A comparative study of TR Band and a new hemostatic compression device after transradial coronary catheterization

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Abstract

Objective: Transradial coronary catheterization has proved to be safe and effective in clinical practice. Various hemostatic compressive devices have been used in subsequent procedures. The objective of this study was to compare the efficacy and safety of a new hemostatic compression device and the widely used TR Band.

Methods: A total of 118 patients were divided randomly into two groups: TR Band and the new hemostatic compression device. Efficacy of hemostasis, patient comfort, local vascular dysfunction, and radial artery occlusion (RAO) were evaluated and compared between groups.

Results: Occurrence of errhysis or hematoma did not significantly differ between groups (13.6% vs. 11.9%, P = 0.782). Fewer patients had moderate to severe pain or moderate to severe numbness in the new hemostatic compression device group (1.7% vs. 22.0%; 1.7% vs. 18.6%, respectively). Pulse loss between distal artery and device was lower in the new hemostatic compression device group (5.1% vs. 22.0%, P = 0.007), and fewer patients experienced obstruction of venous reflux compared with the TR Band group (6.8% vs. 25.4%, P = 0.006). Combined incidence of RAO at discharge was 7.6%, and was lower in the new hemostatic compression device group (1.7% vs. 13.6%, P = 0.015). In contrast to the TR Band, application of the new hemostatic compression device was independently associated with lower incidence of RAO at discharge (odds ratio: 0.062, 95% confidence interval: 0.006–0.675, P = 0.022).

Conclusions: Both the new hemostatic compression device and the TR Band can efficiently achieve hemostasis following transradial coronary catheterization. However, fewer patients felt discomfort with application of the new hemostatic compression device. Pulse loss in the artery distal to the compression device, obstruction of venous reflux, and RAO occurred significantly less often with application of the new device.

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Most cited references 16

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Radial versus femoral approach for percutaneous coronary diagnostic and interventional procedures; Systematic overview and meta-analysis of randomized trials.

Giovanni de Castro, Martial Hamon, M Luisa de Benedictis … (2004)

We sought to compare, through a meta-analytic process, the transradial and transfemoral approaches for coronary procedures in terms of clinical and procedural outcomes. The radial approach has been increasingly used as an alternative to femoral access. Several trials have compared these two approaches, with inconclusive results. The MEDLINE, CENTRAL, and conference proceedings from major cardiologic associations were searched. Random-effect odds ratios (ORs) for failure of the procedure (crossover to different entry site or impossibility to perform the planned procedure), entry site complications (major hematoma, vascular surgery, or arteriovenous fistula), and major adverse cardiovascular events (MACE), defined as death, myocardial infarction, emergency revascularization, or stroke, were computed. Twelve randomized trials (n = 3,224) were included in the analysis. The risk of MACE was similar for the radial versus femoral approach (OR 0.92, 95% confidence interval [CI] 0.57 to 1.48; p = 0.7). Instead, radial access was associated with a significantly lower rate of entry site complications (OR 0.20, 95% CI 0.09 to 0.42; p < 0.0001), even if at the price of a higher rate of procedural failure (OR 3.30, 95% CI 1.63 to 6.71; p < 0.001). The radial approach for coronary procedures appears as a safe alternative to femoral access. Moreover, radial access virtually eliminates local vascular complications, thanks to a time-sparing hemostasis technique. However, gaining radial access requires higher technical skills, thus yielding an overall lower success rate. Nonetheless, a clear ongoing trend toward equalization of the two procedures, in terms of procedural success, is evident through the years, probably due to technologic progress of materials and increased operator experience.

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A randomized comparison of percutaneous transluminal coronary angioplasty by the radial, brachial and femoral approaches: the access study.

