BRIEF SUMMARY

Title  

COMPARISON OF DISTAL RADIAL ACCESS WITH CONVENTIONAL RADIAL ACCESS FOR CORONARY CATHETERISATION

Type of Study

Prospective, single-center, clinical observational study.

Aims & objectives

Aim

To compare distal radial access with conventional radial access for coronary procedures.

Objectives

a)      To compare the procedural parameters of distal radial access with conventional radial access for coronary procedures.

b)      To compare clinical outcomes and safety of distal radial access with conventional radial access for coronary procedures.

Purpose of the study

Distal transradial access (dTRA) by the snuffbox approach for coronary catheterization has emerged as an alternative to the classic forearm TRA with certain advantages and limitations. In dTRA, the arm can be placed in a neutral position, without requiring wrist rotation, being more comfortable for the patient and the operator.(10) An occlusion at this site maintains antegrade flow through the superficial palmar arch. Flow to the thumb will still be maintained via the superficial palmar arch, preventing ischemia and hand disability.

Patients in India have lower Body Surface area and are shorter in heights and are likely to have smaller radial artery at wrist and at anatomical snuff box compared to western population.

Conventional trans-radial access is already being used safely in Indian patients. However, Distal Trans Radial Access (dTRA) is relatively newer approach which is being used by many operators including in our center. Data regarding technical aspects, complications and safety are lacking from India.

This has not been studied in coastal Karnataka before. The aim of this study was to evaluate the effectiveness, reproducibility, feasibility and safety of the dTRA approach over conventional radial access site in Indian population.

This study has not been started. No publications on this study yet.

Materials and methods

            a) Inclusion and exclusion criteria: Described above        

            c) Statistical methods:

Mean and standard deviations will be used to describe continuous variables. Categorical variables will be expressed as frequencies and percentages along with medians and interquartile ranges. Chi square test and student t-test will be used to test null hypothesis for categorical variables and continuous variables respectively.

Detailed description of procedure/processes

The study will be conducted in the Department of Cardiology, Kasturba Hospital, Manipal. Patients undergoing coronary catheterisation as a part of standard care who fulfill the inclusion criteria mentioned above will be approached. Eligible patients will be explained in detail about the study in their own language and given the participant information sheet. An informed consent will be taken from patients who are willing to participate in the study after fully understanding the nature of the study and risk/benefits involved.

 This is an observational study in which data will be collected from the patients who are undergoing coronary catheterisation through either distal radial or conventional radial approach as a part of their standard care. 

Baseline characteristics of the patients, their indication for catheterisation, risk factors or comorbidities will be recorded first in the proforma (data collection form).  Procedural characteristics such as site of puncture, no. of attempts and time needed; size of sheath and its success or failure; vasodilators; type of coronary procedure; no of catheter/ guide exchanges used with its size will be recorded. Total heparin dosage, contrast volume, total procedural and radiation time along with radiation exposure will be recorded in proforma.

Post procedural hemostasis method and time; any complication like hematoma or bleeding or radial artery occlusion or any other symptoms at 24 hrs. will be recorded in proforma. Complete list of parameters to be recorded is enlisted in the proforma (separate file)

Potential risks and benefits:

This study involves recording of few parameters during your standard coronary catheterisation procedure. Hence minimal risks involved.

You may not get benefit from participating in the study. Your participation in this study will possibly help us in the assessment of procedural parameters, feasibility, effectiveness and safety of distal radial – snuffbox approach over conventional radial approach in different group of people.

Ethical considerations and methods to address issues:

This is an observational study where patients already undergoing coronary catheterisation either through distal radial or conventional radial approach will be included. Informed consent will be taken from study participants for the prospective part of the study and confidentiality of the data will be maintained. There are no additional costs, invasive procedures or drugs involved. It takes only a few extra minutes to obtain the few additional procedural parameters necessary for the study.

Review of literature 

            Transradial access (TRA) is constantly evolving as the first choice for coronary catheterization.(1,2) Its lower incidence of bleeding and access site complications, shorter length of hospital stay, lower cost, and better convenience for the patient due to immediate post procedural mobilization, than those with the transfemoral access.(1,8,9)

The most operators prefer the right radial approach. The main reason is the working position of the operator on the right side of the patient. However, frequently the operator needs to cross over to the left radial approach or femoral approach. The most common reasons to cross over artery access are: radial occlusion, underdeveloped radial artery (RA), extreme tortuosity, sclerosis or calcifications, arteria lusoria, previous right radial failure, presence of an arteriovenous shunt in the arms, past or future use of the RA as free arterial graft and patient preference.

