EXPERIENCE AFTER 500 ENDOLUMINAL STENT GRAFTS. DEVICES SPECIFIC OUTCOME AND LESSONS LEARNED.

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EXPERIENCE AFTER 500 ENDOLUMINAL STENT GRAFTS. DEVICES SPECIFIC OUTCOME AND LESSONS LEARNED. A/Prof. B. Patrice Mwipatayi MD, MMed (Surg), MClinEd (Melb), FCS, FRACS Department of Vascular Surgery, Royal Perth Hospital, Perth, Australia University of Western Australia Director of PIVAR

DISCLOSURE Speaker name: Prof. B. Patrice Mwipatayi I have the following potential conflicts of interest to report: Consulting Biotronic, Medtronic Employment in industry Stockholder of a healthcare company Owner of a healthcare company Other(s) I do not have any potential conflict of interest

A pedigree history of initial EVAR DEVICES at RPH by the team of Michael L Brown and David Hartley

INTRODUCTION Registry 2004-2018 Registry 1998-2003 (MLB One shot, TFFB, ZALB, Zenith alpha) Abdominal Aortic Aneurysms (AAA) & Thoracic Aortic Aneurysms 3 sites RPH, HPH, JHC 10 year follow up (?)

BASELINE DEMOGRAPHICS n = 527 95% CI Age (years) [Mean ± SD] 72.50 ± 11.52 0.50 (73.48-71.51) Gender [Male - n (%)] 421 (79.9%) -- [Female - n (%)] 106 (20.1%) -- Race n (%) Caucasian 443 (83.9%) -- Asian 72(13.67%) -- African 4 (0.76%) Maori/Pacific 6(1.14%) -- ATSI 2 (0.38%) --

RISK FACTORS n = 527 (%) Smoker 61 (37.20) Ex-Smoker 69 (42.07) Hypertension 208 (77.90) Coronary Artery Disease 189 (60.75) CAS/CEA 25 (10.1) CABG 15 (6.07) Heart Failure 10 (3.92) Arrhythmia 48 (18.60) Previous history of CVA 21 (8.17) PVD 55 (21.40) Hypercholesterolaemia 148 (56.06) Diabetes Mellitus 61 (23.28) COPD 48 (18.53) Renal Impairment 39 (15.23) Dialysis 4 (1.57) Previous History of Malignancy 43 (43.00)

INDICATION FOR TREATMENT Indication n (%) n = 527 Abdominal 385 (73.0) AAA 50mm 198 (37.6) Leaking AAA 2 (1.6) Dissection 3 (2.5) Rupture 1 (0.8) Tenderness 16 (13.3) Thoracic 142 (26.9) TAA 60mm 80 (15.2) Dissection 62 (11.8))

ANEURYSM DIMENSIONS n = 527 (%) SEM (95%CI) Max. AAA Diameter (mm) [Mean ± SD] 57.21 ± 12.29 0.77 (58.73-55.70) Infrarenal Neck Length (mm) [Mean ± SD] 32.54 ± 16.55 1.66 (35.79-29.29) Proximal Neck Diameter (mm) [Mean ± SD] 22.32 ± 2.69 0.29 (22.89-21.75) Distal Neck Diameter (mm) [Mean ± SD] 24.90 ± 3.55 0.37 (25.64-24.16) Flaring Neck > 1mm per 1cm [n (%)] 29 (38.67) -- Flaring Over Proximal Seal Zone [n (%)] 20 (27.03) -- Neck Angulation (degrees) [Mean ± SD] 35.30 ± 23.53 2.44 (40.09-30.51) Neck Angulation > 60 [n (%)] 85 (16.1) -- Suprarenal Neck Angulation 45 [n (%)] 12 (2.3) -- Neck Thrombus [n (%)] 78 (14.8) -- Neck Calcification [n (%)] 75(14.2) -- Infrarenal Aorta Length (mm) [Mean ± SD] 121.61 ± 17.63 2.05 (125.64-117.59) Lumbar Vessel Patency [n (%)] 67 (91.78) --

