A Comparison Between Radial Artery Compression Devices for Patent Hemostasis After Transradial Percutaneous Interventions

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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 < .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 < .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.

Trans-radial coronary interventions are proven to be safe and effective, and to reduce access site vascular complications and mortality when compared with the femoral approach.^1-7 In addition, early mobilization and discharge can be warranted, thereby reducing overall costs.^5,6 Unfortunately, radial artery occlusion (RAO) represents one of the most common complications of trans‐radial procedures, occurring soon after the procedure in about 1% to 10% of cases.⁸ Although RAO is rarely associated with major clinical consequences such as hand ischemia, and up to 50% of patients have spontaneous recanalization of the artery within 1 to 3 months,^9,10 it remains an important complication because it prohibits future trans-radial uses, such as pressure monitoring and utilization of the radial artery as a conduit for coronary artery bypass grafting or for preparing arteriovenous fistula in patients with chronic kidney disease.

Prevention of RAO is possible by administrating unfractionated heparin (UFH) to prevent vessel thrombosis and by obtaining a patent hemostasis (PH) that preserves antegrade radial flow while avoiding bleedings during radial compression.^11,12 The introduction of specific radial artery compression devices to obtain PH made radial compression easier and safer compared with when it had to be performed manually. Two types of devices are currently available to obtain radial hemostasis: an adjustable pneumatic compression device (adjustable device [AD]), and a non-adjustable compression device (non-AD). However, these devices are considered “bleeding preventing” devices since they are inflated or tighten on the wrist as long as bleeding is avoided, regardless of radial artery patency, and there is no consensus about how PH should be obtained with their use. Indeed, PH might be easily achieved with the AD, which can be inflated or deflated during radial hemostasis evaluating the oximetry curves, but this procedure is poorly used in the current practice because it is time-demanding and perceived as dangerous for patients because deflation of the compression device might allow bleeding from the access site. To overcome these potential limitations, the exact amount of air to be inflated in the AD could be determined before the procedure. On the contrary, since a non-AD does not permit objective regulation of the pressure applied on the radial artery, PH cannot be guaranteed.

Thus, the aim of this study was to evaluate whether the use of an AD inflated with a pre-determined amount of air (AoA) was more effective than a non-AD for achieving PH, thereby reducing the incidence of acute RAO.

Study population. From June 2019 to June 2020, patients undergoing trans-radial catheterization at the following 3 Italian institutions were selected: (1) Division of Cardiology, University of Naples Federico II, (2) Division of Cardiology, Di Venere Hospital, Bari, and (3) Division of Cardiology, Bonomo Hospital, Andria. Patients presenting with ST-elevation myocardial infarction and cardiogenic shock were excluded, as well as patients in whom the invasive procedure was not fully performed through the radial route, whether due to tortuosity or the occurrence of arterial spasm. Finally, patients who had previously undergone trans-radial procedure and those with a history of immunologic disorder (ie, scleroderma or Raynaud’s disease) were also excluded.¹³ The study protocol was approved by the institutional investigation committees and all patients signed informed consent (Local Ethics Committee protocol n. 345/18).

Study protocol. Before the invasive procedure, both Barbeau Tests (BT) and modified Reverse Barbeau Tests (mRBT) were performed for all patients. BT was used to evaluate the ulnar compensation of palmar circulation before radial puncture; however, the result of the test was undisclosed for the access site selection. BT was performed as previously described.¹⁴ Briefly, a plethysmography was recorded with a pulse oximeter with the clamp sensor applied to the thumb. The readings were recorded before and immediately after radial artery compression for 2 minutes and divided into 4 different profile types:

          A. No dampening of pulse tracing immediately after radial artery compression;

          B. Dampening of pulse tracing;

          C. Loss of pulse tracing after occlusion and recovery within 2 minutes;

          D. Loss of pulse tracing without recovery (Supplemental Figure).

An mRBT was also performed before the procedure to evaluate the AoA to eventually be inflated into the AD to guarantee PHT while preventing bleeding during radial artery compression at the end of the procedure (Figure). Briefly, before the procedure, a pulse-oximeter was placed with the clamp sensor applied to the thumb while the AD was positioned on the wrist at the level of the selected access site (Figure, A). During manual compression of the ulnar artery, the AD was progressively inflated with a fully air-filled syringe (20 mL) until the plethysmograph disappeared (Figure, B). Immediately after, the AD was gently deflated until the plethysmograph appeared again, identifying at this level the exact amount of air to eventually be inflated into the AD at the end of the invasive procedure (Figure, C).

