A randomised controlled study of standard versus accelerated deflation of the Terumo radial band haemostasis device after transradial diagnostic cardiac catheterisation

Deuling, J. H. H.; Vermeulen, R. P.; Heuvel, A.d F.M. Van den; Schurer, Remco A. J.; Harst, Pim van der

doi:10.1177/1474515116672123

Cited by 8 publications

(10 citation statements)

References 21 publications

(24 reference statements)

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“…The radial pathway has been widely used in percutaneous cardiovascular procedures, since it allows performing complex interventions with reduction of intensity and duration of hemostasis after arterial pressure, and is associated with lower rates of vascular complications and major bleedings with potential impact on morbidity and mortality (1)(2)(3)(4) . Another important factor of this approach is the preferential choice by patients, because it provides greater comfort in recovery after the intervention by enabling early ambulation and shorter hospitalization time (5)(6) . However, the small caliber of the artery makes puncture difficult and requires a longer learning curve compared to femoral access, but these challenges are often overcome with operators' experience (7)(8) .…”

Section: Introductionmentioning

confidence: 99%

Incidence of hemorrhagic complications with use of a radial compression device: a cohort study

Córdova

Santos

Toebe

et al. 2018

Rev. esc. enferm. USP

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Objective: To examine the incidence of hemorrhagic complications in patients undergoing radial cardiac catheterization and using a hemostatic device for arterial compression. Method: A prospective cohort study conducted with patients undergoing elective cardiac catheterization in two hemodynamic laboratories in southern Brazil. The TR Band® radial compression device was used during 4 hours for hemostasis of the arterial puncture site. Hematomas and minor bleeding were the outcomes evaluated. Results: A total of 244 patients were evaluated. The mean age was 63.5±10.9 years, 61.9% were male, 73.8% had systemic arterial hypertension (SAH) and 42.8% were dyslipidemic. Type I hematoma occurred in 1.2% of patients and minor bleeding in 9% after removal of the device. There was no significant association between hematomas and bleeding, and patients who used oral anticoagulants (p=0.604) and prior use of antiplatelets (p=0.958). Conclusion: The use of the hemostatic device for radial artery compression was safe in clinical practice and there was a low incidence of hematomas and minor bleeding after radial coronary angiography.How to cite this article: Córdova ESM, Santos LR, Toebe D, Moraes MAP, Souza EN. Incidence of hemorrhagic complications with use of a radial compression device: a cohort study. Rev Esc Enferm USP. 2018;52:e03410.

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Section: Introductionmentioning

confidence: 99%

Incidence of hemorrhagic complications with use of a radial compression device: a cohort study

Córdova

Santos

Toebe

et al. 2018

Rev. esc. enferm. USP

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“…However, as mentioned earlier, there are no clear protocols for weaning off the band. There are various protocols that have been reported, including accelerated protocols and standard protocols and protocols that are individualized according the medications given during the procedure, with some studies [ 12 , 13 ] showing that the accelerated protocols are safe with comparable bleeding complications.…”

Section: Discussionmentioning

confidence: 99%

“…We hypothesized that standard protocol of early initiation of deflation of air (within an hour) but with longer intervals of deflation would be inferior to the modified protocol that involves a delayed initiation but shorter intervals. Recently, there have been trials which show that an accelerated protocol that starts almost 30 minutes after the sheath removal is safe without an increase in bleeding complications [ 12 , 13 ] but with overall longer time to removal. However, other groups have demonstrated increased bleeding with these accelerated protocols [ 13 , 14 ] and suggested the delayed protocol.…”

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confidence: 99%

Comparison between two protocols for deflation of the TR band following coronary procedures via the radial route

