Abstract
Background
Despite the use of vascular closure devices (VCDs) following catheter ablation for atrial fibrillation (AF) effectively shortening postprocedural immobilization time, they carry the risk of subcutaneous hemorrhage, which often requires extended bed rest, exceeding 2 h. We assessed whether combining skin adhesives (SAs) with a VCD can safely enable earlier mobilization without increasing bleeding risk.
Methods and Results
This retrospective analysis evaluated 244 patients who underwent catheter ablation for AF between April 2022 and March 2024 and achieved successful hemostasis with a VCD. Patients with cardiac surgery history, dual antiplatelet therapy, cognitive impairment, or intensive care needs were excluded. Ultrasound-guided VCDs were used in all procedures. The SA group (n=162) received Dermabond Mini® with immediate post-anesthesia mobilization. The control group (n=82) underwent angio-roll compression and followed physician-guided rest protocols. Endpoints included rest duration, total procedural time, hemorrhagic events, opioid administration, and length of hospital stay. Despite immediate post-anesthesia mobilization, the SA group showed shorter time to ambulation (129±95 vs. 513±440 min, P<0.01) with lower rates of hemorrhagic complications (BARC type 1: 1.2% vs. 6.1%, P=0.044; BARC type 2: 5.6% vs. 23.2%, P<0.01) than the control group. Procedural duration was comparable. The SA group required less fentanyl.
Conclusions
The combination of SA and VCDs enabled immediate post-anesthesia mobilization without increasing bleeding complications, improving patient outcomes and resource utilization.
Key Words: Atrial fibrillation, Catheter ablation, Hemostasis, Skin adhesives, Venous access closure
Central Figure.
In recent years, catheter ablation for atrial fibrillation (AF) has significantly improved in terms of efficacy and safety. Notably, pulmonary vein isolation has become the standard procedure and can typically be performed within approximately 120 min.1,2 Despite these improvements, AF catheter ablation necessitates the use of large-caliber sheaths and perioperative anticoagulation therapy, which may lead to minor complications such as bleeding and hematomas.3 Although direct comparisons between modalities are limited by differences in sheath caliber, the number of vascular access sites has emerged as a potential determinant of the risk of postprocedural bleeding.
Traditionally, postoperative hemostasis has been managed through manual compression or figure-of-eight sutures, which necessitate prolonged bed rest,4 and this extended immobility not only diminishes patient comfort but also prolongs hospital stays, thereby increasing the burden on healthcare providers. Additionally, reliance on compression bandages often requires patients to remain at rest until the attending physician removes compression, necessitating more vigilant and extended monitoring and increasing the medical staff’s workload.5
The recent introduction of vascular closure devices (VCDs) has reduced postoperative resting time, facilitated early ambulation, enhanced patient satisfaction, and lowered the risk of complications.6 However, VCDs address hemostasis primarily at the vessel level and do not prevent subcutaneous oozing from the tissue tract, which can necessitate prolonged bed rest to ensure complete hemostasis. This concern regarding subcutaneous hemorrhage often leads clinicians to maintain extended observation periods even after VCD deployment, limiting the potential benefits of these devices for early mobilization. Skin adhesives (SAs) may address this limitation by providing additional hemostatic barrier at the skin surface level. Dermabond Mini® (EBOS, Healthcare, Australia) is a synthetic topical SA containing 2-octyl cyanoacrylate monomer, which polymerizes using tissue moisture as an initiator. Upon polymerization, it forms a transparent flexible film layer with strong adhesive properties that tightly approximates and seals the skin edges. By firmly covering and securing the puncture site at the epidermal level, this adhesive film prevents subcutaneous bleeding from reaching the skin surface, effectively achieving hemostasis for bleeding that originates from deeper tissue planes.7,8 The transparent nature of the film allows continuous wound visualization, facilitating early detection of any hemostatic complications. Additionally, Dermabond® has demonstrated bactericidal activity against gram-positive cocci, potentially preventing bloodstream infections originating from skin commensals.9 By complementing vessel-level closure with tissue-level sealing, the combination of a VCD and SA may enable safe immediate mobilization without the bleeding risks associated with VCD use alone. However, the safety and efficacy of this combined approach for AF catheter ablation have not been systematically evaluated.
Therefore, in this study we aimed to investigate whether adding SA to a VCD can safely facilitate immediate post-anesthesia mobilization without increasing hemorrhagic complications compared to conventional VCD-based hemostasis with prolonged bed rest protocols.