As soon as the introducer sheath was in place, all patients received UFH (50-70UI/Kg) and, at the end of invasive procedures, were randomized in 2 groups:

1. AD Group: A TR-Band (Terumo) was used to obtain radial artery hemostasis. It was placed on the access site and, while removing the introducer sheath, it was inflated with the previously determined AoA.
2. Non-AD Group: A RadiStop (Abbott) was used to obtain radial artery hemostasis. It was placed on the access site and was fixed on the wrist while removing the introducer sheath.

Patients were randomized (1:1) to either the AD or non-AD group. Group assignment was determined by a computer-based randomization system, which used the 3 letters of the patients’ first and last names to allocate them into the “AD group” or “non-AD group.” The computer program operates in blocks of 3 to 6 patients to achieve a balanced allocation for devices. The randomization system discloses the treatment assignment of the patient without recording the date and time of randomization.

Immediately upon correct positioning of the compression device on the wrist, attention was placed on the presence of bleeding, defined as some drops of blood coming out from the access site. In the case of bleeding, the AD was further inflated by 1 mL until the bleeding stopped, while the non-AD was tightened harder. RBT was performed to evaluate the patency of the radial artery during compression, thereby evaluating whether a correct PH was achieved. Briefly, with the pulse oximeter placed to the thumb, and the compression device in place, the ulnar artery was manually compressed and the plethysmographic waveform variation was evaluated. The presence of types A, B, and C waveforms demonstrated the patency of the radial artery, thereby indicating a correct PH.

Compression devices were left on the wrist for up to 4 hours, as per common local practice. At 24 hours, the presence of hematoma on the access site was evaluated and defined according to the EASY hematoma classification after trans-radial/ulnar PCI.¹⁵ RBT was also performed at 24 hours to evaluate radial artery patency, as previously described.¹⁶ In cases where RAO was suspected, a radial doppler was performed to confirm the occlusion of the vessel.

Statistical analysis. Continuous variables are presented as mean ± standard deviation (SD) or median with interquartile range (IQR) as appropriate. Categorical variables are reported as frequencies and percentages. Normal distribution was tested with the D'Agostino-Pearson omnibus K2 test. Comparisons between categorical variables were evaluated using the Fisher's exact test or the Pearson χ2 test, as appropriate. Student’s t test or the Mann-Whitney U test was used to compare continuous variables, as appropriate. Logistic regression analysis was used to identify those factors associated with selected endpoints. In addition, all variables with a probability value less than 0.10 were candidates for the multivariable regression model, which was performed to identify independent predictors of selected endpoints. Sample size calculation compared proportions for 2 independent samples; calculation was based on the incidence of early RAO as described in a previous study comparing patent (5%) vs conventional (12%) radial artery compression devices.¹⁷ Assuming that patent hemostasis would have been obtained in most of the patients enrolled in the AD Group, a sample size of 454 patients might have been necessary to detect the same difference in terms of early RAO occurrence between the 2 groups of patients (alpha: 0.05, statistical power: 0.80). Finally, a number of 480 patients was required to complete the trial, in order to account for failure in radial hemostasis. Statistical analysis was performed using GraphPad Prism version 9.0 (GraphPad Software) and SPSS version 28 (IBM Corporation), and a P-value of less than .05 was considered significant.

