Radiation Exposure During Coronary Procedures According to Vascular Access
Radiation Exposure During Coronary Procedures According to Vascular Access
Trial's objective is to evaluate:

 i. if there's any difference between the operator radiation exposure during diagnostic
 coronary angiography and/or percutaneous coronary intervention (PCI) performed through
 right-side artery accesses (wrist transradial access and distal transradial access) versus
 left distal radial artery access ii. the relationship between operator radiation exposure and
 other clinical and procedural characteristics, to assess independent predictors of operator
 radiation exposure. Design of the study: prospective multicenter observational cohort
 registry (OCR).

 The purpose of this OCR is to assess the radiation exposure of interventional cardiologist
 during a diagnostic coronary angiography and/or PCI according to vascular access used (see
 above). Coronary angiography and PCI will be performed according to usual practice
Patient population:

 During 6 months, at least 1000 consecutive patients (age > 18 years) referred for diagnostic
 coronary angiography in up to 10 centers in Italy involving a minimum of 4 operators will be
 enrolled. To be qualified as expert, operators should have performed at least 250 transradial
 procedure/year in the previous 3 years and have performed at least 20 right and left distal
 radial procedures.

 Demographic and medical history data of patients including age, sex, history of diabetes
 mellitus, hypertension, height and weight will be collected. Height and weight of operators
 will be also recorded. Type of angiographic system will be recorded. Procedural data as
 contrast medium amount, subclavian tortuosity, numbers of diagnostic and guiding catheters
 and numbers of cine-angiographic acquisitions (frames) will be also recorded.

 Subclavian tortuosity will be classified as:

 -  Grade 1: tortuosity or calcification of the subclavian artery that can be crossed by a
 standard 0.035" nonhydrophilic wire facilitated with deep inspiration

 -  Grade 2: tortuosity or calcification of the subclavian artery that can be crossed with a
 0.0035" hydrophilic wire and a standard diagnostic catheter

 -  Grade 3: tortuosity or calcification of the subclavian artery or congenital anomalies
 that require a 0.035" stiff wire and a standard catheter

 -  Grade 4: severe tortuosity and/or calcification of the subclavian artery or congenital
 anomalies preventing the catheter or guide to reach the aortic valve plane or engage the
 coronary ostia with a stiff wire Subclavian tortuosity > grade 2 will be considered as
 significative. Type of catheters and the number of views for angiography and PCI will be
 left to the discretion of the operator. Lead shields placed under the catheterization
 table, as well as ceiling mounted lead shields, will be used in every procedure.
 Procedural success is defined as completion of the procedure through the intended
 arterial access. Crossover, if needed, is permitted to femoral access or to
 contralateral arm or approach.

 Arterial access protocol:

 Right radial access: radial artery access will be obtained with a 20-gauge Teflonsheated
 needle using the Seldinger or the counter puncture technique. An introducer sheath is
 inserted in the radial artery according to local practice. An intra-arterial vasodilator
 cocktail will be administered consisting of ntroglycerin 200 mcg and verapamil 5 mg after
 sheath insertion. 5000 IU of unfractioned heparin will be administered intravenously after
 sheath insertion, and adequately adjusted in case of interventions. The introducer sheath
 will be removed at the end of the procedure, and a mechanical or inflatable pressure band
 will be applied to the access site to achieve hemostasis.

 Distal radial accesses: following distal radial artery palpation, 1 of the 2 possible
 puncture sites (anatomic snuffbox or in the first intermetacarpal space) is chosen. In case
 of left-side access, the left hand is bent toward the left groin with support below the left
 elbow to ensure patient's comfort. The operator is positioned at the right side of the
 patient. To favor a shift of the distal radial artery to the surface of the fossa, the
 patient is asked to grasp his or her thumb under the other 4 fingers or to hold a roll of
 gauze, a 20 ml syringe, or the handle of a dedicated system. After disinfection and local
 anesthesia, the artery is punctured according to operator preference and/or experience using
 a micropuncture needle or a cannula-over-needle. An introducer sheath (preferably a slender
 introducer sheath) is inserted in the radial artery according to local practice. An
 intra-arterial vasodilator cocktail will be administered consisting of nitroglycerin 200 mcg
 and verapamil 5 mg after sheath insertion. 5000 IU of unfractioned heparin will be
 administered intravenously after sheath insertion, and adequately adjusted in case of
 interventions.

