Clinical evaluation of SyvekPatch in patients undergoing interventional, EPS and diagnostic cardiac catheterization procedures.

BACKGROUND: The SyvekPatch (Marine Polymer Technologies, Danvers, Massachusetts) has received Food and Drug Association market clearance for the rapid control of bleeding from vascular access sites and percutaneous catheters. A clinical evaluation was designed to determine the efficacy and safety of this vascular closure device in 1,000 consecutive patients after routine diagnostic and interventional procedures.

METHODS: During a 3-month period, a total of 364 interventional patients (stenting, 55%; PTCA, 30%; EPS, 15%) and 636 diagnostic patients (left heart catheterization, 77%; right/left heart catheterization, 23%) were treated. Catheter sheaths ranged in size from 4 12 French (Fr). Antiplatelet therapy was employed in 35% of the interventional procedures. In approximately 20% of the cases, same-side repuncture occurred within 2 3 days.

RESULTS: The use of the SyvekPatch on a total of 1,000 consecutive patients resulted in the rapid control of bleeding with only 1 major complication (0.1%; pseudoaneurysm) and few minor complications (1.3%). The pseudoaneurysm was most likely caused by the aberrant location of the sheath. All minor complications were either small hematomas (< 2.5 cm; rate, 0.75%) or slight oozing from the puncture site (rate, 0.6%). Outcomes measured included clinical effectiveness, ability to maintain the femoral access site for future interventions, major complication rates (access-site related hematoma that required blood transfusion or an extended hospital stay, pseudoaneurysm, arteriovenous fistula, arterial or venous thrombosis, and infection), patient comfort and operational efficiency.

CONCLUSION: The strong safety and efficacy profile of the SyvekPatch has made a significant impact in our cardiac catheterization lab. Unlike existing vascular closure devices, the SyvekPatch was used following a diagnostic procedure even when a future interventional procedure was scheduled. The effectiveness of the SyvekPatch was not altered by anticoagulation or antiplatelet therapy. The patients and clinical staff were extremely satisfied with the use of the SyvekPatch .