Comparison of distal radial access with conventional radial access for coronary catheterisation

BRIEF SUMMARY

 Title

 COMPARISON OF DISTAL RADIAL ACCESS WITHCONVENTIONAL 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 forcoronary procedures.

Objectives

a)      To compare the proceduralparameters of distal radial access with conventional radial access for coronaryprocedures.

b)      To compare clinical outcomes andsafety of distal radial access with conventional radial access for coronaryprocedures.

Purpose of the study

Distal transradialaccess (dTRA) by the snuffbox approach for coronary catheterization has emergedas an alternative to the classic forearm TRA with certain advantages andlimitations. In dTRA, the arm can be placed in a neutral position, withoutrequiring wrist rotation, being more comfortable for the patient and theoperator.(10) An occlusion at this site maintains antegrade flow throughthe superficial palmar arch. Flow to the thumb will still be maintained via thesuperficial palmar arch, preventing ischemia and hand disability.

Patients in Indiahave lower Body Surface area and are shorter in heights and are likely to havesmaller radial artery at wrist and at anatomical snuff box compared to westernpopulation.

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

This has not beenstudied in coastal Karnataka before. The aim of this study was to evaluate theeffectiveness, reproducibility, feasibility and safety of the dTRA approachover conventional radial access site in Indian population.

This study has notbeen started. No publications on this study yet.

Materials and methods

a)Inclusion and exclusion criteria: Described above

c)Statistical methods:

Mean and standarddeviations will be used to describe continuous variables. Categorical variableswill be expressed as frequencies and percentages along with medians andinterquartile ranges. Chi square test and student t-test will be used to testnull hypothesis for categorical variables and continuous variablesrespectively.

 Detailed description of procedure/processes

The study will be conducted in the Department of Cardiology, KasturbaHospital, Manipal. Patients undergoing coronary catheterisation as a part ofstandard care who fulfill the inclusion criteria mentioned above will beapproached. Eligible patients will be explained in detail about the study intheir own language and given the participant information sheet. An informedconsent will be taken from patients who are willing to participate in the studyafter fully understanding the nature of the study and risk/benefits involved.

This is anobservational study in which data will be collected from the patients who areundergoing coronary catheterisation through either distal radial orconventional radial approach as a part of their standard care.

Baselinecharacteristics of the patients, their indication for catheterisation, riskfactors or comorbidities will be recorded first in the proforma (datacollection form).  Procedural characteristics such as site ofpuncture, no. of attempts and time needed; size of sheath and its success orfailure; vasodilators; type of coronary procedure; no of catheter/ guideexchanges used with its size will be recorded. Total heparin dosage, contrastvolume, total procedural and radiation time along with radiation exposure willbe recorded in proforma.

Post proceduralhemostasis method and time; any complication like hematoma or bleeding orradial artery occlusion or any other symptoms at 24 hrs. will be recorded inproforma. Complete list of parameters to be recorded is enlisted in theproforma (separate file)

 Potential risks andbenefits:

This study involvesrecording of few parameters during your standard coronary catheterisationprocedure. Hence minimal risks involved.

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

Ethicalconsiderations and methods to address issues:

This is an observational study where patients already undergoingcoronary catheterisation either through distal radial or conventional radialapproach will be included. Informed consent will be taken from studyparticipants for the prospective part of the study and confidentiality of thedata will be maintained. There are no additional costs, invasive procedures ordrugs involved. It takes only a few extra minutes to obtain the few additionalprocedural parameters necessary for the study.

 Review of literature

Transradialaccess (TRA) is constantly evolving as the first choice for coronarycatheterization.(1,2) Its lower incidence of bleeding and access sitecomplications, shorter length of hospital stay, lower cost, and betterconvenience for the patient due to immediate post procedural mobilization, thanthose with the transfemoral access.(1,8,9)

The most operatorsprefer the right radial approach. The main reason is the working position ofthe operator on the right side of the patient. However, frequently the operatorneeds to cross over to the left radial approach or femoral approach. The mostcommon reasons to cross over artery access are: radial occlusion,underdeveloped radial artery (RA), extreme tortuosity, sclerosis orcalcifications, arteria lusoria, previous right radial failure, presence of anarteriovenous shunt in the arms, past or future use of the RA as free arterialgraft and patient preference.

