Daijiro Tomii, Bashir Alaour, Dik Heg, Taishi Okuno, Masaaki Nakase, Daryoush Samim, Fabien Praz, Jonas Lanz, Stefan Stortecky, David Reineke, Stephan Windecker, Thomas Pilgrim
{"title":"主动脉瓣瓣尖过度钙化患者的自我扩张与球囊扩张的经导管心脏瓣膜。","authors":"Daijiro Tomii, Bashir Alaour, Dik Heg, Taishi Okuno, Masaaki Nakase, Daryoush Samim, Fabien Praz, Jonas Lanz, Stefan Stortecky, David Reineke, Stephan Windecker, Thomas Pilgrim","doi":"10.1016/j.ahj.2025.09.011","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Excessive aortic cusp calcification increases the risk of periprocedural complications after transcatheter aortic valve replacement (TAVR). Differences in device performance in patients with excessive calcification may affect long-term clinical outcomes.</p><p><strong>Objectives: </strong>To compare periprocedural and long-term outcomes between self-expanding (SEV) and balloon-expandable (BEV) prostheses in patients with excess cusp calcification undergoing TAVR.</p><p><strong>Methods: </strong>Consecutive patients with severe aortic stenosis and aortic valve complex calcium volume ≥235 mm³ (on contrast images with Hounsfield unit threshold of 850) who underwent TAVR with either CoreValve/Evolut SEV or SAPIEN BEV from August 2007 to June 2023 were included from a prospective-single center registry. A 1:1 propensity-matched analysis was performed to account for baseline differences between groups.</p><p><strong>Results: </strong>Among 1,345 patients, 271 matched pairs were identified. Procedural success was achieved in >85% of patients with no difference between groups. Annular rupture occurred more frequently with BEV compared to SEV (2.2% vs 0%, p=0.030). SEV had a lower transprosthetic gradient (8.0 mmHg vs. 11.2 mmHg, p <0.001) but higher rates of mild or greater paravalvular regurgitation (69.7% vs. 58.1%, p=0.008) and new permanent pacemaker implantation (22.6% vs. 15.5%, p=0.001). At 5 years, there was no statistically significant difference in mortality between groups (45.1% vs. 50.2%, p=0.173).</p><p><strong>Conclusions: </strong>In patients with excessive leaflet calcification undergoing TAVR, BEV had a higher risk of annular rupture, but a lower risk of paravalvular regurgitation, and a lower risk of permanent pacemaker implantation compared to SEV. Mortality was comparable between SEV and BEV throughout 5 years of follow-up.</p><p><strong>Clinical trial registration: </strong>https://www.</p><p><strong>Clinicaltrials: </strong>gov. NCT01368250.</p>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":" ","pages":""},"PeriodicalIF":3.5000,"publicationDate":"2025-09-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Self-Expanding Versus Balloon-Expandable Transcatheter Heart Valves in Patients with Excessive Aortic Valve Cusp Calcification.\",\"authors\":\"Daijiro Tomii, Bashir Alaour, Dik Heg, Taishi Okuno, Masaaki Nakase, Daryoush Samim, Fabien Praz, Jonas Lanz, Stefan Stortecky, David Reineke, Stephan Windecker, Thomas Pilgrim\",\"doi\":\"10.1016/j.ahj.2025.09.011\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Excessive aortic cusp calcification increases the risk of periprocedural complications after transcatheter aortic valve replacement (TAVR). Differences in device performance in patients with excessive calcification may affect long-term clinical outcomes.</p><p><strong>Objectives: </strong>To compare periprocedural and long-term outcomes between self-expanding (SEV) and balloon-expandable (BEV) prostheses in patients with excess cusp calcification undergoing TAVR.</p><p><strong>Methods: </strong>Consecutive patients with severe aortic stenosis and aortic valve complex calcium volume ≥235 mm³ (on contrast images with Hounsfield unit threshold of 850) who underwent TAVR with either CoreValve/Evolut SEV or SAPIEN BEV from August 2007 to June 2023 were included from a prospective-single center registry. A 1:1 propensity-matched analysis was performed to account for baseline differences between groups.</p><p><strong>Results: </strong>Among 1,345 patients, 271 matched pairs were identified. Procedural success was achieved in >85% of patients with no difference between groups. Annular rupture occurred more frequently with BEV compared to SEV (2.2% vs 0%, p=0.030). SEV had a lower transprosthetic gradient (8.0 mmHg vs. 11.2 mmHg, p <0.001) but higher rates of mild or greater paravalvular regurgitation (69.7% vs. 58.1%, p=0.008) and new permanent pacemaker implantation (22.6% vs. 15.5%, p=0.001). At 5 years, there was no statistically significant difference in mortality between groups (45.1% vs. 50.2%, p=0.173).