29
6.6 Aneurysm Change
Tables 6.6.1 - 6.6.3 present the change in aneurysm diameter for the endovascular patients, as identified by the Core Lab. Table 6.6.1 presents maximum
aneurysm diameter change by interval. Tables 6.6.2 and 6.6.3 present aneurysm change and endoleak at 12 and 24 months, respectively.
Table 6.6.1 Change in Maximum Aneurysm Diameter by Interval*
Item
Zenith Standard Risk
Zenith High Risk
Zenith Roll-in
From pre-discharge 30-day
1.7%
(3/180)
4.8%
(4/84)
0.0%
(0/40)
Decrease >5 mm
Unchanged
97%
(174/180)
94%
(79/84)
97.5%
(39/40)
Increase >5 mm
1.7%
(3/180)
1.2%
(1/84)
2.5%
(1/40)
Change from pre-discharge 6-month
36%
(63/173)
41%
(30/73)
49%
(18/37)
Decrease >5 mm
Unchanged
62%
(108/173)
59%
(43/73)
51%
(19/37)
Increase >5 mm
1.2%
(2/173)
0.0%
(0/73)
0.0%
(0/37)
Change from pre-discharge 12-month
68%
(102/151)
63%
(39/62)
67%
(20/30)
Decrease >5 mm
Unchanged
31%
(47/151)
35%
(22/62)
33%
(10/30)
Increase >5 mm
1.3%
(2/151)
1.6%
(1/62)
0.0%
(0/30)
Change from pre-discharge 24-month
78%
(74/94)
75%
(27/36)
71%
(17/24)
Decrease >5 mm
Unchanged
19%
(18/94)
25%
(9/36)
25%
(6/24)
Increase >5 mm
2.1%
(2/94)
0.0%
(0/36)
4.2%
(1/24)
*Only includes subjects with interpretable films and measurements of aneurysm change from 1 to 24 months.
Table 6.6.2 Change in Aneurysm Size and Endoleak at 12 Months
Zenith Standard Risk
N=140
Zenith High Risk
N=53
Zenith Roll-in
N=27
Endoleak
Endoleak
Endoleak
Item
N
n
%
N
n
%
N
n
%
Aneurysm size change from pre-discharge
to 12 months
Decrease >5 mm
96
3
3.0
35
3
9.0
20
0
0.0
Unchanged
42
8
19
17
2
12
7
1
14
Increase >5 mm
2
0
0.0
1
0
0.0
0
0
0.0
Table 6.6.3 Change in Aneurysm Size and Endoleak at 24 Months
Zenith Standard Risk
N=90
Zenith High Risk
N=31
Zenith Roll-in
N=21
Endoleak
Endoleak
Endoleak
Item
N
n
%
N
n
%
N
n
%
Aneurysm size change from pre-discharge
to 24 months
Decrease >5 mm
71
3
4.0
24
1
4.0
16
0
0.0
Unchanged
18
1
6.0
7
3
43
5
0
0.0
Increase >5 mm
1
1
100
0
0
0.0
0
0
0.0
6.7 AAA-Related Secondary Interventions
AAA-related secondary interventions within the first year were performed in 11% of the Zenith standard risk, 13% Zenith high risk and 5.8% Zenith roll-in
subjects as shown in Table 6.7.1. Greater than 50% of the secondary interventions involved catheterization to treat an endoleak. AAA-related secondary
interventions within the second year were performed in 4.2% of the Zenith standard risk, 2.2% Zenith high risk and 2.3% Zenith roll-in subjects as shown in
Table 6.7.2.
Table 6.7.1 Secondary Interventions (to 12 Months)
Zenith Standard Risk
N=199
Zenith High Risk
N=100
Zenith Roll-in
N=52
Intervention
n
%
n
%
n
%
Conversion to open repair
2
1.0
1
1.0
0
0.0
Subjects with ≥1 intervention
21
11
13
13
3
5.8
Treat an endoleak
5
2.5
3
3.0
1
2.0
Embolization
Ancillary component
6
3.0
4
4.0
1
2.0
Stent
1
0.5
0
0.0
0
0.0
Angioplasty
0
0.0
1
1.0
0
0.0
Treat an aneurysm increase
0
0.0
0
0.0
0
0.0
Embolization
Treat a limb occlusion
1
0.5
3
3.0
1
2.0
Treat a limb stenosis
1
0.5
0
0.0
0
0.0
Treat a renal artery
5
2.5
0
0.0
0
0.0
Treat infra-inguinal ischemia
1
0.5
1
1.0
0
0.0
Treat multiple events
1
0.5
1
1.0
0
0.0
Table 6.7.2 Secondary Interventions (>12 to 24 Months)
Zenith Standard Risk
N=190
Zenith High Risk
N=90
Zenith Roll-in
N=44
Intervention
n
%
n
%
n
%
Conversion to open repair
1
0.5
1
1.1
0
0.0
Subjects with ≥1 intervention
8
4.2
2
2.2
1
2.3
Treat an endoleak
3
1
1.6
0
0.0
1
2
2.3
Embolization
Ancillary component
1
0.5
0
0.0
0
0.0
Stent
0
0.0
1
1.1
0
0.0
Angioplasty
0
0.0
0
0.0
0
0.0
Treat an aneurysm increase
1
0.5
0
0.0
1
2
2.3
Embolization
Treat a limb occlusion
1
0.5
0
0.0
0
0.0
Treat a limb stenosis
0
0.0
0
0.0
0
0.0
Treat a renal artery
0
0.0
1
1.1
0
0.0
Treat infra-inguinal ischemia
1
0.5
0
0.0
0
0.0
Treat multiple events
1
0.5
0
0.0
0
0.0
1
Patient also received ancillary component.
2
Patient underwent intervention to treat aneurysm increase and endoleak.
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