RESULTS OF VIABAHN IN AORTO ILIAC OCCLUSION Piazza M. J Vasc Surg 2011; 54:402-11 VIABAHN RESULTS OF VIABAHN IN AORTO ILIAC OCCLUSION ILIAC OCCLUSION HYBRID TECHNIQUE RESULTS OF VIABAHN

RESULTS OF

VIABAHN IN

AORTO ILIAC

OCCLUSION

JORGE FERNÁNDEZ NOYA

ANGIOLOGY AND VASCULAR SURGERY DEPARTMENT

UNIVERSITY CLINICAL HOSPITAL

SANTIAGO DE COMPOSTELA

RESULTS OF VIABAHN IN AORTO

ILIAC OCCLUSION

ALTERNATIVAS TERAPÉUTICAS DE LA AFS

ALTERNATIVAS TERAPÉUTICAS DE LAS LESIONES

OCLUSIVAS EN LA ARTERIA FEMORAL SUPERFICIAL

ENDOVASCULAR TREATMENT FOR SFA

OBSTRUCTIVE DISEASE

TASC C

TASC D

•

•

•

•

•

•

•

Bilateral EIA stenoses 3-10 cm long notextending into the CFAUnilateral EIA stenosis extending into the CFAUnilateral EIA occlusion that involves the originsof internal iliac and/or CFA

Diffuse disease involving the aorta and both iliac

arteriesDiffuse multiple stenoses involving the unilateralCIA, EIA and CFAUnilateral occlusions of both CIA and EIABilateral occlusions of EIA

ILIAC SECTOR


ILIAC OCCLUSION


ILIAC OCCLUSION


ILIAC OCCLUSION

COVERED-STENTSILIAC OCCLUSION


ILIAC OCCLUSION

COVERED-STENTS

ILIAC OCCLUSION





OBSTRUCTIVE DISEASE

Clinical benefit with balloon-

expandable stent-grafts in complex

TASC II C & D lesions

COVERED-STENTS


ILIAC OCCLUSION

5 yr. follow up PP 74.7% CS vs 62.5 % BM

SP 96% CS vs 74% BM

ILIAC OCCLUSION





OBSTRUCTIVE DISEASE

WHY FOR

COMPLEX

LESIONS???

COVERED-STENTS


ILIAC OCCLUSION

- PREVENT BLEEDING

- AVOID DIFUSE RE-STENOSIS

- INDEPENDENT OF THE LESION LENGTH

- HIGH PRESSURE BALLOONS CAN BE USED

ILIAC OCCLUSION





OBSTRUCTIVE DISEASE

Creating a physical barrier

Prevents Ingrowth of

proliferating SMCs

COVERED-STENTS


ILIAC OCCLUSION

ILIAC OCCLUSION

Try to obtain the PATENCY of open

surgery

Endovascular advantage:

• Lower morbimortality

• Shorter hospital stay

• PATIENT CONFORT


ILIAC OCCLUSION

ILIAC OCCLUSION

COVERED-STENTS

V12CERAB 6m 12m 18 24 36

Primpatency

97.0% 89.55% 88.07% 85.07% 86.6%

SecPatency

100% 95.5% 93.5% 93.5% 92.5%

Freedom

fromTLR98.5% 91.5% 89.55% 86.5% 85.0%

P. Goverde. CERAB 3 years results @ LINC17

COVERED-STENTS


ILIAC OCCLUSION

ILIAC OCCLUSION




COVERED-STENTS

CONFORMABILITY MATTERS!!!


ILIAC OCCLUSION

ILIAC OCCLUSION

- Nitinol Stent

- Inner layer of ePTFE

-Superb flexibility

-Low fractures reported

-Heparin-bonded luminal surface for thrombo-resistance

- Actually up to 25 cm lenght

GORE VIABAHN® Endoprosthesis with Heparin Bioactive Surface Control Endoprosthesis


