An evaluation of allergic reactions following radial access. SACRED: Systematic Assessment of the Cook® Radial shEath Device

2. The SACRED study was supported by an unrestricted
educational grant from Cook Medical
The funder played no part in study design
and was not involved in the analysis or
presentation of results

3. Transradial access, growing popularity:
• Reduced access site related bleeding
• Reduced procedural costs
• Patient preference
Challenges include:
• Radial artery spasm
• Radial artery occlusion

4. Hydrophilic sheaths widely used, associated with::
Radial granuloma
• Reported since 2003: incidence 1.6% - 6.0%
• Observed with previous generation of Cook sheaths
• Peak onset 2-3 weeks post procedure
• Resolution with conservative management
Histology
• Foreign body presence – dislodged sheath coating

5. • Observation of routine practice using…
• The current generation Cook hydrophilic sheath
• Examining:
• Safety
• Efficacy
• Subsequent incidence of cutaneous reaction

6. • Observation of routine practice using…
• The current generation Cook hydrophilic sheath
• Examining:
• Safety
• Efficacy
• Subsequent incidence of cutaneous reaction
SACRED:
Systematic Assessment of the Cook®
Radial shEath Device

7. • Nurse led prospective, single-centre registry study
• Recruiting consecutive eligible patients
• Primary outcome measure
• Incidence of cutaneous granuloma at 28 days
• Secondary outcome measures
• Procedural success rate with the study sheath
• Radial-related intra-arterial vasodilator use
• Access site complications during index admission

8. • In our centre, a sample size of 400 would be:
• Practical
• Achievable, and…
• Provide reasonable precision for the reported result
Sample size Event rate 95% Confidence Interval Width
400 0.25% 0% - 0.74% ±0.37%
400 4% 2.08% - 5.92% ±1.92%
400 6% 3.67% - 8.33% ±2.33%

9. October 2013 - January 2014: 54 working days
Total eligible patients 460
Consented patients 432
No radial attempt in the cath lab 6
Radial access attempts: patients 426
Radial access attempts: sites 446
Full or partial sheath insertions 433
Lost to follow-up: (4 patients with 4 single radial sites) 4
Sites analysed for primary outcome measure 429

10. October 2013 - January 2014: 54 working days
Total eligible patients 460
Consented patients 432
No radial attempt in the cath lab 6
Radial access attempts: patients 426
Radial access attempts: sites 446
Full or partial sheath insertions 433
Lost to follow-up: (4 patients with 4 single radial sites) 4
Sites analysed for primary outcome measure 429

11. October 2013 - January 2014: 54 working days
Total eligible patients 460
Consented patients 432
No radial attempt in the cath lab 6
Radial access attempts: patients 426
Radial access attempts: sites 446
Full or partial sheath insertions 433
Lost to follow-up: (4 patients with 4 single radial sites) 4
Sites analysed for primary outcome measure 429

12. October 2013 - January 2014: 54 working days
Total eligible patients 460
Consented patients 432
No radial attempt in the cath lab 6
Radial access attempts: patients 426
Radial access attempts: sites 446
Full or partial sheath insertions 433
Lost to follow-up: (4 patients with 4 single radial sites) 4
Sites analysed for primary outcome measure 429

13. October 2013 - January 2014: 54 working days
Total eligible patients 460
Consented patients 432
No radial attempt in the cath lab 6
Radial access attempts: patients 426
Radial access attempts: sites 446
Full or partial sheath insertions 433
Lost to follow-up: (4 patients with 4 single radial sites) 4
Sites analysed for primary outcome measure 429

14. Female (%) 31.2
Diabetes Mellitus (%) 19.7
Hypertension (%) 53.4
Hyperlipidaemia (%) 57.3
Current smoker (%) 24.9
Age, years - mean (SD) 63.9 (10.7)
BMI, kg/m² - mean (SD) 28.7 (5.2)
Wrist circ., cm - mean
(SD)
17.6 (1.6)

