Key result
Transapical J-Valve TAVI for aortic regurgitation shows ~6% mortality at mid-term follow-up.
Observational (n=47)
No
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Transapical TAVI with the J-Valve system shows encouraging mid-term clinical outcomes and durability up to 4 years in high-risk patients with predominant aortic regurgitation.
Background: Transcatheter aortic valve implantation (TAVI) has become the gold standard for high-risk severe aortic stenosis. However, the experience of treating aortic regurgitation (AR) with this technology is still limited. Previously, we have demonstrated excellent 1-year outcomes of transapical TAVI with J-Valve TM (JieCheng Medical Technology Co., Ltd., Suzhou, China) in treating predominant AR, while the mid-term outcomes up to 4 years have never been reported. Methods: Transapical TAVI with J-Valve TM to treat predominant AR was performed in 47 patients in Zhongshan Hospital from May 2014 through October 2018. Procedural and clinical outcomes with follow-up up to 4 years were analyzed using Valve Academic Research Consortium-2 criteria (VARC-2). Results: All patients (age 73.7±7.9 years) were considered to be prohibitive or high-risk for surgical aortic valve replacement (SAVR) (logistic European System for Cardiac Operative Risk Evaluation, 21.1% to 44.4%; mean, 24.3%±5.1%) after evaluated by a multidisciplinary heart team. Transapical implantations were successful in all patients. The clinical outcomes of the entire cohort in the latest follow-up (371 to 1,968 days, median 574 days) included all-cause mortality (6.4%), disabling stroke (2.3%), new permanent pacemaker (6.8%) and valve-related re-intervention (0). Paravalvular leak (PVL) was rate as none or trace in 37 of 44 and mild in 7 of 44 patients at the latest follow-up. Mean transvalvular gradient was favorable after valve implantation during follow-up at 9.3±2.5 mmHg. Conclusions: This study revealed that, transapical TAVI with J-Valve TM for treating AR has encouraging mid-term outcomes, and the advantages at one year demonstrated in previous study can be maintained through 4 years.
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Liu et al. (2020) conducted an observational in Predominant aortic regurgitation (n=47). Transapical transcatheter aortic valve implantation with J-Valve TM was evaluated on All-cause mortality. Transapical TAVI with J-Valve for predominant aortic regurgitation resulted in 6.4% all-cause mortality, 2.3% disabling stroke, and 0% valve-related re-intervention at a median 574 days follow-up.
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