RADIATION PROTECT trial: a randomized controlled trial of radiation protection with a patient lead shield and a novel non-lead surgical cap for operators performing coronary angiography or intervention

1. RADIATION PROTECT Trial
A Randomized Controlled Trial of
RADIATION PROTECTion with a Patient Lead Shield and a
Novel, Non-Lead Surgical Cap for Operators Performing
Coronary Angiography or Intervention
Co-principal investigators:
Ashraf Alazzoni, MD, FRCPC
Sanjit Jolly, MD, FRCPC
McMaster University
Hamilton, Ontario, Canada

2. • Lead drape was designed in collaboration
and provided by UltraRay Medical
(Oakville, Canada)
• Lead free Cap was provided by Worldwide
Innovations & Technologies Inc (Kansas
City, USA)
Disclosure Statement of Financial Interest

3. Radiation and Cancer*
•36 Cases of Brain Tumours in interventional
Cardiologists
•Half Glioblastoma, 86%Left Temporal
•Mean 23 years of practice
•Uncertainty if causal.
•ALARA: As Low As Reasonably
Attainable
*Roguin, A, et al. Eurointervention. 2012;7:1081-86 & Roguin, A. SOLACI, 2014.

4. RADIATION PROTECT RCT
Study objective: To evaluate the efficacy of the
pelvic lead drape on patient and the non-lead
surgical cap in reducing interventional cardiologists’
radiation exposure

5. Pelvic Lead Drape
Produced by UltraRay Medical, Oakville, Canada

6. A novel surgical cap (No Brainer , RADPAD )
•Light (53 grams in
weight)
•Lead Free
•It contains bismuth
and barium
Provided by Worldwide Innovations & Technologies Inc,
Kansas City, USA

7. Methods
•Prospective, randomized, controlled trial
• Inclusion Criteria:
i) Planned percutaneous coronary intervention (PCI)
ii) ACS referred for coronary angiography and possible PCI
iii) Stable angina referred for coronary angiography and high
likelihood of undergoing same sitting PCI
• The only exclusion criterion was an age younger than 18
years

8. Primary Outcome
Lead shield objective, co-primary outcomes:
I. Operator Dose (µSv)
II. Operator dose indexed for Air Kerma (µSv/mGy)
Radiation protection cap: difference between radiation
doses external and internal to the cap

9. Statistical Analyses
•Based on a mean radiation exposure dose during PCI
of 21 µSv ± 14 in a control sample and assuming a one-
sided alpha of 0.025, 226 patients were required to have
80% power to detect a 25% reduction in dose.
•Analyses were conducted using the mixed linear
regression adjusted for physician effects for the lead
shield comparison and the mixed linear regression
with repeated measurement for the cap comparison.

10. Results 230 Patients with high likelihood of
undergoing same sitting percutaneous
coronary intervention (PCI) were enrolled
and underwent randomization
Randomization was stratified by chronic
total occlusion PCI cases in a 1:1 ratio
1 patient was missed
since procedure was
done without putting the
dosimeters on operator
1 patient operator’s left
chest dosimeter was
severed before starting
procedure
115 Patients were
assigned to the lead
shield group
115 Patients were
assigned to the
control group
113 Patients were
included in the lead
shield group
115 Patients were
included in the
control group
229 were included in the surgical cap analysis

11. Results
Study Population
Characteristic
Lead Shield
(N=113)
Control
(N=115)
Age - years 65.08 ± 11.35 66.93 ± 11.60
Female sex –
no. (%)
38 (33.63) 36 (31.30)
Body-mass
index
29.24 ± 6.63 30.13 ± 7.57
Previous CABG
- no. (%)*
10 (8.85) 22 (19.13)
In-patients –
no. (%)
78 (69.03) 74 (64.35)
*Difference in previous CABG was significant p =0.025

12. Results
Study Population
Characteristic
Lead Shield
(N=113)
Control
(N=115)
Indication for procedure* – no. (%)
Planned PCI 39 (34.51) 49 (42.61)
Stable angina 7 (6.19) 6 (5.22)
Unstable angina 11 (9.73) 11 (9.57)
NSTEMI 54 (47.79) 47 (40.87)
STEMI 1 (0.88) 0 (0.00)
Heart failure 1 (0.88) 2 (1.74)
*No significant difference between both groups

