Table 3. Reported adverse events between procedures in intention-to-treat population.
MIPDO (N=50) | Surgical (N=50) | Difference between groups (95% CI) | |
---|---|---|---|
Severe adverse events (n) | 0 | 0 | – |
All-cause death | 0 | 0 | – |
Cardiac-specific death | 0 | 0 | – |
Cardiac perforation or tamponade | 0 | 0 | – |
Operation-related valve disfunction | 0 | 0 | – |
Dislocation or distortion of occluders | 0 | 0 | – |
Severe hemolysis | 0 | 0 | – |
Adverse events (n) | 1 | 2 | −0.02 (−0.087 to 0.047) |
Arrhythmia | 1a | 0 | 0.02 (−0.019 to 0.059) |
Undesirable healing or infection of the incision | 0 | 2 | −0.04 (−0.094 to 0.014) |
Residual shunt | 0 | 0 | – |
Infective endocarditis | 0 | 0 | – |
Hemorrhage | 0 | 0 | – |
Postoperative murmur | 0 | 0 | – |
a, newly onset of ‘left anterior fascicular block’, recovered at 6-month post-procedural examination.