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Original Contribution
Hemostatic Efficacy of Hysrophilic Wound Dressing after Transradial Catheterization
September 2005
Transradial coronary angiography (TRA) has proven to be a feasible, safe, and effective method, and steadily growing in popularity.1,2 Furthermore, TRA carries great advantages in terms of reducing the risk of major entry-site complications, hospital staff workload and cost. Until recently, tourniquets and hemostatic compressive devices (CD) have been used routinely to induce hemostasis at the radial artery access site.3 However, tourniquets and other compressive devices carry serious disadvantages: restriction of wrist movement, necessity for prolonged application of the device, and the risk of lateral occlusion. Recently, a soft, nonwoven hydrophilic wound dressing (HWD) called the Closur PAD™ (Scion Cardio-Vascular, Miami, Florida) was introduced.4 This device received FDA clearance for use in the local management of bleeding wounds, most notably in vascular access sites.5 The purpose of this randomized study was to evaluate the efficacy and safety of HWD compared to CD with regard to achieving hemostasis after the complication of transradial catheterization.
Materials and Methods
Study population. The study was a single-center randomized trial. We obtained the approval of the investigational review board separately for both the intravascular ultrasound (IVUS)-guided stenting (IGS) follow-up study and the hemostasis study. Neither of the 2 studies had an exclusion criteria prohibiting participation in another study. We studied 80 patients who had undergone TRA with or without intravascular ultrasonography (IVUS) for the follow-up of previous stenting as a part of the IGS protocol. IVUS was performed in patients who had undergone the deployment of a drug-eluting stent 6 months beforehand. Exclusion criteria for the radial approach included: 1) a negative Allen’s test; 2) inaccessible radial arteries in cases where there were hypoplastic radial arteries or a radioulnar loop; 3) chronic renal failure (to preserve the radial artery for future arteriovenous shunt construction).6 All of the study patients provided informed consent for the radial coronary angiography and the hemostasis study.
TRA and IVUS procedure. All patients received 100 mg of aspirin at least 3 days prior to the procedure. In patients undergoing a right radial approach, the right arm was positioned beside the trunk with the wrist hyperextended. The skin was anesthetized with 0.5–1.0 ml of 1% lidocaine. The radial artery was punctured with a 20 gauge intravenous needle and a 0.025 inch straight guidewire was inserted through the needle.7 The external sheath of the needle was advanced into the radial artery and an inta-arterial cocktail consisting of 2.5 mg of verapamil, 2.5 mg of nitroglycerin, and 2,500 units of heparin, was administered to prevent spasm.8 A 10 cm long, 6 French (Fr) sheath (Terumo, Tokyo, Japan) was used in all patients undergoing TRA, as well as in those who had been additionally investigated by IVUS. TRA was performed using 5 Fr Judkins catheters. IVUS was performed under the guidance of a 6 Fr guiding catheter after the additional intravenous injection of 3,000 units of heparin.
Radial artery access site hemostasis. At the end of catheterization procedure, hemostasis assignments were directly determined by opening the patient’s own randomization card. Patients with bleeding diasthesis and systolic blood pressure higher than 200 mmHg were excluded in the randomization process and underwent manual compression. Enrolled patients were randomized to the HWD group or the CD group (Radistop, RADI Medical Systems AB, Uppsala, Sweden) (Figure 1). In the HWD group, the hemostasis procedure was performed as follows: after maintaining proximal pressure above the puncture site, the sheath was removed. The pad was then placed over the puncture site and proximal pressure continued. After allowing a small amount of blood to contact the pad, constant pressure was maintained for another 30 seconds, and the pressure was released. Finally, we covered the site with a sterile dressing. After removal, the HWD was dissolved in water. As a control, the CD was applied as described next. The pad was positioned precisely on the puncture site, and moderate pressure was applied over the sheath. The sheath was then removed and the pressure was adjusted using the Velcro strap until both hemostasis and residual radial flow were achieved.9 Monitoring of hemostasis. The time required for hemostasis was measured from the time of sheath removal to the time hemostasis was achieved at the puncture site. Hemostasis was checked every 30 minutes with the method of releasing the HWD and the CD. If hemostasis was not achieved, the dressing and compression were continued. All vascular complications, including hematoma formation, acute radial occlusion and puncture site infection were observed. Hematomas were classified as large (> 2 cm in diameter) or small (? 2 cm in any diameter), immediate (developing within 30 minutes) or delayed (developing after 30 minutes). After removal of the device, the radial pulse was checked clinically, and an Allen’s test was performed immediately to assess the patency of the radial artery. At 1-month follow-up, the arterial access site wounds and radial pulse of all patients were examined.