13. Results Procedural Data*
Characteristic
Lead Shield
(N=113)
Control
(N=115)
Total
(N=228)
P Value
Operator being a
clinical fellow – no.
(%)
64 (56.64) 69 (60.00) 133 (58.33) 0.61
Radial access – no.
(%)
88 (77.88) 84 (73.04) 172 (75.44) 0.4
Procedure
performed – no. (%)
PCI 66 (58.41) 74 (64.35) 140 (61.40) 0.36
Chronic total
occlusion PCI
9 (7.96) 9 (7.83) 18 (7.89) 0.97
Rotablation 7 (6.19) 6 (5.22) 13 (5.70) 0.75
Coronary
angiography
31 (27.43) 26 (22.61) 57 (25.00) 0.4
Patient referred for
CABG
12 (10.62) 10 (8.70) 22 (9.65) 0.62
*No significant difference between both groups

14. Results Procedural Data
Characteristic*
Lead Shield
(N=113)
Control
(N=115)
Median contrast
volume used – mL
(IQR)
130.00 (92.00-
184.00)
126.00 (90.00-
190.00)
Median fluoroscopy
time – minutes
(IQR)
9.52 (5.43-
15.48)
9.98 (5.42-
15.48)
Median air kerma –
mGy (IQR)
857.94 (512.00-
1324.0)
942.49 (552.68-
1485.0)
*No significant difference between both groups

15. Results
Pelvic lead drape reduced radiation dose by 75.6%
Primary Outcomes
0
5
10
15
20
25
Mean Left Chest Radiation Dose (µSv)
Lead Shield No Lead Shield
6.38
23.57
P<0.0001

16. Results
Primary Outcomes
0
0.005
0.01
0.015
0.02
0.025
Operator dose indexed for air kerma (µSv/mGy)
Lead Shield No Lead Shield
0.006
0.02
P<0.0001
Pelvic lead drape reduced operator dose indexed for air
kerma by 71%

17. Results Sub-Group Analysis
Sub-Group Lead Shield Control
Percentage
of Reduction
(%)
P Value
CTO 10.34 ±10.38 56.50 ± 57.74 80.29 0.002
non CTO 6.04 ± 7.20 20.77 ± 22.06 75.3 <0.0001
PCI including
rotablation
7.91 ± 8.44 18.73 ± 9.89 75.6 <0.0001
Coronary
angiography only
3.40 ± 3.21 8.44 ± 5.89 72.38 <0.0001
Femoral 4.62 ± 7.49 38.28 ± 37.11 91.32 <0.0001
Radial 6.88 ± 7.51 18.14 ± 21.36 66.52 <0.0001
BMI tertile 1 3.33 ± 2.61 18.62 ± 21.16 77.98 <0.0001
BMI tertile 2 6.06 ± 6.62 31.94 ± 39.01 81.06 <0.0001
BMI tertile 3 9.77 ± 10.09 20.57 ± 18.25 65.63 <0.0001
Fellow 6.58 ± 7.93 21.67 ± 22.86 73.81 <0.0001
Staff 6.12 ± 7.05 26.41 ± 34.06 77.56 <0.0001

18. Results
The cap use resulted in an 80.58% reduction in operator
head radiation exposure
Primary Outcomes
0
2
4
6
8
10
12
Operator Head Radiation Dose (µSv)
Inside Cap Outside Cap
2.99
10.75
P<0.0001

19. •Median operator comfort level with cap during the
procedure on a 1-10 point scale was 9
Results

20. Limitations
•Single center
•Patients radiation dose wasn’t directly measured but
there was no difference in air kerma between groups

21. Conclusion
•Lead shield and the No Brainer cap reduced operator
radiation exposure by >75%
•These simple protective measures can be easily
incorporated into clinical practice and increase
operators safety
Perspective: These interventions can reduce the
operator dose of complex retrograde CTO to a
diagnostic cath

22. Thank You