Table 2. Summary of the Major SICD Studies.
SICD-IDE Study | Effortless Registry | SICD-PAS Study | |
Number of Patients | 330 | 472 | 1637 |
Average Age, yrs | 51.9 ± 15.5 | 49 ± 18 | 53.2 ± 15 |
Mean EF, % | 36.1 ± 15.9 | 42 ± 19 | 32 ± 14.6 |
Complications, % | 7.9% (180-day complication rate) | 3% and 6% (30-day and 1 year complication rate respectively) | 3.8% (30-day complication rate) |
Acute Conversion Success of Induced VF | 100% | 99.7% | 98.7% |
Spontaneous VT/VF Total Shock Efficacy | 97.1% | 100% | N/A* |
*The SICD-PAS was an acute complication study. Long-term Follow-up not published at this time. EF: ejection fraction; IDE: Investigational Device Exemption; PAS: post approval registry; SICD: subcutaneous implantable cardioverter defibrillator; VT/VF: ventricular tachycardia/ventricular fibrillation. This table is modified from Gold MR.[24]