A. Fargion. Forum tecnico sulle anatomie complesse in EVAR. EVAR nelle arterie iliache comuni con diametro > 20 mm

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Norma Cuomo
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1 EU470 03/14 Cordis Corporation 2014 INCRAFT AAA Stent Graft System is an investigational device, not commercially available Forum tecnico sulle anatomie complesse in EVAR EVAR nelle arterie iliache comuni con diametro > 20 mm A. Fargion

2 Opzioni durante EVAR per AIC ectasiche/aneurismatiche: Bell bottom Vs embolizzazione AII + overstenting

185 pts treated with EVAR; 260 large CIAAs treated; BB

underwent IIA exclusion + overstenting (Group 2) The

reinterventions is significantly higher with IIA exclusion

3 185 pts treated with EVAR; 260 large CIAAs treated; BB limbs were used to treat 166 CIAA (Group 1), and 94 underwent IIA exclusion + overstenting (Group 2) The combined incidence of perioperative complications and reinterventions is significantly higher with IIA exclusion than with BB; therefore, when feasible, BBT is desirable Naughton PA. et al., JVS 2012

compared with normal LZs, but no significant difference in outcome was noted in midterm follow-up.

4 57 EVAR with 70 CIAAs (diameter 20 mm) Vs 25 control EVAR subjects with 50 normal ( 15mm) CIA LZs treated consecutively during the same time interval Aneurysmal CIA LZs used during EVAR experience greater dilatation compared with normal LZs, but no significant difference in outcome was noted in midterm follow-up. However, an increased incidence of graft limb complications or endograft-related reintervention may be encountered Griffin CL. et al., JET 2015

<20 mm (Group I), and 61 20 mm (Group II,

5 ; 239 limbs from 129 pts; mean FU was 53 mths 178 iliac limb diameter <20 mm (Group I), and mm (Group II, CIA cut-off 16mm) Gray D. et al., EJVES 2017

6 Opzioni durante EVAR per AIC ectasiche/aneurismatiche: Bell bottom evoluzione a distanza Nel 2003 (69 anni) EVAR Bell-bottom 24 mesi: endoleak di tipo Ib trattato mediante embolizzazione AII ed estensione 60 mesi: aneurisma iliaco destro (3,5 cm) con migrazione prossimale; no endoleak

Ischemia del nervo sciatico Ischemia pelvica Colite

7 Preservare l arteria ipogastrica: Complicanze ischemiche da embolizzazione AII Claudicatio glutea Disfunzione erettile Ischemia del nervo sciatico Ischemia pelvica Colite ischemica Ischemia del midollo spinale Ruolo dell Hypogastric Network

8 61 non-randomised studies; 2748 IIAs excluded in 2671 pts Claudicatio glutea: coils 32.6% vs plugs 23.8%; OR 2.52, p.01 unilaterale 29.2% vs bilaterale 30.3%; OR 2.37, p.02 prossimale 22.2% vs distale 70.9%; OR 3.01, p.003 Bosanquet DC. et al., EJVES 2017

occlusione: 8.8% (6.8-11.3); ischemia pelvica: 4.1% (2.9-5.

9 27 retrospective single-center cohort studies; 816 pts with IIA preservation during EVAR Pooled event follow up medio: 15 mesi occlusione: 8.8% ( ); ischemia pelvica: 4.1% ( ) EL 1B da ipogastrica: 4.6% ( ); reinterventi: 7.8% ( ) Kouvelos GN. et al., EJVES 2016

10 Preservare l arteria ipogastrica: tecniche alternative Trattamento Ibrido Multilayer Stent Double Barrell Nessun dato sull efficacia a lungo termine

11 Preservare l arteria ipogastrica: IBDs presenti sul mercato

Standard bifurcated component in abdominal aorta

trunk in one limb of the original aortic stent-graft:

the iliac aneurysm Transbrachial extension with

12 Standard bifurcated component in abdominal aorta Modified bifurcated component is deployed with its trunk in one limb of the original aortic stent-graft: long limb in the external iliac artery short limb in the iliac aneurysm Transbrachial extension with covered-stent in hypogastric artery Abraham CZ., Chuter TAM. et al., JET 2003

13 ; single-center prospective trial; 87 IBDs deployed in 75 pts Vs 255 standard EVAR pts Farivar BS. et al., JVS 2017 (Oct)

14 , 157 consecutive IBD in 149 pts for unilateral or bilateral common iliac artery aneurysms combined or not with abdominal aortic aneurysms (isolated IBD in 17.8%) Simonte G. et al., EJVES 2017

2005-2015; 650 IBDs in 575 pts, mean follow-up 32.6±9.

a low incidence of secondary procedures due to type I endoleaks and

The main reasons for reinterventions seem to be short proximal

15 ; 650 IBDs in 575 pts, mean follow-up 32.6±9.9 mths Midterm experience with placement of IBDs is associated with a low incidence of secondary procedures due to type I endoleaks and occlusions. The main reasons for reinterventions seem to be short proximal sealing zone and poor conformability of the ZBIS device in elongated EIAs. Donas KP. et al. on behalf of pelvis Registry collaborators, JET 2017

2013-2014, 51 CIA aneurysms treated with IBE in 46 pts

0) mm All but one implantation were successful; two type

noticed, resulting in a procedural success rate of 93.

