Usefulness of ‘figure-of-eight’ suture to achieve haemostasis after removal of 15-French calibre femoral venous sheath in patients undergoing cryoablation Free

Abstract

Introduction

Catheter ablation of atrial fibrillation (AF) has become a mainstay of therapy in patients with antiarrhythmic drug-refractory symptomatic AF.¹ Among various techniques, cryoenergy is an established therapeutic option to achieve pulmonary vein isolation (PVI) due to its evidenced efficacy and safety profile.^1–3 The rate of any complications for these procedures varies widely, with most studies suggesting complication rates around ∼5–6%.^1,4 Vascular access site complications are the most common complications of AF ablation (up to 13%) and include groin haematoma, retroperitoneal bleeding, femoral pseudoaneurysm, or femoral arteriovenous fistula, which might be associated with increased morbidity, prolonged hospital stay, and surgical repair as well.¹ It has been known that cryoablation procedure requires large-calibre [outer diameter of 15 French (Fr)] delivery sheath and full anticoagulation during the procedure, which may also increase the risk of vascular complications.²

In this regard, various techniques (pressure dressing, closure devices, etc.) have been implemented into clinical practice over years to achieve a safe and complete vascular haemostasis. But all those techniques have a prominent cost and carry a risk of device failure and vascular complications.^5–7 In recent years, a temporary figure-of-eight (FoE) subcutaneous suture (Z-stitch) for femoral venous haemostasis after removal of large-calibre venous sheaths has been introduced in children and adults after interventional cardiac procedures.^8–11 However, there were no data regarding feasibility, efficacy, and safety of FoE suture after cryoballoon-based AF ablation.

Thus, we aimed to assess immediate and short-term (3 months) efficacy and safety profile of FoE suture when compared with conventional manual compression in patients undergoing cryoballoon-based AF ablation.

Methods

Study population

In this prospective and observational study, we enrolled a total of 200 patients who underwent initial PVI with second-generation cryoballoon technique for documented AF between December 2012 and May 2015. Based on sequential allocation approach, study population assigned to one of the postablation sheath removal techniques as (a) FoE group (n = 100) and (b) conventional manual compression group (n = 100) upon admission to electrophysiology laboratory. Thus, primary operator was aware of the choice for haemostasis at the beginning of the procedure and initial puncture. All the patients had symptomatic paroxysmal or persistent AF and had failed with ≥1 antiarrhythmic drug(s) previously. Patients who had episodes of AF lasting longer than 7 days were defined as persistent, and those whose episodes self-terminated within 7 days were defined as paroxysmal AF.¹²

Patients who had moderate–severe valvular disease, thrombus in left atrium (LA), uncontrolled thyroid dysfunction, preprocedural significant coronary artery stenosis, myocardial infarction or cardiac surgery in the previous 3 months, contraindication of anticoagulation, pregnancy, and an LA diameter of >55 mm were excluded from the study.

Detailed medical history regarding AF and related cardiovascular and/or systemic conditions was taken from all the patients. Symptomatic severity of the patient was recorded according to European Heart Rhythm Association (EHRA) score. The CHA₂DS₂-VASc and HAS-BLED scores were calculated for each patient based on a point system.¹²

Informed consent was obtained from each patient before enrolment. The study was in compliance with the principles outlined in the Declaration of Helsinki and approved by Institutional Ethics Committee.

Electrophysiological study and ablation procedure

All procedures were performed under conscious sedation using boluses of midazolam and fentanyl. Invasive arterial blood pressure, oxygen saturation, and electrocardiogram were continuously monitored throughout the entire procedure. Right femoral vein and left femoral vein/artery punctures were performed with the Seldinger technique. A 6 Fr steerable decapolar catheter (Dynamic Deca, Bard Electrophysiology, Lowell, MA, USA) was placed into the coronary sinus. By using right femoral venous access site, single transseptal puncture with using modified Brockenbrough technique (BRK-1, St. Jude Medical, Minnetonka, MN, USA) was performed under fluoroscopy and 8 Fr transseptal sheath (Biosense Webster, CA, USA) placed into the LA. Once LA access is obtained, unfractionated heparin boluses were repeatedly administered to maintain the activated clotting time (ACT) between 300 and 350 s. The sheath was then exchanged with the steerable transseptal sheath (FlexCath®, Medtronic CryoCath, Minneapolis, USA) over a guidewire (0.032 inch, 180 cm Super Stiff, St. Jude Medical, St. Paul, MN, USA). The FlexCath® has an inner diameter of 12 Fr and an outer diameter of 15 Fr. Baseline potentials of all pulmonary veins (PVs) were recorded by using Achieve^TM mapping and guiding catheter (Medtronic, Minneapolis, MN, USA), which has been positioned at the PV ostium. We paced the distal coronary sinus to confirm the presence of left PV potentials. In all patients, the second-generation 28 mm cryoballoon catheter (Arctic Front Advance^TM, Medtronic CryoCath LP, Kirkland, Canada) was used for PVI. The cryoballoon was manoeuvred to all PV ostia by use of a steerable 15 Fr sheath and an Achieve^TM catheter inserted through the lumen of the balloon catheter. The balloon is inflated in the LA and then directed towards the PV ostia. The assessment of balloon occlusion is performed through the injection of 50% diluted contrast through the cryoballoon catheter's central lumen. The duration of each freezing cycle was 240 s. A minimum of two consecutive freezing cycles for each targeted PV were delivered with excellent or good occlusion. The procedure systematically began with the left superior, then the left inferior, followed by the right superior, and ended with the right inferior PVs. The right phrenic nerve was constantly paced from the superior vena cava during freezing at the right-sided PVs. Also, direct palpation of the right hemi-diaphragmatic excursion was performed during phrenic nerve stimulation. At the end of the procedure, PV conduction was re-evaluated by the Achieve^TM mapping catheter. Successful PV isolation was defined as the elimination (or dissociation) of all the PV potentials recorded from an Achieve^TM catheter.

