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.