Is radial artery occlusion and local vascular complications following transradial coronary procedures affected by the type of haemostasis device used? A non-inferiority Randomized Controlled Trial (RadCom trial)

Author(s):  
Nicole Due-Tønnessen ◽  
Cecile H Egeland ◽  
Oliver J Meyerdierks ◽  
Anders Opdahl

Abstract Aims Vascular access site complications following transradial coronary procedures are less common and severe compared to femoral approach. Radial artery occlusion is considered the main adverse effect. As radial access is gaining more acknowledgement, complication awareness, and understanding is important. The aim was to assess complication rates following transradial coronary procedures and to compare two radial compression devices in a non-inferiority randomized controlled trial. Methods and results Four hundred and ninety-nine patients were randomized to radial compression with a new device (RY Stop, n = 248) or the reference device (TR Band, n = 251) following transradial coronary procedures. Radial artery occlusion persistent at 90 days was the primary endpoint. Discomfort and accounts of vascular complications at access site were secondary endpoints. Radial artery occlusion was observed in 5% (n = 26) for the entire cohort with no difference between groups (RY Stop 6% vs. TR Band 5%; P = 0.69). Patients overall reported low levels of discomfort and the median scores were similar in both groups; RY Stop: 7 vs. TR Band: 10 (P = 0.90). There were few incidents of bleeding (7%), however, they were significantly more frequent with the RY Stop (12%) than with the TR Band (3%; P = 0.001). Few patients (4%) developed access site haematomas, and the incidence was similar in the two groups (P = 0.98). Conclusion We observed a radial artery occlusion rate of 5% at 90 days post-procedure. Access site discomfort and vascular complication rates were low. Overall, the RY Stop compression device was not inferior to the TR Band except occurrences of bleeding.

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
S Takamatsu ◽  
N Kagiyama ◽  
T Shiomi ◽  
M Mizobuchi ◽  
N Sone ◽  
...  

Abstract Background Trans-radial access (TRA) has been established as a safe and established approach for invasive coronary catheter procedures. However, protocols for post-procedural hemostasis varies depending on institutes and an evidence-based protocol is lacking. Purpose The objective of this study was to investigate the clinical implications of procedural hemostasis. Methods Consecutive patients who were referred to outpatient catheter examination before and after April 2018 were treated with an old and a new protocol, respectively. In both protocols, we used the same commercially available hemostasis band with injecting an air of 16 ml for hemostasis. In the old protocol, the amount and timing of deflation were fixed, whereas the air was removed as much as possible for every 30 minutes in the new protocol. Time to complete hemostasis, the rate of major bleeding, and the rate of radial artery occlusion (RAO) at 6 months after the catheter examination were compared between the protocols. Results Total of 1,843 (71±10 years old, 77% male) patients was included in the study. Between patients in the old and the new protocol group (n=1,000 and 843, respectively), there was no significant difference in age, gender, body size, or systolic blood pressure. The new group had significantly higher prevalence of diabetes (47% vs 39%, p=0.002), slightly larger sheath size (4.1±0.3 vs 4.0±0.2 Fr, p<0.001), and lower rate of dual antiplatelet therapy (DAPT: 24% vs. 35%, p<0.001). Time for complete hemostasis was about one-third with the new protocol compared with the old protocol (65±32 vs. 190±16 min, p<0.001) and there was no major bleeding in either group. The rate of radial artery occlusion was 0.7% and 9.8% in the old and the new group (p<0.001). Multivariate analysis showed that the significant predictor of prolonged hemostasis time were the old protocol (odds ratio: OR 80.5, p<0.001) and the prescription of DAPT (OR 2.9, p<0.001), while the factors associated with higher risk of radial occlusion were the old protocol (OR 13.9, p<0.001), the number of previous TRA (OR 1.1, p<0.001), and smaller body size (OR 0.127 per 1 m2 increase p=0.005). Conclusions Our new protocol for hemostasis after TRA was strongly associated with shorter hemostasis time and a lower rate of radial artery occlusion. This approach will decrease the post-procedural hospital time with even fewer complication rates. Study outline Funding Acknowledgement Type of funding source: None


2021 ◽  
Author(s):  
Matthaios Didagelos ◽  
Areti Pagiantza ◽  
Thomas Zegkos ◽  
Christos Papanastasiou ◽  
Konstantina Zarra ◽  
...  

