Preliminary Insights Into Early Ambulation and Hemostasis After Atrial Fibrillation Ablation Using the Perclose Vascular Closure Device

Abstract

Background: The introduction of the Perclose vascular closure device (VCD) for atrial fibrillation (AF) ablation procedures in Japan is expected to facilitate early ambulation.

Methods and Results: The study population comprised 554 patients undergoing AF ablation, of whom 377 successfully underwent Perclose VCD deployment at the end of the procedure. At 4 h after the procedure, 94% (353/377 patients) achieved early hemostasis and 57% (213/377 patients) achieved early ambulation. Notably, 0.5% (2/377 patients) developed acute deep vein thrombosis.

Conclusions: The Perclose VCD demonstrated promising efficacy in achieving early hemostasis, potentially facilitating early ambulation and discharge in appropriate patients.

Vascular complications are the most prevalent complications of catheter ablation for atrial fibrillation (AF) and include groin hematoma, pseudoaneurysm of the femoral artery, retroperitoneal bleeding, and deep vein thrombosis (DVT). Currently the incidence rate of these complications ranges from 1% to 3%.^1,2 Furthermore, vascular complications are the most common cause of delayed ambulation following AF ablation.³ With the increasing demand for AF ablation, shorter hospitalization protocols, including same-day discharge, are increasingly being used in the West to maximize healthcare resources.^3–5 Shorter hospitalization can improve patient satisfaction while reducing nurse stress, but same-day discharge protocols are still uncommon in Japan. To achieve same-day discharge, early ambulation is essential, for which the use of the Perclose ProGide^TM Suture-Mediated Closure System (Abbott Vascular Devices, Santa Clara, CA, USA) may be beneficial; however, data in Japan are limited, so in the current study we aimed to evaluate the viability of early ambulation after AF ablation, the safety profile of the Perclose vascular closure device (VCD), and the associated procedural complications.

Methods

This retrospective study included 554 consecutive patients undergoing AF ablation at Kurashiki Central Hospital, of whom 377 achieved immediate hemostasis with a Perclose VCD within 1 min, and scheduled ambulation 4 h after the procedure between May 2022 and July 2023. Inclusion criteria were achievement of immediate hemostasis with a Perclose VCD and scheduled ambulation 4 h after the procedure at the operator’s discretion. These patients were defined as Perclose VCD success patients and included in this study. Exclusion criteria were failure to achieve immediate hemostasis with a Perclose VCD or scheduled ambulation after >4 h of bed rest after the procedure at the operator’s discretion. Early ambulation, defined as walking within 4 h postoperatively, and early hemostasis, defined as achieving hemostasis within 4 h postoperatively, were the primary goals. All AF ablation procedures, using the Perclose ProGlide^TM, were performed under non-general anesthesia. Prior to the current study period, all patients who received standard subcutaneous sutures such as figure Z suture hemostasis, even in the morning ablation cases, were instructed to stay in bed until the next morning. Therefore, nurses were required to monitor patients’ compliance with bed rest until the next morning. Therefore, we conducted a survey to determine whether nurses’ work levels had changed since the introduction of the Perclose VCD. In addition, we compared patients who achieved early ambulation with patients who did not, aiming to identify the characteristics of patients who achieved same-day ambulation and could potentially be considered for same-day discharge. The study was approved by the Institutional Review Board of Kurashiki Central Hospital, and patient consent for the use of their clinical data for research purposes was obtained using an opt-out system. The current study adhered to the principles outlined in the Declaration of Helsinki.

Sedation Protocol

Buprenorphine 0.2 mg, hydroxyzine 25 mg, and dexmedetomidine 3 μg/kg were administered intravenously every hour for 20 min (initial intensive high dose), followed by dexmedetomidine 0.2 μg/kg/h (maintenance dose). Additional sedatives and analgesics were administered at the physician’s discretion.

Procedure Protocol

In all patients, an arterial line was placed in a radial or brachial artery before the ablation procedure. Ultrasound-guided puncture was used for venous access in all procedures. For the cryosystem, a cryosheath (FlexCath Advance Medtronic Inc., Minneapolis, MN, USA, 15.0 Fr; Polarsheath, Boston Scientific, St. Paul, MN, USA, 15.9Fr) was inserted through the patient’s right femoral vein and a 7Fr short sheath was inserted through the patient’s right jugular vein. For the radiofrequency (RF) or laser system, a steerable sheath (8.5Fr) or a laser sheath (HeartLight X3 System, CardioFocus, Marlborough, MA, USA, 16.0Fr) together with an additional SL-0 sheath (8.5Fr) was inserted through the patient’s right femoral vein and a 7Fr short sheath was inserted through the patient’s right jugular vein. In all patients, no arterial catheters were placed in the femoral artery. The cryosheath and laser sheath were used with the Pre-close technique, and all other sheaths were used with the Post-close technique. One Perclose VCD was used for each sheath. The ablation system and continuation of oral anticoagulation (OAC) on the day were chosen at the physician’s discretion. For a target activated clotting time ≥300 s during the procedure, heparin was administered intravenously. At the end of the procedure, 50 mg protamine was administered intravenously.