However, there arelimitations of the TRA, such as radial artery occlusion, ergonomic and comfortreasons (patients must lie with their arm in a supine position), orthopedicreasons (injuries, frozen shoulders, and elbows causing inability to flex thewrist), and operator inconvenience (the patient needs to stand in a bentposition 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 tosurpass these difficulties.3 After cannulation of the radial artery along itsroute through the anatomical snuffbox and sheath placement, the arm can beplaced in a neutral position, without requiring wrist rotation, being morecomfortable for the patient and the operator.(10)

The anatomicalsnuffbox is a hollow space on the radial side of the wrist when the thumb isextended; it is bounded by the tendon of the extensor pollicis longusposteriorly and of the tendons of the extensor pollicis brevis and abductorpollicis longus anteriorly. The Radial artery crosses the floor that is formedby the scaphoid and the trapezium bones (11). Another important feature of thistechnique is a puncture is distal from the branch supplying the superficialpalmar arch (3). An occlusion at this site maintains antegrade flow through thesuperficial palmar arch. This reduces the risk of retrograde thrombus formationin the proximal RA located in the forearm, a frequent finding in patients whodevelop a forearm RA occlusion due to puncture trauma or hemostasis trauma atthe traditional RA puncture site. Flow to the thumb will still be maintained viathe superficial palmar arch, preventing ischemia and hand disability.

The distal RA accessfrom the radial fossa was described for the first time to open occludedipsilateral RA by Babunashvili et al (12)

The dTRA approach hasbeen applied in five patient cohorts worldwide, exclusively from the left sidein four of them3-6 and in both arms in the last one.(7) Conclusion of all thestudies were similar that Distal trans-radial access for diagnosticcatheterization and percutaneous coronary intervention is a reproducible, safeand feasible technique.

Kiemeneij F.Published a study in EuroIntervention. 2017 Sep 20, Left distal transradialaccess in the anatomical snuffbox for coronary angiography (ldTRA) andinterventions (ldTRI).(3) 70 patients were included for left distal radialaccess. There were eight procedural failures, requiring crossover totraditional right or left conventional radial approach. All other procedureswere successful, without major discomfort for the patient and operator. Noradial 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 studyof 54 patients undergoing left dTRA coronary catheterisation with Judkin 6Fcatheter. Seventeen patients admitted with acute coronary syndrome. They allunderwent successful left distal transradial coronary angiography andintervention. Primary angioplasty was performed in 10 patients. In total, 20patients had coronary intervention. Left anterior descending artery was theartery requiring most intervention (11 patients). Two patients experiencedbrachial spasm requiring crossover to right femoral artery. There were no casesof radial artery occlusion, hematoma, or hand numbness. Hemostasis was achievedwith manual compression.

Toledo et al., JCardiovasc Dis Diagn 2018 (17) published a study of 151 cases from sevendifferent institutions, made by three operators experienced with conventionalradial access. All the procedures were done either left or right distal TRAapproach. Puncture was attempted successfully in 142 cases (94%), 114 (80.3%)diagnostic and 28 (19.7%) coronary interventional procedures. Mean proceduretime 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 etal. Published article Right arm distal transradial (snuffbox) access forcoronary 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 laboratorycenters, regardless of the indication, were recruited. Right dTRA wasexclusively used. Catheterization was done in an acute coronary syndrome in24.5%, stable coronary artery disease in 22.4%, and other reasons in 53.1%. Theoverall 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 bypercutaneous coronary intervention in 18.2% of the patients. Manual hemostasiswas applied in 63.6% of the patients, which had a significantly shorterduration than device hemostasis (11 ± 7 versus 198 ± 42 min, p < 0.001). Nodistal or forearm radial artery occlusion was observed on triplexultrasonography 24 h after successful hemostasis. No major complications wererecorded.

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

The aim of this studywas to evaluate the effectiveness, reproducibility, feasibility and safety ofthe 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 coronaryangiography and percutaneous coronary intervention in people with coronaryartery 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 transradialaccess in the anatomical snuffbox for coronary angiography (ldTRA) andinterventions (ldTRI). EuroIntervention.2017;13(7):851-857.https://doi.org/10.4244/EIJ-D-17-00079.

4.      SoydanE, Akın M. Coronary angiography using the left distal radial approach - Analternative site to conventional radial coronary angiography. Anatol JCardiol.2018. https://doi.org/10.14744/AnatolJCardiol.2018.59932.

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

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

7.      ValsecchiO, Vassileva A, Cereda AF, et al. Early Clinical Experience With Right and LeftDistal Transradial Access in the Anatomical Snuffbox in 52 ConsecutivePatients. J Invasive Cardiol. 2018;30(6):218-223.

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

9.  KoÅ‚towskiÅ, Filipiak KJ, Kochman J, et al. Cost-effectiveness of radial vs. Femoralapproach 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.  DaviesRE, 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.  AladinoCerda, Mariano del Sol (2015) Anatomical Snuffbox and it Clinical Significance:A Literature Review. Int. J. Morphol 33:1355-60.

12.  BabunashviliA, Dundua D (2011) Recanalization and re-use of early occluded radial arterywithin 6 days after previous transradial diagnostic procedure. CatheterCardiovasc Interv. 77:530-6.

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

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

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

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

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