The Role of Endovascular The Role of Endovascular Repair Repair - - PowerPoint PPT Presentation

Abdominal Aortic Aneurysm Abdominal Aortic Aneurysm Abdominal Aortic Aneurysm Abdominal Aortic Aneurysm A service in need of surgery? A service in need of surgery?

The Role of Endovascular The Role of Endovascular Repair Repair Repair Repair

John Rose John Rose Freeman Hospital Freeman Hospital p Newcastle upon Tyne Newcastle upon Tyne

Th R l f End l r R p ir Th R l f End l r R p ir The Role of Endovascular Repair The Role of Endovascular Repair

• Endovascular technique

Endovascular technique q

• Endovascular results

Endovascular results

• NCEPOD study & conclusions

NCEPOD study & conclusions

Endovascular treatment for AAA Endovascular treatment for AAA

Transfemoral Intraluminal Graft Implantation F Abd i l A i A For Abdominal Aortic Aneurysm

J Parodi, J Palmaz, H Barone Annals of Vascular Surgery (1991)

EVAR morbidity & mortality EVAR morbidity & mortality

Intuitively, stent grafts should be better... Intuitively, stent grafts should be better...

• No laparotomy

No laparotomy

• No aortic cross clamping

No aortic cross clamping

• Rapid recovery

Rapid recovery

• Reduced hospital stay

Reduced hospital stay

First Commercial Devices 1993 First Commercial Devices 1993 -

• 1997

1997 First Commercial Devices 1993 First Commercial Devices 1993 -

• 1997

1997 993 993 997 997 993 993 997 997

…disintegrate …disintegrate g

Device Migration Device Migration g

33 MONTHS 33 MONTHS POST POST-

• DEPLOYMENT

DEPLOYMENT

Endoleaks Endoleaks …

2nd generation 2nd generation devices devices

Results of newer grafts appear better... Results of newer grafts appear better...

Zenith at 6 years Zenith at 6 years

EVAR Registries EVAR Registries Morbidity & mortality: level 2 evidence EUROSTAR DATABASE EUROSTAR DATABASE h ld 8 012 h ld 8 012 holds > 8,012 cases holds > 8,012 cases

• Devices used: 28% Zenith

Devices used: 28% Zenith 22% Talent 22% Talent 17% Van/Stentor 17% Van/Stentor 14% AneuRx 14% AneuRx 11% Excluder 11% Excluder www.eurostar-online.org

Early morbidity & mortality

EUROSTAR DATABASE EUROSTAR DATABASE

y y y

EUROSTAR DATABASE EUROSTAR DATABASE July 2003 analysis of 5 466 cases July 2003 analysis of 5 466 cases July 2003 analysis of 5,466 cases July 2003 analysis of 5,466 cases

• 3 985 (73%) men

3 985 (73%) men 3,985 (73%) men 3,985 (73%) men

• mean age 71.8

mean age 71.8

• mean D

mean D 57 2 (30 57 2 (30-45) 45) mean D mean Dmax

max 57.2 (30

57.2 (30 45) 45)

• mean hosp. stay 6.2 days

mean hosp. stay 6.2 days in in-

• hosp. mortality 1.7%
• hosp. mortality 1.7%

Harris, 2004 Harris, 2004

Early morbidity & mortality Level 1 evidence: EVAR 1 trial

• pen
• pen

evar evar

• pen
• pen

evar evar R d i d l ti AAA > 5 5 R d i d l ti AAA > 5 5 Randomised elective AAAs > 5.5cm Randomised elective AAAs > 5.5cm 41 UK hospitals: 1999 41 UK hospitals: 1999 – – 2004 2004

EVAR I EVAR I : EARLY RESULTS : EARLY RESULTS EVAR I EVAR I : EARLY RESULTS : EARLY RESULTS

Lancet August 2004 Lancet August 2004

OPEN OPEN 539 539 1082 1082 EVAR EVAR 543 543 Age Age 74 74 74.2 74.2 Male Male 91% 91% 91% 91% Dmax

max

6.5 6.5 6.5 6.5

i k f t ll t h d i k f t ll t h d risk factors well matched risk factors well matched

EVAR I EVAR I : EARLY RESULTS EVAR I EVAR I : EARLY RESULTS

OPEN 539 OPEN 539 EVAR 543 EVAR 543 OPEN 539 OPEN 539 EVAR 543 EVAR 543

(p:0.0004) (p:0.0004)

35 35 Days to Op. Days to Op. 43 43 10 10 Pre Pre op rupture

• p rupture

3 10 10 Pre Pre-op rupture

• p rupture

3 Intention to treat Intention to treat Intention to treat Intention to treat

(p:0.016) (p:0.016)

4.7% 4.7% 30 day Mortality 30 day Mortality 1.7% 1.7% 6.2% 6.2% In In-hosp Mortality hosp Mortality 2.1% 2.1% 6.2% 6.2% In In hosp Mortality hosp Mortality 2.1% 2.1%

EVAR I: Secondary Interventions EVAR I: Secondary Interventions EVAR I: Secondary Interventions EVAR I: Secondary Interventions

5.8% v 9.8% 5.8% v 9.8%

0 open conversion 10 1 1 endoleak correction endoleak correction 18 18 15 15 open exploration

