1. STROKE AND TIA - OPTIMAL SURGICAL MANAGEMENT OF SYMPTOMATIC CAROTID DISEASE
Mr. Patrick Chong Consultant Vascular & Endovascular Surgeon
Surrey Heart, Stroke and Vascular Centre
Frimley Health NHS Foundation Trust
Guildford November 2014

2. Stroke – the figures 3rd leading cause of death and
new strokes annually
new strokes annually
3 times as many women die from stroke as from breast cancer.

3. Stroke – the costs
$51 billion - Stroke related treatment costs and disability payments in 2003
£7 billion – Stroke related treatment costs and disability payments in 2005
Treatment and research under funded in the UK?
£2 million per annum in the UK
c.f. Cancer £120 million and Heart Disease £43 million
Rothwell 2001 Lancet

4. The dangers of stroke 1 in 4 men before 85 years old
1 in 5 women before 85 years old
30% of stroke patients die within 30 days
Up to 32% will have a recurrent stroke within 30 days
1 in 4 stroke patients have a recurrent stroke

5. Brain Attack! Vladimir C. Hachinski MD Canadian Neurologist
r-TPA currently the only FDA approved
treatment for acute stroke to be given
within 4.5 HOURS of the start of symptoms.
The majority of patients don't report to the emergency room until more than 24 hours after the onset of stroke symptoms
52 % of acute stroke patients unaware they were experiencing a stroke.

6. Current organisation of care in UK
National Sentinel Audit
Stroke units % % 83%
Thrombolysis offered % %
Neurovascular clinics % % 98%
Rapid transfer protocols % % 22%
High risk patients seen < 7 days % %
TIA clinic median waiting (days)
1 FPH

7. Current emergency care in UK
National Sentinel Audit vs vs. 2014
Access to brain imaging < 12 hours 48% vs %
Access to brain imaging < 24 hours 95% vs %
Thrombolysis offered to eligible pts 18% vs. 50% vs %
WHAT HAS CHANGED?
Stroke Telemedicine
Ambulance Services Pre-alerts
24 imaging and reporting for CT / CT in ED
ED led thrombolysis

8. “There is more to stroke prevention than CEA” – AR Naylor 2007

9. Risk factors for stroke
Modifiable
Hypertension
Smoking
Hyperlipidaemia
High grade carotid stenosis
Atrial Fibrillation
Diabetes
Controversial e.g. OCP, Obesity, Alcohol
Non-modifiable
Age
Male sex
Ethnicity

11. Fate of symptomatic carotid disease
Stroke incidence
1 Year 5 years
Previous Symptoms
TIA % 30-35%
Stroke % %
Norris JW et al. Stroke 1991

12. Fate of asymptomatic carotid disease
1 Year
< 75% ICA stenosis 1.5% Stroke
> 75% ICA stenosis 3.3% Stroke
7.5% TIA
Norris JW et al. Stroke 1991

13. Does plaque morphology matter?
Risk of stroke in symptomatic patients
95% stenosis %
Non-ulcerated plaque
95% stenosis %
Ulcerated plaque
NASCET study 1991

14. Does symptomatic carotid stenosis matter?

15. Which patients should be treated first?
4799 patients tested using ABCD (2) score
2-day risk of stroke
Score of 0 – 3 (1012 patients) 1%
Score of 4 – 5 (2169 patients) 4.1%
Score of 6 – 7 (1628 patients) 8.1%
Johnston SC, Rothwell PM, Nguyen-Huynh MN, et al.
Validation and refinement of scores to predict very early stroke risk after transient ischaemic attack.
Lancet 2007

16. Carotid Endarterectomy (CEA)

17. The earliest report Loucks et al. 1936
Union Medical College, Beijing, China.
Young male with recurrent TIAs
Right hemiplegia and aphasia
Excision of ICA occlusion
Patient recovered
Archives of Surgery 1938

