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Complexity of Iliac Occlusive Disease, Current Treatment Algorithm,

and Treatment Gaps

Prof. Antonello M. MD, PhDHead Endovascular Surgery Section

DSCTV, University of Padua. Chief. Prof. F. Grego

www.chirurgiavascolarepadova.it

Carico…

INTRODUCTION

Previous experiences demonstrated a freedom of binary restenosis > 90% at 1 year when CSwas used. In 2011 the COBEST multicenter randomized trial demonstrated an increased patency at 18months in favor of CS compared to BMS in TASC C and D lesions. In the real world practice the use of covered or uncovered stent in severe iliac disease isstrictly related not only to the TASC classification (C or D lesions) itself but also to thelesion quality, extension and laterality.


Vascular and Endovascular SurgeryPadova University – School of Medicine


Disclosure

Speaker name:

Michele Antonello

I have the following potential conflicts of interest to report:

Consulting

Employment in industry

Stockholder of a healthcare company

Owner of a healthcare company

Other(s)

I do not have any potential conflict of interest



Carico…

INTRODUCTION




Heavy calcification

Long lesions

Common Femoral Artery

Aortic bifurcation

Complex procedure

Type of stent


Carico…

INTRODUCTION




Size Fr✓

- L✓ ✓

Intimal

hyperplasia ✓

Fracture ✓

Calcification ✓

Cost✓

BMS CS


External Iliac Artery


Contemporary deployment with SECS


AORTIC BIFURCATION


GORE® VIABAHN® VBX Balloon

Expandable Stent Graft

https://doi.org/10.1177/1526602817725056

Journal of Endovascular Therapy

2017, Vol. 24(5) 638 –639

© The Author(s) 2017

Reprints and permissions:

sagepub.com/journalsPermissions.nav

DOI: 10.1177/1526602817725056

www.jevt.org

Commentary

In the October 2017 issue of the JEVT, Bismuth et al1 pres-

ent a pivotal study evaluating the safety and efficacy of the

Viabahn Balloon Expandable (VBX) Endoprosthesis (W. L.

Gore & Associates, Flagstaff, AZ, USA) for the treatment

of aortoiliac occlusive disease. In the modern era, an

endovascular-first approach has been proven effective for

TransAtlantic Inter-Society Consensus (TASC) A/B lesions.

Even TASC C/D iliac lesions have shown excellent results

in recent randomized (COBEST)2 and nonrandomized stud-

ies,3,4 demonstrating a preference for the use of covered

rather that bare metal stents. In this context, the current piv-

otal study1 plays a major role since there are still some tech-

nical concerns regarding the use of balloon-expandable

covered stents (BECS) in specific subgroups of patients in

relation to the site and quality of the lesion treated. In fact,

the current BECS technologies, despite advantages such as

small shaft size, precise delivery, high radial force, and

postdilation capability, have some major limitations. For

example, stent rigidity may limit their use in tortuous ves-

sels such as the external iliac artery (EIA). The possibility

of stent dislodgment from its delivery system during

advancement may limit its use in case of extremely calci-

fied lesions or long occlusion. Finally, the length of these

stents is usually short (no longer that 7 cm), which limits

their use in long lesions. The VBX, thanks to its modern

geometry and materials, theoretically seems to incorporate

the ability to be flexible and adaptable to arterial wall char-

acteristics while guaranteeing adequate radial strength.

Recently, the US Food and Drug Administration approved

the VBX as the first BECS specifically for treatment of de

novo or restenotic iliac artery lesions; the device has not yet

received the Conformité Européenne mark. Preliminary

clinical experience with the VBX for iliac artery disease in

30 patients has already assessed the safety of this device (no

device- or procedure-related death and no amputation at 30

days), with a 12-month primary patency of 96.6%. 5

The present prospective multicenter study analyzed a

larger cohort of 134 patients with 213 iliac lesions.1

Compared to other similar pivotal BECS experiences in the

iliac artery,6–10 this study’s eligibility criteria were designed

to select a group of patients that better reflected “real-world

practice,” with a wide range of different lesions treated.

What emerged from the study was that if we compare the

mean length of the lesions (42 mm) with the mean length

of the VBX implanted (72 mm), there is a difference of

30 mm. This aspect may be considered of no relevance but

indeed is a key point that reflects the quality of the proce-

dures performed based on the “healthy-to-healthy artery”

stent deployment principle.

Excellent results were reported overall in terms of tech-

nical success at 30 days (100%) with no device/procedure

major adverse events; the per-lesion 9-month primary patency

(PP) for the full cohort was 96.9%. Subgroup analysis demon-

strated excellent patency rates at 9 months in TASC C/D

lesions (32% of cases with 95.3% PP), EIAs (15% of cases

with 97.4% PP) and lesions involving both the common and

external iliac arteries (8% of cases with 97.4% PP). These

outcomes seem to confirm that the specific design and tech-

nical characteristics of the VBX allow not only proper con-

formability in complex lesions or those located in the EIA

but also guarantee adequate radial force in case of aortic

bifurcation reconstruction.

Limitations of the study are primarily related to the non-

randomized design, the limited number of cases treated, and

the short follow-up. These become more relevant when the

725056 JETXXX10.1 177/1526602817725056 Journal of Endovascular Therapy Piazza and Antonelloresear ch-article 2017

1Clinic of Vascular and Endovascular Surgery, Padova University School

of Medicine, Padua, Italy

Invited commentaries published in the Journal of Endovascular Therapy

reflect the opinions of the author(s) and do not necessarily represent

the views of the Journal, the INTERNATIONAL SOCIETY OF ENDOVASCULAR

SPECIALISTS, or SAGE Publications Inc.

Corresponding Author:

Michele Piazza, Clinic of Vascular and Endovascular Surgery, Padova

University School of Medicine, Padua, Italy.

Email: [email protected]

The First Balloon-Expandable Stent-Graft Approved for Treatment of Iliac Occlusive Disease

Michele Piazza, MD 1, and Michele Antonello, MD 1

Keywords

aortoiliac occlusive disease, balloon-expandable stent, common iliac artery, external iliac artery, occlusion, peripheral

artery disease, stenosis, stent-graft


AORTIC BIFURCATION


VERAB


N. At risk:

ET: 100 87 73 54 28 19 14

ABF: 100 82 68 60 48 40 34

41

52

10

26

P=.485

89.9%

88.5%

Primary patency

Pe

rce

nta

ge

Long Term Outcomes

ET


Complexity of Iliac Occlusive Disease, Current Treatment Algorithm,

and Treatment Gaps

Prof. Antonello M. MD, PhDHead Endovascular Surgery Section

DSCTV, University of Padua. Chief. Prof. F. Grego


Carico…

INTRODUCTION




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