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ULnar Artery Transient Compression Facilitating Radial Artery Patent Hemostasis (ULTRA): A Novel Technique to Reduce Radial Artery Occlusion After Transradial Coronary Catheterization
Abstract: Aims. To evaluate the safety and efficacy of a novel technique with simultaneous compression of the ulnar artery in order to reduce the incidence of radial artery occlusion (RAO) after transradial cardiac catheterizations. Methods and Results. Ipsilateral ulnar artery transient compression for 1 hour facilitating radial artery patent hemostasis (ULTRA) was performed in all patients treated transradially in October 2015 and was compared with patients treated with conventional patent hemostasis in September 2015. The primary endpoint of the study was to evaluate the incidence of RAO within 1 hour after removing the closure device, confirmed by the absence of palpation and the consecutive absence of flow signal with Doppler examination. A total of 119 patients were treated with the ULTRA method and 121 patients with conventional patent hemostasis. None of the patients treated with ULTRA had RAO compared with 6 patients (5%) of those treated with conventional patent hemostasis (P=.01). No hematomas EASY class ≥3, nerve injury, or ischemic pain complications were recorded in either group. Conclusion. The ULTRA technique may reduce the incidence of RAO in patients treated with the radial approach compared with conventional patent hemostasis.
J INVASIVE CARDIOL 2016;28(11):451-454. Epub 2016 August 15.
Key words: transradial access, radial artery occlusion, ulnar compression
Transradial approach (TRA) for coronary intervention is characterized by less frequent hemorrhage at the access site,1 improved patient tolerability,2 and shorter hospitalization stay.3,4 Radial artery occlusion (RAO) in patients undergoing coronary intervention via TRA occurs in 1%-10%.5,6 The incidence of RAO is affected by the compression method,7,8 cannulation time,9,10 radial artery diameter to sheath size ratio,11-14 repeated procedures, and heparin dosage.11,15 Although RAO after TRA catheterization is usually an asymptomatic complication, it has recently raised concerns in the TRA community. A persistent RAO excludes the possibility of future transradial catheterization through the same artery. In the incidence of RAO, blood flow from the ulnar artery provides sufficient perfusion for the thumb and index and minimizes ischemic consequences. Augmentation of blood flow in the radial artery through simultaneous ipsilateral ulnar artery compression may keep the radial artery patent. We assessed the efficacy and safety of transient ipsilateral ulnar artery compression simultaneously with the radial patent hemostasis (the ULTRA method) as a non-pharmacologic method to reduce the incidence of RAO.
Methods
All consecutive patients who underwent coronary angiography and/or coronary angioplasty at the 2nd Cardiology Department of Hellenic Red Cross Hospital of Athens through the TRA during September-October 2015 were recruited, irrespective of the indication for which these procedures were conducted. The TRA is the main approach in our department and was used in 95% of patients who underwent catheterization during the study period. All procedures were performed by interventional cardiologists experienced in the TRA. There were no exclusion criteria for patients with radial access catheterization. Out of a total 240 successfully catheterized TRA patients, a total of 121 patients (September 2015) underwent conventional patent hemostasis compression, while 119 patients (October 2015) were treated with the ULTRA method. Informed consent was signed by all participants and the methodology was performed according to the guidelines of the ethics committee. The primary endpoint of the study was the incidence of RAO within 1 hour after closure device removal, confirmed by the absence of flow signal with Doppler examination.
The cannulation of the radial artery was previously described.16 Allen’s test was not performed before radial artery cannulation, since it is not part of the clinical routine in our laboratory.16 Sterile preparation and local anesthesia with 1-4 mL of lidocaine were performed. The radial artery was cannulated using a through-and-through puncture technique, and 6 Fr hydrophilic 11 cm-long Arrow sheaths (Teleflex) were used. After sheath insertion, a radial cocktail containing 5 mg of verapamil and heparin 5000 IU diluted in a 5 mL syringe was injected gradually through the sheath side arm into the radial artery. If ad hoc coronary angioplasty was decided by the treating physician, more unfractionated heparin (total of 100 IU/kg patient weight) or bivalirudin (0.75 mg/kg bolus and 1.75 mg/kg/h infusion) were administered. Platelet glycoprotein IIb/IIIa receptor inhibitors were used only as a bail-out strategy.
