Table 3.
Primary analysis—shock efficacy (per protocol episode data set)
| Total | Without DF test | With DF test | |
|---|---|---|---|
| All patients with at least one delivered appropriate shock for a true VT/VF episode, n/total n (%) | 91/1046 (8.7) | 46/523 (8.8) | 45/523 (8.6) |
| All true VT/VF episodes with at least one delivered appropriate ICD shock (VT/VF), n | 429 | 218 | 211 |
| Delivered appropriate shocks per true VT/VF episode (mean (±SD)) | 1.18 (±0.69) | 1.09 (±0.37) | 1.28 (±0.90) |
| True VT/VF episodes terminated with first appropriate ICD shock, n/total n (%) | 384/429 (89.5) | 204/218 (93.6) | 180/211 (85.3) |
| True VT/VF episodes terminated with any appropriate ICD shock, n/total n (%) | 422/429 (98.4) | 218/218 (100.0) | 204/211 (96.7) |
| True VT/VF episodes not terminated with any appropriate ICD shock, n/total n (%) | 7/429 (1.6) | 0/218 (0.0) | 7/211 (3.3) |
| Conversion efficacy [proportion (95% CI)] | 0.98 (0.97;0.99) | 1.00 (0.98;1.00) | 0.97 (0.93;0.99) |
| First shock efficacy model based [proportion (95% CI)] | 0.96 (0.89;0.98) | 0.97 (0.91;0.99) | 0.94 (0.83;0.98)) |
Difference between the groups (without DF testing vs. with DF testing): 0.03 (−0.03;0.09).
DF, defibrillation; ICD, implantable cardioverter-defibrillator; P-PPS, per protocol episode data set; VT/VF, ventricular tachycardia/ventricular fibrillation.