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Torque device suture technique to achieve hemostasis in large‐bore venous access

Abstract Objectives To describe and compare a novel technique using a torque device to manage figure‐of‐eight suture tension for venous access hemostasis in patients who have undergone atrial septal defect (ASD) or patent foramen ovale (PFO) closure. Background Large bore venous access has become increasingly important in transcatheter procedures, but management of hemostasis can be time‐consuming and/or resource intensive. As such, various techniques have sought to provide cost effective and safe alternatives to manual compression. We describe a modification of the figure‐of‐eight suture technique wherein we apply a torque device to manage variable suture tension instead of tying a knot and compare it to the standard figure‐of‐eight suture technique. Methods We performed a retrospective study of 40 consecutive patients who underwent ASD or PFO closure, 20 of whom underwent standard figure‐of‐eight technique and 20 of whom underwent figure‐of‐eight with torque device modification. Bleeding Academic Research Consortium definitions were used to categorize bleeding events. Results The groups were similar in age, gender, weight, aspirin use, platelet count, procedure time, hemoglobin, and international normalized ratio. Standard figure‐of‐eight suture had seven patients with bleeding, with six classified as BARC II and one as BARC I. Figure‐of‐eight plus torque device had three patients with bleeding, with two classified BARC II and one as BARC I. There were no incidences of hematoma in either group. Conclusion The torque device suture technique is a unique modification of the figure‐of‐eight suture technique to achieve venous hemostasis. In addition, the modification allows secure and variable suture tension as well as easy removal by nursing staff.


| INTRODUCTION
The proliferation of endovascular procedures from structural heart interventions to electrophysiology ablations, pulmonary thrombectomy, and atrial septal defect (ASD) and patent foramen ovale (PFO) closures has led to increasing use of large-bore venous access that can increase the risk of bleeding, access site complications, and increased length of hospitalization. Typically, manual compression has been used after sheath removal to achieve post-procedure venous hemostasis; however, full anticoagulation may prohibit immediate sheath removal or require reversal of anticoagulation. Recently, the figure-of-eight suture technique has become a more widely used alternative as it has been shown to be as safe and effective as manual compression. 1,2 An innovative twist on this technique is the use of a stopcock device to apply tension on venous access site suture in lieu of the figure-of-eight suture knot for hemostasis after radiofrequency catheter ablation of atrial fibrillation. 3 Here, we describe the use of a 0.035" in torque device (Boston Scientific, Marlborough, MA and Terumo Interventional Systems, Somerset, NJ) as an alternative to the stopcock device or suture knot to apply tension on figure-of-eight sutures. This technique provides operators with the ability to increase or decrease tension on the suture, as needed, to achieve and maintain secure hemostasis. In this preliminary evaluation, figure-of-eight plus torque device closure technique appears to be similar or better in efficacy when compared to standard figure-of-eight suture technique.  4 Patients who had been on therapeutic anticoagulation (whether warfarin or Xa inhibitors) had their anticoagulation held prior to procedure. Those on aspirin, clopidogrel, or both were continued on their therapy prior to intervention.

| Venous hemostasis technique
Venous access was obtained using ultrasound guidance with micropuncture system and an 8 Fr sheath was placed in the femoral vein.
Procedural anticoagulation was achieved with intravenous heparin with a target ACT of 250-300 s. After percutaneous ASD or PFO closure was completed, closure with either standard figure-of-eight suture technique or figure-of-eight and torque device technique was performed. All patients were then loaded with 325 mg aspirin and 300 mg of clopidogrel.
In the standard figure-of-eight technique group, 0 silk or 0 Ethibond (Ethicon, Bridgewater, NJ) sutures were placed in the skin and the needle was passed once on the caudal side of the sheath insertion site and once on the cranial side of the insertion site, with diligence to avoid the femoral vasculature. After removing the needle, the sheath was pulled out while the suture was simultaneously tightened to achieve hemostasis and knotted. A sterile dressing was then placed on the site.
In the torque device group, instead of tying a knot, the free ends of the figure-of-eight suture were threaded into the 0.035" in torque device. The torque device was then advanced over the suture, achieving firm tension at the skin and soft tissue and the sheath was removed ( Figure 1 and Video S1). The torque device was then locked into position to maintain tension needed to achieve hemostasis. The suture was then trimmed and a sterile dressing placed on the site.   (Table 1).
There was one major complication whereby a patient in the stan-  Second, suture tension can only be released by cutting the suture, such that if rebleeding occurs, manual hemostasis is required. In contrast, Payne et al. provided an innovative improvement with the application of a stopcock device that allowed for variable suture tension without the need to cut or tie a knot and allowed for easy suture removal. 3 Our technique replaces the stopcock with a torque device that improves the level of tension achieved. In addition, the screw of the torque device ensures more secure tension and reduces the likelihood of inadvertent suture tension release.
Similar to the stopcock device, suture removal with figure-ofeight plus torque device may be easier than standard figure-of-eight and requires no additional equipment. In addition, the torque device can be tentatively loosened to partially release tension and allow for inspection of the access site, but also allows reapplication/tightening in the event of rebleeding. The suture can then be removed without a suture removal kit.
To the best of our knowledge, this is the first description of using a figure-of-eight plus torque device to achieve venous hemostasis after percutaneous ASD or PFO closure. It appears to be a safe and effective method of providing hemostasis after closure and had lower    Our study does have limitations. It is a pilot retrospective study, which could potentially lead to selection bias and is a single center study with a small number of patients that can reduce our power to detect bleeding outcomes between the two groups.

| CONCLUSION
In this proof of concept pilot study, our novel figure-of-eight plus torque device closure technique was effective at managing venous access hemostasis after percutaneous ASD or PFO closure. The pilot nature of this initial evaluation precluded a power calculation, and as such we are unable to conclude a significant reduction in bleeding or noninferiority when compared to conventional techniques. However, limited analyses demonstrated no significant difference between patient populations.

CONFLICT OF INTEREST
Ponraj Chinnadurai is a full-time senior staff scientist at Siemens Healthcare, USA. C. Huie Lin is a data monitoring committee member of ACI clinical, speaker for Abiomed, course director for Gore Medical, and proctor for Abbott Structural Heart.