Clin Res Cardiol (2022). https://doi.org/10.1007/s00392-022-02002-5

Anatomical suitability and off-label use of contemporary transcatheter heart valves

N. Werner1, M. Renker2, T. Bauer1, O. Dörr3, Y.-H. Choi4, H. Nef3, C. W. Hamm3, R. Zahn5, W.-K. Kim2

1Medizinische Klinik I, Sana Klinikum Offenbach GmbH, Offenbach; 2Abteilung für Kardiologie, Kerckhoff Klinik GmbH, Bad Nauheim; 3Medizinische Klinik I - Kardiologie und Angiologie, Universitätsklinikum Gießen und Marburg GmbH, Gießen; 4Herzchirurgie, Kerckhoff Klinik GmbH, Bad Nauheim; 5Medizinische Klinik B, Klinikum der Stadt Ludwigshafen gGmbH, Ludwigshafen am Rhein;

Background: Despite excellent procedural results in a broad clinical population, certain anatomical or clinical conditions are still challenging for TAVR today. Data on anatomical and clinical suitability of new-generation THVs are sparse. Methods: The anatomical suitability of new-generation transcatheter heart valves (THVs) was evaluated in an all-comers transcatheter aortic valve replacement (TAVR) population at a high-volume center. In addition, the incidence, patient characteristics, and outcomes of off-label TAVR and TAVR using clinically unsuitable new-generation THVs were assessed. Criteria of clinical suitability of each THV were evaluated in an international survey of twenty experienced TAVR operators. Results: A total of 540 patients underwent transfemoral TAVR in our center in 2019 and were evaluated for the present analysis. 16.3% of the THVs implanted were clinically unsuitable with respect to anatomical or clinical criteria. Clinically unsuitable THV use was associated with increased device embolization. Clinical suitability was markedly different between all THVs, with highest rates with the SAPIEN 3/Ultra (94.8%) and lowest rates with the PorticoTM (33.1%). Anatomical instructions for use conformity was highest in the EVOLUTTM R (82.8%) and lowest in the PorticoTM(66.9%). 20% of all patients were treated off-label based on anatomical considerations, with marked differences between four new-generation THVs. Device success was significantly lower in off-label TAVR compared with on-label TAVR. Thirty-day all-cause mortality was not different between clinically suitable and unsuitable and between on- vs. off-label TAVR. Conclusions: Off-label TAVR and TAVR using clinically unsuitable THVs were frequent and were associated with less favorable procedural results after transfemoral TAVR. Vast differences exist in the anatomical coverage and clinical eligibility between four new-generation THVs, which emphasizes the importance of individualized THV selection to achieve optimal procedural and clinical results after TAVR.

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