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

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.