Tissue Adhesive Versus Figure-of-Eight Suture for Femoral Venous Closure After Electrophysiology Procedures (GLUE-EP) (GLUE-EP)

Topical Cyanoacrylate Tissue Adhesive Versus Figure-of-Eight Suture for Closure of Femoral Venous Access After Electrophysiology Procedures, Including Large-Bore Pulsed-Field Ablation: a Single-Centre Retrospective Cohort Study With Prospective Continuation (GLUE-EP)

In July 2026 the electrophysiology laboratory of a Czech tertiary cardiology centre introduced topical cyanoacrylate tissue adhesive (DERMABOND Mini or Histoacryl) as a routine alternative to the figure-of-eight suture for closing femoral venous puncture sites after electrophysiology procedures, including pulsed-field ablation performed through 13-17 F sheaths. After sheath removal, haemostasis is achieved by manual compression and the adhesive seals the skin over the puncture. The change was a clinical decision of the department, not a study intervention.

Published experience with this approach is limited, particularly for large-bore venous sheaths. GLUE-EP evaluates the access-site safety of the practice change using routinely recorded data only. Procedures closed with tissue adhesive are compared with a historical cohort closed with a figure-of-eight suture in 2024-2025 (propensity-score matched) and with a concurrent cohort closed with a suture during the same period. A prospective continuation collects the same routine data until 30 June 2027 from patients who give written informed consent.

The study assigns no treatment, adds no examination, questionnaire or study visit, and does not influence how the puncture site is closed. The primary outcome is any major or minor access-site vascular complication within 30 days of the procedure.

Study Overview

• Status: Not yet recruiting
• Conditions: Atrial Fibrillation; Arrhythmias, Cardiac; Hematoma; Vascular Access Site Complication
• Intervention / Treatment: Device: Topical cyanoacrylate tissue adhesive; Procedure: Figure-of-eight suture

Detailed Description

BACKGROUND

Closure of the femoral venous puncture site is the most frequent source of complications after electrophysiology (EP) procedures. The departmental standard has been a percutaneous figure-of-eight suture, removed 2 to 6 hours after the procedure. Topical cyanoacrylate tissue adhesive is an alternative that requires no removal: after sheath removal, haemostasis is achieved by manual compression and the adhesive then seals the skin over the puncture, which is the use for which the CE-marked products are intended. With the spread of pulsed-field ablation, venous sheath size has increased to 13-17 F, so the question of closure is most pressing for large-bore access. Published experience is limited: the only comparative report identified in PubMed concerns skin adhesive combined with a vascular closure device after atrial fibrillation ablation, not adhesive used instead of a suture.

PRACTICE CHANGE

Since 1 July 2026 the EP laboratory of Nemocnice AGEL Trinec-Podlesi a.s. (Czechia) has used topical cyanoacrylate tissue adhesive (2-octyl cyanoacrylate, DERMABOND Mini; or n-butyl-2-cyanoacrylate, Histoacryl) as a standard alternative to the figure-of-eight suture. This was a clinical decision of the department, not a research intervention. By 17 September 2026, 192 procedures had been closed with adhesive (177 catheter ablations and 15 diagnostic EP studies; 127 pulsed-field ablations through 13-17 F sheaths). Adhesive was used in 40%, 73% and 72% of procedures in July, August and September 2026, respectively.

DESIGN

Single-centre observational cohort study in two parts with identical population and outcome definitions. The study does not assign the closure method; it is chosen by the treating physician.

Part R (retrospective):

• Group A: procedures closed with adhesive from 1 July 2026 to the date of the ethics committee opinion (data cut-off 30 September 2026 for the first analysis).
• Group B: procedures closed with a figure-of-eight suture from 1 January 2024 to 31 December 2025 (historical comparator).
• Group C: procedures of the same period as Group A closed with a figure-of-eight suture (concurrent comparator).

