Unwanted effects of interventions in the trials included
| Study | ICD treatment | Anti-arrhythmic drug |
|---|---|---|
| Numbers of patients in brackets. | ||
| CNS, central nervous system; ICD, implantable cardioverter-defibrillator; VF, ventricular fibrillation; VT, ventricular tachycardia. | ||
| Primary prevention of VT/VF | ||
| MADIT (multicenter automatic defibrillator implantation trial) | 19/95 patients with adverse events: 2 pneumothorax, 2 infection, 7 lead problems, 7 rhythm problems | 12/101 patients with adverse events: 5 unexplained syncope, 7 VT/VF; amiodarone discontinued in 46% |
| MUSTT (multicenter unsustained tachycardia trial) | EP guided arm: complications occurred in 5 patients with inducible sustained VT (0.7%), non-fatal | |
| CABG patch (coronary artery bypass patch trial) | Significantly different complications in ICD: 12.3% infection, 8.5% pneumonia, deep sternal wound infection 2.7% | |
| Secondary prevention (recurrent VT/VF) | ||
| AVID (antiarrhythmic versus implantable defibrillator) | 19/507: 6 bleeding, 13 haematoma, 10 infection, 8 pneumothorax, 1 cardiac perforation | 5% pulmonary toxic, 16% needed thyroid replacement treatment |
| CASH (cardiac arrest study Hamburg) | 5.1% died perioperatively (5); 3/5 epicardial devices; infection (3), explantation (2), haematoma (6), pericardial effusion (1), pleural effusion (3), pneumothorax (1), dislodgement/migration of leads (3), device dysfunction (5). Overall complication, 23%; explantation rate, 2.1% | Propefenone: 12/56 side effects, 61% higher total mortality; drug stopped Amiodarone: hyperthyroidism in 3% (3); drug stopped in 9% (9) |
| Metoprolol: drug stopped in 10% (10) | ||
| CIDS (Canadian implantable defibrillator study) | At 3 years: infection 5.1%, lead fracture 2.6%, pulmonary toxicity 11.9%, hepatic toxicity 0.9%, thyroid problems 1.8%, CNS problems 8.5% | Amiodarone at 3 years: 22% stopped; pulmonary toxicity 19.6%, hepatic toxicity 5.1%, thyroid 8.8%, CNS 26% |
| Wever et al | Migration of lead in 1 patient, infection in 1 patient | 16/31 late ICD (15 pre-discharge) |