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Transcript of malas savs 2015
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
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,
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
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
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]
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