Part P (prospective continuation): procedures closed with adhesive from the day after the ethics committee opinion to 30 June 2027, in patients who gave written informed consent before the procedure. Consent is sought at admission from all patients scheduled for an elective EP procedure with femoral venous access, because the closure method is decided during the procedure; only patients whose puncture site is closed with adhesive enter the analysis. The same routine variables are collected from the same sources; apart from obtaining consent, there is no additional examination, measurement, questionnaire or patient contact.

ASCERTAINMENT OF THE CLOSURE METHOD

In 2026, adhesive use is recorded in the departmental procedure registry. For Groups B and C, the closure method is taken from the procedure report and discharge summary. Because the figure-of-eight suture was the departmental standard, a procedure is classified as suture-closed unless another method is documented; procedures with another documented method (compression alone, vascular closure device) are excluded. The proportion of procedures without an explicit record of the suture is reported, and a sensitivity analysis restricts Groups B and C to procedures with an explicit record.

ASCERTAINMENT OF OUTCOMES

Access-site complications are identified from discharge summaries and from all records in the hospital information system up to day 30 after the procedure (outpatient visits, emergency department visits, readmissions, telephone contacts), not from the complication field of the departmental registry. A procedure without any record after discharge is counted as having no recorded complication; the proportion of such procedures is reported by group, and these procedures are excluded in a sensitivity analysis.

STATISTICAL ANALYSIS

Groups A and B are matched 1:1 by propensity score (nearest neighbour without replacement, caliper 0.2 SD of the logit of the score, exact matching on sheath size 5-9 F versus 13-17 F). The score is estimated by logistic regression from age, sex, procedure type, ablation system, number and size of sheaths, antithrombotic therapy and ultrasound-guided puncture; balance is checked by standardised differences (target below 0.1). The primary comparison (Group A versus matched Group B) uses the McNemar test and conditional logistic regression (odds ratio with 95% confidence interval). The comparison with Group C uses covariate-adjusted logistic regression, with inverse probability weighting as a sensitivity analysis. Binary secondary outcomes are analysed by logistic regression and length of stay (nights) by negative binomial regression. Part P is analysed descriptively and compared with Group A, with complication and conversion rates shown by calendar quarter. The large-bore (13-17 F) subgroup is pre-specified and analysed descriptively.

There is no formal sample size calculation; all eligible procedures in the defined periods are included. The study is estimation-oriented and is not designed to demonstrate non-inferiority. With 192 adhesive procedures, 0, 2 and 4 observed events correspond to upper limits of the 95% Wilson confidence interval of 2.0%, 3.7% and 5.2%, respectively.

Not collected: time to haemostasis, time to ambulation, pain scores, patient satisfaction, closure cost and operator confidence. These are not recorded in routine documentation and will not be reported.

ETHICS AND DATA PROTECTION

The protocol was submitted to the Ethics Committee of Nemocnice AGEL Trinec-Podlesi a.s. in October 2026, with a request for waiver of informed consent for Groups A, B and C; written informed consent is obtained in Part P. The analytic dataset is pseudonymised; the key is held on a secure hospital server and is accessible only to the principal investigator. Only aggregate data are reported.

DISSEMINATION

Abstract at an international cardiology congress and publication in a peer-reviewed journal regardless of the direction of the results.

• Study Type: Observational
• Enrollment (Estimated): 1400

Contacts and Locations

• Study Contact: Name: Otakar Jiravsky, MUDr., Ph.D., MBA; Phone Number: +420 602 579 193; Email: otakar.jiravsky@npo.agel.cz
• Study Contact Backup: Name: Jan Chovancik, MUDr., Ph.D., MBA; Phone Number: +420 558 304 111; Email: jan.chovancik@npo.agel.cz

