Abstract
Background
Asymptomatic radial artery occlusion (RAO) is a major limitation of transradial catheterization (TRC). Two radial compression hemostatic devices are compared for their respective effects on RAO.
Methods
In a prospective, randomized, single center, blinded trial, 320 patients were randomly treated with a TR band (Terumo Corporation) or Safeguard Radial (Merit Medical). Institution wide protocols consisting of anticoagulation, patent hemostasis, duration of compression, and use of 6 French slender sheaths (Terumo Corporation) were observed. Patient discomfort related to the device was recorded using the universal pain scale. Radial artery patency was evaluated by reverse Barbeau’s test prior to discharge (1-hour post-diagnostic catheterization or 6–24 hour post-intervention) and at 30-days.
Results
Of the 320 patients, 155 were randomized to the TR group (TRG) and 159 to the Safeguard group (SGG). 6 patients were excluded due to the inability to insert 6 Fr slender sheaths or patient withdrawing consent. Demographic and procedural characteristics were similar with the exception of the type of coronary procedure performed. Both bands were equally effective in achieving patent hemostasis. Despite having a higher rate of post-procedure hematoma (1.29% TRG vs. 3.1% SGG, p = 0.04) and acute RAO (3.8% TRG vs. 6.28% SGG, p = 0.05) with the Safeguard band, at 30 days RAO was similar in both groups (1.9% TRG vs. 2.5% SGG; p = 0.21). Patients in the SGG reported significantly less band discomfort and were found to require less air to achieve patent hemostasis.
Conclusion
Evidence-based contemporary TRC protocols of using smaller diameter access, anticoagulation, and use of just enough pressure for the shortest duration of time to achieve hemostasis is associated with very low RAO rate at 30 days irrespective of the radial compression device used.
Highlights
- •
Evidence based practices of TRI are linked to low RAO & unrelated to type of compression device. Local hematoma is a predictor of RAO.
- •
The development of a > 2 cm radial hematoma is associated with a high likelihood of RAO.
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While the overall safety, success in achieving patent hemostasis, and time to hemostasis are equal with both pneumatic compression bands (TR Band and Safe Guard Radial), the Safe Guard
1
Introduction
Transradial catheterization (TRC) for diagnostic and interventional coronary procedures is now considered standard of care [ ]. When compared to transfemoral access, transradial catheterization was not only associated with better outcomes and patient satisfaction scores, but also decreased rates of access site complications [ ]. Asymptomatic radial artery occlusion (RAO) is the most common access site complication encountered with transradial approach coronary catheterization [ ]. Although hand ischemia is rarely encountered, the significance of this complication cannot be understated due to the frequent need for repeat procedures. One of the known risk factors for RAO is the ratio of the inner arterial diameter to the outer diameter of the introducer [ ]. Radial artery spasm, also an RAO risk factor, may be attenuated with administration of post-procedural, pre-hemostasis intra-arterial nitroglycerin [ ]. Heparinization has been found to be an effective method of reducing the occurrence of radial artery occlusion [ ]; moreover, providing 50 unit/kg of heparin either intra-arterially or intra-venous has been recommended as best practice [ ]. Non-occlusive hemostasis has also been shown to reduce the rates of radial artery occlusion [ ]. Despite these recommendations, the contemporary “real-world” incidence of acute RAO reported from institutions with expertise in performing TRC continues to reach 10% [ ]. Various pneumatic compression devices have been developed by industry for local compression hemostasis allowing the mobility of the wrist joint without compression of venous return. The objective of our study was to compare the TR band (Terumo Corporation, Summerset, NJ) and Safeguard Radial compression hemostatic devices (Merit Medical, South Jordon, UT) for their ability to provide patent hemostasis, time to achieve hemostasis, radial artery occlusion rates, patient’s level of discomfort related to compression device use, and local vascular complications rates post-procedure and at 30 days follow up.
2
Methods
This study was performed at a tertiary care academic teaching hospital with extensive experience in transradial catheterization (TRC), and an institution wide TRC rate of 67%. Four full time interventional cardiologists, enrolled patients prospectively in this single center trial over an 11-month period. All patients presenting for elective diagnostic or interventional cardiac catheterization procedures were evaluated with pre-procedural Barbeau’s test. Patients with a history of heparin intolerance, scleroderma, Raynaud’s phenomenon, active use of anticoagulation, and Barbeau’s type D response were excluded. Those patients who consented to participate and were eligible for post-radial procedure use of a compression device were randomized 1:1 to receive either TR band (TRG) or Safeguard Radial Band (SGG) for radial hemostasis, using a random number table.
