Matt Thompson St Georges Vascular Institute, London, UK EVAS FORWARD Global Registry Early Results in 300 Patients Treated with Nellix
Matt Thompson St Georges Vascular Institute, London, UK
EVAS FORWARD Global Registry Early Results in 300 Patients Treated with Nellix
Disclosures
Endologix – Research funding / Consultancy
PI – Global Registry
Endovascular Aortic Repair (EVAR) Challenges 1-4
! Hostile Morphology – Endoleaks
– Migration
! Reinterventions / Late Rupture
! Ongoing Costs of Surveillance – Financial Costs
– Psychological Stress
– Radiation / Contrast
1Schanzer A, et al. Circulation 2011;123:2848-55. 2Becquemin J-P, et al. J Vasc Surg 2011;53:1167-73. 3Lederle FA, et al. N Engl J Med 2012;367:1988-97. 4Karthikesalingam A, et al. Eur J Vasc Endovasc Surg 2013;46:440-45.
Endovascular Aneurysm Sealing (EVAS)
Nellix (EVAS) – a unique therapy ! New generation endovascular AAA therapy ! Designed to seal the entire aneurysm and overcome limitations with
conventional endografts ! Very limited evidence base
Study Design and Status
• 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 still in review
! 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
N=41 Neck Length 5 -10mm Infrarenal Angle 61 - 90°
Cohort Descriptions
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
EVAS Forward Global Registry Includes Many More Complex AAAs than Other Studies
0%
5%
10%
15%
20%
Neck Length <10mm
Neck Angle >60°
Chimney Procedure
Rupture or EVAR Repair
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
8
Baseline Aneurysm and Vascular Characteristics
Parameter 1
Neck Length ≥ 10mm Infrarenal Angle ≤ 60°
2 Neck Length 5 -10mm Infrarenal Angle 61° - 90°
3 Neck Length < 5mm Infrarenal Angle > 90° Juxtarenal - Pararenal
Maximum Sac Diameter, mm 60 (55-65) 60 (56-66) 63 (58-71)
Neck Length, mm 27 (19-39) 10 (7-18) 5 (3-15)
Neck Diameter, mm 25 (23-28) 25 (22-27) 27 (22-29)
Neck Angulation° 29 (13-42) 44 (26-66) 34 (24-54)
Results are given as a median (25th, 75th %itle)
Procedural Characteristics
>60, ≤90 min
35%
>120 min
25%
96 95
120
60
80
100
120
140
160
Procedure Time (min)
11 12
18
5
10
15
20
25
30
35
Fluoroscopy Time (min)
Cohort 1 Cohort 2 Cohort 3 Cohort 1 Cohort 2 Cohort 3
p = NS p = 0.001
MAEs ≤30 days N=298
>30 days N=284
Patients with one or more MAE 3.0% 0.7%
All Cause Death 1.0% 1.1% Renal Failure 0.3% 0% Myocardial Infarction 0.7% 0.5% Bowel Ischemia 0% 0% Respiratory Failure 0.7% 0% Stroke 0.3% 0% Blood loss >1000 mL 1.4% 0.4%
Major Adverse Events
Mean follow-up 6 months
Endoleaks ≤30 days
Total N=289
Cohort 1 N=190
Neck Length ≥ 10mm Infrarenal Angle ≤ 60°
Cohort 2 N=41
Neck Length 5 -10mm Infrarenal Angle 61° - 90°
Cohort 3 N=31
Neck Length < 5mm Infrarenal Angle > 90° Juxtarenal - Pararenal
All Patients 6 (2.1%) 6 (3.2%) 0 0
Type IA 5 (1.7%) 5(2.6%) 0 0
Type IB 0 0 0 0 Type II 1
(0.3%) 1 (0.5%) 0 0
Type III 0 0 0 0 Type IV 0 0 0 0
• Five (5) Type IA endoleaks attributed to malpositioning and/or under-filling • Majority of Type 1A occurred during early learning curve • One (1) Type II endoleaks show <0.2mL blood flow into aneurysm with no
