The Auckland Experience with the Nellix EVAS System. Andrew Holden, MBChB, FRANZCR
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1 The Auckland Experience with the Nellix EVAS System Andrew Holden, MBChB, FRANZCR
2 Disclosure Speaker name: Associate Professor Andrew Holden I have the following potential conflicts of interest to report: X Consulting Clinical Investigator for Endologix 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 Nellix EndoVascular Aneurysm Sealing System (EVAS) New generation endovascular AAA therapy Designed to seal the entire aneurysm and overcome limitations with conventional endografts
4 Nellix Evolution: Toward a Commercial Product CE Gen 1 Gen 2 Gen 3
5 Nellix Pilot Study: Early Outcomes N = 35 patients Dec 2010 and Dec 2012 NZ and Latvia Core Lab observations No deaths or surgical conversions No stent fracture, endobag fatigue, or device migration No type I, III, or IV endoleak Two small, clinically insignificant Type II EL (<1mL volume) No changes in aneurysm sac diameters to current follow-up Sac diameters remain stable in all patients to current follow-up mm Pre-Op 1 mo 6 mo 12 mo 2 yrs n=35 n=35 n=21 n=13 n=4 Eur J Vasc Endovasc Surg 2011;42:38-46
6 Nellix Early Commercial Experience: Developing the EVAS Procedure Report of first commercial patients treated with Nellix Purpose: To document early initial commercial outcomes and key learnings 171 patients, 7 centers, over a 17 month period Mean follow-up 5 months (range 0-14) Centers: Auckland City Hospital (NZL) University of Heidelberg (DE) St. George s Hospital London (UK) Addenbrooke s Hospital Cambridge Univ. (UK) Arnhem Hospital (NL) St. Antonius Hospital (NL) University Hospital Riga (LAT)
7 Nellix Early Commercial Experience: Results 99% technical success Type Ia EL = 5 Type Ib EL = 4 Type II EL = 4 Limb occlusion = 4 95% freedom from aneurysm-related intervention No aneurysm rupture No conversions Key Learnings Ensure proper device positioning Ensure adequate filling Optimize flow lumen Blow Back completion angiogram to confirm adequate deployment
8 Advantages of Nellix EVAS or Standard EVAR Procedural Simplicity Essentially kissing stent procedure Predictable procedure time Extended Applications for the Proximal Neck Extended Applications for the Iliac Arteries Advanced Applications
9 9
10 Durability 1 month 3 years 5 years
11 Advantages of Nellix EVAS or Standard EVAR Procedural Simplicity Essentially kissing stent procedure Predictable procedure time Extended Applications for the Proximal Neck Extended Applications for the Iliac Arteries Advanced Applications
12 EVAS for Conical Neck Anatomy
13 EVAS for Short Neck Anatomy LAO 15 o, Cran 15 o LAO 15 o, Cran 15 o
14 Advantages of Nellix EVAS or Standard EVAR Procedural Simplicity Essentially kissing stent procedure Predictable procedure time Extended Applications for the Proximal Neck Extended Applications for the Iliac Arteries Advanced Applications
15 EVAS for Concomitant CIAAs
16 EVAS for Short CIAs
17 Advantages of Nellix EVAS or Standard EVAR Procedural Simplicity Essentially kissing stent procedure Predictable procedure time Extended Applications for the Proximal Neck Extended Applications for the Iliac Arteries Advanced Applications
18 Advanced Applications for Nellix EVAS Chimney EVAS Ruptured AAA repair Isolated iliac aneurysm repair Repair of supra-anastomotic AAAs Repair of failed EVAR devices (eg type 1A, type 3 endoleaks)
19 Chimney EVAS (Ch-EVAS)
20 Nellix EVAS in Failed Surgical AAA Repair
21 EVAS FORWARD Global Registry Principal Investigators Andrew Holden, MBChB, Auckland, NZ Matt Thompson, MD, London, UK 300 patients, 30 centers with five year follow-up Real-world experience; no prospective screening of patients CT scan core lab analysis (Cleveland Clinic Core Lab) Independent adverse events adjudication Primary outcomes typical of therapy Total Patients (n=300) Cohort 1 (n=190) Cohort 2 (n=41) Cohort 3 (n=31) Enrollment completed September, 2014 (enrollment period 10 months) Mean follow-up 165 days; range 0 to 1 year Cohort 4 (n=12) 26 (9%) CTs to be classified by core lab
22 Real World Observations Cohort 1 69% Cohort 2 15% Cohort 3 11% Cohort 4 5% N=190 Neck Length 10mm Infrarenal Angle 60 N=41 Neck Length 5-10mm Infrarenal Angle N=31 Neck Length < 5mm Infrarenal Angle > 90 Juxtarenal / Pararenal N=12 Ruptured AAA EVAR revisions 16 Chimney Procedures 26 (9%) CTs still in review
23 Real World Registry Anatomical Classifications 20% 17,0% EVAS Global Registry 15% ENGAGE Registry GREAT Registry 10% 9,0% 6,0% 5,7% 5% 0% 2,2% 1,5% Neck Length <10mm 0,0% Neck Angle >60 Chimney Procedure 3,5% 0,5% 0,1% 0,0% 2,5% Rupture or EVAR Repair
24 Study Comparison: Endoleak / Limb Occlusion REVIEW (n=130) 30d >30d GLOBAL (n=288) REVIEW (n=99) GLOBAL (n=284) Type IA 3 (2%) 5 (2%) 2 (2%) 1 (0.4%) Type IB 3 (2%) 0 1 (1%) 0 Type II 3 (2%) 1 (0.3%) 1 (1%) 1 (0.4%) Type III Type IV Occlusion 3 (2%) 3 (1%) 1 (1%) 0 Stenosis
25 Longer Term Follow Up: Single Centre Experience at Auckland Hospital Experience from December 2008 to November 2014 Mean follow up 46 months Median follow up 14 months 120 cases: 104 elective AAA repair 4 symptomatic, non-ruptured aneurysms 2 RAAAs 5 Ch-EVAS 2 AUI EVAS 3 isolated CIAAS
26 Longer Term Follow Up: Single Centre Experience at Auckland Hospital Technical success in 119 patients (99.2%) 4 cases with early device prototype without eptfe covering on the stent required covered stent re-lining of the stent lumens 2 type 1A endoleaks successfully treated with catheter directed embolization 1 surgical repair of a CFA occlusion due to a vascular closure device complication 1 type 2 endoleak (0.8%) Overall re-intervention rate 6.7% but only 4% in the last 100 cases with the commercial device
27 Nellix Evolution: Toward Evidence-Based Results Nellix Pilot Study Gen 2,3 N=35 CE Mark Jan 2013 Long-term follow-up Retro Review: Early Commercial Experience 7 Ctrs n=171 Initiate Global Registry N=300 Enrollment Completion 1 YR FU N=300 2 YR FU N=300 3 YR FU N=300 Initiate IDE N=180 Enrollment Completion PMA Submission US Commercial Launch
28 Conclusions Experience with Nellix EVAS at Auckland Hospital extends from early first in man, through the post-approval registries to new product developments Without doubt, the most innovative and potentially disruptive new device platform platform I have been involved in Long awaited clinical data is becoming available Future looks exciting
29 The Auckland Experience with the Nellix EVAS System Andrew Holden, MBChB, FRANZCR
EndoVascular Aneurysm Sealing (EVAS) with Nellix
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