ZEBRA study: The Z stitch Early Bed Rest Assessment study

Abstract

Background: Safe and effective management of venous vascular access is a key component of electrophysiology (EP) procedures. Recently, the Z-stitch method has been developed for effective venous hemostasis. However, the standard postprocedure protocol often includes prolonged bed rest, which may affect patient satisfaction. The ZEBRA (Z stitch Early Bed Rest Assessment) study aims to systematically investigate and quantify patient satisfaction metrics and safety parameters associated with the early mobilization after Z-stitch placement.

Objective: This study primarily investigates whether early mobilization following Z-stitch placement in venous vascular access management during EP procedures enhances patient satisfaction without compromising safety.

Methods: In this prospective, multicenter, randomized clinical trial, approximately 200 patients undergoing various EP procedures at Oregon Health and Science University and Veterans Affairs Portland Health Care System will be randomly assigned to either a 1- or 4-hour bed rest regimen post-Z stitch. Patient satisfaction will be assessed through survey, alongside monitoring for hematomas, bleeding complications, and other safety endpoints. The study includes stratification based on heparin administration and sheath size to ensure robust and nuanced data analysis.

Results: We anticipate that early mobilization will lead to higher patient satisfaction scores. We also expect to closely monitor and report the incidence of hematomas, pain medication use, healthcare costs, patient outcomes at 30 days, time to ambulation, and hospital readmissions or emergency visits related to groin complications.

Conclusion: The ZEBRA study is poised to fill a critical knowledge gap in postprocedure care in EP labs. By rigorously evaluating the impact of early mobilization on patient satisfaction and safety, this study could significantly influence future guidelines and improve patient experiences in EP procedures.

Keywords: Electrophysiology procedures; Postprocedure management; Randomized clinical trial; Venous vascular hemostasis; Z stitch.

Figure 1

Z-stitch closure technique for femoral venous sheath removal. The sequential steps of a Z-stitch closure for femoral venous sheath removal. A: Initial view with indwelling venous sheaths in the right femoral vein. B, C: Placement of the first suture bite in a mediolateral direction beneath the venous sheaths, ensuring that it remains superficial to the femoral vessels. D, E: Positioning of the second suture bite cranial to the first, maintaining a superficial trajectory above the sheaths. F–H: Approximation of the suture, application of a protective gauze pad, and attachment of a stopcock. I: Removal of the venous sheaths with sustained downward pressure applied to the stopcock. J: Final appearance of the completed Z-stitch closure.

Figure 2

ZEBRA (Z stitch Early Bed Rest Assessment) design overview with key steps. BMI = body mass index; CIED = cardiovascular implantable electronic device; EP = electrophysiology.