| Hypothesis . | Value . |
|---|---|
| MRI-related SADE | |
| Number of patients included | 111a |
| Number of SADEs | 0 |
| SADE-free rate (95% CI) | 100% (95.98–100) |
| P-value for ‘>90% hypothesis’ | <0.0001 |
| Pacing threshold invariance (1-month vs. pre-MRI) | |
| Right atrium | |
| Number of patients included | 28b |
| Mean ± SD of log-transformed patient-wise ratiosc | −0.132 ± 0.226 |
| 95% CI | Infinity to −0.059 |
| P-value for ‘<0.10 hypothesis’d | <0.0001 |
| Right ventricle | |
| Number of patients included | 108e |
| Mean ± SD of log-transformed patient-wise ratiosc | −0.021 ± 0.189 |
| 95% CI | Infinity to 0.009 |
| P-value for ‘<0.10 hypothesis’d | <0.0001 |
| Sensing amplitude invariance (1-month vs. pre-MRI) | |
| Right atrium | |
| Number of patients included | 31f |
| Mean ± SD of log-transformed patient-wise ratiosc | 0.009 ± 0.184 |
| 95% CI | −0.047 to infinity |
| P-value for ‘>−0.10 hypothesis’g | 0.0012 |
| Right ventricle | |
| Number of patients included | 107h |
| Mean ± SD of log-transformed patient-wise ratiosc | −0.005 ± 0.133 |
| 95% CI | −0.026 to infinity |
| P-value for ‘>−0.10 hypothesis’g | <0.0001 |
| Hypothesis . | Value . |
|---|---|
| MRI-related SADE | |
| Number of patients included | 111a |
| Number of SADEs | 0 |
| SADE-free rate (95% CI) | 100% (95.98–100) |
| P-value for ‘>90% hypothesis’ | <0.0001 |
| Pacing threshold invariance (1-month vs. pre-MRI) | |
| Right atrium | |
| Number of patients included | 28b |
| Mean ± SD of log-transformed patient-wise ratiosc | −0.132 ± 0.226 |
| 95% CI | Infinity to −0.059 |
| P-value for ‘<0.10 hypothesis’d | <0.0001 |
| Right ventricle | |
| Number of patients included | 108e |
| Mean ± SD of log-transformed patient-wise ratiosc | −0.021 ± 0.189 |
| 95% CI | Infinity to 0.009 |
| P-value for ‘<0.10 hypothesis’d | <0.0001 |
| Sensing amplitude invariance (1-month vs. pre-MRI) | |
| Right atrium | |
| Number of patients included | 31f |
| Mean ± SD of log-transformed patient-wise ratiosc | 0.009 ± 0.184 |
| 95% CI | −0.047 to infinity |
| P-value for ‘>−0.10 hypothesis’g | 0.0012 |
| Right ventricle | |
| Number of patients included | 107h |
| Mean ± SD of log-transformed patient-wise ratiosc | −0.005 ± 0.133 |
| 95% CI | −0.026 to infinity |
| P-value for ‘>−0.10 hypothesis’g | <0.0001 |
CI, confidence interval; ICD, implantable cardioverter-defibrillator; MRI, magnetic resonance imaging; SADE, serious adverse device effect; SD, standard deviation.
All patients reaching the 1-month follow-up. One patient of 112 who underwent study-specific MRI had a panic attack and prematurely terminated the study after the MRI-procedure follow-up.
Of 31 patients with atrial lead and 1-month follow-up, 3 did not contribute because of missing data.
Corresponding to the geometric mean of non-log-transformed ratios.
Corresponding to ‘<1.07 hypothesis’ for non-log-transformed ratios.
Of 111 patients with ICD lead and 1-month follow-up, 3 did not contribute because of missing data.
All 31 patients with atrial lead and 1-month follow-up contributed.
Corresponding to ‘>0.933 hypothesis’ for non-log-transformed ratios.
