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Venous access-site closure with vascular closure device vs. manual compression in patients undergoing catheter ablation or left atrial appendage occlusion under uninterrupted anticoagulation: a multicentre experience on efficacy and complications

Venous access-site closure with vascular closure device vs. manual compression in patients... Aims Manual compression (MC), widely used to achieve venous access haemostasis, needs prolonged immobilization and extended time-to-haemostasis. Vascular closure devices (VCD) have been reported to have significantly shorter time to haemostasis and ambulation in arterial access-site management. The current study aimed to evaluate the safety and efficacy as well as rate of urinary tract complications in patients receiving MC vs. VCD for venous access-site closure. Methods and results A total of 803 consecutive patients undergoing catheter ablation or left atrial appendage closure were classified into the VCD (n = 304) and the MC (n = 499) group, based on the methods used for haemostasis at the venous access site. Foley catheter was used for bladder-emptying in all MC cases and 15 VCD patients. At one site, VCD group patients with experience of MC in prior ablations were asked to describe their overall satisfaction level after comparing the past experience with the present. Haemostasis was achieved effectively in both populations. No VCD cases required >2 h bed rest, whereas 7 (1.4%) patients in the MC group needed prolonged immobilization (P = 0.04). Significantly higher incidence of access-site haematoma (P = 0.004) and urinary complications (P < 0.05) were observed in the MC group. Majority of VCD patients (68%) with prior experience of MC for haemostasis expressed satisfaction over the early ambulation and ability to void urine without bladder catheterization. Conclusion Vascular closure devices provided effective haemostasis, while reducing the access-site complications, ambulation time, and urinary complications. Manual compression, Vascular closure device, Vascade, Venous access site, Haemostasis, Ambulation, Foley What’s new? Utilization of vascular closure device (VCD) reduced the time to venous access-site haemostasis and ambulation compared with the traditional manual compression (MC) method. Due to shorter immobilization period, bladder catheterization was not required in most patients receiving VCD; thus urinary tract complication rate was very low in this population. Manual compression was associated with significantly higher number of access-site haematoma compared with the VCD group. Majority of the VCD patients with prior experience of MC for haemostasis expressed high satisfaction over the early ambulation and ability to void urine without bladder catheterization. Introduction The cardiac catheterization procedures involving percutaneous femoral vein puncture have been reported to be associated with access-site complications such as haematoma, pseudoaneurysm, and extended time to haemostasis and patient-ambulation.1 Manual compression (MC) is one of the most widely-used methods to achieve arterial and venous access haemostasis after the sheath removal.2 In fact, it was the only means available before the vascular closure devices (VCD) were introduced in 1990s.3 Effective haemostasis can take up to 30 min with the MC that could be uncomfortable for the patient as well as the operator.2–4 Use of oral anticoagulation and large-sized sheaths often prolong the process further.4 Additionally, MC necessitates an immobilization period of up to 6–8 h, during which patients are asked to avoid limb movements as much as possible to facilitate haemostasis and minimize bleeding risks from the groin sites.2–4 As most of the patients undergoing catheter ablation receive large volume of fluid from irrigated-tip catheters, systematic bladder catheterization is performed in many centres during the prolonged immobilization period, which adds another layer of discomfort for the patients. On the other hand, VCD have been reported to have non-inferiority in terms of access-site complications and significantly shorter time to haemostasis and ambulation compared with MC.5 In this observational analysis, we sought to evaluate the proportion of cases requiring prolonged immobilization (>2 h for Group 1 and 6 h for Group 2) and haemostasis time (>4 min in the VCD group and >10 min in the MC group) as well as perception of satisfaction and convenience, bleeding complications, rate of urinary tract infection (UTI), and other associated urinary complications in patients receiving VCD or MC. Methods In this retrospective cohort study, a total of 803 consecutive patients undergoing catheter ablation for atrial or ventricular arrhythmia or left atrial appendage (LAA) closure procedures from May 2017 to February 2018 were included and classified into two groups based on the method used to achieve haemostasis; Group 1: VCD (VASCADE, Cardiva Medical, Inc., Santa Clara, CA, USA) (Figure 1) and Group 2: MC. Decision to use one of the above two methods was taken at the discretion of the patients and their operators. The procedures were performed by three operators in total. The study was reviewed and approved by the institutional review board. Figure 1 View largeDownload slide Picture of the VASCADE device used for venous access-site closure. Figure 1 View largeDownload slide Picture of the VASCADE device used for venous access-site closure. Vascular closure device This device utilizes a completely bioabsorbable extravascular collagen patch that is easy to use through the existing intravenous sheath and leaves no permanent components behind.1,2,6 The VASCADE device is labelled for US in closing arterial access sites achieved with 5–7 Fr sheaths. However, it is also known to successfully close venotomy sites.2 The choice between the conventional MC and venous closure was at the discretion of the operator. The most common reasons for using the device in our patients were the patient preference for early ambulation, unwillingness for prolonged confinement to bed, reluctance to receive the Foley catheter because of discomfort or potential complications of urethral catheterization. All patients receiving the device had the venous access achieved with the sheath size of ≥5 Fr. The device was inserted into the introducer sheath after the completion of the procedure and the disc at the tip of the device was deployed.1 Fluoroscopy was used to verify the positioning of the disc against the intimal aspect of the vessel. The collagen patch was then deployed into the tissue tract (Figure 2). The disc was collapsed, and the device was removed.2 A gentle MC of 2–4 min was performed in all patients. In the absence of bleeding at the access site, ambulation following 2 h of bed rest was recommended for all patients receiving the VCD. Foley catheter was placed only in some patients during the initial part of the device-use period as the operators were not sure about the effective haemostasis and immobilization time. Figure 2 View largeDownload slide Illustration showing the steps involved in the device deployment. (A) Insert VASCADE into the existing procedure sheath and deploy. (B) Remove the sheath and seat the disc against intima; release the collagen patch. (C) Remove the device; the collagen is left in the tissue tract to obtain haemostasis. Figure 2 View largeDownload slide Illustration showing the steps involved in the device deployment. (A) Insert VASCADE into the existing procedure sheath and deploy. (B) Remove the sheath and seat the disc against intima; release the collagen patch. (C) Remove the device; the collagen is left in the tissue tract to obtain haemostasis. Manual compression After sheath removal, sustained compression was applied proximal to the puncture site for at least 10 min or until haemostasis was achieved. A pressure bandage was applied for 6 h after the MC and patients were directed to have 6 h of bed rest before ambulation. Foley catheter was placed in all patients for easy voidance of urine without interrupting the bed rest. Anticoagulation All procedures were conducted under uninterrupted anticoagulation with apixaban or rivaroxaban. Before transseptal punctures, a heparin bolus (100–150 U/kg) was administered to maintain the activated clotting time in the range of 350–450 s. At the end of the procedure, anticoagulation was partially reversed with protamine 30–50 mg. Follow-up The access sites were examined immediately after the procedure, after the mandatory bed rest and before discharge. Patients were followed up by phone call at 1 week and office-visit at 1 month during which they were asked about any access-site pain, bleeding, haematoma, repeat urethral catheterization, re-hospitalization, infection, haematuria, or urination problems. They were also instructed to contact the nurse practitioner if they experienced any of these symptoms any time. The outcomes measured included number of patients requiring prolonged immobilization (>2 h for Group 1 and 6 h for Group 2) and haemostasis time (>4 min in the VCD group and >10 min in the MC group), pain at the puncture site, back pain, use of pain medication, vascular complications, urinary complications such as UTI, haematuria, and obstruction to urine flow in the immediate post-procedure period (7–10 days post-procedure). Presence or absence of pain was determined as the following; having moderate-severe pain with or without the use of pain medication was interpreted as ‘yes’ and having no pain or minimal pain without the need for pain medication as ‘no’. Moreover, at one site, the VCD group patients with prior ablations were asked to describe their overall satisfaction level (no change or satisfied or very satisfied) after comparing the experience from the previous procedure with MC and urinary catheterization vs. the present experience. Statistical analysis Comparison of the VCD vs. MC regarding the primary and secondary endpoints was performed in this retrospective analysis. Normally distributed continuous data were expressed as mean and standard deviation, while median and interquartile range was used for non-normal data. Categorical variables were expressed as count and percentage. Descriptive analysis was performed for age, gender, comorbidities, type of cardiac procedures, and patient satisfaction. Outcomes were categorized into vascular complication, urinary complication, and pain at the puncture site. Student’s t-test, χ2, and