Clinical Evaluation of the SyvekPatch® in Consecutive Patients Undergoing Interventional, EPS and Diagnostic Cardiac Catheteriz

ABSTRACT Background.The SyvekPatch® (Marine Polymer Technologies, Danvers, MA) 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 (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. Management of bleeding at the femoral vascular access site following percutaneous catheterization is of paramount importance. Traditionally, manual or mechanical compression has been the standard approach to achieve hemostasis. Prior to this clinical evaluation, the Mt. Sinai Medical Center & Miami Heart Institute’s protocol directed that a sandbag be used to compress the vascular access site for 4-6 hours. Unfortunately, this method has many shortcomings. First, the process is time consuming, labor intensive and costly because it involves several hours of in-hospital observation. Second, sandbag compression is not desirable because the patient must remain immobilized for an extended period of time to avoid local hematoma formation. Third, extended compression can increase the risk of arterial occlusive complications. Hypertension and obesity can further complicate the procedure. Fourth, the required cessation of daily anticoagulation therapy prior to cardiac catheterization increases the risk of procedural complications. Vascular complications after femoral artery catheterization add significant morbidity to the procedure,¹ lengthen hospital stay and in some cases require blood transfusion and/or surgical repairs. Recent reports^1-4 on post-catheterization complications have also documented serious groin infections with the use of certain closure devices. Several of these infections have led to limb amputation or death. Complication rates have a direct impact on patient satisfaction, the ability to maintain the femoral access site for future interventions, clinical outcomes and incremental costs associated with treating complications. In the past several years, a number of vascular closure devices have entered the market. These devices are intended to allow the removal of the sheath in a timely manner, decrease the time to hemostasis following diagnostic and interventional procedures, and decrease the patient time to ambulation. However, the use of any of these existing vascular closure devices precludes re-intervention at the same site for extended periods of time. The present study was undertaken to test the safety and efficacy of a new closure device, the SyvekPatch® [(Marine Polymer Technologies (MPT), Danvers, Massachusetts] in treating 1,000 consecutive diagnostic and interventional patients. METHODS Materials. The SyvekPatch has been cleared by the Food and Drug Administration (FDA) as an external device to control bleeding from vascular access sites and percutaneous catheters. It consists of a specific formulation of MPT’s proprietary polymer poly-N-acetyl glucosamine (pGlcNAc), which is isolated from a microalga.^5,6 MPT has previously demonstrated that SyvekPatch is effective in treating medically and genetically induced coagulopathies and hemorrhage in a wide array of clinical settings.^7-10 Mechanism studies suggest that the SyvekPatch invokes both clot formation and local vasoconstriction as part of its overall hemostatic effect.^7,11Protocol. Once the diagnostic procedures were completed and the catheter sheath was removed, the SyvekPatch was applied and manually compressed for 10 minutes. Following interventional procedures, once activated clotting times (ACT) were below 300 seconds, the SyvekPatch was applied immediately after removal of the catheter sheath and held in place with 20 minutes of manual compression. If there was any blood oozing following manual compression, Femostop (Medtronic AVE, Minneapolis, Minnesota) was applied. Patient ambulation and discharge followed current standard operating procedures. Patient demographics. The study population included 656 males and 344 females. Patient age: = 80 years, n = 122. Body mass index (BMI): BMI 40, n = 36. ACTs ranged from 146-272 seconds. Procedures. A total of 364 consecutive patients had interventional procedures: Stenting, 55%; Percutaneous transluminal coronary angioplasty, 30%; EPS, 15%). A parallel 636 consecutive patients had diagnostic procedures Left heart catheterization, 77%; Right/left heart catheterization, 23%. The catheter sheath sizes ranged from 4-12 Fr: 4-5 Fr, 24%; 6-8 Fr, 69%; 12 Fr, 7%. Antiplatelet therapy (Integrilin®, Aggrastat® or ReoPro®) was employed in 35% of the interventional procedures. Study endpoints. The primary endpoint of the study was to determine the occurrence and incidence of major or minor complications at the femoral arterial access site. Major complications were defined as: 1) Surgical vascular repair or ultrasound-guided compression (for pseudoaneurysm, arterial-venous fistula or laceration); 2) Femoral nerve injury (sensory or motor); 3) Blood transfusion related to a groin complication; 4) Groin infection requiring intravenous antibiotics or prolonged hospitalization; 5) Thrombosis or loss of distal pulses. Minor complications were defined as: 1) Oozing from the puncture site; 2) The occurrence of small hematomas. RESULTS Outcomes measured included clinical effectiveness, the ability to maintain the femoral access site for future interventions, complication rates, patient comfort and operational efficiencies. Data are summarized in Table 1. Vascular complications. The use of the SyvekPatch on a total of 1,000 consecutive patients resulted in only 1 major complication (0.1%; pseudoaneurysm) and few minor complications (1.3%), which occurred in 7 patients (0.7%) with a small area (12-15 In addition, these vascular closure devices preclude reintervention at the same site for extended periods of time. Furthermore, the use of large-diameter sheaths and systemic anticoagulation/fibrinolytic agents (aspirin, heparin and platelet glycoprotein IIb/IIIa inhibitors) has been found to increase the frequency and severity of complications at the access site.^16-18 Complication rates have a direct impact on patient satisfaction, clinical outcomes and incremental costs associated with treating the complications. This study demonstrates that the SyvekPatch is safe, effective and easy to use. Previously, every catheterization patient in our institution was subjected to 4“6 hours of sandbag compression. However, the SyvekPatch facilitates rapid control of bleeding with minimal minor complications. In light of recent reports documenting serious groin infections with the use of certain subcutaneous closure devices,^1-4 it is important to note that there were no infections associated with the use of the SyvekPatch. Since the SyvekPatch is an externally applied product, there are no arterial/groin changes that preclude reintervention or surgery. This contrasts with other vascular access closure devices that compromise the femoral access site. The effectiveness of the SyvekPatch was not restricted by the use of anticoagulation or antiplatelet therapy. Sheath pull was accomplished immediately after the procedure as long as the ACT was 7-10 in a wide range of pre-clinical and clinical settings of medically or genetically induced coagulopathy and hemorrhage. Studies⁷ have determined that the mechanism of hemostasis with the SyvekPatch involves the immediate formation of red blood cell and platelet aggregates at the surface of the SyvekPatch in contact with the bleeding site. It is theorized that the SyvekPatch accelerates the concentration of red blood cells, clotting factors and platelets at the bleeding site to the critical levels needed for clot formation. A subsequent study¹¹ has demonstrated that the SyvekPatch significantly contracts isolated aortic rings via an endothelium-dependent mechanism, possibly via enhancement of endothelin-1 release from endothelial cells. In conclusion, the patients and clinical staff were extremely satisfied with the use of the SyvekPatch. This study demonstrated that the SyvekPatch provides several major advantages over existing devices due to its safety and effectiveness. The results of this study may need to be confirmed in larger comparative trials.

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