However, there are limitations of the TRA, such as radial artery occlusion, ergonomic and comfort reasons (patients must lie with their arm in a supine position), orthopedic reasons (injuries, frozen shoulders, and elbows causing inability to flex the wrist), and operator inconvenience (the patient needs to stand in a bent position for long periods and closer to the radiation source for left TRA).(10)

Recently, introduction of the distal TRA through the anatomical snuffbox (dTRA) seems to surpass these difficulties.3 After cannulation of the radial artery along its route through the anatomical snuffbox and sheath placement, the arm can be placed in a neutral position, without requiring wrist rotation, being more comfortable for the patient and the operator.(10)

The anatomical snuffbox is a hollow space on the radial side of the wrist when the thumb is extended; it is bounded by the tendon of the extensor pollicis longus posteriorly and of the tendons of the extensor pollicis brevis and abductor pollicis longus anteriorly. The Radial artery crosses the floor that is formed by the scaphoid and the trapezium bones (11). Another important feature of this technique is a puncture is distal from the branch supplying the superficial palmar arch (3). An occlusion at this site maintains antegrade flow through the superficial palmar arch. This reduces the risk of retrograde thrombus formation in the proximal RA located in the forearm, a frequent finding in patients who develop a forearm RA occlusion due to puncture trauma or hemostasis trauma at the traditional RA puncture site. Flow to the thumb will still be maintained via the superficial palmar arch, preventing ischemia and hand disability.

The distal RA access from the radial fossa was described for the first time to open occluded ipsilateral RA by Babunashvili et al (12)

The dTRA approach has been applied in five patient cohorts worldwide, exclusively from the left side in four of them3-6 and in both arms in the last one.(7) Conclusion of all the studies were similar that Distal trans-radial access for diagnostic catheterization and percutaneous coronary intervention is a reproducible, safe and feasible technique.

Kiemeneij F. Published a study in EuroIntervention. 2017 Sep 20, Left distal transradial access in the anatomical snuffbox for coronary angiography (ldTRA) and interventions (ldTRI).(3) 70 patients were included for left distal radial access. There were eight procedural failures, requiring crossover to traditional right or left conventional radial approach. All other procedures were successful, without major discomfort for the patient and operator. No radial artery occlusions at the site of the forearm were encountered.()

Soydan E Et al. Presented in 33rd Turkish Cardiology Congress on October 6th 2017,(4) a study of 54 patients undergoing left dTRA coronary catheterisation with Judkin 6F catheter. Seventeen patients admitted with acute coronary syndrome. They all underwent successful left distal transradial coronary angiography and intervention. Primary angioplasty was performed in 10 patients. In total, 20 patients had coronary intervention. Left anterior descending artery was the artery requiring most intervention (11 patients). Two patients experienced brachial spasm requiring crossover to right femoral artery. There were no cases of radial artery occlusion, hematoma, or hand numbness. Hemostasis was achieved with manual compression.

Toledo et al., J Cardiovasc Dis Diagn 2018 (17) published a study of 151 cases from seven different institutions, made by three operators experienced with conventional radial access. All the procedures were done either left or right distal TRA approach. Puncture was attempted successfully in 142 cases (94%), 114 (80.3%) diagnostic and 28 (19.7%) coronary interventional procedures. Mean procedure time was 11.1 ± 9.65 minute and mean fluoroscopy time was 5.3 ± 5.93 minute. There were no ischemic complications and only one mild bleeding (0.7%).

Antonios Ziakas et al. Published article Right arm distal transradial (snuffbox) access for coronary catheterization: Initial experience, in Hellenic Journal of Cardiology (14) included 49 patients (31 males and 18 females, mean age 64 ± 12 years), who were candidates for coronary catheterization in two cath laboratory centers, regardless of the indication, were recruited. Right dTRA was exclusively used. Catheterization was done in an acute coronary syndrome in 24.5%, stable coronary artery disease in 22.4%, and other reasons in 53.1%. The overall failure attempt incidence was 10.2% and the mean puncture time 3.9 ± 4.1 min. Angiography only was performed in 81.8% and angiography followed by percutaneous coronary intervention in 18.2% of the patients. Manual hemostasis was applied in 63.6% of the patients, which had a significantly shorter duration than device hemostasis (11 ± 7 versus 198 ± 42 min, p < 0.001). No distal or forearm radial artery occlusion was observed on triplex ultrasonography 24 h after successful hemostasis. No major complications were recorded.

