Abstract：Objective This study aimed to collect and analyze the short-term efficacy of transcatheter aortic valve implantation (TAVI) using the J-Valve™ system. Methods A retrospective cohort study was conducted. Forty-two patients who were admitted to the First Affiliated Hospital of Anhui Medical University from January 2020 to May 2022, including 24 males and 18 females, aged 47-85 (71.5±8.0) years with BMI of (22.2±3.4) kg/m2, were included. Among the 42 patients, two had simple aortic stenosis, 25 had aortic stenosis combined with aortic insufficiency, and 15 had simple aortic insufficiency. All 42 patients underwent TAVI using the J-Valve™ system. Whether or not the aortic valve had a bicuspid aortic valve, 32 cases were included in the non-bicuspid aortic valve group and 10 cases in the bicuspid aortic valve group. Whether or not they had aortic stenosis, 27 patients were classified in the aortic stenosis group and 15 in the simple aortic insufficiency group. The observation indicators were as follows: (1) the clinical baseline data of patients in different groups; (2) the intraoperative, postoperative, and overall conditions of the patients during follow-up; (3) the operation time of patients in different groups, the duration of mechanical ventilation in cardiovascular intensive care unit (CICU), CICU duration, postoperative hospital stay, total hospital stay, and postoperative complications in different groups were compared. In addition, the left atrium (LA) diameter, left ventricle (LV) diameter, ejection fraction (EF), transvalve pressure, and perivalvular leakage of echocardiography were measured at the first week after surgery. Results (1) The differences in age, sex, cardiac function grade, echocardiographic examination of LA, EF, number of regurgitation above the moderate mitral valve, and complications were not significant between the non-bicuspid aortic valve group and bicuspid aortic valve group, as well as between the aortic stenosis group and simple aortic insufficiency group (all P values >0.05). The differences in LV diameter and transvalve pressure were not significant between the non-bicuspid aortic valve group and bicuspid aortic valve group (all P values >0.05). The differences in LV diameter and transvalve pressure were significant between the aortic stenosis group and simple aortic insufficiency group (all P values<0.05). (2) The operation was successfully performed in all 42 patients, and the operation time was from 65 to 330 (151.1±62.2) min. During the operation, two patients underwent aortic lumen isolation stent implantation, and two patients completed TAVI surgery with the support of cardiopulmonary bypass equipment. Two patients had intraoperative valve displacement, and the procedure was successfully completed after adjustment. All 42 patients had CICU mechanical ventilation time of 357.5 (115.0, 600.0) min and CICU duration of 18.0 (14.0,38.3) h. During CICU treatment, one patient had poor cardiac function, and two patients had low oxygen saturation, which improved after the corresponding treatment. Forty-two patients had good postoperative incision recovery; all surgical wounds healed by first intention and postoperative cardiac function below grade 2. After leaving the CICU and transferring to the general ward, three patients had a permanent pacemaker because of new-onset third-degree atrioventricular block. After surgery, four patients had new atrial fibrillation, and two patients had cerebrovascular accident, and the symptoms improved after corresponding treatment. Echocardiography was repeated 1 week after surgery, and the result revealed normal artificial valve opening and closure, none of them had moderate and more moderate regargitation. Twenty-one patients had postoperative perivalvular leakage, none of them had moderate and more moderate perivalvular leakage. Postoperative LA diameter, transvalve pressure, and the number of regurgitations above the moderate mitral valve were all lower than preoperative ones, and the differences were statistically significant (t=4.14, Z=4.98, χ2=6.76; all P values <0.05). The differences in LV diameter and EF were not statistically significant (all P values >0.05). Forty-two patients were recovered and discharged. The postoperative hospital stay was 7.0 (6.8, 10.5) days, and the total hospital stay was 23.5 (16.0,32.0) days. Of the 42 patients, 29 were followed up for 1-12 months (mean 4.7 months). During the follow-up period, chest tightness and palpitation improved compared with preoperative symptoms, such as increased activity endurance, and no new atrioventricular block, atrial fibrillation, and other related complications were observed. Head CT re-examination of patients with cerebrovascular accidents 1 month after discharge showed a decrease in infarct size. (3) The differences in operation time; CICU mechanical ventilation time; CICU duration; postoperative hospital stay; total hospital stay, 1 week postoperative echocardiography of the LA diameter, LV diameter, EF, and transvalvular pressure; perivalvular leakage; and the occurrence of postoperative complications were not statistically significant between the non-bicuspid aortic valve group and the bicuspid aortic valve group, as well as between the aortic stenosis group and simple aortic insufficiency group (all P values >0.05). Conclusion Using the J-Valve™ system is a preferred option for the treatment of aortic valve disease, the patients have good results in short term (less than 12 months) after surgery, with significant improvement in cardiac function.
李梓玮, 张帅朋, 张成鑫, 刘善东, 葛圣林. J-Valve™系统经导管主动脉瓣置入术治疗主动脉瓣疾病的短期疗效观察[J]. 中华解剖与临床杂志, 2023, 28(8): 519-526.
Li Ziwei, Zhang Shuaipeng, Zhang Chengxin, Liu Shandong, Ge Shenglin. Short-term efficacy of the J-Valve™ system in transcatheter aortic valve implantation in the treatment of aortic valve disease. Chinese Journal of Anatomy and Clinics, 2023, 28(8): 519-526.
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2023, Vol. 28 