Radial artery occlusion (RAO) is the commonest complication of transradial catheterization. There is no evidence-based therapy, in the frame of a randomized control study, for the treatment of RAO. The purpose of the LOW-RAO study is to question the hypothesis if low-molecular-weight heparin is effective in the treatment of RAO after transradial coronary catheterization (both angiography and percutaneous coronary intervention). It is a prospective, open label, randomized controlled trial that will randomize 60 patients with RAO, irrespective of symptoms, into two groups, one receiving anticoagulation with low-molecular-weight heparin and the other receiving no treatment. The primary end point is improvement in radial artery patency rate at 4 weeks after the procedure. Trial registration number: NCT04196309 (ClinicalTrials.gov)


2020 ◽  
Vol 2020 ◽  
pp. 1-7
Author(s):  
Dmitrii V. Ognerubov ◽  
Alexander Sedaghat ◽  
Sergey I. Provatorov ◽  
Andrey S. Tereshchenko ◽  
Olivier F. Bertrand ◽  
...  

Background. Despite the enormous benefits of radial access, this route is associated with a risk of radial artery occlusion (RAO). Objective. We compared the incidence of RAO in patients undergoing transradial coronary angiography and intervention after short versus prolonged hemostasis protocol. Also we assessed the efficacy of rescue 1-hour ipsilateral ulnar artery compression if RAO was observed after hemostasis. Material and Methods. Patients referred for elective transradial coronary procedures were eligible. After 6 F radial sheath removal, patients were randomized to short (3 hours) (n = 495) or prolonged (8 hours) (n = 503) hemostasis and a simple bandage was placed over the puncture site. After hemostasis was completed, oximetry plethysmography was used to assess the patency of the radial artery. Results. One thousand patients were randomized. Baseline characteristics were similar between both groups with average age 61.4 ± 9.4 years (71% male) and PCI performed on half of the patients. The RAO rate immediately after hemostasis was 3.2% in the short hemostasis group and 10.1% in the prolonged group ( p < 0.001 ). Rescue recanalization was successful only in the short group in 56.2% (11/19); at hospital discharge, RAO rates were 1.4% in the short group and 10.1% in the prolonged group ( p < 0.001 ). Conclusion. Shorter hemostasis was associated with significantly less RAO compared to prolonged hemostasis. Rescue radial artery recanalization was effective in > 50%, but only in the short hemostasis group.


2021 ◽  
Author(s):  
Sachiko Takamatsu ◽  
Nobuyuki Kagiyama ◽  
Naohiko Sone ◽  
Kiyotaka Tougi ◽  
Shuichiro Yamauchi ◽  
...  

Abstract Protocols for hemostasis after trans-radial approach (TRA) vary depending on the institute as there is no established evidence-based protocol. This study aimed to investigate the clinical implications of radial compression protocols. Consecutive patients who underwent outpatient invasive catheter angiography before and after April 2018 were treated with traditional and new protocols, respectively. Using the same hemostasis band, the amount and timing of deflation were fixed in the traditional protocol, whereas the air was removed as much as possible every 30 min in the new protocol. A total of 1,842 patients (71±10 years old, 77% male) were included. Compared with the traditional protocol group (n=1,001), the new protocol group (n=841) had a significantly lower rate of dual antiplatelet therapy (24% vs. 35%, p<0.001). The time required for complete hemostasis was approximately one-third with the new protocol (66±32 min vs. 190±16 min, p<0.001) with no clinically relevant bleeding. The incidence of radial artery occlusion (RAO) was 9.8% and 0.9% in the traditional and new protocol groups, respectively (p<0.001). After adjusting for covariates, the new protocol was associated with a shorter hemostasis time (odds ratio 0.01, p<0.001) and a reduced risk of RAO (odds ratio 0.09, p<0.001). Our new protocol for hemostasis after TRA was strongly associated with a shorter hemostasis time and a lower rate of RAO.


