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1
Medium and long term results
following 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=299
Risk: 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 without
cardiovascular 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 mortality 2 %/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)
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
Avoidance of
laparotomy
vein injury
retroperitoneal damage
hypotension (pre-load)
clamping (after-load)
hypothermia
paralytic ileus
Potential advantage of EVAR for ruptured AAA
21
rEVAR with a bifurcated stent-graft
22
rEVAR with a aorto-uniiliac stent-graft
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
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
Diagnosis: rAAA
permissive hypotension, no intubation, sonography
OPEN
EVAR suitable & available
EVAR
CTA
no yes
Stable hemodynamicsUnstable hemodynamics
Treatment algorithm for ruptured AAA
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
Choosing the best management of AAA for individual pts.
Cronenwett JL – Lancet 2005;365:2156
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
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

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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
  • 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

Editor's Notes

  1. There was no significant difference in cumulative mortality for open vs endovascular repair (hazard ratio, 0.7; 95% confidence interval, 0.4-1.1; log-rank P = .13).
  2. Kaplan-Meier curve of survival free of death or reintervention after open surgical repair (OSR) or endovascular aneurysm repair (EVAR).
  3. Kaplan–Meier estimates for time to first cardiovascular event stratified by randomised group.
  4. Multiple correspondence analysis (MCA); the original variables are represented in a space defined by factorial axes, which are characterized by a percentage of inertia (i.e. the amount of total variability explained by the axis itself). The distance between points indicates the dissimilarities between categories, while categories that plot close to each other are statistically related and are similar with regard to the pattern of relative frequencies.12 COPD, chronic obstructive pulmonary disease.
  5. Hilpold, Hermann – 04.08.33
  6. Aortic aneurysm sac freedom from enlargement after endovascular aortic repair stratified according to (A) conservative instructions for use (IFU), (B) liberal instructions for use, (C) time-dependent instructions for use, and (D) year of procedure performed before or after January 1, 2004.
  7. Wyss TR – Ann Surg 2010;252:805
  8. Mastracci TM – JVS 2008;47:214-221
  9. Cronenwett JL – Lancet 2005;365:2156