Methods
Patient Selection and Study Population
During the study period (April 2022 to May 2024), 301 consecutive patients underwent catheter ablation for documented AF. All procedures were performed via femoral venous access only, without any arterial access including arterial sheaths or arterial line placement for blood pressure monitoring. Blood pressure was monitored noninvasively throughout all procedures. Patients were excluded based on the following criteria: history of prior cardiac surgery, receiving dual antiplatelet therapy, cognitive impairment or delayed emergence from sedation (including pre-existing dementia, postoperative delirium, or prolonged sedative effects preventing adequate compliance with bed rest protocols), left ventricular ejection fraction ≤40%, patients with vascular access-related complications, or requiring intensive care management. After applying these exclusion criteria, 269 patients remained, all of whom received Perclose® ProGlide (Abbott, USA) for venous hemostasis. Among these 269 patients, 25 (9.3%) were subsequently excluded due to failed VCD deployment, leaving 244 patients who were categorized into 2 groups based on the postprocedural hemostasis method. The SA group (n=162, 66%) received Dermabond Mini® (EBOS Healthcare, Australia) in addition to the VCD, and the control group (n=82, 34%) was managed with angio-roll compression following VCD deployment (Figure 1). Patient allocation to treatment groups was based on physician discretion rather than randomization.
Figure 1.
Flowchart of the study: 25 patients with failed vascular closure device deployment were excluded. AF, atrial fibrillation.
The study protocol was approved by the Ethics Committee of the Tokyo Medical University (T2023-0082). The procedures were performed in accordance with the Declaration of Helsinki and the ethical standards of the responsible committee on human experimentation (the Ethics Committee of Tokyo Medical University). Informed consent was not required given the observational nature of the study.
Procedure
AF Classification Paroxysmal AF was defined as an AF episode that terminated within 7 days of onset either spontaneously or following antiarrhythmic drug therapy. Persistent AF was defined as an AF episode lasting ≥7 days.
Preprocedural Management All patients received anticoagulation therapy for ≥4 weeks before the procedure. Antiarrhythmic drugs were discontinued for ≥5 half-lives before the ablation procedure. Transesophageal echocardiography or multidetector computed tomography was performed before catheter ablation in all patients to evaluate the anatomy of the left atrium (LA) and rule out thrombus in the LA.
Ablation Procedure AF catheter ablation was performed according to standard protocols. Ablation procedures were performed using either radiofrequency (RF) energy or cryoablation based on operator preference and patient characteristics. RF ablation typically required 3 femoral venous sheaths (1 for the mapping catheter, 1 for the ablation catheter, and 1 for the coronary sinus catheter) and intracardiac echocardiography (ICE). Cryoablation procedures generally used 2 sheaths (1 for the cryoballoon catheter and 1 for the coronary sinus catheter) and ICE. All venous sheaths were large-bore (8–15Fr) and were closed with VCDs. Echo-guided puncture was performed in all cases. Each venous sheath was individually closed with a dedicated Perclose® ProGlide device (Abbott). In the cases of RF ablation, 3 separate VCDs were deployed (1 per sheath); in the cryoablation cases, 2 VCDs (1 per sheath) were required. No sheaths were left without VCD closure, eliminating the possibility of bleeding from untreated access sites.
Intraprocedural Anticoagulation During the procedure, heparin (3,000 units) was administered after sheath insertion, with an additional 5,000 units administered after LA access. The activated clotting time (ACT) target was maintained at 300–400 s. Upon completion of the procedure, anticoagulation was reversed with protamine sulfate (30 mg) in all patients. None of the patients had known allergies or contraindications to protamine.
Sedation Protocol All procedures were performed under deep sedation according to a standardized protocol with propofol and fentanyl, administered according to institutional guidelines for electrophysiology procedures. For respiratory management, an I-gel device (InterSurgical, UK) was used to deliver oxygen.
Postprocedural Hemostasis In the SA group, patients were permitted to stand once they had fully recovered from anesthesia with normal consciousness. After standing, the puncture site was inspected for bleeding. If no bleeding was observed, the patient was allowed to ambulate freely. In the control group, bed rest duration was determined by the attending physician based on clinical judgment and wound inspection findings. Mobilization was authorized at the physician’s discretion during the recovery period.
Data Collection and Outcomes
In this retrospective analysis, data on primary and secondary outcomes were systematically collected.
The primary endpoints were time to ambulation and total procedure time. Time to ambulation was defined as the duration from catheter room exit until ambulation without rebleeding was achieved. Patients were permitted to stand after full recovery from anesthesia, and the puncture site was inspected for bleeding. If no bleeding was observed, patients were allowed to ambulate freely. Total procedure time was calculated from the initiation of the timeout procedure until confirmed hemostasis completion.
Secondary endpoints included the quantification of fentanyl administration and hemorrhagic events during hospitalization. Fentanyl (from a stock solution of 0.5 mg/10 mL) was used for both intraoperative sedation and postoperative analgesia as needed, and the total volume administered was recorded. No other analgesic agents were used during the perioperative period. Hemorrhagic events were classified according to the Bleeding Academic Research Consortium (BARC) criteria. BARC type 1 events were defined as those requiring physician consultation but no active intervention. BARC type 2 events were defined as those requiring additional compression, suturing, or prolonged hospitalization without transfusion or surgical intervention. BARC type 3 or higher events included bleeding requiring transfusion or surgical intervention. The hospital’s discharge protocol is usually 2 days after surgery for a procedure initiated at 10:00 am. Extended hospitalization was defined as any stay that exceeded the standard institutional discharge protocol.