Upon completion of the procedure, the radial sheaths were removed with a tourniquet screw-down pressure plate hemostatic device (KDL, type ZXD II-22; Shanghai Kindly Enterprise Development Group Co) applied at the access site. Initially, the device was screwed tightly and promptly partially unscrewed for minimum hemostatic pressure (conventional patent hemostasis method), without performing Barbeau’s test. At the same time, 1-hour ipsilateral ulnar artery compression with another closure device was used in order to increase peak velocity blood flow into the radial artery. When the ulnar artery was palpable, the physician compressed the artery until no palpation was felt distal to the closure device. If the ulnar pulse was too weak, making the detection of the artery ambiguous, the device was deployed over the expected anatomically ulnar territory. Neither pulse oxymetry nor duplex ultrasonography was performed in case of ulnar artery compression. After ulnar artery compression and before transferring the patient to the recovery room, the initial compression of the radial artery was further reduced by letting up the pressure until bleeding was seen and then adding the minimal pressure needed in order to maintain radial artery patency. Figure 1 shows how the two closure devices are applied. After 1 hour, the ulnar device was removed as per the ULTRA method. Great care was taken to obtain radial artery hemostasis while maintaining minimal pressure. The radial closure device was left in place until hemostasis was completed.
Within 1 hour after device removal, radial artery pulsation was evaluated in all patients and ultrasonography was performed when needed. If the radial artery was not palpable, the patency was reevaluated by duplex ultrasonography. If a duplex ultrasound was compatible with artery flow, the patent hemostasis was considered sufficient. Hematomas defined as EASY class ≥3 before discharge were considered significant.17 Duplex ultrasonographic assessment of the radial artery was performed by physicians who were experienced with the ULTRA method.
Categorical variables are expressed as numbers and percentages and continuous variables as the mean ± standard deviation. The baseline and procedural characteristics were compared using the chi-square test for categorical variables and Student’s t-test for continuous variables. A P-value <.05 was considered significant. All tests were performed using SPSS v. 20.0 software (IBM version 20.0; SPSS, Inc).
Results
The baseline characteristics of the patients are presented in Table 1. All demographic data were comparable between groups with the exception of body mass index. Coronary angiography without PCI was performed in 67 patients (46.3%) in the conventional method group and in 73 patients (53.7%) in the ULTRA method group (P=.35). The radial artery had been previously cannulated in 13 patients in the conventional group and 14 patients in the ULTRA group. The antithrombotic therapy was not statistically different between the groups (Table 2). No differences in the radiation times and doses during the procedures were observed (Table 2).
The duration of radial artery compression was 4.2 ± 1.2 hours in the conventional group vs 4.2 ± 2 hours in the ULTRA group (P=.89). No complications were observed related to the ULTRA method. Fifteen patients (12.4%) were found to have no pulse in the radial artery in the conventional method group vs 3 patients (2.5%) in the ULTRA group (P=.01). After Duplex ultrasonography, 6 patients (5%) had RAO in the conventional patent hemostasis group vs 0 patients in the ULTRA group (P=.01) (Table 3). No hematomas EASY class ≥3 were observed in either group. We did not observe any ischemic signs in any ULTRA patients and there were no specific complaints of pain and injury or nerve damage from either group.