A total of 480 patients were enrolled. Clinical and procedural characteristics of the patients are reported in Table 1. There was no significant difference between the 2 study groups. A significant difference was observed between the 2 groups in terms of radial perfusion profiles evaluated with RBT at the end of the procedure (Table 2). In fact, most of the patients included in the AD group were found to have an RBT profile less than or equal to C. Conversely, in the non-AD group, more than one-third of the patients presented with an RBT profile of D. Therefore, PH was more often obtained in patients in the AD group compared with those in the non-AD group (90% vs 64%, respectively, P < .001). Furthermore, only a few bleeding events were reported during compression, with no significant difference between the 2 groups. Of note, a trend towards a higher incidence of local bleedings was observed in patients with an RBT profile of D (P = .05) (Table 3).

At 24 hours, only type I hematomas at the access site were detected, with no significant difference between patients enrolled in the AD group compared with the non-AD group (20 [8] vs 12 [5], respectively, P = .20). Interestingly, a trend towards higher incidence of local hematoma was observed in patients with an RBT profile of A (P = .08). At 24 hours, RAO occurred more often in patients included in the non-AD group compared with the AD group (10% vs 3%, respectively, P < .001). Of note, as reported in Table 3, RAO more often occurred in patients in whom PH was not achieved (P < .001). Clinical and procedural features associated with a non-patent hemostasis (non-PH) are shown in Table 4.

The use of AD for radial artery compression was found to be protective, while the need of a small AoA (< 15 mL) was independently associated with a non-PH. Of note, a poorly developed ulno-palmar circulation, as indicated by the finding of a profile D at the BT performed prior to the procedure, was also independently associated with non-PH. Clinical and procedural features associated with the need of a small AoA (< 15 mL) are shown in Table 5. Male gender, a BSA greater than 2, hypertension, and the use of the right radial artery were found to be protective. Clinical and procedural features associated with the occurrence of RAO are shown in Table 6. PH was found to be protective regardless of the device used for radial artery compression. Interestingly, the finding of a profile D at the BT was significantly associated with the occurrence of RAO at 24 hours.

In this randomized study, we showed the following: (1) the use of adjustable compression devices, filled with a predetermined AoA, allowed the achievement of PH significantly more often  compared with non-adjustable compression devices, finally providing a significantly reduced incidence of RAO without any significant difference in terms of bleedings; and (2) the occurrence of RAO is not negligible, and can be prevented by performing PH in high-risk patients, particularly those who need a gentle radial artery compression; these patients can be identified by performing an mRBT before the procedure.

PH is considered to be of high importance for the prevention of RAO, however, it remains unclear how it should be obtained. In the Prophet study, an RBT-guided AD inflation during radial compression was able to guarantee PH after trans-radial procedure with a 5-French introducer sheath.17 However, the presence of blood between the compression device and the access site during deflation of the AD might prevent the operator from evaluating the presence of active bleeding, even after further inflation of the AD. Of note, the RBT-guided inflation cannot be easily performed with a non-AD. In the RACOMAP study, radial compression was guided by invasive mean arterial pressure (MAP) and showed a lower incidence of RAO compared with standard compression obtained by inflation of 15 mL of air.18 However, despite a lower compression force in the MAP-guided group, the presence of PH was not confirmed.

In our study, we have investigated the hypothesis that if the exact amount of air to be inflated into the AD is known before its use, PH would be easier to obtain with an AD, thereby leading to a reduced incidence of RAO. Thus, we have calculated the AoA to be inflated into the AD by performing an mRBT before the procedure. This strategy was effective at guaranteeing PH in most of the patients without any additional risk of bleeding. Furthermore, performing an mRBT before the procedure was also useful in identifying those patients who required gentler radial artery compression in order to guarantee PH, namely an inflation of the AD with less than 15 mL of air. These patients were more often women, non-hypertensive, with a small body surface area (BSA < 2), and in whom the invasive procedure was performed through the left radial artery. Of note, in our study, in patients with at least 2 of the above-mentioned features, the AoA was significantly lower compared with the others (respectively, 14.8 ± 2.2 mL vs 15.5 ± 2.4 mL, P < .01) and PH was achieved significantly more often in the AD group compared with the non-AD group (89% vs 57%, respectively, P < .001). As consequence, in this subset of patients, the incidence of RAO was significantly lower in the AD group compared with the non-AD group (3% vs 12%, respectively, P = .01). Therefore, in this context, if radial compression was performed with an AD filled with a predetermined AoA, RAO would have been avoided in 3 out of 4 patients. For these reasons, we suggest performing an mRBT before the procedure not only to evaluate the AoA to be inflated into the AD, but also to identify the high-risk patients who would most benefit from radial compression with an AD.

