Fujita Kosuke, Matsumura Koichiro, Sugimoto Keishiro, Onishi Kyohei, Kakehi Kazuyoshi, Yoshida Ayano, Kawamura Takayuki, Yasuda Masakazu, Matsuzoe Hiroki, Mizutani Kazuki, Miyoshi Tatsuya, Ueno Masafumi, Sakaguchi Genichi, Nakazawa Gaku
Division of Cardiology, Department of Medicine, Kindai University Faculty of Medicine, 377-2 Ohno-Higashi, Osakasayama, Osaka, 589-8511, Japan.
Division of Cardiology, Sakurabashi Watanabe Advanced Healthcare Hospital, Osaka, Japan.
Cardiovasc Interv Ther. 2025 Apr;40(2):378-388. doi: 10.1007/s12928-024-01081-7. Epub 2025 Jan 6.
Transcatheter aortic valve implantation (TAVI) using the NAVITOR system has been relatively underreported due to its recent introduction in Japan. This study aimed to assess the short-term outcomes of TAVI with the NAVITOR in real-world clinical practice. Patients with severe aortic stenosis who underwent TAVI using the NAVITOR system at our institution between December 2022 and December 2023 were prospectively enrolled. We evaluated the 30-day post-TAVI outcomes using the Valve Academic Research Consortium 3 (VARC-3). Among 32 consecutive patients (mean age, 84 years; 19% female), technical success was achieved in 31 (96.8%). One patient developed a subclavian artery vascular dissection, requiring balloon angioplasty during the TAVI procedure, and another received a permanent pacemaker due to persistent advanced atrioventricular block. At the 30-day follow-up, device success was achieved in 31 (96.8%) patients, with early safety observed in 27 (84.3%). One patient experienced sudden unexplained death after discharge. None of the patients experienced myocardial infarction, valve embolisation, life-threatening bleeding, or acute kidney injury within 30 days after the procedure. Echocardiographic follow-up showed a median effective orifice area index of 1.26 ± 0.27. Contrast-enhanced computed tomography was performed in 19 patients 30 days after the procedure, revealing hypo-attenuated leaflet thickening (HALT) in 10 (52.6%). Although the 30-day outcomes of TAVI using the NAVITOR system appeared promising, a relatively high incidence of HALT was observed.
由于NAVITOR系统最近才引入日本,经导管主动脉瓣植入术(TAVI)使用该系统的相关报道相对较少。本研究旨在评估在实际临床实践中使用NAVITOR系统进行TAVI的短期结果。2022年12月至2023年12月期间在我院接受使用NAVITOR系统进行TAVI的重度主动脉瓣狭窄患者被前瞻性纳入研究。我们使用瓣膜学术研究联盟3(VARC-3)评估TAVI术后30天的结果。在连续32例患者(平均年龄84岁;19%为女性)中,31例(96.8%)手术成功。1例患者发生锁骨下动脉血管夹层,在TAVI手术期间需要进行球囊血管成形术,另1例患者因持续性高度房室传导阻滞植入了永久性起搏器。在30天随访时,31例(96.8%)患者手术成功,27例(84.3%)观察到早期安全性良好。1例患者出院后发生不明原因猝死。术后30天内无患者发生心肌梗死、瓣膜栓塞、危及生命的出血或急性肾损伤。超声心动图随访显示有效瓣口面积指数中位数为1.26±0.27。19例患者在术后30天进行了对比增强计算机断层扫描,其中10例(52.6%)显示瓣叶增厚低密度影(HALT)。尽管使用NAVITOR系统进行TAVI的30天结果看起来很有前景,但观察到HALT的发生率相对较高。