Medium and long term results following evar success or disappointment

1. 1
Medium and long term results
following EVAR -
Success or disappointment?
Gustav Fraedrich - Innsbruck - Austria

2. 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)

3. 3Rutherford RB, J Vasc Surg 2004; 39:1129
Devices for Endovascular Repair of AAAs

4. 4
Endovascular Aneurysm Repair (EVAR)

5. 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. 6
EVAR 1 trial - Survival and aneurysm-related survival
EVAR Trial Investigators – NEJM 2010;362:1863

7. 7EVAR Trial Investigators – NEJM 2010;362:1863
EVAR 1 trial - Survival without complication

8. 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

9. 9Lederle FA – JAMA 2009;302:1535
OVER trial – Cumulative mortality

10. 10
Fig 3
Becquemin JP - J Vasc Surg 2011;53:1167
ACE trial – Survival free of death or reintervention
n=299
Risk: low or
intermediate
f-u 3 yrs

11. 11Lederle FA – Ann Int Med 2007;146:735
RCTs comparing EVAR vs OPEN

12. 12EVAR Trial Investigators – NEJM 2010;362:1872
EVAR 2 trial - Survival and aneurysm-related survival

13. 13Brown LC – Eur J Vasc Endovasc Surg 2010;39:396
EVAR 2 trial – Cardiovascular events
Survival without
cardiovascular event
Freedom from
cardiovascular event
n=404 – f-u 2.8 yrs

14. 14Steinmetz E – Eur J Vasc Endovasc Surg 2010;39:403
EVAR vs OPEN – Survival using high-risk criteria selection

15. 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 mortality 2 %/y
HR risk of re-intervention 2.9

16. 16Schanzer A - Circulation 2011;123:2848
EVAR – Instructions for use (IFU)

17. 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 %

18. 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)

19. 19
CAESAR trial – Surveillance vs small AAA repair
AAA 4.1 to 5.4 cm - n=360 – f-u 54 months
Cao P – Eur J Vasc Endovasc Surg 2011;41:13

20. 20
Avoidance of
laparotomy
vein injury
retroperitoneal damage
hypotension (pre-load)
clamping (after-load)
hypothermia
paralytic ileus
Potential advantage of EVAR for ruptured AAA

21. 21
rEVAR with a bifurcated stent-graft

22. 22
rEVAR with a aorto-uniiliac stent-graft

23. 23
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. 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%

25. 25
Diagnosis: rAAA
permissive hypotension, no intubation, sonography
OPEN
EVAR suitable & available
EVAR
CTA
no yes
Stable hemodynamicsUnstable hemodynamics
Treatment algorithm for ruptured AAA

26. 26
Consideration
for repair
Assessment of fitness Assessment of morphology
Fit for repair
optimisation Standard
AAA repair
OPEN or EVAR
Transabdominal
Unfit for repair
optimisation
Fit
Unfit 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. 27
Choosing the best management of AAA for individual pts.
Cronenwett JL – Lancet 2005;365:2156

28. 28
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

29. 29
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