Study Locations

• Czechia
  • Třinec, Czechia, 73961
    • Nemocnice AGEL Trinec-Podlesi a.s.
    • Contact: Otakar Jiravsky, MUDr., Ph.D., MBA; Phone Number: +420 602 579 193; Email: otakar.jiravsky@npo.agel.cz
    • Principal Investigator: Otakar Jiravsky, MUDr., Ph.D., MBA
    • Sub-Investigator: Bogdan Szmek, MUDr.
    • Sub-Investigator: Jan Chovancik, MUDr., Ph.D., MBA
    • Sub-Investigator: Radek Jancar, MUDr.
    • Sub-Investigator: Ivan Ranic, MUDr., MBA
    • Sub-Investigator: Jan Adamek, MUDr.
    • Sub-Investigator: Martina Hrosova, MUDr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adults undergoing elective electrophysiology procedures (diagnostic EP studies and catheter ablations, including pulsed-field ablation) with femoral venous access at the electrophysiology laboratory of Nemocnice AGEL Trinec-Podlesi a.s., Czechia, identified consecutively from the departmental procedure registry within the defined periods.

Description

Inclusion Criteria:

• Age 18 years or older
• Elective electrophysiology procedure (diagnostic study or catheter ablation) with at least one femoral venous sheath
• Femoral venous puncture site closed with topical cyanoacrylate tissue adhesive (Groups A and P) or with a figure-of-eight suture (Groups B and C)
• Group P only: written informed consent to the use of routine medical records

Exclusion Criteria:

• Arterial access during the same procedure
• Non-elective or emergency procedure
• Groups B and C: documentation of a closure method other than a figure-of-eight suture (compression alone, vascular closure device)
• Group P only: inability to understand the patient information or to give consent

Study Plan

How is the study designed?

Design Details

• Observational Models: COHORT
• Time Perspectives: OTHER

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group A: Tissue adhesive (retrospective); Elective EP procedures with femoral venous puncture sites closed with topical cyanoacrylate tissue adhesive from 1 July 2026 to the date of the ethics committee opinion. Data from routine records; waiver of consent requested.	Device: Topical cyanoacrylate tissue adhesive; Routine clinical practice, not assigned by the study. After sheath removal and haemostasis by manual compression, the skin over the femoral venous puncture is sealed with CE-marked topical cyanoacrylate tissue adhesive: 2-octyl cyanoacrylate (DERMABOND Mini) or n-butyl-2-cyanoacrylate (Histoacryl).; Other Names: DERMABOND Mini; Histoacryl
Group B: Figure-of-eight suture (historical); Elective EP procedures closed with a percutaneous figure-of-eight suture from 1 January 2024 to 31 December 2025; propensity-score matched 1:1 to Group A. Data from routine records; waiver of consent requested.	Procedure: Figure-of-eight suture; Routine clinical practice, not assigned by the study. Percutaneous figure-of-eight (purse-string) skin suture placed over the femoral venous puncture after sheath removal and released 2 to 6 hours later.
Group C: Figure-of-eight suture (concurrent); Elective EP procedures of the same period as Group A (from 1 July 2026 to the date of the ethics committee opinion) in which adhesive was not used and the puncture site was closed with a figure-of-eight suture. Data from routine records; waiver of consent requested.	Procedure: Figure-of-eight suture; Routine clinical practice, not assigned by the study. Percutaneous figure-of-eight (purse-string) skin suture placed over the femoral venous puncture after sheath removal and released 2 to 6 hours later.
Group P: Tissue adhesive (prospective continuation); Elective EP procedures closed with topical cyanoacrylate tissue adhesive from the day after the ethics committee opinion to 30 June 2027, in patients who gave written informed consent before the procedure. Same routine variables and sources as Group A.	Device: Topical cyanoacrylate tissue adhesive; Routine clinical practice, not assigned by the study. After sheath removal and haemostasis by manual compression, the skin over the femoral venous puncture is sealed with CE-marked topical cyanoacrylate tissue adhesive: 2-octyl cyanoacrylate (DERMABOND Mini) or n-butyl-2-cyanoacrylate (Histoacryl).; Other Names: DERMABOND Mini; Histoacryl

