Evidence map›Paper›PMID 33855140›Full record

ArticleData in brief2021

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 and 1 more

Abstract read
In one paragraph

Article in Data in brief, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

Rutger-Jan NuisDepartment of Cardiology, Erasmus Medical Center, Room Nt-645, Dr. Molewaterplein 40, 3015 GD Rotterdam, the Netherlands.
David WoodCentre for Cardiovascular and Heart Valve Innovation, St. Paul's and Vancouver General Hospital, Vancouver, Canada.
Herbert KroonDepartment of Cardiology, Erasmus Medical Center, Room Nt-645, Dr. Molewaterplein 40, 3015 GD Rotterdam, the Netherlands.
Maarten van WiechenDepartment of Cardiology, Erasmus Medical Center, Room Nt-645, Dr. Molewaterplein 40, 3015 GD Rotterdam, the Netherlands.
Darra BigelowClinical and Medical Affairs, Teleflex Inc., Exton, PA, USA.
Chris BullerClinical and Medical Affairs, Teleflex Inc., Exton, PA, USA.
Joost DaemenDepartment of Cardiology, Erasmus Medical Center, Room Nt-645, Dr. Molewaterplein 40, 3015 GD Rotterdam, the Netherlands.
Peter de JaegereDepartment of Cardiology, Erasmus Medical Center, Room Nt-645, Dr. Molewaterplein 40, 3015 GD Rotterdam, the Netherlands.
Zvonimir KrajcerBaylor St Luke Hospital, Houston, TX, USA.
John WebbCentre for Cardiovascular and Heart Valve Innovation, St. Paul's and Vancouver General Hospital, Vancouver, Canada.
Nicolas Van MieghemDepartment of Cardiology, Erasmus Medical Center, Room Nt-645, Dr. Molewaterplein 40, 3015 GD Rotterdam, the Netherlands.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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.

Indexed as

Access siteAortic stenosisClosure deviceTAVIVascular complications

Identifiers

PMID33855140
PMCPMC8026902

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.