A randomized comparison of modified subcutaneous “Z”‐stitch versus manual compression to achieve hemostasis after large caliber femoral venous sheath removal
Abstract:Objectives: To compare subcutaneous "Z"-stitch versus manual compression in attaining hemostasis after large bore femoral venous access, and to assess its impact on venous patency. Background: Structural interventions increasingly require large caliber venous access, for which convenient, safe, and effective method of postprocedural hemostasis is needed. "Z"-stitch has been introduced for this purpose in some centers but systematic data on its performance is limited. Methods: This single center study randomize… Show more
“…To date, these closure devices have not been certified for venous access, although they are used off‐label in this indication . As a less costly alternative, temporary figure‐of‐eight suture (Z‐suture), achieving hemostasis by compression of the femoral vein through wrapped and folded subcutaneous soft tissue, has been introduced for closure of larger venous sheaths …”
Both Z-suture and closure device use after percutaneous mitral valve repair are feasible and safe. However, there is no benefit of one strategy over the other according to VARC2 major and minor complications.
“…To date, these closure devices have not been certified for venous access, although they are used off‐label in this indication . As a less costly alternative, temporary figure‐of‐eight suture (Z‐suture), achieving hemostasis by compression of the femoral vein through wrapped and folded subcutaneous soft tissue, has been introduced for closure of larger venous sheaths …”
Both Z-suture and closure device use after percutaneous mitral valve repair are feasible and safe. However, there is no benefit of one strategy over the other according to VARC2 major and minor complications.
“…Finally, despite the large diameter, we did not experience any acute femoral venous complications. In all cases venous hemostasis was achieved with a suture, either preplaced or deployed just prior to removal of the sheath which has been shown to result in faster hemostasis and less access site complications . The use of large bore femoral sheaths has been previously reported and the necessity of this approach is likely to increase with the development of transcatheter mitral valve systems .…”
Background
The Edwards SAPIEN valve and its delivery system may complicate transit through the right heart during transcatheter pulmonary valve replacement (tPVR). We report our early experience using a large diameter, 65 cm delivery sheath to facilitate delivery of the SAPIEN valve to the right ventricular outflow tract (RVOT).
Methods
Retrospective analysis of all patients from three large congenital heart centers undergoing tPVR with the Edwards SAPIEN valve delivered with the 65 cm Gore Dryseal Sheath.
Results
Over a 12 month period, 30 patients (17 female) with median age 17.5 years (range 8–72) underwent attempted tPVR with the SAPIEN valve delivered using the 65 cm Dryseal sheath (20–26Fr). All procedures resulted in successful valve delivery to the target area. Twenty patients had a native RVOT. The most commonly used valve diameter was 29 mm (n = 15) with the majority of cases requiring a 26Fr Dryseal sheath (n = 20). One patient with severe RVOT stenosis underwent prestenting. Median procedure time was 100 min (59–225). No patient had increase in tricuspid valve regurgitation as a consequence of valve delivery. One patient required a synchronous cardioversion for intraprocedural VT and another required ECMO postprocedure due to severe pre‐existing left ventricular dysfunction. On median follow‐up of 5 months, all patients had mild or less pulmonary regurgitation. Median peak Doppler velocity across the pulmonary valve was 2.2 m/s (1.7–4). There were no clinically relevant complications relating to vascular access.
Conclusions
Using 65 cm Dryseal sheaths facilitates delivery of SAPIEN valves in patients with dysfunctional RVOTs.
“…Standard figure‐of‐eight suture is a well‐tolerated, safe, and resource efficient alternative to manual compression for hemostasis of femoral venous access sites with the added benefit of reduced procedure time, decreased time to hemostasis, reduced bleeding rate, and allowed for earlier patient ambulation . However, standard figure‐of‐eight suture technique has some limitations: First, insufficient tension with the suture knot can result in failure of hemostasis.…”
Section: Discussionmentioning
confidence: 99%
“…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 . 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 .…”
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.
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