TABLE 2.
Major complication listing for MAP EMEA
| No. events (no. subjects, %) | MAP EMEA (n = 928) | |
|---|---|---|
| Adverse event | Acute (≤30 days) | Total |
| Total major complications | 24 (24, 2.59%) | 35 (33, 3.56%) |
| Events at groin puncture site | 10 (10, 1.08%) | 10 (10, 1.08%) |
| Arterial injury/arteriovenous fistula fistula | 4 (4, 0.43%) | 4 (4, 0.43%) |
| Hematoma | 4 (4, 0.43%) | 4 (4, 0.43%) |
| Incision site hemorrhage | 2 (2, 0.22%) | 2 (2, 0.22%) |
| Cardiac effusion/perforation | 6 (6, 0.65%) | 7 (7, 0.75%) |
| Cardiac tamponade | 3 (3, 0.32%) | 3 (3, 0.32%) |
| Pericardial effusion | 3 (3, 0.32%) | 3 (3, 0.32%) |
| Pericardial haemorrhage | 0 (0, 0%) | 1 (1, 0.11%) |
| Pacing issues | 4 (4, 0.43%) | 7 (5, 0.54%) |
| Device capturing issue | 1 (1, 0.11%) | 1 (1, 0.11%) |
| Device pacing issue | 3 (3, 0.32%) | 5 (4, 0.43%) |
| Device stimulation issue | 0 (0, 0%) | 1 (1, 0.11%) |
| Cardiac rhythm disorder | 0 (0, 0%) | 1 (1, 0.11%) |
| Ventricular dyssynchrony | 0 (0, 0%) | 1 (1, 0.11%) |
| Infection | 3 (3, 0.32%) | 4 (4, 0.43%) |
| Bacteraemia | 1 (1, 0.11%) | 1 (1, 0.11%) |
| Endocarditis | 0 (0, 0%) | 1 (1, 0.11%) |
| Pulmonary sepsis | 1 (1, 0.11%) | 1 (1, 0.11%) |
| sepsis | 1 (1, 0.11%) | 1 (1, 0.11%) |
| Other | 1 (1, 0.11%) | 6 (6, 0.65%) |
| Cardiac failure | 0 (0, 0%) | 2 (2, 0.22%) |
| Haemodynamic instability | 1 (1, 0.11%) | 1 (1, 0.11%) |
| Pacemaker syndrome | 0 (0, 0%) | 2 (2, 0.22%) |
| Tricuspid valve incompetence | 0 (0, 0%) | 1 (1, 0.11%) |