Radial artery occlusion after conventional and distal radial access: Impact of preserved flow and time-to-hemostasis in a propensity-score matching analysis of 1163 patients.

OBJECTIVES: To compare incidence of forearm radial artery occlusion (RAO) and hemostasis characteristics between distal and conventional transradial approach (DRA and TRA, respectively). BACKGROUND: DRA has the potential advantage of reducing RAO. DRA effectively reduces time-to-hemostasis, however its role on preserving flow in the radial artery (PF) during hemostasis and consequent impact on RAO remains speculative. METHODS: Eight hundred thirty-seven patients with TRA were previously enrolled in a prospective registry investigating the relationship of residual anticoagulation and RAO. Three hundred twenty-six additional patients with DRA were added to the cohort and matched to the original cohort by propensity score. The composite end-point of RAO at forearm and distal site of puncture (dRAO) was evaluated as secondary end-point. RESULTS: RAO occurred in 4.8% (41 of 837) of patients undergoing TRA and in 0% (0 of 326) of those undergoing DRA (p < 0.0001). DRA was associated with higher percentage of PF (97.2% vs. 78.5% in TRA group, p < 0.0001) and reduced time-to-hemostasis (147 ± 99 min vs. 285 ± 138 min, p < 0.0001). After matching, hemostasis characteristics were still significant different (PF 95.7% vs. 90.1%, p = 0.023, and 190 ± 92 vs. 323 ± 162 min, p < 0.0001) with reduction in the incidence of RAO (0 of 213, 0% vs. 7 of 213, 3.3%, p = 0.0015). dRAO occurred in one case (0.3% and 0.5% after matching, p < 0.0001 and p = 0.032 compared to TRA). CONCLUSIONS: DRA was associated with lower rates of RAO compared to TRA. This effect is potentially explained by reduced time-to-hemostasis and maintained flow at the wrist during hemostasis.

Predictors of patent and occlusive hemostasis after transradial coronary procedures.

OBJECTIVES: To assess the independent predictors of patent and occlusive hemostasis (PH and OH, respectively) during radial hemostasis after coronary procedures. BACKGROUND: Radial artery occlusion (RAO) is a thrombotic complication of transradial catheterization that can lead to permanent occlusion of the radial artery. Sheath-vessel diameter ratio, postprocedure compression time, occlusive hemostasis, inadequate, and excessive anticoagulation are all predictors of RAO. METHODS: As a part of a previously published study investigating the relationship between residual anticoagulation and risk of RAO, 837 patients undergoing transradial diagnostic coronary angiography or percutaneous coronary interventions were enrolled. Cumulative heparin dose used during the procedure and ACT measured before sheath removal were recorded. PH with reverse Barbeau test was attempted in all patients (NCT02762344). RESULTS: PH was less frequently obtained for increasing cumulative heparin dose and ACT values (p < .0001 and p = .0034, respectively). At logistic regression analysis both cumulative heparin dose and ACT values were independent predictors of OH (OR 1.017, 95% IC 1.011-1.023 p < .0001 and OR 1.004, 95% IC 1.001-1.006, p = .0004) while adjusted probability for RAO showed exponential relationship with both parameters. CONCLUSIONS: The level of anticoagulation is strongly related to the incidence of RAO, and should be taken into account when choosing hemostasis protocol.

Ankaferd blood stopper as a new strategy to avoid early complications after transradial procedures: A randomized clinical trial.

BACKGROUND: We planned a three arm randomized study to evaluate the safety and efficacy of a new blood stopper, Ankaferd blood stopper (ABS) along with short-time compression, compared to either short-time compression with conventional sterile gauzes (CSG) or with a TR band after transradial (TRA) procedures. METHODS: The Ankaferd blood stopper as a new strategy to avoid early complications. After transradial procedures (ABS transradial) trial is designed in a prospective, randomized, placebo-controlled fashion and registered with http://clinicaltrials.gov (NCT02982733). Six hundred and thirty patients were randomized into three arms in a 1:1:1 fashion corresponding to three different strategies of patent hemostasis techniques after diagnostic or interventional catheterization. RESULTS: One (0.49%) patient in the CSG group and one patient (0.48%) in the TR Band group developed RAO at the end of the hemostasis, compared with 0 (0%) in the ABS group. At 30 days follow-up none of the groups had any patients with RAO. As a secondary end-points the difference was not statistically significant regarding hematoma among the three groups (P = 0.70). Bleeding during deflation of the TR Band or removal of the elastic bandage occurred in 55 patients (26.96%) in the CSG group and in 56 (27.31%) patients in the TR Band group compared to 19 patients (9.40%) in the ABS group (P < 0.001). CONCLUSION: Ankaferd blood stopper is a promising device for use in patent hemostasis, with no evidence on RAO at short-term or long term and with reduced risk of re-bleeding at the end of hemostasis.

