu Gunasekaran, Mussayev Abdurashid, Mario García-Gómez, Clara Fernandez-Cordón, Alberto Campo, Marcelo Rodriguez, Mathias D Jorgensen, Sofía Campillo, Manuel Carrasco-Moraleja, Alberto San Román, Ignacio J Amat-Santos\",\"doi\":\"10.1002/ccd.70034\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Recently, Acurate neo2 (ACN2; Boston Scientific, US) and Sapien-3 series (Edwards Lifesciences, US) were compared in the IDE trial failing to demonstrate non-inferiority of ACN2. The Myval series (MyV), an alternative balloon-expandable device, demonstrated non-inferiority compared to Sapien-3 and Evolut (Medtronic, US) in the LANDMARK trial. However, no direct comparison exists between ACN2 and MyV.</p><p><strong>Aims: </strong>We aimed to compare mid-term clinical and hemodynamic outcomes of the ACN2 and MyV transcatheter heart valves.</p><p><strong>Methods: </strong>This multicenter retrospective analysis included patients implanted with ACN2 and MyV series devices. The primary objective was to assess 1-year mortality and stroke rates. Secondary outcomes included technical success, mortality, stroke, residual aortic regurgitation (AR), mean aortic gradients, and new permanent pacemaker implantation (PPI) rates up to 4 years. A matched comparison adjusting for clinical and anatomical characteristics was performed and echocardiograms were centrally analyzed.</p><p><strong>Results: </strong>A total of 545 patients (ACN2: 144; MyV: 401) from nine institutions were included. Matched technical success rates were 87.6% and 94.4%, p = 0.180 (90.3% for ACN2 and 97% for MyV; p < 0.001 in unmatched). In-hospital matched PPI rates were 10.1% for ACN2 and 9% for MyV. At 4 years, matched residual ≥ moderate AR rates were similar (ACN2: 15.8% vs. MyV: 21.1%, p = 0.706), though ACN2 showed better mean aortic gradients (9.2 ± 4.2 vs. 13.1 ± 5.4, p = 0.001) and effective orifice area. Unmatched mortality + stroke rates were comparable but lower for ACN2 after matching (3.4% vs. 15.7%, p = 0.005). Importantly, cardiovascular mortality (3.4% for ACN2 and 5.6% for MyV, p = 0.720) and valve-related deaths were comparable.</p><p><strong>Conclusion: </strong>ACN2 showed superior long-term hemodynamics and lower matched 4-year mortality and stroke rates, though cardiovascular mortality and valve-related deaths were comparable.</p>\",\"PeriodicalId\":520583,\"journal\":{\"name\":\"Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2025-07-23\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1002/ccd.70034\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1002/ccd.70034","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
Comparison of Self-Expandable Acurate Neo-2 and Balloon-Expandable Myval Transcatheter Heart Valves at 4-Year Follow-Up.
Background: Recently, Acurate neo2 (ACN2; Boston Scientific, US) and Sapien-3 series (Edwards Lifesciences, US) were compared in the IDE trial failing to demonstrate non-inferiority of ACN2. The Myval series (MyV), an alternative balloon-expandable device, demonstrated non-inferiority compared to Sapien-3 and Evolut (Medtronic, US) in the LANDMARK trial. However, no direct comparison exists between ACN2 and MyV.
Aims: We aimed to compare mid-term clinical and hemodynamic outcomes of the ACN2 and MyV transcatheter heart valves.
Methods: This multicenter retrospective analysis included patients implanted with ACN2 and MyV series devices. The primary objective was to assess 1-year mortality and stroke rates. Secondary outcomes included technical success, mortality, stroke, residual aortic regurgitation (AR), mean aortic gradients, and new permanent pacemaker implantation (PPI) rates up to 4 years. A matched comparison adjusting for clinical and anatomical characteristics was performed and echocardiograms were centrally analyzed.
Results: A total of 545 patients (ACN2: 144; MyV: 401) from nine institutions were included. Matched technical success rates were 87.6% and 94.4%, p = 0.180 (90.3% for ACN2 and 97% for MyV; p < 0.001 in unmatched). In-hospital matched PPI rates were 10.1% for ACN2 and 9% for MyV. At 4 years, matched residual ≥ moderate AR rates were similar (ACN2: 15.8% vs. MyV: 21.1%, p = 0.706), though ACN2 showed better mean aortic gradients (9.2 ± 4.2 vs. 13.1 ± 5.4, p = 0.001) and effective orifice area. Unmatched mortality + stroke rates were comparable but lower for ACN2 after matching (3.4% vs. 15.7%, p = 0.005). Importantly, cardiovascular mortality (3.4% for ACN2 and 5.6% for MyV, p = 0.720) and valve-related deaths were comparable.
Conclusion: ACN2 showed superior long-term hemodynamics and lower matched 4-year mortality and stroke rates, though cardiovascular mortality and valve-related deaths were comparable.
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