To ensure data quality and completeness, all outcomes were independently verified through medical record review, and any discrepancies were resolved through consensus discussions among the investigating physicians.
Statistical Analysis
Normally distributed continuous data are expressed as mean±standard deviation and were compared using unpaired Student’s t-tests. For outcome variables that did not follow a normal distribution, a log transformation was applied to meet the assumption of normality prior to the linear regression analysis. Categorical variables were compared between groups using the chi-square or Fisher’s exact test. All tests were two-sided, and the statistical significance level was set at P<0.05. Statistical analyses were conducted using IBM SPSS Statistics (version 28.0; SPSS Inc. Corp., USA).
Results
Patients’ Characteristics
The patients’ characteristics are shown in Table 1. We retrospectively analyzed the outcomes of 244 patients who underwent catheter ablation for AF. The VCD deployment success rate was 90.7% (244/269 patients). RF ablation was performed in 80.5% of the control group and 79.6% of the SA group (P=0.987). Baseline characteristics, including age, AF type, ablation modality, and comorbidities, did not differ significantly between the groups. Only 1 patient in the SA group received warfarin therapy; all other patients in this study were administered direct oral anticoagulants. Antiplatelet therapy was administered to 8% and 5% of the SA and control groups, respectively. The intraoperative administration of heparin was comparable between the groups, confirming consistent anticoagulation management.
Table 1.
Baseline Characteristics of the Patients Undergoing Catheter Ablation for AF
| Parameter | Total (N=244) |
Control group (n=82) |
SA group (n=162) |
P value |
|---|---|---|---|---|
| Age, years | 65±11 | 64±10 | 65±11 | 0.952 |
| Male sex, n (%) | 209 (86) | 68 (83) | 141 (87) | 0.389 |
| BMI, kg/m2 | 25±3.8 | 24.6±3 | 25.2±4.2 | 0.267 |
| Paroxysmal AF, n (%) | 149 (61) | 49 (60) | 100 (62) | 0.765 |
| Persistent AF, n (%) | 95 (39) | 33 (40) | 62 (38) | 0.767 |
| Ablation modality | 0.987 | |||
| Radiofrequency, n (%) | 195 (79.9) | 66 (80.5) | 129 (79.6) | |
| Cryoablation, n (%) | 49 (20.1) | 16 (19.5) | 33 (20.4) | |
| CHADS2 score | 0.9±0.9 | 1.1±1.0 | 1.2±1.1 | 0.496 |
| Hypertension, n (%) | 127 (52) | 43 (52) | 84 (52) | 0.996 |
| Antiplatelet drug, n (%) | 17 (7) | 4 (5) | 13 (8) | 0.364 |
| BNP, pg/mL | 117±132 | 131±143 | 111±127 | 0.285 |
| eGFR, mL/min/1.73 m2 | 67.1±15.5 | 67.8±14.9 | 66.8±15.9 | 0.647 |
| APTT, s | 35.1±7.2 | 35.3±7.5 | 35±7.1 | 0.722 |
| Heparin, U | 13,463±4,248 | 14,376±3,894 | 13,457±4,440 | 0.974 |
| LVEF, % | 62.2±7.7 | 63.8±6.9 | 62.2±7.6 | 0.906 |
| LA dimension, mm | 39.5±6.3 | 39.5±6.9 | 39.5±6.5 | 0.982 |
Data are presented as mean±standard deviation or number (%) of patients. P value=Control vs. SA. AF, atrial fibrillation; APTT, activated partial thromboplastin time; BMI, body mass index; BNP, B-type natriuretic peptide; eGFR, estimated glomerular filtration rate; LA, left atrial; LVEF, left ventricular ejection fraction.
Primary Endpoints
The time to ambulation was significantly shorter in the SA group than in the control group (129±95 vs. 513±440 min, P<0.01). The total procedure time from timeout to hemostasis completion was comparable between the SA group and control group (179±51 vs. 192±54 min, P=0.522; Figure 2A).
Figure 2.
Skin adhesive (SA) use improved patient outcomes. (A) Primary endpoints showing time to ambulation and total procedure time. (B) Secondary endpoints showing BARC type 1 and type 2 bleeding events and fentanyl administration. Continuous variables are presented as mean±standard deviation and were compared using unpaired Student’s t-tests. Categorical variables were compared using the chi-square test or Fisher’s exact test, as appropriate.
Secondary Endpoints
The amount of fentanyl administered was significantly lower in the SA group than in the control group (7.08±1.60 vs. 8.11±1.63 mL, P<0.01). BARC type 1 events were observed in 1.2% (2/162) of the SA group vs. 6.1% (5/82) of the control group (P=0.044). BARC type 2 events occurred in 5.6% (9/162) of the SA group vs. 23.2% (19/82) of the control group (P<0.01; Figure 2B). No BARC type 3 or higher events occurred in either group. Among the 19 BARC type 2 bleeding events in the control group, in 14 cases the patient required additional manual compression, 4 required suturing, and in 1 case the patient required prolonged hospitalization. In the SA group, 8 of the 9 BARC type 2 bleeding events required additional compression, and 1 patient required suturing; none required prolonged hospitalization.
