Mark Fillinger MD for the PYTHAGORAS Investigators

Two-year Pythagoras US Pivotal Trial Results for the Aorfix device in

Highly Angulated Aortic Necks

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Disclosure

Speaker name: Mark Fillinger

.................................................................................

x I have the following potential conflicts of interest to report:

x Consulting (WL Gore, Endologix, Cook)

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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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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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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 groupD00979a

Interaction between neck angle, gender

0

5

10

15

20

25

30

>0 >10 >20 >30 >40 >50 >60 >70 >80 >90

Num

ber o

f Pat

ient

s

Neck Angle (Degrees)

Angle Distribution By Gender

M Count F Count

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Gender Distribution, EVAR Trials

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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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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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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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Freedom from SVS Major Adverse Events (MAEs): Aorfix EVAR Superior to Open Controls

* P<0.0001 for all Aorfix groups vs Open controls

**

* **

*

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EVAR-specific Results

%

Aorfix™All

N=218

Aorfix™60-110°

N=151

Aorfix™<60°

N=67

SVS control group

N=323Freedom 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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EVAR-specific Results – 2 years

%

Aorfix™All

N=218

Aorfix™60-110°

N=151

Aorfix™<60°

N=67

SVS control group

N=323Freedom 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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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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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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Freedom from Secondary Interventions: Intent to Treat Basis

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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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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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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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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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Pythagoras Investigators

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