"SACRED: A nurse-led evaluation of allergic reactions following radial access": Christine Mars' presentation for the conference.

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. •Diagnostics
•Interventions

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

5. 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

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

7. •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

8. •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

9. •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%

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. 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

15. 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)

16. 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)

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

18. 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
Radial sheath insertion, femoral completion
2
0.4

19. •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

20. 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 †

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

22. 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

23. 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

24. Observed in a single patient:
Day 26

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

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

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

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

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

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

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

32. •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

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

34. Thank you