Riyami¹,

Riyami²,

Nadar³

2020

Journal of the Saudi Heart Association

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Aim Coronary interventions are increasingly being performed via the radial rather than femoral route because of the lower complication rate. Compression devices such as the TR band are used to achieve hemostasis after the procedure. At present, there are no clear protocols for the deflation of the band. In this study we compared two protocols (early deflation with increased intervals vs. late deflation with smaller intervals) in terms of total time to band removal and complications, and patient and staff satisfaction. Methods All patients who underwent a transradial coronary procedure and had a TR band fitted were enrolled into the study. The TR band was applied using the patent hemostasis method (2 ml air pushed in after the radial pulse appears on pulse oximetry after full occlusion with 16 ml air). Patients were randomly assigned to either protocol. Protocol 1 involved removal of 2 ml of air starting 1 hour after the sheath removal and then removal of 2 ml every 30 minutes until the band came off. Protocol 2 involved removal of 4 ml of air 2 hours after the sheath removal and then further 4 ml of air every 15 minutes until the band came off. Patient and staff satisfaction was measured with a visual analogue scale. Results A total of 174 patients were recruited (mean age, 60 ± 11 years; 127 male, 47 female). The baseline characteristics including total heparin dose and type of procedure, in the two arms were the same. Protocol 2 ( n = 84) was associated with a significantly lower time to TR band removal as compared to protocol 1 ( n = 90; 201 ± 43 min vs. 274 ± 54 min; p < 0.001). There was no difference in complications such as bleeding or hematoma formation between the two groups. Patient satisfaction was the same between the two groups. However, the staff preferred protocol 1 ( p = 0.01). Conclusion A protocol of delayed initiation of TR band deflation followed by quick deflations is associated with a lower time to band removal with no increase in bleeding complications or patient satisfaction. However, the staff preferred longer intervals between deflations.

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“…Notably, we did not install a fixed air volume, but instead deflated until bleeding occurred and then re-installed a volume of approximately 1 ml air. It seems logical that the optimal volume in the TR band varies from patient to patient, depending on how tight the TR-band is applied, and maybe the high rates of RAO observed in other studies can be explained by delayed initiation of deflation and inflation of fixed volumes [13]. More use of 5 French sheaths, or even sheath-less procedures, may further reduce RAO [14].…”

Section: Discussionmentioning

confidence: 99%

Randomized Comparison of Terumo® Coated Slender™ versus Terumo® Noncoated Traditional Sheath during Radial Angiography or Percutaneous Coronary Intervention

Sindberg

Nielsen

Poulsen

et al. 2019

Journal of Interventional Cardiology

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Background. The transradial approach is generally associated with few complications. However, periprocedural pain is still a common issue, potentially related to sheath insertion and/or arterial spasm, and may result in conversion to femoral access. Radial artery occlusion (RAO) following the procedure is also a potential risk. We evaluate whether the design of the sheath has any impact on these variables. Methods. A total of 1,000 patients scheduled for radial CAG or PCI were randomized (1:1) to the use of a Slender or a Standard sheath during the procedure. Randomization was stratified according to chosen sheath size (5, 6, 7 French) and gender. A radial band was used to obtain hemostasis after the procedure, employing a rapid deflation technique. A reverse Barbeau test was performed to evaluate radial artery patency after removal of the radial band, and level of pain was assessed using a numeric rating scale (NRS). Results. Use of the Slender sheath was associated with less pain during sheath insertion (median NRS 1 versus 2, p=0.02), whereas no difference was observed in pain during the procedure, radial procedural success rates, use of analgesics and sedatives during the procedure, and radial artery patency following the procedure. Rate of RAO was 1.5% with no difference between groups. Conclusion. The use of the hydrophilic coated Slender sheath during radial CAG or PCI was associated with less pain during sheath insertion, whereas no difference in other endpoints was observed. A rapid deflation technique was associated with RAO of only 1.5%.

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A randomised controlled study of standard versus accelerated deflation of the Terumo radial band haemostasis device after transradial diagnostic cardiac catheterisation

Abstract: There was no increase in local bleedings in the accelerated pressure reduction of the Terumo radial band after diagnostic cardiac catheterisation, increasing patient comfort and reducing hospital stay. These findings will further facilitate the widespread implementation of radial access.

Cited by 8 publications

References 21 publications

Incidence of hemorrhagic complications with use of a radial compression device: a cohort study

Incidence of hemorrhagic complications with use of a radial compression device: a cohort study

Comparison between two protocols for deflation of the TR band following coronary procedures via the radial route

Randomized Comparison of Terumo® Coated Slender™ versus Terumo® Noncoated Traditional Sheath during Radial Angiography or Percutaneous Coronary Intervention

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