Evaluation of the incidence of radial artery occlusion using different introducer sheaths and hemostasis techniques
Selected in Catheterization and Cardiovascular Interventions by A. Cader
This retrospective observational study was undertaken in patients referred for transradial coronary angiography (CA) or PCI to assess the impact of sheath sizes and haemostasis techniques on RAO incidence.
References
Authors
Purveshkumar Patel, Nishant Sethi, Gaurav A. Patel, Deepika Kalisetti, Tejas M. Patel
Reference
doi: 10.1002/ccd.30328. Online ahead of print.
Published
16 July 2022
Link
Read the abstract
Reviewer
My Comment
Why this study – the rationale/objective?
Radial artery occlusion (RAO) is the most frequent complication of transradial access (TRA)1. Predictors of RAO include larger sheath-to-artery ratio, insufficient anticoagulation and occlusive haemostasis (i.e. non-patent haemostasis)1,2. While these have been studied individually by randomised controlled trials, the interaction between these predictors of RAO has not been evaluated.
Increasingly more complex PCI procedures are being undertaken by TRA, requiring the use of larger calibre sheaths and guide catheters. In addition to patent haemostasis, ipsilateral ulnar artery compression has also shown to reduce RAO3.
This retrospective observational study was undertaken in patients referred for transradial coronary angiography (CA) or PCI to assess the impact of sheath sizes and haemostasis techniques on RAO incidence4.
How was it executed? - the methodology
Design:
This was a retrospective analysis of data from an ongoing registry of patients undergoing CA or PCI via TRA.
Exclusion criteria:
- Patients on long‐term oral anticoagulation or receiving postprocedural systemic anticoagulation
- Previous ipsilateral TRA
- Haemodynamic instability requiring vasopressors periprocedurally
Objectives and comparison of interventions:
- to compare RAO rates between 6‐Fr versus 7‐Fr Glidesheath slender introducers sheaths: choice of sheath was at operator discretion
- to compare haemostasis compression techniques: patent haemostasis only using one‐bladder compression band (TR band TM, Terumo Interventional Systems) versus simultaneous ipsilateral ulnar compression technique using the two‐bladder compression band (Vasoband, Vasoinnovations Inc.)
Which band was determined by time period, where the same haemostasis bands were given to all consecutive patients across two time periods: TR band (January 2020 to April 2021) and Vasoband (all patients from April 2021 onwards)
Primary outcome:
RAO at 24 hours of the procedure as assessed by ultrasound showing absence of antegrade flow
TRA & haemostasis:
Best practice was maintained including vasodilator cocktail and adequate anticoagulation. Haemostasis was achieved as per standard protocol with least necessary pressure.
What is the main result?
A total of 2,019 patients undergoing CA or PCI were included, 1,592 in the one-bladder band group, and 427 in the two-bladder band group.
The two-bladder group were older, with greater height and eight, and greater frequency of Barbeau test pattern A.
Radial artery diameter and important procedural characteristics including heparin dose, number of catheters, haemostasis time (139 vs 138 minutes) were not different across the groups4.
RAO rates:
In the one‐bladder band group, the incidence of RAO with a 6‐Fr slender introducer sheath was 4.2 %.
As no patients in the one-bladder band arm received a 7 Fr sheath, no comparison of 6-Fr vs 7-Fr sheath size could be made for this group.
In the two‐bladder band arm, no difference in RAO incidence was seen for 6‐Fr slender sheath (1 %) versus 7‐Fr slender sheath (0.9 %; p = 0.68).
Furthermore, rebound bleeding was significantly lower in the two‐bladder band arm compared to the 1‐bladder band arm (4.3 % vs. 1.6 %, p = 0.009), as was the number of nurse visits to evaluate access extremity.
A larger radial artery diameter, greater body weight and haemostasis achieved by a two-bladder band were predictors of reduced RAO incidence on multivariable analysis.
Critical reading and the relevance for clinical practice
This study found lower RAO rates with the practice of patent haemostasis along with ipsilateral ulnar artery compression via a two-bladder Vasoband, compared to patent haemostasis alone with a one-bladder TR band.
