Table 3.
Technical and medical adverse events before/after discharge from the hospital in each study group
| Adverse event | All patients | Active group | Control group |
|---|---|---|---|
| Major | |||
| Technical | |||
| Lead dislodgement and twiddler syndrome | 6/8 | 1/4 | 5/4 |
| Intermittent pacing; undersensing | 1/1 | 1/0 | 0/1 |
| Medical | |||
| Death from lung cancera | 0/1 | 0/0 | 0/1 |
| Arrhythmia | 12/2 | 5/2 | 7/0 |
| Pneumothorax | 1/0 | 1/0 | 0/0 |
| Myocardial perforation and tamponade | 4/0 | 3/0 | 1/0 |
| Pulse generator pocket complications | 1/3 | 0/1 | 1/2 |
| Hypotension, hypertension, near-syncope, syncope | 1/2 | 0/0 | 1/2 |
| Acute pulmonary oedema | 0/1 | 0/0 | 0/1 |
| All major adverse events, before/after (total) | 26/18 (44) | 11/7 (18) | 15/11 (26) |
| Non-major | |||
| Technical | |||
| Rise in ventricular capture threshold | 0/2 | 0/2 | 0/0 |
| Permanent atrial undersensing | 0/4 | 0/4 | 0/0 |
| Deactivation of autothreshold | 2/2 | 2/2 | 0/0 |
| Telemetry-related stressa | 0/2 | 0/1 | 0/1 |
| Medical | |||
| Pulse generator pocket complication | 0/1 | 0/1 | 0/0 |
| Arrhythmia | 1/7 | 0/3 | 1/4 |
| Fever | 1/0 | 1/0 | 0/0 |
| Hypotension, light-headedness | 2/1 | 2/0 | 0/1 |
| Haematoma | 6/2 | 3/0 | 3/2 |
| Cutaneous allergic reaction | 1/0 | 1/0 | 0/0 |
| All non-major adverse events, before/after (total) | 13/21 (34) | 9/13 (22) | 4/8 (12) |
| All adverse events | 39/39 (78) | 20/20 (40) | 19/19 (38) |
Values indicate numbers of observations before/after discharge from the hospital.
aNo associated telemetry transmission.