18. Speed is of the essence! Reconstruction of internal carotid artery in
a patient with intermittent attacks of hemiplegia
Eastcott, Pickering and Rob Lancet 1954
First carotid endarterectomy
1953
De Bakey JAMA 1975

19. The evolution of carotid surgery
Reported 1955
Reported 1954
Reported 1975

20. Pre-CEA imaging – current UK
Duplex only %
Duplex and MRA 13%
Duplex and arch angiogram 9%
Duplex and CTA %
MRA only 2%
CTA only %
Arch angiogram only %
GALA trial preliminary data
Gough et al. 2007
Leeds

21. Mofidi et al. 2006

22. To patch or not to patch? GALA Trial (current UK practice) Always 75%
Selective 20%
Never %
“Patch angioplasty versus
primary closure for CEA”
Bond et al. 2003
Cochrane Database of Systematic Reviews
Outcome no different for different patch types
Significant reductions
Stroke
Death
Early Thrombosis
Late Restenosis

23. Intra-operative cerebral perfusion
Never shunt 5%
Speed
Shunt all patients 70%
Mainly GA patients
Selectively shunt 25%
Stump pressures 25%
EEG 5%
TCD 35%
Awake patient – regional cervical block
“Routine or selective carotid artery shunting for CEA”
Bond et al. 2001
Cochrane Database of Systematic Reviews
No evidence to support a policy of routine, selective or no shunting

24. How does surgery compare with best medical therapy in symptomatic carotid disease?
Primary
Endpoint
Trial N
Stenosis
(%)
Medical
Surgical
P value
ARR
NNT
NASCET
1991
659
>70
32.3
15.8
<0.001
11.3 9
ECST
3008
21.9
12.3
1.5 68
VASST
189
>50
19.4
7.7
0.01
17.2 6

25. Surgery versus Stenting outcomes
CAVATAS
2001
LEXINGTON 1
SAPPHIRE
2004
EVA-3S
2006
SPACE
ICSS
2010
CREST
CEA / CAS
71% No
Symptoms
Number
randomised
253 / 251
53 / 51
151 / 156
262 / 265
595 / 605
855 / 858
1251 / 1271
Cranial nerve
8.7% / 0%
8.0 % / NS
5.3% / 0%
7.7% / 1.1%
NS / NS
5.3% / 0.1%
4.7% / 0.3%
Wound
6.7%/ 1.2 %
8.0% / 0 %
10.6% / 8.3%
1.2% / 3.1%
5.8% / 3.6%
0.2% / 1.6%
Stroke
9.9% / 10%
0% / 0%
20 % / 12%
/ 9.6%
7.4 % / 6.8%
4.1% / 7.5%
2.3 %/ 4.1%
Death
2 % / 3 %
1.9% / 0 %
Combined 6%
1.2% / 0.8%
0.9% / 0.7%
0.8% / 2.2%
0.3% / 0.7%
Combined
Any Stroke
5.9% / 6.4%
1.9% / 0%
6.1 % / 5.8%
For AS patients
3.9% / 9.6%
6.5% / 7.7%
5.2% / 8.5%
3.2% / 6.0%

26. What would you rather choose?

27. Are you sure you
still want a stent?

28. Carotid endarterectomy outcomes
*N=2236
2007 J Vas Surg
*N=5513
2008
30-day Stroke / TIA (%)
3.1% (n=5)
1.4%
1.8%
30-day MI (%)
2.5% (n=4)
0.5%
0.8%
30-day Death (%)
0.6%
Cranial Nerve Injuries (%)
2.1% (n=2)
0.4%
4.5%
Return to theatres
0.6% (n=1) NS
2.1%
Median length of stay (days) 3
4.3
Asymptomatic patients 8.8% FPH 64% MGH 16% NVD

29. Vascular Services Quality Improvement Programme (VSQIP)
November 2014
Surgeon outcomes for carotid endarterectomy
Dates 1st October 2010 to 30th September 2013
Institution
No. of Procedures
Patients
Discharged
Without stroke / death in 30 days
Adjusted rate of stroke / death %
Days from symptom to surgery Median (IQR)
Length of stay (days)
Median (IQR)
FPH
211
207
2.0
8 (5,12)
2 (1,5)
National
2.5 12