Also, where best haemostasis practice with a two-bladder band was undertaken, RAO rates were comparable between 6-Fr and 7-Fr sheath, suggesting that the penalty for sheath size in terms of RAO might be mitigated by using a two-bladder band4.
The benefits of both patent haemostasis (PROPHET)2 and ipsilateral ulnar artery compression (PROPHET II)3 have been previously demonstrated by seminal randomised evidence. The latter facilitates maximal radial artery flow and flow velocity during radial artery haemostatic compression, and likely helps overcome the higher burden of prothrombotic processes caused by larger sheaths at the puncture site.
More recently, the 3-arm randomised Prevention of radial artery occlusion by simultaneous ulnar and radial compression (PRO-SURC) trial (n = 450) found significantly lower 1-hour and 30-day RAO rates among patients who received by simultaneous ulnar and radial compression (SURC), as compared conventional and patent haemostasis (1.3 %, 6.7 %, and 7.3 %, respectively – p = 0.03)5.
In contrast, the PROTHECT (Prevention of Radial artery Occlusion of Three HEmostatiC methods in Transradial intervention for coronary angiography) trial comparing 3 non-occlusive radial haemostasis methods (n = 1,469) found no difference in 24-hour RAO between patent haemostasis (3.6 %), patent hemostasis with ulnar compression or the ulnar artery transient compression facilitating radial artery patent hemostasis (ULTRA) method (5.5 %), and facilitated hemostasis with a hemostatic disc (4.7 %)6.
Although ulnar compression time in both these two trials was similar to the present study (1 hour), the technique of achieving ipsilateral ulnar artery compression differed, where a second inflatable band was placed for ulnar compression5,6. The point of pressure in the ulnar artery is crucial (at the level of the Guyon’s canal), so as to not inadvertently compress the radial artery, and thus devices need to be tailored accordingly.
This study must be interpreted on the background of its limitations. The retrospective nature of the study lends itself to residual confounding, and this interaction needs to be tested in a randomised controlled trial.
Furthermore, only slender sheaths were used, limiting generalisability, and there was no comparison between 6-Fr vs 7-Fr for the patent haemostasis arm.
References
- Rashid M, Kwok CS, Pancholy S, Chugh S, Kedev SA, Bernat I, et al. Radial Artery Occlusion After Transradial Interventions: A Systematic Review and Meta-Analysis. J Am Heart Assoc 2016 Jan 1 [cited 2022 Mar 11];5(1).
- Pancholy S, Coppola J, Patel T, Roke-Thomas M. Prevention of radial artery occlusion-patent hemostasis evaluation trial (PROPHET study): a randomized comparison of traditional versus patency documented hemostasis after transradial catheterization. Catheter Cardiovasc Interv. 2008;72(3):335–40.
- Pancholy SB, Bernat I, Bertrand OF, Patel TM. Prevention of Radial Artery Occlusion After Transradial Catheterization: The PROPHET-II Randomized Trial. JACC Cardiovasc Interv 2016;9(19):1992–9.
- Patel P, Sethi N, Patel GA, Kalisetti D, Patel TM. Evaluation of the incidence of radial artery occlusion using different introducer sheaths and hemostasis techniques. Catheter Cardiovasc Interv. 2022 Jul 16 [cited 2022 Jul 19];
- Ahmed TAN, Abbas E, Bakr AH, Demitry SR, Algowhary MI. Prevention of radial artery occlusion by simultaneous ulnar and radial compression (PRO-SURC). A randomized duplex ultrasound follow-up study. Int J Cardiol. 2022 Sep 15 [cited 2022 Jul 19];363:23–9.
- Eid-Lidt G, Reyes-Carrera J, Farjat-Pasos JI, Saenz AL, Bravo CA, Rangel SN,et al. Prevention of Radial Artery Occlusion of 3 Hemostatic Methods in Transradial Intervention for Coronary Angiography. JACC Cardiovasc Interv. 2022;15(10):1022-1029.
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