A1 Refereed original research article in a scientific journal
Impact of Sheath Type on Vascular and Bleeding Complications After Transcatheter Aortic Valve Replacement: A Post Hoc Analysis From the MARVEL Registry Study
Authors: Pan, Emily; Kroon, Herbert G.; Tonino, Pim A. L.; Amoroso, Giovanni; Laine, Mika; Christiansen, Evald H.; Toggweiler, Stefan; Ten Berg, Jur; Malmberg, Markus; Slagboom, Ton; Moriyama, Noriaki; Terkelsen, Christian J.; Moccetti, Federico; Gheorghe, Livia; Bigelow, Darra; Webb, John; Wood, David; Van Mieghem, Nicholas; Savontaus, Mikko
Publisher: Wiley
Publication year: 2025
Journal: Catheterization and Cardiovascular Interventions
Journal name in source: Catheterization and Cardiovascular Interventions
Volume: 105
Issue: 4
First page : 787
Last page: 794
ISSN: 1522-1946
eISSN: 1522-726X
DOI: https://doi.org/10.1002/ccd.31396
Web address : https://doi.org/10.1002/ccd.31396
Self-archived copy’s web address: https://research.utu.fi/converis/portal/detail/Publication/484850042
Background
Vascular and bleeding complications remain a concern after transfemoral transcatheter aortic valve replacement (TAVR). The impact of the sheath type on these complications remains unclear.
MethodsThe prospective MARVEL registry study analyzed enrolled 500 patients undergoing large-bore transfemoral procedures and arteriotomy closure with the MANTA vascular closure device from 10 hospitals in Europe and Canada. We stratified these patients according to type of sheath used (expandable or conventional). A propensity-matched analysis was performed using VARC-2 major or minor vascular and bleeding complications as the primary endpoint. The secondary endpoint was time to hemostasis.
ResultsWe identified 196 propensity-matched pairs. Major vascular complications occurred in 3.6% in the expandable sheath group and 4.1% in the conventional sheath group (p = 1.0). Minor vascular complications occurred in 5.6% in the expandable sheath group and 4.6% in the conventional sheath group (p = 0.819). There were no significant differences in bleeding complications between groups. Time to hemostasis after MANTA closure was significantly shorter in the expandable sheath group (30 vs. 60 s, p < 0.001).
ConclusionsA propensity-matched analysis demonstrated no significant differences in vascular complication rates with MANTA arteriotomy closure after removal of large bore expandable or conventional sheaths. Time to hemostasis was significantly shorter in the expandable sheath group.
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