• pen exploration 1

14 14

• ther surgery
• ther surgery

21 21 14 14

• ther surgery
• ther surgery

21 21

EVAR 1 trial: mid-term results

Lancet, June 2005 (47% cases > 3 yrs) 47% cases > 3 yrs) All cause mortality All cause mortality

29% 29%

p = 0.46 p = 0.46

26% 26%

Aneurysm related deaths Aneurysm related deaths 7%

7%

p = 0.04 p = 0.04

4%

Hazard ratio: re Hazard ratio: re-

• intervention after EVAR 2.7 (1.8

intervention after EVAR 2.7 (1.8 – – 4.1) 4.1)

p = 0.0001 p = 0.0001

EVAR 2 trial: mid-term results

Lancet, June 2005 (36% cases > 3 yrs)

best best evar evar medical medical therapy therapy 338 338 patients randomised

patients randomised

166 166 172 172

30 day mortality 30 day mortality

9% 9%

An r r l t d d th

20 22

Aneurysm related deaths 20

nss

22

Deaths from all causes 74

nss

68

Abdominal Aortic Aneurysm: Abdominal Aortic Aneurysm: y

A service in need of surgery? A service in need of surgery? g y g y The provision of facilities for diagnosis and The provision of facilities for diagnosis and treatment of Abdominal Aortic Aneurysms treatment of Abdominal Aortic Aneurysms treatment of Abdominal Aortic Aneurysms treatment of Abdominal Aortic Aneurysms

NCEPOD study NCEPOD study

Sample Size Sample Size 884 884

• Elective

Elective open

• pen

434 434 E 264 264

• Emergency open

Emergency open 264 264

• Endovascular

Endovascular 53 53

• Non

Non-

• operative
• perative

79 79

NCEPOD study: NCEPOD study: endovascular repair

endovascular repair

• 49 / 53 (92%): male

49 / 53 (92%): male 49 / 53 (92%): male 49 / 53 (92%): male

• 43 / 53 (81%): elective

43 / 53 (81%): elective

• 36 / 53 (68%): EVAR chosen = ASA status

36 / 53 (68%): EVAR chosen = ASA status

• 48 / 53 (91%): unruptured, asymptomatic

48 / 53 (91%): unruptured, asymptomatic ( ) p , y p ( ) p , y p status of radiologist = consultant in 100% status of radiologist = consultant in 100%

• status of radiologist = consultant in 100%

status of radiologist = consultant in 100%

38% radiologists: no EVAR workload record 38% radiologists: no EVAR workload record 64% di l i t did > 10 / 64% di l i t did > 10 / 64% cases: radiologist did > 10 evars / year 64% cases: radiologist did > 10 evars / year

NCEPOD study: NCEPOD study: endovascular repair endovascular repair

• status of anaesthetist = consultant in 86%

status of anaesthetist = consultant in 86%

• spinal anaesthesia: 33% cases

spinal anaesthesia: 33% cases

• post

post-

• op care:
• p care: recovery area in 40%

recovery area in 40% HDU bed in 48% HDU bed in 48% HDU bed in 48% HDU bed in 48% ICU bed in 2% only ICU bed in 2% only

endovascular repair endovascular repair p

morbidity < 30 days morbidity < 30 days morbidity < 30 days morbidity < 30 days

• 17 / 53 (32%) device ‘complications’

17 / 53 (32%) device ‘complications’ ( ) p ( ) p

• nly 1 required re-intervention
• 1 myocardial infarct (<2%)

1 myocardial infarct (<2%) 1 myocardial infarct (<2%) 1 myocardial infarct (<2%)

• 4 chest infections (9%)

4 chest infections (9%)

• 2 renal impairment (4%)

2 renal impairment (4%)

• 2 renal impairment (4%)

2 renal impairment (4%) All th All th d i li ti d i li ti All the non All the non-device complications more device complications more frequent in the open repair group. frequent in the open repair group.

endovascular repair endovascular repair p

mortality < 30 days mortality < 30 days mortality < 30 days mortality < 30 days

• No outcome given for 6 cases

No outcome given for 6 cases No outcome given for 6 cases No outcome given for 6 cases

• All other patients survived

All other patients survived 6 2% t lit i i 6 2% t lit i i

• 6.2% mortality in open repair group

6.2% mortality in open repair group

The role of endovascular repair ? The role of endovascular repair ? p

evar suitability 54% infra evar suitability 54% infra renal aneurysms renal aneurysms

• evar suitability ~ 54% infra

evar suitability ~ 54% infra-renal aneurysms renal aneurysms

• sophisticated imaging for planning

sophisticated imaging for planning

• high level of training

high level of training

• issues: durability & cost

issues: durability & cost

The role of endovascular repair The role of endovascular repair

80 60 70 40 50

Open Elective Stent

20 30

Stent

10 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005- date

The role of endovascular repair The role of endovascular repair

• Treatment of choice in:

‘hostile abdomen’ fit patients over 70 fit patients over 70

• Unproven: holding technique in acute / r AAA
• Unproven: holding technique in acute / r AAA

U h l t l i i d

• Unproven where long term exclusion required
• Unproven for peri-renal / supra-renal AAA

John Rose John Rose Freeman Hospital Freeman Hospital Newcastle Newcastle