{"title":"小主动脉环内与环上自扩张经导管心脏瓣膜的比较。","authors":"Masanori Yamamoto, Toshinobu Ryuzaki, Hirofumi Hioki, Ai Kagase, Shinichi Shirai, Yohei Ohno, Fumiaki Yashima, Toru Naganuma, Masahiro Yamawaki, Yusuke Watanabe, Futoshi Yamanaka, Kazuki Mizutani, Masahiko Noguchi, Masaki Izumo, Kensuke Takagi, Masahiko Asami, Hiroshi Ueno, Hidetaka Nishina, Hiroto Suzuyama, Kazumasa Yamasaki, Kenji Nishioka, Daisuke Hachinohe, Yasushi Fuku, Toshiaki Otsuka, Kentaro Hayashida, On Behalf Of The Ocean-Tavi Investigators","doi":"10.4244/EIJ-D-24-00966","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Clinical data are scarce comparing supra-annular self-expanding valves (SA-SEVs) and intra-annular (IA)-SEVs after transcatheter aortic valve implantation (TAVI), particularly in patients with a small aortic annulus (SAA).</p><p><strong>Aims: </strong>We aimed to compare early clinical outcomes, including echocardiographic parameters, between the latest generation of IA-SEV and SA-SEV after TAVI in patients with SAA.</p><p><strong>Methods: </strong>Focused on patients with SAA, defined as an annulus area ≤430 mm<sup>2</sup>, the data of 919 patients who underwent TAVI with an IA-SEV (n=518, Navitor) or an SA-SEV (n=401, Evolut FX) were retrospectively extracted. Differences in valve design on postprocedural results were investigated between the two groups and in the propensity score-matched (PSM) cohort.</p><p><strong>Results: </strong>The postprocedural effective orifice area (EOA), indexed EOA, and mean pressure gradient (mPG) were similar in the overall cohort between the two groups (allp>0.05), whereas the mPG was higher with IA-SEVs than with SA-SEVs (8.74±5.01 mmHg vs 7.84±4.43 mmHg; p=0.049) after PSM (n=219 patients/group). There were no significant differences in the incidence of severe prosthesis-patient mismatch (1.9% vs 0.9%; p=0.405) or paravalvular leakage ≥mild (34.1% vs 42.2%; p=0.084) between the 2 groups in the PSM cohort. The rates of technical success (95.9% vs 95.8%), device success at discharge (91.3% vs 87.8%), and in-hospital death (1.4% vs 0.5%) were comparable in the overall cohort (allp>0.05). These results were not changed in the PSM cohort (allp>0.05).</p><p><strong>Conclusions: </strong>The latest-generation IA-SEV and SA-SEV demonstrated similar clinical results except for a few echocardiographic findings after TAVI in patients with SAA.</p>","PeriodicalId":54378,"journal":{"name":"Eurointervention","volume":"21 13","pages":"e749-e757"},"PeriodicalIF":9.5000,"publicationDate":"2025-07-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12207337/pdf/","citationCount":"0","resultStr":"{\"title\":\"Intra- versus supra-annular self-expanding transcatheter heart valves in small aortic annuli.\",\"authors\":\"Masanori Yamamoto, Toshinobu Ryuzaki, Hirofumi Hioki, Ai Kagase, Shinichi Shirai, Yohei Ohno, Fumiaki Yashima, Toru Naganuma, Masahiro Yamawaki, Yusuke Watanabe, Futoshi Yamanaka, Kazuki Mizutani, Masahiko Noguchi, Masaki Izumo, Kensuke Takagi, Masahiko Asami, Hiroshi Ueno, Hidetaka Nishina, Hiroto Suzuyama, Kazumasa Yamasaki, Kenji Nishioka, Daisuke Hachinohe, Yasushi Fuku, Toshiaki Otsuka, Kentaro Hayashida, On Behalf Of The Ocean-Tavi Investigators\",\"doi\":\"10.4244/EIJ-D-24-00966\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Clinical data are scarce comparing supra-annular self-expanding valves (SA-SEVs) and intra-annular (IA)-SEVs after transcatheter aortic valve implantation (TAVI), particularly in patients with a small aortic annulus (SAA).</p><p><strong>Aims: </strong>We aimed to compare early clinical outcomes, including echocardiographic parameters, between the latest generation of IA-SEV and SA-SEV after TAVI in patients with SAA.