The Performance of The Aorfix Endograft in Severely Angulated Proximal Necks in the

PYTHAGORAS U.S. Clinical Trial

Mahmoud Malas, MD, MHSDirector Of The Center For Surgical Trial and Outcome Research

Johns Hopkins HospitalChief Of Endovascular Surgery

Johns Hopkins Bayview Medical Center

SOUTHERN ASSOCIATION FOR VASCULAR SURGERY39th Annual Meeting

DisclosuresDisclosure

Speaker name: Mahmoud Malas

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

Principle Investigator:

1. PYTHAGORAS: AORFIX (Lombard Medical)2. PRICELESS: EndoSure (CardioMEMS)3. ENDOREFIX: Endorefix (Lombard Medical)4. Anchor: HeliFX (Aptus Endosystems)5. Relay: (Bolton Medical)

Acknowledgement For the Pythagoras Investigators

William D Jordan, MD, University of Alabama, Birmingham, AL

Michol A Cooper, MD, PhD, Johns Hopkins, Baltimore, MD

Umair Qazi, MD, Johns Hopkins, Baltimore, MD

Adam W Beck, MD3, University of Florida, Gainesville, FL

Michael Belkin, MD4, Brigham and Women’s Hospital, Boston, MA

William Robinson, MD UMass , Worcester. MA

Mark Fillinger, MD, Dartmouth-Hitchcock Medical Center, Lebanon, NH

Aorfix™ Device

Designed and tested to treat highly angulated aortic necks

Highly flexible, soft, conformable device

Polyester fabric, Nitinol rings

Aorfix™ Device4 pairs of hooks proximally

Can be deployed trans-renal

Dimensions of Aorfix™ Seal Zone

0mm

8mm

15mm

Radial force in the proximal 8mm is 4 times greater than in the next 7mm because stent rings are more closely spaced

U.S. Pythagoras Clinical Trial

EVAR Arms:

‘Roll-in’ Group: 67 EVAR pts (standard neck angle <60°)

Primary Study Group: 151 EVAR pts (neck angles >60°): 109 pts highly-angled (60°-90°)

42 pts severely angled >90°

U.S. Pythagoras Clinical Trial

Control Arms:

SVS Registry meta-analysis of control patients from US EVAR clinical trials (n=323)

Concurrently enrolled Open Surgical controls (n=76)

Demographics Age: EVAR 76 ± 7, vs. open 69 ± 7 years

(p<0.001)

Female: EVAR 29%, high angle 35%, open 20%(p<0.02)

Similar AAA sac diameter (5.8 cm in each group, p=ns)

Hostile Neck

20% rate of aneurysm expansion

30% rate of device migration

24% rate of type I endoleak

Fourfold increased risk of type I endoleak at 1 year (meta-analysis).

Lovegrove et al., 2008,; Aburahma et al., 2011; Sternberghet al., 2002; Torsello et al., 2011; Abbruzzese et al., 2008, Antoniou et al., 2013,

ObjectivesTo evaluate the performance of Aorfix in highly and severely angled aortic neck

Absence of proximal neck dilatation and graft migration

following endovascular aneurysm repair with balloon expandable

stent-based endograft.

J Vasc Surg October 2005; 42: 639-644

Recoil Force

Radial Force

Radial Force > Recoil Force PND

Over size approximately 20%

ObjectivesTo evaluate the performance of Aorfix in highly and severely angled aortic neck