Fisher’s exact test were used to compare groups. All tests were two sided and P < 0.05 was considered statistically significant. Propensity score matching was performed in order to balance the covariates between the groups. The caliper matching technique was used with caliper width of with a 0.001 in the matching algorithm. Matching was performed by including VCD as a dependent variable [Group 1 (VCD) and Group 2 (MC)] in a multivariable logistic regression model and age, gender, and body mass index as covariates. One to one matching was performed which resulted in propensity score-matched population of 281 patients in both the groups. Statistical analysis was performed using SPSS version 24.0 (IBM Software, Inc., Armonk, NY, USA). Results A total of 803 patients [Group 1 (VCD): 304 and Group 2 (MC): 499] undergoing cardiac catheterization procedure at our centres were included in the analysis. Baseline characteristics were not different between the groups (Table 1). A total of 91 (30%) and 128 (25.8%) had paroxysmal atrial fibrillation (AF) in Groups 1 and 2, respectively. Table 1 Baseline table: clinical characteristics of the study population Variables Unmatched data Propensity score-matched data Group 1: VCD (N = 304) Group 2: MC (N = 499) P-value Group 1: VCD (N = 281) Group 2: MC (N = 281) P-value Age (years) 66.7 ± 10.2 65.7 ± 10.2 0.20 66.7 ± 9.3 66.0 ± 9.9 0.38 Male 195 (64.1) 343 (68.7) 0.18 93 (33.1) 99 (35.2) 0.59 Body mass index 29.7 ± 6.7 29.4 ± 6.0 0.84 29.4 ± 6.6 29. ± 6.2 0.50 Hypertension 188 (61.8) 305 (61.1) 0.20 179 (63.9) 186 (66.2) 0.57 Diabetes 51 (16.8) 102 (20.4) 0.20 42 (14.9) 50 (17.8) 0.36 Dyslipidaemia 127 (41.8) 229 (45.9) 0.25 115 (40.9) 135 (48.0) 0.10 Renal insufficiency 20 (6.6) 27 (5.4) 0.49 19 (6.8) 20 (7.1) 0.87 Sleep apnoea 64 (21.1) 83 (16.6) 0.12 61 (21.7) 53 (18.9) 0.40 Heart failure 60 (19.7) 86 (17.2) 0.37 56 (19.9) 47 (16.7) 0.33 Coronary artery disease 57 (18.8) 108 (21.6) 0.32 53 (18.9) 63 (22.4) 0.30 Variables Unmatched data Propensity score-matched data Group 1: VCD (N = 304) Group 2: MC (N = 499) P-value Group 1: VCD (N = 281) Group 2: MC (N = 281) P-value Age (years) 66.7 ± 10.2 65.7 ± 10.2 0.20 66.7 ± 9.3 66.0 ± 9.9 0.38 Male 195 (64.1) 343 (68.7) 0.18 93 (33.1) 99 (35.2) 0.59 Body mass index 29.7 ± 6.7 29.4 ± 6.0 0.84 29.4 ± 6.6 29. ± 6.2 0.50 Hypertension 188 (61.8) 305 (61.1) 0.20 179 (63.9) 186 (66.2) 0.57 Diabetes 51 (16.8) 102 (20.4) 0.20 42 (14.9) 50 (17.8) 0.36 Dyslipidaemia 127 (41.8) 229 (45.9) 0.25 115 (40.9) 135 (48.0) 0.10 Renal insufficiency 20 (6.6) 27 (5.4) 0.49 19 (6.8) 20 (7.1) 0.87 Sleep apnoea 64 (21.1) 83 (16.6) 0.12 61 (21.7) 53 (18.9) 0.40 Heart failure 60 (19.7) 86 (17.2) 0.37 56 (19.9) 47 (16.7) 0.33 Coronary artery disease 57 (18.8) 108 (21.6) 0.32 53 (18.9) 63 (22.4) 0.30 MC, manual compression; VCD, vascular closure device. View Large Table 1 Baseline table: clinical characteristics of the study population Variables Unmatched data Propensity score-matched data Group 1: VCD (N = 304) Group 2: MC (N = 499) P-value Group 1: VCD (N = 281) Group 2: MC (N = 281) P-value Age (years) 66.7 ± 10.2 65.7 ± 10.2 0.20 66.7 ± 9.3 66.0 ± 9.9 0.38 Male 195 (64.1) 343 (68.7) 0.18 93 (33.1) 99 (35.2) 0.59 Body mass index 29.7 ± 6.7 29.4 ± 6.0 0.84 29.4 ± 6.6 29. ± 6.2 0.50 Hypertension 188 (61.8) 305 (61.1) 0.20 179 (63.9) 186 (66.2) 0.57 Diabetes 51 (16.8) 102 (20.4) 0.20 42 (14.9) 50 (17.8) 0.36 Dyslipidaemia 127 (41.8) 229 (45.9) 0.25 115 (40.9) 135 (48.0) 0.10 Renal insufficiency 20 (6.6) 27 (5.4) 0.49 19 (6.8) 20 (7.1) 0.87 Sleep apnoea 64 (21.1) 83 (16.6) 0.12 61 (21.7) 53 (18.9) 0.40 Heart failure 60 (19.7) 86 (17.2) 0.37 56 (19.9) 47 (16.7) 0.33 Coronary artery disease 57 (18.8) 108 (21.6) 0.32 53 (18.9) 63 (22.4) 0.30 Variables Unmatched data Propensity score-matched data Group 1: VCD (N = 304) Group 2: MC (N = 499) P-value Group 1: VCD (N = 281) Group 2: MC (N = 281) P-value Age (years) 66.7 ± 10.2 65.7 ± 10.2 0.20 66.7 ± 9.3 66.0 ± 9.9 0.38 Male 195 (64.1) 343 (68.7) 0.18 93 (33.1) 99 (35.2) 0.59 Body mass index 29.7 ± 6.7 29.4 ± 6.0 0.84 29.4 ± 6.6 29. ± 6.2 0.50 Hypertension 188 (61.8) 305 (61.1) 0.20 179 (63.9) 186 (66.2) 0.57 Diabetes 51 (16.8) 102 (20.4) 0.20 42 (14.9) 50 (17.8) 0.36 Dyslipidaemia 127 (41.8) 229 (45.9) 0.25 115 (40.9) 135 (48.0) 0.10 Renal insufficiency 20 (6.6) 27 (5.4) 0.49 19 (6.8) 20 (7.1) 0.87 Sleep apnoea 64 (21.1) 83 (16.6) 0.12 61 (21.7) 53 (18.9) 0.40 Heart failure 60 (19.7) 86 (17.2) 0.37 56 (19.9) 47 (16.7) 0.33 Coronary artery disease 57 (18.8) 108 (21.6) 0.32 53 (18.9) 63 (22.4) 0.30 MC, manual compression; VCD, vascular closure device. View Large Distribution of the procedure type is listed in Table 2. Majority of the patients received either AF ablation [247 (81.3%), 435 (87.2%)] or LAA occlusion by Watchman device [47 (15.5%), 49 (9.8%)], in the VCD and MC group, respectively. All three operators performed the procedures at site 1 that included 84.5% of VCD cases and 68% of MC cases and the remaining procedures were performed at site 2 and 3 by operator 1. Table 2 Procedure types Group 1: vascular closure device (N = 304) Group 2: manual compression (N = 499) Atrial fibrillation 247 (81.3) 435 (87.2) Ventricular arrhythmia 6 (2.0) 11 (2.2) Left atrial appendage occlusion with Watchman 47 (15.5) 49 (9.8) Left atrial appendage exclusion with Lariat 4 (1.3) 4 (0.8) Group 1: vascular closure device (N = 304) Group 2: manual compression (N = 499) Atrial fibrillation 247 (81.3) 435 (87.2) Ventricular arrhythmia 6 (2.0) 11 (2.2) Left atrial appendage occlusion with Watchman 47 (15.5) 49 (9.8) Left atrial appendage exclusion with Lariat 4 (1.3) 4 (0.8) View Large Table 2 Procedure types Group 1: vascular closure device (N = 304) Group 2: manual compression (N = 499) Atrial fibrillation 247 (81.3) 435 (87.2) Ventricular arrhythmia 6 (2.0) 11 (2.2) Left atrial appendage occlusion with Watchman 47 (15.5) 49 (9.8) Left atrial appendage exclusion with Lariat 4 (1.3) 4 (0.8) Group 1: vascular closure device (N = 304) Group 2: manual compression (N = 499) Atrial fibrillation 247 (81.3) 435 (87.2) Ventricular arrhythmia 6 (2.0) 11 (2.2) Left atrial appendage occlusion with Watchman 47 (15.5) 49 (9.8) Left atrial appendage exclusion with Lariat 4 (1.3) 4 (0.8) View Large All patients received uninterrupted novel oral anticoagulants (apixaban or rivaroxaban) before, during and after the procedure. Range of sheath sizes used was 7–11 Fr. VCD was successfully deployed in all 304 patients; 3–4 devices were used per patient. Haemostasis was achieved in 100% of cases in both arms. Complication rates were comparable across the operators. Vascular complications Access-site haematoma was observed in 12 (2.4%) cases from Group 2 compared with none from Group 1 (P = 0.004) (Table 3). None of the haematomas required blood transfusion or prolonged hospital stay or discontinuation of anticoagulation. Table 3 Complications across groups Complications Unmatched data Propensity score-matched data Vascular closure device (N = 304) Manual compression (N = 499) P-value Vascular closure device (N = 281) Manual compression (N = 281) P-value Vascular complication  Access-site haematoma 0 (0.0) 12 (2.4) 0.004 0 (0.0) 7 (2.5) 0.015 Post-Watchman: 2 Post-Watchman: 1 Post-catheter ablation: 10 Post-catheter ablation: 6  Minor bleeding 2 (0.7) 3 (0.6) 1.0 2 (0.7) 2 (0.7) 1.00 Post-Watchman: 1 Post-Watchman: 1 Post-Watchman: 1 Post-catheter ablation: 2 Post-catheter ablation: 1 Post-catheter ablation: 2 Post-catheter ablation: 1  Haemostasis time (min) 6.2 ± 2.1 13.7 ± 3.6 <0.001 6.2 ± 2.1 13.9 ± 3.8 <0.001  Prolonged bed rest 0 (0.0) 7 (1.4) 0.04 0 (0.0) 5 (1.8) 0.02  Post-ambulatory complications 0 (0.0) 0 (0.0) 1.0 0 (0.0) 0 (0.0) 1.00  Patients managed with pain medication for puncture site pain 0 (0.0) 7 (1.4) 0.048 0 (0.0) 6 (2.1) 0.03  Patients managed with pain medication for back pain 74 (24.3) 239 (47.9) <0.001 39 (13.8) 145 (51.6) <0.001 Urinary complications  Urinary tract infection 0 (0.0) 19 (3.8) <0.001 0 (0.0) 12 (4.3) <0.001  Gross haematuria 0 (0.0) 15 (3.0) <0.001 0 (0.0) 8 (2.9) 0.007  Urinary retention 0 (0.0) 10 (2.0) 0.02 0 (0.0) 6 (2.1) 0.03 Complications Unmatched data Propensity score-matched data Vascular closure device (N = 304) Manual compression (N = 499) P-value Vascular closure device (N = 281) Manual compression (N = 281) P-value Vascular complication  Access-site haematoma 0 (0.0) 12 (2.4) 0.004 0 (0.0) 7 (2.5) 0.015 Post-Watchman: 2 Post-Watchman: 1 Post-catheter ablation: 10 Post-catheter ablation: 6  Minor bleeding 2 (0.7) 3 (0.6) 1.0 2 (0.7) 2 (0.7) 1.00 Post-Watchman: 1 Post-Watchman: 1 Post-Watchman: 1 Post-catheter ablation: 2 Post-catheter ablation: 1 Post-catheter ablation: 2 Post-catheter ablation: 1  Haemostasis time (min) 6.2 ± 2.1 13.7 ± 3.6 <0.001 6.2 ± 2.1 13.9 ± 3.8 <0.001  Prolonged bed rest 0 (0.0) 7 (1.4) 0.04 0 (0.0) 5 (1.8) 0.02  Post-ambulatory complications 0 (0.0) 0 (0.0) 1.0 0 (0.0) 0 (0.0) 1.00  Patients managed with pain medication for puncture site pain 0 (0.0) 7 (1.4) 0.048 0 (0.0) 6 (2.1) 0.03  Patients managed with pain medication for back pain 74 (24.3) 239 (47.9) <0.001 39 (13.8) 145 (51.6) <0.001 Urinary complications  Urinary tract infection 0 (0.0) 19 (3.8) <0.001 0 (0.0) 12 (4.3) <0.001  Gross haematuria 0 (0.0) 15 (3.0) <0.001 0 (0.0) 8 (2.9) 0.007  Urinary retention 0 (0.0) 10 (2.0) 0.02 0 (0.0) 6 (2.1) 0.03 View Large Table 3 Complications across groups Complications Unmatched data Propensity score-matched data Vascular closure device (N = 304) Manual compression (N = 499) P-value Vascular closure device (N = 281) Manual compression (N = 281) P-value Vascular complication  Access-site haematoma 0 (0.0) 12 (2.4) 0.004 0 (0.0) 7 (2.5) 0.015 Post-Watchman: 2 Post-Watchman: 1 Post-catheter ablation: 10 Post-catheter ablation: 6  Minor bleeding 2 (0.7) 3 (0.6) 1.0 2 (0.7) 2 (0.7) 1.00 Post-Watchman: 1 Post-Watchman: 1 Post-Watchman: 1 Post-catheter ablation: 2 Post-catheter ablation: 1 Post-catheter ablation: 2 Post-catheter ablation: 1  Haemostasis time (min) 6.2 ± 2.1 13.7 ± 3.6 <0.001 6.2 ± 2.1 13.9 ± 3.8 <0.001  Prolonged bed rest 0 (0.0) 7 (1.4) 0.04 0 (0.0) 5 (1.8) 0.02  Post-ambulatory complications 0 (0.0) 0 (0.0) 1.0 0 (0.0) 0 (0.0) 1.00  Patients managed with pain medication for puncture site pain 0 (0.0) 7 (1.4) 0.048 0 (0.0) 6 (2.1) 0.03  Patients managed with pain medication for back pain 74 (24.3) 239 (47.9) <0.001 39 (13.8) 145 (51.6) <0.001 Urinary complications  Urinary tract infection 0 (0.0) 19 (3.8) <0.001 