</p><p><strong>Conclusions: </strong>In patients with excessive leaflet calcification undergoing TAVR, BEV had a higher risk of annular rupture, but a lower risk of paravalvular regurgitation, and a lower risk of permanent pacemaker implantation compared to SEV. Mortality was comparable between SEV and BEV throughout 5 years of follow-up.</p><p><strong>Clinical trial registration: </strong>https://www.</p><p><strong>Clinicaltrials: </strong>gov. NCT01368250.</p>\",\"PeriodicalId\":7868,\"journal\":{\"name\":\"American heart journal\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":3.5000,\"publicationDate\":\"2025-09-18\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"American heart journal\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1016/j.ahj.2025.09.011\",\"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":"American heart journal","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1016/j.ahj.2025.09.011","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"CARDIAC & CARDIOVASCULAR SYSTEMS","Score":null,"Total":0}
引用次数: 0
摘要
背景：主动脉尖过度钙化增加经导管主动脉瓣置换术（TAVR）后围手术期并发症的风险。过度钙化患者的器械性能差异可能影响长期临床结果。目的：比较自扩式（SEV）和球囊可扩式（BEV）假体在TAVR中治疗牙尖钙化过度患者的围术期和远期疗效。方法：从2007年8月至2023年6月，采用CoreValve/Evolut SEV或SAPIEN BEV进行TAVR的严重主动脉瓣狭窄和主动脉瓣复合钙容量≥235 mm³（Hounsfield单位阈值850）的连续患者纳入前瞻性单中心登记。进行1:1倾向匹配分析，以解释各组之间的基线差异。结果：在1345例患者中，鉴定出271对配对。85%的患者手术成功，组间无差异。与SEV相比，BEV的环空破裂发生率更高（2.2% vs 0%, p=0.030）。结论：在接受TAVR的小叶过度钙化的患者中，BEV与SEV相比有更高的环破裂风险，但瓣旁反流的风险较低，永久性起搏器植入的风险较低。在5年的随访中，SEV和BEV的死亡率具有可比性。临床试验注册：https://www.Clinicaltrials: gov. NCT01368250。
Self-Expanding Versus Balloon-Expandable Transcatheter Heart Valves in Patients with Excessive Aortic Valve Cusp Calcification.
Background: Excessive aortic cusp calcification increases the risk of periprocedural complications after transcatheter aortic valve replacement (TAVR). Differences in device performance in patients with excessive calcification may affect long-term clinical outcomes.
Objectives: To compare periprocedural and long-term outcomes between self-expanding (SEV) and balloon-expandable (BEV) prostheses in patients with excess cusp calcification undergoing TAVR.
Methods: Consecutive patients with severe aortic stenosis and aortic valve complex calcium volume ≥235 mm³ (on contrast images with Hounsfield unit threshold of 850) who underwent TAVR with either CoreValve/Evolut SEV or SAPIEN BEV from August 2007 to June 2023 were included from a prospective-single center registry. A 1:1 propensity-matched analysis was performed to account for baseline differences between groups.
Results: Among 1,345 patients, 271 matched pairs were identified. Procedural success was achieved in >85% of patients with no difference between groups. Annular rupture occurred more frequently with BEV compared to SEV (2.2% vs 0%, p=0.030). SEV had a lower transprosthetic gradient (8.0 mmHg vs. 11.2 mmHg, p <0.001) but higher rates of mild or greater paravalvular regurgitation (69.7% vs. 58.1%, p=0.008) and new permanent pacemaker implantation (22.6% vs. 15.5%, p=0.001). At 5 years, there was no statistically significant difference in mortality between groups (45.1% vs. 50.2%, p=0.173).
Conclusions: In patients with excessive leaflet calcification undergoing TAVR, BEV had a higher risk of annular rupture, but a lower risk of paravalvular regurgitation, and a lower risk of permanent pacemaker implantation compared to SEV. Mortality was comparable between SEV and BEV throughout 5 years of follow-up.
期刊介绍：
The American Heart Journal will consider for publication suitable articles on topics pertaining to the broad discipline of cardiovascular disease. Our goal is to provide the reader primary investigation, scholarly review, and opinion concerning the practice of cardiovascular medicine. We especially encourage submission of 3 types of reports that are not frequently seen in cardiovascular journals: negative clinical studies, reports on study designs, and studies involving the organization of medical care. The Journal does not accept individual case reports or original articles involving bench laboratory or animal research.
求助内容：
应助结果提醒方式：
京公网安备 11010802042870号