To evaluate the long term morphological changes in aneurysm neck following EVAR

To evaluate the impact of neck diameter changes on graft related complications

AnatomyMean ± SD

Aorfix<60°N=67

Aorfix60 - 90°N=109

Aorfix>90°N=42

COSITT

N=76

Sac Diameter (mm) 54 ± 9.0▲ 59 ± 11.7 58 ± 12.6 58 ± 8.8

Sac Volume (cc) 168 ± 68.4▲ 215 ± 103.7 227 ± 119.9 201 ± 88.7

Neck Dia (mm)1mm Infrarenal 23± 3.4 22± 2.7▲ 22± 2.7▲ 25 ± 5.2

Neck Dia (mm)7mm Infrarenal 23 ± 3.1▲ 23 ± 3.2▲ 22 ± 3.0▲ 28 ± 6.8

Neck Dia (mm)15mm Infrarenal 25 ± 4.3▲ 24 ± 4.9▲ 25 ± 7.2▲ 33 ± 8.8

Proximal Neck Length (mm) 24 ± 15.4▲ 23 ± 11.5▲ 19 ± 14.9▲ 13 ± 12.7

Proximal Neck Angle (°) 45 ± 12.3 76 ± 8.1▲ 101 ± 11.9▲ 48 ± 23.3

Major Adverse Events and Mortality

Aorfix™<60°N=67

Aorfix™60-90°N=109

Aorfix™> 90°N=42

COS GroupN = 76

p-value: Aorfix vs COS control

Freedom fromSVS MAE (30 d) (%) 92.5 83.5 76.2 57.9

<60: 0.00160 - 90: 0.001

> 90: 0.04

Mortality (30 d) (%) 1.5 0.9 4.8 1.3<60: 0.9

60 - 90: 0.80> 90: 0.26

Mortality (1 yr) (%) 3.0 7.3 9.5 6.6<60: 0.32

60 - 90: 0.97> 90: 0.56

Mortality (2 yr) (%) 4.5 13.8 14.3 10.5<60: 0.32

60 - 90: 0.51> 90: 0.55

Effectiveness at 1 and 2 yearsAorfix< 60°

Aorfix60 - 90°

Aorfix> 90°

p-value: Aorfix 60° – 90°

and Aorfix > 90°

vs. Aorfix <60°

Sac shrinkage (>5 mm)

1 year (%) 39.2 43.0 42.9 60 – 90: 0.72> 90: 0.81

2 years (%) 55.1 54.7 48 60 – 90: 1.00> 90: 0.63

Sac expansion (>5 mm)

1 year (%) 0 1.2 3.6 60 – 90: 1.00> 90: 0.35

2 years (%) 4.1 5.3 8 60 – 90: 1.00> 90: 0.60

Type I/III leak

1 year (%) 0 1.3 3.7 60 – 90: 1.00> 90: 0.37

2 years (%) 0 1.2 3.7 60 – 90: 1.00> 90: 1.00

Migration (>10 mm)

1 year (%) 0 1.2 3.6 60 – 90: 1.00> 90:0.35

2 years (%) 2.0 1.2 3.6 60 – 90: 1.00> 90:1.00

Freedom from Migration at 5 Years

Neck Measurement Pre-Determined Points

SMA

1mm below SMA

5mm above proximal Renal

1mm below distal Renal7mm below distal Renal

15mm below distal Renal

Relative Risk of Complications subsequent to Aortic Diameter Increases

in first 5 years≥ 10% diameter

change at:

Barb FractureN=471

Migration>10mmN=543

Sac Shrinkage

N=511

Sac Expansio

nN=511

Type 1 & 3 Endoleak

sN=456

1mm below SMA

5mm Above P renal

RR 4.39 p 0.010

RR 2.64P 0.078

1mm below D Renal

RR 1.49p 0.081

RR 4.34 p 0.002

RR 2.17 p 0.060

7mm below D Renal

RR 0.21 p 0.166

RR1.17P 0.090

15mm below D Renal

[All annual observations over 5 years used: multiple data points for every patient drives significance. Empty cells had no statistical significance]

Oversizing

Oversize % = (1 – aortic diameter measured at a given time/stent graft diameter) x 100

Planned Oversizing vs Change in Oversizing at 3 years: 1mm below

Distal Renal

Planned Oversizing vs Change in Oversizing at 3 years: 15mm below

Distal Renal

Evaluation of changes in aortic diameter from the SMA to lower end of the

infrarenal neck

-5

0

5

10

15

20

25

Index 30 Day 1 Year 2 Years 3 Years 4 Years 5 Years

% O

vers

ize

Follow-Up Time Point

1mm below SMA 5mm above Proximal Renal1mm below Distal Renal 7mm below Distal Renal15mm below Distal Renal

ConclusionsPYTHAGORAS is the first clinical trial to include patients with >60° angled neck

Freedom from MAE was better in standard, highly and severely angled groups compared to open

Postoperative, one and two year survival rates were similar among all groups compared to open

There is constant morphological changes in aneurysm neck following EVAR

The infra-renal aorta dilates more rapidly than the suprarenal aorta

There is a trend over 5 years to match the endograft size

Conclusions

Conclusions

Proximal neck dilatation >10% (1mm below the distal renal) increase the risk of:

MigrationSac expansion (trend)

Distal neck dilatation >10% (> 7mm below the distal renal) did not significantly increase the risk of complications

Conclusions

Suprarenal aorta neck dilatation was associated with migration

There was an association between the degree of endograft oversizing and aortic neck dilation