Table 3.
Summary of reported Serious Adverse Events
| Category | All (N = 143) | EF ≥35% (N = 29) | EF <35% (N = 113) | |||
|---|---|---|---|---|---|---|
| Events | Patients (%) | Events | Patients (%) | Events | Patients (%) | |
| Arrhythmia | 20 | 14 (10) | 3 | 3 (10) | 17 | 13 (12) |
| General cardiopulmonary | 30 | 23 (16) | 3 | 23 (10) | 27 | 20 (17) |
| Worsening heart failure | 55 | 37 (26) | 11 | 6 (21) | 44 | 33 (29) |
| Infection | 16 | 14 (10) | 3 | 3 (10) | 13 | 11 (10) |
| Bleeding | 5 | 4 (3) | 1 | 1 (3) | 4 | 3 (3) |
| ICD related | 5 | 5 (3) | 1 | 1 (3) | 4 | 4 (4) |
| Optimizer IPG malfunction | 5 | 5 (3) | 2 | 2 (7) | 3 | 3 (3) |
| Lead migration/revision | 12 | 10 (7) | 4 | 3 (10) | 8 | 7 (6) |
| General medical | 41 | 28 (20) | 6 | 5 (17) | 35 | 23 (20) |
| Death—unknown cause | 4 | 4 (3) | – | – | 4 | 4 (4) |
| SAE probably or possibly related to device | 32 | 25 (17) | 6 | 5 (17) | 26 | 20 (18) |
| Total | 193 | 91 (64) | 34 | 17 (59) | 159 | 74 (65) |
Arrhythmia includes: supraventricular tachyarrhythmia (atrial fibrillation, atrial flutter, supraventricular tachycardia, ectopic atrial tachycardia), VT, and VF. General cardiopulmonary includes: angina, dyspnea, pericardial effusion/tamponade, pulmonary related (except pneumonia), syncope, venous thromboembolic disease, and valvular disease. Infection includes: ICD pocket infection, optimizer pocket infection, pneumonia, and sepsis. General medical includes: renal failure, neurological dysfunction, peripheral arterial disease/event, stroke, and other non-cardiac medical abnormalities. SAE’s probably or possibly related to the device are included in the total values