1. Abdominal Aortic Aneurysm Repair Hugo Londero Sanatorio Allende Córdoba - Argentina

4. Device Development –Phase 2

5. Device Development - Phase 3

6. Phase 4: Self-expanding and multi-modular devices

7. Phase 5: Trans-renal fixation

8. AAA Treatment goal Eliminate the expansion which produces aneurysm
Rupture and Death

9. Asymptomatic AAA: High Risk of Rupture : Diameter
Rapid expansion (> 0,5 cm. or 10% in 1 year)
Major Concurrent factors:
Smokers
COPD
Un controlled arterial hypertension
Familiar history of rupture
Eccentric expansion

10. Estimated Rupture Risk related with aneurysm diameter
Asymptomatic AAA
Estimated Rupture Risk related with aneurysm diameter
Diameter Rupture Risk
(cm) (%/year)
< 4 0
,5 - 5
>
J Vasc Surg 37:

11. Systemic Co Morbidities
Anatomic risk:
Aneurysm Diameter
Very Low Risk< 5.0 cm
Intermediate Risk cm
High Risk> 6.0 cm
Surgical Risk:
Surgical Impairments
Systemic Co Morbidities

12. AAA Endovascular Treatment
Anatomical requirements of available prosthesis
Proximal Neck
Diameter >17 mm < 32 mm
Neck/aneurysm angle < 60ª
Neck length > 10mm
Neck thrombosis < 50% of the circumference
Neck calcification < 50% of the circumference
Aortic Bifurcation
Diameter > 20mm
Iliac Arteries
Luminal Diameter > 7mm
Iliac neck <
> 15 mm in length
Diameter < 22 mm
Aortic/Iliac angle < 60º
Eur J Vasc Endovasc Surg 2011; 41: S1-S58

13. AAA Endovascular Treatment
Indications:
High Surgical Risk Aneurysms
Normal Surgical Risk Aneurysms
Low Anatomical Risk Aneurysms

14. For Open Repair-The United Kingdom EVAR Trial Investigators
Endovascular Repair of Aortic Aneurysm in Patients Physically Ineligible
For Open Repair-The United Kingdom EVAR Trial Investigators
N Engl J Med 2010;362:
EVAR 2 Trial :
Non Surgical High Risk Candidates
AAA ≥ 5.5 cm.
338 randomized patients
MEDICAL TREATMENT
N=172
ENDOVASCULAR TREATMENT
N=166
END POINTS:
Global Mortality
Aneurysm Related Mortality
Health Realated Quality of life
Postoperative Complications
Hospital costs

15. For Open Repair-The United Kingdom EVAR Trial Investigators
Endovascular Repair of Aortic Aneurysm in Patients Physically Ineligible
For Open Repair-The United Kingdom EVAR Trial Investigators
N Engl J Med 2010;362:

16. Low Adherence to protocol (20% Cross over to EVAR)
EVAR 2 TRIAL – CRITICS:
Low Adherence to protocol (20% Cross over to EVAR)
High Hospital Mortality (9%)
6 ruptures waiting for treatment
High Risk is not synonym of moribund
LESONS LEARNED:
The patients at high surgical risk must be carefully selected for EVAR:
Avoid severe co-morbidities that significant reduce life expectancy
Include patients with Surgical Impairments that not compromise the life expectancy

17. AAA Endovascular Treatment
Indications:
High Surgical Risk Aneurysms
Normal Surgical Risk Aneurysms
Low Anatomical Risk Aneurysms

18. DREAM Trial 6 years evolution:
Long Term Outcome of Open or Endovascular repair of Abdominal Aortic Aneurysm. De Bruin JL et al. N Engl J Med 2010;362:1881-9
DREAM Trial 6 years evolution:
Patients suitable for EVAR or Surgery
AAA ≥ 5.0 cm.
% ASA Class I ó II
351 randomized patients
SURGICAL TREATMENT
N=178
ENDOVASCULAR TREATMENT
N=173
END POINTS:
Global Mortality
AAA related mortality
Complications and re-interventions

19. Long Term Outcome of Open or Endovascular repair of Abdominal Aortic Aneurysm. De Bruin JL et al. N Engl J Med 2010;362:1881-9

20. Long Term Outcome of Open or Endovascular repair of Abdominal Aortic Aneurysm. De Bruin JL et al. N Engl J Med 2010;362:1881-9

21. EVAR 1 Trial –5-10 years Evolution :
Endovascular versus Open Repair of Abdominal Aortic Aneurysms
The United Kingdom EVAR trial Investigators N Engl J Med 2010;362:
EVAR 1 Trial –5-10 years Evolution :
Patients suitable for EVAR or Surgery
AAA ≥ 5.5 cm.
1082 randomized patients
SURGICAL TREATMENT
N=626
ENDOASCULAR TREATMENT
N=626
END POINTS:
Death
Graft Related Complications
Re Interventions
Resources

22. Endovascular versus Open Repair of Abdominal Aortic Aneurysms
The United Kingdom EVAR trial Investigators N Engl J Med 2010;362:

23. Endovascular versus Open Repair of Abdominal Aortic Aneurysms
The United Kingdom EVAR trial Investigators N Engl J Med 2010;362:

25. 1119 pacientes (534 EVAR – 585 OR) – seguimiento hasta 7 años
Clinical effect of Abdominal Aortic Aneurysm Endografting: 7 years concurrent comparison with open repair. Cao P et al. J Vasc Surg 2004ñ 40,5:841-8
1119 pacientes (534 EVAR – 585 OR) – seguimiento hasta 7 años
AAA realted mortality

26. 1119 pacientes (534 EVAR – 585 OR) – seguimiento hasta 7 años
Clinical effect of Abdominal Aortic Aneurysm Endografting: 7 years concurrent comparison with open repair. Cao P et al. J Vasc Surg 2004ñ 40,5:841-8
1119 pacientes (534 EVAR – 585 OR) – seguimiento hasta 7 años
Global Survival

27. 1119 pacientes (534 EVAR – 585 OR) – seguimiento hasta 7 años
Clinical effect of Abdominal Aortic Aneurysm Endografting: 7 years concurrent comparison with open repair. Cao P et al. J Vasc Surg 2004ñ 40,5:841-8
1119 pacientes (534 EVAR – 585 OR) – seguimiento hasta 7 años
Free of reinterventions

28. 45660 “matched patients” - Seguimiento hasta 5 años
Endovascular vs. Open Repair of Abdominal Aortic Aneurysms in Medicare Population - Schermerhorn ML et al. N Engl J Med 2008;358:464-74
45660 “matched patients” - Seguimiento hasta 5 años
Mortalidad Periop.(%) Cirugía EVAR P
Global < 0.001
67-69 años < 0.001
70-74 años < 0.001
75-79 años < 0.001
80-84 años < 0.001
> 85 años < 0.001

29. EVAR 1 and DREAM TRIALS
The patients at normal surgical risk EVAR treated have:
Lower hospital (30 days) mortality than surgical ones
Equal mortality at mid term follow up (5-10 years)
More re-interventions during mid term evolution
LESONS LEARNED:
Young patients with long life expectancy could be good candidates for Surgery
Patients with limited life expectancy, due to the age or systemic diseases, could be good candidates for EVAR

30. AAA Endovascular Treatment
Indications:
High Surgical Risk Aneurysms
Normal Surgical Risk Aneurysms
Low Anatomical Risk Aneurysms

31. Is EVAR indicated in AAA between 4 to 5 cm.?
Background
Historical Paradigm that guided the Surgical momentum in AAA was the time when the accumulated risk of rupture exceed the surgical risk. Aneurysm diameter greater than 5 cm. was the accepted threshold for surgical treatment.
The ADAM and UK-SAT Trials falls in demonstrate benefits of surgery compared with medical follow up in small aneurysms
Due to low hospital mortality of EVAR procedures the logic question is:
Is EVAR an effective treatment of
4 to 5 cm AAA ?
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Grube E. et al, Am Journal Cardiol 2006; “in press” 31

32. Tratamiento Quirúrgico Precoz vs
Tratamiento Quirúrgico Precoz vs. Seguimiento Estricto en Aneurismas Pequeños(< 5.5 cm) UK SAT & ADAM TRIALS

33. Mortality results for randomised controlled trial of early elective surgery or ultrasonographic surveillance for small abdominal aortic aneurysms (The UK Small Aneurysms Trial-Lancet :1649)

34. Is EVAR indicated in AAA between 4 to 5 cm
Is EVAR indicated in AAA between 4 to 5 cm.? Randomized Trial comparing EVAR vs. Surveillance in small AAA
CAESAR 360 patients at normal surgical risk, AAA between 4.1&5.4 cm, EVAR adequate. Mean follow up 26 months (Charing Cross meeting; London 2010)
PIVOTAL 728 patients at normal surgical risk, AAA between 4.0&5.0 cm, EVAR adequate. Mean follow up 20±12 months (J Vasc Surg 2010;51:1081-7)
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35. Randomized Trial comparing EVAR vs
Randomized Trial comparing EVAR vs. Surveillance in small AAA (CAESAR - PIVOTAL)
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36. Surveillance Group – Aneurysm Repair:
CAESAR: 76/178 patients (43%) met criteria to be converted to surgery
PIVOTAL: 112/362 Patients (30.9%) underwent aneurysms repair
EVAR
Surveillance
Pivotal Trial: Aneurysm repair
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37. Rupture Increased risk:
Females:
Brown LC et al. Ann Surg 1999;230”289-96
Fillinger MF et al.J Vasc Surg 2004;39:
Fillinger MF et al. J Vasc Surg 2003;37:724-32
Arterial Hypertension:
Brown LC et al. Ann Surg 1999;230:289-96
Cronenwett JL et al. Surgery 1985;98:472-83
Sterpetti AV et al. Surg Gynecol Obstet 1991;173:175-78
Foster JH et al. Surg Gynecol Obstet 1969;129:1-9
Szilagyi DE et al. Arch Surg 1972;104:600-06
Smokers:
COPD (FEV1-Bronquiectasis):

38. CONCLUSIONS:
Patients at high surgical risk must be carefully selected for EVAR, avoiding severe co-morbidities that significant reduce life expectancy and including patients with Surgical Impairments that not compromise the life expectancy
Patients at normal surgical risk and limited life expectancy, due to the age or systemic diseases, are good candidates for EVAR
There are not evidences that small aneurysms could be beneficiate with EVAR.

39. Thank you very much !