1970 ◽  
Vol 2 (1) ◽  
Author(s):  
Nurhusna N ◽  
F Sri Susilaningsih ◽  
Purwo Suwigjo

Radial artery occlusion merupakan salah satu komplikasi vaskular postkateterisasi jantung trans radial. Kompresi lokal menggunakan alat kompresi setelah tindakan kateterisasi jantung trans radial dapat menurunkan angka kejadian komplikasi vaskular Radial Artery Occlusion(RAO). Penelitian ini bertujuan untuk mengetahui perbandingan antara metode Barbeau test dan metode pengamatan klinik dalam menilai keutuhan arteri radialis selama proses kompresi pada pasien postprosedur kateterisasi jantung trans radial. Penelitian ini merupakan penelitian kuantitatif dengan desain studi komparatif. Subjek penelitian adalah 20 pasien yang menjalani prosedur kateterisasi jantung dengan akses arteri radialis. Pengukuran dilakukan secara bertahap menit ke-15 dan setelah tiga jam menggunakan alat kompresi stepty-p. Uji komparasi menggunakan uji McNemar. Data univariat dianalisis menggunakan distribusi frekuensi. Hasil uji statistik menunjukkan ada perbedaan penilaian keutuhan arteri radialis antara metode Barbeau testdengan metode pengamatan klinik pada menit ke-15 (p=0.035) dan ke-30 (p=0.035). Namun secara keseluruhan hasil uji statistik menunjukkan tidak ada perbedaan yang bermakna dalam menilai kepatenan arteri pada setiap waktu pengamatan dari kedua metode. Kata kunci:Arteri radialis, Barbeau test, kateterisasi jantung, keutuhan, pengamatan klinik AbstractRadial artery occlusion is one of the trans radial vascular complications post cardiac catheterization. The local compression using compression methods after cardiac catheterization can be reduced the vascular complication such as radial artery occlusion (RAO). This research was conducted to determine the comparison between the Barbeau test method and the clinical observation method carried out by the researcher in order to examine the patency of radial artery during compression, post procedure cardiac catheterization at the Angiography Coroner Unit and the Cardiac Intensive Care Unit, Hasan Sadikin Bandung General Hospital, Indonesia. This research was a quantitative research using the comparative study design. The subjects were 20 patients who took cardiac catheterization procedure using radial artery access and checked in pairs. The measurement divided into two periods: the fifteenth minute and the third hour using the stepty-p compression tool. The statistical test used the McNemar test to analyze the comparison, and the single variable data were analyzed using the distribution frequency. There were a significant difference in radial artery evaluation during compression period between two methods, in which at the first fifteen minutes (p=0.035) and the first thirty minutes (p=0.035), respectively. Overall, the result shows that there were no significant difference in comparison of two methods. Key words:Barbeau test, cardiac catheterization, clinical observation, patency, radial artery


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
Z Ruzsa ◽  
N Sandor ◽  
J Toth ◽  
M Deak ◽  
B Zafirovska ◽  
...  

Abstract Introduction The primary purpose of this multicenter prospective register was to evaluate the success and complication rate of different access sites for subclavian artery intervention. Secondary purpose was to investigate the safety of the distal radial artery access for subclavian artery intervention. Methods The clinical and angiographic data of 223 consecutive patients with symptomatic subclavian and anonym artery stenosis treated via transradial (TR), transbrachial (TB) and transfemoral (TF) access between 2015 and 2019 were evaluated in a multicenter registry. The exclusion criteria of the intervention was the acute proximal subclavian artery thrombosis. Primary endpoint: angiographic outcome of the subclavian and anonym artery intervention, rate of major and minor access site complications. Secondary endpoints: procedural complications, consumption of the angioplasty equipment, cross over rate to another puncture site and hospitalization in days. Results The procedure was successful in 182/184 in TR, in 5/5 in TB and in 32/32 patients in TF group. The cross over rate in the TR, TB and TF group was 0%. Chronic total occlusion recanalization was successful in 75/77 cases in TR, and 15/15 cases in the TF group. Contrast consumption was 152±106 ml in TR, 99±22.5 ml in TB and 152±95 in TF group, respectively (p=ns). Cummulativ dose was 602±1205 mGray in RA, 455±210 mGray in BA and 1089±1674 mGray in FA group (p&lt;0.05). Procedural complications occurred in 1/184 (0.5%) case in RA group, in 0 case (0%) in BA group and in 4/32 cases (12.5%) in the FA group (p&lt;0.05). Major access site complication were detected in 3 patients (1.6%) in RA, in 1 patient in BA (20%) and in 1 patient in FA group (3.1%) (p&lt;0.05). Minor access site complication were encountered in 9 patients in the RA (4.8%), in 1 patient in the BA (20%) and in 8 patients in the FA group (25%) (p&lt;0.05). Distal radial access was used in 29 cases and proximal radial access in 155 patients. The rate of radial artery occlusion in proximal and distal radial group was 5.1% and 0% (p&lt;0.05). Conclusions Subclavian artery intervention can be safely and effectively performed using radial access with acceptable morbidity and high technical success. Femoral and brachial access is associated with more access site complications than radial artery access. Distal radial access is associated with less radial artery occlusion than proximal radial artery access. Funding Acknowledgement Type of funding source: None