Although a gentle radial compression, as obtained in the AD group, might have led to a higher risk of bleedings from the access site, no difference in terms of bleedings during compression was found between patients included in the AD group compared with those in the non-AD group (4% vs 5%, respectively, P = .66). Of note, local bleedings were numerically higher in patients in whom PH was not achieved (profile D at RBT, Table 3), probably because the compression devices were tightened as per protocol. However, this case more often occurred in patients enrolled in the non-AD group compared with the AD group (9 out of 12 [75%] vs 1 out of 9 [11%], respectively, P = .010).

Finally, we showed that the finding of a type D profile at BT performed before the invasive procedure, demonstrating a poorly developed ulno-palmar circulation, was significantly associated with RAO occurrence. Although this could be considered an accidental finding, it is possible to speculate that a well-developed ulno-palmar circulation, which would preserve contralateral flow during radial compression, might favor PH and finally reduce the incidence of RAO. This data would support the importance of the assessment of ulno-palmar circulation before trans-radial procedures, but should be confirmed in larger studies.

Limitations. First, neither the operator nor the nurse removing the device could be blinded to the compressive device, which might have induced a potential bias due to a perceived superiority of one device over the other. Second, we did not systematically perform any follow-up for the included patients, therefore, we cannot report on the spontaneous radial recanalization rate. However, acute RAO was asymptomatic in all of the patients. Third, the use of ADs filled with a predetermined AoA did not guarantee PH for all patients. It is possible that contemporary compression of the ulnar artery would have been effective in increasing the rate of PH and reducing the rate of RAO even further.19-21

The use of an AD filled with a predetermined AoA facilitated the achievement of PH, thereby reducing the incidence of RAO compared with a non-AD, without any additional risk of bleedings. Patients at higher risk of RAO can be identified before the invasive procedure, allowing for a better selection of radial artery compression device.

From the ¹Department of Advanced Biomedical Sciences, University of Naples Federico II, Naples, Italy; ²Division of Cardiology, Di Venere Hospital, Bari, Italy; ³Division of Cardiology, Bonomo Hospital, Andria, Italy; ⁴Division of Cardiology, San Carlo Hospital, Potenza, Italy.

Acknowledgements: The authors are grateful for the important jobs conducted by all the nurses, technicians, and students of the 3 institutions involved in the present study; they express their gratefulness to Antonella D’Ascoli, Francesca Del Prete, and Loredana De Cicco for their collaboration.

Disclosures: Dr Di Serafino reports consultant fees from Abbott Vascular, Boston Scientific, Philips, and Hexacath, outside the submitted work. Dr Piccolo reports consultant fees from Abbott Vascular, Biotronik, Terumo, Amgen, Boehringer Ingelheim, and Daiichi-Sankyo, outside the submitted work. Dr Esposito reports consultant fees from Abbott Vascular, Amgen, Boehringer Ingelheim, Edwards Lifesciences, Terumo, and Sanofi, outside the submitted work, and research grants to the institution from Alvimedica, Boston Scientific, and Medtronic. The remaining authors report no financial relationships or conflicts of interest regarding the content herein.

Address for correspondence:  Luigi Di Serafino, MD, PhD, Department of Advanced Biomedical Sciences, Division of Cardiology, University of Naples “Federico II”, 80131, Naples, Italy. Email: luigi.diserafino@unina.it

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