Thorac Cardiovasc Surg 2014; 62 - OP37
DOI: 10.1055/s-0034-1367114

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

M. Seiffert 1, R. Bader 2, U. Kappert 3, S. Krapf 4, A. Rastan 5, S. Bleiziffer 6, S. Hofmann 7, M. Arnold 8, K. Kallenbach 9, L. Conradi 10, F. Schlingloff 2, M. Wilbring 3, U. Schäfer 11, H. Reichenspurner 10, H. Treede 10
  • 1Universitäres Herzzentrum Hamburg GmbH, Klinik für Allgemeine und Interventionelle Kardiologie, Hamburg, Germany
  • 2Asklepios Klinik St Georg, Klinik für Herzchirurgie, Hamburg, Germany
  • 3Herzzentrum Dresden, Klinik für Herzchirurgie, Dresden, Germany
  • 4Klinikum Augsburg, Klinik für Herz- und Thoraxchirurgie, Augsburg, Germany
  • 5Herz- und Kreislaufzentrum Rotenburg, Klinik für Herz- und Gefäßchirurgie, Rotenburg a.d. Fulda, Germany
  • 6Deutsches Herzzentrum München, Klinik für Herz- und Gefäßchirurgie, München, Germany
  • 7Schüchtermann Klinik Bad Rothenfelde, Klinik für Herzchirurgie, Bad Rothenfelde, Germany
  • 8Universitätsklinikum Erlangen, Medizinische Klinik 2 - Kardiologie und Angiologie, Erlangen, Germany
  • 9Universitätsklinikum Heidelberg, Klinik für Herzchirurgie, Heidelberg, Germany
  • 10Universitäres Herzzentrum Hamburg GmbH, Klinik für Herz- und Gefäßchirurgie, Hamburg, Germany
  • 11Asklepios Klinik St Georg, Klinik für Kardiologie, Hamburg, Germany

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.