Impact of Two Different Hemostatic Devices on Radial Artery Outcomes after Transradial Catheterization

From the Department of Cardiology, Mercy Hospital and Community Medical Center, Scranton, Pennsylvania. Disclosure: The author serves as a consultant for Medtronic Interventional, USA and Terumo Medical Corporation. Manuscript submitted October 28, 2008, provisional acceptance given November 14, 2008, manuscript accepted November 19, 2008. Address for correspondence: Samir B. Pancholy, MD, FACC, FSCAI, P.O. Box 620, Chinchilla, PA. 18410. E-mail: drpancholy@yahoo.com

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ABSTRACT: Objective. Our objective was to evaluate the effect of two different hemostatic devices on radial artery outcomes after transradial catheterization. Background. Radial artery occlusion is an infrequent but discouraging complication of transradial access. It is related to factors such as sheath-to-artery ratio and its incidence is decreased by the administration of heparin. It usually does not lead to ischemic complications, but precludes future transradial access. Patients and Methods. 500 consecutive patients undergoing transradial catheterization were prospectively enrolled in the study. 250 consecutive patients received hemostasis by application of the HemoBand (Group I), and the next 250 patients received hemostasis using the inflatable TR Band (Group II). Radial artery patency was studied at the time of application of the hemostasis device, at 30 minutes, 60 minutes and at 24 hours and 30 days using Barbeau’s test. Results. 28 patients in Group I (11.2%), developed early occlusion (at 24 hours), compared to 11 patients (4.4 %) in Group II (p Conclusion. A significant reduction in radial artery occlusion was noted with hemostasis using the TR Band compared to the HemoBand, without compromising hemostatic efficacy.

J INVASIVE CARDIOL 2009;21:101–104

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Transradial catheterization has been shown to have a lower incidence of major access site-related complications compared to transfemoral access.^1,2 It is comparable to the transfemoral approach from the standpoint of cardiac endpoints. The anatomy of the distal forearm, with the unique isolation of the radial artery from the other structures such as nerves, makes it ideal for applying liberal compression. This has allowed for the near elimination of access site-related hemorrhagic complications. The most frequent complication of transradial catheterization is radial artery occlusion. This itself is an infrequent complication, with essentially no major clinical sequelae. Despite its clinical quiescence, it limits future utility of the radial artery as an access site for angiographic and therapeutic procedures. Occlusive hemostasis³ and repeated entry⁴ have been observed to be risk factors for future radial artery occlusion. Earlier, we reported a patent hemostasis technique that was shown to significantly reduce the occurrence of radial artery occlusion.⁵ Radial artery diameter and the introducer sheath diameter ratio have also been shown to be related to the risk of radial artery occlusion.6 Heparin administration during transradial catheterization has been shown to significantly reduce the incidence of radial artery occlusion.⁷ Different devices have been used to apply local pressure at the site of arterial entry to achieve hemostasis. These include a variety of “homemade” devices such as elastic or tape dressings, industry-manufactured dedicated devices, and so forth. There are no data comparing the efficacy and outcomes following the use of these devices. We studied the effect of the HemoBand™ (Hemoband Corp., Portland, Oregon) versus TR Band™ (Terumo Medical Corp., Somerset, New Jersey) on subsequent radial artery outcomes after transradial catheterization.

