Objective To evaluate the early clinical outcomes of the Renatus® balloon-expandable valve in the treatment of severe aortic stenosis. MethodsFrom November 2021 to April 2022, a total of 38 patients who received Renatus® balloon-expandable valve for severe aortic stenosis in Guangdong Provincial People's Hospital were included. There were 22 males and 16 females, with an average age of 73.7±5.3 years. Mean aortic gradient and peak aortic jet velocity at baseline, post-procedure, and follow-up were compared. Clinical outcomes including all-cause mortality, perivalvular leakage, serious adverse cardiovascular events and the occurrence of permanent pacemaker implantation were assessed. ResultsAll patients completed the procedure successfully without conversion to thoracotomy or perioperative death. The post-implant mean aortic pressure gradient was decreased from 41.5 (27.8, 58.8) mm Hg to 6.0 (3.0, 8.0) mm Hg, and the peak aortic jet velocity was also decreased from 4.1±0.9 m/s to 1.7±0.4 m/s (P<0.001). Pacemakers were required in 2 (5.3%) patients. The median follow-up time was 27.5 (23.0, 87.5) d, with a follow-up rate of 100.0%. The mean aortic gradient was 8.0 (7.0, 10.8) mm Hg and peak aortic jet velocity was 2.0±0.3 m/s, showing significant improvement compared with those in the preoperative period (P<0.001). No severe aortic regurgitation or paravalvular leak was observed. There was no serious cardiovascular adverse event or reoperative event during the study period. ConclusionTranscatheter aortic valve replacement with the domestic Renatus® balloon-expandable valve system is a safe and effective procedure for selected patients with severe aortic stenosis who are at high risk or not candidates for surgical aortic valve replacement.
ObjectiveTo analyze the factors influencing the occurrence of subclinical leaflet thrombosis (SLT) after percutaneous aortic valve replacement using balloon-expandable valve (Sapien3, S3). Methods Retrospective analysis was made on 62 patients with severe aortic stenosis undergoing percutaneous aortic valve replacement using S3 in our center from September 2020 to June 2022. Patients with a history of vascular atherosclerosis or with significant increase or insignificant decrease of aortic valve flow or gradient pressure during follow-up were selected for CT examination. Results A total of 26 patients were finally included, with an average age of 70.31±8.90 years, and the male proportion was higher (n=15, 57.69%). Among them, 5 patients had SLT. Compared with the non-SLT group, patients in the SLT group were older (68.52±8.80 years vs. 77.80±4.66 years, P=0.007). The age factor (≥75 years) and the diameter of the ascending aorta were associated with SLT (both P<0.05). Conclusion The incidence of SLT is higher in the elderly patients. It is speculated that SLT is related to the characteristics of short balloon dilation valves and low blood flow dynamics of valve racks.
Transcatheter aortic valve replacement is an effective treatment for aortic stenosis currently, especially in elderly, surgical high-risk, and surgical procedures-intolerant patients with severe aortic stenosis. After several generations of updates in design and function, the self-expandable valves have shown significant efficacy in treating aortic stenosis patients with bicuspid aortic valve, bioprosthetic valve failure or small annulus, and superiority in terms of valve durability, and the favorable hemodynamic outcomes could translate into clinical endpoint benefit. This literature review summarizes the advantages and recent advances of the self-expandable valves in transcatheter aortic valve replacement.
Objective To evaluate the safety and early-stage efficacy of transcatheter aortic valve replacement (TAVR) for severe aortic stenosis (AS) using a new generation balloon-expandable (BE) valve by collecting the baseline and follow-up data. Methods We retrospectively reviewed the clinical data of severe AS patients who received TAVR with BE valve (Sapien 3) in Fuwai Hospital from September 2020 to June 2022. We collected the echocardiographic data as well as follow-up results at post-procedure, 1, 3, 6 and 12 months. According to the Sievers classification criteria, the patients were divided into a normal group and a bicuspid aortic valve group. Results Finally 62 patients were collected, including 31 females and 31 males with an average age of 71.44±9.17 years. There was 61 patients implanted successfully with BE valve and only 1 was transferred to surgical replacement. There was no mortality or severe complications. Echocardiographic assessment showed significant reduction of the pressure gradient (P＜0.001) and the effect was consistent to postoperative 12 months. After the treatment of patients with different aortic valve morphology using balloon dilation, the condition of valve stenosis improved. ConclusionThe use of BE valves has good safety and early efficacy in patients with severe AS of different valve morphology.