Transapical implantation of a second-generation transcatheter heart valve for the treatment of aortic regurgitation - initial German experience

Background: Experience with transcatheter aortic valve implantation (TAVI) for severe aortic regurgitation is limited due to the risk for insufficient anchoring of the valve stent within the non-calcified aortic annulus. Feasibility using the JenaValve (JenaValve Technology, Munich) system has recently been demonstrated. We report on acute results of the initial German multicenter experience using this second-generation transcatheter heart valve (THV) in patients with pure aortic regurgitation. Methods: Transapical TAVI was performed in 28 patients (age 72.7 ± 8.8 years) employing a JenaValve THV for severe aortic regurgitation in 9 German centers (off-label use). All patients were considered high risk for surgical aortic valve replacement after evaluation by the local interdisciplinary heart team (logistic EuroSCORE 22.7 ± 14.9%, STS-PROM 5.2 ± 3.6%). Aortic annulus diameters were 24.5 ± 1.9 mm and respective JenaValve prostheses implanted were 23 mm (n = 4), 25 mm (n = 6), and 27 mm (n = 18). Procedural and acute clinical outcomes were analyzed. Results: Implantation of the JenaValve THV was successful in 27/28 cases. Due to dislodgement of the device in one patient, valve-in-valve implantation with an Edwards Sapien XT (Edwards Lifesciences, Irvine, CA) was performed. Postprocedural aortic regurgitation was none or trace in 26/28 and mild in 2/28 patients. During 30-day follow up, 4/28 patients died (cardiac n = 1, non-cardiac n = 3). Due to access site complications (n = 2), the VARC 30 day safety endpoint was reached in 6/28 patients, overall. One patient underwent valve-in-valve implantation 3 months after initial implantation due to increasing paravalvular regurgitation and transvalvular gradients and one patient underwent surgical aortic valve replacement for endocarditis 6 months after TAVI. Both patients exhibited good valve function afterwards. The remaining patients displayed an unremarkable short-term follow-up without signs of valve failure. Conclusions: Aortic regurgitation continues to be a challenging pathology for TAVI. After initial demonstration of feasibility, this multicenter experience provides broader evidence that the JenaValve THV is a reasonable option in these specific patients due to its unique stent design and fixation mechanism. Short-term follow-up was promising with regard to valve function. However, a significant early non-cardiac mortality related to the high-risk patient population emphasizes the need for differentiated patient selection.