OBSTRUCTIVE DISEASE


ILIAC OCCLUSION

VIABAHN

ILIAC OCCLUSION

BeG

raftao

rticS

tent

Graft

System

….Restoring and improving the patency of the iliac arteries

ILIAC OCCLUSION


ILIAC OCCLUSION

VIABAHN


VIABAHN


ILIAC OCCLUSION

ILIAC OCCLUSION

BeG

raftao

rticS

tent

Graft

System


VIABAHN


ILIAC OCCLUSION

ILIAC OCCLUSION

BeG

raftao

rticS

tent

Graft

System


ILIAC OCCLUSION

VIABAHN


ILIAC OCCLUSION

BeG

raftao

rticS

tent

Graft

System


ILIAC OCCLUSION

VIABAHN


ILIAC OCCLUSION

HYBRID TECHNIQUE


VIABAHN


ILIAC OCCLUSION

ILIAC OCCLUSION

Objective

Healthy distal landing zone

Improve the outflow

Patency is not affected4

Go across inguinal ligament

24%–53% patients4 CFA LESIONS

4 Piazza M. J Vasc Surg 2011; 54:402-11

VIABAHN


ILIAC OCCLUSION

ILIAC OCCLUSION

HYBRID TECHNIQUE


ILIAC OCCLUSION

ILIAC OCCLUSION

24%–53% patients4 CFA LESIONS

Objective

Healthy distal landing zone

Improve the outflow

Patency is not affected4

Go across inguinal ligament

4 Piazza M. J Vasc Surg 2011; 54:402-11

• Retrospective study.

• Jan 2008 - Dec 2014. 43 patients. 22 EVR, 21 OSR.

• Primary patency at 2 years 94% EVR vs 97% OSR

• Secondary patency 97% EVR vs 100% OSR

• Complications rate 4% EVR vs 18% OSR. (p .32)

• Femoral thromboendarterectomy 36% EVR

100%

VIABAHN®


ILIAC OCCLUSION

VIABAHN ILIAC OCCLUSION

TORINO EXPERIENCE2014-2016: 22 cases

6 Juxtarenal occlusion

5 Distal aortic occlusion

11 total iliac occlusion

Rutherford Class

III 13

IV 7

V and VI 2

M. FERRI @ LINC2017

VIABAHN


ILIAC OCCLUSION

ILIAC OCCLUSION

TORINO EXPERIENCE2014-2016: 22 cases

M. FERRI @ LINC2017

90.9%

96.5%

Follow up (12± 9.1 m)

Primary patency

Secondary patency

Technical success 100% Renal/Visceral embolization 0%Days hospital stay 3.9+/-2.2

VIABAHN


ILIAC OCCLUSION

ILIAC OCCLUSION


ILIAC OCCLUSION


• Retrospective study.

• Jan 2009 - Jun 2014. 167 iliac /125 patients.

• TASC C (51%) y D (49%) . 82 CS (49%) 85 BMS (51%)

• Primary patency for 2 years 93% CS vs 80% BMS (p=0.14)

• Permeability TASC D 88% CS vs 61% BMS (p=0.07)

• Permeability TASC D (CIA + EIA) 88% CS vs 57% BMS (p=0.03)

56.1 %

VIABAHN


ILIAC OCCLUSION


60% Viabahn

- TOTAL LESSION LENGTH > 6 cm

- OCCLUSION LENGTH > 3.5 cm

- CALCIFICATION INVOLVING > 75%

ENERO 2015- DIC 2016 138 ptes (178 iliacas)

Rutherford 3/4-5

ASA III/IV

69.2%/30.2%

50.8%

TASC C/TASC D• Aorto-iliac obstruction

45.5%/40.3%

11.1%

Covered stents

- Viabahn® (7-8 mm)

- Advanta®

364 (2.64)

78.7%21.3%

Bare metal Stents 44

Tech. Succes 98.3% (174/178)


ILIAC OCCLUSION

HOSPITAL UNIVERSITARIO CENTRAL DE

ASTURIAS EXPERIENCE

Courtesy Dr. Zanabili/ Dr. Camblor

TEA / Femoral Patch

• EIA Occlusion

57%

74%

Infrainguinal revascularization 7% (9)

Extra-anatomic by-pass1 FEM-FEM

0 AXILO-FEMORAL

Follow -up 3-24 months

PatencyPrimary

Secondary

96.6% (172/178)

100%

TLR (100% EIA envolvement)

6 re-stenosis (distal edge Viabahn)

6 thrombosis (3 percutaneus access)

6.74% (12)