Open Radial Artery Study.

Radial artery occlusion (RAO) has been the most common postprocedural complication of transradial artery access. The optimal method of prevention of RAO is still lacking. In our study, we aimed to evaluate the effect of patent hemostasis on early (24 hours) and late (2 weeks) RAO prevention. The Open Radial Artery Study was a single-arm, prospective, and multicenter study. The primary end points were early and late RAO at the vascular access site after transradial coronary procedures. Secondary end points were access site hematoma, pseudoaneurysm formation, arteriovenous fistula, and nerve injury. A total of 2,181 patients were analyzed (67% male, mean age 68 years). The mean interventional duration and hemostatic times were 75.6 ± 55.6 and 60 ± 5.6 minutes, respectively. Radial artery spasm occurred in 10% of patients (n = 218). Catheter kinking, radial artery rupture, or dissection were not observed during the procedure. RAO, hematoma, pseudoaneurysm, arteriovenous fistula, or nerve damage was not observed in any of the patients in the early or late period. In patients who undergo coronary diagnostic or interventional procedures through transradial artery access, the patent hemostasis method seems a critical step in the prevention of early and late RAO.

A comparison between radial artery compression devices for patent hemostasis after transradial percutaneous interventions.

OBJECTIVES: Patent hemostasis (PH) is essential for preventing radial artery occlusion (RAO) after trans-radial procedures; however, it remains unclear how it should be obtained. The aim of this multicenter randomized study was to evaluate whether the use of an adjustable device (AD), inflated with a pre-determined amount of air (AoA), was more effective than a non-adjustable device (non-AD) for achieving PH, thereby reducing the incidence of RAO. METHODS: We enrolled a total of 480 patients undergoing transradial procedure at 3 Italian institutions. Before the procedure, a modified Reverse Barbeau Test (mRBT) was performed in all patients to evaluate the AoA to be eventually inflated in the AD. After the procedure, patients were randomized into 2 groups: (1) AD Group, using TR-Band (Terumo) inflated with the pre-determined AoA; and 2) non-AD Group, using RadiStop (Abbott). An RBT was performed during compression to demonstrate the achievement of PH, as well as 24 hours later to evaluate the occurrence of RAO. RESULTS: PH was more often obtained in the AD Group compared with the non-AD Group (90% vs 64%, respectively, P less than .001), with no difference in terms of bleedings. RAO occurred more often in the non-AD Group compared with the AD Group (10% vs 3%, respectively, P less than .001). Of note, mRBT was effective at guiding AD inflation and identifying high-risk patients in whom PH was more difficult to obtain. CONCLUSIONS: The use of AD, filled with a predetermined AoA, allowed PH significantly more often compared with non-AD, providing a significantly reduced incidence of RAO.

Outcomes of a Modified Technique for Deflation of Distal Radial Artery Occlusion Device on Radial Artery Patency After Percutaneous Coronary Intervention.

Objective: This study aimed to compare two protocols of deflation with increased intervals versus late deflation with smaller intervals for distal radial artery occlusion device (DROAD) removal to assess for radial artery occlusion (RAO). Methods: All patients who underwent PCI with distal radial access were enrolled in the study. The DROAD was applied using an occlusive hemostasis method. Patients were assigned to either protocol 1 or protocol 2 at the primary physician's discretion. Protocol 1 involved the removal of 2 ml of air starting 1 h after the sheath removal and then the removal of 2 ml every 30 min until the band came off. Protocol 2 involved the removal of 4 ml of air 2 h after the sheath removal and then a further 4 ml of air every 15 min until the band came off. Results: A total of 446 patients were enrolled in this study (mean age; 61 ± 6 (Group 1) and 60 ± 5 (Group 2); females 45.83% (Group 1) and 46.34% (Group 2)). The baseline characteristics were the same, including mean hemostasis time (256 ± 25 min (Group 1) and 254 ± 28 min (Group 2), P-value = 0.611). Primary and secondary endpoints did not reach significance in either group (RAO; 21 (8.71) Group 1 and 18 (8.78) Group 2 (P-value = 0.932)). Age (OR (95%CI): 1.07 (0.57-1.45); P-value = 0.031), female gender (OR (95%CI): 1.42 (0.93-1.74); P-value = 0.012), distal artery diameter (OR (95%CI): 0.57 (0.21-0.93); P-value = 0.005), procedure time (OR (95%CI): 2.64 (0.95-4.32); P-value = 0.001), and sheath size (OR (95%CI): 2.47 (1.43-3.76); P-value = 0.044) were predictors of RAO in our cohort. Conclusion: This investigation shows no difference in the incidence of RAO with the standard versus accelerated deflation protocol after PCI. However, local vascular complications, including hematoma were increased with the accelerated protocol.