30. Rationale for delaying CEA
Risks of haemorrhagic transformation infarct
with early surgery in acute stroke
Delay of 4-6 weeks recommended
Wylie (1964)
Thompson (1970)
DeWeese (1971)
Torgovnick (2007)

31. When should surgery be offered
When should surgery be offered? Risk of stroke and timing of carotid endarterectomy

32. DOES TIMING OF SURGERY MATTER
DOES TIMING OF SURGERY MATTER? Carotid Endarterectomy Trialists Collaboration (CETC)
Number of ipsilateral strokes prevented at five years by performing 1000 CEAs in symptomatic patients with 50-99% stenoses relative to days from last symptom to surgery
(based on reanalysis of CETC data) Rothwell Lancet 2004

33. Faster surgery for females
“Benefit from CEA in women was
apparent in those randomized within
2 weeks of their last symptomatic
ischemic event”
“Current guidelines in
Europe and the USA which state
only that CEA should be performed
within 6 months of last symptoms
should be amended in the light of
these results.”
Rothwell PM et al. Stroke 2004; 35:

34. Median time to surgery Days
Delays! Delays! Delays!
Median time to surgery Days
UK national carotid audit
Newcastle audit
Oxford audit
GALA trial
Frimley Park Hospital
Frimley Park Hospital

35. 12% admitted patients required surgery
University of Calgary experience Stroke 2006
12% admitted patients required surgery
72% operated within 2 weeks in 2002
92% operated within 2 weeks in 2004
37% operated within 2 weeks on NVD
14% operated within 2 weeks at Frimley in 2010
100% operated within 2 weeks at Frimley in 2014

36. All TIA or non-disabling stroke
43 consecutive patients 12 months prior to NICE stroke guidelines (July 2008)
All TIA or non-disabling stroke
94% patients scored ABCD2 > 4 (high risk)
Mean time to consultant vascular opinion 28 days
81% patients had carotid duplex within 7 days
32% of high risk patients had CT scan within 24 hours
14% of patients had surgery within 2 weeks
ASIT Conference Nottingham March 2009

37. Conclusions (in 2008) WE WERE NOT FAST ENOUGH!
Significant delays existed in our local urgent carotid surgery pathway prior to the NICE guidelines (July 2008).

38. 7 days 48hrs from diagnosis According to NICE How quickly do we
need to investigate &
Treat symptomatic
Carotid Stenosis?
7 days
South East Coast
Stroke Clinical
Reference
Group target for CEA
48hrs from
diagnosis

39. Stroke and TIA Surgical Helpline – allow direct consultant to consultant referrals from HASU and acute stroke unites from RSCH, BNHH and HWPH
SEND IMAGES VIA IEP and FAX PATIENT DETAILS
GPs to refer to their nearest HASU or Acute Stroke units or Rapid Access TIA clinic - MDT

40. Limitations of CEA Severe OA / ankylosis cervical spine
Long length lesions
High bifurcations (above C2)
Previous cervical surgery
Previous cervical irradiation
Concomitant intra-cranial lesion
Concomitant thoracic lesion
Medically “high risk” patient

41. The first report of endoluminal carotid intervention
“Catheter dilatation of proximal carotid stenosis during distal bifurcation endarterectomy.”
Kerber CW et al. 1980
Am J Neuroradiol

42. Carotid artery stenting (CAS)

43. Overview of CAS Patient preparation Femoral access
Aortic arch angiogram
Selective arch vessel cannulation
Intracranial and extracranial cannulation
Common carotid sheath access
EPD placement
Predilatation, stenting and postdilatation
Completion angiogram
EPD removal
Access site management
Postprocedural care and followup
Overview of CAS