2.1
Transradial catheterization
After sterile preparation and 2% Lidocaine infiltration, using a 21 gauge Teflon-sheathed needle or a 21-gauge bare needle, radial artery access was obtained using the counterpuncture technique or anterior wall puncture technique, respectively. An eleven-centimeter-long 6 Fr Slender hydrophilic introducer sheath (Terumo Interventional Systems, Tokyo, Japan) was inserted into the radial artery lumen over a 0.021-inch guidewire. All patients received 200 μm of Nitroglycerin and 2.5 mg of Verapamil, as the radial artery “cocktail”. As soon as the wire crossed into the ascending aorta, 50 units/kg of unfractionated Heparin was injected intravenously for all patients. If the procedure was a percutaneous coronary intervention, >70 units/kg of unfractionated Heparin was injected intravenously. Diagnostic coronary angiography was performed using 5-Fr or 6-Fr catheters. Selection of catheter shape was left up to the operator’s discretion. During the procedure, radial sheaths were not fixed with tegaderm or sutures.
2.2
Hemostasis protocol
An attending physician or trained cardiology fellow in the cardiac catheterization lab applied the randomly assigned radial hemostasis band (TR Band or Safeguard Band), following the package insert instruction and previously described patent hemostasis technique [ ]. Briefly, after applying the band with optimal approximation and full pneumatic compression (18 cc for TR band and 7 cc of air for Safeguard Band) the sheath was removed. The compression was reduced in the band by a controlled, slow aspiration of air from the band until bleeding was seen at the access site. At that point, compression was increased slightly (by adding 1 cc of air) to apply just enough pressure to achieve hemostasis. Plethysmography probe was applied on the index finger of the accessed hand. The ulnar artery on the affected hand was compressed and the presence of pulse oxygen waveform was evaluated and documented. While hemostasis was the primary objective, success or failure to achieve patent hemostasis was documented. The initial lowest compression volume in the band (cc) used to achieve hemostasis was documented. Reassessment of patent hemostasis was observed after the patient was transferred to the recovery area. An objective universal pain assessment tool evaluated the discomfort associated with the band application [ ]. The discomfort level on the pain scale was noted at the time of application of the band, on arrival to the post-procedure ward, and after the removal of the hemostatic band. The picture of the pain scale was shown to the patient prior to recording the pain score. If crossover to the other compression device occurred, it was documented along with the reason.
2.3
Time to hemostasis
Time to hemostasis was defined as time from sheath removal to complete removal of the hemostatic band. The first attempt to remove the compression band for both the groups was performed at either one or 2 h after band application, for the diagnostic (Heparin 50 unit/kg) or interventional (Heparin >70 unit/kg) procedures, respectively. At the time of removal, initially the band was decompressed by slowly aspirating air, with the device kept in same position. If bleeding or oozing was noted the band was re-inflated to the initial compression volume; however, if no bleeding or oozing was seen, then the band was removed. If the initial attempt was unsuccessful, a second attempt to remove the band was made 30 min after the initial, and every 30 min thereafter if each subsequent attempt resulted in bleeding or oozing. Each attempt at removal followed the same method as previously outlined.
2.4
Radial artery patency evaluation
Radial artery patency was assessed by digital plethysmography using the reverse Barbeau’s test. A digital sensor was placed on the index finger or the thumb with both the radial and ulnar arteries compressed transiently, until loss of plethysmography signal, after which the radial artery was released. If there was return of the plethysmography signal while maintaining ulnar compression, the radial artery was considered patent. Each patient was assessed by the investigator, interventional or general cardiology fellow, or trained clinical research nurse before the patient’s discharged (2–3 hour post-procedure for diagnostic procedure and 8–18 h for intervention procedure) and at one-month follow-up. Duplex-ultrasound was used to confirm an occluded radial artery. Prospectively all of the demographic data, procedural data, patient pain scale, device success, radial artery patency, and local access site complications such as hematoma, inflammation, AV fistula, and pseudoaneursym formation were recorded at the time of discharge and at one month follow up.
2.5
Statistical analysis
All variables were analyzed to characterize the type of distribution. Analyses were performed with patients assigned to their original randomization group, on an intention-to-treat basis. Differences among normally distributed continuous variables were evaluated using the Student t -test, and those not normally distributed were evaluated using the Mann-Whitney U test. Differences among categorical variables were evaluated using the chi-square test or Fisher exact test. Sample size calculation was calculated for binary outcomes in a parallel group non-inferiority trial. Based on a previous comparison study with the TR band [ ], if there is a true difference in favor of the Safeguard band of 3%, then 300 patients are required to be 80% sure that the upper limit of a one-sided 90% confidence interval will exclude a difference in favor of the TR band group of >1.5%. Therefore 320 patients were enrolled considering 5% loss of follow-up. Analyses were performed using SPSS version 20 (IBM, Armonk, New York).
2
Methods
This study was performed at a tertiary care academic teaching hospital with extensive experience in transradial catheterization (TRC), and an institution wide TRC rate of 67%. Four full time interventional cardiologists, enrolled patients prospectively in this single center trial over an 11-month period. All patients presenting for elective diagnostic or interventional cardiac catheterization procedures were evaluated with pre-procedural Barbeau’s test. Patients with a history of heparin intolerance, scleroderma, Raynaud’s phenomenon, active use of anticoagulation, and Barbeau’s type D response were excluded. Those patients who consented to participate and were eligible for post-radial procedure use of a compression device were randomized 1:1 to receive either TR band (TRG) or Safeguard Radial Band (SGG) for radial hemostasis, using a random number table.
