Teoman Kilic, Alfonso Ielasi, Vlasis Ninios, Levent Korkmaz, Demosthenes Panagiotakos, Gokhan Yerlikaya, Ahmet Ozderya, Carolina Montonati, Maurizio Tespili, Senol Coskun, Tayfun Sahin, Ilias Ninios, Konstantina Vlasopoulou, Ali Hakan Konus, Selim Kul, Ali Riza Akyuz
{"title":"Myval经导管心脏瓣膜系统对重度主动脉瓣狭窄患者的临床疗效：一项为期两年的随访观察研究。","authors":"Teoman Kilic, Alfonso Ielasi, Vlasis Ninios, Levent Korkmaz, Demosthenes Panagiotakos, Gokhan Yerlikaya, Ahmet Ozderya, Carolina Montonati, Maurizio Tespili, Senol Coskun, Tayfun Sahin, Ilias Ninios, Konstantina Vlasopoulou, Ali Hakan Konus, Selim Kul, Ali Riza Akyuz","doi":"10.5114/aoms/176937","DOIUrl":null,"url":null,"abstract":"<p><strong>Introduction: </strong>Limited data exist on long-term follow-up of severe aortic stenosis (SAS) patients who have undergone transcatheter aortic valve implantation (TAVI) with a new generation, balloon expandable Myval transcatheter heart valve (THV). Thus, we sought to investigate the performance and 2-year clinical outcome of the Myval THV system based on Valve Academic Research Consortium-3 (VARC-3) criteria.</p><p><strong>Material and methods: </strong>A multi-centre, registry-based, observational study was conducted, which included 207 consecutive degenerative SAS patients, from Turkey (<i>n</i> = 128), Italy (<i>n</i> = 58), and Greece (<i>n</i> = 21) (mean [standard deviation] 81 (7) years, 94 [45%] men; 73% NYHA III or IV; EuroSCORE II 5.2% [2.4%]); all patients underwent TAVI with Myval. Patients were followed up at 1 year and 2 years after implantation. Clinical and procedural outcomes were defined according to VARC-3 criteria.</p><p><strong>Results: </strong>Technical success was observed in 204 (99%), device success was observed in 189 (91%), early safety was observed in 161 (78%), and clinical efficacy was observed in 163 (79%) patients. The 30-day death rate was 7.7%; of these, 3.4% were due to cardiovascular reasons. All-cause and cardiovascular mortality rates were 9.7% and 4.3% at 1-year follow-up, and 17.4% and 9.7% at 2-year follow-up, respectively. Incidence of ≥ moderate paravalvular leak (PVL) at 30 days, 1 year and 2 years of follow-up were 3.4%, 4.3% and 4.8%. A total of 11.1% of patients required a permanent pacemaker implantation (PPI) at 30 days after implantation, while the cumulative rate of PPI at 2 years was 12.1%.</p><p><strong>Conclusions: </strong>In this cohort of patients with SAS, the Myval was found to be safe and effective in up to 2 years of follow-up.</p>","PeriodicalId":8278,"journal":{"name":"Archives of Medical Science","volume":"20 2","pages":"410-419"},"PeriodicalIF":3.0000,"publicationDate":"2024-03-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11094825/pdf/","citationCount":"0","resultStr":"{\"title\":\"Clinical outcomes of the Myval transcatheter heart valve system in patients with severe aortic valve stenosis: a two-year follow-up observational study.\",\"authors\":\"Teoman Kilic, Alfonso Ielasi, Vlasis Ninios, Levent Korkmaz, Demosthenes Panagiotakos, Gokhan Yerlikaya, Ahmet Ozderya, Carolina Montonati, Maurizio Tespili, Senol Coskun, Tayfun Sahin, Ilias Ninios, Konstantina Vlasopoulou, Ali Hakan Konus, Selim Kul, Ali Riza Akyuz\",\"doi\":\"10.5114/aoms/176937\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Introduction: </strong>Limited data exist on long-term follow-up of severe aortic stenosis (SAS) patients who have undergone transcatheter aortic valve implantation (TAVI) with a new generation, balloon expandable Myval transcatheter heart valve (THV). Thus, we sought to investigate the performance and 2-year clinical outcome of the Myval THV system based on Valve Academic Research Consortium-3 (VARC-3) criteria.