Mid-term results of 300+ patients treated by endovascular aortic sealing (EVAS)

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Mid-term results of 300+ patients treated by endovascular aortic sealing (EVAS) Jean-Paul P.M. de Vries Dept Vascular Surgery St. Antonius Hospital, Nieuwegein,The Netherlands On behalf of the DEVASS study group 7th MAC Conference München, Dec 7th-9th 2017

Disclosures: Co-founder of Endovascular Diagnostics Consultant for Medtronic, Endologix Advisory board member for Medtronic, Arsenal Research grants: Cardionovum, BARD, Endologix, BTG

Case Control Studies RCTs Why searching for an alternative? Trial/Author Year N Follow-up Years (Mean or Median) Secondary Procedures (% of Patients) EVAR-1 2010 626 6 23 EVAR-2 2010 197 3.1 28 DREAM 2010 173 6.4 28 OVER 2009 444 1.8 10 Carpenter 2010 157 1.8 8.9 Conrad 2010 832 2.9 11 Mehta 2010 1,768 2.8 18 AbuRahma 2009 238 2 26 Dias 2009 279 4.5 20 Abbruzzese 2009 565 2.5 11 Pitoulias 2009 617 3.8 23 Kim 2008 310 3.3 19 Schermerhorn 2008 22,830 4 9.0 Aneurysm related readmissions: Average 3.5 Years 18% 61% cost-differential vs open surgery

Endovascular Aneurysm Sealing System (Nellix) Introduce both catheters over.035 wires Balloon expand both stents (CoCr Alloy) Fill with Polymer using pressure monitoring Designed to fill and seal the entire aneurysm sac and target the direct causes of secondary interventions Endobags filled with biostable polymer seal anatomy from renals to hypogastrics

Freedom from type IA endoleaks (IFU 2013) 96.9% 85.6% On-IFU Off-IFU Complex Proximal Neck Anatomy p-value = 0.0008 Large proximal necks >28mm Thrombus-laden necks

Freedom from secondary interventions (IFU 2013) 92.2% 80.7% p-value = 0.0066 On-IFU Off-IFU Reason (N = 277) Endoleak 20 (7.2%) Occlusion 8 (2.9%) Migration 3 (1.1%) Other 13 (4.7%) Mean follow-up 25 months (0-35 )

Refined Nellix IFU (2016)

Refined Nellix IFU (2016)

Start N = 355 16 Symptomatic 11 Ruptured 3 Missing CT 17 Nellix as relining 12 Unilateral Nellix 19 Ch-EVAS 3 Nellix in Nellix 10 CIAA Asymptomatic N = 325 Elective EVAS procedure N = 264 DEVASS Tilburg, Arnhem, Nieuwegein Anatomy outside IFU 2013 N = 96 Anatomy within IFU 2013 N = 168 Anatomy within IFU 2016 N = 48 Anatomy outside IFU 2016 N = 216 168 within IFU 2013 = 64% 48 within IFU 2016 = 18%

Baseline characteristics Baseline characteristics Total cohort IFU 2013 IFU 2016 P value** Sex Male Female 310 (87.3) 45 (12.7) 155 (92.3) 13 (7.7) 40 (83.3) 8 (16.7) 0.064 Age at procedure* 75 (68-79) 74 (68-79) 75 (68.25-79) 0.702 ASA class 2 >2 missing 199 (56.1) 146 (41.1) 10 (2.8) 107 (63.7) 60 (35.7) 1 (0.6) 29 (60.4) 18 (37.5) 1 (2.1) 0.766 Hypertension 242 (68.2) 112 (66.7) 33 (68.8) 0.786 Hyperlipidemia 267 (75.2) 126 (75.0) 38 (79.2) 0.552 Smoking, or history of smoking in last 10 years 159 (44.8) 78 (46.4) 20 (41.7) 0.559 Cardiac disease 151 (42.5) 72 (42.9) 27 (56.3) 0.117 Pulmonary disease 96 (27.0) 47 (28.0) 13 (27.1) 0.903 Renal disease 91 (25.6) 34 (20.2) 8 (16.7) 0.581 Diabetes mellitus 51 (14.4) 27 (16.1) 11 (22.9) 0.272

