Table 2. Procedural details and in-hospital complications of people included in the registry.
PFO closure procedures (n = 973)* | |
---|---|
Anaesthesia, n (%): | |
General | 700 (74.9%) |
Local with sedation | 160 (17.1%) |
Local only | 75 (8.0%) |
Intra-operative echo imaging, n (%): | |
TOE (planned) or TTE) | 694 (73.6%) |
ICE planned | 208 (22.1%) |
ⱡUnplanned (TOE/ICE) | 10 (1.1%) |
None | 31 (3.3%) |
Device, n(%): | |
Abbot (Amplatzer range) | 523 (54.9%) |
GORE (Cardioform Septal Occluder) | 288 (30.2%) |
Occlutech (Figulla Flex) | 121 (12.7%) |
Other (incl. combination) | 21 (2.2%) |
Procedural duration (mins), median (Q1:Q3) [range] | 45 (30,60) [0–229] |
Major complications, n (%) | 8 (0.8% [95% CI 0.4 to 1.6]%) |
Minor complication, n (%) | 23 (2.4% [95% CI 1.5 to 3.5]%) |
Any complication, n (%) | 30 (3.3%, [95% CI 2.2:4.6]); from 970 available * |
Device implanted, n (%) | 934 (99.4%, [95% CI 98.6:99.8]), from 940 available * |
Procedural success † , n (%) | 928 (95.4%, [95% CI 93.9:96.6]), from 973 available * |
Abbreviations: CI, 95% confidence interval; ICE, intracardiac echocardiography; TOE, transoesophageal echocardiogram; TTE, transthoracic echocardiogram.
* Not all data fields were complete for every patient at baseline and follow-up. The percentages presented in this table were calculated using the number of patients with each characteristic reported as the denominator.
† Defined as device implanted successfully in absence of major complications.
ⱡ Unplanned at start of procedure