Table 5.
Pacing threshold and sensing amplitude changes at 1 month vs. pre-MRI (primary endpoints 2&3).
| Lead category | No. of leadsa | Mean ± SD | Median | Minimum, maximum | 95%-CI (component of hypothesisb) |
|---|---|---|---|---|---|
| PT change, V @ 0.4 ms | |||||
| ICD lead with DF-1 (RV)c | 78 | 0.0 ± 0.1 | 0.0 | −0.2, +0.2 | — |
| ICD lead with DF-4 (RV) | 65 | 0.0 ± 0.1 | 0.0 | −0.5, +0.2 | — |
| Solia (RA)d | 79 | 0.0 ± 0.1 | 0.0 | −0.3, +0.5 | — |
| Corox (LV) | 28 | 0.0 ± 0.2 | 0.0 | −0.5, +0.5 | — |
| Primary endpoint 2 (change in log-transformed PT) | Upper limit:e | ||||
| ICD lead with DF-1 (RV)c | 78 | 0.0 ± 0.2 | — | −0.3, +0.5 | 0.06 (H1) |
| ICD lead with DF-4 (RV) | 65 | 0.0 ± 0.2 | — | −0.7, +0.6 | 0.07 (H2) |
| Solia (RA)d | 79 | 0.0 ± 0.3 | — | −0.6, +1.2 | 0.08 (H1, H2) |
| Corox (LV) | 28 | 0.0 ± 0.2 | — | −0.5, +0.7 | 0.14 (H1, H2) |
| SA change, mV | |||||
| ICD lead with DF-1 (RV)c | 74 | −0.1 ± 1.7 | 0.0 | −5.8, +8.9 | — |
| ICD lead with DF-4 (RV) | 62 | 0.0 ± 1.1 | 0.0 | −4.1, +3.0 | — |
| Solia (RA)d | 67 | 0.0 ± 0.6 | 0.0 | −3.3, +2.0 | — |
| Corox (LV) | 28 | −0.2 ± 3.0 | 0.2 | −12.7, +3.7 | — |
| Primary endpoint 3 (change in log-transformed SA) | Lower limit:f | ||||
| ICD lead with DF-1 (RV)c | 74 | 0.0 ± 0.2 | — | −0.4, +1.1 | −0.05 (H1) |
| ICD lead with DF-4 (RV) | 62 | 0.0 ± 0.1 | — | −0.4, +0.4 | −0.02 (H2) |
| Solia (RA)d | 67 | 0.0 ± 0.3 | — | −2.1, +0.8 | −0.11 (H1, H2) |
| Corox (LV) | 28 | 0.0 ± 0.4 | — | −1.9, +0.4 | −0.20 (H1, H2) |
aLeads with both 1-month and pre-MRI result available. Only measurement pairs in the same polarity and with the same pulse width are taken into account.
bH1 and H2 are predefined composite primary hypotheses (see Methods). In addition to SADE-free rate (Table 4), also primary endpoints 2 and 3 contribute to H1 and H2.
cIncluding 4 Solia leads positioned in the right ventricle.
dExcluding 4 Solia leads positioned in the right ventricle.
eUpper limit ≤ 0.10 was needed to reject the null hypothesis.
fLower limit ≥ −0.10 was needed to reject the null hypothesis.
CI: confidence interval; DF-1: old-standard connector type; DF-4: new-standard connector type; ICD: implantable cardioverter-defibrillator; LV: values for left ventricle; PT: pacing threshold; RA: values for right atrium; RV: values for right ventricle; SA: sensing amplitude; SD: standard deviation.