1

Medium and long term resultsfollowing EVAR -

Success or disappointment?

Gustav Fraedrich - Innsbruck - Austria

2

Volodos NL, Karpovich IP, Troyan VI, Kalashnikova YV, Shekhanin VE, Ternyuk NE, Neoneta AS, Ustinov NI, Yakovenko LF Grudn Khir 1988;6:84-86

Parodi JC, Palmaz JC, Barone HD Ann Vasc Surg 1991;5:491-499

Endovascular Aneurysm Repair (EVAR)

3Rutherford RB, J Vasc Surg 2004; 39:1129

Devices for Endovascular Repair of AAAs

4

Endovascular Aneurysm Repair (EVAR)

5

3% reduced 30-day mortality, increased reintervention rate

n=682

EVAR Trial participants – Lancet 2005;365:2179

EVAR 1 trial – Early & midterm results

6

EVAR 1 trial - Survival and aneurysm-related survival

EVAR Trial Investigators – NEJM 2010;362:1863

7EVAR Trial Investigators – NEJM 2010;362:1863

EVAR 1 trial - Survival without complication

8De Bruin JL – NEJM 2010;362:1881

DREAM trial - Survival and freedom from intervention

Survival

Freedom from reintervention

n=351 – f-u 6.4 yrs

9Lederle FA – JAMA 2009;302:1535

OVER trial – Cumulative mortality

10

Fig 3

Becquemin JP - J Vasc Surg 2011;53:1167

ACE trial – Survival free of death or reintervention

n=299Risk: low or intermediate

f-u 3 yrs

11Lederle FA – Ann Int Med 2007;146:735

RCTs comparing EVAR vs OPEN

12EVAR Trial Investigators – NEJM 2010;362:1872

EVAR 2 trial - Survival and aneurysm-related survival

13Brown LC – Eur J Vasc Endovasc Surg 2010;39:396

EVAR 2 trial – Cardiovascular events

Survival withoutcardiovascular event

Freedom from cardiovascular event

n=404 – f-u 2.8 yrs

14Steinmetz E – Eur J Vasc Endovasc Surg 2010;39:403

EVAR vs OPEN – Survival using high-risk criteria selection

15Eurostar Database 2002 / 2004 / 2007 / NICE guidance 2009

Endoleak after EVAR

14 %

4 %

7 %

Endoleak at dimission 15 %

Late endoleak 5 %/y

Conversion 2 %/y

Aneurysm-related mortality2

%/y

HR risk of re-intervention 2.9

16Schanzer A - Circulation 2011;123:2848

EVAR – Instructions for use (IFU)

17Schanzer A - Circulation 2011;123:2848

Aneurysm sac enlargement following EVAR

conservative IFU liberal IFU date of implantation

n = 10.228 (1999-2008)

AAA Ø < 55 mm 59 %

Conservative IFU 42 %

Liberal IFU 69 %

Sac enlargement at 5 yrs 41 %

18Wyss TR – Ann Surg 2010;252:805

Complications following EVAR

n = 848 (EVAR 1 & 2) mean F-U 4.8 a

Late rupture: 27 (3 % - mortality 67 %) Crude rate 0.7/100 pt.yr

HR complication/rupture: 8.83 (p<0.0001)

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CAESAR trial – Surveillance vs small AAA repair

AAA 4.1 to 5.4 cm - n=360 – f-u 54

monthsCao P – Eur J Vasc Endovasc Surg 2011;41:13

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Avoidance of

laparotomy

vein injury

retroperitoneal

damage

hypotension (pre-

load)

clamping (after-load)

hypothermia

paralytic ileus

Potential advantage of EVAR for ruptured AAA

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rEVAR with a bifurcated stent-graft

22

rEVAR with a aorto-uniiliac stent-graft

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rAAA – Ineligibility for EVAR

Mastracci TM – J Vasc Surg 2008;47:214

Aortic neck length, diameter, or angle, acessory renal artery, narrow aortic bifurcation, iliac artery diameter, access vessels

24

Lesperance K - JVS 2008;47:1165

National Inpatient SampleMedicare Inpatient Database

Mureebe L - JVS 2008;48:1101

Visser JJ - Radiology 2007;245:122

EVAR for ruptured AAA - mortality

Review - n=478 - EVAR vs OPEN = 22% vs 38%

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Diagnosis: rAAA

permissive hypotension, no intubation, sonography

OPEN

EVAR suitable & available

EVAR

CTA

no yes

Stable hemodynamicsUnstable hemodynamics

Treatment algorithm for ruptured AAA

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Consideration for repair

Assessment of fitness Assessment of morphology

Fit for repair

optimisation Standard

AAA repair OPEN or

EVAR

Transabdominal

Unfit for repair

optimisation

FitUnfit for OPEN or

EVAR

Manage conservatively

Suitable for EVAR

Not suitable for EVAR

Custom Open Laparoscopic

Retroperitoneal

Patient preference

Center preference

> 8cm

urgent

Guidelines from the European Society for Vascular Surgery – EJVES 2011;41:S1

Treatment algorithm for unruptured AAA

27

Choosing the best management of AAA for individual pts.

Cronenwett JL – Lancet 2005;365:2156

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Conclusions

The anatomical suitability for EVAR is a proxy for subsequent complications and potential aneurysm-related mortality

The rate of re-intervention continues to increase with time regardless of the device

The compliance with EVAR device guidelines is far too liberal (demand & supply, profiling, curiosity, industrial interests)

Patients with acceptable operative risk and longer life-expectancy are the best candidates for open repair

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Conclusions

High-risk patients with marginal anatomical suitability or short life-expectancy will not benefit from EVAR

Early repair of small aneurysms gives no substantive advantage over surveillance

The promising results of EVAR for ruptured AAA are not fairly conclusive because of the heterogenity of the cases and significant logistic limitations

Whilst the overall management of abdominal aortic aneurysms has undoubtedly benefited from the introduction of stent-grafts, open repair currently remains the gold standard treatment