Leadless VVI (N=6,219) Leadless VVI (N=6,219) Transvenous VVI (N=10,212) Transvenous VVI (N=10,212) Leadless VVI vs. Transvenous VVI Leadless VVI vs. Transvenous VVI
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