Patients and Methods

Five hundred consecutive patients who underwent transradial diagnostic catheterization were studied; 250 patients received hemostasis using local compression with the HemoBand (Group I) (before the availability of the TR Band). The following 250 consecutive patients received hemostasis using the TR Band (Group II) (after the availability of the TR Band). Transradial catheterization procedure. After sterile preparation and injection of 2% lidocaine at the puncture site, a 20 gauge Teflon catheter was used to enter the radial artery 5–6 cm above the crease of the wrist using the Seldinger technique with through-and-through puncture. The stylet was removed and a Terumo 0.021 inch guidewire was placed in the hub of the cannula, and the system was gradually withdrawn. Upon appearance of pulsatile flow, the guidewire was advanced into the radial artery lumen. A 5 Fr Radiofocus glide sheath (Terumo Medical) was then advanced over the guidewire into the radial artery. A “radial cocktail” consisting of 200 µg of nitroglycerin, 5 mg of diltiazem and 50 units/kg of unfractionated heparin (maximal dose of 5,000 units) was administered diluted in a 20 ml syringe, intra-arterially. The procedure was completed using 4 Fr diagnostic coronary catheters. Hemostasis procedure. All sheaths were immediately removed. HemoBand (Group I). Patients in Group I received a HemoBand for hemostasis, which is comprised of a plastic band with a “head” end that is flat, and a “tail” end that has a corrugated locking mechanism to prevent slippage after application. It was used in conjunction with a pledget made using a 1.5 inch needle cap wrapped in a 4 x 4 inch dry gauze piece. This composite pledget was placed under the head end of the HemoBand. The sheath was pulled out 4–5 cm and a HemoBand plastic band was placed around the wrist. The composite of a needle cap covered with a 4 x 4 gauze piece rolled around the needle cap was placed under the HemoBand at the sheath entry site and the band was tightened, after which the sheath was pulled out. The band was left in place for 2 hours, then slowly removed, and a light dressing was applied to the site. TR Band (Group II). Patients in Group II received a TR Band for hemostasis, which is a device with an inflatable bladder equipped with an access-site position marker mounted on a transparent plastic band and a Velcro mechanism to prevent slippage after application. After the sheath was pulled out 4–5 cm, the device was applied to the access site and the position marker was placed at the site of the arterial entry (dependent upon the angle of the accessing needle). The Velcro was applied to make it a tight application. The inflatable bladder was then inflated with 15 ml of air by connecting the syringe provided in the kit to the one-way valve. The sheath was then pulled out of the artery. If hemostasis was not achieved, the band was inflated with a larger volume of air. The TR Band was left in place for 2 hours then gradually deflated and subsequently removed, after which a light dressing was applied. Follow-up evaluation. Radial artery patency was assessed using Barbeau’s test. The clinic personnel assessing patency had no knowledge of the procedural details. A pulse-oximeter sensor was placed over the index finger. A plethysmographic signal was observed and both radial and ulnar arteries were compressed to observe loss of the plethysmographic signal. Next, the radial artery was released and return of the plethysmographic signal was observed. A return of signal confirmed radial artery flow and hence patency. The absence of return of a signal was interpreted as radial artery occlusion. The ulnar artery was then released to observe return of the signal, confirming proper functioning of the equipment. This test was performed at the time of application, 30 minutes, 60 minutes, 24 hours and 1 month after the procedure. All patients with occlusion were confirmed ultrasonographically. TR Band pressure measurement. The TR Band was applied to the access site. Through the connecting tubing, the inflation chamber (bladder) was connected to an aneroid barometer and pressure in the chamber was recorded at baseline, 30 minutes and 60 minutes. Statistical methods. Continuous variables were analyzed using the Student’s t-test. Categorical variables were analyzed using the chi-square test. SPSS version 15.0 software (SPSS, Inc., Chicago, Illinois) was used to perform these analyses.