Postprocedure Protocol and Outcome

All enrolled patients were scheduled to walk 4 h after the procedure, so the postprocedure protocol was that all patients received 2 h of sinker compression and an additional 2 h of bed rest after removal of the sinker compression. Early hemostasis was assessed at bed rest 4 h after the procedure. Slight oozing at the puncture site that did not require dressing change was defined as early hemostasis. Anything that required dressing change or additional sinker compression was defined as a bleeding event. Obvious hematoma requiring recompression was defined as bleeding. Patients who achieved early hemostasis before 10 pm, were alert with stable vital signs, and willing to walk 4 h after the procedure attempted early ambulation. Walking 10 m without bleeding was considered early ambulation. Stable vital signs consisted of the following: alert (Japan Coma Scale: 1 digit), absence of fever ≥38℃, pulse rate >50 or <120 beats/min, systolic blood pressure >90 or <200 mmHg, and oxygen saturation >90%. Early hemostasis and ambulation were assessed by a nurse or physician at 4 h after the procedure. OAC was resumed in all patients the day after the procedure.

Survey Conducted Among Nurses

The survey conducted among nurses included the following items: nursing stress, maintaining rest after ablation, and patient’s back pain complaint.

Statistical Analysis

Categorical variables are presented as numbers and percentages. Continuous variables are presented as means with standard deviations or medians with interquartile range based on their distributions. Chi-square test was used to compare categorical variables, and one-way analysis of variance or Kruskal-Wallis test was used to compare continuous variables based on their distributions. Statistical significance was defined as a P value <0.05. All statistical analyses were performed using the Statistical Package for the Social Sciences version 23 (IBM Corp., Armonk, NY, USA).

Results

The patients’ characteristics are listed in Table 1. The mean age of the cohort was 69±9.8 years, 261 patients were men and 199 had paroxysmal AF. The mean CHADS₂, CHA₂DS₂-VASc, and HAS-BLED scores were 1.5±1.2, 2.6±1.6, and 1.7±1.0 points, respectively. The continuation rate of OAC was 26%. The study flow chart is shown in Figure A. The characteristics of the early ambulation group were young age, male sex, high body weight, and low thrombotic risk (Table 2). There were no significant differences in the characteristics of patients with early hemostasis. In the case of cryoablation procedures conducted in the morning, the rate of early ambulation reached 79% (48/61 patients) (Figure B). Six of the patients who attempted early ambulation experienced bleeding after the first ambulation. Two patients experienced bleeding and were discharged late. One patient was discharged late due to procedural oozing bleeding. Another patient was diagnosed with retroperitoneal bleeding and received only blood transfusion treatment without surgical intervention. Both of these patients underwent catheter treatment using the same transfemoral approach within 4 months.

Table 1.

Characteristics of the Patients and Procedures

	N=377
Patient’s characteristics
Age, years	69±9.8
Male, n (%)	261 (69)
Body weight, kg	65±13
Body mass index, kg/m2	24±3.9
Atrial fibrillation (AF) type
Paroxysmal, n (%)	199 (53)
Persistent, n (%)	162 (43)
Longstanding persistent, n (%)	16 (4.2)
Risk scores
CHADS2	1.5±1.2
CHA2DS2-VASc	2.6±1.6
HAS-BLED	1.7±1.0
Comorbidities
Hypertension, n (%)	249 (66)
Diabetes, n (%)	63 (17)
Heart failure, n (%)	84 (22)
History of stroke, n (%)	27 (7.2)
Oral anticoagulant (OAC)
Warfarin, n (%)	15 (4.0)
Direct OACs, n (%)	362 (96)
Skipped OAC on the day of the procedure, n (%)	279 (74)
Continuation of OAC on the day of the procedure, n (%)	98 (26)
Laboratory tests at diagnosis
Estimated glomerular filtration rate	65.7±47.0
Hemoglobin, g/dL	13.9±2.2
Transthoracic echocardiography
Left ventricular ejection fraction, %	56±8.5
Left atrial diameter, mm	41±18
Procedure
Procedure time, min	147±80
Morning procedure, n (%)	223 (59)
Radiofrequency (RF) ablation, n (%)	257 (68)
• Morning RF ablation, n (%)	155 (41)
Cryo ablation, n (%)	107 (28)
• Morning cryo ablation, n (%)	61 (16)
Laser ablation, n (%)	13 (3.4)
• Morning laser ablation, n (%)	7 (1.9)
Hospitalization
Length of hospitalization, days	3 [3, 3]
3	285 (76)
2	2 (0.5)
1	0
Length of hospitalization after ablation	2 [2, 2]
2 days after ablation	322 (85)
1 day after ablation	2 (0.5)

Continuous variables are presented as the median and interquartile range or mean±standard deviation.

