Noninvasive Hemostasis Pad
This device is associated with significantly fewer complications after both diagnostic and interventional procedures.
To view the tables related to this article, please refer to the print version of our April issue, page 60.
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 to 8F or larger sheaths and frequently involve anticoagulants, fibrinolytic agents, and antiplatelet agents such as ASA (Aspirin, Bayer AG, Leverhausen, Germany), clopidogrel bisulfate (Plavix, Bristol-Myers Squibb, New York, NY), and GP IIb/IIIa platelet inhibitors. This has resulted in an increase in access site complications, a serious problem that can add significant morbidity and even potential mortality to the procedure. Complications have been reported in as much as 14% of patients undergoing interventional procedures.1-3 These complications may also result in longer hospital stays and increased costs.
INVASIVE ARTERIOTOMY CLOSURE DEVICES
A variety of vascular closure devices can produce hemostasis in a shorter period of time and may allow for earlier ambulation and discharge when compared to manual compression.3,4 This can be advantageous for the patient, the hospital, and third-party payers. Use of these devices, however, has resulted in a variety of vascular complications, and most patients require a femoral angiogram before placement of the device.3-6 Hematomas, retroperitoneal bleeding, arterial occlusions, significant drops 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
One study examined the incidence of vascular complications with manual compression compared to that of four leading arteriotomy closure devices: Angio-Seal (St. Jude Medical, St. Paul, MN), Vasoseal (Datascope, Montvale, NJ), Duett (Vascular Solutions, Minneapolis, MN), and Perclose (Abbott Laboratories, Abbott Park, IL).7 Hematomas occurred in 9.3% of cases involving a closure device compared to 5.1% of cases with manual compression (P<.001). Five and two-tenths percent of patients treated with a closure device experienced more than a 15% decrease in hemocrit, compared to 2.5% with manual compression (P<.001). The necessity for vascular surgical repair was 2.5% using a closure device and 1.5% using manual compression (P=.03). These data confirm other findings demonstrating that the above devices have increased complication rates compared to manual compression.3-8
NONWOVEN, HYDROPHILIC WOUND DRESSING
To address these problems, a soft, nonwoven, hydrophilic wound dressing has been developed. The Clo-Sur PAD (Scion Cardio-Vascular, Miami, FL) consists of naturally occurring biopolymer polyprolate acetate. This linear biopolymer is cationically charged, and this chain of positive charges gives it potent coagulating properties. The device has received FDA clearance for use in local management of bleeding wounds such as vascular access sites. It 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 potentially decrease time to ambulation and discharge for patients undergoing percutaneous vascular procedures.
The technique for using the Clo-Sur PAD is as follows. Hold proximal pressure above the puncture site, and then remove the sheath. Place the device over the puncture site and continue to hold proximal pressure. Allow a small amount of blood to contact the pad, then hold constant pressure for a minimum of 10 minutes. More time may be required depending on sheath size and ACT. Next, release the pressure and confirm hemostasis. Cover the site with a sterile dressing and leave it in place for 24 hours. After removal, the Clo-Sur PAD will dissolve in water.
Investigators have gained experience with the Clo-Sur PAD in both an outpatient setting (Heart and Vascular Center of Hollywood, FL) and with inpatients undergoing diagnostic cardiac catheterizations (Tables 1 and 2) or who had just undergone interventional procedures (Tables 3 and 4) at the Memorial Regional Hospital in Hollywood, Florida. The PAD was also used in 3 patients undergoing the removal of intra-aortic balloon sheaths (Table 5). Complications were defined as hematomas that required intervention, transfusion, or delayed discharge, hematocrit drop greater than 15%, retroperitoneal bleeding, pseudoaneurysm, arteriovenous fistula, or the necessity for any surgical intervention.
Published data report vascular complication rates of as much as 6% for diagnostic procedures and from 2.5% to 14% for interventional procedures.2-8 Most reports suggest higher rates of complications with the use of currently available closure devices. Overall, the incidence of significant complications in these 1,488 cases using the Clo-Sur PAD was 0.17% for diagnostic procedures and 1.9% for interventional procedures. The complication rate for all patients combined was 0.50% (Table 6). These rates are well below the lower range of vascular complications in any reported study for both diagnostic and interventional procedures.
These data confirm the efficacy, usefulness, and low complication rate of the Clo-Sur PAD in patients who have undergone procedures involving femoral arteriotomy. Unlike other closure devices, the Clo-Sur PAD is totally noninvasive and in comparison, it is very effective, considerably less expensive, and apparently associated with a significantly lower incidence of serious complications.
Barry R. Alter, MD, is Medical Director of the Heart & Vascular Center of Hollywood, Florida and an Interventional Cardiologist at Memorial Regional Hospital in Hollywood. Dr. Alter does not have a financial interest in any products or companies mentioned herein. He may be reached at (954) 962-1400; CathmanA@aol.com.
1. Pompa JJ, Satler LF, Pichard AD, et al. Vascular complications after balloon and new device angioplasty. Circulation. 1993;88:1569-78.
2. Muller DW, Shamir KJ, Ellis SG, Topol EJ. Peripheral vascular complications after conventional and complex percutaneous coronary interventional procedures. Am J Cardiol. 1992;69:63-68.
3. Silber S. Vascular closure devices for immediate sheath removal after coronary interventions: luxury or necessity? In: Serruys PW, Rensing BJ, Kutryk MJ, eds. Handbook of Coronary Stents, 3rd ed. London: Martin Dunitz Ltd.; 1999.
4. Silber S. 10 years of vascular closure devices: a critical analysis of their usefulness after PTCA. Z Kardiol. 2000;89(5):383-89.
5. Carey D, Martin JR, Moore CA, Valentine MC, Nygard T. Complications of femoral artery closure devices. Catheter Cardiovasc Interv. 2001;52:3-7.
6. "Real world" data required on vascular closure devices, CDRH advises. The Gray Sheet. 2001;27(38):13.
7. Dangas G, Mehran R, Koklis S, et al. Vascular complications after percutaneous coronary interventions following hemostasis with manual compression versus arteriotomy closure devices. J Am Coll Cardiol. 2001;38(3):638-41.
8. Ferreira AC, Eton D, de Marchena E. Late clinical presentation of femoral artery occlusion after deployment of the Angio-Seal device. J Invasive Cardiol. 2002;14(11):689-91.