Key result
Transcatheter aortic valve implantation using the NAVITOR system achieved a 96.8% device success rate at 30 days, although hypo-attenuated leaflet thickening was observed in 52.6% of evaluated patients.
Why the study?
Outcomes of TAVI using the NAVITOR system have been relatively underreported due to its recent introduction in Japan.
Does transcatheter aortic valve implantation using the NAVITOR system provide safe and effective 30-day outcomes in patients with severe aortic stenosis?
Cohort (n=32)
No
Does transcatheter aortic valve implantation using the NAVITOR system provide safe and effective 30-day outcomes in patients with severe aortic stenosis?
TAVI with the NAVITOR system demonstrated high 30-day device success and safety, but was associated with a relatively high incidence of hypo-attenuated leaflet thickening (HALT).
High device success and safety seen with NAVITOR TAVI; leaves open HALT clinical relevance for prospective study.
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.
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Fujita et al. (2025) conducted a cohort in Severe aortic stenosis (n=32). NAVITOR system (Transcatheter aortic valve implantation) was evaluated on 30-day device success. Transcatheter aortic valve implantation using the NAVITOR system achieved a 96.8% device success rate at 30 days, although hypo-attenuated leaflet thickening was observed in 52.6% of evaluated patients.
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