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 Th R l The Role of Endovascular Repair The Role of Endovascular Repair f End f End l r R p ir l r R p ir • 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 For Abdominal Aortic Aneurysm Abd i l A i A 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 - First Commercial Devices 1993 First Commercial Devices 1993 - 993 993 993 993 - 1997 - 1997 1997 1997 997 997 997 997

…disintegrate …disintegrate g

Device Migration Device Migration g POST POST- -DEPLOYMENT DEPLOYMENT 33 MONTHS 33 MONTHS

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 h ld holds > 8,012 cases holds > 8,012 cases 8 012 8 012 • 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 y y y EUROSTAR DATABASE EUROSTAR DATABASE 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 mean D mean D max max 57.2 (30 57.2 (30 45) 57 2 (30-45) 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 open open open open evar evar evar evar R Randomised elective AAAs > 5.5cm R Randomised elective AAAs > 5.5cm d d i i d l d l ti ti AAA > 5 5 AAA > 5 5 41 UK hospitals: 1999 41 UK hospitals: 1999 – – 2004 2004

EVAR I EVAR I : EARLY RESULTS EVAR I EVAR I : EARLY RESULTS : 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% D max 6.5 6.5 6.5 6.5 max risk factors well matched risk factors well matched i k f i k f t t ll ll t h d t h d

EVAR I EVAR I : EARLY RESULTS EVAR I : EARLY RESULTS EVAR I OPEN 539 OPEN 539 OPEN 539 OPEN 539 EVAR 543 EVAR 543 EVAR 543 EVAR 543 35 35 Days to Op. Days to Op. 43 43 (p:0.0004) (p:0.0004) 10 10 10 10 Pre Pre op rupture Pre Pre-op rupture op rupture op rupture 3 3 Intention to treat Intention to treat Intention to treat Intention to treat 4.7% 30 day Mortality 4.7% 30 day Mortality 1.7% 1.7% (p:0.016) (p:0.016) 6.2% In 6.2% 6.2% 6.2% In In-hosp Mortality In hosp Mortality hosp Mortality hosp Mortality 2.1% 2.1% 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 open exploration 1 14 14 14 14 other surgery other surgery other surgery other surgery 21 21 21 21

EVAR 1 trial: mid-term results Lancet, June 2005 ( 47% cases > 3 yrs) 47% cases > 3 yrs) 29% 29% 26% 26% All cause mortality All cause mortality p = 0.46 p = 0.46 Aneurysm related deaths 7% 7% 4% Aneurysm related deaths p = 0.04 p = 0.04 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 medical medical therapy therapy evar evar 338 338 patients randomised 166 166 172 172 patients randomised 9% 9% 30 day mortality 30 day mortality Aneurysm related deaths 20 20 22 22 An r r l t d d th nss Deaths from all causes 74 68 nss

Abdominal Aortic Aneurysm: Abdominal Aortic Aneurysm: y A service in need of surgery? A service in need of surgery? g g y 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 open 434 434 • Emergency open E Emergency open 264 264 264 264 • Endovascular Endovascular 53 53 • Non Non- -operative operative 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 p , , y y p p • status of radiologist = consultant in 100% status of radiologist = consultant in 100% status of radiologist status of radiologist = consultant in 100% = consultant in 100% 38% radiologists: no EVAR workload record 38% radiologists: no EVAR workload record 64% 64% 64% cases: radiologist did > 10 evars / year 64% cases: radiologist did > 10 evars / year di l di l i t did > 10 i t did > 10 / /

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: op 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 only 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 the non-device complications more All th All th All the non d d device complications more i i li li ti ti 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% mortality in open repair group 6 2% 6 2% 6.2% mortality in open repair group t lit i t lit i i i

The role of endovascular repair ? The role of endovascular repair ? p • evar suitability ~ 54% infra evar suitability ~ 54% infra-renal aneurysms evar suitability evar suitability 54% infra 54% infra renal aneurysms 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 70 60 50 Open Elective 40 Stent Stent 30 20 10 0 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 • Unproven where long term exclusion required U h l t l i i d • Unproven for peri-renal / supra-renal AAA

John Rose John Rose Freeman Hospital Freeman Hospital Newcastle Newcastle