|
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%) |
|