Analysis of BARC Type 2 Bleeding Events in the SA Group
A detailed subgroup analysis was conducted within the SA group to identify the potential risk factors for BARC type 2 bleeding complications. Comparative analysis between patients with BARC type 2 bleeding (n=9) and BARC type 0 and 1 (n=153) demonstrated equivalent demographic and clinical profiles, including age (66±10 vs. 65±11 years, P=0.779), sex distribution (male: 89% vs. 87%, P=0.866), body mass index (BMI: 25±3.5 vs. 25.2±4.2 kg/m2, P=0.838), and CHADS₂ score (1.1±1.5 vs. 1.2±1.1, P=0.892; Table 2).
Table 2.
Comparison of Parameters Based on BARC Type 2 Bleeding in the SA Group
| Parameter | BARC type 2 bleeding (n=9) |
BARC type 0 and 1 bleeding (n=153) |
P value |
|---|---|---|---|
| Age, years | 66±10 | 65±11 | 0.779 |
| Male sex, n (%) | 8 (89) | 133 (87) | 0.866 |
| BMI, kg/m2 | 25±3.5 | 25.2±4.2 | 0.838 |
| Paroxysmal AF, n (%) | 7 (78) | 93 (61) | 0.484 |
| Persistent AF, n (%) | 2 (22) | 60 (39) | 0.484 |
| Radiofrequency, n (%) | 9 (100) | 120 (78) | 0.206 |
| Cryoablation, n (%) | 0 (0) | 33 (22) | 0.206 |
| Hypertension, n (%) | 3 (33) | 82 (54) | 0.311 |
| CHADS2 score | 1.1±1.5 | 1.2±1.1 | 0.892 |
| Antiplatelet drug, n (%) | 0 (0) | 8 (13) | 1.000 |
| BNP, pg/mL | 117±82 | 111±127 | 0.876 |
| eGFR, mL/min/1.73 m2 | 65.7±17.5 | 66.9±15.9 | 0.826 |
| APTT, s | 34.8±4.5 | 35.8±7.0 | 0.926 |
| ACT, s | 331±51 | 336±45 | 0.783 |
| Heparin, U | 14,000±4,031 | 13,425±4,473 | 0.707 |
Data are presented as mean±standard deviation or number (%) of patients. P value=BARC type 2 bleeding vs. BARC type 0 and 1 bleeding. ACT, activated clotting time; BARC, Bleeding Academic Research Consortium. Other abbreviations as in Table 1.
Examination of periprocedural anticoagulation parameters revealed comparable values for ACT at the end of the procedure (331±51 vs. 336±45 s, P=0.783), and total heparin administration (14,000±4,031 vs. 13,425±4,473 units, P=0.707). Antiplatelet therapy was not associated with BARC type 2 bleeding events (0% vs. 13%, P=1.000, Fisher’s exact test).
Stratification by ablation modality revealed that all BARC type 2 bleeding events occurred exclusively in patients who underwent RF ablation (n=9/129, 7.0%), which required 3 venous access sites with VCDs, whereas no BARC type 2 bleeding was documented among cryoablation recipients (n=0/33, 0%), who required only 2 venous access sites with VCDs (P=0.121, Fisher’s exact test). Despite the similar distribution of ablation modality between groups (P=0.987), the differential bleeding risk associated with RF ablation highlights the importance of optimized hemostatic strategies, particularly for procedures requiring multiple vascular access sites. Among the patients without bleeding complications, 120 underwent RF ablation and 33 underwent cryoablation. This distribution pattern corresponds to the generally followed procedural requirement of 3 femoral venous sheaths in RF ablation vs. 2 sheaths in cryoablation procedures.
Logistic Regression Analysis for Predictors of BARC Type 2 Bleeding
Multivariate logistic regression analysis was performed to identify factors independently associated with BARC type 2 bleeding in both the entire cohort and the SA group separately. In the entire cohort (n=244), SA treatment was the only independent protective factor against BARC type 2 bleeding (odds ratio (OR)=0.187, 95% confidence interval (CI): 0.077–0.456, P<0.001). Other demographic, clinical, and procedural variables showed no significant association with BARC type 2 bleeding (Table 3). Within the SA group (n=162), no patient risk factors or procedural variables independently predicted BARC type 2 bleeding (Table 4). All 9 BARC type 2 events occurred in RF ablation recipients (7.1%, 9/127), compared with 0 events in cryoablation recipients (0%, 0/35).
Table 3.
