Table 2. Unadjusted and Adjusted 30-Day Complication Rates in Patients With Leadless VVI Pacemakers vs Patients With Transvenous VVI Pacemakers .
| Measure | Unadjusted event, No. (%) | Adjusted rates | |||||
|---|---|---|---|---|---|---|---|
| Leadless VVI (n = 5746) | Transvenous VVI (n = 9662) | P value | % | Risk difference, % (95% CI) | P value | ||
| Leadless VVI (n = 5746) | Transvenous VVI (n = 9662) | ||||||
| Overall complications | 484 (8.4) | 707 (7.3) | .02 | 7.7 | 7.4 | 0.3 (−0.6 to 1.3) | .49 |
| Embolism and thrombosis | 202 (3.5) | 286 (3.0) | .07 | 3.2 | 3.1 | 0.1 (−0.5 to 0.7) | .81 |
| Deep vein thrombosis | 145 (2.5) | 176 (1.8) | .003 | 2.2 | 2.0 | 0.3 (−0.2 to 0.7) | .27 |
| Pulmonary embolism | 72 (1.3) | 128 (1.3) | .74 | 1.2 | 1.3 | −0.1 (−0.5 to 0.3) | .52 |
| Thrombosis due to cardiac device | ≤10a | ≤10a | .64 | ≤10a | ≤10a | 0 (0 to 0) | .52 |
| Embolism due to cardiac device | ≤10a | 0 | NA | ≤10a | NA | NA | NA |
| Events at puncture site | 78 (1.4) | 31 (0.3) | <.001 | 1.2 | 0.3 | 0.8 (0.5 to 1.2) | <.001 |
| Arteriovenous fistula | 40 (0.7) | ≤10a | <.001 | 0.5 | NA | NA | .003 |
| Vascular aneurysm | 49 (0.9) | 24 (0.3) | <.001 | 0.9 | 0.2 | 0.7 (0.4 to 0.9) | <.001 |
| Cardiac effusion and/or perforation | 47 (0.8) | 38 (0.4) | <.001 | 0.8 | 0.4 | 0.4 (0.1 to 0.7) | .004 |
| Device-related complicationb | 81 (1.4) | 247 (2.6) | <.001 | 1.4 | 2.5 | −1.1 (−1.5 to −0.6) | <.001 |
| Other complications | 136 (2.4) | 169 (1.8) | .01 | 2.1 | 1.7 | 0.4 (−0.1 to 0.9) | .10 |
| Device-related AMI | ≤10a | ≤10a | .71 | ≤10a | ≤10a | .0 (0 to 0.1) | .40 |
| Postprocedural hematoma | 30 (0.5) | 40 (0.4) | .33 | 0.5 | 0.4 | 0.1 (−0.1 to 0.3) | .45 |
| Postprocedural hemorrhage | 32 (0.6) | 11 (0.1) | <.001 | 0.5 | 0.1 | 0.4 (0.2 to 0.6) | <.001 |
| Intraoperative cardiac arrest | 20 (0.4) | 24 (0.3) | .30 | 0.3 | 0.3 | 0.1 (−0.2 to 0.3) | .51 |
| Pericarditis | 51 (0.9) | 23 (0.2) | <.001 | 0.8 | 0.3 | 0.6 (0.3 to 0.9) | <.001 |
| Vascular complication | 38 (0.7) | 16 (0.2) | <.001 | 0.6 | 0.2 | 0.4 (0.2 to 0.6) | <.001 |
| Hemothorax | 0 | 0 | NA | NA | NA | NA | NA |
| Pneumothorax | 0 | 77 (0.8) | NA | NA | 0.8 | NA | NA |
Abbreviations: AMI, acute myocardial infarction; NA, not applicable.
a
Cells with 10 or less patients were suppressed to protect beneficiary privacy as required by the US Centers of Medicare & Medicaid Services.
b
Includes complications related to the mechanical integrity of the device or codes explicitly stating device relatedness (eg, device dislodgement, device infection, device pocket complication). See eTable 1 in the Supplement for details.