0 (0.0) 12 (4.3) <0.001  Gross haematuria 0 (0.0) 15 (3.0) <0.001 0 (0.0) 8 (2.9) 0.007  Urinary retention 0 (0.0) 10 (2.0) 0.02 0 (0.0) 6 (2.1) 0.03 Complications Unmatched data Propensity score-matched data Vascular closure device (N = 304) Manual compression (N = 499) P-value Vascular closure device (N = 281) Manual compression (N = 281) P-value Vascular complication  Access-site haematoma 0 (0.0) 12 (2.4) 0.004 0 (0.0) 7 (2.5) 0.015 Post-Watchman: 2 Post-Watchman: 1 Post-catheter ablation: 10 Post-catheter ablation: 6  Minor bleeding 2 (0.7) 3 (0.6) 1.0 2 (0.7) 2 (0.7) 1.00 Post-Watchman: 1 Post-Watchman: 1 Post-Watchman: 1 Post-catheter ablation: 2 Post-catheter ablation: 1 Post-catheter ablation: 2 Post-catheter ablation: 1  Haemostasis time (min) 6.2 ± 2.1 13.7 ± 3.6 <0.001 6.2 ± 2.1 13.9 ± 3.8 <0.001  Prolonged bed rest 0 (0.0) 7 (1.4) 0.04 0 (0.0) 5 (1.8) 0.02  Post-ambulatory complications 0 (0.0) 0 (0.0) 1.0 0 (0.0) 0 (0.0) 1.00  Patients managed with pain medication for puncture site pain 0 (0.0) 7 (1.4) 0.048 0 (0.0) 6 (2.1) 0.03  Patients managed with pain medication for back pain 74 (24.3) 239 (47.9) <0.001 39 (13.8) 145 (51.6) <0.001 Urinary complications  Urinary tract infection 0 (0.0) 19 (3.8) <0.001 0 (0.0) 12 (4.3) <0.001  Gross haematuria 0 (0.0) 15 (3.0) <0.001 0 (0.0) 8 (2.9) 0.007  Urinary retention 0 (0.0) 10 (2.0) 0.02 0 (0.0) 6 (2.1) 0.03 View Large Minor bleeding was observed in 2 (0.7%) patients from Group 1 and 3 (0.6%) from Group 2 (P-value = 0.92), which stopped after a short period of gentle compression. Haemostasis time was 6.2 ± 2.1 vs. 13.7 ± 3.6 min (P < 0.001) in the VCD vs. the MC group. It was achieved within the stipulated time frame in all cases except the 2 (0.7%) patients with minor bleeding in Group 1 and 5 (1.0%) in Group 2 (P-value = 0.7). No patients in the VCD group required bed rest longer than 2 h; however, in the MC group, 7 (1.4%) patients required prolonged immobilization (P-value = 0.04). In these seven patients, a median time of 7.1 (6.9–7.4) h of bed rest was needed to obtain ambulatory haemostasis. Remaining patients in the MC group were ambulated after the mandatory 6 h of immobilization. No vascular complications (bleeding or haematoma) were recorded following ambulation in both groups. Pain at the puncture site Eight (1.6%) and 6 (2%) patients from the MC and VCD group, respectively (P = 0.7), experienced pain at the puncture-site at the start of the ambulation (Table 3). Out of those, no patients in the VCD group and 7 (1.4%) in the MC group required pain medications (P-value: 0.048). In the propensity-matched population, 6 (2.1%) and 5 (1.8%) patients in MC and VCD group, respectively (P = 0.76) had puncture site pain and no patients in the VCD group vs. 6 (2.1%) in the MC group required pain medications (P-value: 0.03). Back pain Significantly higher number of patients in the MC group complained of back pain that necessitated use of pain medications [239/499 (47.9%) vs. 74/304 (24.3%), P < 0.001] (Table 3). In the propensity-matched population, 39 (13.8%) patients in VCD and 145 (51.6%) patients in MC group required pain medication (P < 0.001). Urinary complications All patients in the MC group and 15 (4.9%) subjects from the VCD group had Foley catheter in place (Table 3). The catheters were removed when patients were mobile and able to void urine. However, one patient from the MC group had urethral injury for which he was discharged with the Foley catheter in place; he underwent surgical repair of the urethra at a later date. After discharge, no patients in the VCD group developed UTI compared with 19 (3.8%) subjects in the MC group (P < 0.001) for which they received antibiotics. Gross haematuria was detected in no patients of the VCD group vs. 15 (15/499, 3.0%) in the MC group (P < 0.001). Twelve (80.0%) out of 15 cases with gross haematuria were male. Moreover, 10 (2.0%) patients from the MC group developed urinary retention after removal of Foley catheter and had to be re-catheterized to empty the bladder compared with none in the VCD population (P = 0.02). Two of the 15 patients from Group 1 that received Foley catheter reported minor haematuria. Satisfaction level A total of 137 patients from the VCD group had prior ablations during which MC and urinary catheterization (Foley) were utilized. These patients were asked to compare their earlier experience with MC + Foley vs. the current use of VCD and comment on their overall satisfaction level in terms of ambulation time and the convenience of voiding urine. Ninety-three (68%) patients reported ‘very satisfied’, 41 (30%) were satisfied, and 3 (2%) patients reported ‘no change’. Estimates of potential cost savings Vascular and urinary complications were the major issues observed in the MC group during the post-ablation period. Vascular complications resolved with conservative management and did not have any financial impact. On the other hand, urinary catheter use and associated complications accounted for substantial number of patients in the MC group and warranted an assessment of potential economic impact. In the VCD population, an average of three devices were used in each patient, leading to an estimated cost of $450 per person. The reported average per-patient cost for management of catheter-associated UTI was $758 to $911.7 With 19 patients experiencing UTI in the MC group and none in the VCD group, the potential cost savings for VCD group, calculated based on the reported rate, was more than $14 402. Additionally, the average per-patient cost of catheter insertion is reported to be $102 (https://www.acepnow.com/article/avoid-foley-catheters-improve-ed-patients-comfort-reduce-costs/). Ten patients in the MC group required re-catheterization for retention of urine. Lastly, one patient with urethral injury received surgical repair of the urethra (estimated cost: $11 500). Thus, the use of VCD resulted in an estimated direct total cost savings of more than $27 000 in complication management. Furthermore, use of pain medication was significantly more in the MC group. The reported median cost of post-operative pain management was $9.46 per person.8 As 172 additional patients in the MC group received pain medication for the back pain or pain at the puncture site (246 vs. 74 patients), estimated cost saving for pain management in the VCD group was ≥$1627.12. Discussion To the best of our knowledge, this is the largest study to report an assessment of the safety and efficacy of the vascular closure system vs. MC in achieving haemostasis at the venous access site. Our main findings were the following: (i) all in the VCD group achieved ambulation by the end of the 2-h period, whereas in the MC group several patients required longer immobilization, (ii) complication of urinary catheterization such as UTI, haematuria, and retention of urine observed only in the MC group, (iii) significantly higher number of access-site haematoma reported in the MC group, and (iv) patients undergoing redo procedures expressed satisfaction with the vascular closure system compared with their prior experience with the MC. While discussing the relevance of our findings, two factors need to be recognized as critical players; (i) more than two-thirds of our cases had non-paroxysmal AF that require prolonged procedure time and (ii) all procedures were performed under uninterrupted anticoagulation. In 2008–2009, radiofrequency ablation procedures utilizing irrigated tip catheters were reported to require administration of a median of >3 L of saline during the procedure in a majorly paroxysmal population.9 Currently, with the advent of catheters with surround flow technology, uniform cooling is effectively achieved with half the volume load to the patient. Still, a substantial amount of fluid is administered when the procedures are longer as in persistent and long-standing persistent AF, which in turn necessitates bladder catheterization in patients mandated to prolonged post-procedure immobilization for haemostasis. Furthermore, use of uninterrupted oral anticoagulation and appropriate heparin dosing to achieve safe activated clotting time levels can cause potential delay in haemostasis. In a case-control study on 376 patients, adequate femoral haemostasis was achieved in 50.7 ± 12.2 min under continuous peri-procedural anticoagulation.10 Therefore, the significance of measures leading to earlier haemostasis and shorter bed rest duration without the need for urinary catheterization cannot be overemphasized especially in non-paroxysmal AF patients undergoing catheter ablation. Haemostasis at the venous access site Complications related to the vascular access site during cardiac catheterization procedures are mostly encountered in relation to haemostasis.3,4 The problem is accentuated by the fact that majority of these patients receive continuous anticoagulation therapy to reduce the risk of thrombus formation in the heart. Haemorrhage following sheath removal resulting in haematoma, pseudoaneurysms, and infection of the access site are some of the common complications; these are considered major when they require surgical intervention, blood transfusion, and antibiotic administration.3,4 Manual compression and VCD are two available options to achieve haemostasis. In our patients, time to haemostasis was 4 min at the maximum with the closure device, whereas it was at least 10 min or more in the MC group. Recent evidences strongly suggest superiority of the closure devices in reducing the haemostasis time. In the ISAR-CLOSURE randomized controlled trial (RCT), it was reported to be significantly shorter in patients with VCD vs. MC.5 In another RCT by Hermiller et al.,5 the mean time to haemostasis was 4.8 ± 5.4 min in the Vascade group vs. 21.4 ± 12.4 min in the MC group (P < 0.001). Significantly shorter time to haemostasis was also reported in the VCD population of the ECLIPSE trial.6 Sairaku et al.4 observed shorter haemostasis time when the pads used for MC were impregnated with kaolin than in those without. However, the mean time of 6.1 min (with the kaolin-soaked pads) was still much longer than what it typically takes with the closure devices. Time to ambulation A period of immobilization (absolute bed rest with minimal limb movement) is mandatory after the haemostatic method is implemented; it is 4–8 h with MC and 2 h with the VCD.1,4 Thus, as it is apparent, faster ambulation time is a prominent advantage of the device. In our study, none in the VCD group