let's talk research annual conference - 24th-25th september 2014 (christine mars)

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

• Diagnostics • Interventions

Transradial access, growing popularity:

• Reduced access site related bleeding

• Reduced procedural costs

• Patient preference

Challenges include:

• Radial artery spasm

• Radial artery occlusion

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

• Observation of routine practice using…

• The current generation Cook hydrophilic sheath

• Examining:

• Safety

• Efficacy

• Subsequent incidence of cutaneous reaction

• 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

• 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

• 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%

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

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

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

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

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

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)

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)

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

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

• 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

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 †

Radial artery occlusion detected by plethysmography:

Incidence: 15/412 3.6%

95% Confidence Interval 1.83% - 5.44.

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

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

Observed in a single patient:

Day 26

Observed in a single patient:

Day 26

Day 57

Observed in a single patient:

Day 26 Day 57 Day 110

• Incidence: 1/429 0.23%

95% Confidence Interval

Conventional method 0% - 0.68%

• Incidence: 1/429 0.23%

95% Confidence Interval

Conventional method 0% - 0.68%

Exact method 0.01% - 1.29%

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

• 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

• 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

• 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

• Kate Cullen RN

• Ian Kemp RN

• Carla Livesey RN

• Dr Rod Stables DM

Thank you