Comparison of Safety of RADial comPRESSion Devices: A Multi-Center Trial of Patent Hemostasis following Percutaneous Coronary Intervention from Conventional Radial Access (RAD-PRESS Trial).

Although radial access is the current gold standard for the implementation of percutaneous coronary interventions (PCI), post-procedural radial compression devices are seldom compared with each other in terms of safety or efficacy. Our group aimed to compare a cost effective and potentially green method to dedicated radial compression devices, with respect to access site complications combined in a device oriented complex endpoint (DOCE), freedom from which served as our primary endpoint. Patients undergoing PCI were randomized to receive either the cost effective or a dedicated device, either of which were removed using patent hemostasis. Twenty-four hours after the procedure, radial artery ultrasonography was performed to evaluate the access site. The primary endpoint was assessed using a non-inferiority framework with a non-inferiority margin of five percentage points, which was considered as the least clinically meaningful difference. The cost-effective technique and the dedicated devices were associated with a comparably low rate of complications (freedom from DOCE: 83.3% vs. 70.8%, absolute risk difference: 12.5%, one-sided 95% confidence interval (CI): 1.11%). Composition of the DOCE (i.e., no complication, hematoma, pseudoaneurysm, and radial artery occlusion) and compression time were also assessed in superiority tests as secondary endpoints. Both the cost-effective technique and the dedicated devices were associated with comparably low rates of complications: p = 0.1289. All radial compression devices performed similarly when considering the time to complete removal of the respective device (120.0 (inter-quartile range: 100.0-142.5) for the vial vs. 120.0 (inter-quartile range: 110.0-180) for the dedicated device arm, with a median difference of [95% CI]: 7.0 [-23.11 to 2.00] min, p = 0.2816). In conclusion, our cost-effective method was found to be non-inferior to the dedicated devices with respect to safety, therefore it is a safe alternative to dedicated radial compression devices, as well as seeming to be similarly effective.

Prevention of Radial Artery Occlusion of 3 Hemostatic Methods in Transradial Intervention for Coronary Angiography.

OBJECTIVES: The main objective of this study was to compare the efficacy of 3 hemostatic methods for the prevention of early radial artery occlusion (RAO): standard patent hemostasis, patent hemostasis with ulnar compression or the ulnar artery transient compression facilitating radial artery patent hemostasis (ULTRA) method, and facilitated hemostasis with a hemostatic disc. BACKGROUND: There are no prospective randomized studies that compare early RAO rates with the 3 most used nonocclusive hemostatic methods. METHODS: This was a prospective, longitudinal, comparative, and randomized study. The final population analyzed was 1,469, and they were randomized into 3 groups: 491 patients in group 1 with standard patent hemostasis, 490 patients in group 2 with the ULTRA method, and 488 patients in group 3 with facilitated hemostasis with a hemostatic disc. RESULTS: The RAO rate at 24 hours of the total population analyzed was 4.6%. By hemostasis groups, it was 3.6% for patent hemostasis, 5.5% for the ULTRA method, and 4.7% for facilitated hemostasis with a hemostatic disc, with no statistical difference among the 3 groups (P = 0.387). At 30 days, the overall rate of RAO was 1.8%, and by groups, it was 1.4% for the patent hemostasis group, 1.8% for the ULTRA method group, and 2.2% for the facilitated hemostasis with a hemostatic disc group, respectively (P = 0.185). CONCLUSIONS: The rates of RAO at 24 hours evaluated by plethysmography oximetry and confirmed by ultrasound among 3 current radial hemostasis methods (ie, patent hemostasis, the ULTRA method, and facilitated hemostasis with a hemostatic disc) are not different.

Prevention of radial artery occlusion by simultaneous ulnar and radial compression (PRO-SURC). A randomized duplex ultrasound follow-up study.