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Access-Site Vascular Complications	Any major or minor vascular complication at the femoral venous access site, using VARC-3 criteria adapted for venous access. Major: bleeding requiring transfusion or surgical or interventional revision; pseudoaneurysm or arteriovenous fistula requiring treatment; access-site infection requiring systemic antibiotics or revision; deep vein thrombosis. Minor: haematoma without transfusion or revision but with prolonged hospital stay or unplanned healthcare contact; pseudoaneurysm or fistula managed conservatively; local reaction requiring treatment. Ascertained from discharge summaries and all hospital records up to day 30. Primary comparison: Group A versus propensity-matched Group B; key secondary comparison: Group A versus Group C. Pre-specified subgroup: 13-17 F sheaths.	From the procedure through 30 days after the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Requiring Conversion From Tissue Adhesive to Figure-of-Eight Suture	Conversion to a figure-of-eight suture because of inadequate haemostasis immediately after sheath removal, in procedures intended for adhesive closure (Groups A and P). Ascertained from the procedure report and discharge summary.	During the index procedure (day 0)
Number of Participants Discharged on the Day of the Procedure	Discharge from hospital on the calendar day of the index procedure, as recorded in the departmental registry.	Day 0 (day of the procedure)
Length of Post-Procedural Hospital Stay	Number of nights spent in hospital after the index procedure, taken from the discharge summary.	From the procedure to hospital discharge, assessed up to 30 days
Number of Participants With Unplanned Healthcare Contact Related to the Access Site	Any unplanned outpatient visit, emergency department visit, readmission or telephone contact related to the femoral access site, as recorded in the hospital information system.	From discharge through 30 days after the procedure

Collaborators and Investigators

• Sponsor: Nemocnice AGEL Trinec-Podlesi a.s.
• Investigators: Principal Investigator: Otakar Jiravsky, MUDr., Ph.D., MBA, Nemocnice AGEL Trinec-Podlesi a.s.

Publications and helpful links

General Publications

• VARC-3 WRITING COMMITTEE:; Genereux P, Piazza N, Alu MC, Nazif T, Hahn RT, Pibarot P, Bax JJ, Leipsic JA, Blanke P, Blackstone EH, Finn MT, Kapadia S, Linke A, Mack MJ, Makkar R, Mehran R, Popma JJ, Reardon M, Rodes-Cabau J, Van Mieghem NM, Webb JG, Cohen DJ, Leon MB. Valve Academic Research Consortium 3: Updated Endpoint Definitions for Aortic Valve Clinical Research. J Am Coll Cardiol. 2021 Jun 1;77(21):2717-2746. doi: 10.1016/j.jacc.2021.02.038. Epub 2021 Apr 19.
• Takada Y, Kamoshida J, Terasawa M, Satomi K, Yazaki Y. Combination of Skin Adhesives and Vascular Closure Device for Complete Hemostasis After Catheter Ablation. Circ Rep. 2026 Apr 29;8(6):869-877. doi: 10.1253/circrep.CR-25-0288. eCollection 2026 Jun 10.

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: November 3, 2026
• First Submitted That Met QC Criteria: November 3, 2026
• First Posted (Actual): November 9, 2026

Study Record Updates

• Last Update Posted (Actual): November 9, 2026
• Last Update Submitted That Met QC Criteria: November 3, 2026
• Last Verified: October 1, 2026

More Information

Terms related to this study

• Keywords: electrophysiology; catheter ablation; tissue adhesive; cyanoacrylate; pulsed-field ablation; Histoacryl; same-day discharge; DERMABOND; femoral venous access; figure-of-eight suture; vascular access closure; large-bore venous access
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Hemorrhage; Pathological Conditions, Signs and Symptoms; Atrial Fibrillation; Hematoma; Arrhythmias, Cardiac
• Other Study ID Numbers: GLUE-EP-2026-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

Only aggregate results will be published. Individual participant data will not be shared: the retrospective part relies on a waiver of consent, and participants in the prospective part consent to the use of their pseudonymised data by the study team only.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No