Of 111 patients with ICD lead and 1-month follow-up, 4 did not contribute because of missing data.
| Hypothesis . | Value . |
|---|---|
| MRI-related SADE | |
| Number of patients included | 111a |
| Number of SADEs | 0 |
| SADE-free rate (95% CI) | 100% (95.98–100) |
| P-value for ‘>90% hypothesis’ | <0.0001 |
| Pacing threshold invariance (1-month vs. pre-MRI) | |
| Right atrium | |
| Number of patients included | 28b |
| Mean ± SD of log-transformed patient-wise ratiosc | −0.132 ± 0.226 |
| 95% CI | Infinity to −0.059 |
| P-value for ‘<0.10 hypothesis’d | <0.0001 |
| Right ventricle | |
| Number of patients included | 108e |
| Mean ± SD of log-transformed patient-wise ratiosc | −0.021 ± 0.189 |
| 95% CI | Infinity to 0.009 |
| P-value for ‘<0.10 hypothesis’d | <0.0001 |
| Sensing amplitude invariance (1-month vs. pre-MRI) | |
| Right atrium | |
| Number of patients included | 31f |
| Mean ± SD of log-transformed patient-wise ratiosc | 0.009 ± 0.184 |
| 95% CI | −0.047 to infinity |
| P-value for ‘>−0.10 hypothesis’g | 0.0012 |
| Right ventricle | |
| Number of patients included | 107h |
| Mean ± SD of log-transformed patient-wise ratiosc | −0.005 ± 0.133 |
| 95% CI | −0.026 to infinity |
| P-value for ‘>−0.10 hypothesis’g | <0.0001 |
| Hypothesis . | Value . |
|---|---|
| MRI-related SADE | |
| Number of patients included | 111a |
| Number of SADEs | 0 |
| SADE-free rate (95% CI) | 100% (95.98–100) |
| P-value for ‘>90% hypothesis’ | <0.0001 |
| Pacing threshold invariance (1-month vs. pre-MRI) | |
| Right atrium | |
| Number of patients included | 28b |
| Mean ± SD of log-transformed patient-wise ratiosc | −0.132 ± 0.226 |
| 95% CI | Infinity to −0.059 |
| P-value for ‘<0.10 hypothesis’d | <0.0001 |
| Right ventricle | |
| Number of patients included | 108e |
| Mean ± SD of log-transformed patient-wise ratiosc | −0.021 ± 0.189 |
| 95% CI | Infinity to 0.009 |
| P-value for ‘<0.10 hypothesis’d | <0.0001 |
| Sensing amplitude invariance (1-month vs. pre-MRI) | |
| Right atrium | |
| Number of patients included | 31f |
| Mean ± SD of log-transformed patient-wise ratiosc | 0.009 ± 0.184 |
| 95% CI | −0.047 to infinity |
| P-value for ‘>−0.10 hypothesis’g | 0.0012 |
| Right ventricle | |
| Number of patients included | 107h |
| Mean ± SD of log-transformed patient-wise ratiosc | −0.005 ± 0.133 |
| 95% CI | −0.026 to infinity |
| P-value for ‘>−0.10 hypothesis’g | <0.0001 |
CI, confidence interval; ICD, implantable cardioverter-defibrillator; MRI, magnetic resonance imaging; SADE, serious adverse device effect; SD, standard deviation.
All patients reaching the 1-month follow-up. One patient of 112 who underwent study-specific MRI had a panic attack and prematurely terminated the study after the MRI-procedure follow-up.
Of 31 patients with atrial lead and 1-month follow-up, 3 did not contribute because of missing data.
Corresponding to the geometric mean of non-log-transformed ratios.
Corresponding to ‘<1.07 hypothesis’ for non-log-transformed ratios.
Of 111 patients with ICD lead and 1-month follow-up, 3 did not contribute because of missing data.
All 31 patients with atrial lead and 1-month follow-up contributed.
Corresponding to ‘>0.933 hypothesis’ for non-log-transformed ratios.
Of 111 patients with ICD lead and 1-month follow-up, 4 did not contribute because of missing data.
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