Key result
Transcatheter aortic valve implantation using the Navitor device achieved 100% device and procedural success, with no cases of moderate or severe aortic regurgitation at 1-month follow-up.
Why the study?
The authors aimed to report their initial clinical experience with Navitor, a novel third-generation TAVI device designed to optimize deliverability and minimize paravalvular leak.
Observational (n=39)
TAVI with the third-generation Navitor device demonstrated 100% procedural success with low rates of pacemaker implantation and no moderate or severe paravalvular leak at 1 month.
Navitor TAVI experience is hypothesis-generating; larger prospective studies needed before clinical adoption.
Transcatheter aortic valve implantation (TAVI) has proved beneficial in patients with severe aortic stenosis, especially when second-generation devices are used. We aimed at reporting our experience with Navitor, a third-generation device characterized by intrannular, large cell, and cuffed design, as well as high deliverability and minimization of paravalvular leak. Between June and December 2021, a total of 39 patients underwent TAVI with Navitor, representing 20% of all TAVI cases. Mean age was 80.0 ± 6.7 years, and 14 (36.8%) women were included. Severe aortic stenosis was the most common indication to TAVI (37 [97.4%] cases), whereas 2 (5.3%) individuals were at low surgical risk. Device and procedural success was obtained in all patients, with a total hospital stay of 6.6 ± 4.5 days. One (2.9%) patient required permanent pacemaker implantation, but no other hospital events occurred. At 1-month follow-up, a cardiac death was adjudicated in an 87-year-old man who had been at high surgical risk. Echocardiographic follow-up showed no case of moderate or severe aortic regurgitation, with mild regurgitation in 18 (47%), and none or trace regurgitation in 20 (53%). The Navitor device, thanks to its unique features, is a very promising technology suitable to further expand indications and risk-benefit profile of TAVI.
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Corcione et al. (2022) conducted an observational in Severe aortic stenosis (n=39). Navitor device (TAVI) was evaluated on Device and procedural success. Transcatheter aortic valve implantation using the Navitor device achieved 100% device and procedural success, with no cases of moderate or severe aortic regurgitation at 1-month follow-up.
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