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Initial German Experience With Transapical Implantation of a Second-Generation Transcatheter Heart Valve for the Treatment of Aortic Regurgitation
Study Questions:
What is the initial German multicenter experience with implantation of a JenaValve transcatheter heart valve (THV) for the treatment of pure aortic regurgitation in patients at high risk for surgery?
Methods:
Transcatheter aortic valve implantation (TAVI) with a JenaValve for the treatment of severe aortic regurgitation was performed in 31 patients (ages 73.8 ± 9.1 years) in nine German centers. All patients were considered high risk for surgery (logistic EuroSCORE [European System for Cardiac Operative Risk Evaluation] 23.6 ± 14.5%), according to a local heart team consensus. Procedural results and clinical outcomes up to 6 months were analyzed.
Results:
Implantation was successful in 30 of 31 cases (aortic annulus diameter 24.7 ± 1.5 mm); THV dislodgement necessitated valve-in-valve implantation in one patient. Post-procedural aortic regurgitation was none/trace in 28 of 31 and mild in 3 of 31 patients. During follow-up, two patients underwent valvular reinterventions (surgical aortic valve replacement for endocarditis, valve-in-valve implantation for increasing paravalvular regurgitation). All-cause mortality was 12.9% and 19.3% at 30 days and 6 months, respectively. In the remaining patients, a significant improvement in New York Heart Association class was observed and persisted up to 6 months after TAVI.
Conclusions:
The authors concluded that the JenaValve THV was a reasonable option in this subset of patients with aortic regurgitation.
Perspective:
This multicenter experience suggests that the JenaValve THV may be an adequate option in patients with aortic regurgitation due to its unique stent design and fixation mechanism. The straightforward implantation technique and good acute results appear to suggest aortic regurgitation as a new indication for this device. However, a significant early noncardiac mortality related to the high-risk population emphasizes the need for careful patient selection. Continued observation and monitoring is warranted to confirm safety and durability of this device during long-term follow-up.
Keywords: Endocarditis, Patient Selection, Heart Valve Prosthesis Implantation, Stents, Consensus
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