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

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.

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.  Table   Subject Cardiology and Cardiovascular Medicine Specific subject area Large-bore catheter-based cardiac and vascular interventions Type of data Tables and Figures  How data were acquired In this patient-level meta-analysis, data were derived from two multicenter, prospective, single arm medical device approval studies (the CE mark study [2] , and the Investigational Device Exemption SAFE-MANTA Pivotal Study [3] ) in addition to a multicenter prospective post-approval study (the MAnta Registry for Vascular Large-borE CLosure [MARVEL] registry [4] ). Statistical analyses were performed using Statistical Package for the Social Sciences version 25 (IBM, Armonk, New York) Data format Analysed Parameters for data collection The one inclusion criterion in all studies was: all patients undergoing percutaneous cardiac interventions with large-bore catheter sizes and planned access closure using the MANTA VCD. Exclusion criteria in each of the three studies are detailed in Table 1 . The main exclusion criteria were: -Morbid obesity or cachexia (body mass index > 40 or < 20 kg/m 2 ) -Excessive femoral calcium or severe peripheral vascular disease -Marked tortuosity of the iliofemoral tract -Puncture site other than the common femoral artery Description of data collection All clinical data were prospectively collected and clinical follow-up was planned between 30-and 60 days after the procedure. An independent clinical research organization overlooked study conduction and monitoring. All vascular-and bleeding complications were adjudicated by independent clinical event committees. For the purpose of this patient-level meta-analysis, a selection of individual patient data were merged in a dedicated database and used for these analyses.

Value of the Data
• Vascular management in large-bore catheter-based interventions is challenging and affects patient outcome. These supplementary data provide detailed insight into the type and management of MANTA related access complications across various large-bore catheter-based interventions and also in a more homogenous population of patients undergoing TAVR using contemporary valves. • The patients in this dataset reflect the largest study population undergoing arteriotomy closure with the MANTA VCD by operators at various levels of experience. It can be valuable to further build on research regarding large-bore arteriotomy management which ultimately benefits patients undergoing large-caliber catheter-based interventions. • The data described should help understand the mechanisms of MANTA related access complications in patients undergoing various catheter-based interventions such as TAVR, which can be useful to optimize risk stratification, pre-procedural planning, vascular management and future iterations in (plug-based) closure technologies.

Data Description
This dataset provides relevant details on the frequency, impact and predictors of MANTA related access complications. Data are presented in Tables and Figures. Table 1 describes the general characteristics of each of the three studies from which data were used for the present dataset. Each study had a prospective, observational, multicenter design with similar inclusion criteria but various exclusion criteria. Table 2 provides raw data on the type, management and outcome of access complications of the entire cohort. The frequency of major / minor access complications was 9%; life-threatening bleeding occurred in 0.4% and mortality in 0.1% (i.e. 1 case of an arterial rupture). In Table 3 , the data are summarized for the subgroup of TAVR procedures in which the Sapien S3 / Ultra or Evolut Pro-valve was used (i.e. the two most commonly used valves in contemporary practice). The frequency of major / minor access complications was 10% in the TAVR-group and none of the access complications in TAVR were associated with life-threatening bleeding or death. The main article demonstrated that the frequency of access complications in Roll-in cases (first or second time operator use of MANTA) was similar as compared to non-Roll-in cases (third time or more operator experience with MANTA). Table 4 demonstrates that this finding was despite the fact that Roll-in cases as a group had higher STS score as compared to patients not labelled as a Roll-in case (median STS score: 3.8 vs. 3.1%, respectively, p = 0.015). Fig. 1 demonstrates the MANTA VCD hemostasis times: 67% of patients had complete hemostasis within 1 min and 88% within 5 min. Because device profile determines arteriotomy size and complication risk, access complication frequencies were further stratified per valve-platform as shown in Fig. 2 . It was found that the valve-platform exhibiting the smallest device profile (Evolut R) was associated with access complications in 7.1% while other (larger profile) valve-platforms were associated with complication rates between 8.3 and 13.1%.

Experimental Design, Materials and Methods
As mentioned above, this patient-level meta-analysis pooled data from two medical device approval studies and one post-approval registry to assess the frequency, impact and      Subgroup analysis of access complications and management in patients undergoing TAVR with SapienS3 / Ultra or Evolut PRO valves.
Access complications minor major all n = 29 (5.0%) a n = 30 (5.2%) a n = 59 (10.2%) a  predictors of MANTA related access complications after large-bore catheter-based cardiovascular interventions. Procedures were performed by 71 operators at 28 sites between 2015 and 2019. Table 1 describes all in-and exclusion criteria of each of the 3 studies from which data were derived. Overall, patients were eligible if they underwent percutaneous cardiovascular interventions and planned access closure using the MANTA VCD. Exclusion criteria were most stringent  in the SAFE MANTA trial, followed by the CE mark study whereas MARVEL applied liberal and only relative exclusion criteria. The most important exclusion criteria were morbid obesity or cachexia (body mass index > 40 or < 20 kg/m 2 ), excessive femoral calcium or severe peripheral vascular disease, marked tortuosity of the iliofemoral tract and puncture site other than the common femoral artery. Of note, in SAFE MANTA poor left ventricular function and severe renal dysfunction were also exclusion criteria. In all patients, major and minor access complications were defined according to the updated Valve Academic Research Consortium 2 criteria [5] . All events were adjudicated by independent clinical event committees. A detailed description of the study population, MANTA device, the percutaneous procedures, ileofemoral data and clinical outcome assessment is presented in the main article [1] . Continuous variables were compared using the Student t-test or Mann Whitney U test when appropriate. Categorical variables are presented as numbers and percentages of patients and categorical variables were compared with the Chi square test. A two-sided p < 0.05 was considered to indicate significance. Statistical analyses were performed using Statistical Package for the Social Sciences version 25 (IBM, Armonk, New York)

Ethics Statement
Informed consent was obtained from all patients that were enrolled with the use of a prespecified patient information form. The herein reported data were derived from the SAFE-MANTA study (protocol identifier: PSD-109), CE-Mark study (protocol identifier: PSD-051) and MARVEL registry (protocol identifier: PSD-212), and study protocols were approved by the Ethics Committees of each participating center.

Declaration of Competing Interest
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.