Objective To investigate the early safety and efficacy of transapical transcatheter aortic valve implantation (TAVI) for high-risk elderly patients with pure aortic valve insufficiency. Methods A prospective multicenter clinical study of domestic J-valveTM TAVI for high-risk native non-calcified aortic valve insufficiency was conducted from April 2014 to May 2018, and the early postoperative results were analyzed. A total of 82 patients were enrolled, including 62 patients from West China Hospital, Sichuan University, 16 patients from Zhongshan Hospital, Fudan University, and 4 patients from Beijing Fuwai Hospital, National Center for Cardiovascular Diseases. There were 55 males and 27 females. The age was 61-90 (73.8±6.3) years. The logistic EuroSCORE was 10.0%-44.4% (17.5%±8.1%). All patients underwent TAVI using J-ValveTM system. Clinical evaluation and echocardiography were performed preoperatively and 1 month postoperatively. Multislice spiral CT was reviewed before discharge. Results Three patients were transferred to thoracotomy for cardiopulmonary bypass operation, and 1 patient had decreased cardiac function due to leakage of the valve 1 week after surgery. The overall technical and procedural success rate was 95.1% and 93.9%, respectively. During hospitalization, 1 patient died of moderate pericyclosis complicated with multiple organ failure, and 1 patient died of pulmonary infection. Six (7.6%) patients received pacemaker implantation due to new onset Ⅲ° atrioventricular block. Echocardiographic follow-up showed paravalvular leak was observed in the few of patients, mild paravalvular leak was in 13 patients on the 30th day. Two patients showed moderate paravalvular leak. Left ventricular end-diastolic volume decreased from 197.7±66.8 mL (pre-TAVI) to 147.2±53.3 mL (30-day post-TAVI) (P<0.05). Mean pressure gradient was 9.5±4.1 mm Hg (30-day post-TAVI). Conclusion This multicenter study demonstrates that TAVI with the J-Valve system for the treatment of pure aortic regurgitation is associated with sustained clinical and functional cardiovascular benefits in high-risk patients with symptomatic aortic regurgitation early-term follow-up. Our results further support that TAVI with the specific designed J-Valve system is an acceptable alternative therapy for high-risk patients with pure AR. Our result demonstrates good early-term durability and preserved hemodynamic function. The procedure appears to offer an adequate and lasting resolution for selected patients with pure aortic regurgitation.
Objective To summarize the early results and clinical experience of using the J-Valve for transcatheter valve-in-valve implantation in patients with degenerated bioprosthesis at different anatomic positions. Methods A retrospective analysis was conducted to evaluate the short-term outcomes of 39 consecutive patients who underwent transcatheter valve-in-valve implantation using the J-Valve System in the Department of Cardiac Surgery of Guangdong Provincial People’s Hospital from April 2020 to August 2021 due to bioprosthetic degeneration at different anatomic positions. Among them, 35 patients underwent transcatheter mitral valve-in-valve (TMViV) implantation, 1 transcatheter aortic valve-in-valve (TAViV) implantation, 1 transcatheter tricuspid valve-in-valve (TTViV) implantation, 1 TMViV implantation with simultaneous TAViV implantation, and another one TMViV implantation with simultaneous transcatheter aortic valve replacement (TAVR) and perivalvular leakage (PVL) closure. Results Among the 35 patients who underwent isolated TMViV implantation, 17 were male and 18 were female with a mean age of 72.6±10.8 years. Mean duration between two operations was 10.5±2.7 years. The mean Society of Thoracic Surgeons and EuroSCORE Ⅱ scores were 12.95%±9.61% and 13.91%±8.94%, respectively. The device success rate was 97.1% and no death occured during the operation. One patient was transferred to thoracotomy due to device displacement, 1 was re-opened for uncontrolled bleeding, and 1 presented left ventricular outflow tract obstruction. One patient underwent craniotomy due to intracranial hemorrhage within 30 days after surgery, and no other complications occurred including death, stroke, permanent pacemaker implantation, cardiac tamponade, or re-hospitalization. The mean follow-up time was 6.0±4.4 months, the mean mitral valve gradient was significantly improved (10.4±2.0 mm Hg vs. 5.5±1.2 mm Hg, P<0.05), and the New York Heart Association class≤Ⅱ in all the patients at the last follow-up. Among the other 4 patients who did not undergo isolated TMViV implantation, the transapical TAViV implantation and the trans-right atrium TTViV implantation were successful without intra- or post-operative complications. The patient who underwent TMViV and TAViV implantation simultaneously via transapical approach died of severe pulmonary hemorrhage and multiple organ failure 16 days after surgery. The other patient who underwent transapical TMViV combined with TAVR and PVL closure died of septic shock 10 days after the surgery. Conclusion Transcatheter valve-in-valve implantation using the J-Valve system is shown to be a safe and effective procedure to treat mitral, aortic and tricuspid bioprosthetic valve dysfunction in high-risk patients, providing a new alternative to surgical surgery for degenerated bioprosthesis at different anatomic positions. However, simultaneous different valves intervention should be very cautious.
ObjectiveTo compare the in-hospital outcomes of transapical transcatheter aortic valve replacement (TA-TAVR) for bicuspid aortic valve (BAV) patients and tricuspid aortic valve (TAV) patients. MethodsPatients (including BAV and TAV patients) who underwent TA-TAVR with the J-ValveTM in West China Hospital from July 2014 to July 2020 were included consecutively. The clinical outcomes of the patients were analyzed. ResultsA total of 354 patients were included in the study, 75 in the BAV group and 279 in the TAV group. There were 229 males and 125 females with a mean age of 72.2±6.0 years. No death occurred during the procedure, and the overall technical success rate was 97.7%. The all-cause in-hospital mortality rate was 1.4%. Twenty (26.7%) patients with BAV and 46 (16.5%) patients with TAV had mild or higher perivalvular leaks immediately after the procedure. No patients with BAV required permanent pacemaker implantation postoperatively, while 13 (4.7%) TAV patients required permanent pacemaker implantation, with an overall pacemaker implantation rate of 3.7%. One (1.3%) BAV patient and 7 (2.5%) TAV patients developed acute kidney injury postoperatively. One (1.3%) BAV patient and 1 (0.4%) TAV patient developed perioperative myocardial infarction. The average postoperative hospital stay was 7.6±3.6 d for BAV patients and 8.6±6.1 d for TAV patients. There was no statistical difference in primary or secondary in-hospital outcomes between BAV and TAV patients (P>0.05). ConclusionCompared to TAV patients, BAV patients have similar in-hospital outcomes, with a low incidence of adverse clinical outcomes, which provides preliminary evidence for its implementation in Chinese patients with a high proportion of BAV.