Impact of Sheath Type on Vascular and Bleeding Complications After Transcatheter Aortic Valve Replacement: A Post Hoc Analysis From the MARVEL Registry Study.
Emily Pan, Herbert G Kroon, Pim A L Tonino, Giovanni Amoroso, Mika Laine, Evald H Christiansen, Stefan Toggweiler, Jur Ten Berg, Markus Malmberg, Ton Slagboom, Noriaki Moriyama, Christian J Terkelsen, Federico Moccetti, Livia Gheorghe, Darra Bigelow, John Webb, David Wood, Nicholas Van Mieghem, Mikko Savontaus
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引用次数: 0
Abstract
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.
Methods: The 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.
Results: We 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).
Conclusions: A 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.
期刊介绍:
Catheterization and Cardiovascular Interventions is an international journal covering the broad field of cardiovascular diseases. Subject material includes basic and clinical information that is derived from or related to invasive and interventional coronary or peripheral vascular techniques. The journal focuses on material that will be of immediate practical value to physicians providing patient care in the clinical laboratory setting. To accomplish this, the journal publishes Preliminary Reports and Work In Progress articles that complement the traditional Original Studies, Case Reports, and Comprehensive Reviews. Perspective and insight concerning controversial subjects and evolving technologies are provided regularly through Editorial Commentaries furnished by members of the Editorial Board and other experts. Articles are subject to double-blind peer review and complete editorial evaluation prior to any decision regarding acceptability.