clinical sequelae
26 (9%) CTs still in review
Endoleaks at 30 days
Total N=289
Cohort 1 N=190
Neck Length ≥ 10mm Infrarenal Angle ≤ 60°
Cohort 2 N=41
Neck Length 5 -10mm Infrarenal Angle 61° - 90°
Cohort 3 N=31
Neck Length < 5mm Infrarenal Angle > 90° Juxtarenal - Pararenal
All Patients 2 (0.7%) 2 (1.1%) 0 0
Type IA 1 (0.3%) 1 (0.5%) 0 0
Type IB 0 0 0 0 Type II 1
(0.3%) 1 (0.5%) 0 0
Type III 0 0 0 0 Type IV 0 0 0 0
• One (1) Type II endoleak shows <0.2mL blood flow into aneurysm with no clinical sequelae
26 (9%) CTs still in review
Reinterventions and Conversions ≤30 days
Cause of reinterventions
Total N=289
Cohort 1 N=190
Neck Length ≥ 10mm Infrarenal Angle ≤ 60°
Cohort 2 N=41
Neck Length 5 -10mm Infrarenal Angle 61° - 90°
Cohort 3 N=31
Neck Length < 5mm Infrarenal Angle > 90° Juxtarenal - Pararenal
Endoleaks 3 (1.0%) 3 (1.6%) 0 0 Occlusions 3 (1.0%) 2 (1.1%) 1 (2.4%) 0 Conversion 1 (0.3%) 0 0 1 (3.2%) Other 4 (1.4%) 1 (0.5%) 3 (7.3%) 0
• 3 Type 1a EL and 3 occlusions successfully treated • One intra-operative conversion • “Others” include two renal stenting and one iliac extension
Reinterventions and Conversions > 30d
Cause of reinterventions
Total N=285
Cohort 1 N=188
Neck Length ≥ 10mm Infrarenal Angle ≤ 60°
Cohort 2 N=40
Neck Length 5 -10mm Infrarenal Angle 61° - 90°
Cohort 3 N=31
Neck Length < 5mm Infrarenal Angle > 90° Juxtarenal - Pararenal
Endoleaks 1 (0.4%) 1 (0.5%) 0 0 Occlusions 0 0 0 0 Conversion 1 (0.4%) 1 (0.5%) 0 0 Other 1 (0.4%) 1 (0.5%) 0 0
• One Type IA endoleak at day 81 successfully treated • One late conversion at day 120 • One Ilio-fem bypass at day 32
Mean follow-up 6 months
Total N=285
Cohort 1 N=188
Neck Length ≥ 10mm Infrarenal Angle ≤ 60°
Cohort 2 N=40
Neck Length 5 -10mm Infrarenal Angle 61° - 90°
Cohort 3 N=30
Neck Length < 5mm Infrarenal Angle > 90° Juxtarenal - Pararenal
All Patients 3 (1.1%) 3 (1.6%) 0 0
Type IA 2 (0.7%) 2 (1.1%) 0 0 Type IB 0 0 0 0 Type II 1 (0.4%) 1 (0.5%) 0 0 Type III 0 0 0 0 Type IV 0 0 0 0
Total Endoleaks >30d
26 (9%) CTs still in review
• Type IA endoleaks related to catheter malpositioning and/or under filling
Mean follow-up 6 months
Overall Endoleak Rates at 6 Months
17
• EVAS Forward Global Registry: Mean follow-up 6 months • 1-year results shown for Aorfix and Incraft (6 month data not reported)
0,0%
5,0%
10,0%
15,0%
20,0%
25,0%
30,0%
35,0%
40,0%
45,0%
Nellix Registry
AFX Zenith IDE Endurant IDE Talent IDE Aorfix IDE Excluder
IDE Incraft CE Study Ovation
IDE Type IA, IB Type II Type III/IV Undetermined
1% 5%
9% 12% 14% 17% 20%
40% 42%
Conclusions
! Very encouraging results in the 1st EVAS real-world, all-comers prospective registry – Early experience underscores importance of training
and best procedural practices ! Low rates of endoleak and reintervention
despite treating a broad range of challenging anatomies across multiple cohorts
Matt Thompson St Georges Vascular Institute, London, UK
EVAS FORWARD Global Registry Early Results in 300 Patients Treated with Nellix