Postprocedural sheath removal

In FoE group, right femoral venous 15 Fr sheath was removed just after the ablation procedure while the patient was on the electrophysiology lab table and without ACT assessment. On the other hand, in conventional manual compression group, right femoral venous 15 Fr sheath was removed in the holding area, without assessing ACT. Furthermore, left femoral access site venous and arterial haemostasis was achieved by means of manual compression in the intensive care unit ∼90 min after the last heparin dose, without assessing ACT. Once the haemostasis was achieved, a period of 6 h of bed rest and 12 h of groin compression bandage was indicated. As per routine for a novel right femoral venous haemostasis technique introduced into the clinic, a vascular Doppler ultrasound was obtained within 24 h of the use of the FoE suture and manual compression for the first 40 patients (20 patients in FoE group and 20 patients in manual compression group).

The figure-of-eight suture technique

The technique was illustrated and represented in Figures 1 and 2 and Supplementary material online, Video S1 in detail. A 0-silk suture on a large-curved needle was passed at ∼5–10 mm caudal to the 15 Fr sheath insertion site and advanced through the subcutaneous tissue, without going so deep as to ligate the femoral vein. The needle and suture were crossed over the sheath. A second pass of the needle was obtained at ∼5–10 mm cranial to the 15 Fr sheath insertion site and advanced above the sheath and through the subcutaneous tissue. So, FoE stitch was formed. After initial knot, the sheath was pulled out gently. Then second knot has been formed over the previous one, and suture was tightened so that the subcutaneous tissue was folded up for haemostasis. The site was assessed after tying the suture, and if there was no bleeding, no pressure was applied and covered by a sterile gauze. If there was slight bleeding then light pressure was applied for <1 min. The wound was closely monitored in the intensive care unit. Compression bandages were not used in the suture group. The sutures were removed on the following morning.

Figure 1

The principles of the subcutaneous FoE suture are illustrated. Initial step involves passing the needle on the caudal side of the femoral puncture site deeply through the subcutaneous tissue and under the femoral sheath. Then, the suture crossed over the skin, and the needle and suture are passed again on the same side of the sheath. During this step, the needle passes through the subcutaneous tissue, but over the sheath. At last, two edges of the suture are caught, and the knots are set to perform a fold over puncture site and achieve a successful haemostasis.

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Figure 2

Schematization of the ‘FoE’ suture technique to achieve right femoral venous haemostasis upon 15 Fr sheath removal. (a) The appearance of FlexCath® (outer diameter of 15 Fr) at the right femoral vein after cryoballoon-based AF ablation. (b) The first stitch is performed at ∼5 mm caudal to the puncture site of the femoral vein. (c) The second stitch is located 5 mm cranial to the femoral vein puncture site and also being careful to pass the needle in the same direction as the first pass. (d) The needle has been removed, and the two free ends of the suture crossed to form the FoE. (e and f) The suture is tied, and the first knot is set anteriorly. (g and h) Again the suture is tied, and the second knot is set posteriorly. The opposite passages of the initial and second knots provide to slide over each other and tightly cover the puncture site. The sheath has been completely pulled out and the silk suture tightened to create folding of the skin over insertion site. Additional knots are added to lock the closure. (i) Showing the occlusion of skin edges, which contributes to the venous haemostasis.

