TY - JOUR

T1 - Computed tomography-based oversizing and incidence of paravalvular aortic regurgitation and permanent pacemaker implantation with a new-generation self-expanding transcatheter heart valve

AU - Kim, Ung

AU - Blanke, Philipp

AU - Windecker, Stephan

AU - Kasel, Albert M.

AU - Schäfer, Ulrich

AU - Walters, Darren

AU - Linke, Axel

AU - Le Breton, Herve

AU - Leipsic, Jonathon A.

AU - Schymik, Gerhard

AU - Spence, Mark S.

AU - Søndergaard, Lars

AU - Abdel-Wahab, Mohammed

AU - Worthley, Stephen

AU - Tchétché, Didier

AU - Reichenspurner, Hermann

AU - Ohana, Mickael

AU - Sellers, Stephanie L.

PY - 2018

Y1 - 2018

N2 - Aims: We aimed to evaluate the relationship between CT-based annular perimeter oversizing and the incidence of paravalvular aortic regurgitation (PAR) and permanent pacemaker (PPM) implantation in patients treated with the new self-expanding CENTERA transcatheter heart valve (THV) for severe aortic stenosis. Methods and results: One hundred and ninety-eight patients in the CENTERA-EU trial were stratified a priori into four groups based on the perimeter oversizing (2.5-10%, 10-15%, 15-20% and >20%). PAR at 30 days was moderate or higher in 0.6% of patients. The frequency of PPM implantation was 4.9%. The mean perimeter oversizing was 16.2±5.6%. For patients with a perimeter oversizing >10%, an inverse relationship between oversizing and ≥mild PAR was observed (43.3% for 10-15% oversizing; 37.7%, 15-20%; 33.3%, >20%). No association between oversizing and effective orifice area was observed. The optimal cutoff value of perimeter oversizing for the prediction of ≥mild PAR was 15.9% (AUC 0.718, 95% CI: 0.576, 0.860). No annular ruptures were observed. Conclusions: The CENTERA THV appears to have a wide range of sizing tolerance. The degree of oversizing to mitigate PAR is relatively low compared to other self-expanding transcatheter devices. There appears to be no compromise between occurrence of PAR and PPM across this wide range of oversizing.

AB - Aims: We aimed to evaluate the relationship between CT-based annular perimeter oversizing and the incidence of paravalvular aortic regurgitation (PAR) and permanent pacemaker (PPM) implantation in patients treated with the new self-expanding CENTERA transcatheter heart valve (THV) for severe aortic stenosis. Methods and results: One hundred and ninety-eight patients in the CENTERA-EU trial were stratified a priori into four groups based on the perimeter oversizing (2.5-10%, 10-15%, 15-20% and >20%). PAR at 30 days was moderate or higher in 0.6% of patients. The frequency of PPM implantation was 4.9%. The mean perimeter oversizing was 16.2±5.6%. For patients with a perimeter oversizing >10%, an inverse relationship between oversizing and ≥mild PAR was observed (43.3% for 10-15% oversizing; 37.7%, 15-20%; 33.3%, >20%). No association between oversizing and effective orifice area was observed. The optimal cutoff value of perimeter oversizing for the prediction of ≥mild PAR was 15.9% (AUC 0.718, 95% CI: 0.576, 0.860). No annular ruptures were observed. Conclusions: The CENTERA THV appears to have a wide range of sizing tolerance. The degree of oversizing to mitigate PAR is relatively low compared to other self-expanding transcatheter devices. There appears to be no compromise between occurrence of PAR and PPM across this wide range of oversizing.

U2 - 10.4244/EIJ-D-17-01040

DO - 10.4244/EIJ-D-17-01040

M3 - Journal article

C2 - 29741486

AN - SCOPUS:85051214826

VL - 14

SP - e511-e518

JO - EuroIntervention

JF - EuroIntervention

SN - 1774-024X

IS - 5

ER -