Treatment of Pure Aortic Regurgitation Using a Novel Second-Generation Trans-catheter Aortic Valve Implantation System (J-ValveTM System) - Initial clinical experience
Da Zhu, Yingqiang Guo, Bengui Zhang, Yingkang Shi.
West China hospital of Sichuan University, Chengdu, China.
OBJECTIVE: Experience with trans-catheter aortic valve implantation (TAVI) for pure aortic regurgitation (AR) is limited due to the risk of insufficient anchoring of the valve stent within the non-calcified aortic annulus. The aim of this study is to report the clinical experience with a novel trans-catheter aortic valve implantation system, the J-ValveTM system for the treatment of pure AR.
METHODS: Trans-apical TAVI with the J-ValveTM system was performed in 28 patients with pure AR in our center with a mean age of 74.1 ± 4.6 years. All patients were considered high risk for open-heart surgery with a mean logistic Euro-SCORE 23.2 ± 3.3%. Clinical and echocardiographic evaluations were performed at baseline, post-procedure and follow-up. Procedural success and complications were reported according to VARC-2 (Valve Academic Research Consortium) definitions.
RESULTS: Implantation was successful in 26 of 28 cases (success rate 93%). All cause in hospital mortality was 0% and 6 month survival of 100%. Two patients were converted to surgical valve replacement due to moderate degree paravalvular AR after valve implantation and valve embolism into the aortic arch. Pacemaker implantation for new onset conduction disorders was necessary in 2 patients (7.1%). Minor access complication was noted in 1 patient (3.6%). Post-procedural paravalvular AR was none/trace in 20 of 26 and mild in 6 of 26 patients at 6 months follow-up. Mean transvalvular gradient was favorable after valve implantation during follow-up at 10.2±3.5 mmHg.
CONCLUSIONS: Pure AR remains a challenging pathology for TAVI. The J-ValveTM system demonstrated feasibility, safety and effectiveness in the treatment of patients with pure AR.
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