Table 2.
Adverse Event | No. of Events per 100 Implants (95% CI) | Odds Ratio (95% CI) | P Value | |
---|---|---|---|---|
Subcutaneous ICD | Transvenous ICD | Subcutaneous versus Transvenous ICD | ||
Any adverse event | 2.39 (1.62 to 3.51) | 1.48 (1.02 to 2.14) | 1.63 (0.95 to 2.82) | 0.08 |
Death | 0.82 (0.4 to 1.68) | 0.31 (0.15 to 0.67) | 2.62 (0.92 to 7.47) | |
Cardiac arrest | 1.53 (0.9 to 2.61) | 0.36 (0.17 to 0.76) | 4.72 (1.71 to 11.17) | 0.002 |
Hematoma | 0.56 (0.3 to 1.05) | 0.25 (0.11 to 0.57) | 2.25 (0.80 to 6.32) | 0.1 |
Hemothorax | — | 0.07 (0.01 to 0.47) | NA | NA |
Infection requiring antibiotics | 0.10 (0.03 to 0.42) | 0.03 (0.00 to 0.22) | 3.29 (0.30 to 36.57) | 0.3 |
Lead dislodgement | 0.22 (0.08 to 0.59) | 0.62 (0.34 to 1.11) | 0.35 (0.11 to 1.13) | 0.08 |
Tamponade | — | 0.03 (0.00 to 0.22) | NA | NA |
Pneumothorax | — | 0.10 (0.03 to 0.42) | NA | NA |
Stroke/TIA | 0.08 (0.01 to 0.60) | — | NA | NA |
Urgent cardiac surgery | — | 0.07 (0.01 to 0.46) | NA | NA |
AMI | — | — | NA | NA |
Cardiac perforation | — | — | NA | NA |
95% CI, 95% confidence interval; ICD, implantable cardioverter defibrillator; NA, not applicable; TIA, transient ischemic attack.