required longer time to ambulation (TTA) (than the stipulated duration) compared with the MC population. Our result is in agreement with earlier published reports. In the RCT by Hermiller et al.,5 mean TTA of arterial closure patients was significantly shorter in the group assigned to Vascade than in the group assigned to MC. Ambulation was achieved in ≤5 h in 93% of all randomized Vascade subjects and in 48% of MC subjects.5 In the ECLIPSE trial, TTA was significantly shorter with the ExoSeal VCD.6 Patient satisfaction Majority of our patients receiving the VCD expressed satisfaction over early ambulation and for being able to avoid the urinary catheterization. Incidence of pain at the puncture-site was comparable between the groups. In a study conducted by Bode et al.,11 61 patients suffered from moderate-to-severe pain within the first 24 h; back pain in 44% (which was most likely due to prolonged bed rest) and pain at the groin puncture site in 7%. In a single-blind RCT, patients in the study group had their position changed intermittently during the first 6 h after cardiac catheterization and were allowed to undertake self-ambulation thereafter, whereas the patients in the control group were restricted to at least 10 h of bed rest in supine position with the affected leg immobilized with a sand-bag on the puncture site for at least 8 h.12 The study group showed significantly higher comfort and satisfaction level than the control group.12 Foley-catheter induced discomfort is an objective finding, especially in older men as evidenced by significant reduction in the discomfort level with caudal block (using 0.3% ropivacaine and 100 µg of fentanyl) vs. without in a double-blind RCT conducted by Tsuchiya et al.13 Urinary complications Catheter-associated UTI accounts for >30% of all nosocomial infections and affects an estimated 2 million patients annually.14 In our study population, UTI rate was observed to be 3.8% in patients receiving Foley catheter, for which they had to remain under antibiotics therapy. Earlier studies including retrospective trials as well as RCTs have reported similar or higher incidence of UTI following catheterization.14–17 Recent evidences suggest decreased utilization and improved compliance to safety measures to be keys to reducing the number of catheter-associated UTIs.18 Urethral trauma resulting in haematuria is another common complication of Foley catheter placement. Although mild haematuria is more common, published studies have also reported life-threatening urethral haemorrhage after placement of Foley catheter in patients with bleeding disorders.19–22 In addition, urethral obstruction (retention of urine) due to inflammation after removal of the Foley catheter was observed in some of our patients. In the meta-analysis by Hollingsworth et al.,14 the pooled percentage of patients who developed urethral stricture after short-term catheterization was 8.7% in men and 37.2% in female patients. Lastly, use of VCDs could reduce the overall procedure-related cost by minimizing the utilization of urinary catheters and subsequent urinary complications and lowering the usage of pain medications. Catheter-associated UTI is common (estimated infection rate: 1 in 333 Foleys) and costly, not only for the patients but also for the hospitals.23 Additionally, reducing catheter utilization lowers the cost associated with catheter-related non-infectious complications.7 Significantly less use of the pain medication was another cost-effective advantage of the VCD group compared with the MC group. In this context, we would like to acknowledge the fact that bladder catheterization can be avoided, plausibly when the ablation procedures are of shorter duration (involving non-complex arrhythmia), done under interrupted anticoagulation and the operators electing to limit the bed rest duration to fewer hours. In that case, needless to say, patients would be spared of the urinary tract complications and associated expenses. However, in most cases involving complex procedures, it is tough to avoid it without adopting means to reduce the immobilization time. The VCD can also be potentially used in procedures other than catheter ablations and LAA occlusion, such as implantation of transvenous intracardiac pacing systems. These systems require relatively large size of delivery sheath. Current version of the VASCADE device is compatible with sheath size of up to 11 Fr. Thus, more than one device can be plausibly used to close access site up to 22 Fr. As per certain earlier publications, the figure-of-eight (FO8) suture provided a safe and effective alternative to the VCD especially when multiple venous sheaths were used.24,25 Vascular-site complications such as haematoma, pseudoaneurysm, and fistula formation were rare following this procedure. However, longer immobilization (compared with reported TTA in the VCD group) was necessary after the removal of the FO8 sutures. Lakshmanadoss et al.24 reported the post-procedure bed rest time to be at least 6 h and in the study by Aytemir et al.25 the time to mobilization was similar in the FO8 group and the MC cohort. Additionally, in our experience, the FO8 suture is frequently associated with pain at the groin-site and some risk of bleeding. Limitations It is an observational analysis with potential patient selection bias. Secondly, the VASCADE device is not usable under certain conditions; patients with body mass index <20 or >45 kg/m2 or if the length of the tissue tract (the distance between the anterior venous wall and skin) is less than 2.5 cm or if the femoral vein diameter is <6 mm. Conclusion In the patients with the VCD, urinary catheterization was performed at a very low rate that consequently reduced the catheter-associated urinary complications, while keeping the time to haemostasis and ambulation at the minimum. Furthermore, VCD patients with prior experience with MC and Foley catheterization expressed higher level of satisfaction over early ambulation and self-voiding. Conflict of interest: A.N. received speaker honorariums from Boston Scientific, Biosense Webster, St. Jude Medical, Biotronik and Medtronic. A.N. is a consultant for Biosense Webster St Jude Medical and Janssen. M.T.: Compensation for Services; Akebia, St. Jude Medical, Precision Health Economics, Cardiva Medical, iRhythm Technologies. Speaker's Bureau; Medscape. Equity Interests/Stock Options Non-Public; AliveCor, Zipline Medical, iBeat Inc. Research Grants; Astra Zeneca Pharmaceuticals, Janssen Pharmaceuticals, Medtronic, Inc., Veterans Administration, Boehringer Ingelheim. All the remaining authors have no conflict of interest. References 1 Nagabandi A , Ratanapo S , Morgan LG , Kapoor D. Use of VASCADE vascular closure system for venous hemostasis . Vasc Dis Manage 2017 ; 14 : E171 – 3 . WorldCat 2 Dou E , Winokur RS , Sista AK. Venous access site closures using the VASCADE vascular closure system . J Vasc Interv Radiol 2016 ; 27 : 1885 – 8 . Google Scholar Crossref Search ADS PubMed WorldCat 3 Barbetta I , van den Berg JC. Access and hemostasis: femoral and popliteal approaches and closure devices-why, what, when, and how? Semin Intervent Radiol 2014 ; 31 : 353 – 60 . Google Scholar Crossref Search ADS PubMed WorldCat 4 Sairaku A , Nakano Y , Oda N , Makita Y , Kajihara K , Tokuyama T et al. Rapid hemostasis at the femoral venous access site using a novel hemostatic pad containing kaolin after atrial fibrillation ablation . J Interv Card Electrophysiol 2011 ; 31 : 157 – 64 . Google Scholar Crossref Search ADS PubMed WorldCat 5 Hermiller JB , Leimbach W , Gammon R , Karas SP , Whitbourn RJ , Wong SC et al. A prospective, randomized, pivotal trial of a novel extravascular collagen-based closure device compared to manual compression in diagnostic and interventional patients . J Invasive Cardiol 2015 ; 27 : 129 – 36 . Google Scholar PubMed WorldCat 6 Wong SC , Bachinsky W , Cambier P , Stoler R , Aji J , Rogers JH et al. ; ECLIPSE Trial Investigators. A randomized comparison of a novel bioabsorbable vascular closure device versus manual compression in the achievement of hemostasis after percutaneous femoral procedures: the ECLIPSE (Ensure's Vascular Closure Device Speeds Hemostasis Trial) . JACC Cardiovasc Interv 2009 ; 2 : 785 – 93 . Google Scholar Crossref Search ADS PubMed WorldCat 7 Kennedy EH , Greene MT , Saint S. Estimating hospital costs of catheter-associated urinary tract infection . J Hosp Med 2013 ; 8 : 519 – 22 . Google Scholar Crossref Search ADS PubMed WorldCat 8 Dalton JA , Carlson J , Lindley C , Blau W , Youngblood R , Greer SM. Clinical economics: calculating the cost of acute postoperative pain medication . J Pain Symptom Manage 2000 ; 19 : 295 – 308 . Google Scholar Crossref Search ADS PubMed WorldCat 9 Seiler J , Steven D , Roberts-Thomson KC , Inada K , Tedrow UB , Michaud GF et al. The effect of open-irrigated radiofrequency catheter ablation of atrial fibrillation on left atrial pressure and B-type natriuretic peptide . Pacing Clin Electrophysiol 2014 ; 37 : 616 – 23 . Google Scholar Crossref Search ADS PubMed WorldCat 10 Issa ZF , Amr BS. Venous hemostasis postcatheter ablation of atrial fibrillation while under therapeutic levels of oral and intravenous anticoagulation . J Interv Card Electrophysiol 2015 ; 44 : 97 – 104 . Google Scholar Crossref Search ADS PubMed WorldCat 11 Bode K , Breithardt OA , Kreuzhuber M , Mende M , Sommer P , Richter S et al. Patient discomfort following catheter ablation and rhythm device surgery . Europace 2015 ; 17 : 1129 – 35 . Google Scholar Crossref Search ADS PubMed WorldCat 12 Rezaei-Adaryani M , Ahmadi F , Asghari-Jafarabadi M. The effect of changing position and early ambulation after cardiac catheterization on patients' outcomes: a single-blind randomized controlled trial . Int J Nurs Stud 2009 ; 46 : 1047 – 53 . Google Scholar Crossref Search ADS PubMed WorldCat 13 Tsuchiya M , Kyoh Y , Mizutani K , Yamashita J , Hamada T. Ultrasound-guided single shot caudal block anesthesia reduces postoperative urinary catheter-induced discomfort . Minerva Anestesiol 2013 ; 79 : 1381 – 8 . Google Scholar PubMed WorldCat 14 Hollingsworth JM , Rogers MA , Krein SL , Hickner A , Kuhn L , Cheng A et al. Determining the noninfectious complications of indwelling urethral catheters: a systematic review and meta-analysis . Ann Intern Med 2013 ; 159 : 401 – 10 . Google Scholar Crossref Search ADS PubMed WorldCat 15 Cluckey A , Perino AC , Fan J , Askari M , Nasir J , Marcus GM et al. Incidence