Aortoiliac stenting: is CERAB replacing kissing stents from a flow dynamic perspective? Michel MPJ Reijnen Rijnstate Hospital Arnhem, The Netherlands

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1 Aortoiliac stenting: is CERAB replacing kissing stents from a flow dynamic perspective? Michel MPJ Reijnen Rijnstate Hospital Arnhem, The Netherlands

2 Disclosure Speaker name: MMPJ Reijnen 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

3 Aorto-iliac occlusive disease Open surgical repair is current standard for complex aorto-iliac occlusive lesions 5-year patency rate 87-91% Complication rate 8-12% Mortality rate 4%

4 Late complications of open repair Incisional hernia Incidence 11% Complication rate 24-30% Recurrence rate 2-10 Postsurgical adhesions Incidence 67-93% Small bowel obstruction Inadvertent enterotomy 19% Gruppo M, et al. Surgery 2012;151:882-8 Lomanto D, et al. Surg Endosc 2006 Jul;20(7): Van der Krabben AA, et al. Br J Surg 2000 Apr;87(4):467-71

5 Extensive aortoiliac occlusive disease Endovascular options: Kissing stents and/or double barrel bare metal stents Kissing covered stents Case courtesy of Dr Mangialardi-Ronchey, San Filippo Neri Hospital, Rome Use of AAA devices Covered endovascular reconstruction of the Aortic Bifurcation (CERAB)

6 Lesions of the aortic bifurcation and Kissing Stents Broad range in patency of kissing stents Inferior compared to isolated stents in iliac artery or the 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: Sharafuddin MJ, et al. Ann Vasc Surg 2008;22: Hughes M, et al. Cardiovasc Intervent Radiol 2006; 29:

7 Covered Endovascular Reconstruction of the Aortic Bifurcation - CERAB Goal: to provide a more anatomical and physiological endovascular reconstruction of the aortic bifurcation

8 Results CERAB Antwerp and Arnhem February 2009 March 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% FAB Grimme, PCJM. Goverde, PJEM Verbruggen, CJ Zeebregts, MMPJ Reijnen. First Results of the Covered Endovascular Reconstruction of the Aortic Bifurcation (CERAB) Technique for Aortoiliac Occlusive Disease. Eur J Vasc Endovasc Surg Nov;50(5):

9 Results CERAB Antwerp and Arnhem 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%) FAB Grimme, PCJM. Goverde, PJEM Verbruggen, CJ Zeebregts, MMPJ Reijnen. First Results of the Covered Endovascular Reconstruction of the Aortic Bifurcation (CERAB) Technique for Aortoiliac Occlusive Disease. Eur J Vasc Endovasc Surg Nov;50(5):

10 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 0.91 ± 0.14 Admission 2 days (range 1-16 days) FAB Grimme, PCJM. Goverde, PJEM Verbruggen, CJ Zeebregts, MMPJ Reijnen. First Results of the Covered Endovascular Reconstruction of the Aortic Bifurcation (CERAB) Technique for Aortoiliac Occlusive Disease. Eur J Vasc Endovasc Surg Nov;50(5):

11 Results CERAB Antwerp and Arnhem Median follow-up 12 months Primary patency 6 months 92% 12 months 87% 18 months 87% Secondary patency 6 months 98% 12 months 95% 18 months 95% Limb salvage 100% FAB Grimme, PCJM. Goverde, PJEM Verbruggen, CJ Zeebregts, MMPJ Reijnen. First Results of the Covered Endovascular Reconstruction of the Aortic Bifurcation (CERAB) Technique for Aortoiliac Occlusive Disease. Eur J Vasc Endovasc Surg Nov;50(5):

12 Covered Endovascular Reconstruction of the Aortic Bifurcation - CERAB CERAB related to: Lowest radial mismatch High conformation ratio ( double-d configuration) Groot Jebbink et al. J Vasc Surg, 2015 May;61(5):

13 Physiological flow model: Methods flow setup Based on second order windkessel model Peak flow 60 ml/sec Flow equal to all out flow vessels 120/80 mmhg, 60 BPM Blood mimicking fluid: 4.3 cp Flow fields obtained with laser particle image velocimetry (PIV) Stent cover made transparant

14 Methods configurations Kissing bare stents Kissing covered stents CERAB

15 Results inflow section limbs

16 Results, flow fields at neobifurcation Flow perturbation little to none at in flow of KS BM configuration

17 Results inflow section limbs Covered KS mismatch induces large zone of recirculation during entire cardiac cycle

18 Wall shear stress (Pa) Wall shear stress (Pa) Wall shear stress (Pa) Results WSS inflow section limbs wallsegment: Left proximal aorta KS BM neobifurcation KS covered neobifurcation CERAB neobifurcation Peak systolic, wallsegment: Left proximal aorta KS BM neobifurcation KS covered neobifurcation CERAB neobifurcation Time (ms) Low WSS in covered KS configuration, over the entire vessel wall WSS values CERAB comparable to KS bare metal stents Distance (mm) Peak Diastolic, wallsegment: Left proximal aorta KS BM neobifurcation KS covered neobifurcation CERAB neobifurcation Distance (mm) Distal iliac Distal aorta

19 Results inflow section CERAB cuff No flow perturbations at the inflow of aortic cuff

20 Results native aortic bifurcation

21 Results native aortic bifurcation Continuous zone of low flow between anatomic bifurcation and neobifurcation End systolic phase: recirculation at the mismatch area

22 Wall shear stress (Pa) Wall shear stress (Pa) Wall shear stress (Pa) Results WSS native aortic bifurcation Peak systolic, wallsegment: Aorta distal Controle KS BM End systolic, wallsegment: Aorta distal Controle KS BM Peak Diastolic, wallsegment: Aorta distal Controle KS BM End iliac Start aorta End iliac End iliac Start aorta Distance (mm) Start aorta Distance (mm) 0.6 End iliac Start aorta Distance (mm) Distal iliac Distal aorta Distal iliac Distal aorta Distal iliac Distal aorta WSS control and bare metal KS configuration comparable WSS bare metal KS configuration at the end systolic closer to zero

23 Conclusion The CERAB configuration is related to undisturbed flow throughout the cardiac cycle Inflow section of limbs is disturbed in the covered KS configuration Large recirculation zones when compared to CERAB Low WSS throughout cardiac cycle compared to CERAB and bare metal KS Bare metal KS related to recirculation and slow blood flow at the native bifurcation Correlated to thrombus formation and intimal hyperplasia in this zone This zone excluded in the CERAB configuration

24 Aortoiliac stenting: is CERAB replacing kissing stents from a flow dynamic perspective? Michel MPJ Reijnen Rijnstate Hospital Arnhem, The Netherlands

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