Catheterization and Cardiovascular Diagnosis 27:298-302 (1992)

Technical Note

Collagen Application for Sealing of Arterial Puncture Sites in Comparison to Pressure Dressing: A Randomized Trial Rainer Schrader, MD, Stefanie Steinbacher, Cand. Med., Wolfram Burger, MD, Christoph Kadel, MD, Christian Vallbracht, MD, and Martin Kaltenbach, MD, FACC One hundred patients undergoing routine diagnostic or interventional catheterization were randomly assigned to receive either percutaneously applied collagen (group A; n = 50) or conventional pressure dressing (group B; n = 50) for sealing of the femoral artery. Clinical variables were comparable in both groups. The heparin dose was 100 IlJlkg in 30 patients and 200 lU/kg in 20 patients of either group. The average compression time was 4.3 min in group A and 42.3 min in group B (p < .001).Bleedingwas not observed in group A but was observed in 6/50patients in group B. The time to ambulation was 6.4hr (range, 4-12 hr) in group A and 21.6 hr (range, 10-48 hr) in group B (p < .00l).Hematomas with a diameter of >6 cm developed in 4/50 patients in group A and in 11/50patients in group B (p < .05). Blood-transfusionsor surgical interventions were not required and there was no loss of ankle pulses in either group. In conclusion, percutaneously applied collagen reduced compression time and duration of bedrest after diagnostic catheterizationand PTCA. Despite earlier ambulation, the incidence of bleeding was lower with collagen than with conventional pressure dressing. o 1992 wiley-Liss, Inc. Key words: cardiac Catheterization, PTCA, femoral artery, peripheral complications

INTRODUCTION

The hemostatic properties of collagen have been used in abdominal and vascular surgery for more than 20 yr [ 1-31. Recently, a novel vascular hemostasis device for percutaneous deposition of collagen was introduced (VasoSealR, Datascope COT., Montvale, NJ, USA). Purified, absorbable, bovine collagen is applied through an applicator sheath to the arterial puncture site. The device has proved to be effective in patients undergoing diagnostic and interventional catheterization [4,S]. However, in these initial clinical trials no control patients with standard treatment were included. In the present study, patients were randomly assigned to receive either collagen or pressure dressing for sealing of the femoral artery after coronary arteriography or angioplasty . PATIENTS AND METHODS Study Design This was a prospective, randomized trial comparing the effectiveness of either percutaneously applied collagen (group A; n = SO) or conventional pressure dressing (group B; n = S O ) for sealing of femoral artery puncture sites. One hundred consecutive patients presenting for routine diagnostic catheterization or coronary angio0 1992 Wiley-Liss, Inc.

plasty were enrolled upon their written informed consent. Patients who were on oral therapy with vitamin K-antagonists, with platelet disorders, preexisting hematoma, or with known allergy to collagen products were excluded. Randomization was performed according to a random list before catheterization. All those who were allocated to collagen received the hemostatic device immediately following the procedure. Patients allocated to pressure dressing who underwent PTCA had their sheath removed approximately 4 hr after discontinuation of heparin, while immediate sheath removal was performed after diagnostic catheterization. No effort was made to reverse the effect of anticoagulation in any patient. The protocol of the study was approved by the institutional review board on clinical investigation.

From the Division of Cardiology, Center of Internal Medicine, University-Hospital, Frankfurt am Main, Germany Received May 14, 1992; revision accepted August 10, 1992 Address reprint requests to Priv. Doz. Dr. Rainer Schrader, Abt. f. Kardiologie, ZIM, Universitatsklinikum, Theodor Stern-Kai 7, D6000 Frankfurt a. M. 70, Federal Republic of Germany.

Percutaneous Collagen Application TABLE 1. Clinical Characteristics of the Study Patients

No. of patients No. of PTCA patients

Sex (MIFj Age ( y V Weight (kg)" Height (cm)" Systolic blood pressure (mrn Hg)" Heparin dose (IU)"

Group A

Group B

so (100%j

50 ( 100%)

20 (40%)

20 (40%)

4317 58.5 ? 10.2 17.2 ? 13.3 173.4 ? 8.8 140.3 ? 27.7 10640 ? 1835

4515 58.5 ? 9.2 80.5 ? 11.4 174.3 -+ 8.4 141.3 ? 19.3 11040 ? 1562

There were no significant differences between group A (collagen plug) and group B (pressure dressing). "Means ? SD.

Patients

There were 12 female and 88 male patients. All were pretreated with oral acetylsalicylic acid (750 mg twice daily). In patients undergoing diagnostic catheterization the size of the arterial sheath was 7F and the heparin dose was 100 IU/kg, while for PTCA an 8F sheath and a heparin dose of 200 IU/kg were used. The clinical variables were comparable in both groups and are summarized in Table I. Procedural DetaiIs Group A, collagen plug. At the beginning of the procedure, the distance between skin and artery was measured. Once the artery had been punctured with the tip of the needle, a clamp was placed at the needle where it entered the skin (Fig. 1A). After completion of the catheterization, a short 35/1,000-in guidewire was reinserted and the sheath removed while hemostasis was maintained by manual compression of the artery. Then, a blunt-tipped 11F dilator was inserted over the guidewire to a depth corresponding to the skin-artery distance measured previously (Fig. 1B). An 11.5F applicator sheath was inserted over the dilator onto the artery (Fig. 1C) and the wire and dilator were removed while maintaining arterial compression (Fig. 1D). Subsequently, the first collagen-loaded cartridge was placed into the proximal end of the sheath and the collagen (100 mg) was pushed out of the sheath towards the puncture site, while the sheath was gradually pulled back (Fig. 1E). The second plug (80 mg) was then applied and the sheath was further pulled back (Fig. 1F). After plug placement, the sheath was removed, manipulation of the insertion site avoided, and gentle upstream compression maintained for 3 to 5 min (Fig. IG). Finally, the ankle pulses were examined and the patients were advised to keep bedrest for 6 hr. Group B, pressure dressing. When the sheath had been removed, the femoral artery was compressed with a clamp. The clamp was left in place for 15 min. The

299

puncture site was then checked for the first time. Thereafter, compression was reduced every 10 min until hemostasis was achieved. A pressure dressing which was attached around the hips and thigh was routinely applied to all patients in group B. The patients were allowed to get up the next morning. Parameters, Follow-up, and Statistics

The time during which the femoral artery was manually or mechanically compressed (compression time) and the duration of bedrest after completion of the catheterization procedure (time to ambulation) were recorded. The diameter of groin hemaromas was measured in centimeters. Requirement for secondary arterial compression and pressure dressing was considered a bleeding complication. The patients were asked to grade discomfort and pain according to a semi-quantitative scale (none, light, moderate, severe, very severe). All patients were examined for evidence of access site complications the next morning. When vascular injury was suspected, duplex color flow imaging was performed. The patients were interviewed by phone 2 wk later and they answered a questionnaire 4 wk after the procedure. A second clinical evaluation was performed approximately 6 wk after hospital discharge. Differences in the clinical variables and the incidence of complications between the two groups were compared using Student's t-test or chi-square analysis, respectively. A two-tailed probability value