CERAB : a haemodynamically proven

technique for treating extensive aortoiliac occlusive

disease

P. Goverde MD,

K. Lauwers MD, K.Taeymans MD, P. Verbruggen MD

Vascular Clinic ZNA, Antwerp, Belgium

M. Reijnen MD Phd, F. Grimme MD, J. Van Oostayen MD

Rijnstate Hospital, Arhnem, The Netherlands

Diclosure

Speaker’s name: Peter Goverde I have the following potential conflicts of interest to report:

Consulting:

Abbott Vascular; Angioslide; Atrium Maquet Getinge

group; Bard Peripheral Vascular; Cardionovum; Cordis Cardinal Health; IMDS; Ivascular; Stille;

Veyran; Ziehm Imaging

How to prevent ?

How

to treat ?

• Results of kissing stents inferior compared to isolated stents in iliac artery or aorta • Patency affected by:

• Radial mismatch; aortic lumen dead space around the protruding segment of the stents • Differences in stent conformation • The overlap of the free proximal stent ends

•Re-circulation, turbulence and stasis •Mesenchymal tissue, thrombus and intimal hyperplasia

Greiner A, et al. J Endovasc Ther 2005; 12: 696-703 Sharafuddin MJ, et al. Ann Vasc Surg 2008;22:346-57. Hughes M, et al . Cardiovasc Intervent Radiol 2006; 29: 255-259

Lesions of the aortic bifurcation & kissing stents

Lesions of the aortic bifurcation & kissing stents

Covered

Endovascular

Reconstruction

Aortic

Bifurcation

A new technique to reconstruct

the aortic bifurcation with

3 Maquet Getinge V12 covered stents

for extensive occlusive disease

“Cerab-technique : a new approach in treating extensive aortoiliac occlusive disease”: Goverde P. Grimme F, Reijnen M., et al ; J Cardiovasc Surg 2013;54:383-7

Advantages of covered stents

• May reduce the impact of radial mismatch

• May reduce the risk on embolization

• Prevention of in-stent re-stenosis

• May reduce the risk on rupture / perforation

due to its specific characteristics:

• low profile

• double ePTFE layer

• easy and accurate deployment

• radial force

• Dog-bone type inflation of balloon

• diameter adaptiveness

(postdilation to a larger diameter is possible without damaging the stent structure and ePTFE )

Why using Bx covered stents ?

Adaptiveness

1 stent V12 LD (12x 61 mm) = 4 different shapes

12mm

20mm

12mm

18mm

16mm

12mm

– In vitro testing :

in collaboration with

• University of Twente, Enschede, The Netherlands; E. Groot Jebbink , P. Goverde, M. Reijnen

– In vivo

• Vascular Clinic ZNA, Antwerp,Belgium

• Rijnstate Hospital, Arhnem, The Netherlands

RESULTS

“The Science behind

the Technology”

Geometrical consequences of kissing stents and the Covered Endovascular Reconstruction of the Aortic Bifurcation configuration in an in vitro model for endovascular reconstruction of aortic bifurcation. Groot Jebbink E, Grimme FA, Goverde PC, van Oostayen JA, Slump CH, Reijnen MM .J Vasc Surg. 2015 May;61(5):1306-11.

Results : in vitro

Groot Jebbink et al. .J Vasc Surg. 2015 May;61(5):1306-11.

.

Results : in vitro

Results : in vitro

• CERAB configuration : – Related to the best geometrical

conditions – Low radial mismatch – High stent conformation – Lower mismatch area – Lowest total mismatch volume or dead

space

– Compared to the other 3 configurations

Particle Image Velocimetry measurements: Turbulence and recirculation at phases B and C

Lesions of the aortic bifurcation & kissing stents

Particle Image Velocimetry measurements: Mostly laminar flow throughout the cardiac cycle

Dye injection

RESULTS In VIVO

February 2009 – March 2014 103 elective patients Acute cases (n=5) and chimney’s (n=5) excluded 61 (36-85) years Rutherford classification:

1 (n=1) 1% 2 (n=0) 0% 3 (n=64) 62% 4 (n=20) 19% 5 (n=17) 17% 6 (n=1) 1%

• Technical success 95%

Results CERAB : Antwerp and Arnhem

First Results of the Covered Endovascular Reconstruction of the Aortic Bifurcation (CERAB) Technique for Aortoiliac Occlusive Disease. Grimme FA, Goverde PC, Verbruggen PJ, Zeebregts CJ, Reijnen MM. Eur J Vasc Endovasc Surg. 2015 Sep 3. [Epub ahead of print]

ABI 0.64 ± 0.21 TASC -2

B n=5 (6%) C n=9 (9%) D n=88 (86%)

Risk factors: Smoking n=89 (87% )

Hypertension n=78 (76%)

Diabetes n=29 (29% )

Dyslipidemia n=91 (88%)

Coronary artery disease n=43 (42%)

Pulmonary disease n=46 (45%)

Renal disease n=18 (18%)

Results CERAB : Antwerp and Arnhem

30-day mortality 0%

30-day complication rate 23% Hematoma groin (n=16)

Re-bleed (n=1)

Pseudoaneurysm (n=2)

Fever eci (n=2)

Atrial fibrillation (n=1)

30-day major complication rate 2% Renal failure (n=1)

Pneumonia (n=1)

ABI : 0.58 ±0.23 -> 0.91 ± 0.14

Hospital Admission 2 days (range 1-16 days)

Results CERAB : Antwerp and Arnhem

6 m 12 m 18 m 24 m

Primary patency 91.5 87.3 87.3 82.3

Secondary patency 97.8 95.0 95.0 85.0

Freedom from TLR 93.7 88.2 88.2 85.6

Median follow-up 19 months

Limb salvage 100%

Results CERAB : Antwerp and Arnhem

Conclusions

Covered endovascular reconstruction of the aortic bifurcation (CERAB) is safe and feasible and seems to be a valid alternative for surgery and/or kissing stents

Exploration of the chimney-CERAB, patient selection and the economic benefit may further expand the indications of this technique

CERAB & Complex iuxtarenal Aortic Occlusive Disease

P. Goverde MD, Antwerp Belgium/ A. Schmidt MD, Leipzig Germany

2 chimney, V12 Atrium Maquet

CERAB : a haemodynamically proven

technique for treating extensive aortoiliac occlusive

disease

P. Goverde MD,

K. Lauwers MD, K.Taeymans MD, P. Verbruggen MD

Vascular Clinic ZNA, Antwerp, Belgium

M. Reijnen MD Phd, F. Grimme MD, J. Van Oostayen MD

Rijnstate Hospital, Arhnem, The Netherlands