Figure.

Study flow chart (A) and (B) successful rate of early ambulation and hemostasis at 4 h. AF, atrial fibrillation; VCD, vascular closure device.

Table 2.

Characteristics of the Patients Who Achieved Early Ambulation

	Early ambulation (N=213)	No early ambulation (N=144*)	P value
Age, years	67±9.9	71±9.3	<0.001
Male, n (%)	161 (76)	85 (59)	0.001
Body weight, kg	67±12	62±13	<0.001
Body mass index, kg/m2	24±3.7	23±3.7	0.03
CHADS2 score	1.3±1.0	1.8±1.3	<0.001
CHA2DS2-VASc score	2.2±1.5	3.1±1.7	<0.001
HAS-BLED score	1.6±1.0	1.9±1.0	0.001
Continuation of OAC on the day, n (%)	55 (26)	37 (26)	1.0
Left ventricular ejection fraction, %	57±7.4	55±9.4	0.02
Morning ablation, n (%)	173 (81)	49 (34)	<0.001
Cryo ablation, n (%)	68 (32)	38 (26)	0.29
Morning cryo ablation, n (%)	49 (23)	12 (8.3)	<0.001
Hospitalization for 3 days after ablation, n (%)	168 (79)	105 (73)	0.21
Hospitalization for 2 days after ablation, n (%)	196 (92)	114 (79)	0.001

Data are mean±standard deviation unless otherwise shown. Categorical variables were compared using the chi-squared test. Continuous variables were compared using one-way analysis of variance or Kruskal-Wallis test based on their distributions. Excluding patients who were restricted from ambulation after 10 pm (20 cases). OAC, oral anticoagulant.

In the entire cohort, 2 patients developed acute DVT and were diagnosed with DVT alone without vein stenosis or occlusion by venous echography and contrast-enhanced computed tomography. Both patients improved with intensified OAC without surgical intervention. One patient was diagnosed the day after ablation, and the other patient was diagnosed 6 days after ablation. Both patients were female and had a low body mass index (21.5 and 18.3 kg/m², respectively). There were no other vascular complications such as arteriovenous fistula, pseudoaneurysm, or infection.

Results of the nurse survey are shown in Table 3. Of 62 nurses, 32 (52%) reported a reduction in nursing stress, 27 (44%) reported a reduction in the number of patients unable to rest after ablation, and 38 (61%) reported a reduction in those complaining of back pain.

Table 3.

Change in Nursing Stress, Patient’s Compliance With Postoperative Bed Rest, and Complaints of Back Pain After Introduction of Perclose Device in AF Ablation

	No. of nurses answering (N=62)
Nursing stress
Experience nursing stress over enforcing postoperative bed rest
• Often, n (%)	24 (39)
• Sometimes, n (%)	32 (51)
• None, n (%)	6 (10)
Change in nursing stress after introduction of Perclose VCD
• Slightly increased, n (%)	1 (1.6)
• No change, n (%)	29 (47)
• Slightly decreased, n (%)	29 (47)
• Significantly decreased, n (%)	3 (4.8)
Patient’s bed rest after ablation
Experience of patients being unable to maintain bed rest after ablation
• Yes, n (%)	39 (63)
• None, n (%)	23 (37)
Change in patients being unable to maintain bed rest after introduction of Perclose VCD
• Slightly increased, n (%)	2 (3.2)
• No change, n (%)	33 (53)
• Slightly decreased, n (%)	24 (39)
• Significantly decreased, n (%)	3 (4.8)
Patient’s back pain complaint
Change in patient’s back pain complaints
• No change, n (%)	24 (39)
• Slightly decreased, n (%)	33 (53)
• Significantly decreased, n (%)	5 (8.1)

AF, atrial fibrillation; VCD, vascular closure device.

Discussion

The results of the current study shed some useful light on the outcomes and complications of using a Perclose VCD in AF ablation in Japanese patients. There are 2 key findings. First, 68% (377/554 patients) achieved success with the Perclose VCD. Of these patients, 94% (353/377 patients) achieved early hemostasis and 57% (213/377 patients) achieved early ambulation. Of the 353 patients who achieved early hemostasis, 26% (92/353 patients) refused to walk and 6.2% (22/353 patients) did not walk at either the nurse’s or physician’s suggestion. Of the 219 patients who attempted to walk, 97.3% (213/219 patients) achieved early ambulation and 2.7% (6/219 patients) failed due to bleeding after walking. Second, in terms of Perclose VCD-related complications, 0.5% (2/377 patients) developed acute DVT, which resolved without surgical intervention.