Discussion
Since the development of the TRA technique for diagnostic coronary angiography and intervention, RAO has been recognized as a potential complication after sheath removal.18 Because most RAO cases are asymptomatic, it was underestimated until recently. More than one-half of operators have recognized that RAO was not assessed at hospital discharge.6
Permanent RAO excludes future radial access from the same radial artery. Therefore, efforts must be made to preserve radial artery patency after TRA catheterization. It has been reported that arterial wall damage during puncture and sheath insertion as well as the occlusive hemostasis technique used are probably the most important factors affecting RAO.19 Another study found that the main RAO mechanism is local thrombus formation.20 Bandage time, compression intensity, and inappropriate anticoagulation15 during diagnostic procedures, as previously mentioned, are other predictors of RAO after transradial catheterization, as assessed by duplex Doppler ultrasonography. The blood flow velocity of patients with weak radial artery pulsation was reduced during the systolic and diastolic period, which may be due to vascular endothelial injury and abnormal vasoconstriction induced by the arterial sheath promoting thrombosis.21 RAO may be recanalized late after hospital discharge.12 For the management of subacute RAO, operators proposed retrograde and anterograde distal recanalization with balloon angioplasty.22-24 The prolonged use of low-molecular-weight heparin after RAO has been described as a pharmacologic method to recanalize subacute RAO.20
Ulnar compression was first used for the treatment of RAO in the PROPHET study8 using HemoBand (HemoBand Corporation) patent hemostasis. After loosening the HemoBand, pulsatile plethysmography signal occurred and release of the compression of the ulnar artery followed. Bernat et al17 tested ulnar compression for 1 hour using 2000 IU heparin vs 5000 IU heparin for the treatment of acute RAO, and found that both heparin doses reduced RAO rates, but the 5000 IU dose resulted in better outcomes. Tian et al21 examined whether ulnar compression 1 hour after bandage removal was an effective method for the prevention of RAO when radial artery pulsation was very weak, and found that this was an effective method to maintain radial artery patency. The reduction of RAO remains the primary endpoint of our study.
In the present study, we have shown that using the ULTRA method for 1 hour is an effective and safe non-pharmacologic method for the prevention of acute RAO. The innovation in our study consists of the simultaneous compression of both the radial and the ulnar arteries. The ipsilateral ulnar artery was compressed in order to increase blood flow in the radial artery and reduce the RAO rate.
In our study, RAO was assessed at hospital discharge and we could not exclude that some RAO in the conventional patent hemostasis group might have spontaneously recanalized later. Our study was performed with heparin-based anticoagulation and only a few patients bivalirudin or glycoprotein inhibitors. However, no significant difference in RAO between heparin and bivalirudin was previously shown.25 Ulnar artery compression was limited to 1 hour. We performed transient ulnar artery compression in order to reduce the likelihood of ulnar artery damage.
Study limitations. There are several limitations to our study. First, it is a non-randomized open-label study and thus there might be bias in terms of patient selection and outcome measurement. However, its strength lies in including all patients catheterized through TRA. The results represent pragmatic outcomes of the TRA during a catheterization procedure in a moderate-sized catheterization laboratory. Our results have important clinical applications, since the technique described shows a significant reduction of RAO. Classification of the weakness of radial artery pulsation was not performed in this study. Finally, we have no quantitative variables to confirm the complete compression of the ulnar artery. Further randomized studies are required to confirm the results of the ULTRA method.
Conclusion
Simultaneous ipsilateral ulnar artery compression facilitating radial artery patent hemostasis (the ULTRA method) seems to be an effective non-pharmacologic approach to reduce the incidence of RAO after TRA catheterization.
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From the 2nd Cardiology Department of Hellenic Red Cross Hospital, Athens, Greece.
Disclosure: The authors have completed and returned the ICMJE Form for Disclosure of Potential Conflicts of Interest. The authors report no conflicts of interest regarding the content herein.
Manuscript submitted January 11, 2016, provisional acceptance given February 29, 2016, final version accepted May 23, 2016.
Address for correspondence: Christos Maniotis, MD, PhD, 2nd Cardiology Department of Hellenic Red Cross Hospital, Athens, Greece. Email: chrmn21@gmail.com