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

• DOI: 10.1016/j.dib.2021.106969
• Publication Date: 2021-03-19T14:30:07Z
• Authors: 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
• Keywords: Science (General); Access site; Aortic stenosis; Computer applications to medicine. Medical informatics; R858-859.7; Vascular complications; 3. Good health; TAVI; Q1-390; 03 medical and health sciences; 0302 clinical medicine; Closure device; Data Article

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.