Ferdinand Kiemeneij, Gert Laarman, Diego Odekerken … (1997)

This study sought to compare procedural and clinical outcomes of percutaneous transluminal coronary angioplasty (PTCA) performed with 6F guiding catheters introduced through the radial, brachial or femoral arteries. Transradial PTCA has been demonstrated to be an effective and safe alternative to transfemoral PTCA; however, no randomized data are currently available. A randomized comparison between transradial, transbrachial and transfemoral PTCA with 6F guiding catheters was performed in 900 patients. Primary end points were entry site and angioplasty related. Secondary end points were quantitative coronary analysis after PTCA, procedural and fluoroscopy times, consumption of angioplasty equipment and length of hospital stay. Successful coronary cannulation was achieved in 279 (93.0%), 287 (95.7%) and 299 (99.7%) patients randomized to undergo PTCA by the radial, brachial and femoral approaches, respectively. PTCA success was achieved in 91.7%, 90.7% and 90.7% (p = NS) of patients, with 88.0%, 87.7% and 90.0% event free at 1-month follow-up, respectively (p = NS). Major entry site complications were encountered in seven patients (2.3%) in the transbrachial group, six (2.0%) in the transfemoral group and none in the transradial group (p = 0.035). Transradial PTCA led to asymptomatic loss of radial pulsations in nine patients (3%). Procedural and fluoroscopy times were similar, as were consumption of guiding and balloon catheters and length of hospital stay ([mean +/- SD] 1.5 +/- 2.5, 1.8 +/- 3.8 and 1.8 +/- 4.2 days, respectively). With experience, procedural and clinical outcomes of PTCA were similar for the three subgroups, but access failure is more common during transradial PTCA. Major access site complications were more frequently encountered after transbrachial and transfemoral PTCA.

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Percutaneous radial artery approach for coronary angiography.

Jody Campeau (1988)

Percutaneous entry into the distal radial artery and selective coronarography using a French 5 sheath and preshaded catheters were attempted in 100 patients with a normal Allen test. Cannulation of the radial artery was not possible in ten patients, and selective catheterization of the coronary arteries was unsuccessful in two. Manipulation of catheters presented no problem, and arterial spasm was rarely observed, only before the use of a 23-cm-long sheath. Only two complications without symptoms were observed: arterial dissection of the brachial artery in one patient and occlusion of the radial artery in another. With experience, this approach may become as effective and possibly safer than the transbrachial entry.

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Contributors

Ruiyan Zhang

Journal

Journal ID (nlm-ta): J Interv Med

Journal ID (iso-abbrev): J Interv Med

Title: Journal of Interventional Medicine

Publisher: Shanghai Journal of Interventional Radiology Press

ISSN (Print): 2096-3602

ISSN (Electronic): 2590-0293

Publication date PMC-release: 30 April 2019

Publication date Collection: November 2018

Publication date (Electronic): 30 April 2019

Volume: 1

Issue: 4

Pages: 221-228

Affiliations

[1 ]Department of Cardiology, Rui Jin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 200025, China

Author notes

[* ] Correspondence: Ruiyan Zhang, Department of Cardiology, Rui Jin Hospital, 197 Rui Jin 2nd Road, Shanghai 200025, China, Email: zhangruiyanrj@126.com zhangruiyanrj@ 123456126.com

[#]

Yong Wang and Jing Tang contributed equally to this work.

Article

Publisher Item ID: S2096-3602(19)30052-3

DOI: 10.19779/j.cnki.2096-3602.2018.04.05

PMC ID: 8586707

PubMed ID: 34805854

SO-VID: 42188acd-09ca-43e2-a0ad-d09259ca117f

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This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

A comparative study of TR Band and a new hemostatic compression device after transradial coronary catheterization

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Most cited references 16

Radial versus femoral approach for percutaneous coronary diagnostic and interventional procedures; Systematic overview and meta-analysis of randomized trials.

A randomized comparison of percutaneous transluminal coronary angioplasty by the radial, brachial and femoral approaches: the access study.

Percutaneous radial artery approach for coronary angiography.

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