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Postprocedural follow-up

A transthoracic echocardiography was performed immediately and 24 h after the procedure to exclude the presence of pericardial effusion. All patients were followed up for at least 24 h in the telemetry unit. Bilateral groins, lower extremities, and peripheral pulses were evaluated and examined for access site complications before discharge. When pseudoaneurysm or arteriovenous fistula was suspected at examination, the patient underwent further evaluation with vascular Doppler ultrasound. Patients were then discharged provided that their clinical status was stable. Oral anticoagulation was initiated in the evening of ablation unless pericardial effusion was detected and continued for at least 3 months after the procedure. Patients who experienced minor vascular complications were closely followed up by means of clinical visits at 1 and 4 weeks after discharge.

Statistical analysis

Continuous variables are presented as mean ± SD or median (range), whereas categorical ones are presented as n (%). The Kolmogorov–Smirnov criterion was used for the assessment of normality. Comparisons of continuous data between two groups (FoE and manual compression groups) were made by unpaired t-test, whereas categorical data were compared in both groups using the χ² test. A P-value of <0.05 was considered statistically significant. All analyses were performed, using the SPSS software, version 20.0 (SPSS, Inc., Chicago, IL, USA).

Results

A total of 200 patients (48% female, mean age 55 ± 12.4 years, and 77% paroxysmal AF) were enrolled. Baseline clinical (including thromboembolic and bleeding risk scores), echocardiographic, and laboratory data of the study groups were similar (P > 0.05). Acute procedural success was achieved in all patients. Procedural time and heparin doses during procedure were also similar in between FoE and manual compression groups (P > 0.05). In the FoE suture group, right femoral venous haemostasis was achieved immediately after tying the knot (n = 95) or within ≤1 min of light pressure (n = 4). Only one patient had failure of the stitch as the silk suture snapped during knotting, and haemostasis was achieved by manual compression as per the conventional protocol. The median time to haemostasis (0 vs. 14 min, P < 0.001) and time spend in the holding area (4 vs. 20 min, P < 0.001) were significantly shorter in the FoE suture group compared with manual compression group. Additionally, occupancy of qualified staff out of procedure was significantly reduced in the FoE suture group (0 vs. 16 min, P < 0.001). On immediate follow-up, there was no evidence of minor or major vascular access site complications like haematoma, re-bleeding, pseudoaneurysm, fistula formation, or thrombosis at right femoral access site in the FoE suture group. However, in the conventional manual compression group, a total of 4 patients (4%) developed haematoma/pseudoaneurysm at right femoral access site within 24 h of sheath removal, which were confirmed by vascular ultrasound. Because left-sided arterial sheaths were removed at the same time for both groups, time to mobilization and duration of hospital stay did not differ among study groups (P > 0.05). In both groups, no unexpected adverse events or right femoral access site complications were reported over a median follow-up of 3 months.

Discussion

In our preliminary study, a temporary subcutaneous FoE silk suture was found as a likely safe and efficacious technique of right femoral venous haemostasis after immediate removal of 15 Fr outer calibre sheath in patients undergoing cryoballoon-based AF ablation. There were no adverse events noted, with clinical examination and vascular Doppler ultrasound suggesting a comparative clinical benefit over conventional haemostasis via manual compression.

Vascular access site complications are reported as the most common complications of AF ablation with the published incidence of between 0 and 13%, which include groin haematoma, retroperitoneal bleeding, femoral arterial pseudoaneurysm, or femoral arteriovenous fistula.^1,4,13 The use of large-calibre sheaths, multiple vascular sites of entry, and full-dose periprocedural anticoagulation may further increase the risk of access site complications during AF ablation. In particular, cryoablation procedure requires a delivery sheath with the outer diameter of 15 Fr, which brings an additional risk for access site complications. Access site complications are also associated with increased pain, patient discomfort, immobilization, anaemia, prolonged length of hospital stay, increased cost, and even death. Thus, effective vascular haemostasis by using appropriate technique at the right time is crucial. Although the efficacy and safety of the heparin reversal just after cryoablation have been reported as an alternative method to reduce access site complications,¹⁴ to date, there was no study in the literature comparing different vascular access site haemostasis techniques among patients undergoing cryoballoon-based AF ablation.

Standard manual compression has already been used as an effective technique for access site haemostasis after AF ablation in most centres. However, this method is also associated with risks of re-bleeding,¹⁵ thrombosis, and embolism.¹⁶ Furthermore, prolonged manual compression, required to achieve haemostasis after removal of large-calibre venous sheaths, may increase the risk for occurrence of deep venous thrombosis.¹⁷ Besides technical risks, manual compression is time consuming and exhausting for the qualified medical staff and electrophysiology fellows, which requires longer time period in the cath lab holding area and increased bed rest for patients. In an effort to reduce patient discomfort and other complications, alternative techniques can be employed to achieve haemostasis. It has been shown that mechanized suture delivery devices used for femoral artery are also effective to achieve haemostasis in the femoral vein.^18,19 However, these devices are costly, which require a learning curve and have specific sets of complications.^19,20 Therefore, cost-effective, time-saving, and safe techniques are needed to achieve venous haemostasis when compared with standard manual compression during AF ablation.

