Endovascular treatmentof aortoiliac aneurysms: is hypogastric artery

preservation the new standard of care?

G Pratesi, MD

Vascular and Endovascular SurgeryIRCCS Policlinico San Martino - University of Genoa

Chief: Prof. D Palombo

Disclosures

Speaker name:

Giovanni Pratesi

I have the following potential conflicts of interest to report:

• Consulting: Abbott, Cook, Cordis, Medtronic, WL Gore & Associates, Terumo Aortic

• Employment in industry

• Stockholder of a healthcare company

• Owner of a healthcare company

• Other(s)

• I do not have any potential conflict of interest

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Hypogastric artery preservation with iliac branch devicehas reached a state of maturity

• Learning curves in the selection of patients and performance of the procedure

• Dedicated endograft

• High technical success

• Low risk of graft-related reintervention rate

• Improved clinical outcomes and quality of life

Eur J Vasc Endovasc Surg 2013

Vascular Surgery – University of Florence, University of Rome “Tor Vergata”

700 EVAR: 85 branch endograft (12.1%)(September 2007 – August 2012)

4-year outcome N %

Non-AAA related mortality 7 8.6

Branch occlusion -

Iliac endoleak -

Reinterventions 3 3.7

CIAA shrinkage 43 53.1

Non IBD limb occlusion -

Buttock claudication 7 8.6

Donas et al. JET 2017

650 iliac branch in 575 Pts between 2005 and 2015; mean follow-up 32.6±9.9

• 621 Cook ZBIS, 29 Gore IBE

• Overall postop reintervention rate 8.9%

• 30 (4.6%) EIA or CIA occlusion

• 28 (4.3%) type I EL

Simple coverage of the IIA may result in significantly fewer major complications compared to embolization; at the same time, the rates

of endoleaks and reinterventions are similar between groups

“…Regardless of the technique used, IIA interruption during EVAR have a significant risk of persistent ischemic

complications.”

“…IIA preservation techniques denote a significant improvement in the treatment of aorto-iliac aneurysms and

should be carefully considered when exclusion of an iliac aneurysm is needed.”

Chaikof EL et al., J Vasc Surg 2018

Eur J Vasc Endovasc Surg 2019

Hypogastric artery preservation with iliac branch device:standard of care for unilateral, bilateral, isolated

Bilateral iliac artery aneurysm:hypogastric preservation with iliac branch device

Isolated iliac artery aneurysm:hypogastric preservation with iliac branch device

Isolated iliac artery aneurysm:hypogastric preservation with iliac branch device

J Vasc Surg 2018

Pelvis Registry• 910 IBDs in 804 patients underwent EVAR for aorto-iliac aneurysm• 9 high-volume European vascular centers• January 2005 and April 2017

231 IBDs were implanted in 207 patientsto treat an isolated common iliac aneurysm

91 isolated IBDs(group 1)

140 IBDs+bifurcated EG(group 2)

Long-term outcomes

Group 1(91 isolated IBDs)

Group 2(140 IBDs+bif EG)

p

Overall mortality 13 (14.3%) 14 (10%) .31

Aneurysm-related mortality 1 (1.1%) 1 (0.7%) .77

Type 1 A-B endoleak 4 (4.4%) 8 (6.1%) .66

Type III endoleak 2 (2.2%) 2 (1.4%) .65

IBD occlusions 5 (5.5%) 8 (5.7%) .96

Isolated target IIA occlusions 2 (2.2%) 2 (1.4%) .65

Isolated EIA occlusions - 4 (2.8%) .11

All-cause reinterventions 14 (15.8%) 26 (18.6%) .53

Conversion to OSR 1 (1.1%) 2 (1.4%) .83

Long-term results

Long-term results

• Tortuous iliac anatomy

• Aneurysmal involvement of hypogastric artery

• “Challenging” iliac bifurcation (diameter, take off angulation)

• Small access vessels

Endovascular preservation of hypogastric artery:technical and anatomical challenges

Eur J Vasc Endovasc Surg 2013

85 EVAR procedures with IBD in 81 pts between 2007 and 2012

IBD-related reintervention

OR p

Ectatic IAA > 10 mm 3.4 .001

BE vs SE stent 2.5 .2

39 vs 59 mm stent .9 .78

ZBIS-45 vs ZBIS-61 1.2 .18

ZBIS-10 vs ZBIS-12 1 .16

650 iliac branch in 575 Pts between 2005 and 2015; mean follow-up 32.6±9.9

• 621 Cook ZBIS, 29 Gore IBE• Overall postop reintervention rate 8.9%

- 4.6% EIA or CIA occlusion- 4.3% type I EL

Distal sealing zone in iliac branch:need for a healthy hypogastric artery

Donas KP et al., J Vasc Surg 2018

HA group(n=310)

Non HA group

(n=595)p

IBD-related type I EL 3% .7% .019

Buttock claudication 2.2% 5.3% .019

IBD-related migration 0.2% 1.9% <.001

5-year freedom from IBD-related typeI EL

93% 98% .006

Overtaking technical and anatomical challenges with IBD: advanced imaging techniques

Overtaking technical and anatomical challenges with IBD: advanced imaging techniques

Overtaking technical and anatomical challenges with IBD: more conformable devices

GORE® EXCLUDER® Iliac Branch Endoprosthesis

Della Schiava N et al., Ann Vasc Surg 2016

• Monocentric retrospective therapeutic study including 13 IBE and 9 ZBIS• Three indices of tortuosity measured with EndoSize: common iliac artery

