TAVI with the Venus A-Valve demonstrated similar 2-year clinical outcomes compared to the CoreValve (7.4% vs 11.1%, P=0.64), with significantly fewer pacemaker insertions (7.4% vs 37.0%, P=0.03).
Cohort (n=54)
Does TAVI with the Venus A-Valve provide comparable safety and efficacy to the CoreValve in high-risk or inoperable patients with aortic stenosis?
The Venus A-Valve demonstrates comparable safety and efficacy to the CoreValve for TAVI in high-risk Chinese patients, with a notably lower rate of permanent pacemaker implantation.
Absolute Event Rate: 7.4% vs 11.1%
p-value: p=0.64
BACKGROUND: Transcatheter aortic valve implantation (TAVI) has been demonstrated to be an effective alternative to surgical aortic valve replacement (SAVR) in patients with aortic stenosis who are deemed high risk or inoperable. Currently, TAVI procedures in China mostly make use of the domestic Venus A-Valve and the CoreValve; however, there is no data on their comparative performance. METHODS: Consecutive patients undergoing TAVI with the aforementioned devices were included. The outcomes were reported according to the Valve Academic Research Consortium-2 (VARC) definitions. RESULTS: A total of 54 TAVI procedures were performed, 27 with the CoreValve and the other 27 with the Venus A-Valve. An additional valve was required in 4 (14.8%) and 3 (11.1%) patients, and the VARC-2 device success rates were 81.5 and 85.2%, respectively. The incidences of common complications were similar, except for the significantly less frequent pacemaker insertion in the Venus A-Valve group (7.4 vs. 37.0%, P = 0.03). Within 30 days, 2 (3.7%) patients died, 1 in each group, and both had a bicuspid aortic valve (BAV). No other serious complications, such as annular rupture, coronary obstruction and aortic dissection, occurred in the 32 BAV patients treated with the Venus A-Valve (14) or the CoreValve (18). After 2-years of follow-up, there was no significant difference between CoreValve group and Venus-A group (11.1 vs. 7.4%, P = 0.64). CONCLUSION: TAVI with the domestic Venus A-Valve is feasible, safe, and can produce favorable short-term outcomes comparable to those with the CoreValve in inoperable or high-risk patients with tricuspid and bicuspid aortic valve stenosis. © 2017 Wiley Periodicals, Inc.
Liao et al. (2017) conducted a cohort in Aortic stenosis (n=54). Venus A-Valve vs. CoreValve was evaluated on Events at 2-years of follow-up (p=0.64). TAVI with the Venus A-Valve demonstrated similar 2-year clinical outcomes compared to the CoreValve (7.4% vs 11.1%, P=0.64), with significantly fewer pacemaker insertions (7.4% vs 37.0%, P=0.03).