Procedural Outcomes
Severa observational studies show that TAVR is a viable option for patients with pure AR6, 7, 16, 17. It is well known that the first-generation THV primarily relying on calcification of the native leaflets for sufficient anchoring of the expanded prosthesis. Patients with AR have more complex and variable anatomy, and the lack of calcification may lead to inaccurate positioning and difficulty of anchoring, or even worse, valve embolization or residual PVL18. TAVR using the new-generation devices was associated with improved procedural outcomes in treating patients with AR 19, 20. Importantly, with the second-generation valves and advanced technique J-Valve has even been certified in the indication AR. With a novel fixation mechanism associated with a significantly higher procedural success rate, these devices are a reasonable option in AR patients 21, 22. In the present study, the device’s success is consistent with previous reports of the same valve in patients with AS 23.
The device’s success was 96.3%, which corresponds to the J-Valve’s initially reported experience for AR treatment, which was 97.6%9. A recent meta-analysis has reported that, based on nineteen studies, with a total number of 988 patients, the rate of devices success was 86.2% (78.8%-92.2%) 24. Our study demonstrated a higher success rate and a lower mortality rate than the studies mentioned above, indicating a novel device’s viable safety profile. However, there was no difference in the device success rate between both devices [J-valve and JeneValve (96.3% vs. 96.8%)]16.
The feelers in JenaValve have a rigid connection with the support frames and J-valve with mobile nitinol graspers, which are both designed to be placed into the sinus of the aortic root to achieve an anatomically correct position. The unique design make it possible to ensure the optimal positioning of the valve stent after deployment.