Computed tomography-based oversizing and incidence of paravalvular aortic regurgitation and permanent pacemaker implantation with a new-generation self-expanding transcatheter heart valve
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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; Kasel, Albert M; Schäfer, Ulrich; Walters, Darren; Linke, Axel; Le Breton, Herve; Schymik, Gerhard; Spence, Mark S; Søndergaard, Lars; Abdel-Wahab, Mohammed; Worthley, Stephen; Tchétché, Didier; Reichenspurner, Hermann; Ohana, Mickael; Sellers, Stephanie L; Leipsic, Jonathon A.
in: EUROINTERVENTION, Jahrgang 14, Nr. 5, 03.08.2018, S. e511-e518.Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung
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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 - 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
AU - Leipsic, Jonathon A
PY - 2018/8/3
Y1 - 2018/8/3
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 cut-off 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 cut-off 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.
KW - Aortic Valve
KW - Aortic Valve Insufficiency/epidemiology
KW - Aortic Valve Stenosis
KW - Heart Valve Prosthesis
KW - Humans
KW - Incidence
KW - Pacemaker, Artificial
KW - Predictive Value of Tests
KW - Prosthesis Design
KW - Severity of Illness Index
KW - Transcatheter Aortic Valve Replacement
KW - Treatment Outcome
U2 - 10.4244/EIJ-D-17-01040
DO - 10.4244/EIJ-D-17-01040
M3 - SCORING: Journal article
C2 - 29741486
VL - 14
SP - e511-e518
JO - EUROINTERVENTION
JF - EUROINTERVENTION
SN - 1774-024X
IS - 5
ER -