BACKGROUND: There might be a beneficial effect of transient ulnar artery compression in prevention of radial artery occlusion (RAO) after trans-radial catheterization. OBJECTIVE: The objective of this study was to assess, by Duplex ultrasound, the efficacy of simultaneous ulnar and radial artery compression (SURC), in prevention of RAO, compared to conventional and patent hemostasis techniques. PATIENTS AND METHODS: Four hundred and fifty consecutive patients undergoing elective trans-radial catheterization were enrolled. Patients were randomized in 1:1:1 fashion into 3 groups; conventional hemostasis (Group A, n = 150 patients), patent hemostasis (Group B, n = 150 patients), and SURC technique (Group C, n = 150 patients). RAO was assessed by duplex ultrasound at 1-h post TR band removal (primary endpoint), and at 1-month. RESULTS: The primary endpoint, RAO 1-h post TR-band removal, was significantly lower among patients of group C as compared to those of group A and B (1.3%, 6.7%, and 7.3%, respectively -p = 0.03). This was still consistent at 1-month (0.7%, 8%, and 6%, respectively -p = 0.03). Multiple regression analyses revealed that lower radial artery diameter (RAD) after flow-mediated dilatation (FMD) independently predicted RAO at 1-h, while RAD at 1-h post-TR band removal was the only independent predictor of RAO at 1-month. Receiver operator characteristic (ROC) analysis showed that RAD at 1-h post-TR band removal at cut-off ≤1.75 mm could predict RAO at 1-month with high accuracy (AUC = 0.9, CI = 0.8-1.0, p < 0.001-86% sensitivity, and 95% specificity). CONCLUSION: A technique of SURC is associated with less incidence of early and late RAO compared to conventional hemostasis techniques.

Distal Transradial Artery Access for Neuroangiography and Neurointerventions : Pitfalls and Exploring the Boundaries.

INTRODUCTION: The distal transradial approach (dTRA) is progressively gaining more clinical use in the fields of cardiology and other vascular interventions, as it offers a number of advantages compared to conventional radial approach (TRA). These include lower rates of vascular occlusion which permits preservation of the proximal radial artery for future procedures in the event of a distal occlusion. AIM: To share the experience in the use of dTRA for neurointerventions, showing its advantages, pitfalls as well as sharing our optimized puncture and hemostatic ultrarapid compression protocols to improve the use of this vascular access. METHODS: A retrospective analysis of our experience of diagnostic and interventional procedures performed via dTRA using an optimized protocol for puncture and postpuncture compression of the dTRA was performed. The rate of complications (hematoma and arterial dissection at puncture site) femoral crossover, and assessment of postprocedural stenosis/occlusion with the ultrarapid compression protocol were also assessed. RESULTS: From March 2019 to July 2020 a total of 100 distal radial procedures were carried out and 53 diagnostic angiograms (53%) and 47 interventional procedures (47%) were included in the analysis. We achieved a 96% technical success, with a femoral crossover requirement in 3 cases (3%), and one conventional TRA crossover due to puncture failure. Of the patients 3 presented puncture site hematomas (3%) with no intervention required, 61 patients (61%) underwent the ultrarapid hemostasis protocol in association with a hemostatic pad. Ultrasound follow-up was performed in 20 patients (20%) at 1-2 months with 1 case of occlusion (5%) and 2 of radial stenosis (10%). In all 3 cases proximal radial artery remained patent. CONCLUSION: The dTRA is a safe and feasible access route for angiography and neurointerventions. Using vasodilators prepuncture, we attained a variable increase in the vascular diameter facilitating puncture and reducing the risk of occlusion and vascular spasm. A rapid deflation protocol for postpuncture hemostasis does not significantly increase the hematoma rate.

Patent Hemostasis Impact in Clinical Routine: Large Monocentric Echo-Doppler Study of Radial Artery Patency After Coronary Catheterization.

BACKGROUND: Radial access is currently the first line of access in interventional cardiology. Nevertheless, this technique carries a 1%-10% risk of radial artery occlusion (RAO) based on series. METHODS: We conducted a large-scale echo-Doppler evaluation of radial patency including prospectively all patients who underwent coronary angiography and/or angioplasty with radial catheterization at our center in 2018. RESULTS: A total of 1106 patients were enrolled in the cohort. Average patient age was 70 years, 24.5% were females and 75.5% were males, and 28.3% were diabetics. Five Fr and 6 Fr devices were used in 527 procedures and 565 procedures, respectively. Our study highlighted a very low RAO rate (0.99%). These results are mainly due to the high attention given to patent hemostasis, which was achieved in 1091 patients (98.6%). According to the literature, female gender is a multivariate predictive factor of RAO (P<.01). Furthermore, we confirm the protective nature of heparin (P=.04) with an average heparin dose of 69.73 IU/kg. CONCLUSIONS: Our study focused on a large population with 1106 patients who underwent radial catheterization shows that a very low rate of RAO (0.99%) can be achieved. These results are correlated with a high attention to patent hemostasis and a close collaboration between the medical and paramedical staff.

