Data on plug-based large-bore arteriotomy vascular closure device related access complications

Rutger Jan Nuis*, David Wood, Herbert Kroon, Maarten van Wiechen, Darra Bigelow, Chris Buller, Joost Daemen, Peter de Jaegere, Zvonimir Krajcer, John Webb, Nicolas Van Mieghem*

*Corresponding author for this work

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Abstract

This article provides supplementary tables and figures to the research article: Frequency, Impact and Predictors of Access Complications with Plug-Based Large-Bore Arteriotomy Closure - A patient level meta-analysis [1]. The data provide insight in the type and management of access complications related to the plug-based MANTA vascular closure device (VCD) for large-bore catheter-based cardiovascular interventions. Since MANTA is mostly used in transcatheter aortic valve replacement (TAVR) procedures, this article also contains a sub-group analysis on TAVR procedures using contemporary valve-platforms. Further, data describing MANTA hemostasis times and mortality causes are included. For this dataset, individual patient data were derived from a European and a North American device approval study (the Conformite Européene [CE] mark study and the investigational device exemption SAFE-MANTA study [2,3]) in addition to a post-approval registry (the MARVEL registry [4]) covering a total of 891 patients who were enrolled between 2015 and 2019 across 28 investigational sites. Eligibility criteria were most stringent in the SAFE MANTA study (38% of patients) whereas the MARVEL registry applied liberal and only relative exclusion criteria (56% of patients). A total of 78 Roll-in cases (i.e. first or second time operator use of the MANTA VCD) who were excluded from analysis in SAFE MANTA were included in the present to evaluate a potential learning curve effect. Therefore, this dataset reflects the largest study population undergoing arteriotomy closure with the MANTA VCD by operators at various levels of experience, which can be valuable to further build on research regarding percutaneous large-bore arteriotomy management.

Original languageEnglish
Article number106969
JournalData in Brief
Volume36
Early online date10 Mar 2021
DOIs
Publication statusPublished - Jun 2021

Bibliographical note

Funding Information:
Dr. Van Mieghem reports receiving grant support from Teleflex. The other authors declare that they have no known competing financial interests or personal relationships which have or could be perceived to have influenced the work reported in this article.

Publisher Copyright:
© 2021

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