Early Ambulation and Hemostasis

A recent study indicated that 96% (48/50 patients) did not require additional manual compression within 5 h after AF ablation using a Perclose VCD.³ In the current study, after AF ablation using a Perclose VCD, 94% (353/377 patients) successfully achieved hemostasis at 4 h postprocedure. Considering the inclusion of an older Japanese population with low body mass index (BMI) in the current study, the results are deemed comparable. A recent randomized trial demonstrated the safety of same-day discharge after cryoballoon AF ablation.⁶ Western eligibility criteria for same-day discharge include, but are not limited to, uncomplicated catheter ablation, at least 3–6 h of postprocedural monitoring, complete hemostasis, well-tolerated ambulation, normal vital signs at discharge, and absence of symptoms or comorbidities. In our study we found that young male patients with a high body weight, and a lower thrombotic and/or bleeding risk score had high rates of early ambulation, which may make this group appropriate for early discharge. Given the lower complication rate of AF ablation in patients without heart disease in Japan,⁷ it is critical to identify suitable patients for early ambulation to achieve same-day discharge.

Perclose VCD-Related Complications

A previous study has reported that femoral vein occlusion or stenosis without DVT occurred as a complication of using the Perclose VCD and was treated surgically.⁸ Another reported that femoral vein stenosis with DVT occurred as a complication of the Perclose VCD and was treated surgically, and that recurrent thrombus formation in the femoral vein was observed even with OAC therapy continuation after surgical suture removal.⁹ In the current study, acute DVT occurred in 0.5% (2/377 patients). Consistent with previous reports, patients who developed a Perclose VCD-related complication were female and had a lower BMI.^8–10 The two patients with acute DVT in this study did not develop femoral vein occlusion or stenosis and both cases resolved with initial intensive high-dose direct OAC (rivaroxaban or apixaban) without requiring surgical intervention. Their DVT symptoms improved on days 55 and 120 after ablation, respectively, and were only right lower extremity edema and/or pain without purplish-red color change. DVT resulting from the Perclose VCD may have delayed resolution of symptoms due to endovascular inflammation caused by endothelial damage or foreign body reaction to the Perclose VCD suture, which requires close monitoring. In addition, DVT with femoral vein occlusion or stenosis due to a Perclose VCD is more severe, and femoral vein occlusion or stenosis is characterized by a purplish-red color change.⁹ On the other hand, there have been no reports of acute DVT associated with Vascade VCD.¹¹

The Perclose VCD is a direct vascular suture system, whereas the Vascade VCD is a collagen patch, which may explain the difference in the incidence of acute DVT.

Study Limitations

There are 2 major limitations in this study. First, this study only included patients who achieved immediate hemostasis with the Perclose VCD and were scheduled to walk within 4 h after the procedure, and excluded patients who did not achieve Perclose VCD success. Therefore, it is important to note that the results of this study do not indicate early hemostasis and early ambulation in all types of patients, but are limited to selected patients who achieved Perclose VCD success. Second, many of the patients who did not achieve early ambulation were those who refused to walk. Although this study analyzed a population of patients capable of early ambulation and potentially suitable for same-day discharge, the group of patients who did not achieve early ambulation may have included many frail patients.

Conclusions

Early hemostasis with a Perclose VCD can reduce the burden on healthcare professionals, including nurses, which is critical in this era of work style reform, contributing to early ambulation and discharge in appropriate patients.

Acknowledgment

The authors thank Miho Kobayashi for her assistance with manuscript preparation.

Conflicts of Interest

All authors have no conflicts of interest to disclose.

Sources of Funding

N/A.

Patient Consent Statement

Written informed consent from each patient was waived as this study used clinical information obtained during routine clinical practice, and none of the patients declined participation during follow-up contacts. This approach aligns with the guidelines for epidemiological studies issued by the Ministry of Health, Labour, and Welfare in Japan.

Permission to Reproduce Material From Other Sources

N/A.

Clinical Trial Registration

N/A.

IRB Information

This study was approved by the Ethics Committee of Kurashiki Central Hospital (approval no. 4296).

Data Availability Statement

The identified participant data that underpin the results reported in this article will be made available upon request immediately following publication and for a period of 12 months thereafter. Kindly contact the corresponding author directly to request data sharing. The data will be only available to verify our research findings. The data requestors will have to sign a data access agreement. The data will be shared as Excel files via email.

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