of urinary tract infection after catheter ablation of atrial fibrillation . Circulation 2017 ; 136 : A17235. WorldCat 16 Hidalgo Fabrellas I , Rebollo Pavón M , Planas Canals M , Barbero Cabezas M. Incidence of urinary tract infections after cardiac surgery: comparative study accordind to catheterization device . Enferm Intensiva 2015 ; 26 : 54 – 62 . Google Scholar Crossref Search ADS PubMed WorldCat 17 Marschall J , Carpenter CR , Fowler S , Trautner BW ; CDC Prevention Epicenters Program. Antibiotic prophylaxis for urinary tract infections after removal of urinary catheter: meta-analysis . BMJ 2013 ; 346 : f3147. Google Scholar Crossref Search ADS PubMed WorldCat 18 Kachare SD , Sanders C , Myatt K , Fitzgerald TL , Zervos EE. Toward eliminating catheter-associated urinary tract infections in an academic health center . J Surg Res 2014 ; 192 : 280 – 5 . Google Scholar Crossref Search ADS PubMed WorldCat 19 Hockberger RS , Schwartz B , Connor J. Hematuria induced by urethral catheterization . Ann Emerg Med 1987 ; 16 : 550 – 2 . Google Scholar Crossref Search ADS PubMed WorldCat 20 Sklar DP , Diven B , Jones J. Incidence and magnitude of catheter-induced hematuria . Am J Emerg Med 1986 ; 4 : 14 – 6 . Google Scholar Crossref Search ADS PubMed WorldCat 21 Khoubehi B , Watkin NA , Mee AD , Ogden CW. Morbidity and the impact on daily activities associated with catheter drainage after acute urinary retention . BJU Int 2000 ; 85 : 1033 – 6 . Google Scholar Crossref Search ADS PubMed WorldCat 22 Ikegami Y , Yoshida K , Imaizumi T , Isosu T , Kurosawa S , Murakawa M. Life-threatening urethral hemorrhage after placement of a Foley catheter in a patient with uroseptic disseminated intravascular coagulation due to chronic urinary retention induced by untreated benign prostatic hyperplasia . Acute Med Surg 2016 ; 3 : 407 – 10 . Google Scholar Crossref Search ADS PubMed WorldCat 23 Saint S , Meddings JA , Calfee D , Kowalski CP , Krein SL. Catheter-associated urinary tract infection and the Medicare rule changes . Ann Intern Med 2009 ; 150 : 877 – 84 . Google Scholar Crossref Search ADS PubMed WorldCat 24 Lakshmanadoss U , Wong WS , Kutinsky I , Khalid MR , Williamson B , Haines DE. Figure-of-eight suture for venous hemostasis in fully anticoagulated patients after atrial fibrillation catheter ablation . Indian Pacing Electrophysiol J 2017 ; 17 : 134 – 9 . Google Scholar Crossref Search ADS PubMed WorldCat 25 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 – 50 . Google Scholar Crossref Search ADS PubMed WorldCat Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2019. For permissions, please email: journals.permissions@oup.com. This article is published and distributed under the terms of the Oxford University Press, Standard Journals Publication Model (https://academic.oup.com/journals/pages/open_access/funder_policies/chorus/standard_publication_model) http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Europace Oxford University Press

Venous access-site closure with vascular closure device vs. manual compression in patients undergoing catheter ablation or left atrial appendage occlusion under uninterrupted anticoagulation: a multicentre experience on efficacy and complications

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Oxford University Press
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Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2019. For permissions, please email: journals.permissions@oup.com.
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1099-5129
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1532-2092
DOI
10.1093/europace/euz004
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Abstract

Aims Manual compression (MC), widely used to achieve venous access haemostasis, needs prolonged immobilization and extended time-to-haemostasis. Vascular closure devices (VCD) have been reported to have significantly shorter time to haemostasis and ambulation in arterial access-site management. The current study aimed to evaluate the safety and efficacy as well as rate of urinary tract complications in patients receiving MC vs. VCD for venous access-site closure. Methods and results A total of 803 consecutive patients undergoing catheter ablation or left atrial appendage closure were classified into the VCD (n = 304) and the MC (n = 499) group, based on the methods used for haemostasis at the venous access site. Foley catheter was used for bladder-emptying in all MC cases and 15 VCD patients. At one site, VCD group patients with experience of MC in prior ablations were asked to describe their overall satisfaction level after comparing the past experience with the present. Haemostasis was achieved effectively in both populations. No VCD cases required >2 h bed rest, whereas 7 (1.4%) patients in the MC group needed prolonged immobilization (P = 0.04). Significantly higher incidence of access-site haematoma (P = 0.004) and urinary complications (P < 0.05) were observed in the MC group. Majority of VCD patients (68%) with prior experience of MC for haemostasis expressed satisfaction over the early ambulation and ability to void urine without bladder catheterization. Conclusion Vascular closure devices provided effective haemostasis, while reducing the access-site complications, ambulation time, and urinary complications. Manual compression, Vascular closure device, Vascade, Venous access site, Haemostasis, Ambulation, Foley What’s new? Utilization of vascular closure device (VCD) reduced the time to venous access-site haemostasis and ambulation compared with the traditional manual compression (MC) method. Due to shorter immobilization period, bladder catheterization was not required in most patients receiving VCD; thus urinary tract complication rate was very low in this population. Manual compression was associated with significantly higher number of access-site haematoma compared with the VCD group. Majority of the VCD patients with prior experience of MC for haemostasis expressed high satisfaction over the early ambulation and ability to void urine without bladder catheterization. Introduction The cardiac catheterization procedures involving percutaneous femoral vein puncture have been reported to be associated with access-site complications such as haematoma, pseudoaneurysm, and extended time to haemostasis and patient-ambulation.1 Manual compression (MC) is one of the most widely-used methods to achieve arterial and venous access haemostasis after the sheath removal.2 In fact, it was the only means available before the vascular closure devices (VCD) were introduced in 1990s.3 Effective haemostasis can take up to 30 min with the MC that could be uncomfortable for the patient as well as the operator.2–4 Use of oral anticoagulation and large-sized sheaths often prolong the process further.4 Additionally, MC necessitates an immobilization period of up to 6–8 h, during which patients are asked to avoid limb movements as much as possible to facilitate haemostasis and minimize bleeding risks from the groin sites.2–4 As most of the patients undergoing catheter ablation receive large volume of fluid from irrigated-tip catheters, systematic bladder catheterization is performed in many centres during the prolonged immobilization period, which adds another layer of discomfort for the patients. On the other hand, VCD have been reported to have non-inferiority in terms of access-site complications and significantly shorter time to haemostasis and ambulation compared with MC.5 In this observational analysis, we sought to evaluate the proportion of cases requiring prolonged immobilization (>2 h for Group 1 and 6 h for Group 2) and haemostasis time (>4 min in the VCD group and >10 min in the MC group) as well as perception of satisfaction and convenience, bleeding complications, rate of urinary tract infection (UTI), and other associated urinary complications in patients receiving VCD or MC. Methods In this retrospective cohort study, a total of 803 consecutive patients undergoing catheter ablation for atrial or ventricular arrhythmia or left atrial appendage (LAA) closure procedures from May 2017 to February 2018 were included and classified into two groups based on the method used to achieve haemostasis; Group 1: VCD (VASCADE, Cardiva Medical, Inc., Santa Clara, CA, USA) (Figure 1) and Group 2: MC. Decision to use one of the above two methods was taken at the discretion of the patients and their operators. The procedures were performed by three operators in total. The study was reviewed and approved by the institutional review board. Figure 1 View largeDownload slide Picture of the VASCADE device used for venous access-site closure. Figure 1 View largeDownload slide Picture of the VASCADE device used for venous access-site closure. Vascular closure device This device utilizes a completely bioabsorbable extravascular collagen patch that is easy to use through the existing intravenous sheath and leaves no permanent components behind.1,2,6 The VASCADE device is labelled for US in closing arterial access sites achieved with 5–7 Fr sheaths. However, it is also known to successfully close venotomy sites.2 The choice between the conventional MC and venous closure was at the discretion of the operator. The most common reasons for using the device in our patients were the patient preference for early ambulation, unwillingness for prolonged confinement to bed, reluctance to receive the Foley catheter because of discomfort or potential complications of urethral catheterization. All patients receiving the device had the venous access achieved with the sheath size of ≥5 Fr. The device was inserted into the introducer sheath after the completion of the procedure and the disc at the tip of the device was deployed.1 Fluoroscopy was used to verify the positioning of the disc against the intimal aspect of the vessel. The collagen patch was then deployed into the tissue tract (Figure 2). The disc was collapsed, and the device was removed.2 A gentle MC of 2–4 min was performed in all patients. In the absence of bleeding at the access site, ambulation following 2 h of bed rest was recommended for all patients receiving the VCD. Foley catheter was placed only in some patients during the initial part of the device-use period as the operators were not sure about the effective haemostasis and immobilization time. Figure 2 View largeDownload slide Illustration showing the steps involved in the device deployment. (A) Insert VASCADE into the existing procedure