Clinical experience with a new thoracic stent graft system (Ankura TM ). Procedural analysis, 30 days and 6-month results in a single center study

Clinical experience with a new thoracic stent graft system (Ankura TM ). Procedural analysis, 30 days and 6-month results in a single center study Theodoros Kratimenos, MD Consultant, Interventional Radiologist Interventional Radiology Unit EVANGELISMOS General Hospital of Athens, Greece

Disclosure Speaker name: Theodoros Kratimenos I have the following potential conflicts of interest to report: Consulting (Bolton, Lifetech, Vascutek) Employment in industry Stockholder of a healthcare company Owner of a healthcare company Other(s) I do not have any potential conflict of interest

ANKURA TM THORACIC STENT GRAFT FEATURES The Ankura Thoracic Stent Graft is designed for endovascular treatment of descending thoracic aorta diseases such as: type B dissection, Aneurysm, Dissecting aneurysm, penetrating aortic ulcer, intramural hematoma, traumatic rupture, etc. It reinforces the vascular wall of thoracic aorta from rupture. 1. e-ptfe Dual Membrane (Excellent biocompatibility and durability) 2. No suture on the main body (Avoid pinhole leakage -Type Ⅳ endoleak) 3. Sinusoidal shape Self-expanding nitinol springs -(provide flexibility and conformability exert active radial force to enhance seal and fixation) 4. Kink-resistant delivery system with Hydrophilic Coating - (facilitates stent graft delivery) 5. The first nitinol spring strut has smaller diameter -(in order to provide enhanced apposition to the aortic wall, decreased endoleak risk and prevent migration). 6. Proximal Bare Stents which are embedded in the graft- (less traumatic)

ANKURA TM THORACIC STENT GRAFT FEATURES Tip capture system (provides controlled deployment and precise placement in the thoracic aorta). Proximal releaser Front handle Safe buckle Tip capture release in 2 movements: remove the safe buckle (green), pull back the tip releaser (black), use left hand to fix the front handle 2 radiopaque markers at the prox. Part of the graft (figure 8 marker at the greater curvature and figure 0 marker at the lesser curvature), Longitudinal supporting bar on the greater curvature (helps to avoid stent shortening, providing axial support to the nitinol springs. No bar at the first and last nitinol spring strut). (21-24) F OD

ANKURA TM THORACIC STENT GRAFT FEATURES Easy and operator friendly deployment process: Deploy Slowly for maximum control keeping fixed with the left hand the first handle and rotating with the right hand the second handle. Straight grafts: 20-46mm diameter 40-200mm length Tapered grafts: 4,6, and 8 mm diameter difference, 160-200mm length IFU Adequate femoral/iliac access Fast deployment: Pull back the blue safety valve and withdraw fast the right handle keeping fixed the left one Proximal landing Zone: 15mm length, 18-42mm width Distal landing Zone: 15mm, 18-42mm width

METHODS: From February 2014 till June 2017, 83 patients, 62 male, 21 female (average age 64,7 years, max 85-min 32) received endovascular treatment with the Ankura Stent Graft device at a single center (Evangelismos Hospital) in Athens, Greece, for diseases of thoracic aorta. Informed consent from each patient and Institutional Review Board permission were obtained. A chest and abdominal Computed Tomography Angiography (CTA) was performed in every patient before the endovascular procedure. All post-cta images were transferred into a dedicated software. A multidisciplinary team, including interventional radiologists, cardiac and vascular surgeons discussed and planned each case on an individual basis. All TEVAR interventions were performed in the Angio Suite A femoral artery cut-down was performed on the device access site We did not routinely used spinal drainage before TEVAR (however drainage was readily available in cases of previous abdominal aortic aneurysm repair, when coverage of LT subclavian artery was planned, or when extensive coverage of thoracic aorta by the stent graft was required).

