Transcatheter aortic valve implantation with different self-expanding devices-a propensity score-matched multicenter comparison
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Transcatheter aortic valve implantation with different self-expanding devices-a propensity score-matched multicenter comparison. / Wienemann, Hendrik; Hof, Alexander; Ludwig, Sebastian; Veulemans, Verena; Sedaghat, Alexander; Iliadis, Christos; Meertens, Max; Macherey, Sascha; Hohmann, Christopher; Kuhn, Elmar; Al-Kassou, Baravan; Wilde, Nihal; Schofer, Niklas; Bleiziffer, Sabine; Maier, Oliver; Kelm, Malte; Baldus, Stephan; Rudolph, Tanja Katharina; Adam, Matti; Mauri, Victor.
In: HELL J CARDIOL, Vol. 70, 2023, p. 1-9.Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review
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TY - JOUR
T1 - Transcatheter aortic valve implantation with different self-expanding devices-a propensity score-matched multicenter comparison
AU - Wienemann, Hendrik
AU - Hof, Alexander
AU - Ludwig, Sebastian
AU - Veulemans, Verena
AU - Sedaghat, Alexander
AU - Iliadis, Christos
AU - Meertens, Max
AU - Macherey, Sascha
AU - Hohmann, Christopher
AU - Kuhn, Elmar
AU - Al-Kassou, Baravan
AU - Wilde, Nihal
AU - Schofer, Niklas
AU - Bleiziffer, Sabine
AU - Maier, Oliver
AU - Kelm, Malte
AU - Baldus, Stephan
AU - Rudolph, Tanja Katharina
AU - Adam, Matti
AU - Mauri, Victor
N1 - Copyright © 2022 Hellenic Society of Cardiology. Published by Elsevier B.V. All rights reserved.
PY - 2023
Y1 - 2023
N2 - OBJECTIVE: Several supra-annular self-expanding transcatheter systems are commercially available for transcatheter aortic valve implantation (TAVI). Comparative data in large-scale multicenter studies are scant.METHODS: This study included a total of 5175 patients with severe aortic stenosis undergoing TAVI with the ACURATE neo (n = 1095), Evolut R (n = 3365), or Evolut PRO (n = 715) by a transfemoral approach at five high-volume centers. Propensity score matching resulted in 654 triplets. Outcomes are reported according to the Valve Academic Research Consortium-3 (VARC-3) consensus.RESULTS: Moderate or severe paravalvular regurgitation (PVR) occurred significantly more often in the ACURATE neo group (5.2%) than in the Evolut R (1.8%) and Evolut PRO (3.3%) groups (p = 0.003). The rates of major vascular-/access-related complications (4.6%, 3.8%, and 5.0%; p = 0.56), type 3 or 4 bleeding (3.2%, 2.1%, and 4.1%; p = 0.12), and 30-day mortality (2.4%, 2.6%, and 3.7%; p = 0.40) were comparable. The rate of new permanent pacemaker implantation (PPI) was significantly lower in the ACURATE neo group (9.5%, 17.6%, and 16.8%; p < 0.001). Independent predictors for 2-year survival were a Society of Thoracic Surgeons (STS) risk score ≥5%, diabetes mellitus, a glomerular filtration rate <30 ml/min, baseline mean transvalvular gradient ≤ 30 mm Hg, treating center, and relevant PVR.CONCLUSION: In this multicenter study, TAVI with the ACURATE neo, Evolut R, or Evolut PRO was feasible and safe. The rate of relevant PVR was more frequent after the ACURATE neo implantation, with, however, lower rates of PPI. Two-year survival was mainly driven by baseline comorbidities.
AB - OBJECTIVE: Several supra-annular self-expanding transcatheter systems are commercially available for transcatheter aortic valve implantation (TAVI). Comparative data in large-scale multicenter studies are scant.METHODS: This study included a total of 5175 patients with severe aortic stenosis undergoing TAVI with the ACURATE neo (n = 1095), Evolut R (n = 3365), or Evolut PRO (n = 715) by a transfemoral approach at five high-volume centers. Propensity score matching resulted in 654 triplets. Outcomes are reported according to the Valve Academic Research Consortium-3 (VARC-3) consensus.RESULTS: Moderate or severe paravalvular regurgitation (PVR) occurred significantly more often in the ACURATE neo group (5.2%) than in the Evolut R (1.8%) and Evolut PRO (3.3%) groups (p = 0.003). The rates of major vascular-/access-related complications (4.6%, 3.8%, and 5.0%; p = 0.56), type 3 or 4 bleeding (3.2%, 2.1%, and 4.1%; p = 0.12), and 30-day mortality (2.4%, 2.6%, and 3.7%; p = 0.40) were comparable. The rate of new permanent pacemaker implantation (PPI) was significantly lower in the ACURATE neo group (9.5%, 17.6%, and 16.8%; p < 0.001). Independent predictors for 2-year survival were a Society of Thoracic Surgeons (STS) risk score ≥5%, diabetes mellitus, a glomerular filtration rate <30 ml/min, baseline mean transvalvular gradient ≤ 30 mm Hg, treating center, and relevant PVR.CONCLUSION: In this multicenter study, TAVI with the ACURATE neo, Evolut R, or Evolut PRO was feasible and safe. The rate of relevant PVR was more frequent after the ACURATE neo implantation, with, however, lower rates of PPI. Two-year survival was mainly driven by baseline comorbidities.
U2 - 10.1016/j.hjc.2022.12.006
DO - 10.1016/j.hjc.2022.12.006
M3 - SCORING: Journal article
C2 - 36538975
VL - 70
SP - 1
EP - 9
JO - HELL J CARDIOL
JF - HELL J CARDIOL
SN - 1109-9666
ER -