The Auckland Experience with the Nellix EVAS System. Holden.pdf · Experience with Nellix EVAS at...
Transcript of The Auckland Experience with the Nellix EVAS System. Holden.pdf · Experience with Nellix EVAS at...
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The Auckland Experience with the Nellix EVAS System
Andrew Holden, MBChB, FRANZCR
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Disclosure
Speaker name:
Associate Professor Andrew Holden
I have the following potential conflicts of interest to report:
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
X
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Nellix EndoVascular Aneurysm Sealing System
(EVAS) New generation endovascular AAA therapy
Designed to seal the entire aneurysm and overcome limitations
with conventional endografts
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Nellix Evolution: Toward a Commercial Product
2008 2009 2010 2011 2012 2013 CE
Gen 2 Gen 3 Gen 1
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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
mm
n=35 n=35 n=21 n=13 n=4
0
10
20
30
40
50
60
70
Pre-Op 1 mo 6 mo 12 mo 2 yrs
Sac diameters remain stable in all patients to current follow-up
Nellix Pilot Study: Early Outcomes
Eur J Vasc Endovasc Surg 2011;42:38-46
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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)
Nellix Early Commercial Experience:
Developing the EVAS Procedure
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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
Nellix Early Commercial Experience: Results
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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
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9
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Durability
1 month
3 years
5 years
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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
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EVAS for Conical Neck Anatomy
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LAO 15o, Cran 15o LAO 15o, Cran 15o
EVAS for Short Neck Anatomy
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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
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EVAS for Concomitant CIAAs
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EVAS for Short CIAs
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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
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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)
Advanced Applications for Nellix EVAS
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Chimney EVAS (Ch-EVAS)
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Nellix EVAS in Failed Surgical AAA Repair
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• Enrollment completed September, 2014
(enrollment period 10 months)
• Mean follow-up 165 days; range 0 to 1 year
Total Patients
(n=300)
Cohort 1
(n=190)
Cohort 2
(n=41)
Cohort 3
(n=31)
Cohort 4
(n=12)
26 (9%) CTs to be classified by core lab
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
EVAS FORWARD Global Registry
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N=41 Neck Length 5 -10mm
Infrarenal Angle 61 - 90°
Real World Observations
N=190 Neck Length ≥ 10mm
Infrarenal Angle ≤ 60°
N=31 Neck Length < 5mm Infrarenal Angle > 90° Juxtarenal / Pararenal
N=12 Ruptured AAA EVAR revisions
Cohort 1
69%
Cohort 2
15%
Cohort 3
11%
Cohort 4
5%
26 (9%) CTs still in review
16 Chimney
Procedures
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Real World Registry Anatomical Classifications
0%
5%
10%
15%
20%
Neck Length<10mm
Neck Angle >60° ChimneyProcedure
Rupture or EVARRepair
17,0%
9,0%
5,7%
3,5%
2,2%
6,0%
0,1% 0,0% 1,5%
0,0% 0,5%
2,5%
EVAS Global Registry
ENGAGE Registry
GREAT Registry
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Study Comparison: Endoleak / Limb Occlusion
≤30d >30d
REVIEW (n=130)
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 0 0 0 0
Type IV 0 0 0 0
Occlusion 3 (2%) 3 (1%) 1 (1%) 0
Stenosis 0 0 0 0
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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
Longer Term Follow Up:
Single Centre Experience at Auckland Hospital
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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
Longer Term Follow Up:
Single Centre Experience at Auckland Hospital
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2014 2015 2016 2017
Initiate
IDE
N=180
PMA
Submission
US
Commercial
Launch
2013
Initiate
Global
Registry
N=300
2 YR FU
N=300 1 YR FU
N=300
3 YR FU
N=300 Enrollment
Completion
Nellix
Pilot
Study
Gen 2,3
N=35
CE Mark Jan 2013
Retro Review:
Early Commercial
Experience
7 Ctrs
n=171
Enrollment
Completion
Long-term follow-up
Nellix Evolution: Toward Evidence-Based Results
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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
Conclusions
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The Auckland Experience with the Nellix EVAS System
Andrew Holden, MBChB, FRANZCR