Patent hemostasis of radial artery: Comparison of two methods.

BACKGROUND: Radial artery obstruction is the most common complication of coronary angiography performed via transradial access. Patent hemostasis can significantly reduce the risk of radial artery occlusion. Previous studies utilized sophisticated methods to evaluate radial artery patency. Simplified and easily applicable methods for successful patent hemostasis are currently lacking. AIM: To determine which method (pulse oximeter vs the traditional radial artery palpation) is better to achieve patent hemostasis. METHODS: This prospective, single center study included 299 consecutive patients who underwent coronary angiography or percutaneous coronary intervention between November 2017 and July 2019. Patients less than 18 years old, with a history of radial artery disease, or no palpable artery pulse were excluded from the study. Patients were randomly assigned to two groups. In the first group, radial artery flow was assessed by palpation of the artery during hemostasis (traditional method). In the second group, radial artery patency was estimated with the use of a pulse oximeter. Two different compression devices were used for hemostasis (air chamber and pressure valve). The primary study endpoint was the achievement of successful patent hemostasis. RESULTS: The two groups (pulse oximeter vs artery palpation) had no significant differences in age, sex, body mass index, risk factors, or comorbidities except for supraventricular arrhythmias. The percentage of patients with successful patent hemostasis was significantly higher in the pulse oximeter group (82.2% vs 68.1%, P = 0.005). A lower percentage of patients with spasm was recorded in the pulse oximeter group (9.9% vs 19.0%, P = 0.024). The incidence of local complications, edema, bleeding, hematoma, vagotonia, or pain did not differ between the two groups. In the multivariate analysis, the use of a pulse oximeter (OR: 2.35, 95%CI: 1.34-4.13, P = 0.003) and advanced age (OR: 1.04, 95%CI: 1.01-1.07, P = 0.006), were independently associated with an increased probability of successful patent hemostasis. The type of hemostatic device did not affect patent hemostasis (P = 0.450). CONCLUSION: Patent hemostasis with the use of pulse oximeter is a simple, efficient, and safe method that is worthy of further investigation. Larger randomized studies are required to consider its clinical implications.

Epidermal bulla: A dermatology complication of radial artery compression band.

Patent hemostasis technique is used with the trans radial (TR) band to prevent radial artery occlusion following diagnostic coronary angiogram or percutaneous coronary intervention using radial artery access. We report epidermal bulla as a complication of TR band usage and a modified patent hemostasis technique using barbeau test to prevent this complication.

Compare Complication of Classic versus Patent Hemostasis in Transradial Coronary Angiography.

BACKGROUND: Coronary artery disease (CAD) is multifactorial disease, in which thrombotic occlusion and calcification occur usually. New strategies have been made for diagnosis and treatment of CAD, such as transradial catheterization. Hemostasis could be done in two approaches: traditional and patent. Our aim is to find the best approach with lowest complication. MATERIALS AND METHODS: In a comparative study, 120 patients were recruited and divided randomly into two subgroups, including traditional group (60 patients; 24 females, 36 males; mean age: 64.35 ± 10.56 years) and patent group (60 patients; 28 females, 32 males; mean age: 60.15 ± 8.92 years). All demographic data including age, gender, body mass index, and CAD-related risk factors (smoking, diabetes, hypertension) and technical data including the number of catheters, procedure duration, and hemostatic compression time and clinical outcomes (radial artery occlusion [RAO], hematoma, bleeding) were collected. Data were analyzed by SPSS version 16. RESULTS: Our findings revealed that the incidence of RAO was significantly lower in patent groups compared with traditional group (P = 0.041). Furthermore, the difference incidence of RAO was higher in early occlusion compare with late one (P = 0.041). Moreover, there were significant relationship between some factors in patients of traditional group with occlusion (gender [P = 0.038], age [P = 0.031], diabetes mellitus [P = 0.043], hemostatic compression time [P = 0.036]) as well as in patent group (age [P = 0.009], hypertension [P = 0.035]). CONCLUSION: Our findings showed that RAO, especially type early is significantly lower in patent method compared classic method; and patent hemostasis is the safest method and good alternative for classical method.