The Journal of thoracic and cardiovascular surgery · 2025
A multicenter prospective clinical study on transcatheter aortic valve implantation for aortic stenosis or pure aortic regurgitation: 5-year outcomes.
СтатьяМногоцентровое исследованиеНазвание и аннотация: Перевод в очереди
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Wang Yuqiang, Wei Lai, Liu Lulu, Shi Jun, Wang Wei, Cao Tingqian, Qin Chaoyi, Ye Jian, Guo Yingqiang
Аннотация
OBJECTIVE: Currently, there is limited evidence regarding the long-term durability of available transcatheter heart valves (THVs). The purpose of this analysis is to evaluate the 5-year outcomes of using the J-Valve for transcatheter aortic valve implantation (TAVI) in aortic stenosis (AS) and pure aortic regurgitation (AR).
METHODS: From March 2014 to August 2015, all consecutive patients with severe AS and pure AR treated with the J-Valve THV at 3 centers in China were prospectively enrolled in a clinical study. Clinical and echocardiographic follow-up were performed according to study protocol. All results were reported according to the Valve Academic Research Consortium 3 criteria.
RESULTS: At 5-year follow-up, the all-cause mortality rate was 15.31% (16/98), with a cardiovascular mortality rate of 7.14% (7/98). The incidence of stroke was 7.14% (7/98), and the permanent pacemaker implantation rate was 8.16% (8/98). Echocardiographic follow-up showed left ventricular ejection fraction significantly improved at 5 years in both patients with AS (58.98 ± 10.45% vs 61.78 ± 9.07%, P for trend <.01) and pure AR (52.86 ± 10.98% vs 61.45 ± 6.90%, P for trend < .01). Structural or hemodynamic valve deterioration occurred in 3 cases (3.06%). In total, 97.59% of patients had significant improvement in New York Heart Association functional class over the 5-year follow-up, which is associated with significant improvement in quality of life.
CONCLUSIONS: Our study demonstrates that TAVI with the J-Valve THV provides excellent 5-year clinical and echocardiographic outcomes, suggesting TAVI with a dedicated THV is a good alternative treatment for AS and pure AR in selected high-risk patients.
METHODS: From March 2014 to August 2015, all consecutive patients with severe AS and pure AR treated with the J-Valve THV at 3 centers in China were prospectively enrolled in a clinical study. Clinical and echocardiographic follow-up were performed according to study protocol. All results were reported according to the Valve Academic Research Consortium 3 criteria.
RESULTS: At 5-year follow-up, the all-cause mortality rate was 15.31% (16/98), with a cardiovascular mortality rate of 7.14% (7/98). The incidence of stroke was 7.14% (7/98), and the permanent pacemaker implantation rate was 8.16% (8/98). Echocardiographic follow-up showed left ventricular ejection fraction significantly improved at 5 years in both patients with AS (58.98 ± 10.45% vs 61.78 ± 9.07%, P for trend <.01) and pure AR (52.86 ± 10.98% vs 61.45 ± 6.90%, P for trend < .01). Structural or hemodynamic valve deterioration occurred in 3 cases (3.06%). In total, 97.59% of patients had significant improvement in New York Heart Association functional class over the 5-year follow-up, which is associated with significant improvement in quality of life.
CONCLUSIONS: Our study demonstrates that TAVI with the J-Valve THV provides excellent 5-year clinical and echocardiographic outcomes, suggesting TAVI with a dedicated THV is a good alternative treatment for AS and pure AR in selected high-risk patients.