Table 3.
Safety Events Included in the Composite Safety Outcome by Ablation Catheter (covariate-unadjusted data)
| Mercy | Mayo Clinic | |||
|---|---|---|---|---|
| ThermoCool STSF (n=35) | ThermoCool ST (n=23) | ThermoCool STSF (n=35) | ThermoCool ST (n=84) | |
| Safety Events | N (%) | N (%) | N (%) | N (%) |
| Death | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) |
| Acute myocardial infarction | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) |
| Acute stroke | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) |
| Deep venous thrombosis | 0 (0.0%) | 0 (0.0%) | 1 (2.9%) | 0 (0.0%) |
| Pulmonary embolus | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) |
| Complete heart block | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) |
| Pericardial effusion with hemodynamic compromise | 0 (0.0%) | 0 (0.0%) | 1 (2.9%) | 0 (0.0%) |
| Cardiac perforation | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) |
| New acute severe mitral or aortic regurgitation | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) |
| Arterial dissection | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) |
| Vascular injury | 0 (0.0%) | 0 (0.0%) | 1 (2.9%) | 1 (1.2%) |
| Number of safety events within 7 days | 0 (0.0%) | 0 (0.0%) | 3 (8.6%) | 1 (1.2%) |
| Number of patients who had safety events within 7 days | 0 (0.0%) | 0 (0.0%) | 3 (8.6%) | 1 (1.2%) |