2.1
Transradial catheterization
After sterile preparation and 2% Lidocaine infiltration, using a 21 gauge Teflon-sheathed needle or a 21-gauge bare needle, radial artery access was obtained using the counterpuncture technique or anterior wall puncture technique, respectively. An eleven-centimeter-long 6 Fr Slender hydrophilic introducer sheath (Terumo Interventional Systems, Tokyo, Japan) was inserted into the radial artery lumen over a 0.021-inch guidewire. All patients received 200 μm of Nitroglycerin and 2.5 mg of Verapamil, as the radial artery “cocktail”. As soon as the wire crossed into the ascending aorta, 50 units/kg of unfractionated Heparin was injected intravenously for all patients. If the procedure was a percutaneous coronary intervention, >70 units/kg of unfractionated Heparin was injected intravenously. Diagnostic coronary angiography was performed using 5-Fr or 6-Fr catheters. Selection of catheter shape was left up to the operator’s discretion. During the procedure, radial sheaths were not fixed with tegaderm or sutures.
2.2
Hemostasis protocol
An attending physician or trained cardiology fellow in the cardiac catheterization lab applied the randomly assigned radial hemostasis band (TR Band or Safeguard Band), following the package insert instruction and previously described patent hemostasis technique [ ]. Briefly, after applying the band with optimal approximation and full pneumatic compression (18 cc for TR band and 7 cc of air for Safeguard Band) the sheath was removed. The compression was reduced in the band by a controlled, slow aspiration of air from the band until bleeding was seen at the access site. At that point, compression was increased slightly (by adding 1 cc of air) to apply just enough pressure to achieve hemostasis. Plethysmography probe was applied on the index finger of the accessed hand. The ulnar artery on the affected hand was compressed and the presence of pulse oxygen waveform was evaluated and documented. While hemostasis was the primary objective, success or failure to achieve patent hemostasis was documented. The initial lowest compression volume in the band (cc) used to achieve hemostasis was documented. Reassessment of patent hemostasis was observed after the patient was transferred to the recovery area. An objective universal pain assessment tool evaluated the discomfort associated with the band application [ ]. The discomfort level on the pain scale was noted at the time of application of the band, on arrival to the post-procedure ward, and after the removal of the hemostatic band. The picture of the pain scale was shown to the patient prior to recording the pain score. If crossover to the other compression device occurred, it was documented along with the reason.
2.3
Time to hemostasis
Time to hemostasis was defined as time from sheath removal to complete removal of the hemostatic band. The first attempt to remove the compression band for both the groups was performed at either one or 2 h after band application, for the diagnostic (Heparin 50 unit/kg) or interventional (Heparin >70 unit/kg) procedures, respectively. At the time of removal, initially the band was decompressed by slowly aspirating air, with the device kept in same position. If bleeding or oozing was noted the band was re-inflated to the initial compression volume; however, if no bleeding or oozing was seen, then the band was removed. If the initial attempt was unsuccessful, a second attempt to remove the band was made 30 min after the initial, and every 30 min thereafter if each subsequent attempt resulted in bleeding or oozing. Each attempt at removal followed the same method as previously outlined.
2.4
Radial artery patency evaluation
Radial artery patency was assessed by digital plethysmography using the reverse Barbeau’s test. A digital sensor was placed on the index finger or the thumb with both the radial and ulnar arteries compressed transiently, until loss of plethysmography signal, after which the radial artery was released. If there was return of the plethysmography signal while maintaining ulnar compression, the radial artery was considered patent. Each patient was assessed by the investigator, interventional or general cardiology fellow, or trained clinical research nurse before the patient’s discharged (2–3 hour post-procedure for diagnostic procedure and 8–18 h for intervention procedure) and at one-month follow-up. Duplex-ultrasound was used to confirm an occluded radial artery. Prospectively all of the demographic data, procedural data, patient pain scale, device success, radial artery patency, and local access site complications such as hematoma, inflammation, AV fistula, and pseudoaneursym formation were recorded at the time of discharge and at one month follow up.
2.5
Statistical analysis
All variables were analyzed to characterize the type of distribution. Analyses were performed with patients assigned to their original randomization group, on an intention-to-treat basis. Differences among normally distributed continuous variables were evaluated using the Student t -test, and those not normally distributed were evaluated using the Mann-Whitney U test. Differences among categorical variables were evaluated using the chi-square test or Fisher exact test. Sample size calculation was calculated for binary outcomes in a parallel group non-inferiority trial. Based on a previous comparison study with the TR band [ ], if there is a true difference in favor of the Safeguard band of 3%, then 300 patients are required to be 80% sure that the upper limit of a one-sided 90% confidence interval will exclude a difference in favor of the TR band group of >1.5%. Therefore 320 patients were enrolled considering 5% loss of follow-up. Analyses were performed using SPSS version 20 (IBM, Armonk, New York).
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