The Z Stitch Early Bed Rest Assessment Study

The ZEBRA study, or the Z stitch Early Bed Rest Assessment study, aims to assess the impact of early mobilization following Z stitch placement on patient satisfaction and safety in the context of venous vascular access management during Electrophysiology (EP) procedures. The study hypothesizes that allowing patients to move sooner after Z stitch placement will lead to higher patient satisfaction scores without compromising safety. The primary endpoint for evaluation is patient satisfaction, gauged through survey-based scores, while secondary endpoints encompass a range of factors including hematoma development, bleeding-related complications, the use of pain medications, associated healthcare costs, 30-day patient outcomes, actual post-procedure ambulation time, and instances of hospital readmissions or emergency department visits within the initial 30 days post-procedure.

Historically, venous vascular access has been managed by employing direct manual pressure for hemostasis following sheath removal, which necessitates a prolonged period of bed rest for the patient. However, a recent advancement, termed the "Z stitch" method, achieves hemostasis by placing a Z-shaped stitch around the vascular access site, providing continuous pressure and allowing for safer sheath removal without the need for anticoagulation reversal. Despite the effectiveness of the Z stitch, current practice still involves extended bed rest post-procedure. This randomized clinical trial aims to fill the existing knowledge gaps by approaching eligible patients ahead of their procedures or during the consent process. Patients will be randomized 1:1 to two distinct protocols: one involving one hour of bed rest post-procedure, followed by ambulation at 60 minutes and Z stitch removal at 4 hours; and the other entailing 4 hours of bed rest, with Z stitch removal and ambulation at the same 4-hour mark. Compression time at the Z stitch placement will also be stratified based on the sheath size and whether systemic anticoagulation is used. Assessments for groin hematoma and patient satisfaction surveys will be completed prior to discharge, with a 30-day phone follow-up to evaluate longer-term outcomes.