 Coronary catheterization:

 Angiographic systems were set according to the standard of the operators, and the field of
 view or fluoroscopic and cine-acquisition speed will be recorded for each procedure. The
 diagnostic procedures will be performed using a standard sequence of 3 projections for the
 right coronary artery and maximum 6 projections for the left coronary artery. Differently,
 the percutaneous coronary interventions will be performed according to the lesion and to the
 operator preference.

 Vascular access as well as the sheath selection, catheter curve used, and the use of
 adjunctive tools will be at the discretion of the operator involved in the procedure.

 In all procedures, standard operator radioprotection will be ensured using a lead apron, a
 thyroid lead collar, lower body x-ray curtain fixed on the angiographic table, an upper
 mobile leaded glass suspended from the ceiling, and leaded glasses. The use of adjunctive
 protective drapes to reduce operator radiation exposition ws left to the operator's
 discretion

 Radiation measurement:

 Radiation measures collected are fluoroscopy time (expressed in minutes), the AK (expressed
 in mGy) and the DAP (expressed in Gy*cm2). The number of acquired cineangiograms will be
 recorded. Fluoroscopy and cineangiography will be performed at 7.5 or 15 frames/s according
 to operators' preferences.

 Operator radiation exposure is measured for each participating operator using 1 dedicated
 electronic dosimeter (PM1610B; Polimaster, Vienna, Austria) to be worn at mid-thorax level,
 in the breast pocket outside the lead apron, and expressed in µSy. The radiation and operator
 measures will be recorded at the beginning and the end of each procedure. For those patients
 who undergo a PCI after the diagnostic procedure, the measures of fluoroscopy time, DAP, and
 dose of the wearable dosimeters will be reset after the end of the diagnostic procedure and
 restart at the beginning of the PCI. To take into account possible differences in patient
 radiation dose affecting the operator exposure, the DAP-normalized operator dose will be also
 calculated.

 The equivalent dose at the thorax will be also converted in operator effective dose dividing
 it by a factor of 33 according to apron thickness, 0.5 lead equivalent with a tube voltage
 under the table. Patient effective dose will be calculated using a conversion factor of 0.20
 mSv/Gy*cm2.

 Statistical Hypothesis and analysis:

 the null hypothesis is that ld-TRA exposure to radiation is the same as right-side TRA
 (access site at the wrist and at the anatomical snuffbox of the right hand). In the previous
 RADIANT study right-side TRA was associated with a mean operator exposition of 13 µSy (SD +10
 µSy); hence, to detect non-inferiority between the two groups (risk of type I error 5%, risk
 of type II error 80%, non-inferiority limit 3 µSy) at least 138 per group are needed. The
 alternative hypothesis is that ld-TRA exposure is reduced compared to rightside TRA. The
 amount of this reduction is to be determined. An arbitrary period of 6 months should be
 sufficient to record the radiological exposition in at least 1000 procedures. Taking into
 account possible crossover between groups, a minimum proportion of 20% of procedures through
 distal left radial artery PCIs was mandated to guarantee adequate numerosity of the group.
 Kolmogorov-Smirnov analysis will be performed to evaluate the distribution of each variable
 analyzed. Categorical variables will be analyzed using chi-square test, and continuous
 variables will be analyzed using analysis of variance for normally distributed variables and
 Kruskal-Wallis test for variables with distribution that were not normal. If needed,
 log-transformation of non-normal variables will be performed. Hierarchical linear regression
 will be used to identify independent predictors of radiation exposure, entering control
 variables found to be significantly associated with radiation exposure on univariate
 analysis. Propensity score matching will be performed to minimize the risks of imbalances due
 to variation in the complexity of the diagnostic or therapeutic procedures within each
 operators. Prespecified analysis of subgroups (diagnostic coronary angiography vs PCI, expert
 operators vs fellows, use of adjunctive drapes, physical characteristics of operators) could
 be planned.
Inclusion Criteria:

 -  patients admitted for coronary diagnostic angiography in the setting of valvular
 disease, stable angina, suspected coronary artery disease, acute coronary syndrome
 with or without ST segment elevation myocardial infarction who underwent diagnostic
 coronary angiography through right radial, right distal radial and left distal radial
 access.

 -  patients admitted for ad-Hoc PCI through any radial access

 -  patients age > 18 years-old

 -  signed informed consent

 Exclusion Criteria:

 -  hemodynamic instability