sheath and deploy. (B) Remove the sheath and seat the disc against intima; release the collagen patch. (C) Remove the device; the collagen is left in the tissue tract to obtain haemostasis. Figure 2 View largeDownload slide Illustration showing the steps involved in the device deployment. (A) Insert VASCADE into the existing procedure sheath and deploy. (B) Remove the sheath and seat the disc against intima; release the collagen patch. (C) Remove the device; the collagen is left in the tissue tract to obtain haemostasis. Manual compression After sheath removal, sustained compression was applied proximal to the puncture site for at least 10 min or until haemostasis was achieved. A pressure bandage was applied for 6 h after the MC and patients were directed to have 6 h of bed rest before ambulation. Foley catheter was placed in all patients for easy voidance of urine without interrupting the bed rest. Anticoagulation All procedures were conducted under uninterrupted anticoagulation with apixaban or rivaroxaban. Before transseptal punctures, a heparin bolus (100–150 U/kg) was administered to maintain the activated clotting time in the range of 350–450 s. At the end of the procedure, anticoagulation was partially reversed with protamine 30–50 mg. Follow-up The access sites were examined immediately after the procedure, after the mandatory bed rest and before discharge. Patients were followed up by phone call at 1 week and office-visit at 1 month during which they were asked about any access-site pain, bleeding, haematoma, repeat urethral catheterization, re-hospitalization, infection, haematuria, or urination problems. They were also instructed to contact the nurse practitioner if they experienced any of these symptoms any time. The outcomes measured included number of patients requiring prolonged immobilization (>2 h for Group 1 and 6 h for Group 2) and haemostasis time (>4 min in the VCD group and >10 min in the MC group), pain at the puncture site, back pain, use of pain medication, vascular complications, urinary complications such as UTI, haematuria, and obstruction to urine flow in the immediate post-procedure period (7–10 days post-procedure). Presence or absence of pain was determined as the following; having moderate-severe pain with or without the use of pain medication was interpreted as ‘yes’ and having no pain or minimal pain without the need for pain medication as ‘no’. Moreover, at one site, the VCD group patients with prior ablations were asked to describe their overall satisfaction level (no change or satisfied or very satisfied) after comparing the experience from the previous procedure with MC and urinary catheterization vs. the present experience. Statistical analysis Comparison of the VCD vs. MC regarding the primary and secondary endpoints was performed in this retrospective analysis. Normally distributed continuous data were expressed as mean and standard deviation, while median and interquartile range was used for non-normal data. Categorical variables were expressed as count and percentage. Descriptive analysis was performed for age, gender, comorbidities, type of cardiac procedures, and patient satisfaction. Outcomes were categorized into vascular complication, urinary complication, and pain at the puncture site. Student’s t-test, χ2, and Fisher’s exact test were used to compare groups. All tests were two sided and P < 0.05 was considered statistically significant. Propensity score matching was performed in order to balance the covariates between the groups. The caliper matching technique was used with caliper width of with a 0.001 in the matching algorithm. Matching was performed by including VCD as a dependent variable [Group 1 (VCD) and Group 2 (MC)] in a multivariable logistic regression model and age, gender, and body mass index as covariates. One to one matching was performed which resulted in propensity score-matched population of 281 patients in both the groups. Statistical analysis was performed using SPSS version 24.0 (IBM Software, Inc., Armonk, NY, USA). Results A total of 803 patients [Group 1 (VCD): 304 and Group 2 (MC): 499] undergoing cardiac catheterization procedure at our centres were included in the analysis. Baseline characteristics were not different between the groups (Table 1). A total of 91 (30%) and 128 (25.8%) had paroxysmal atrial fibrillation (AF) in Groups 1 and 2, respectively. Table 1 Baseline table: clinical characteristics of the study population Variables Unmatched data Propensity score-matched data Group 1: VCD (N = 304) Group 2: MC (N = 499) P-value Group 1: VCD (N = 281) Group 2: MC (N = 281) P-value Age (years) 66.7 ± 10.2 65.7 ± 10.2 0.20 66.7 ± 9.3 66.0 ± 9.9 0.38 Male 195 (64.1) 343 (68.7) 0.18 93 (33.1) 99 (35.2) 0.59 Body mass index 29.7 ± 6.7 29.4 ± 6.0 0.84 29.4 ± 6.6 29. ± 6.2 0.50 Hypertension 188 (61.8) 305 (61.1) 0.20 179 (63.9) 186 (66.2) 0.57 Diabetes 51 (16.8) 102 (20.4) 0.20 42 (14.9) 50 (17.8) 0.36 Dyslipidaemia 127 (41.8) 229 (45.9) 0.25 115 (40.9) 135 (48.0) 0.10 Renal insufficiency 20 (6.6) 27 (5.4) 0.49 19 (6.8) 20 (7.1) 0.87 Sleep apnoea 64 (21.1) 83 (16.6) 0.12 61 (21.7) 53 (18.9) 0.40 Heart failure 60 (19.7) 86 (17.2) 0.37 56 (19.9) 47 (16.7) 0.33 Coronary artery disease 57 (18.8) 108 (21.6) 0.32 53 (18.9) 63 (22.4) 0.30 Variables Unmatched data Propensity score-matched data Group 1: VCD (N = 304) Group 2: MC (N = 499) P-value Group 1: VCD (N = 281) Group 2: MC (N = 281) P-value Age (years) 66.7 ± 10.2 65.7 ± 10.2 0.20 66.7 ± 9.3 66.0 ± 9.9 0.38 Male 195 (64.1) 343 (68.7) 0.18 93 (33.1) 99 (35.2) 0.59 Body mass index 29.7 ± 6.7 29.4 ± 6.0 0.84 29.4 ± 6.6 29. ± 6.2 0.50 Hypertension 188 (61.8) 305 (61.1) 0.20 179 (63.9) 186 (66.2) 0.57 Diabetes 51 (16.8) 102 (20.4) 0.20 42 (14.9) 50 (17.8) 0.36 Dyslipidaemia 127 (41.8) 229 (45.9) 0.25 115 (40.9) 135 (48.0) 0.10 Renal insufficiency 20 (6.6) 27 (5.4) 0.49 19 (6.8) 20 (7.1) 0.87 Sleep apnoea 64 (21.1) 83 (16.6) 0.12 61 (21.7) 53 (18.9) 0.40 Heart failure 60 (19.7) 86 (17.2) 0.37 56 (19.9) 47 (16.7) 0.33 Coronary artery disease 57 (18.8) 108 (21.6) 0.32 53 (18.9) 63 (22.4) 0.30 MC, manual compression; VCD, vascular closure device. View Large Table 1 Baseline table: clinical characteristics of the study population Variables Unmatched data Propensity score-matched data Group 1: VCD (N = 304) Group 2: MC (N = 499) P-value Group 1: VCD (N = 281) Group 2: MC (N = 281) P-value Age (years) 66.7 ± 10.2 65.7 ± 10.2 0.20 66.7 ± 9.3 66.0 ± 9.9 0.38 Male 195 (64.1) 343 (68.7) 0.18 93 (33.1) 99 (35.2) 0.59 Body mass index 29.7 ± 6.7 29.4 ± 6.0 0.84 29.4 ± 6.6 29. ± 6.2 0.50 Hypertension 188 (61.8) 305 (61.1) 0.20 179 (63.9) 186 (66.2) 0.57 Diabetes 51 (16.8) 102 (20.4) 0.20 42 (14.9) 50 (17.8) 0.36 Dyslipidaemia 127 (41.8) 229 (45.9) 0.25 115 (40.9) 135 (48.0) 0.10 Renal insufficiency 20 (6.6) 27 (5.4) 0.49 19 (6.8) 20 (7.1) 0.87 Sleep apnoea 64 (21.1) 83 (16.6) 0.12 61 (21.7) 53 (18.9) 0.40 Heart failure 60 (19.7) 86 (17.2) 0.37 56 (19.9) 47 (16.7) 0.33 Coronary artery disease 57 (18.8) 108 (21.6) 0.32 53 (18.9) 63 (22.4) 0.30 Variables Unmatched data Propensity score-matched data Group 1: VCD (N = 304) Group 2: MC (N = 499) P-value Group 1: VCD (N = 281) Group 2: MC (N = 281) P-value Age (years) 66.7 ± 10.2 65.7 ± 10.2 0.20 66.7 ± 9.3 66.0 ± 9.9 0.38 Male 195 (64.1) 343 (68.7) 0.18 93 (33.1) 99 (35.2) 0.59 Body mass index 29.7 ± 6.7 29.4 ± 6.0 0.84 29.4 ± 6.6 29. ± 6.2 0.50 Hypertension 188 (61.8) 305 (61.1) 0.20 179 (63.9) 186 (66.2) 0.57 Diabetes 51 (16.8) 102 (20.4) 0.20 42 (14.9) 50 (17.8) 0.36 Dyslipidaemia 127 (41.8) 229 (45.9) 0.25 115 (40.9) 135 (48.0) 0.10 Renal insufficiency 20 (6.6) 27 (5.4) 0.49 19 (6.8) 20 (7.1) 0.87 Sleep apnoea 64 (21.1) 83 (16.6) 0.12 61 (21.7) 53 (18.9) 0.40 Heart failure 60 (19.7) 86 (17.2) 0.37 56 (19.9) 47 (16.7) 0.33 Coronary artery disease 57 (18.8) 108 (21.6) 0.32 53 (18.9) 63 (22.4) 0.30 MC, manual compression; VCD, vascular closure device. View Large Distribution of the procedure type is listed in Table 2. Majority of the patients received either AF ablation [247 (81.3%), 435 (87.2%)] or LAA occlusion by Watchman device [47 (15.5%), 49 (9.8%)], in the VCD and MC group, respectively. All three operators performed the procedures at site 1 that included 84.5% of VCD cases and 68% of MC cases and the remaining procedures were performed at site 2 and 3 by operator 1. Table 2 Procedure types Group 1: vascular closure device (N = 304) Group 2: manual compression (N = 499) Atrial fibrillation 247 (81.3) 435 (87.2) Ventricular arrhythmia 6 (2.0) 11 (2.2) Left atrial appendage occlusion with Watchman 47 (15.5) 49 (9.8) Left atrial appendage exclusion with Lariat 4 (1.3) 4 (0.8) Group 1: vascular closure device (N = 304) Group 2: manual compression (N = 499) Atrial fibrillation 247 (81.3) 435 (87.2) Ventricular arrhythmia 6 (2.0) 11 (2.2) Left atrial appendage occlusion with Watchman 47 (15.5) 49 (9.8) Left atrial appendage exclusion with Lariat 4 (1.3) 4 (0.8) View Large Table 2 Procedure types Group 1: vascular closure device (N = 304) Group 2: manual compression (N = 499) Atrial fibrillation 247 (81.3) 435 (87.2) Ventricular arrhythmia 6 (2.0) 11 (2.2) Left atrial appendage occlusion with Watchman 47 (15.5) 49 (9.8) Left atrial appendage exclusion with Lariat 4 (1.3) 4 (0.8) Group 1: vascular closure device (N = 304) Group 2: manual compression (N = 499) Atrial fibrillation 247 (81.3) 435 (87.2) Ventricular arrhythmia 6 (2.0) 11 (2.2) Left atrial appendage occlusion with Watchman 47 (15.5) 49 (9.8) Left atrial appendage exclusion with Lariat 4 (1.3) 4 (0.8) View Large All patients received uninterrupted novel oral anticoagulants (apixaban or rivaroxaban) before, during and after the procedure. Range of sheath sizes used was 7–11 Fr. VCD was successfully deployed in all 304 patients; 3–4 devices were used per patient. Haemostasis was achieved in 100% of cases in both arms. Complication rates were comparable across the operators. Vascular complications Access-site haematoma was observed in 12 (2.4%) cases from Group 2 compared with none from Group 1 (P = 0.004) (Table 3). None of the haematomas required blood transfusion or prolonged hospital stay or discontinuation of anticoagulation. Table 3 Complications across groups Complications Unmatched data Propensity score-matched data Vascular closure device (N = 304) Manual compression (N = 499) P-value Vascular closure device (N = 281) Manual compression (N = 281) P-value Vascular complication  Access-site haematoma 0 (0.0) 12 (2.4) 0.004 0 (0.0) 7 (2.5) 0.015 