Results

Demographics. Demographic and procedural data for patients in Group I (HemoBand) and Group II (TR Band) are shown in Table 1. No significant difference was found between the two groups in the distribution of age, gender, body surface area and fluoroscopy time. Radial artery occlusion data. The incidence of early (24 hours) radial artery occlusion in Group I (HemoBand) was 11.2% (28 patients). The incidence of early radial artery occlusion in Group II (TR Band) was 4.4% (11 patients). The difference between the two groups was statistically significant (chi-square 8.03; p p p p p p Discussion Radial artery occlusion is one of the few infrequent complications of transradial catheterization that limits future transradial access and very rarely causes symptomatic ischemia.1 We have recently described a technique to reaccess an occluded radial artery.⁸ Despite its clinical and symptomatic quiescence in general, a transradial operator seeks strategies to lower the incidence of radial artery occlusion, as reaccessing an occluded radial artery is fairly challenging from a technical standpoint. Since the radial artery is fairly isolated in its course in the distal forearm and there is a flat surface provided by the radius bone, application of liberal pressure to achieve hemostasis is very well tolerated. Occlusive radial artery compression has been found to be a risk factor for subsequent radial artery occlusion.³ We have recently reported a marked reduction of the incidence of radial artery occlusion by using a patency documented hemostasis technique.⁵ The most basic form of hemostasis after transradial procedures is manual hemostasis, although in view of heparin use during the procedure, this becomes a fairly labor-intensive approach, limiting patient mobility and increasing staff engagement, hence different devices have been used to apply constant pressure at the access site to achieve hemostasis. A gauze tape dressing, a plastic strap supported by gauze, a foam pad with a Velcro band, etc., have been used. The latest addition to these devices is the TR Band, featuring a plastic band with an inflatable bladder that applies pressure. Our data indicate that the HemoBand and TR Band are equally effective in achieving hemostasis. In view of the fact that the TR Band has a blunt and pliable surface, it appears to be more comfortable and better tolerated. The most important finding of this observation is the 56% lower incidence of chronic (30 days) radial artery occlusion using the TR Band compared to the HemoBand. Serial monitoring of radial artery patency during the hemostatic process has provided important insights into how and why radial artery occlusion rates are different with these two devices. Most radial arteries are occluded with the introducer sheath in place, presumably due to local spasm. Most radial arteries, in their noninstrumented state, are larger than a 5 Fr introducer sheath, although a 5 Fr sheath is nearly always occlusive, implying the role of spasm and or thrombosis in creating this occlusive state. Once the radial artery sheath is pulled, and a pressure device applied, the radial artery is occluded a majority of the time (88%). Radial artery patency status at the time of hemostasis is a function of systemic blood pressure versus the pressure applied by the device on the arterial wall. As the TR Band allows for pressure measurement in its inflatable chamber, we measured the pressure in the TR Band bladder at the time of hemostasis. The mean pressure applied on the forearm at the time of hemostasis using the recommended 15 cc air inflation was 241 mmHg. The pressure applied to the radial artery may not be equal to the pressure in the inflatable chamber, but is probably higher than the systolic pressure in nearly every patient undergoing transradial catheterization. The HemoBand and devices like it continue to maintain the same applied pressure until they are loosened by the operator. The TR Band, on the other hand, appears to self-deflate, as observed by the decrease in pressure in the inflated bladder. This may be a result of the patient moving his/her wrist and appears to vary in its magnitude, although all TR Bands appear to lose pressure over the first 60 minutes after application. This is probably related to the observed establishment of patency of the radial artery within the first 30 minutes of application of the TR Band. A gradual increase in systemic blood pressure after transradial procedures may also play a role in this reestablishment of patency after an initial occlusive hemostatic hold. Most radial arteries are occluded with the HemoBand at 1 hour (61%), probably because of unchanged pressure applied by the HemoBand at the radial artery access site, which continually exceeds systemic blood pressure despite a gradual increase in systemic blood pressure. There was a significant decrease in pressure in the TR Band chamber over 30–60 minutes after its application, likely allowing for reestablishment of radial artery flow at the access site and hence converting the initial occlusive hold to a nonocclusive or patent hold. Patency during hemostasis has been shown to be a strong predictor of maintenance of radial artery patency.⁵ This may be the reason for the difference in the incidence of radial artery occlusion between the two hemostatic devices. The only concern with a self-deflating system from a hemostatic standpoint would be its hemostatic efficacy. Our data prove that this gradual process of self-deflation does not lead to any increase in bleeding complications. This is probably related to the gradual nature of the decrease in hemostatic pressure and the decrease in the steady leak as the pressure in the inflatable chamber gradually falls, leveling off the pressure after the initial decline. Study limitations. This was a nonrandomized study. Despite this design, the patient population was unselected, as the patients in Group I and Group II were consecutive and the choice of the HemoBand or the TR Band was not at the discretion of the operator as was the case at the time of the procedure with the Group I patients. The TR Band was not commercially available in the U.S, and after the introduction of the TR Band, the HemoBand was not used at all at our institution. As the selection of patients or hemostatic device did not occur, and all data were collected prospectively, we believe this issue does not significantly affect the findings. These data were collected on patients undergoing diagnostic cardiac catheterization using 4 Fr angiographic catheters through a 5 Fr introducer sheath. These data should not be extrapolated to procedures involving larger introducer and catheter sizes.

Conclusions

Our data indicate that the TR Band provides equivalent hemostatic efficacy and a lower incidence of radial artery occlusion after transradial catheterization compared to the HemoBand. As radial artery occlusion is one the few complications of modern transradial access, a device with a lower incidence of this complication is desirable over other available choices.

References

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