44. Catch of the day!

45. Risk of micro-emboli: CAS vs. CEA
Diffusion-weighted MRI
Events in the 48 hours following CEA and CAS.
19 / 27 (70%) CAS vs. 0 / 19 (0%) CEA
9 ipsilateral / 7 bilateral / 3 contralateral
3 CAS patients had post-operative neurology but all resolved within 36 hours.
The only factor associated with the development of microemboli was the use of a diagnostic arch angiogram.
Preoperative MRI/A or CT-A recommended as alternative instead

46. NICE guidance for CAS Safe and efficacious in the short term
Unsure about benefits in asymptomatic
Clear written information with consent
Audit and review all cases
Submit cases to registries and studies
Last updated September 2006

47. Asymptomatic carotid disease - what was known before ACST
ACAS (USA) 1995
If a patient had a CEA before developing symptoms, they might be less likely to have a stroke, providing the operation had a very low morbidity and mortality
Benefits confined to men under 65 years
No difference in outcome for stenosis 60-99%
Benefits were not greater for those with tighter stenosis as seen in the symptomatic trials
MAJORITY OF PATIENTS IN USA & EUROPEAN SERIES ARE ASYMPTOMATIC!
ACST (UK) 2003
1560 allocated immediate CEA
1560 allocated follow-up with deferred CEA
3.4 years mean follow-up

48. Asymptomatic Carotid Studies Total 5 year Stroke related mortality

49. What we know post ACST
Benefits significant for men as well as for women up to the age of 75 years.
Benefits seen in patients with a stenosis > 70% on ultrasound.
5 year net risk of all strokes in ACST.
6% with immediate CEA
12% with deferred CEA
Fatal and disabling stroke, not just stroke overall was prevented by surgery.

50. ACST Caveats Best medical therapy (BMT) not optimised.
Higher event rates compared with medical trials.
Surgeons with event rates > 3%?
CAPRIE (n= 19185)
2 yr Stroke, MI, Vascular Death
5.8% ASA vs. 5.3% Plavix
4S study (n=4444)
Simvastatin 2.7% vs. Placebo 4.3%
No plaque morphology characterisation.

51. RCTs of CEA for asymptomatic disease
Primary
Endpoint
Trial N
Stenosis
(%)
Medical
Surgical
P value
ARR
NNT VA
1993
444
>50
20.6 8
<0.001 3 32
ACAS
1995
1662
>60 11
5.1
0.004
1.2 85
CASANOVA
2001
410
50-90 NS
ACST
2004
3120
11.8
6.4
1.1 93

52. Future asymptomatic data
ECST-2
Role of BMT + Surgery vs. BMT
FPH will be recruiting Dr. Giosue Gulli PI
ACST -2
Role of CEA vs. CAS.
Funding approved.
Now recruiting.
TACIT
Role of BMT vs. BMT + CEA vs. BMT + CAS

53. Timing of surgery and efficacy
Risks of further stroke are the highest in the first 2 weeks following TIA/Minor stroke
Early carotid surgery is safe in ASA I / II patients following stable, non-disabling stroke
Safer to delay ASA III / IV patients
Patients with large areas of brain injury on CT or MRI
Patients with unstable symptoms are at higher risk of peri-operative stroke

54. Future role for Best medical therapy?
Antiplatelets
NOACs
Statins
Antihypertensives

55. Can we go faster? RACE (Rapid Access Carotid Endarterectomy)
Follow the local Stroke/TIA pathways
Refer to TIA clinic or ED
Stroke units to admit high risk ABCD2 > 4 patients
Fast track investigations for TIA/Stroke
Surgical referral to vascular surgeon – USE HOTLINE
Inform colleagues in primary and secondary care

56. Summary
The use of a stroke/TIA pathway to expedite access to assessment
Imaging and treatment is mandatory.
Carotid endarterectomy remains the “gold standard” in intervention
for symptomatic carotid disease.
The ideal patient group for CAS remains to be defined and long term
results from ICSS and CREST are awaited. The traditional indications
for CAS still hold. CAS patients should be entered into registries.
There is no place for the routine screening of patients for
asymptomatic carotid disease.