AAA – 19 YEARS of EXPERIENCE WITH EVAR Hugo F Londero MD, FSCAI Sanatorio Allende – Córdoba - Argentina

AAA – 19 YEARS of EXPERIENCE WITH EVAR Parodi initial experience Second Phase: Modular Grafts Third Phase: Design improvement Actual indications

Transfemoral Intraluminal Graft Implantation for Abdominal Aortic Aneurysms. JC Parodi, JC Palmaz and HD Barone. Ann Vasc Surg 1991;5:491-9

2011: Aorto-Aortic stent graft implant : 12 mm AAA diameter increase Type 3 endoleak

2011: Aorto-Aortic stent graft implant : 12 mm AAA diameter increase Type 3 endoleak

Parodi ´s Device – Phase 3

AAA – 19 YEARS of EXPERIENCE WITH EVAR Parodi initial experience Second Phase: Modular Grafts Third Phase: Design improvement Actual indications

Stentor-Mihalle / Vanguard I-II (No longer available)

Favaloro Foundation: Initial Experience Stenthor-Mihalle 5 cases Vanguard l-ll 38 cases

Favaloro Foundation: Initial Experience Stenthor-Mihalle ® 5 cases Vanguard l-ll ® 38 cases Follow up: 11.9 ± 10 months – Related complications Prosthesis Migration: Type l Endoleak Treatment: Cuff implantation Late Complications: Persistent Type I proximal leak

Favaloro Foundation: Initial Experience Stenthor-Mihalle ® 5 cases Vanguard l-ll ® 38 cases Follow up: 11.9 ± 10 months – Related complications Late Complications: Iliac Stump Dislocation Stent Graft Dislocation

Favaloro Foundation: Initial Experience Stenthor-Mihalle ® 5 cases Vanguard l-ll ® 38 cases Follow up: 11.9 ± 10 months – Related complications Late Complications: Iliac Stump Dislocation Stent-Graft Dislocation New aneurysmal sac Intraoperative Findings Explanted Endo-graft

Favaloro Foundation: Initial Experience Stenthor-Mihalle ® 5 cases Vanguard l-ll ® 38 cases Follow up: 11.9 ± 10 months – Related complications Late Complications: Limb Thrombosis Graft Limb Thrombosis Intraoperative Findings Explanted Endo-graft

Favaloro Foundation: Initial Experience Stenthor-Mihalle ® 5 cases Vanguard l-ll ® 38 cases Follow up: 11.9 ± 10 months – Related complications Late Complications: Limb Thrombosis Suture Breakages

Favaloro Foundation: Initial Experience Stenthor-Mihalle ® 5 cases Vanguard l-ll ® 38 cases Follow up: 11.9 ± 10 months – Related complications Late Complications: Suture Breakage of the Stent Frame Suture Breakages Stent-Graft Disruption Cuff Implantation inside the Stent Graft

Favaloro Foundation: Initial Experience Stenthor-Mihalle ® 5 cases Vanguard l-ll ® 38 cases Follow up: 11.9 ± 10 months – Related complications Late Complications: Prosthesis Migration Suture Breakages

Favaloro Foundation: Initial Experience Stenthor-Mihalle ® 5 cases Vanguard l-ll ® 38 cases Follow up 11.9±10 months – Late related complications Total Incidence1023 % Type l Persistent Endoleak24,6 % Type ll Endoleak (Retrograde)12.3 % Type lll Endoleak (Stump Dislocation)12.3 % Graft limb Thrombosis36.9 % Acute Popliteral Occlussion1 2.3 % Suture Breakages of the Stent Frame12.3 % Prosthesis Migration12.3 %

AAA – 19 YEARS of EXPERIENCE WITH EVAR Parodi initial experience Second Phase: Modular Grafts Third Phase: Design improvement Actual indications

Endologix MedtronicGore Cook

DREAM Trial: 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)

EVAR I Trial: Endovascular versus Open Repair of Abdominal Aortic Aneurysms The United Kingdom EVAR trial Investigators (N Engl J Med 2010;362: )

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

Sanatorio Allende: Second Generation Endograft Experience Contralateral Iliac-limb Mal-position

Sanatorio Allende: Second Generation Endograft Experience Retrograde Disection Type I leak -. Balloon expansion. Retrograde disection.

Sanatorio Allende: Second Generation Endograft Experience Type I Endoleaks : Balón Expandable Stent

Sanatorio Allende: Second Generation Endograft Experience Endoleaks Tipo Il: Selective embolization

Sanatorio Allende: Second Generation Endograft Experience Delayed (5 years) Non Cover Right Common Iliac Aneurysm Rupture

Delayed (5 years) Non Cover Right Common Iliac Aneurysm Rupture

Sanatorio Allende: Second Generation Endograft Experience 2009 Endologix prosthesis with a Proximal Fre-flow Cuff and Distal Extension

Sanatorio Allende: Second Generation Endograft Experience Endologic Stent Graft components dislogement

Sanatorio Allende: Second Generation Endograft Experience Balloon expandable knitted dacron covered stent deployed between the main body and proximal extension.

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

DREAM Trial: 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)

EVAR I Trial: Endovascular versus Open Repair of Abdominal Aortic Aneurysms The United Kingdom EVAR trial Investigators (N Engl J Med 2010;362: )

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

Randomized Trial comparing EVAR vs. Surveillance in small AAA (CAESAR - PIVOTAL)

AAA – 19 YEARS of EXPERIENCE WITH EVAR Parodi initial experience Second Phase: Modular Grafts Third Phase: Design improvement Actual indications

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 moderate 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.

Thank you very much !

A AA Endovascular Treatment Indications: High Surgical Risk Aneurysms Normal Surgical Risk Aneurysms Low Anatomical Risk Aneurysms

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 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 – 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

A AA Endovascular Treatment Indications: High Surgical Risk Aneurysms Normal Surgical Risk Aneurysms Low Anatomical Risk Aneurysms

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 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

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

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

Note: References should be 12pt Arial bold with the Journal title in Italics 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

Rupture Increased risk: Females: Brown LC et al. Ann Surg 1999;230” Fillinger MF et al.J Vasc Surg 2004;39: Fillinger MF et al. J Vasc Surg 2003;37: Arterial Hypertension: Brown LC et al. Ann Surg 1999;230: Cronenwett JL et al. Surgery 1985;98: Sterpetti AV et al. Surg Gynecol Obstet 1991;173: Foster JH et al. Surg Gynecol Obstet 1969;129:1-9 Szilagyi DE et al. Arch Surg 1972;104: Smokers: Brown LC et al. Ann Surg 1999;230” Fillinger MF et al.J Vasc Surg 2004;39: COPD (FEV 1 -Bronquiectasis): Fillinger MF et al.J Vasc Surg 2004;39: Cronenwett JL et al. Surgery 1985;98:472-83

Sanatorio Allende: Second Generation Endograft Experience

Sanatorio Allende: Second Generation Endograft Experience Contralateral Iliac-limb Mal-position Endologix Powerlink® bifurcated stent graft (25/100 mm) Proximal extension stent graft (28/75 mm) 34/80 mm proximal extension stent graft Final angiogram. Residual disection

Sanatorio Allende: Second Generation Endograft Experience Contralateral Iliac-limb Mal-position Oclusión de arterias renales - Embolización Planeada