Table 4.
MRI-related SADE-free rate for predefined device categories (primary endpoint 1).
| Device category (analysis population) |
No. of devices | No. of SADEs | SADE-free rate | 95%-CIa | Contributing to hypothesisb |
|---|---|---|---|---|---|
| Pulse generator | |||||
| Single-chamber ICD (DF-1) | 18 | 0 | 100% | 81.5–100% | H1 |
| Single-chamber ICD (DF-4) | 23 | 0 | 100% | 85.2–100% | H2 |
| Dual-chamber ICD (DF-1) | 25 | 0 | 100% | 86.3–100% | H1 |
| Dual-chamber ICD (DF-4) | 26 | 0 | 100% | 86.8–100% | H2 |
| ICD DX | 23 | 0 | 100% | 85.2–100% | H1 |
| CRT-D (DF-1) | 10 | 0 | 100% | 69.2–100% | H1 |
| CRT-D (DF-4) | 17 | 0 | 100% | 80.5–100% | H2 |
| CRT-P | 4 | 0 | 100% | 39.8–100% | H1 |
| Lead | |||||
| ICD lead DF-1c | 76c | 0c | 100%c | 95.3–100%c | H1 |
| ICD lead DF-4d | 66d | 0d | 100%d | 94.6–100%d | H2 |
| Solia | 85 | 0 | 100% | 94.8–100% | H1, H2 |
| Corox | 30 | 0 | 100% | 88.4–100% | H1, H2 |
aThe lower limit of the 95%-CI had to be >90% to reject the null hypothesis for a device category.
bH1 and H2 are predefined composite primary hypotheses (see Methods). In addition to SADE-free rate, also primary endpoints 2 and 3 (Table 5) contribute to H1 and H2.
c,dThe results are also valid for the entire ICD/CRT-D system with DF-1 (c) or DF-4 (d) connection (post-hoc analysis).
CI: confidence interval; CRT-D/-P: cardiac resynchronisation therapy defibrillator/pacemaker; DF-1: old-standard connector type; DF-4: new-standard connector type; DX: ICD lead allowing atrial sensing via floating dipole; ICD: implantable cardioverter-defibrillator; SADE: serious adverse device effect.