Statistics. Statistical analysis was performed with SPSS version 11.0 (SPSS Inc., Chicago, Illinois). Quantitative data are presented as mean ± standard deviation (SD). As the variables were not normally distributed, comparisons of variable parameters between the HWD and CD groups were performed using the nonparametric Wilcoxon method. A p-value Results
A total of 80 patients were enrolled in this study. The patient population consisted of 66 patients undergoing only TRA with 5 Fr catheters, and 14 patients who underwent TRA, coupled with an IVUS evaluation with a 6 Fr guiding catheter. The randomization process assigned 40 patients to the CD group (34 for TRA only and 6 for TRA with IVUS), and 40 patients to the HWD group (32 for TRA only and 8 for TRA with IVUS). Three patients underwent left radial approaches due to a weak right radial pulse. No differences in clinical characteristics or procedure-related variables were observed between the 2 groups, with the exception of procedural time. This may have been due to the high IVUS performance rate in the HWD group, but no differences were seen with regard to final activated clotting times (ACT). Details of patients and procedures are summarized in Tables 1 and 2. The mean hemostasis time for the HWD group (58.7 ± 32.6 minutes) was significantly shorter than that of the CD group (131.3 ± 59.1 minutes) (p 2 cm in diameter were reported in only 1 patient (2.5%) in the CD group, and hematomas Discussion
Several radial access hemostatic devices have been developed in recent years. These devices, however, classically applied prolonged mechanical compression, resulting in the restriction of wrist movement.9 Average hemostasis time with such devices was about 2 hours, and the incidence of acute arterial occlusion was 5% at most. Recently, several noninvasive hemostatic patches, including the SyvekPatch® (Marine Polymer Technologies, Denver, Massachusetts), the Chito-Seal topical hemostasis pad (Abbott Vascular Devices, Redwood City, California), and the Clo-Sur PAD have been introduced.10 Only a few study results indicated that poly-N-acetylglucosamine (pGlcNAc), a material used in the SyvekPatch, was associated with accelerated compression and decrease of hemostasis time with no concomitant increases in the incidence of complications.11 The pGlcNAc facilitates hemostasis via mechanisms involving vasoconstriction, red blood cell agglutination, and platelet activation for fibrin clot formation.12 The Clo-Sur PAD applied in this study uses a different physiologic method for inducing hemostasis than does pGlcNAc.4,12 The Clo-Sur PAD consists of polyprolate acetate, a hydrophilic, naturally-occurring biopolymer. This biopolymer is cationically (positively) charged. Once the pad is applied to the access site and contacts blood, it begins to cause the blood to coagulate. This positively-charged polyprolate pad reacts with the negatively-charged red blood cells, forming a coagulum. It also reacts with heparinized blood, defibrinated blood, and washed cells, but will not form a clot with serum albumin, serum globulin, or white blood cells.5 Our data indicate that hemostasis can be achieved more quickly with HWD than with CD, with no concomitant increase in access site complications.
Permanent radial artery occlusion is the prevalent local complication associated with arterial compression. Although it is known that permanent radial artery occlusion is not related to compression technique, this complication should be avoided to whatever extent possible in order to maintain a patent vascular access site.13 Our results with HWD involved no incidents of acute or chronic arterial occlusion. This result implies that the use of HWD without compression can reduce the occurrence of this complication.
Study limitations. First, the study population is small and includes only patients undergoing diagnostic procedures, thus we could not include patients with higher ACTs and those on adjunctive glycoprotein IIb/IIIa inhibitors. Second, for the method of confirming hemostasis, the time required for hemostasis was relatively longer than that which has been previously reported. However, if this confirmation method was applied to each group in the same way, this limitation can be overcome.
Conclusion
In conclusion, HWD can decrease hemostasis time without any concomitant increase in access site complications and can also increase patient comfort due to the allowance of free wrist movement. Another benefit is the method’s user-friendliness, resulting in a reduction in hospital staff workloads. These advantages may render HWD a popular method in the future.
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