Table 3.
Agreement and Disagreement Between Events Reported in the Micra CED and Micra PAR Studies
| Acute (30-Day) Event | Agreement Between Events and No Events (%) | Disagreement Between Events (%) | Disagreement Between Physician-Adjudicated Events (%) |
|---|---|---|---|
| All Events | 95% | 65% | 0% |
| Effusion/Perforation | 100% | 0% | 0% |
| Deep Vein Thrombosis | 98% | 100% | N/A |
| Pulmonary Embolism | 99% | 67% | 0% |
| Arteriovenous Fistula | 99% | 50% | 0% |
| Dislodgement | 100% | N/A | N/A |
| Infection | 100% | 0% | 0% |
| Hemorrhage/Hematoma | 98% | 75% | 0% |
| All-cause 30-day mortality | 100% | 0% | 0% |
Abbreviations: CED, coverage with evidence development; PAR, post-approval registry.