Logistic Regression Analysis for BARC Type 2 Bleeding in All Patients
| Parameter | OR | 95% CI Lower | 95% CI Upper | P value |
|---|---|---|---|---|
| Hemostasis with SA | 0.187 | 0.077 | 0.456 | <0.001 |
| Age, years | 1.01 | 0.951 | 1.075 | 0.715 |
| Sex | 0.567 | 0.140 | 2.305 | 0.428 |
| BMI, kg/m2 | 1.020 | 0.880 | 1.182 | 0.795 |
| Paroxysmal AF | 0.882 | 0.344 | 2.266 | 0.795 |
| Cryoablation (vs. radiofrequency) | 0.258 | 0.053 | 1.252 | 0.093 |
| Hypertension | 0.909 | 0.312 | 2.646 | 0.861 |
| CHADS2 score | 0.970 | 0.545 | 1.727 | 0.919 |
| Antiplatelet drug | 0.405 | 0.042 | 3.885 | 0.433 |
| BNP, pg/mL | 0.998 | 0.994 | 1.002 | 0.424 |
| eGFR, mL/min/1.73 m2 | 0.999 | 0.965 | 1.034 | 0.948 |
| APTT, s | 0.998 | 0.942 | 1.058 | 0.954 |
| ACT, s | 1.005 | 0.995 | 1.016 | 0.329 |
| Heparin, U | 1.000 | 1.000 | 1.000 | 0.663 |
Data are presented as odds ratio (OR) with 95% confidence interval (CI). Results are from multivariate logistic regression analysis. P<0.05 was considered statistically significant. SA, skin adhesive. Other abbreviations as in Tables 1,2.
Table 4.
Logistic Regression Analysis for BARC Type 2 Bleeding in the SA Group
| Parameter | OR | 95% CI Lower | 95% CI Upper | P value |
|---|---|---|---|---|
| Age, years | 1.033 | 0.941 | 1.134 | 0.497 |
| Sex | 0.592 | 0.056 | 6.304 | 0.664 |
| BMI, kg/m2 | 1.068 | 0.866 | 1.318 | 0.539 |
| Paroxysmal AF | 0.251 | 0.042 | 1.505 | 0.130 |
| Hypertension | 0.247 | 0.034 | 1.813 | 0.169 |
| CHADS2 score | 1.124 | 0.492 | 2.567 | 0.782 |
| BNP, pg/mL | 1.002 | 0.995 | 1.009 | 0.517 |
| eGFR, mL/min/1.73 m2 | 1.007 | 0.949 | 1.067 | 0.823 |
| APTT, s | 1.002 | 0.895 | 1.123 | 0.968 |
| ACT, s | 0.998 | 0.979 | 1.017 | 0.798 |
| Heparin, U | 1.000 | 1.000 | 1.000 | 0.843 |
Data are presented as odds ratio (OR) with 95% confidence interval (CI). Results are from multivariate logistic regression analysis. P<0.05 was considered statistically significant. SA, skin adhesive. Other abbreviations as in Tables 1,2.
Postprocedural Clinical Course and Hospital Length of Stay
None of the patients in the SA group required extended hospitalization, but 1 patient (1.2%) in the control group did. None of the patients required surgical intervention or blood product transfusion during the study period.
Discussion
The results of this study demonstrated that combining SA with VCD enables safe immediate post-anesthesia mobilization following catheter ablation for AF. Despite a 4-fold reduction in bed rest duration compared to the control group, the SA group exhibited significantly lower rates of hemorrhagic complications, indicating that the addition of SA provided sufficient additional hemostatic security to support early mobilization protocols.
The critical finding is not merely that bed rest duration was shorter in the SA group, but that early mobilization was achievable without compromising hemostatic safety. In the control group, prolonged bed rest (mean 513 min) reflects standard cautious practice when relying on VCDs alone, yet still resulted in higher bleeding rates (BARC type 2: 23.2%). The superior hemostatic outcomes in the SA group, despite immediate mobilization (mean 129 min) validated the clinical utility of this combined approach. The clearest benefit was the markedly lower incidence of BARC type 2 bleeding (5.6% vs. 23.2%, P<0.01). BARC type 1 bleeding events were also less frequent in the SA group (1.2% vs. 6.1%, P=0.044).
The low rate of BARC type 2 bleeding in the SA group indicates that SA provide additional protection against subcutaneous oozing, which often necessitates prolonged bed rest when VCDs are used alone. The overall frequency of bleeding events in our cohort may appear higher than that reported in some previous studies; however, this likely reflects differences in event capture and classification, as we systematically included minor access-site bleeding events within the BARC type 1 and type 2 categories.
Optimized Hemostasis and Early Mobilization
The marked reduction in time to ambulation represents a substantial improvement over the traditional method. Previous studies using figure-of-eight sutures report mobilization times of 4–6 h,10 whereas use of a VCD achieved mobilization within 3–4 h.6 Our combined approach demonstrated further improvement, likely due to complementary mechanisms of action. The 2-h average ambulation time in the SA group represents the recovery time from deep sedation, indicating that hemostasis was achieved without requiring additional time for bleeding control, and reflects the physiological minimum time required for safe mobilization post-procedure. The VCD provides primary hemostasis at the vessel level, while the SA creates an additional barrier that prevents subcutaneous oozing, which often necessitates prolonged bed rest.