2020 ◽  
Vol 13 (1) ◽  
Author(s):  
Kashif Ali Hashmi ◽  
Zahid Iqbal ◽  
Atif Ali Hashmi ◽  
Maira Shoaib ◽  
Muhammad Irfan ◽  
...  

Abstract Objectives Radial artery occlusion is a silent complication of a transradial approach to cardiac catheterization that may complicate subsequent transradial procedures in patients undergoing cardiac catheterization. A transradial band reduces vascular complications and provides brisk, powerful and effective haemostasis. The purpose of this study was to assess the frequency of radial artery occlusion in 180 patients undergoing transradial coronary catheterization. Results The median age of the study cohort was 58 years. Radial artery occlusion was found in 14 (7.8%) patients. When stratifying by age group and sex, there was no significant difference in radial artery occlusion between age groups and sex. It was likewise found that comorbidities such as diabetes mellitus, hypertension and smoking, increased the risk of radial artery occlusion however this was observed to be significant only for diabetes mellitus. We therefore conclude that a transradial pneumatic pressure band is an extremely helpful and safe strategy to prevent radial artery occlusion.


2015 ◽  
Vol 87 (5) ◽  
pp. 868-874 ◽  
Author(s):  
Alessandro Sciahbasi ◽  
Stefano Rigattieri ◽  
Alessandro Sarandrea ◽  
Maria Cera ◽  
Cristian Di Russo ◽  
...  

2019 ◽  
Vol 34 (2) ◽  
pp. 111-117
Author(s):  
Mohammad Abdul Matin ◽  
Mir Jamal Uddin ◽  
Abdul Momen ◽  
Mustafizul Aziz ◽  
Abeeda Tasnim Reza ◽  
...  

Background: Although transradial approach (TRA) has better outcome and reduced vascular complications, radial artery occlusion (RAO) is now a major concern as it limits future radial artery use for further TRA, for use as a conduit during CABG, for invasive hemodynamic monitoring and for creation of arteriovenous fistula for hemodialysis in CKD patients. Vascular doppler study is the most accurate method for evaluation of RAO and yet this is not practiced in our population. Objectives: To detect the frequency and identify the predictors of RAO after coronary procedure through TRA. Methods: This cross-sectional analytical study was done in the department of cardiology, NICVD from July-2015 to June- 2016 by including a total 125 patients undergoing coronary procedures (CAG and/or PCI) through TRA. Vascular doppler study of the radial artery were performed before and one day after the procedure. RAO was defined as an absence of antegrade flow and monophasic flow on doppler study. Univariate and multivariate logistic regression analysis were done to evaluate the predictors of RAO. Results: On the day after the procedure, radial artery vascular doppler examination revealed RAO in 12 (09.6%) patients. On univariate analysis female gender (p= 0.038), diabetes mellitus (p= 0.024), prolonged hemostatic compression for more than 02 hours after sheath removal (p= 0.003) were identified as predictors of RAO. Interestingly hypertension, low BMI, smaller radial artery diameter and use of reprocessed sheath were not identified as predictors of RAO. On multivariate analysis diabetes mellitus (p= 0.016), prolonged hemostatic compression for more than 02 hours after sheath removal (p= 0.004) were found as independent predictors for RAO. Conclusion: Frequency of RAO was 09.6% after coronary procedure through TRA. Diabetes mellitus and hemostatic compression after sheath removal for more than two hours were identified as independent predictors of RAO. Strategies should be taken from patient selection for TRA to end of hemostatic compression removal to prevent RAO. Bangladesh Heart Journal 2019; 34(2) : 111-117


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