Risk factors for venous bleeding complication at the femoral puncture site after catheter ablation of atrial fibrillation

Abstract Background Venous bleeding complication is often observed after catheter ablation of atrial fibrillation (AF), but the risk factors remain unclear. Methods We retrospectively evaluated 570 consecutive patients who underwent catheter ablation of AF from April 2012 to March 2017. After the procedure, the sheaths were removed, and hemostasis was obtained by manual compression followed by application of rolled gauze with elastic bandage and continuous pressure to the puncture site. We evaluated the risk factors for venous bleeding complications defined as hemorrhage from the puncture site that needed recompression after removal of the elastic bandage and rolled gauze. Results After excluding 11 patients because of missing data, 559 patients (395 [70.7%] men, mean age: 65.6 ± 8.7 years) were included for analysis. Venous bleeding complication was observed in 213 patients (38.1%). In the multivariate logistic regression analysis, low body mass index (BMI; odds ratio [OR] 0.95, 95% CI 0.90‐1.00, P = .04), short compression time (OR 0.77, 95% CI 0.68‐0.88, P < .001), and antiplatelet therapy (OR 1.86, 95% CI 1.09‐3.16, P = .02) were independent risk factors for venous bleeding complication. Conclusions Low BMI, short compression time, and antiplatelet therapy were independent risk factors for venous bleeding complication after catheter ablation of AF. Longer compression time may be needed for patients with low BMI and/or those receiving antiplatelet therapy.

Heart Rhythm Association guidelines. Data on baseline characteristics at the time of catheter ablation, procedure characteristics, and postprocedure care regarding hemostasis of the puncture site were collected. We excluded cases with missing data on any of these factors. The outcome assessed was venous bleeding complication that needed recompression after bandage release, and the contributing factors for this end point were analyzed.

| Peri-procedural anticoagulation control
Warfarin therapy, with PT-INR controlled between 2.0 and 3.0 for patients aged <70 years and between 1.6 and 2.6 for patients aged >70 years according to the recommendation of the Guidelines for Drug Treatment of Arrhythmia of Japanese Circulation Society, 14 was continued. The morning dose was skipped in twice-per-day prescriptions of direct oral anticoagulants, including apixaban and dabigatran. However, dabigatran was not skipped after the introduction of idarcizumab in November 2016. In the cases of once-per-day prescriptions, including rivaroxaban and edoxaban, they were taken in the evening and continued. Intravenous injection of unfractionated heparin was used to maintain an activated clotting time of >300 seconds during the procedure. The recommended protamine sulfate dose was injected before the sheath removal after the procedure.
The day after the procedure, anticoagulation drugs were taken as usual.

| Sheath introduction during catheter ablation
All the patients were treated with RF ablation or cryo-balloon ablation.
Mainly, three sheaths were introduced from the femoral vein for ablation, mapping, and insertion of ultrasonography catheters. We used an 8.5-Fr steerable sheath, Agilis™ NxT (Abbott) or Destino™ (Oscor) for RF ablation and a 12-Fr steerable sheath, FlexCath Advance™ (Medtronic), for cryo-balloon ablation. The Swartz™ Braided F I G U R E 1 Angio-hemostasis roll. We used an angio-hemostasis roll for all the patients to compress the puncture site after manual compression Transseptal Guiding Introducer SL1 8.5 F (Abbott) was used for the mapping catheter. The Radifocus Introducer IIH® 9-or 10-Fr sheath (Terumo) was used for intracardiac echocardiography. The puncture site was decided on the discretion of the operator, but we mainly inserted the sheaths for ablation and mapping catheter from the right femoral vein and the sheath for the ultrasonography catheter from the left femoral vein from April 2012 to March 2015. Thereafter, we inserted the three sheaths only from the right femoral vein.
We monitored the arterial blood pressure in all the cases with a 20-G monitoring catheter or the Radifocus Introducer IIH ® 4-Fr sheath (Terumo) for the patients who received concurrent coronary angiography. We inserted these catheters from the right femoral artery.

| Hemostasis after the procedure
We applied manual compression after sheath removal until hemostasis was achieved. Thereafter, a 30-× 60-mm angio-hemostasis roll (Hakujuji; Figure 1 F I G U R E 2 Angio-hemostasis roll with an elastic bandage. An angio-hemostasis roll was fixed with an elastic bandage. We instructed the patients not to move their hip joint on the puncture side until the bandage was removed

| Statistical analyses
The unpaired t test and Mann-Whitney U test were used for continuous variables with normal and nonnormal distributions, respectively, and the Fisher exact test was used for categorical variables to compare data between the rehemorrhage and nonhemorrhage groups. F I G U R E 3 Venous bleeding complication rate in the compression time groups. The white bars indicate the incidence rate of venous bleeding complication. As the compression time was prolonged, the incidence rate of venous bleeding complication significantly decreased (P < .0001) nisms. 12 Lack of these effects of obesity may have resulted in the higher incidence of venous bleeding complication in patients with low BMI.
In the previous reports, anticoagulation was continued in most cases before AF ablation, 7 and the compression time was 4 hours in all the cases. 8 Nevertheless, the incidence of venous bleeding complication in this study was higher than that in the previous reports.
The BMI in our cohort was lower than that in the previously reported cohort. This may be one of the reasons why the incidence rate of venous bleeding complication in our study was higher than the reported rate. The odds ratio of BMI for venous bleeding complication was 0.948 for 1 BMI increase, which corresponds to 0.766 for 5 BMI increases and 0.586 for 10 BMI increases.
Several procedures or devices such as the figure-of-eight suture, 17

| CON CLUS IONS
Low BMI, short compression time, and antiplatelet therapy were the significant risk factors for venous bleeding complication after PVI.
The use of hemostatic methods such as figure-of-eight suture should be considered especially for patients with these risk factors.

CO N FLI C T O F I NTE R E S T
There is no conflict of interest.