(CIA), pelvic artery index (PAI), and the double iliac sign (DIS)• The centerline lengths of the iliac axis and the IIA were measured by 2

different operators as a blind fashion

IBE, more conformable with the anatomy of the patient, could decrease the incidence of graft related complication due to anatomical constraints

Technical and anatomical challenges in IBD: external iliac tortuosity

Hypogastric preservation:IBE in external iliac tortuosity

IBE in external iliac tortuosity:expanding iliac branch applicability

Technical and anatomical challenges in IBD:hypogastric aneurysm

• MV, male, 65 yrs• Bilateral CIAA (60 mm

Rt side; 45 mm Lt side)

• Bilateral IIAA (37 mm Rt side; 25 mm Lt side)

IBE in Hypogastric aneurysm:anterior branch embolization +

posterior branch stenting

IBE in hypogastric aneurysm:expanding iliac branch applicability

Technical and anatomical challenges in IBD:Cook’s ZBIS vs Gore’s IBE

◼ Cook IBD:− Longitudinal indipendent stainless

steel stent− Different proximal lengths, with

longer overlapping zones

− Need for an IIA mating stent

◼ Gore IBE:− Sinusoidal nitinol stent design− Increased conformability

− Dedicated IIA component

Aim of the study

To compare early and late outcomes of endovascular treatment of aorto-iliac aneurysms with two different dedicated iliac branch devices:

◼ Cook ZBIS(Cook Medical, Bloomington, In, USA)

◼ Gore IBE(W. L. Gore and Associates, Flagstaff, Ariz)

Study Group

180 iliac brancheddevices implantedbetween January2007 and December 2017

◼ 123 Cook ZBIS (Group 1)

◼ 57 Gore IBE (Group 2)

Comparison of the two groups was performed on the basis of a propensity score matching (1:1) analysis

Demographics and baseline characteristicsMatched Groups: 35 ZBIS vs 35 IBE

Clinical Features Group 1 (ZBIS; n=35) Group 2 (IBE; n=35) p

Mean age 72.9 ± 8.3 70.1 ± 8.7 .21

Male sex 35 (100%) 35 (100%) 1

Arterial hypertension 26 (74.3%) 30 (85.7%) .20

Hyperlipidemia 14 (40%) 16 (45.7%) .41

Diabetes mellitus 3 (8.6%) 2 (5.7%) .50

CAD 9 (25.7%) 9 (25.7%) 1

COPD 21 (60%) 21 (60%) 1

CKD 2 (5.7%) 2 (5.7%) 1

PAOD 1 (1.7%) 0 (-) .50

Anatomical Features Group 1 (ZBIS; n=35) Group 2 (IBE; n=35) p

Proximal neck diameter 23.3 ± 2.4 mm 23.1 ± 2.5 mm .78

Proximal neck lenght 25.1 ± 17.5 mm 26.1 ± 13.5 mm .81

Aortic diameter 43.3 ± 15.6 mm 48.9 ± 17 mm .18

Right CIA diameter 30.6 ± 11.5 mm 35.1 ± 15.1 mm .19

Left CIA diameter 27.8 ± 10.4 mm 30.1 ± 14.8 mm .49

CIA diameter on branched side 34.5 ± 9.1 mm 39.8 ± 14.7 mm .11IIA diameter on branched side 12.7± 6.1 mm 10.5 ± 5.6 mm .27

Perioperative Outcomes

Perioperative OutcomesGroup 1

(ZBIS; n=35)

Group 2

(IBE; n=35)p

Technical success 35 (100%) 35 (100%) 1

IBD - occlusion 1 (2.8%) (-) .49

IBD - Type I/III

endoleak(-) (-) 1

Adjunctive procedures 35 (28.2%) 240 (21.7%) .10

Conversion (-) (-) 1

Mortality (-) (-) 1

Outcomes at Follow-up

Outcomes at Follow-upGroup 1

(ZBIS; n=35)

Group 2

(IBE; n=35)p

Mortality 3 (8.6%) 4 (11.4%) .69

Aneurysm-related mortality 2 (5.7%) 1 (2.8%) .67

IBD occlusion 0 (-) 0 (-) 1

IBD-type I endoleak 1 (2.8%) 1 (2.8%) 1

IBD-type III endoleak 1 (2.8%) 1 (2.8%) 1

IBD-related reinterventions 2 (5.7%) 1 (2.8%) .57

Migration 1 (2.8%) 0 (-) .49

Bridging stent occlusion 0 (-) 0 (-) 1

Conversion to open surgery 2 (5.7%) 0 (-) .49

Mean follow-up was 46.7 months in group 1 (SD ± 36.3), 20.8 months in group 2 (SD ± 15.9); p <.001

Outcomes at Follow-up

86.8%

97.1%

p=.34, log-rank0.9

93.3%

97.1%

p=.81, log-rank0.5

Expanding hypogastric artery preservation:conformable endograft and bridging stent

Aorto-iliac aneurysm: challenging anatomyGore IBE with Viabahn VBX bridging stent

Aorto-iliac aneurysm: challenging anatomyGore Excluder endograft with active control

Aorto-iliac aneurysm: Excluder with active control andIBE with VBX bridging stent

Conclusions

◼ Hypogastric preservation with Iliac branch is the standard of care to preserve antegrade flow to IIAs, whenever anatomically feasible, during endovascular aneurysm repair involving the iliac bifurcation

◼ New generation branch endograft and bridging stents offer high conformability in challenging anatomies (stenosis, tortuousity, hypogastric aneurysm)

◼ Tailored iliac branch selection is crucial in overtaking technical and anatomical challenges of hypogastric preservation in the treatment of iliac aneurysmal disease