Safety Profile and Bleeding Risk
The significant reduction in both BARC type 1 and type 2 bleeding complications demonstrated that this combined approach may address multiple aspects associated with postprocedural bleeding risk. These results compare favorably with those of previous reports on VCDs alone, which showed complication rates of 11.1%.11 The particularly low rate of BARC type 2 bleeding events in our SA group indicates that SAs may provide additional protection against delayed bleeding complications. The BARC type 2 bleeding rate in our control group may appear elevated compared to that in the published literature. This reflects our broader classification of BARC type 2 events, which included bleeding requiring additional compression or suturing. Other studies often categorize such events as minor bleeding.
The multivariate analysis revealed that SA treatment was the dominant factor protecting against BARC type 2 bleeding, with an 81% relative risk reduction. This finding suggested that the hemostatic benefit of SA treatment is largely independent of the patient’s baseline characteristics. The absence of significant predictive factors within the SA group indicated that the SA–VCD combination provided relatively uniform protection across diverse clinical profiles. Our multivariate analysis included key potential confounders such as BMI, ablation modality (which determines the number of venous sheaths), age, and other baseline characteristics. Regarding anticoagulation therapy, nearly all patients (99.6%) received direct oral anticoagulants, with only 1 patient receiving warfarin, eliminating anticoagulant type as a significant confounder between groups. The absence of time to ambulation multivariate analysis reflects the fact that this outcome was primarily determined by the mobilization protocol difference rather than patient-specific factors.
The complete absence of BARC type 2 events in cryoablation recipients (0/35) compared to 7.1% in RF ablation recipients (9/127) reflects the increased hemostatic challenge posed by multiple vascular access sites. This differential outcome underscores the importance of optimized hemostatic strategies, particularly for procedures requiring extensive vascular access.
Procedural Considerations and Bleeding Sources
An important technical aspect of our study was the comprehensive application of VCDs to all vascular access sites. The differential bleeding rates observed between RF ablation (requiring 3 VCDs) and cryoablation (requiring 2 VCDs) suggest that the number of access sites may influence bleeding risk despite VCD use. Notably, all access sites in our study received VCD treatment, eliminating the potential confounding effect of bleeding from untreated smaller sheaths, which might be present in other studies. This comprehensive closure strategy ensures that any observed bleeding events originated from VCD-treated sites, allowing for accurate assessment of the combined SA–VCD hemostatic efficacy.
Clinical Implications for Patient Care
The reduced fentanyl requirements and the absence of prolonged hospitalization in the SA group indicates broader benefits beyond hemostasis. These findings align with those of previous studies in other clinical settings demonstrating improved patient comfort with tissue adhesives.7,8
Japanese Population Considerations
Our findings should be interpreted in the context of the unique characteristics of anticoagulation sensitivity in the Japanese population. Previous studies have demonstrated that Asian populations, particularly Japanese populations, exhibit increased sensitivity to anticoagulant therapy and require lower therapeutic anticoagulant doses than Western populations.12,13 The clinical significance of these ethnicity-specific anticoagulation characteristics warrants careful consideration when determining optimal perioperative antithrombotic strategies for catheter ablation procedures. Large-scale clinical trials focusing on Asian populations have provided additional insights into the relationship between ethnicity and anticoagulation outcomes. These findings further substantiate the necessity for careful dose adjustment strategies in the Japanese population.14
Despite these race-specific bleeding risk factors, our protocol demonstrated a favorable safety profile, with the successful prevention of thromboembolic events while maintaining an acceptable bleeding risk profile.
Study Limitations
Several methodological limitations of this study should be acknowledged when interpreting its findings. VCD deployment failed in 25 of 269 patients (9.3%), defined as the inability to achieve adequate hemostasis with the VCD due to unsuccessful suture placement, incomplete device deployment, or device malfunction. The learning curve associated with early adoption of Perclose ProGlide in the Japanese market likely contributed to some deployment failures. All affected patients achieved successful hemostasis with manual compression without complications. Procedure timing varied throughout the day. Some cases that concluded in the evening may have had bed rest extended until the following morning for bleeding monitoring purposes, potentially contributing to the longer mean bed rest duration observed in the control group. However, in our study, no procedures were initiated after 15:00 hours, and no patients exited the catheter room later than 20:00 hours. Given these constraints on procedure timing, the impact of this factor on our primary findings was likely minimal. The single-center, retrospective nature of this study introduces potential selection bias that may affect the generalizability of our results. Although the baseline characteristics were well matched between groups, the nonrandomized study design could have influenced group allocation and introduced unmeasured confounding factors. The physician-directed allocation strategy, while reflecting real-world clinical practice, introduces selection bias. Future randomized controlled trials are needed to validate these findings while minimizing allocation bias. Our multivariate analysis included key potential confounders such as BMI, ablation modality (which determines the number of venous sheaths), age, and other baseline characteristics. Regarding anticoagulation therapy, nearly all patients (99.6%) received direct oral anticoagulants, with only 1 patient receiving warfarin, eliminating anticoagulant type as a significant confounder between groups. The absence of a time to ambulation multivariate analysis reflects the fact that this outcome was primarily determined by the mobilization protocol difference rather than patient-specific factors. In addition, our study did not provide an objective assessment of pain intensity or patient comfort. Furthermore, the absence of a formal cost-effectiveness analysis precludes a comprehensive evaluation of the economic implications of our approach.