Firstly, Bagai et al.²¹ reported that the FoE suture technique might be effective to achieve immediate femoral venous haemostasis after removal of large-calibre sheaths ranging from 8 to 21 Fr in fully anticoagulated patients while the patient was still on the cath lab table. The mechanism of the temporary subcutaneous FoE suture (‘fellows stitch’) includes the compression of the femoral vein at the puncture site by wrapped and folded up subcutaneous soft tissue around it.^8,9 Cilingiroglu et al.⁸ confirmed the compressive effect of subcutaneous soft tissue by using venography from the contralateral site and also reported that there was no thrombus, embolism, or venous stenosis on vascular ultrasound after suture removal. Zhou et al.¹⁰ showed that the FoE suture technique was efficacious and safe to achieve immediate haemostasis after the removal of 7–14 Fr femoral vein sheaths in children. Although there were several studies using FoE suture technique in children,^9,10 there was no study evaluating the efficacy and safety of this technique among adults.

To the best of our knowledge, our study is the first evaluating the efficacy and safety of the FoE suture technique to achieve immediate haemostasis after removal of 15 Fr right femoral venous sheaths after cryoablation procedure without waiting to reverse anticoagulation. The suture technique was interestingly easily performed by all the staffs at our electrophysiology lab within ∼30–60 s without any requirement for a learning curve. In the FoE suture group, 99% of the patients achieved satisfactory and immediate right femoral access site haemostasis. Only one patient (1%) developed an immediate groin bleeding due to breakage of silk stitch, and conventional manual compression was applied. The FoE suture significantly reduced the median time to haemostasis, time spend in the holding area, and occupancy of qualified staff/fellows out of procedure compared with manual compression group. Also, there was no right venous access site complication like haematoma, arteriovenous fistula, or pseudoaneurysm in the FoE suture group. Furthermore, vascular ultrasound within 24 h revealed no thrombus, embolism, or venous stenosis among randomly selected 20 patients in the FoE group. It was reported that the size of sheath was known to be significantly associated with access site complications.¹ Thus, the absence of access site complications in our FoE suture group might be due to early removal of 15 Fr sheath without heparin reversal and immediate haemostasis by using the FoE suture. Because of the contralateral arterial sheath was removed at the same time interval in both groups, time to mobilization and duration of hospital stay did not differ among study groups. As a suggestion, combination of the FoE suture (for venous sheaths) and mechanized suture delivery devices (for arterial sheaths) may offer the advantage of removing both arterial and venous sheaths at the same time just after cryoablation in the future. Although our results are preliminary, the FoE suture can be effectively and safely performed for right femoral venous access sites just after cryoablation procedure to achieve immediate haemostasis without heparin reversal. Additionally, the electrophysiologists and/or interventionalists performing FoE suture should be careful while passing the needle throughout the deep subcutaneous tissue to avoid locking femoral vein in stitch, which may cause venous thrombosis. The needle also should not pass too shallow in subcutaneous tissue, which may result in inadequate haemostasis and groin haematoma or re-bleeding.

Limitations

Our study should be evaluated with some limitations. First, it is not designed as randomized controlled trial. Our sequential allocation approach upon admission to laboratory lacks (a) a random numbers table or computer program to generate the random allocation sequence and (b) allocation concealment, which might result in a biased estimate of the treatment effect. Second, this study is a single-centre experience; thus, further large-scale validation studies are needed in patients undergoing electrophysiological studies and ablation therapies to confirm the efficacy and safety of FoE suture to achieve haemostasis. One additional limitation of our study is that only a subgroup of patients in each group underwent more detailed evaluation of the access site using vascular Doppler ultrasound. In order to achieve a more decisive result in regard to safety, vascular Doppler ultrasound should be done in all participants during follow-up period.

Conclusion

Among patients undergoing cryoballoon-based AF ablation, in order to reduce access site complications, time to haemostasis, time spend in holding area, improve staff efficiency, and improve patient comfort, various techniques have been implemented to achieve immediate haemostasis. The ‘FoE’ suture, as a simple, inexpensive, available, efficacious, and likely safe technique, might be an alternative approach to achieve immediate haemostasis without heparin reversal after removal of 15 Fr right femoral venous sheaths in patients undergoing cryoablation. However, a controlled and probably randomized study would be required in order to confirm our preliminary findings.

Supplementary material

Supplementary material is available at Europace online.

Conflict of interest: none declared.

References