16 , 51 CIA aneurysms treated with IBE in 46 pts across 13 sites CIA median diameter 40.5 (range, ) mm All but one implantation were successful; two type Ib endoleaks (spontaneously 30 days) were noticed, resulting in a procedural success rate of 93.5%; mean follow-up 6 mths Van Sterkenburg SMM. et al., JVS 2016

17 13 Gore IBE vs 9 Cook ZBIS in 22 consecutive pts (mean age 72, range 56-85) 11 AAA+AACIA, 4 isolated AACIA, 4 bilateral AACIA, 10 concomitant AAIIA Della Schiava N. et al., Ann Vasc Surg 2017

18 Unit of Vascular Surgery University of Florence Study Group (Jan 2007 Aug 2017) 115 IBDs in 109 pz (età media 74.7±7.5, range 52-91)

19 Unit of Vascular Surgery University of Florence Study Group (Jan 2007 Aug 2017) Comorbilities and anatomical details % Female sex 0.8% Median age (years) 74.7 (52-91) COPD 48.6% Hypertension 71.6% Hyperlipaemia 49.5% Diabetes 14.7% ASA III-IV 70.2% CVD 16.5% CAD 41.3% CKD 8.3%

1% AAA+CIAA bilateral 29.4% Isolated CIAA in previous EVAR 1.

20 Unit of Vascular Surgery University of Florence Study Group (Jan 2007 Aug 2017) Comorbilities and anatomical details %; mm mean (range) AAA+CIAA monolateral 43.1% AAA+CIAA bilateral 29.4% Isolated CIAA in previous EVAR 1.8% Isolated CIAA in previous OSR 4.6% Isolated CIAA 21.2% D (20-38) D (19-78) D5a 32.5 (12-85) D5b 28.1 (10-61) D IIA IBD side 13.8 (8-45)

Unit of Vascular Surgery University of Florence Study Group (Jan 2007 Aug 2017) Intraoperative and 30-day results Intraoperative details Techincal success 99% Mean intervention time (min) 160.

21 Unit of Vascular Surgery University of Florence Study Group (Jan 2007 Aug 2017) Intraoperative and 30-day results Intraoperative details Techincal success 99% Mean intervention time (min) (60-405) Mean fluoroscopy time (min) 42.2 (17-134) Mean CM volume (ml) (50-300) Total percutaneous access 29.8% Brachial access 1.9% IIA stent type Nitinol SE BE Adjunctive stents IIA EIA Kissing 33.7% 66.3% 6.7% 4.8% 12.5%

9%* Access-related complications 4.8% Systemic complications 0.9% ICU (days) 1.

22 Unit of Vascular Surgery University of Florence Study Group (Jan 2007 Aug 2017) Intraoperative and 30-day results 30-day results Mortality - Graft-related complications 2.9%* Access-related complications 4.8% Systemic complications 0.9% ICU (days) 1.9 (0-9) Hospitalization time (days) 6.3 (2-19) New onset claudication - Early reintervention - * 2 type 1B ELs, 1 IBD occlusion

23 Unit of Vascular Surgery University of Florence Study Group (Jan 2007 Aug 2017) Long-term results; mean FU 32.2 mths (1-103) 62 mths 82.4%; S.E. = mths 87.1%; S.E. =.046

24 Unit of Vascular Surgery University of Florence Study Group (Jan 2007 Aug 2017) Long-term results; mean FU 32.2 mths (1-103) 62 mths 91.4%; S.E. = mths 93.6%; S.E. =.036

25 Unit of Vascular Surgery University of Florence Study Group (Jan 2007 Aug 2017) Long-term results; mean FU 32.2 mths (1-103)

Preservare l arteria ipogastrica in caso

26 Preservare l arteria ipogastrica in caso di patologia aortica complessa: C1 T2 Inferior thyroidal artery Thyrocervical trunk Ascending cervical artery Subclavian artery Deep cervical artery Costo-cervical trunk Intercostal arteries Thoracic aorta L1 Lumbar arteries Abdominal aorta L5 S1-5 Lateral sacral arteries Hypogastric artery Median sacral arteries Aorta

27 Conclusioni In caso di EVAR con AIC di diametro superiore a 20mm la copertura con brachette iliache bell-bottom è associate ad un incremento di reinterventi nel FU (spesso causati da comparsa di EL tipo 1B) L embolizzazione dell arteria ipogastrica non è una procedura del tutto benigna e si associa alla comparsa di complicanze legate all ischemia pelvica in una percentuale considerevole di pazienti Gli IBDs hanno mostrato di garantire ottimi risultati anche nel lungo termine con bassi tassi di reinterventi e ottime pervietà Nella nostra esperienza i risultati della metodica sono tali da giustificare la possibilità di considerare questa opzione terapeutica come prima scelta anche in caso di dilatazione monolaterale di AIC

28 Grazie per l attenzione

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