Evidence map›Paper›PMID 40678573›Full record

ArticleFrontiers in cardiovascular medicine2025

Safety and effectiveness of single ProStyle™/ProGlide™ for aortic endovascular procedures: single-style study.

Rocco Cangiano, Alessia Di Girolamo, Marta Ascione, Francesca Miceli, Carola D'Amico, Andrea Molinari, Ada Dajci, Antonio Sterpetti, Giovanni Gagliardo, Luca di Marzo and 1 more

Abstract read
In one paragraph

Article in Frontiers in cardiovascular medicine, 2025. 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.

Rocco CangianoVascular and Endovascular Surgery Division, Department of General Surgery and Surgical Specialties, Policlinico Umberto I, "Sapienza" University of Rome, Rome, Italy.
Alessia Di GirolamoVascular and Endovascular Surgery Division, Department of General Surgery and Surgical Specialties, Policlinico Umberto I, "Sapienza" University of Rome, Rome, Italy.
Marta AscioneVascular and Endovascular Surgery Division, Department of General Surgery and Surgical Specialties, Policlinico Umberto I, "Sapienza" University of Rome, Rome, Italy.
Francesca MiceliVascular and Endovascular Surgery Division, Department of General Surgery and Surgical Specialties, Policlinico Umberto I, "Sapienza" University of Rome, Rome, Italy.
Carola D'AmicoVascular and Endovascular Surgery Division, Department of General Surgery and Surgical Specialties, Policlinico Umberto I, "Sapienza" University of Rome, Rome, Italy.
Andrea MolinariVascular and Endovascular Surgery Division, Department of General Surgery and Surgical Specialties, Policlinico Umberto I, "Sapienza" University of Rome, Rome, Italy.
Ada DajciVascular and Endovascular Surgery Division, Department of General Surgery and Surgical Specialties, Policlinico Umberto I, "Sapienza" University of Rome, Rome, Italy.
Antonio SterpettiDepartment of General Surgery, Policlinico Umberto I, "Sapienza" University of Rome, Rome, Italy.
Giovanni GagliardoVascular and Endovascular Surgery Division, Department of General Surgery and Surgical Specialties, Policlinico Umberto I, "Sapienza" University of Rome, Rome, Italy.
Luca di MarzoVascular and Endovascular Surgery Division, Department of General Surgery and Surgical Specialties, Policlinico Umberto I, "Sapienza" University of Rome, Rome, Italy.
Wassim MansourVascular and Endovascular Surgery Division, Department of General Surgery and Surgical Specialties, Policlinico Umberto I, "Sapienza" University of Rome, Rome, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: The Perclose ProStyle™/ProGlide™ Suture-Mediated Closure and Repair (SMCR) System is designed to close the common femoral artery (CFA) access during percutaneous endovascular procedures. Instructions for use (IFU) recommend the use of at least two devices, per single access, and the pre-close technique for arterial sheath sizes greater than 8 F. Besides, recent clinical studies suggest that a single ProStyle™/ProGlide™ pre-implantation can safely close percutaneous access for larger diameters. Aim: The purpose of this study was to analyse the efficacy of a single pre-implanted ProStyle™/ProGlide™ in closing the Common Femoral Artery (CFA) access site in patients undergoing aortic endovascular procedures using sheaths with diameter 12-16 French (F). Methods: We performed a prospective study including 72 consecutive patients who underwent aortic endovascular surgery from December 2022 to June 2024 in our University Hospital. In this group, only a single pre-implanted ProStyle™/ProGlide™ was used to close the access site in the CFA after using sheaths with diameters 12-16 F. The primary endpoint was technical success, defined as the absence of intraoperative open surgical conversion. The secondary endpoint was clinical success, defined as the absence of bleeding, pseudoaneurysms, and arteriovenous fistulas in the peri and postoperative period. We compared the results of this group with a cohort of patients in whom two ProStyle™/ProGlide™ were used to close the access site in the CFA. Result: Technical success was achieved in all cases (100%). Clinical success was achieved in 98% of cases. Only two minor bleedings occurred: one resulted in a small pseudoaneurysm, completely thrombosed 48 h after the procedure. One patient suffered from CFA dissection, requiring an open surgical endarterectomy. There were no statistically significant differences of clinical and technical success rates between the two groups. Conclusions: This study demonstrates that a Single ProStyle™/ProGlide™ preimplantation can be safe and effective in the closure of vascular accesses up to 16 Fr, with a low complication rate.

Indexed as

aortic endovascular procedurepre-close techniquevascular accessvascular access closure devicesvascular-diagnosis

Identifiers

PMID40678573
PMCPMC12267288

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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.