Clinical Evaluation of the SyvekPatch in Consecutive Patients Undergoing Interventional, EPS and Diagnostic Cardiac Catheterization Procedures

ABSTRACT:

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 .

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.^7,11

Protocol. 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) 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%) and 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; and 5) thrombosis or loss of distal pulses. Minor complications were defined as: 1) oozing from the puncture site; and 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 (

References

1. Smith TP. Infectious complications resulting from use of hemostatic puncture closure devices. Am J Surg 2001;182:658–662.

2. Toursarkissian B, et al Changing pattern of access site complications with the use of percutaneous closure devices. Vasc Endovasc Surg 2001;35:203–206.

3. Resnic FS, et al. Vascular closure devices and the risk of vascular complications after percutaneous coronary intervention in patients receiving glycoprotein IIb/IIIa inhibitors. Am J Cardiol 2001;88:493–496.

4. Johanning JM. Femoral artery infections associated with percutaneous arterial closure devices. J Vasc Surg 2001;34:983–985.

5. Vournakis, et al. Poly-N-acetyl glucosamine. U.S. Patent Number 5,623,064. April 22, 1997.

6. Vournakis, et al. Methods and compositions for poly-N-acetyl glucosamine biological barriers. U.S. Patent Number 5,624,679. April 29, 1997.

7. Cole, et al. A pilot study evaluating the efficacy of a fully acetylated poly-N-acetyl glucosamine membrane formulation as a topical hemostatic agent. Surgery 1999;126:510–517.

8. Kulling, et al. Endoscopic injection of bleeding esophageal varices with a poly-N-acetyl glucosamine gel formulation in the canine portal hypertension model. Gastrointest Endosc 1999;49:764–771.

9. Meyer, et al. Control of post dialysis bleeding in patients on chronic anticoagulation therapy. Presented at the American Society of Nephrology Meeting, 1999.

10. Chan, et al. Pre-clinical comparison of p-GlcNAc with absorbable collagen (Actifoam) and fibrin sealant for achieving hemostasis in a swine model of splenic hemorrhage. J Trauma 2000;48:454–458.

11. Lefer AM, et al. Vascular effects of poly-N-acetyl glucosamine in isolated rat aortic rings. J Surg Res 2002;102:215–220.

12. Eidt, et al. Surgical complications from hemostatic puncture closure devices. Am J Surg 1999:178:511–516.

13. Shrake KL. Comparison of major complication rates associated with four methods of arterial closure. Am J Cardiol 2000;85:1024–1025.

14. Mondy, et al. Early experience with infectious complications of percutaneous femoral artery closure devices. J Vasc Surg 2000;32:205–208.

15. Carey, et al. Complications of femoral artery closure devices. Cathet Cardiovasc Intervent 2001;52:3–7.

16. Katzenschlager R, et al. Incidence of pseudoaneurysm after diagnostic and therapeutic angiography. Radiology 1995;195:463–466.

17. Muller DW, et al. Peripheral vascular complications after conventional and complex percutaneous interventional procedures. Am J Cardiol 1992;69:63–68.

18. Chamberlin JR, et al. Use of vascular sealing devices vs. assisted manual compression in transcatheter coronary interventions requiring abciximab. Cathet Cardiovasc Intervent 1999;47:143–147.

19. Fleischhauer FJ, et al. Effectiveness of suture mediated closure of vascular access sites following diagnostic and interventional catheterizations. Current Innovations in Vascular Sealing (Suppl). Cath Lab Digest Sept 2000.