Table I Number of patients Average n o of devices used Pathology treated 83 1,36 Degenerative aneurysms 30 1,5 Type B dissection 22 1,22 Dissecting aneurysms 13 1,5 Traumatic pseudoaneurysm 7 1 Penetrating Aortic Ulcer (PAU)+Intramural Heamatoma (IMH) 5 1,2 PAU 3 1,3 IMH 2 1 Isthmic Stenosis 1 1

RESULTS: INTRAPROCEDURAL DATA During operation there was no major complication or death. Successful Implantation in 81/83 patients (97,6%) 2 cases demanded the implantation of a surgical conduit in the common iliac arteries through which finally passed the device. In one single case the device presented mechanical damage of the delivery sheath, due to extreme tortuosity of descending thoracic aorta, where a different company s device also did not succeded to be released. In one case (under hemodialysis) was not possible to advance the delivery system of the device through the iliac art. (rigid and tortuous). In all other cases the stent graft was easily and precisely released with no migration.

Clinical case: 77y/o male with an 8 cm diameter descending thoracic aorta aneurysm, Pre Operation CT: Aortic Arch with a normal caliber, Descending Thoracic Aorta Aneurysm with mural thrombus starting a few centimeters after the origin of Lt Subcl. Art., Atelectasis of the lt pulmonary lower lobe and pleural effusion 6 months post op. CT: Exclusion of the aneurysm, no proximal or distal Type Endoleak, No Atelectasis, No Pleural Effusion

Table 2. Operation-related characteristics Operation-related characteristics Clinical symptomatology elective repair (n, %) 42 50,6% symptomatic (n, %) 22 27% emergency (n, %) 19 23% Type of prior aortic treatment none (n, %) 77 92,8% surgical repair of type A aortic dissection (n, %) 4 4,8% surgical repair for AAA (n, %) NONE EVAR (n, %) 2 2,4% Type of anaesthesia used local /IV sedation (n, %) 81 97,6% general (n, %) 2-2,4% regional (n, %) NONE Coverage of LSA (n, %) Need for carotid-subcl. Bypass (n, %) 9 10,8% 1 1,2% Fluoroscopy time (min) (mean±sd) 13 ± 6,2 DAP (dgy cm2) (mean±sd) 313,08±228,2 Contrast administered (ml) (mean±sd) 120 ± 55,44 Blood loss (ml) (mean±sd) 172 ±149,4 Need for Transfusion (n, %) 1 1,2 % Length of hospital stay (days) (mean±sd) 4,25 ± 2,93

Clinical case: Male, 76 years old with acute thoracic pain CT scan images: PAU+IMH in descending Thor. Ao 1 MONTH POST TEVAR CT Clinical case : Female 34 years old, bilateral lower limb bone fractures and pelvis fracture, post car accident, Pre op. MRA, DSA, CT: 6-Months f-up

Table 4. 30-day and 6 months outcomes 30-day Outcomes 6 months Outcomes Access site complications (n, %) 10 9,6% Endoleak (n, %) type I prox. 2 2,4% 1 1,2% Type I distal 2 2,4% 1 1,2% type II 3 3,6% 5 6% Type III NONE 1 1,2% Type IV NONE NONE Stroke / TIA (cerebral complications) (n, %) 1 1,2% / 2 2,4% 1 1,2% MI (cardiac complications) (n, %) 1 1,2% 2 2,4% Paralysis / Paraparesis (n, %) 1 1,2% / 3 3,6%* NONE/ 1 1,2% Pulmonary complications (n, %) 2 2,4% NONE Renal failure (n, %) NONE NONE Retro type A dissection (n, %) NONE NONE Re-intervention 1 1,2% (Type Ia endoleak) Aorta related Death (n, %) NONE NONE All cause death (n, %) 2 2,4 % 5 6% In-hospital Death (n, %) 1 1,2 % 4 4,8% Graft migration 0 1 1,2% Graft thrombosis 0 0 Graft infection 0 0 Conversion to open surgery 0 0 *All cases treated with lumbar drainage and medications Paraparesis cases did not leave permanent sequela The case with paralysis became permanent paraparesis 3 3,6% (2 Type Ib, and 1 III endoleak)

Clinical case: 73yo male, TEVAR 18 months ago, now symptomatic aneurysm 7,5cm of diameter in the distal aortic arch, because of type Ia endoleak, with no prox. landing zonesurgical debranching of aortic arch vessels was performed in order to expand the prox. landing zone

CONCLUSION In this single center clinical study the Ankura Thoracic Stent Graft system, has demonstrated: high intra- procedural technical success, very satisfactory 30 days and 6 months clinical outcome, showing a promising capacity to treat a variety of thoracic aortic diseases. Further studies and longer follow ups are needed.

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