Clin Res Cardiol (2023). https://doi.org/10.1007/s00392-023-02180-w

Multicenter comparison of the new generation self-expanding NAVITOR with its predecessor, the PORTICO transcatheter heart valve in severe native aortic valve stenosis
J. Blumenstein1, C. Eckel1, C. Grothusen1, V. Tiyerili1, D. Soetemann1, G. Dohmen2, Y.-H. Choi3, E. Charitos3, C. W. Hamm4, M. Renker5, W.-K. Kim1, H. Möllmann1
1Klinik für Innere Medizin I, Kath. St. Paulus Gesellschaft, Dortmund; 2Herzchirurgie, St. Paulus Gesellschaft, Dortmund; 3Herzchirurgie, Kerckhoff Klinik GmbH, Bad Nauheim; 4Medizinische Klinik I - Kardiologie und Angiologie, Universitätsklinikum Gießen und Marburg GmbH, Gießen; 5Abteilung für Kardiologie, Kerckhoff Klinik GmbH, Bad Nauheim;

Background: New generation transcatheter heart valves aim to reduce typical TAVR problems such as paravalvular leackage, the occurrence of conduction alterations and secondary pacemaker implantations. Data on the new intra-annular self-expanding NAVITOR in comparison to prior PORTICO valve are scarce. 

Methods: Data was collected retrospectively from two German high volume heart centers. In total 263 patients with severe native aortic stenosis treated with PORTICO (n=139) or NAVITOR (n=124) using the new FlexNav delivery catheter from 03/2020 to 09/2022 were included. Clinical and hemodynamic outcomes were evaluated according to VARC-3 recommendations.

Results: Overall technical success (91.4% vs. 96.77%, p=0.116) and device success at 30 days (82.7% vs. 87.1%, p=0.417) after transcatheter implantation according to VARC-3 definition was high with Portico and NAVITOR. Postprocedural mean gradient (7.00 vs. 7.50mmHg, p=0.255) and estimated aortic valve area (1.90 vs. 1.98, p=0.345) were comparable. A clear trent was seen towards less paravalvular leakage (PVL) (7.2 vs. 1.6 %, p=0.062) after NAVITOR without concomitant significant higher pacemaker rate (15.32% vs. 21.57%, p=0.299). Furthermore rate of severe bleeding (27.3 vs. 12.9%, p=0.006) and major vascular complications (5.8 vs. 0.81%, p=0.039) were significantly lower after NAVITOR. 

Conclusion: The new generation NAVITOR valve prosthesis could optimize results of prior generation PORTICO valve prosthesis and could demonstrate favourable intrahospital procedural outcome data with remarkable low rate of relevant PVL without significantly higher pacemaker rate.

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