Treatment Of Pure Aortic Regurgitaton Using A Novel Tavi System
Da Zhu, M.D1, Yingqiang Guo1, Lai Wei2, Simeng Wang1.
1West China hospital of Sichuan University, Chengdu, China, 2zhongshan hospital of fudan university, shanghai, 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 investigate the safety and feasibility of using a novel trans-catheter aortic valve implantation system (J-ValveTM) in treatment of patient with pure AR.
Methods: Trans-apical TAVI with the J-ValveTM system was performed in 43 patients with pure AR with a mean age of 74.3 ± 5.6 years. All patients were considered high risk for open-heart surgery with a mean logistic Euro-SCORE 25.2 ± 5.4%. 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 41 of 43 cases (success rate 95 %). All cause mortality was 2.3% (1/43) at 1 month and 4.7% (2/43) in 1-year follow-up. 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 3 patients (6.9% - 3/43). Major access complication was noted in 1 patient (2.3%-1/43) and 1 patient (2.3%-1/43) was noted to have major cerebrovascular event during follow-up. No patient was noted to have moderate or severe paravalvular AR. In 1-year follow-up, paravalvular AR was none/trace in 28 of 39 (71.8%) and mild in 11 of 39 patients (28.2%). Mean transvalvular gradient was favorable after valve implantation with PGmean 10.2±3.5 mmHg at 1-year follow-up.
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.
Key Words: Aortic regurgitation, TAVI, J-ValveTM system
Abbreviation: TAVI – Transcatheter aortic valve implantation; AR- aortic regurgitation; VARC-Valve Academic Research Consortium; 3D-CTA - three-dimensional computer tomography angiography.
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