Alternative Hemostatic Approaches
Although simpler reinforcement methods such as Steri-Strips might provide some mechanical support at the puncture site, SA offer distinct advantages that extend beyond simple wound approximation. Dermabond provides antimicrobial properties against gram-positive organisms, creates a waterproof barrier, and allows transparent visualization of the wound site.9 Additionally, the liquid formulation of SA ensures complete coverage of irregular wound edges and potential bleeding points, which rigid adhesive strips cannot achieve. Although a direct comparison with Steri-Strips was not performed in this study, the substantial reduction in bleeding complications suggests that the unique properties of cyanoacrylate-based adhesives contribute meaningfully to hemostatic efficacy beyond what mechanical reinforcement alone could provide.
Applicability to Other VCDs
Other VCDs such as Vascade MVP® (Cardiva Medical, a part of Haemonetics, USA) are available, giving our findings limited applicability. Vascade MVP® is a collagen-based hemostatic device that requires bed rest and additional manual compression as recommended by the manufacturer. Although reduction in bed rest may be possible with collagen-based devices, the required compression and manufacturer recommendations may limit the degree of early mobilization achievable compared to our combined approach of SA with suture-based devices.
Clinical Implications
The integration of SA with a VCD demonstrated superior efficacy in post-ablation care, as characterized by the key findings. First, this combined approach significantly reduced the postprocedural immobilization time while maintaining optimal hemostasis. A marked reduction in the time to ambulation was achieved without compromising safety outcomes. Second, compared to conventional management, the combined strategy substantially decreased bleeding complications. Third, this approach reduced analgesic requirements and eliminated prolonged hospitalization. Finally, this novel method combined a hemostatic approach, utilizing a transparent SA without compression, and facilitated direct wound visualization by both healthcare providers and patients, thereby significantly reducing the nursing workload while maintaining effective surveillance of the access site.
Conclusions
Combined use SA–VCDs allowed safe early mobilization after catheter ablation for AF without increasing bleeding complications. This approach may offer an alternative to traditional compression-based hemostasis protocols. Although further research is needed to validate these findings in larger multicenter studies, this strategy appears to effectively balance the competing demands of early mobilization and reliable hemostasis. The implementation of this combined approach may lead to standardized protocols that enhance postprocedural care efficiency while maintaining patient safety. Future studies in larger, multicenter randomized trials should determine whether the superior hemostatic efficacy of the SA–VCD combination translates to improved clinical outcomes and cost savings, and whether these findings are applicable to other percutaneous cardiac procedures.
Disclosures
K.S. received honoraria from Medtronic and Abbott Medical Japan, LLC. The other authors declare no conflicts of interest associated with this manuscript.
Credit Author Contributions
Y.T.: Writing – original draft, Writing – review and editing, Conceptualization, Data curation, Formal analysis, Investigation, Methodology, Project administration, Supervision. K.S.: Writing – review and editing. J.K.: Writing – review and editing. M.T.: Writing – review and editing. Y.Y.: Writing – review and editing.
IRB Information
The study protocol was approved by the Ethics Committee of the Tokyo Medical University (T2023-0082). The procedures were in accordance with the Declaration of Helsinki and the ethical standards of the responsible committee on human experimentation (the Ethics Committee of Tokyo Medical University). Informed consent was not required given the observational nature of the study.
Funding Statement
Funding: his research received no grant from any funding agency in the public, commercial, or not-for-profit sectors.
Data Availability Statement
The deidentified individual participant data underlying this study, including baseline characteristics, procedural parameters, and clinical outcomes, are accessible. Researchers interested in accessing the dataset may contact the corresponding author (Y.T., takadaya@tokyo-med.ac.jp) with a detailed research proposal outlining the intended use of the data. Data will be made available within 6 months of the publication date and will remain available for a minimum of 5 years. Access to the data is limited to legitimate research purposes, and researchers must execute a data use agreement prior to data transfer. Additional materials, including the study protocol and statistical analysis plan, are available upon request. Data will be provided in a de-identified format via secure electronic transfer.
