The document summarizes the results of the Pythagoras clinical trial of the Aorfix endograft for the treatment of abdominal aortic aneurysms (AAAs) in highly angulated aortic necks between 60-90 degrees. The trial showed lower major adverse event rates for Aorfix endovascular aneurysm repair (EVAR) compared to open surgery, despite EVAR patients being older with more risk factors. EVAR outcomes were similar to prior trials with less angulated anatomy. Based on these positive results, Aorfix received FDA approval for the treatment of AAAs with neck angles up to 90 degrees.

1. Mark Fillinger MD for the PYTHAGORASInvestigators
Two-year Pythagoras US Pivotal
Trial Results for the Aorfix device in
Highly Angulated Aortic Necks
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2. Disclosure
Speaker name: Mark Fillinger
.................................................................................
x I have the following potential conflicts of interest to report:
x Consulting(WLGore, Endologix, Cook)
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3. Aorfix™ Device
 Designed and tested to treat
highly angulated aortic necks
 Highly flexible, soft,
conformable device
 Polyester fabric, Nitinol rings
 4 pairs of hooks proximally
 8 mm long primary seal zone
 Commonly placed in a trans-
renal position
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4. U.S. Pythagoras Clinical Trial: First EVAR
Trial in aortic neck angles 60-90 degrees
 EVAR Arms
 ‘Roll-in’ Group: 67 EVAR pts, neck angle <60°
 Primary Study Group: 151 EVAR pts, neck angles 60-90°
(and higher)
 The US trial enrolled 218 patients on intent-to-treat
 Control Arms
 SVS Registry meta-analysis of control patients from US
EVAR clinical trials (n=323)
 Concurrently enrolled Open Surgical controls (n=76) for
neck angulation and other variables not in SVS registry
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5. Demographics, Comorbidities, Anatomy
• EVAR and open control patients had similar AAA
sac diameter (5.8 cm in each group, p=ns), but the
high-angle group differed from open controls with
regard to factors previously shown to adversely
affect outcomes:
 Age (EVAR 76 ± 7, vs 69 ± 7 years, p<0.001),
 Female (EVAR 29%, high angle 35%, vs open 20%, p<0.02)
 Neck angle (EVAR all 71 ± 22, EVAR high angle 83 ± 15, vs Open 48
± 23 degrees, p<0.001); EVAR 69% > 60°, Open 27% > 60° (p<.05)
First trial with more female pts in the test group
First trial with more severe neck angles in the test group
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6. Interaction between neck angle, gender
0
5
10
15
20
25
30
>0 >10 >20 >30 >40 >50 >60 >70 >80 >90
NumberofPatients
Neck Angle (Degrees)
Angle Distribution By Gender
M Count F Count
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7. Gender Distribution, EVAR Trials
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8. Effect of Neck Angle on Seal Zone
Centerline:
15 mm long
“neck”
Inner Curve:
8 mm long
seal zone
In highly angulated aortic necks, the
central lumen line (centerline) is not a
good indicator of the actual seal zone.
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9. Mean Neck Lengths (± 1SD) in IDE Studies
0
5
10
15
20
25
30
35
40
45
50
Talent Endurant Ovation Aorfix All Aorfix <60 Aorfix ≥60
-1SD
+1SD
Mean
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10. Results: 30 day + Hospital
 Aortic endografts were successfully implanted in
210/218 cases on intent-to-treat (all 8 were
access-related, device not attempted in 4/8).
 Mortality was 1.8% for the entire cohort (4/218),
2.0% for the 60-110° angle group (3/153), and
2.8% for the open controls (9/323, p=ns)
 30-day outcomes favored the test group for
procedure duration, EBL, transfusion, and hospital
length of stay (all p<0.05).
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11. Freedom from SVS Major Adverse Events (MAEs):
Aorfix EVAR Superior to Open Controls
* P<0.0001for
all Aorfix groups
vs Open controls
*
*
* *
*
*
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12. EVAR-specific Results
%
Aorfix™
All
N=218
Aorfix™
60-110°
N=151
Aorfix™
<60°
N=67
SVS control
group
N=323
Freedom from
SVS-defined MAE (30 d)
85% 82% 93% 56%
Freedom from
SVS-defined MAE (1 yr)
80% 76% 88% 55%
Mortality (30 d) 1.8% 2.0% 1.5% 2.8%
Sac shrinkage(5mm 1 yr) 42% 44% 37% -
Sac expansion(5mm 1 yr) 1.2% 1.8% 0% -
Type I/III leak (1yr) 1.6% 2.0% 0% -
Migration (1yr) 1.4% 1.7% 0% -
Wire Fracture (1yr)
(pre-Nitinol change)
6.2% 6.1% 6.4% -
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13. EVAR-specific Results – 2 years
%
Aorfix™
All
N=218
Aorfix™
60-110°
N=151
Aorfix™
<60°
N=67
SVS control
group
N=323
Freedom from
SVS-defined MAE (2 yr)
73% 70% 79% 55% (1 yr)
Mortality (2 yr) 11% 14% 5% NA
Sac shrinkage(5mm 2yr) 54% 54% 55% -
Sac expansion(5mm 2yr) 5% 5% 4% -
Type I/III leak (2 yr) 0% 0% 0% -
Migration (2 yr) 3% 4% 2% -
Wire Fracture (2 yr)
(pre-Nitinol change)
14% 16% 10% -
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14. Freedom from All-cause Mortality:
Intent to Treat Basis
Test subjects older: EVAR 76 ±8, vs 69 ±7 years, p=0.001
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15. Freedom from Aneurysm-Related
Mortality: Intent to Treat Basis
Test subjects older: EVAR 76 ±8, vs 69 ±7 years, p=0.001
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16. Freedom from Secondary Interventions:
Intent to Treat Basis
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17. DHMC Case #2: Device straightens, short
available seal zone remains sealed
Pre-implant 1 Month post-implant 1 Year post-implant
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18. Norfolk case: Adapts at neck and iliac limbs
6 month Post Op
Images Courtesy of Dr Marc Glickman and Dr Jean Panneton, Sentara Heart Hospital, Norfolk, VA
Limbs in sac
adapt to
dramatic AAA
sac shrinkage
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19. Limitations and Tips
 Read the IFU, learn the device deployment,
start with normal anatomy
 Access: make sure its adequate, do open
conduits if you aren’t good at endoconduits
 Put the device at the renal arteries: that is
where the neck is stable
 Watch the renals in angulated necks: use
proper c-arm gantry angles based on CTA
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20. Summary
 The Pythagoras Clinical Trial of the Aorfix endograft is the
first EVAR Pivotal trial focusing on highly-angulated aortic
necks (60-90 degrees).
 Despite predictors of worse short and long-term
outcomes, MAEs are superior to open repair, and EVAR-
specific outcomes are similar to trials with much less
severe anatomy.
 Based on Pythagoras results, Aorfix was FDA-approved
for 0-90°neck angles, and remains the only on-label
alternative to open repair for patients with highly
angulated aortic necks.
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21. Pythagoras Investigators
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