</p><p><strong>Methods: </strong>Focused on patients with SAA, defined as an annulus area ≤430 mm<sup>2</sup>, the data of 919 patients who underwent TAVI with an IA-SEV (n=518, Navitor) or an SA-SEV (n=401, Evolut FX) were retrospectively extracted. Differences in valve design on postprocedural results were investigated between the two groups and in the propensity score-matched (PSM) cohort.</p><p><strong>Results: </strong>The postprocedural effective orifice area (EOA), indexed EOA, and mean pressure gradient (mPG) were similar in the overall cohort between the two groups (allp>0.05), whereas the mPG was higher with IA-SEVs than with SA-SEVs (8.74±5.01 mmHg vs 7.84±4.43 mmHg; p=0.049) after PSM (n=219 patients/group). There were no significant differences in the incidence of severe prosthesis-patient mismatch (1.9% vs 0.9%; p=0.405) or paravalvular leakage ≥mild (34.1% vs 42.2%; p=0.084) between the 2 groups in the PSM cohort. The rates of technical success (95.9% vs 95.8%), device success at discharge (91.3% vs 87.8%), and in-hospital death (1.4% vs 0.5%) were comparable in the overall cohort (allp>0.05). 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引用次数: 0
摘要
背景：经导管主动脉瓣植入术（TAVI）后，比较环上自扩瓣膜（sa - sev）和环内自扩瓣膜（IA）的临床资料很少，特别是在小主动脉环（SAA）患者中。目的：我们旨在比较SAA患者TAVI后最新一代IA-SEV和SA-SEV的早期临床结果，包括超声心动图参数。方法：回顾性分析919例使用IA-SEV（518例，Navitor）或SA-SEV（401例，Evolut FX）行TAVI的SAA患者的资料，SAA定义为环面积≤430 mm2。研究了两组之间以及倾向评分匹配（PSM）队列中瓣膜设计对术后结果的差异。结果：两组患者术后有效孔口面积（EOA）、指数EOA和平均压力梯度（mPG）相似（p < 0.05）， ia - sev组mPG高于sa - sev组(8.74±5.01 mmHg vs 7.84±4.43 mmHg；p=0.049) （n=219例/组）。严重假体与患者不匹配的发生率无显著差异(1.9% vs 0.9%；P =0.405)或瓣旁渗漏≥轻度(34.1% vs 42.2%；p=0.084)。在整个队列中，技术成功率（95.9%对95.8%）、出院时装置成功率（91.3%对87.8%）和住院死亡率（1.4%对0.5%）具有可比性（allp>0.05）。这些结果在PSM队列中没有改变（p < 0.05）。结论：最新一代IA-SEV和SA-SEV具有相似的临床结果，除了SAA患者在TAVI后的一些超声心动图结果。
Intra- versus supra-annular self-expanding transcatheter heart valves in small aortic annuli.
Background: Clinical data are scarce comparing supra-annular self-expanding valves (SA-SEVs) and intra-annular (IA)-SEVs after transcatheter aortic valve implantation (TAVI), particularly in patients with a small aortic annulus (SAA).
Aims: We aimed to compare early clinical outcomes, including echocardiographic parameters, between the latest generation of IA-SEV and SA-SEV after TAVI in patients with SAA.
Methods: Focused on patients with SAA, defined as an annulus area ≤430 mm2, the data of 919 patients who underwent TAVI with an IA-SEV (n=518, Navitor) or an SA-SEV (n=401, Evolut FX) were retrospectively extracted. Differences in valve design on postprocedural results were investigated between the two groups and in the propensity score-matched (PSM) cohort.
Results: The postprocedural effective orifice area (EOA), indexed EOA, and mean pressure gradient (mPG) were similar in the overall cohort between the two groups (allp>0.05), whereas the mPG was higher with IA-SEVs than with SA-SEVs (8.74±5.01 mmHg vs 7.84±4.43 mmHg; p=0.049) after PSM (n=219 patients/group). There were no significant differences in the incidence of severe prosthesis-patient mismatch (1.9% vs 0.9%; p=0.405) or paravalvular leakage ≥mild (34.1% vs 42.2%; p=0.084) between the 2 groups in the PSM cohort. The rates of technical success (95.9% vs 95.8%), device success at discharge (91.3% vs 87.8%), and in-hospital death (1.4% vs 0.5%) were comparable in the overall cohort (allp>0.05). These results were not changed in the PSM cohort (allp>0.05).
Conclusions: The latest-generation IA-SEV and SA-SEV demonstrated similar clinical results except for a few echocardiographic findings after TAVI in patients with SAA.
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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