Post-Watchman: 2 Post-Watchman: 1 Post-catheter ablation: 10 Post-catheter ablation: 6  Minor bleeding 2 (0.7) 3 (0.6) 1.0 2 (0.7) 2 (0.7) 1.00 Post-Watchman: 1 Post-Watchman: 1 Post-Watchman: 1 Post-catheter ablation: 2 Post-catheter ablation: 1 Post-catheter ablation: 2 Post-catheter ablation: 1  Haemostasis time (min) 6.2 ± 2.1 13.7 ± 3.6 <0.001 6.2 ± 2.1 13.9 ± 3.8 <0.001  Prolonged bed rest 0 (0.0) 7 (1.4) 0.04 0 (0.0) 5 (1.8) 0.02  Post-ambulatory complications 0 (0.0) 0 (0.0) 1.0 0 (0.0) 0 (0.0) 1.00  Patients managed with pain medication for puncture site pain 0 (0.0) 7 (1.4) 0.048 0 (0.0) 6 (2.1) 0.03  Patients managed with pain medication for back pain 74 (24.3) 239 (47.9) <0.001 39 (13.8) 145 (51.6) <0.001 Urinary complications  Urinary tract infection 0 (0.0) 19 (3.8) <0.001 0 (0.0) 12 (4.3) <0.001  Gross haematuria 0 (0.0) 15 (3.0) <0.001 0 (0.0) 8 (2.9) 0.007  Urinary retention 0 (0.0) 10 (2.0) 0.02 0 (0.0) 6 (2.1) 0.03 Complications Unmatched data Propensity score-matched data Vascular closure device (N = 304) Manual compression (N = 499) P-value Vascular closure device (N = 281) Manual compression (N = 281) P-value Vascular complication  Access-site haematoma 0 (0.0) 12 (2.4) 0.004 0 (0.0) 7 (2.5) 0.015 Post-Watchman: 2 Post-Watchman: 1 Post-catheter ablation: 10 Post-catheter ablation: 6  Minor bleeding 2 (0.7) 3 (0.6) 1.0 2 (0.7) 2 (0.7) 1.00 Post-Watchman: 1 Post-Watchman: 1 Post-Watchman: 1 Post-catheter ablation: 2 Post-catheter ablation: 1 Post-catheter ablation: 2 Post-catheter ablation: 1  Haemostasis time (min) 6.2 ± 2.1 13.7 ± 3.6 <0.001 6.2 ± 2.1 13.9 ± 3.8 <0.001  Prolonged bed rest 0 (0.0) 7 (1.4) 0.04 0 (0.0) 5 (1.8) 0.02  Post-ambulatory complications 0 (0.0) 0 (0.0) 1.0 0 (0.0) 0 (0.0) 1.00  Patients managed with pain medication for puncture site pain 0 (0.0) 7 (1.4) 0.048 0 (0.0) 6 (2.1) 0.03  Patients managed with pain medication for back pain 74 (24.3) 239 (47.9) <0.001 39 (13.8) 145 (51.6) <0.001 Urinary complications  Urinary tract infection 0 (0.0) 19 (3.8) <0.001 0 (0.0) 12 (4.3) <0.001  Gross haematuria 0 (0.0) 15 (3.0) <0.001 0 (0.0) 8 (2.9) 0.007  Urinary retention 0 (0.0) 10 (2.0) 0.02 0 (0.0) 6 (2.1) 0.03 View Large Table 3 Complications across groups Complications Unmatched data Propensity score-matched data Vascular closure device (N = 304) Manual compression (N = 499) P-value Vascular closure device (N = 281) Manual compression (N = 281) P-value Vascular complication  Access-site haematoma 0 (0.0) 12 (2.4) 0.004 0 (0.0) 7 (2.5) 0.015 Post-Watchman: 2 Post-Watchman: 1 Post-catheter ablation: 10 Post-catheter ablation: 6  Minor bleeding 2 (0.7) 3 (0.6) 1.0 2 (0.7) 2 (0.7) 1.00 Post-Watchman: 1 Post-Watchman: 1 Post-Watchman: 1 Post-catheter ablation: 2 Post-catheter ablation: 1 Post-catheter ablation: 2 Post-catheter ablation: 1  Haemostasis time (min) 6.2 ± 2.1 13.7 ± 3.6 <0.001 6.2 ± 2.1 13.9 ± 3.8 <0.001  Prolonged bed rest 0 (0.0) 7 (1.4) 0.04 0 (0.0) 5 (1.8) 0.02  Post-ambulatory complications 0 (0.0) 0 (0.0) 1.0 0 (0.0) 0 (0.0) 1.00  Patients managed with pain medication for puncture site pain 0 (0.0) 7 (1.4) 0.048 0 (0.0) 6 (2.1) 0.03  Patients managed with pain medication for back pain 74 (24.3) 239 (47.9) <0.001 39 (13.8) 145 (51.6) <0.001 Urinary complications  Urinary tract infection 0 (0.0) 19 (3.8) <0.001 0 (0.0) 12 (4.3) <0.001  Gross haematuria 0 (0.0) 15 (3.0) <0.001 0 (0.0) 8 (2.9) 0.007  Urinary retention 0 (0.0) 10 (2.0) 0.02 0 (0.0) 6 (2.1) 0.03 Complications Unmatched data Propensity score-matched data Vascular closure device (N = 304) Manual compression (N = 499) P-value Vascular closure device (N = 281) Manual compression (N = 281) P-value Vascular complication  Access-site haematoma 0 (0.0) 12 (2.4) 0.004 0 (0.0) 7 (2.5) 0.015 Post-Watchman: 2 Post-Watchman: 1 Post-catheter ablation: 10 Post-catheter ablation: 6  Minor bleeding 2 (0.7) 3 (0.6) 1.0 2 (0.7) 2 (0.7) 1.00 Post-Watchman: 1 Post-Watchman: 1 Post-Watchman: 1 Post-catheter ablation: 2 Post-catheter ablation: 1 Post-catheter ablation: 2 Post-catheter ablation: 1  Haemostasis time (min) 6.2 ± 2.1 13.7 ± 3.6 <0.001 6.2 ± 2.1 13.9 ± 3.8 <0.001  Prolonged bed rest 0 (0.0) 7 (1.4) 0.04 0 (0.0) 5 (1.8) 0.02  Post-ambulatory complications 0 (0.0) 0 (0.0) 1.0 0 (0.0) 0 (0.0) 1.00  Patients managed with pain medication for puncture site pain 0 (0.0) 7 (1.4) 0.048 0 (0.0) 6 (2.1) 0.03  Patients managed with pain medication for back pain 74 (24.3) 239 (47.9) <0.001 39 (13.8) 145 (51.6) <0.001 Urinary complications  Urinary tract infection 0 (0.0) 19 (3.8) <0.001 0 (0.0) 12 (4.3) <0.001  Gross haematuria 0 (0.0) 15 (3.0) <0.001 0 (0.0) 8 (2.9) 0.007  Urinary retention 0 (0.0) 10 (2.0) 0.02 0 (0.0) 6 (2.1) 0.03 View Large Minor bleeding was observed in 2 (0.7%) patients from Group 1 and 3 (0.6%) from Group 2 (P-value = 0.92), which stopped after a short period of gentle compression. Haemostasis time was 6.2 ± 2.1 vs. 13.7 ± 3.6 min (P < 0.001) in the VCD vs. the MC group. It was achieved within the stipulated time frame in all cases except the 2 (0.7%) patients with minor bleeding in Group 1 and 5 (1.0%) in Group 2 (P-value = 0.7). No patients in the VCD group required bed rest longer than 2 h; however, in the MC group, 7 (1.4%) patients required prolonged immobilization (P-value = 0.04). In these seven patients, a median time of 7.1 (6.9–7.4) h of bed rest was needed to obtain ambulatory haemostasis. Remaining patients in the MC group were ambulated after the mandatory 6 h of immobilization. No vascular complications (bleeding or haematoma) were recorded following ambulation in both groups. Pain at the puncture site Eight (1.6%) and 6 (2%) patients from the MC and VCD group, respectively (P = 0.7), experienced pain at the puncture-site at the start of the ambulation (Table 3). Out of those, no patients in the VCD group and 7 (1.4%) in the MC group required pain medications (P-value: 0.048). In the propensity-matched population, 6 (2.1%) and 5 (1.8%) patients in MC and VCD group, respectively (P = 0.76) had puncture site pain and no patients in the VCD group vs. 6 (2.1%) in the MC group required pain medications (P-value: 0.03). Back pain Significantly higher number of patients in the MC group complained of back pain that necessitated use of pain medications [239/499 (47.9%) vs. 74/304 (24.3%), P < 0.001] (Table 3). In the propensity-matched population, 39 (13.8%) patients in VCD and 145 (51.6%) patients in MC group required pain medication (P < 0.001). Urinary complications All patients in the MC group and 15 (4.9%) subjects from the VCD group had Foley catheter in place (Table 3). The catheters were removed when patients were mobile and able to void urine. However, one patient from the MC group had urethral injury for which he was discharged with the Foley catheter in place; he underwent surgical repair of the urethra at a later date. After discharge, no patients in the VCD group developed UTI compared with 19 (3.8%) subjects in the MC group (P < 0.001) for which they received antibiotics. Gross haematuria was detected in no patients of the VCD group vs. 15 (15/499, 3.0%) in the MC group (P < 0.001). Twelve (80.0%) out of 15 cases with gross haematuria were male. Moreover, 10 (2.0%) patients from the MC group developed urinary retention after removal of Foley catheter and had to be re-catheterized to empty the bladder compared with none in the VCD population (P = 0.02). Two of the 15 patients from Group 1 that received Foley catheter reported minor haematuria. Satisfaction level A total of 137 patients from the VCD group had prior ablations during which MC and urinary catheterization (Foley) were utilized. These patients were asked to compare their earlier experience with MC + Foley vs. the current use of VCD and comment on their overall satisfaction level in terms of ambulation time and the convenience of voiding urine. Ninety-three (68%) patients reported ‘very satisfied’, 41 (30%) were satisfied, and 3 (2%) patients reported ‘no change’. Estimates of potential cost savings Vascular and urinary complications were the major issues observed in the MC group during the post-ablation period. Vascular complications resolved with conservative management and did not have any financial impact. On the other hand, urinary catheter use and associated complications accounted for substantial number of patients in the MC group and warranted an assessment of potential economic impact. In the VCD population, an average of three devices were used in each patient, leading to an estimated cost of $450 per person. The reported average per-patient cost for management of catheter-associated UTI was $758 to $911.7 With 19 patients experiencing UTI in the MC group and none in the VCD group, the potential cost savings for VCD group, calculated based on the reported rate, was more than $14 402. Additionally, the average per-patient cost of catheter insertion is reported to be $102 (https://www.acepnow.com/article/avoid-foley-catheters-improve-ed-patients-comfort-reduce-costs/). Ten patients in the MC group required re-catheterization for retention of urine. Lastly, one patient with urethral injury received surgical repair of the urethra (estimated cost: $11 500). Thus, the use of VCD resulted in an estimated direct total cost savings of more than $27 000 in complication management. Furthermore, use of pain medication was significantly more in the MC group. The reported median cost of post-operative pain management was $9.46 per person.8 As 172 additional patients in the MC group received pain medication for the back pain or pain at the puncture site (246 vs. 74 patients), estimated cost saving for pain management in the VCD group was ≥$1627.12. Discussion To the best of our knowledge, this is the largest study to report an assessment of the safety and efficacy of the vascular closure system vs. MC in achieving haemostasis at the venous access site. Our main findings were the following: (i) all in the VCD group achieved ambulation by the end of the 2-h period, whereas in the MC group several patients required longer immobilization, (ii) complication of urinary catheterization such as UTI, haematuria, and retention of urine observed only in the MC group, (iii) significantly higher number of access-site haematoma reported in the MC group, and (iv) patients undergoing redo procedures expressed satisfaction with the vascular closure system compared with their prior experience with the MC. While discussing the relevance of our findings, two factors need to be recognized as