References
- 1. Reddy VY, Grimaldi M, De Potter T, Vijgen JM, Bulava A, Duytschaever MF, et al.. Pulmonary vein isolation with very high power, short duration, temperature-controlled lesions: The QDOT-FAST Trial. JACC Clin Electrophysiol 2019; 5: 778–786, doi:10.1016/j.jacep.2019.04.009. [DOI] [PubMed] [Google Scholar]
- 2. Calkins H, Hindricks G, Cappato R, Kim YH, Saad EB, Aguinaga L, et al.. 2017 HRS/EHRA/ECAS/APHRS/SOLAECE Expert Consensus Statement on catheter and surgical ablation of atrial fibrillation. Europace 2018; 20: e1–e160, doi:10.1093/europace/eux274. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 3. Gupta A, Perera T, Ganesan A, Sullivan T, Lau DH, Roberts-Thomson KC, et al.. Complications of catheter ablation of atrial fibrillation: A systematic review. Circ Arrhythm Electrophysiol 2013; 6: 1082–1088, doi:10.1161/CIRCEP.113.000768. [DOI] [PubMed] [Google Scholar]
- 4. Aytemir K, Canpolat U, Yorgun H, Evranos B, Kaya EB, Şahiner ML, et al.. Usefulness of ‘figure-of-eight’ suture to achieve haemostasis after removal of 15-French calibre femoral venous sheath in patients undergoing cryoablation. Europace 2016; 18: 1545–1550, doi:10.1093/europace/euv375. [DOI] [PubMed] [Google Scholar]
- 5. Schiks IE, Schoonhoven L, Aengevaeren WR, Nogarede-Hoekstra C, van Achterberg T, Verheugt FW.. Ambulation after femoral sheath removal in percutaneous coronary intervention: A prospective comparison of early vs late ambulation. J Clin Nurs 2009; 18: 1862–1870, doi:10.1111/j.1365-2702.2008.02587.x. [DOI] [PubMed] [Google Scholar]
- 6. Natale A, Mohanty S, Liu PY, Mittal S, Al-Ahmad A, De Lurgio DB, et al.. Venous vascular closure system versus manual compression following multiple access electrophysiology procedures: The AMBULATE trial. JACC Clin Electrophysiol 2020; 6: 111–124, doi:10.1016/j.jacep.2019.08.013. [DOI] [PubMed] [Google Scholar]
- 7. Fluellen S, Mackey K, Hagglund K, Aslam MF.. Randomized clinical trial comparing skin closure with tissue adhesives vs subcuticular suture after robotic urogynecologic procedures. World J Methodol 2020; 10: 1–6, doi:10.5662/wjm.v10.i1.1. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 8. Singer AJ, Quinn JV, Clark RE, Hollander JE, TraumaSeal Study Group.. Closure of lacerations and incisions with octylcyanoacrylate: A multicenter randomized controlled trial. Surgery 2002; 131: 270–276, doi:10.1067/msy.2002.121377. [DOI] [PubMed] [Google Scholar]
- 9. Prince D, Solanki Z, Varughese R, Mastej J, Prince D.. Antibacterial effect and proposed mechanism of action of a topical surgical adhesive. Am J Infect Control 2018; 46: 26–29, doi:10.1016/j.ajic.2017.07.008. [DOI] [PubMed] [Google Scholar]
- 10. Okada M, Inoue K, Tanaka K, Ninomiya Y, Hirao Y, Oka T, et al.. Efficacy and safety of figure-of-eight suture for hemostasis after radiofrequency catheter ablation for atrial fibrillation. Circ J 2018; 82: 956–964, doi:10.1253/circj.CJ-17-1213. [DOI] [PubMed] [Google Scholar]
- 11. Tilz RR, Feher M, Vogler J, Bode K, Duta AI, Ortolan A, et al.. Venous vascular closure system vs. figure-of-eight suture following atrial fibrillation ablation: the STYLE-AF Study. Europace 2024; 26: euae105, doi:10.1093/europace/euae105. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 12. Chiang CE, Wang KL, Lin SJ.. Asian strategy for stroke prevention in atrial fibrillation. Europace 2015; 19(Suppl 2): 1461–1469, doi:10.1093/europace/euv231. [DOI] [PubMed] [Google Scholar]
- 13. Okumura K, Hori M, Tanahashi N, John Camm A.. Special considerations for therapeutic choice of non-vitamin K antagonist oral anticoagulants for Japanese patients with nonvalvular atrial fibrillation. Clin Cardiol 2017; 40: 126–131, doi:10.1002/clc.22596. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 14. Giugliano RP, Ruff CT, Braunwald E, Murphy SA, Wiviott SD, Halperin JL, et al.. Edoxaban versus warfarin in patients with atrial fibrillation. N Engl J Med 2013; 369: 2093–2104, doi:10.1056/NEJMoa1310907. [DOI] [PubMed] [Google Scholar]
Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Data Availability Statement
The deidentified individual participant data underlying this study, including baseline characteristics, procedural parameters, and clinical outcomes, are accessible. Researchers interested in accessing the dataset may contact the corresponding author (Y.T., takadaya@tokyo-med.ac.jp) with a detailed research proposal outlining the intended use of the data. Data will be made available within 6 months of the publication date and will remain available for a minimum of 5 years. Access to the data is limited to legitimate research purposes, and researchers must execute a data use agreement prior to data transfer. Additional materials, including the study protocol and statistical analysis plan, are available upon request. Data will be provided in a de-identified format via secure electronic transfer.