Gender and the Impact on
Pythagoras PMA Study Outcomes
William D. Jordan Jr, MD
University of Alabama at Birmingham
Female AAA Patients are
Complicated!
(Abedi, 2009)
Mortality and morbidity were higher in women than men undergoing EVAR
(Egorova, 2011)
EVAR benefit for women was sustained longer than for men
(Sweet, 2011)
Women are significantly less likely to meet device IFU criterion for EVAR....
(Mehta, 2012)
Mortality for females undergoing elective EVAR is significantly greater than for
males... and type 1 endoleaks are more frequent
(Lo, 2013)
Females have less favorable vascular anatomy.
(Hultgren, 2013)
Aortic neck pathology is the dominating cause of EVAR exclusion in both genders
Distribution of Neck Angles with
Gender in Pythagoras
35
N=218 (ITT Population)
30
Number of Patients
25
20
Female
Male
15
10
5
0
>0°
>10°
>20°
>30°
>40°
>50°
Neck Angle
>60°
>70°
>80°
>90°
Division of Gender Cohorts
between Angle Groups
N=218 (ITT Population)
100.0%
90.0%
N=67
N=109
N=42
Percent of Gender in Angle Group
80.0%
70.0%
60.0%
50.0%
Male
Female
40.0%
52%
30.0%
20.0%
28%
10.0%
15%
0.0%
<60°
60° to 90°
>90°
P<0.01
P=1.0
P<0.01
(Deviation from ratio of females to males in overall study population)
Gender Differences, Medical
History
Male
(N=153)
Female
(N=57)
Coronary Artery Disease
51.0%
34.5%
History of Stroke or TIA
9.9%
22.8%
Diabetes
15.8%
22.8%
Allergies
19.6%
52.6%
In all cases difference between genders within group, p<0.05
Overall Distribution of Sac
Diameters with Gender and Angle
62
N=67
N=109
N=42
P (Ttest, <60° to
≥60° >0.5 Female,
<0.001 Male)
Sac Diameter (mm)
60
58
Female
56
Male
54
52
50
<60°
60° to 90°
>90°
• Males with Severely Angled Necks had larger pre-op sac
diameters. Females did not.
Differences in Age Profile
Age Distribution by Angle Group: Female
Age Distribution by Angle Group: Male
50.0%
70.0%
45.0%
60.0%
40.0%
50.0%
35.0%
30.0%
40.0%
30.0%
20.0%
<60°
25.0%
<60°
60° to 90°
20.0%
60° to 90°
>90°
15.0%
>90°
10.0%
10.0%
5.0%
0.0%
0.0%
<= 55
56 to
65
66 to
75
76 to
85
> 85
<= 55
56 to
65
N
<60°
60°-90°
>90°
Female
10
31
22
Male
57
78
20
66 to
75
76 to
85
> 85
Summary of Gender Differences in
presenting neck angles
€
Males with Severely Angled Necks had:
y Same distribution of ages as males with minor neck angles
y Larger Sac diameters
€
Females with Severely Angled Necks had:
y Older ages than females with minor neck angles
y Same sac diameters
€
Supports hypothesis that degenerative disease is a more
significant factor in developing neck angulation in women
than in men
High Angle Aortic Neck
75yr female, ex smoker, ambulatory Hx MI, CAD, CHF (NYHA 3) HTN
arrythmia, thyroid cancer.
Neck Angle 102°. Neck diameter 21mm to 24mm. Max Sac Diameter
63.8mm. Minimum Access Diameter 6.5mm(L) and 5.5mm(R).
No endoleaks after initial Type II. 7mm sac shrinkage to Oct 2010.
Died 11 Jan 2011. Cause of Death: Congestive Heart Failure
Access Vessel Diameters
45.0%
% of Gender in Study
40.0%
35.0%
Female N=63
Male N = 155
30.0%
25.0%
Female
20.0%
Male
15.0%
10.0%
5.0%
0.0%
3
4
5
6
7
8
Diameter (mm)
9
10
11
Female AAA Anatomy:
102° Angled Neck,
5mm Ext Iliac Origin
Loss (cc)
Procedural Details
N
<60°
60°-90°
>90°
Female
10
31
22
Male
57
78
20
Blood Loss
500
400
Time (min)
200
Volume (cc)
300
150
Procedure Duration
190
170
Contrast Volume
170
Time (min)
120
50
Fluoro Time
40
30
20
M
F
Aorfix < 60°
M
F
Aorfix 60° to 90°
M
F
Aorfix > 90°
Device Access
N=218 (ITT Population)
Male
N= 155
Female
N=63
Access Failure
2/155
6/63▲
Access-Related
Adjunctive
Procedures
3/155
5/63▲
Access-Related
Secondary
Procedures
0
4/57▲
▲P<0.05
MAEs
N=218 (ITT Population)
MAE through 30d
Male
(N=155)
Female
(N=63)
Any Major Adverse Event
21.9%
30.2%
Mortality
1.3%
3.2%
(Not Significant)
Effectiveness at 1 Year
N=210 As-Treated Population
Male
(153)
Female
(57)
All Aorfix™ Subjects
Meeting Primary
Effectiveness Endpoint
94.2%
81.1%▲
Freedom from Type 1
Endoleak
100%
98.2%
Freedom from Type 3
Endoleak
99.3%
100%
Freedom from Migration
100%
96.5%
▲P<0.05
Effectiveness: Freedom from Type I or III endoleak, Migration or Fracture
Conclusions
€
Female AAA EVAR patients present multiple
anatomic challenges
€
Pythagoras Trial: female patients had more access
problems (similar to other studies)
€
Aorfix addresses many of the problems of hostile
neck anatomy
€
If IFU is followed, including careful use of adjunctive
access techniques, Aorfix addresses the long term
anatomical challenges of AAA in female patients