</p><p><strong>Material and methods: </strong>A multi-centre, registry-based, observational study was conducted, which included 207 consecutive degenerative SAS patients, from Turkey (<i>n</i> = 128), Italy (<i>n</i> = 58), and Greece (<i>n</i> = 21) (mean [standard deviation] 81 (7) years, 94 [45%] men; 73% NYHA III or IV; EuroSCORE II 5.2% [2.4%]); all patients underwent TAVI with Myval. Patients were followed up at 1 year and 2 years after implantation. Clinical and procedural outcomes were defined according to VARC-3 criteria.</p><p><strong>Results: </strong>Technical success was observed in 204 (99%), device success was observed in 189 (91%), early safety was observed in 161 (78%), and clinical efficacy was observed in 163 (79%) patients. The 30-day death rate was 7.7%; of these, 3.4% were due to cardiovascular reasons. 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引用次数: 0
摘要
导言：使用新一代球囊扩张型 Myval 经导管心脏瓣膜（TAVI）进行经导管主动脉瓣植入术（TAVI）的重度主动脉瓣狭窄（SAS）患者的长期随访数据有限。因此，我们试图根据瓣膜学术研究联盟-3（VARC-3）标准研究 Myval THV 系统的性能和 2 年临床结果：我们进行了一项基于登记的多中心观察性研究，纳入了 207 名连续的退行性 SAS 患者，他们分别来自土耳其（128 人）、意大利（58 人）和希腊（21 人）（平均 [标准差] 81 (7) 岁，男性 94 [45%]；73% NYHA III 或 IV；EuroSCORE II 5.2% [2.4%]）；所有患者都接受了 Myval TAVI。患者在植入后 1 年和 2 年接受随访。临床和手术结果根据VARC-3标准进行定义：204例（99%）患者观察到技术成功，189例（91%）患者观察到设备成功，161例（78%）患者观察到早期安全性，163例（79%）患者观察到临床疗效。30天内的死亡率为7.7%，其中3.4%是由于心血管原因。随访1年的全因死亡率和心血管死亡率分别为9.7%和4.3%，随访2年的全因死亡率和心血管死亡率分别为17.4%和9.7%。随访30天、1年和2年时，≥中度腔旁漏（PVL）的发生率分别为3.4%、4.3%和4.8%。在植入心脏后30天，共有11.1%的患者需要植入永久起搏器（PPI），2年后的累计PPI率为12.1%：结论：在这批 SAS 患者中，Myval 在长达 2 年的随访中是安全有效的。
Clinical outcomes of the Myval transcatheter heart valve system in patients with severe aortic valve stenosis: a two-year follow-up observational study.
Introduction: Limited data exist on long-term follow-up of severe aortic stenosis (SAS) patients who have undergone transcatheter aortic valve implantation (TAVI) with a new generation, balloon expandable Myval transcatheter heart valve (THV). Thus, we sought to investigate the performance and 2-year clinical outcome of the Myval THV system based on Valve Academic Research Consortium-3 (VARC-3) criteria.
Material and methods: A multi-centre, registry-based, observational study was conducted, which included 207 consecutive degenerative SAS patients, from Turkey (n = 128), Italy (n = 58), and Greece (n = 21) (mean [standard deviation] 81 (7) years, 94 [45%] men; 73% NYHA III or IV; EuroSCORE II 5.2% [2.4%]); all patients underwent TAVI with Myval. Patients were followed up at 1 year and 2 years after implantation. Clinical and procedural outcomes were defined according to VARC-3 criteria.
Results: Technical success was observed in 204 (99%), device success was observed in 189 (91%), early safety was observed in 161 (78%), and clinical efficacy was observed in 163 (79%) patients. The 30-day death rate was 7.7%; of these, 3.4% were due to cardiovascular reasons. All-cause and cardiovascular mortality rates were 9.7% and 4.3% at 1-year follow-up, and 17.4% and 9.7% at 2-year follow-up, respectively. Incidence of ≥ moderate paravalvular leak (PVL) at 30 days, 1 year and 2 years of follow-up were 3.4%, 4.3% and 4.8%. A total of 11.1% of patients required a permanent pacemaker implantation (PPI) at 30 days after implantation, while the cumulative rate of PPI at 2 years was 12.1%.
Conclusions: In this cohort of patients with SAS, the Myval was found to be safe and effective in up to 2 years of follow-up.
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