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

Ung Kim; Philipp Blanke; Stephan Windecker; Albert M. Kasel; Ulrich Schäfer; Darren Walters; Axel Linke; Herve Le Breton; Jonathon A. Leipsic; Gerhard Schymik; Mark S. Spence; Lars Søndergaard; Mohammed Abdel-Wahab; Stephen Worthley; Didier Tchétché; Hermann Reichenspurner; Mickael Ohana; Stephanie L. Sellers

doi:10.4244/EIJ-D-17-01040

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

Ung Kim, Philipp Blanke, Stephan Windecker, Albert M. Kasel, Ulrich Schäfer, Darren Walters, Axel Linke, Herve Le Breton, Jonathon A. Leipsic^*, Gerhard Schymik, Mark S. Spence, Lars Søndergaard, Mohammed Abdel-Wahab, Stephen Worthley, Didier Tchétché, Hermann Reichenspurner, Mickael Ohana, Stephanie L. Sellers

^*Corresponding author for this work

Department of Clinical Medicine

6 Citations (Scopus)

Abstract

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.

Original language	English
Journal	EuroIntervention
Volume	14
Issue number	5
Pages (from-to)	e511-e518
ISSN	1774-024X
DOIs	https://doi.org/10.4244/EIJ-D-17-01040
Publication status	Published - 2018

Access to Document

10.4244/EIJ-D-17-01040

Cite this

Kim, U., Blanke, P., Windecker, S., Kasel, A. M., Schäfer, U., Walters, D., Linke, A., Le Breton, H., Leipsic, J. A., Schymik, G., Spence, M. S., Søndergaard, L., Abdel-Wahab, M., Worthley, S., Tchétché, D., Reichenspurner, H., Ohana, M., & Sellers, S. L. (2018). Computed tomography-based oversizing and incidence of paravalvular aortic regurgitation and permanent pacemaker implantation with a new-generation self-expanding transcatheter heart valve. EuroIntervention, 14(5), e511-e518. https://doi.org/10.4244/EIJ-D-17-01040

Computed tomography-based oversizing and incidence of paravalvular aortic regurgitation and permanent pacemaker implantation with a new-generation self-expanding transcatheter heart valve. / Kim, Ung; Blanke, Philipp; Windecker, Stephan et al.

In: EuroIntervention, Vol. 14, No. 5, 2018, p. e511-e518.

Research output: Contribution to journal › Journal article › Research › peer-review

Kim, U, Blanke, P, Windecker, S, Kasel, AM, Schäfer, U, Walters, D, Linke, A, Le Breton, H, Leipsic, JA, Schymik, G, Spence, MS, Søndergaard, L, Abdel-Wahab, M, Worthley, S, Tchétché, D, Reichenspurner, H, Ohana, M & Sellers, SL 2018, 'Computed tomography-based oversizing and incidence of paravalvular aortic regurgitation and permanent pacemaker implantation with a new-generation self-expanding transcatheter heart valve', EuroIntervention, vol. 14, no. 5, pp. e511-e518. https://doi.org/10.4244/EIJ-D-17-01040

@article{1e5c502a855f4873a5fe4a05c64e26c4,

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

abstract = "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.",

author = "Ung Kim and Philipp Blanke and Stephan Windecker and Kasel, {Albert M.} and Ulrich Sch{\"a}fer and Darren Walters and Axel Linke and {Le Breton}, Herve and Leipsic, {Jonathon A.} and Gerhard Schymik and Spence, {Mark S.} and Lars S{\o}ndergaard and Mohammed Abdel-Wahab and Stephen Worthley and Didier Tch{\'e}tch{\'e} and Hermann Reichenspurner and Mickael Ohana and Sellers, {Stephanie L.}",

year = "2018",

doi = "10.4244/EIJ-D-17-01040",

language = "English",

volume = "14",

pages = "e511--e518",

journal = "EuroIntervention",

issn = "1774-024X",

publisher = "Europa Digital & Publishing",

number = "5",

}

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

SN - 1774-024X

VL - 14

SP - e511-e518

JO - EuroIntervention

JF - EuroIntervention

IS - 5

ER -

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

Abstract

Access to Document

Fingerprint

Cite this