3 overlap/3 TEA /

6 thrombolysis/4 TEA


ILIAC OCCLUSION

Courtesy Dr. Zanabili/ Dr. Camblor

HOSPITAL UNIVERSITARIO CENTRAL DE

ASTURIAS EXPERIENCE

LOS PACIENTES CON ISQUEMIA CRÍTICA DEBERÍAN TRATARSE

PRIMERO CON TRATAMIENTOS ENDOVASCULARES. ÚLTIMOS

RESULTADOS EUROPEOS DE LA ENDOPRÓTESIS GORE® VIABAHN

CON SUPERFICIE BIOACTIVA PROPATEN

BEYOND THE SFA. THE VERSATILITY OF GORE®

VIABAHN® ENDOPROSTHESIS FROM HEAD TO

FOOT


ILIAC OCCLUSION

CHUS experience

- More than 100 iliac treated with viabahn SE

- Adjuntive proximal or distal treatment

- Combine different devices






OBSTRUCTIVE DISEASE


ILIAC OCCLUSION

ILIAC OCCLUSIONVIABAHN BX

Both surfaces covered with Heparin coated PTFE

Available pre-mounted• 5mm-11mm diameter• 15mm-79 mm length• No foreshortening, except on over dilatation

Balloon expandable stent developed on SEplatform

Stainless steel

Stent is not continuous : Flexibility

Scalloped edges.

Semi-compliant covered balloon


ILIAC OCCLUSION

VIABAHN BX ILIAC OCCLUSION

12 month follow-up results

96.6% primary patency (per-subject)

– 1 patient with edge stenosis at 7months, managed with angioplastyand stenting

A. HOLDEN @ LINC2017

Interim 24 month analysis

• 28 patients ongoing in study at 24 months

– 1 further edge stenosis > 50% diameter loss detected on 2 year

US (day 723) – no TLR as yet – 0 TLR from 12 to 24 months

• Primary patency @ 2 years 93%

• Freedom from TLR @ 2 years 97%

Clinical Trialresults

• Gore VBX FLEX IDE Clinical Study

• VBX FLEX IDE clinical study (n=134),

• 32 percent presented with TASC II type C or D lesions,

• 18 percent required contralateral access to the lesion,

• and 42 percent involved kissing stents at the aortic bifurcation.

• 100 percent success rate in device delivery and coverage of target lesions inall study subjects

• 100 percent success rate in reducing the target lesion to less than or equal to30 percent of the original stenosis

• Zero change in median length of the device upon deployment

• 96.9 percent primary patency at nine-months, including a 95.3 percentprimary patency rate in those patients with TASC II C or D type lesions.

• Further, there were no reported incidences of device dislodgement, failuresin stent integrity, or device-related serious adverse events through theprimary endpoint follow up.


ILIAC OCCLUSION

VIABAHN BX ILIAC OCCLUSION

LOS PACIENTES CON ISQUEMIA CRÍTICA DEBERÍAN TRATARSE

PRIMERO CON TRATAMIENTOS ENDOVASCULARES. ÚLTIMOS

RESULTADOS EUROPEOS DE LA ENDOPRÓTESIS GORE® VIABAHN

CON SUPERFICIE BIOACTIVA PROPATEN

BEYOND THE SFA. THE VERSATILITY OF GORE®

VIABAHN® ENDOPROSTHESIS FROM HEAD TO

FOOT

COMMENTS

- MARKS IN THE STENT

- DRUG IN THE EDGES

- CONICAL STENTS

- MORE STENT LENGTHS

- WHAT ELSE?


ILIAC OCCLUSION

SUMMARY


ILIAC OCCLUSION

Covered stents prevent athero prolapse and future restenosis an occlusion

in TASC C and D lesions covered stents perform better than BMS ( ENDOVASCULAR BY-PASS)

COMFORMABILITY MATTERS!!!!

Good results using Viabahn in TASC C & D (EIA & cross inguinal lig)

Too much BIAS in the studies

Viabahn Bx is a new tool that combine the best of the Bx and SE Covered Stents

THE USE OF STENT GRAFT AS A PRIORITY

FOR LESIONS GREATER THAN 25 CM


ILIAC OCCLUSION

Documents

RESULTS OF VIABAHN IN AORTO ILIAC OCCLUSION Piazza M. J Vasc Surg 2011; 54:402-11 VIABAHN RESULTS OF VIABAHN IN AORTO ILIAC OCCLUSION ILIAC OCCLUSION HYBRID TECHNIQUE RESULTS OF VIABAHN