Few case reports for dTRA approach has also been published.(13,15,16)

The aim of this study was to evaluate the effectiveness, reproducibility, feasibility and safety of the dTRA approach over conventional radial access site in Indian population. This has not been studied in coastal Karnataka before.

References

1.      Kolkailah AA, Alreshq RS, Muhammed AM, Zahran ME, Anas El-Wegoud M, Nabhan AF. Transradial versus transfemoral approach for diagnostic coronary angiography and percutaneous coronary intervention in people with coronary artery disease. Cochrane Database Syst Rev.2018;4:CD012318. https://doi.org/10.1002/ 14651858.CD012318.pub2.

2.      Ziakas A, Katranas S, Bobotis G, et al. The TRACE registry (Trans-Radial Approach in Central and northErn Greece). Hellenic J Cardiol. 2016;57(5):323-328. https://doi.org/10.1016/j.hjc.2016.11.004

3.      Kiemeneij F. Left distal transradial access in the anatomical snuffbox for coronary angiography (ldTRA) and interventions (ldTRI). EuroIntervention.2017;13(7):851-857. https://doi.org/10.4244/EIJ-D-17-00079.

4.      Soydan E, Akın M. Coronary angiography using the left distal radial approach - An alternative site to conventional radial coronary angiography. Anatol J Cardiol.2018. https://doi.org/10.14744/AnatolJCardiol.2018.59932.

5.      Kim Y, Ahn Y, Kim I, et al. Feasibility of Coronary Angiography and Percutaneous Coronary Intervention via Left Snuffbox Approach. Korean Circ J. 2018. https://doi.org/10.4070/kcj.2018.0181.

6.      Al-Azizi KM, Lotfi AS. The distal left radial artery access for coronary angiography and intervention: A new era. pii: S1553-8389 Cardiovasc Revascularization Med. 2018;(18):30123-30124. https://doi.org/10.1016/j.carrev.2018.03.020.

7.      Valsecchi O, Vassileva A, Cereda AF, et al. Early Clinical Experience With Right and Left Distal Transradial Access in the Anatomical Snuffbox in 52 Consecutive Patients. J Invasive Cardiol. 2018;30(6):218-223.

8.      Sandoval Y, Burke MN, Lobo AS, et al. Contemporary Arterial Access in the Cardiac Catheterization Laboratory. JACC Cardiovasc Interv. 2017;10(22):2233-2241. https://doi.org/10.1016/j.jcin.2017.08.058.

9.  KoÅ‚towski Ł, Filipiak KJ, Kochman J, et al. Cost-effectiveness of radial vs. Femoral approach in primary percutaneous coronary intervention in STEMI - Randomized, control trial. Hellenic J Cardiol. 2016;57(3):198-202. https://doi.org/10.1016/j.hjc.2016.06.005.

10.  Davies RE, Gilchrist IC. Back hand approach to radial access: The snuff box approach. pii: S1553-8389 Cardiovasc Revascularization Med. 2017;(17). https://doi.org/10.1016/j.carrev.2017.08.014, 30336-6.

11.  Aladino Cerda, Mariano del Sol (2015) Anatomical Snuffbox and it Clinical Significance: A Literature Review. Int. J. Morphol 33:1355-60.

12.  Babunashvili A, Dundua D (2011) Recanalization and re-use of early occluded radial artery within 6 days after previous transradial diagnostic procedure. Catheter Cardiovasc Interv. 77:530-6.

13.  Emrah Bayam et al. Safe entry site for coronary angiography: Snuff box. Turk Kardiyol Dern Ars 2018;46(3):228-230 doi: 10.5543/tkda.2017.74711

14.  Ziakas A et al., Right arm distal transradial (snuffbox) access for coronary catheterization: Initial experience, Hellenic Journal of Cardiology, https://doi.org/10.1016/j.hjc.2018.10.008

15.  Latsios G, et al., Left distal radial artery for cardiac catheterization: Insights from our first experience, Hellenic Journal of Cardiology (2018), https://doi.org/10.1016/j.hjc.2017.12.004

16.  Vilela FD et al., Distal Transradial Access in the Anatomical Snuffbox for Coronary Angiography and Aortography. J Anat Physiol Stud Volume 1(1): 2017.

17.  Toledo JFBD, Gubolino LA,Teixeirense PT, Bragalha AMLA, Filho IJZ (2018) Diagnostic and Interventional Coronary Procedures by the Distal Radial Artery in the Anatomical SnuffBox: A Real World Analysis. J Cardiovasc Dis Diagn 6: 337. doi:10.4172/2329-9517.1000337