The Journal of thoracic and cardiovascular surgery · 2018
Transapical transcatheter aortic valve replacement for aortic regurgitation with a second-generation heart valve.
СтатьяМногоцентровое исследованиеНаблюдательное исследованиеVideo-Audio MediaНазвание и аннотация: Перевод пока не подготовлен
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Liu Huan, Yang Ye, Wang Wenshuo, Zhu Da, Wei Lai, Guo Kefang, Zhao Weipeng, Yang Xue, Zhu Liming, Guo Yingqiang, Wang Wei, Wang Chunsheng
Аннотация
OBJECTIVE: To report on the Chinese multicenter study of the J-Valve transcatheter heart valve for treatment of predominant aortic regurgitation.
METHODS: Transapical transcatheter aortic valve replacement with the J-Valve for treating high-risk severe aortic regurgitation was performed in 43 patients in 3 Chinese centers. The study was registered with the Chinese Clinical Trial Registry (ChiCTR-OPC-15006354). Procedural results and clinical outcomes up to 1-year were analyzed using Valve Academic Research Consortium 2 criteria.
RESULTS: All patients (mean age, 73.9 ± 5.7 years) were considered at prohibitive or high risk for surgical valve replacement (logistic European System for Cardiac Operative Risk Evaluation, 20.0% to 44.4%; mean, 25.5% ± 5.3%) after evaluation by an interdisciplinary heart team. Transapical implantation was successful in 42 patients (97.7%). The 1-year outcomes included all-cause mortality (4.7%), disabling stroke (2.3%), new permanent pacemaker (4.7%), and valve-related reintervention (7.0%). At the 1-year follow-up, postprocedural paravalvular regurgitation was none/trace in 30 of 39 patients and mild in 8 of 39 patients, and the mean transvalvular gradient after valve implantation was favorable at 10.4 ± 4.5 mm Hg.
CONCLUSIONS: After an initial demonstration of feasibility, this multicenter study shows that the J-Valve transcatheter heart valve system is a reasonable option for patients with predominant aortic regurgitation.
METHODS: Transapical transcatheter aortic valve replacement with the J-Valve for treating high-risk severe aortic regurgitation was performed in 43 patients in 3 Chinese centers. The study was registered with the Chinese Clinical Trial Registry (ChiCTR-OPC-15006354). Procedural results and clinical outcomes up to 1-year were analyzed using Valve Academic Research Consortium 2 criteria.
RESULTS: All patients (mean age, 73.9 ± 5.7 years) were considered at prohibitive or high risk for surgical valve replacement (logistic European System for Cardiac Operative Risk Evaluation, 20.0% to 44.4%; mean, 25.5% ± 5.3%) after evaluation by an interdisciplinary heart team. Transapical implantation was successful in 42 patients (97.7%). The 1-year outcomes included all-cause mortality (4.7%), disabling stroke (2.3%), new permanent pacemaker (4.7%), and valve-related reintervention (7.0%). At the 1-year follow-up, postprocedural paravalvular regurgitation was none/trace in 30 of 39 patients and mild in 8 of 39 patients, and the mean transvalvular gradient after valve implantation was favorable at 10.4 ± 4.5 mm Hg.
CONCLUSIONS: After an initial demonstration of feasibility, this multicenter study shows that the J-Valve transcatheter heart valve system is a reasonable option for patients with predominant aortic regurgitation.
Предметные рубрики MeSH
AgedAortic ValveAortic Valve InsufficiencyChinaEchocardiography, Doppler, ColorEchocardiography, TransesophagealFeasibility StudiesFemaleHeart Valve ProsthesisHemodynamicsHumansMaleMultidetector Computed TomographyPostoperative ComplicationsProspective StudiesProsthesis DesignRecovery of FunctionRisk FactorsTime FactorsTranscatheter Aortic Valve ReplacementTreatment Outcome