15. Durations, minutes Median IQR
Procedure 35 22, 53
Sheath in-situ 30 17, 45
Compression device 250 213, 294
Sheath diameter (%) Sheath length (%)
5 French
91/433
(21.0)
13 cm
6/433
(1.4)
6 French
338/433
(78.1)
23 cm
427/433
(98.6)

16. Radial access sites prepared n = 446
Success n %
Successful cannulations with study sheath 427 95.7
Procedural completion via any radial 421 94.4
Procedural completion via first lateralisation 408 91.5

17. Radial access sites prepared n = 446
Success n %
Successful cannulations with study sheath 427 95.7
Procedural completion via any radial 421 94.4
Procedural completion via first lateralisation 408 91.5
Failure
Unsuccessful radial attempts 19 4.3
Completed via contra-lateral radial 13 2.9
Completed femorally 6 1.3

18. • Not used routinely by 9/12 radial operators
Radial access sites instrumented 433 %
Given by a routine-use operator 70 16.2
No routine administration of vasodilator 363 83.8
Given in response to radial artery spasm 13/363 3.6

19. Vascular complications
33/446 (7.4%)
Managed by nurses
20 (60.6%)
Required medical
review
13 (39.4%)
Required surgical
review
0
Required transfusion 0
Unplanned night in hospital 3
(0.7%)
† Independent of haematoma or ecchymosis
Haematoma ≤3cm
9 Haematoma >3cm
16
Ecchymosis >4cm
7
Arm discomfort 1
†

20. Radial artery occlusion detected by plethysmography:
Incidence: 15/412 3.6%
95% Confidence Interval 1.83% - 5.44.

21. Radial artery occlusion detected by plethysmography:
Incidence: 15/412 3.6%
Total not anticoagulated 31/412 7.5%
Anticoagulation given No anticoagulation given p Value
11/381
2.9%
4/31
12.9%
0.02

22. No other significant factors identified
Patent Occluded p Value
Age - years, mean 63.82 71.53 0.007
Weight - kg, mean 84.39 70.82 0.002
BMI - kg/m², mean 28.85 25.58 0.011

23. Observed in a single patient:
Day 26

24. Observed in a single patient:
Day 26
Day 57

25. Observed in a single patient:
Day 26 Day 57 Day 110

26. • Incidence: 1/429 0.23%
95% Confidence Interval
Conventional method 0% - 0.68%

27. • Incidence: 1/429 0.23%
95% Confidence Interval
Conventional method 0% - 0.68%
Exact method 0.01% - 1.29%

28. • A single incidence 1/429 (0.23%) of a self-limiting skin reaction

29. • A single incidence 1/429 (0.23%) of a self-limiting skin reaction
• Access:
• Failure rate of 19/446 (4.3%) consistent with other studies
• Predominant non-routine use of intra-arterial vasodilators

30. • A single incidence 1/429 (0.23%) of a self-limiting skin reaction
• Access:
• Failure rate of 19/446 (4.3%) consistent with other studies
• Predominant non-routine use of intra-arterial vasodilators
• Radial access site complications:
• Mostly managed by nursing teams
• No surgical review or intervention required
• Few requiring overnight stay for primary radial reason

31. • A single incidence 1/429 (0.23%) of a self-limiting skin reaction
• Access:
• Failure rate of 19/446 (4.3%) consistent with other studies
• Predominant non-routine use of intra-arterial vasodilators
• Radial access site complications:
• Mostly managed by nursing teams
• No surgical review or intervention required
• Few requiring overnight stay for primary radial reason
• Radial artery occlusion:
• Detected in 15/412 (3.6%) sheath instrumented sites
• Associated with failure to anticoagulate, and…
• Older age and lower body weight

32. • Kate Cullen RN
• Ian Kemp RN
• Carla Livesey RN
• Dr Rod Stables DM