PROCEDURAL DETAILS n = 527 SEM (95%CI) Min-Max LOS ICU (Days ± SD) 1.1 ± 0.83 0.13 (0.82-1.32) (0-4) LOS Hospital (Days ± SD) 77 ± 0.44 0.44 (7.10-8.84) (0-77) Procedure duration (min ± SD) 113.56 ± 67.40 4.63 (104.46-122.65) (10.00-503.00) Anaesthetic Type n (%) Epidural/Spinal 37 (24.03) -- -- General 117 (75.97) -- -- ASA SCORE N (%) 2 13 (16.05) -- -- 3 49 (60.49) -- -- 4 19 (23.46) -- -- PRE OPERATIVE Creatinine [umol / L] 104.83 ± 58.40 3.41 (98.14-111.52) (49.00-676.00) Haemoglobin [g/l] 133.75 ± 20.35 1.43 (130.94-136.56) (68.00-20.35) POST OPERATIVE Creatinine [umol / L] 98.96 ± 41.00 5.31 (88.52-109.40) (41.00-820.00) Haemoglobin [g/l] 114.18 ± 16.83 1.29 (111.65-116.72) (71.00-154.00) RADIATION Radiation Dosage (microgym2) 15204.94 ± 23778.82 1531.73 (18213.99-12195.88) (33.00-122683.00) Fluoroscopy Time (min.) 818.04 ± 1538.48 98.69 (1011.92-624.16) (0.56-10237.00) Contrast Volume (ml) 169.73 ± 81.49 5.34 (159.24-180.21) (15.00-800.00)

STENT TYPE Uncorrected Data n = 527 (%) EVAR Stent Type n (%) Endurant 160 (30.4) Cook Flex 85 (16.1) Excluder 84(15.9) Nellix 10 (1.9) Anaconda 25 (4.7) AFX 12 (2.3) Ovation Alto 16 (3.0) Talent 65 (12.3) Fenestrated Graft n (%) 58 (11) Fenestrated Graft Type n (%) Cook Fenestrated Graft 47 (8.9) Anaconda Fenestrated Graft 11 (2.1) Ch-EVAR n (%) 10 Br-EVAR n (%) 12 Cook IBD n (%) 25 Gore IBE n (%) 6 Thoracic Graft n (%) 12 Thoracic Graft Stent Type n (%) Cook Thoracic Graft 52 Medtronic Valiant Thoracic Graft 72 Gore TAG Thoracic Endoprosthesis 18 Combination n (%) 48 Aptus Heli-Fx Anchor n (%) 25

ENDPOINT (30 DAYS) n = 527 SEM (95% CI) Successful Stent Deployment n (%) 527 (100.00) 0.00 (1.00-1.00) End Point n (%) Death 1 (0.19) 0.00 (0.01-0.00) Endoleak 1 1 (0.52) 0.01 (0.01-0.01) Endoleak 2 23 (4.4) 0.01 (0.04-0.04) Endoleak 3 0 0.00 (0.00-0.00) Endoleak 4 0 0.00 (0.00-0.00) AAA rupture during procedure 0 0.00 (0.00-0.00) Conversion to Open repair 0 0.00 (0.00-0.00)

STENT TYPE & OVERALL MORTALITY n = 527 Total Deaths 60 (28.44) Procedure n(%) Standard EVAR 11 (18.33) FEVAR 2 (3.33) ChEVAR 0 (0.00) BrEVAR 0 (0.00) TEVAR 0 (0.00) Stent Type n(%) Endurant 8 (13.33) Cook Flex 1 (1.67) Excluder 2 (3.33) Nellix 0 (0.00) Anaconda 0 (0.00) AFX 1 (1.67) Ovation Alto 0 (0.00) Talent 0 (0.00) Cook Fenestrated 1 (1.67) Anaconda Fenestrated Graft 0 (0.00) Cook IBD 2 (3.33) Gore IBE 0 (0.00) Cook Thoracic Graft 0 (0.00) Medtronic Valiant Thoracic Graft 0 (0.00) Gore TAG Thoracic Endoprosthesis 0 (0.00) Combination 0 (0.00) Aptus Heli-Fx Anchor n (%) 0 (0.00)

COMPLICATIONS n = 527 Surgical Complications n (%) Wound Infection 5 (2.91) Seroma 4 (2.33) Haematoma 6 (3.51) Access Vessel Flow Dissection 1 (0.58) False Aneurysm 1 (0.58) Distal Vessel Embolisation 0 (0.00) Ischaemic Limb 2 (1.17) Ischaemic Collitis 0 (0.00) General Complications n (%) CVS (MI, Arrhythmia) 7 (4.19) Respiratory 1 (0.60) Renal (Contrast nephropathy) 3 (1.80) GIT Bleed 0 (0.00) CNS (Stroke, TIA, Amaurosis Fugax) 0 (0.00)

TYPE I ENDOLEAK AFTER EVAR

CONCLUSION 1. Multiple devices have been for variable indication 2. RPH still offer opportunities for teaching all staff on aortic endografts 3. Lessons have to be learned from all outcome, but this still work in progress. 4. Further analysis will be reported later this year

EXPERIENCE AFTER 500 ENDOLUMINAL STENT GRAFTS. DEVICES SPECIFIC OUTCOME AND LESSONS LEARNED. A/Prof. B. Patrice Mwipatayi MD, MMed (Surg), MClinEd (Melb), FCS, FRACS Department of Vascular Surgery, Royal Perth Hospital, Perth, Australia University of Western Australia Director of PIVAR

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