Anatomical characteristics Anatomical characteristics IFU 2013 IFU 2016 P-value** Infrarenal neck diameter 23.3 (21.8 25.5) 22.3 (20.9 24.3) *0.031 Infrarenal neck angle 21.9 (13.1 35.0) 25.2 (15.2 38.2) 0.234 Infrarenal neck length at 10% diameter increase 18.0 (12.0 31.0) 20.0 (15.0 30.8) 0.548 AAA lumen diameter 42.3 (37.9 48.1) 46.6 (41.3 50.8) *0.003 AAA outer diameter 57.9 (54.3 61.7) 56.4 (53.0 61.2) 0.141 Ratio AAA outer diameter to AAA lumen diameter 1.35 (1.19 1.57) 1.27 (1.15 1.32) *0.000 Infrarenal lumen volume 80.3 (64.1 107.3) 93.6 (73.7 110.8) 0.128 Right CIA lumen diameter 10.5 (9.3 12.0) 10.0 (9.2 11.0) 0.054 Right CIA outer diameter 18.0 (15.0 21.4) 16.5 (14.1 18.2) *0.002 Left CIA lumen diameter 10.5 (9.3 12.0) 10.2 (9.1 11.0) 0.133 Left CIA outer diameter 17.2 (14.8 20.4) 16.0 (14.1 18.1) *0.019

Exclusion from IFU 2016 Instructions for use 2016 Infrarenal neck IFU 2016 Length > 10mm and < 10% diameter change Diameter > 18 mm Diameter < 28 mm Missing data Patients compliant with criteria. N(%) 183 (69.3) 204 (77.3) 254 (96.2) 207 (78.4) 3 (1.1) Infrarenal neck angle < 60 258 (97.7) Aneurysm blood lumen diameter < 60mm 254 (96.2) Ratio of max aortic aneurysm diameter to max aortic blood lumen diameter <1.4 149 (56.4) CIA luminal diameter 9 to 35mm CIA diameter > 9 mm CIA diameter < 35 mm Missing data Distal iliac artery seal (length >10mm and outer diameter 9 to 20mm) 207 (78.4) 206 (78.0) 264 (100.0) 5 (1.9) 167 (63.3) Access diameter >7mm 236 (89.4)

Follow up Total cohort: 18 months (IQR 11-24) IFU 2013: 23 months (IQR 12-26) IFU 2016: 23 months (IQR 12-29)

Initial outcome IFU 2013 IFU 2016 Initial technical success 165 (98.2) 47 (97.9) Technical failure 3 (1.8) 1 (2.1) Unplanned distal extension 8 (4.8) 1 (2.1) Duration of hospital stay 3 (3-4) 3 (3-4) Procedure time 90 (70-108) 90 (74-106) Blood loss 130 (100-300) 150 (63-300)

Reinterventions IFU 2013 IFU 2016 p Reintervention 19 (11.3) 4 (8.3).555 Conversions to open repair o IFU 2013: 6 (3.6%) o IFU 2016: 1 (2.1%)

Reinterventions 30 days o 1 femoral-femoral bypass (also IFU 2016) o 1 thrombectomy with relining o 1 thrombectomy with endarterectomy of CFA 30 days - 1 year o 1 thrombectomy with relining (also IFU 2016) o o o o 2 thrombectomy with iliac extension/stenting 1 thrombolysis with iliac stenting 1 relining of both EVAS stents for iliac stenosis 1 conversion to open repair for an aorto-enteral fistual (3 months after EVAS procedure

Reinterventions 1 year - 2 years o o 1 relining for stenosis 1 femoral-femoral bypass for occlusion o 1 Embolization for type IA endoleak (IFU 2016) o 2 Nellix-in-Nellix proximal extensions (one for secondary rupture and one for migration) o 5 conversions to open repair (IFU 2016) 1 Endoleak type Ia with migration (24 months) 1 AAA sac expansion (15 months) 1 Para-aortitis (22 months) 2 Endoleak type IA (13 and 24 months, last within IFU 2016)

Reinterventions

Novel classification proximal endoleaks 1S1 1S2 1S3 1S4 MMPJ Reijnen et al. Submitted for publication

Endoleaks IFU 2013 IFU 2016 p Endoleak 9 (5.4) 3 (2.1).583 1 year: o 2 type 1S2 (1 within IFU 2016) o 1 type 1S3 o 1 type 1b 1 year 2 years o 3 type 1S2 o 3 type 1S3 (2 within IFU 2016)

Endoleaks

Migration

Comparison IFU 2013 vs 2016 Freedom from: IFU 2013 IFU 2016 P-value Reintervention 89.7% 95.7%.342 Primary patency 94.0% 95.8%.846 Secondary patency 97.6% 100%.432 All endoleak 92.7% 90.1%.708 Type IA endoleak 93.3% 90.1%.577 Migration 89.9% 100%.150 Aneurysm growth 91.8% 89.3%.843 Mortality 90.9% 95.5%.472

Conclusions EVAS when used within the IFU has acceptable 2-year results (certainly not better compared to EVAR), but longer follow-up and a bigger sample size is clearly indicated, as the Kaplan-Meier curves are not flattening out. The refined IFU significantly reduced the applicability of the technique, but didn t improve results significantly. Proposed advantages of EVAS didn t come out with the current generation device.

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