critical players; (i) more than two-thirds of our cases had non-paroxysmal AF that require prolonged procedure time and (ii) all procedures were performed under uninterrupted anticoagulation. In 2008–2009, radiofrequency ablation procedures utilizing irrigated tip catheters were reported to require administration of a median of >3 L of saline during the procedure in a majorly paroxysmal population.9 Currently, with the advent of catheters with surround flow technology, uniform cooling is effectively achieved with half the volume load to the patient. Still, a substantial amount of fluid is administered when the procedures are longer as in persistent and long-standing persistent AF, which in turn necessitates bladder catheterization in patients mandated to prolonged post-procedure immobilization for haemostasis. Furthermore, use of uninterrupted oral anticoagulation and appropriate heparin dosing to achieve safe activated clotting time levels can cause potential delay in haemostasis. In a case-control study on 376 patients, adequate femoral haemostasis was achieved in 50.7 ± 12.2 min under continuous peri-procedural anticoagulation.10 Therefore, the significance of measures leading to earlier haemostasis and shorter bed rest duration without the need for urinary catheterization cannot be overemphasized especially in non-paroxysmal AF patients undergoing catheter ablation. Haemostasis at the venous access site Complications related to the vascular access site during cardiac catheterization procedures are mostly encountered in relation to haemostasis.3,4 The problem is accentuated by the fact that majority of these patients receive continuous anticoagulation therapy to reduce the risk of thrombus formation in the heart. Haemorrhage following sheath removal resulting in haematoma, pseudoaneurysms, and infection of the access site are some of the common complications; these are considered major when they require surgical intervention, blood transfusion, and antibiotic administration.3,4 Manual compression and VCD are two available options to achieve haemostasis. In our patients, time to haemostasis was 4 min at the maximum with the closure device, whereas it was at least 10 min or more in the MC group. Recent evidences strongly suggest superiority of the closure devices in reducing the haemostasis time. In the ISAR-CLOSURE randomized controlled trial (RCT), it was reported to be significantly shorter in patients with VCD vs. MC.5 In another RCT by Hermiller et al.,5 the mean time to haemostasis was 4.8 ± 5.4 min in the Vascade group vs. 21.4 ± 12.4 min in the MC group (P < 0.001). Significantly shorter time to haemostasis was also reported in the VCD population of the ECLIPSE trial.6 Sairaku et al.4 observed shorter haemostasis time when the pads used for MC were impregnated with kaolin than in those without. However, the mean time of 6.1 min (with the kaolin-soaked pads) was still much longer than what it typically takes with the closure devices. Time to ambulation A period of immobilization (absolute bed rest with minimal limb movement) is mandatory after the haemostatic method is implemented; it is 4–8 h with MC and 2 h with the VCD.1,4 Thus, as it is apparent, faster ambulation time is a prominent advantage of the device. In our study, none in the VCD group required longer time to ambulation (TTA) (than the stipulated duration) compared with the MC population. Our result is in agreement with earlier published reports. In the RCT by Hermiller et al.,5 mean TTA of arterial closure patients was significantly shorter in the group assigned to Vascade than in the group assigned to MC. Ambulation was achieved in ≤5 h in 93% of all randomized Vascade subjects and in 48% of MC subjects.5 In the ECLIPSE trial, TTA was significantly shorter with the ExoSeal VCD.6 Patient satisfaction Majority of our patients receiving the VCD expressed satisfaction over early ambulation and for being able to avoid the urinary catheterization. Incidence of pain at the puncture-site was comparable between the groups. In a study conducted by Bode et al.,11 61 patients suffered from moderate-to-severe pain within the first 24 h; back pain in 44% (which was most likely due to prolonged bed rest) and pain at the groin puncture site in 7%. In a single-blind RCT, patients in the study group had their position changed intermittently during the first 6 h after cardiac catheterization and were allowed to undertake self-ambulation thereafter, whereas the patients in the control group were restricted to at least 10 h of bed rest in supine position with the affected leg immobilized with a sand-bag on the puncture site for at least 8 h.12 The study group showed significantly higher comfort and satisfaction level than the control group.12 Foley-catheter induced discomfort is an objective finding, especially in older men as evidenced by significant reduction in the discomfort level with caudal block (using 0.3% ropivacaine and 100 µg of fentanyl) vs. without in a double-blind RCT conducted by Tsuchiya et al.13 Urinary complications Catheter-associated UTI accounts for >30% of all nosocomial infections and affects an estimated 2 million patients annually.14 In our study population, UTI rate was observed to be 3.8% in patients receiving Foley catheter, for which they had to remain under antibiotics therapy. Earlier studies including retrospective trials as well as RCTs have reported similar or higher incidence of UTI following catheterization.14–17 Recent evidences suggest decreased utilization and improved compliance to safety measures to be keys to reducing the number of catheter-associated UTIs.18 Urethral trauma resulting in haematuria is another common complication of Foley catheter placement. Although mild haematuria is more common, published studies have also reported life-threatening urethral haemorrhage after placement of Foley catheter in patients with bleeding disorders.19–22 In addition, urethral obstruction (retention of urine) due to inflammation after removal of the Foley catheter was observed in some of our patients. In the meta-analysis by Hollingsworth et al.,14 the pooled percentage of patients who developed urethral stricture after short-term catheterization was 8.7% in men and 37.2% in female patients. Lastly, use of VCDs could reduce the overall procedure-related cost by minimizing the utilization of urinary catheters and subsequent urinary complications and lowering the usage of pain medications. Catheter-associated UTI is common (estimated infection rate: 1 in 333 Foleys) and costly, not only for the patients but also for the hospitals.23 Additionally, reducing catheter utilization lowers the cost associated with catheter-related non-infectious complications.7 Significantly less use of the pain medication was another cost-effective advantage of the VCD group compared with the MC group. In this context, we would like to acknowledge the fact that bladder catheterization can be avoided, plausibly when the ablation procedures are of shorter duration (involving non-complex arrhythmia), done under interrupted anticoagulation and the operators electing to limit the bed rest duration to fewer hours. In that case, needless to say, patients would be spared of the urinary tract complications and associated expenses. However, in most cases involving complex procedures, it is tough to avoid it without adopting means to reduce the immobilization time. The VCD can also be potentially used in procedures other than catheter ablations and LAA occlusion, such as implantation of transvenous intracardiac pacing systems. These systems require relatively large size of delivery sheath. Current version of the VASCADE device is compatible with sheath size of up to 11 Fr. Thus, more than one device can be plausibly used to close access site up to 22 Fr. As per certain earlier publications, the figure-of-eight (FO8) suture provided a safe and effective alternative to the VCD especially when multiple venous sheaths were used.24,25 Vascular-site complications such as haematoma, pseudoaneurysm, and fistula formation were rare following this procedure. However, longer immobilization (compared with reported TTA in the VCD group) was necessary after the removal of the FO8 sutures. Lakshmanadoss et al.24 reported the post-procedure bed rest time to be at least 6 h and in the study by Aytemir et al.25 the time to mobilization was similar in the FO8 group and the MC cohort. Additionally, in our experience, the FO8 suture is frequently associated with pain at the groin-site and some risk of bleeding. Limitations It is an observational analysis with potential patient selection bias. Secondly, the VASCADE device is not usable under certain conditions; patients with body mass index <20 or >45 kg/m2 or if the length of the tissue tract (the distance between the anterior venous wall and skin) is less than 2.5 cm or if the femoral vein diameter is <6 mm. Conclusion In the patients with the VCD, urinary catheterization was performed at a very low rate that consequently reduced the catheter-associated urinary complications, while keeping the time to haemostasis and ambulation at the minimum. Furthermore, VCD patients with prior experience with MC and Foley catheterization expressed higher level of satisfaction over early ambulation and self-voiding. Conflict of interest: A.N. received speaker honorariums from Boston Scientific, Biosense Webster, St. Jude Medical, Biotronik and Medtronic. A.N. is a consultant for Biosense Webster St Jude Medical and Janssen. M.T.: Compensation for Services; Akebia, St. Jude Medical, Precision Health Economics, Cardiva Medical, iRhythm Technologies. Speaker's Bureau; Medscape. Equity Interests/Stock Options Non-Public; AliveCor, Zipline Medical, iBeat Inc. Research Grants; Astra Zeneca Pharmaceuticals, Janssen Pharmaceuticals, Medtronic, Inc., Veterans Administration, Boehringer Ingelheim. 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Google Scholar Crossref Search ADS PubMed WorldCat Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2019. For permissions, please email: journals.permissions@oup.com. This article is published and distributed under the terms of the Oxford University Press, Standard Journals Publication Model (https://academic.oup.com/journals/pages/open_access/funder_policies/chorus/standard_publication_model)

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Europace – Oxford University Press

Published: Jul 1, 2019

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