|
Observed Events (%†) |
3-Year Adjusted CIF Estimates (95% CI) |
Observed
Events (%†) |
3-Year Adjusted CIF Estimates
(95% CI) |
Relative Risk Reduction (95% CI) |
P-Value |
Chronic Complications |
|
|
|
|
|
|
Overall complications |
310 (5.0%) |
4.9% (4.6% - 5.2%) |
699 (6.8%) |
7.1% (6.7% - 7.6%) |
32% (22% - 41%) |
<.0001 |
Embolism and Thrombosis |
<11 (<0.2%)* |
* |
28 (0.3%) |
0.3% (0.3% - 0.3%) |
56% (6% - 79%) |
0.03 |
Thrombosis due to cardiac device |
<11 (<0.2%)* |
* |
24 (0.2%) |
0.2% (0.2% - 0.3%) |
57% (-2% - 82%) |
0.06 |
Embolism due to cardiac device |
<11 (<0.2%)* |
* |
<11 (<0.1%)* |
* |
16% (-397% - 86%) |
0.85 |
Device-related complications†† |
172 (2.8%) |
2.6% (2.5% -
2.7%) |
538 (5.3%) |
5.2% (5.1% - 5.3%) |
51% (41% - 59%) |
<.0001 |
Breakdown |
91 (1.5%) |
1.5% (1.4% - 1.8%) |
218 (2.1%) |
2.4%
(2.1% - 2.7%) |
34% (14% - 50%) |
0.002 |
Dislodgement |
24 (0.4%) |
0.4% (0.3% - 0.5%) |
128 (1.3%) |
1.3%
(1.2% - 1.6%) |
71% (53% - 82%) |
<.0001 |
Other mechanical failure |
64 (1.0%) |
1.0% (0.9% - 1.2%) |
117
(1.2%) |
1.4% (1.2% - 1.6%) |
26% (-3% - 47%) |
0.08 |
Infection |
<11 (<0.2%)* |
* |
66 (0.7%) |
0.7%
(0.6% - 0.9%) |
96% (82% - 99%) |
<.0001 |
Pain due to device |
0 (0.0%) |
* |
<11 (<0.1%)* |
* |
* |
NE |
Stenosis due to device |
29 (0.5%) |
0.5% (0.4% - 0.6%) |
37 (0.4%) |
0.4% (0.3% - 0.5%) |
-28% (-113% - 23%) |
0.34 |
Pocket complications |
N/A |
N/A |
146 (1.4%) |
1.5% (1.3% - 1.7%) |
NE |
NE |
Other complications |
145 (2.3%) |
2.1% (2.0% - 2.2%) |
156
(1.5%) |
1.5% (1.4% - 1.6%) |
-39% (-76% - -9%) |
0.01 |
Pericarditis |
104 (1.7%) |
1.7% (1.4% - 1.9%) |
84 (0.8%) |
0.9%
(0.8% - 1.0%) |
-93% (-161% - -42%) |
<.0001 |
Hemothorax |
45 (0.7%) |
0.7% (0.6% - 0.8%) |
81 (0.8%) |
0.9%
(0.7% - 1.0%) |
22% (-18% - 48%) |
0.24 |
Reinterventions |
|
|
|
|
|
|
Any reintervention |
199 (3.2%) |
3.6% (3.2% - 3.9%) |
548
(5.4%) |
6.0% (5.5% - 6.5%) |
41% (22% - 56%) |
0.0002 |
System reinterventions |
|
|
|
|
|
|
Revisions |
11 (0.2%) |
0.2% (0.1% - 0.3%) |
59 (0.6%) |
0.6%
(0.5% - 0.8%) |
70% (40% - 85%) |
0.0007 |
Lead-related reinterventions |
N/A |
N/A |
69 (0.7%) |
0.7% (0.6% -
0.9%) |
NE |
NE |
Replacement |
74 (1.2%) |
1.2% (1.0% - 1.5%) |
53 (0.5%) |
0.5%
(0.4% - 0.7%) |
-124% (-290% - -28%) |
0.005 |
System switch (replacement with opposite type of device) |
24 (0.4%) |
0.5% (0.4% - 0.7%) |
31 (0.3%) |
0.4% (0.3% - 0.5%) |
-36%
(-145% - 25%) |
0.31 |
Removal |
* |
* |
88 (0.9%) |
1.0% (0.8% - 1.2%) |
98% (83% -
100%) |
0.0002 |
Upgrades |
|
|
|
|
|
|
Dual-chamber |
26 (0.4%) |
0.5% (0.3% - 0.6%) |
83 (0.8%) |
0.9%
(0.7% - 1.1%) |
49% (15% - 70%) |
0.01 |
CRT |
76 (1.2%) |
1.5% (1.3% - 1.7%) |
194 (1.9%) |
2.2% (1.9% -
2.6%) |
35% (15% - 50%) |
0.002 |
Composite of reinterventions requiring new device††† |
198
(3.2%) |
3.6% (3.2% - 4.0%) |
449 (4.4%) |
5.0% (4.5% - 5.5%) |
29% (6% - 46%) |
0.02 |