Table 2.
Illustration of different device types used for interventional ASD device closure in both groups, technically challenging or special events occurring during cardiac catheter device closure procedures in both groups [significantly more events in the fluoroscopy group (p<0.001)] and illustration of intraprocedural complications and complications within 24 hours after procedure in both groups.
| Variables | Fluoroscopy Group | TOE Group |
|---|---|---|
| (n = 238) | (n = 159) | |
| Device Types | ||
|
| ||
| Amplatzer™ Septal Occluder, n (%) | 167 (72%) | 125 (80%) |
| Solysafe™ Septal Occluder, n (%) | 45 (20%) | 0 |
| CeraFlex™ ASD Occluder, n (%) | 0 | 11 (7%) |
| GORE™ CARDIOFORM Septal Occluder, n (%) | 4 (2%) | 9 (6%) |
| pfm NitOcclud® ASD-R-Device, n (%) | 5 (2%) | 13 (8%) |
| BioSTAR™ Device, n (%) | 8 (4%) | 0 |
| HELEX™ Septal Occluder, n (%) | 3 (1%) | 0 |
|
| ||
| Technical Aspects | ||
|
| ||
| No event, n (%) | 191 (80%) | 149 (94%) |
| Two devices needed, n (%) | 13 (5%) | 0 |
| Three devices needed, n (%) | 2 (1%) | 0 |
| Missizing, n (%) | 13 (6%) | 5 (3%) |
| Device repositioning, n (%) | 19 (8%) | 4 (3%) |
| Equipment failure, n (%) | 0 | 1 (1%) |
|
| ||
| Intraprocedural Complications | ||
|
| ||
| No complication, n (%) | 230 (96.7%) | 158 (99.4%) |
| Device embolization, n (%) | 2 (0.8%) | 1 (0.6%) |
| Heart rhythm disturbance, n (%) | 6 (2.5%) | 0 |
|
| ||
| Postprocedural Complications within 24 hours | ||
|
| ||
| No complication, n (%) | 230 (96.6%) | 155 (97.5%) |
| Device embolization, n (%) | 1 (0.4%) | 1 (0.6%) |
| Heart rhythm disturbance, n (%) | 2 (0.8%) | 2 (1.3%) |
| Pericardial effusion, n (%) | 2 (0.8%) | 0 |
| Vascular access related problems, n (%) | 1 (0.4%) | 0 |
| Impairment of neighbouring cardiac structures, n (%) | 2 (0.8%) | 1 (0.6%) |