Industry News
Clo-Sur P.A.D.:A New, Non-Invasive Closure Device
March 2002
Control of the arterial access site following percutaneous vascular procedures remains a crucial aspect of both invasive diagnostic and interventional cardiology.
Most interventional procedures are performed with 6-8 French sheaths, or larger, and frequently include anticoagulants, fibrinolytic agents, and antiplatelet agents such as aspirin, Plavix® (Bristol-Myers Squibb/Sanofi Pharmaceuticals Partnership, New York, NY) and GP IIb/IIIa platelet inhibitors. This has resulted in an increase in access site complications and has become a serious problem that can add significant morbidity and even potential mortality to the procedure. Complications have been reported in up to 14% of patients undergoing interventional procedures.1-2 These complications may also result in longer hospital stays and increased costs. A variety of vascular closure devices have been developed which have the ability to produce hemostasis in a shorter period of time, and may allow for earlier ambulation and discharge.3 This can be advantageous for the patient, the hospital and the third party payers.
Use of these devices, however, has resulted in a variety of vascular complications, and most require a femoral angiogram before placement of the device.3-5 Hematomas, retroperitoneal bleeding, arterial occlusion, significant drop in hematocrit, and pseudoaneurysms have been reported. The Gray Sheet quoted an FDA finding of 1,879 serious injuries and 36 deaths related to arteriotomy closure devices.6 In a study by Dangas, et. al., from the Cardiovascular Research Institute at the Lenox Hill Heart and Vascular Institute, New York, and the Washington Hospital Center, Washington, D.C., complications of manual compression were compared to the use of:
Angio-Seal (St. Jude Medical, Minnetonka, Minn.);
VasoSeal® (Datascope Corp., Mahwah, NJ);
Duet Vascular Solutions, Inc., Minneapolis, Minn.) and
Perclose (Redwood City, Calif.)
for the incidence of complications. 7 Hematomas, using a closure device, were 9.3% vs. 5.1% for manual compression ( pThe Clo-Sur P.A.D.
Scion Cardiovascular (Miami, Florida) has introduced a soft, non-woven hydrophilic wound dressing called Clo-Sur P.A.D. The Clo-Sur P.A.D. consists of naturally occurring biopolymer polyprolate acetate. This linear biopolymer is cationically charged, and it is this chain of positive charges, which gives it potent blood-coagulating properties. The Clo-Sur P.A.D. has received clearance by the U.S. Food and Drug Administration for use in local management of bleeding wounds, such as vascular access sites. This pad provides an inexpensive, simple and safe alternative to other closure devices and could potentially reduce vascular complications, shorten time in the recovery area and decrease throughput time. In addition, it can decrease time to ambulation and discharge for patients undergoing percutaneous vascular procedures.
How to Use It. The technique for use of the Clo-Sur P.A.D. is as follows:
1. Proximal pressure is held above the puncture site and the sheath is then removed.
2. The Clo-Sur P.A.D. is then placed over the puncture site and proximal pressure is released.
3. A small amount of blood is allowed to contact the Clo-Sur P.A.D.
4. Constant pressure is then held for a minimum of 10 minutes. More time may be required depending on sheath size and ACT.
5. Pressure is then released and hemostasis is confirmed.
6. The site is then covered with a sterile dressing.
7. The dressing is left in place for 24 hours. It may then be removed and the Clo-Sur P.A.D. will dissolve when wet down with water.
Initial experience with the Clo-Sur P.A.D. was gained in both an outpatient setting with patients undergoing diagnostic cardiac catheterizations, and in a hospital setting on patients who had just undergone interventional procedures. The outpatient laboratory was the Heart and Vascular Center of Hollywood, and the inpatient facility was Memorial Regional Hospital, both in Hollywood, Florida. Complications were defined as:
Hematomas that either require intervention, delay discharge or require transfusion;
Hematocrit drop of >15%,
Retroperitoneal bleeding,
Pseudoaneurysms,
Arteriovenous fistulae
The necessity for any surgical intervention. (See the table at left and on page 20.)
Initial Data: 122 Patients
This is an initial experience with 122 patients using the Clo-Sur P.A.D. in both an outpatient setting with 82 patients undergoing diagnostic catheterizations, and in a hospital setting on 40 patients undergoing interventional procedures. Of the 40 post interventional procedure patients who were on a variety of medications to delay hemostasis, 2 developed clinically insignificant hematomas and the rest had no post sheath removal groin complications. The only 2 significant complications were experienced by 2 outpatients who developed pseudoaneurysms, both four days post procedure.
Published data gives vascular complication rates for diagnostic procedures up to 6% and for interventional procedures from 2.5“14%.2,7 Overall, the incidence of significant complications in these 122 patients was 1.6%, well within the lower range of vascular complications.
Conclusion
These data confirm the efficacy and usefulness of the Clo-Sur P.A.D in patients who have undergone procedures involving a femoral arteriotomy. Unlike most other closure devices, the Clo-Sur P.A.D. is totally non-invasive, is significantly less expensive, and appears to have a lower incidence of significant complications.
Further studies are about to begin in fully anticoagulated patients to confirm and supplement this initial data, and will specifically look at complications, time for initial hemostasis, and time to ambulation.
1. Pompa JJ, Satler LF, Pichard AD, et al. Vascular complications after balloon and new device angioplasty. Circulation 1993;88:1569-1578.
2. Muller DW, Shamir KJ, Ellis SG et al. Peripheral Vascular Complications After Conventional and Complex Percutaneous Coronary Interventional Procedures. Am J Cardiol 1992;69:63-68
3. Serruys PW, Kutryk MJ. Vascular Closure Devices for Immediate Sheath Removal after Coronary Interventions: Luxury or Necessity?, in Handbook of Coronary Stents, 3rd ed. (London: Martin Dunitz Publishers, 1999).
4. Silber S. 10 Jahre arterielle Verschlussysteme: Eine kritische Analyse ihrer Andwendung nach PTCA. Zeitschrift fur Kardiologie 2000. Band 89; Heft
5: 383-“389.5. Carey D, Martin JR, Moore CA, Valentine MC and Nygard T. Complications of Femoral Artery Closure Devices. Cathet Cardiovasc Intervent 2001; 52:3-“7.
6. -The Gray Sheet-, Medical Devices, Diagnostics & Instrumentation. September 17, 2001;27(38):13. Available online at: http://www.fdcreports.com.
7. Dangas G, Mehran R, Koklis S, et al. Vascular Complications After Percutaneous Coronary Interventions Following Hemostasis With Manual Compression Versus Arteriotomy Closure Devices. JACC 2001; 38 (3):638-641.
