Endovascular treatment of aortic arch using Relay branched stent grafts

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Endovascular treatment of aortic arch using Relay branched stent grafts B. Saint-Lèbes Vascular surgery unit Rangueil Universitary hospital Toulouse France

Disclosure of Interest Speaker name: SAINT-LEBES I do not have any potential conflict of interest

Introduction Endovascular treatment of aortic arch aneurysms using branched stent graft provide attractive alternativ for elderly patients Feasibility study Prospective, multicentre study Assessment of morbidity and effectiveness 1st step: mono branched, after double branched

Relay branched stent graft 25-26Fr Custom-made version Based on Relay NBS (Non-Bare Stent) platform Nosecone shorter: 40 mm (LV Trauma) Window with one or two internal tunnels, 14 mm Ø for the extension to the supra-aortic trunks Introduced by a trans femoral approach Implementation of branches by cervical approach

Device overview Delivery system is based on relay NBS Plus Thoracic Stent-Graft Proximal Clasping mechanism to allow stent-graft repositioning and pre-curved guidewire lumen to allow self-orientation V-Patch inner sheath to allow expansion and optimal alignment of the inferior portion of the graft to the inner aortic curve Atraumatic Support Wires to control the expansion of the inferior portion of the graft and prevent retroflex

Device overview Radiopaque markers Tunnel entrance Tunnel window End of tunnel

Mono-branched Internal branch proximally oriented and window-targeted to be deployed under ostium of target vessel(s) Single internal branch (innominate) Intended for zone 0 deployment combined with extra-anatomic arch branch bypass(es): carotidcarotid (-LSA)

Double-branched

Sizing: case assessment Anatomical Limitations Subject must have a proximal landing neck with: Diameter of 42 mm or less and a healthy proximal neck length of 40mm (measurement 1 and 2) Minimum required distance between the sinotubular junction and the innominate artery of 60mm (measurement 4) Distance between proximal end of ostium of BCT and distal end of ostium of LCCA of 45mm or less (measurement 9) Access Vessels: Compatible with sheath caliber (24 FR to 26FR outer diameter)

Computer Assisted Design Design attributes of previous request Graft Diameters Window Dimensions Tunnel Dimensions Marker Locations Zone 0 length

In-vitro analysis After approval Construction of anatomical model based on converted CT data Manufacturing of prototype graft and delivery system In-vitro deployment testing under fluoroscopy Submit proposed procedural steps and deployment images to treating physician Deployment in anatomical model under fluoroscopy with treating physician the day before Perform implant

Device Deployment Technique STEP 1 Advance graft with tunnel (Tunnel Graft) to deployment site in Ascending Aorta

Device Deployment Technique STEP 2 Full deploy tunnel graft with PACING

Device Deployment Technique STEP 3 Cannulate tunnel prior to deployment of branch graft (bridging graft)

Device Deployment Technique STEP 4 Deploy branch graft

Single-branched Clinical experience Implanting centers Center Investigator City Country Ospedale Niguarda Ca Granda Dr. Rampoldi dr. Martinelli Milano Italy Ospedale G. Brotzu Dr. Camparini Roma Italy Ospedale di Circolo Prof. Castelli dr. Piffaretti Varese Italy Ospedale San Camillo Forlanini Prof. Cao Roma Italy Policlinico di Bari Prof. A. S. Bortone Bari Italy Osaka University Hospital Dr. Kuratani Osaka Japan Linköping University Hospital dr. C. Forssell Linköping Sweden Utrecht University Hospital prof. F. Moll, dr. J. Van Herwaarden Utrecht Netherlands

Mono-branched Results Total Male Female N 8 75% (6/8) 25% (2/8) Age 74 76 69 TAA 3 (37,5%) 2 1 PAU 4 (50%) 3 1 Type B Dissection 1 (12,5%) 1 0 General anesthesia 100% Target vessel bridged Procedures completed Freedom from endoleak 100% 100% 100% 100% 100% 100% 87,5% (7/8) 83,3% (5/6) 100% (2/2) Perioperative death 25% (2/8) 33,3% (2/6) 0% (0/2)

3D CT reconstruction

Double-branched Clinical experiences Implanting centers # Center Country Investigators 1 Ospedale G. Brotzu - Cagliari Italy Dr. S. Camparini 2 Osaka University Hospital Japan Dr. T. Kuratani 3 Hopital Rangueil - Toulouse France Pr. H. Rousseau Dr. Saint-Lèbes 4 Ospedale San Camillo - Roma Italy Pr. P.G. Cao 5 Hôpital George Pompidou - Paris France Dr. J. M. Alsac 6 St. Mary's Hospital - London United Kingdom Dr. M. Hamady 7 Linköping University Hospital - Linköping Sweden Dr. C. Forssell 8 Hospital UCA de Oviedo Spain Dr. M. Alonso 9 Utrecht University Hospital - Utrecht Netherlands Dr. F. Moll, Dr. J. Van Herwaarden 10 Mainz Hospital Germany Dr. M. Youssef 11 Hospital de La Coruña Spain Dr. V. Mosquera 12 Heart Center Freiburg University Germany Dr. M. Czerny 13 Universitätsklinikum Standort Gießen Germany Dr. A. Koshty

Double-branched Results Total Male Female N 26 69,2% (18/26) 30,8% (8/26) Age 72 75 64 TAA 21 (80,8%) 14 7 PAU 1 (3,8%) 1 0 Type B Dissection 4 (15,4%) 3 1 General anesthesia 100% Target vessels bridged Procedures completed Freedom from endoleak 100% 100% 100% 100% 100% 100% 92,3% 88,9% 100% Perioperative death 11,5% (3/26) 11,1% (2/18) 12,5% (1/8) late death 11,5% (3/26) 11,5% 0

Arch graft Clinical experience Branch usage Manufacturer N Cook-Zenith AAA 7 Medtronic-Endurant AAA 6 Atrium (combination with Viabhan) 1* Innomed Bently 2 Trivascular-Ovation 5 Gore-Excluder AAA 38 Gore-Viabahn 3* Jotec covered stent (combination with Viabhan) 1*

Double branched Clinical experience Case 1: First in Human Courtesy of Dr. Camparini, Az. Osp. Brotzu, Cagliari (IT) Case Courtesy of Dr. Kuratani, Osaka University Hospital, Osaka (JP) Pre-op CT scan 1 month F. up Pre-op CT scan 1 month F. up

Computational Fluid Dynamic

Computational Fluid Dynamic

Conclusion We have demonstrated the technical feasibility of a new modular trans femoral branched stent graft for treatment of aortic arch aneurysms The method is relatively safe, based on initial experience and we currently recommend it to high-risk patients and suitable anatomy Safety and efficacy will be better defined with longer follow-up and increased worlwide experience

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