Table 2:
Procedural characteristics (among 0 mm; 0 – 5 mm and larger than 5 mm) (secondary)
| 0 mm | (N = 37696) | 0 – 5 mm | (N = 13258) | larger than 5 mm | (N = 379) | p-value | |
|---|---|---|---|---|---|---|---|
| Characteristic | |||||||
| LAAOrificeMaxWidth | Mean(std) | 21.1 (4.2) | Mean(std) | 22.3 (4.3) | Mean(std) | 23.7 (4.4) | <.0001 |
| Range | 0.0 – 50.0 | Range | 0.0 – 50.0 | Range | 12.0 – 49.0 | ||
| Observations | 36658 (97.2%) | Observations | 12987 (98.0%) | Observations | 368 (97.1%) | ||
| Sedation | |||||||
| minimalseda | N(Yes%) | 61 (0.2%) | N(Yes%) | 15 (0.1%) | N(Yes%) | 0 (0.0%) | 0.3433 |
| moderatesed | N(Yes%) | 512 (1.4%) | N(Yes%) | 270 (2.0%) | N(Yes%) | 4 (1.1%) | <.0001 |
| deepsedatio | N(Yes%) | 155 (0.4%) | N(Yes%) | 67 (0.5%) | N(Yes%) | 2 (0.5%) | 0.3543 |
| generalanes | N(Yes%) | 36895 (97.9%) | N(Yes%) | 12877 (97.1%) | N(Yes%) | 373 (98.4%) | <.0001 |
| Indication for LAAO | |||||||
| Increased thromboembolic risk | N(Yes%) | 24184 (64.2%) | N(Yes%) | 8620 (65.0%) | N(Yes%) | 235 (62.0%) | 0.1286 |
| History of major bleeding | N(Yes%) | 23357 (62.0%) | N(Yes%) | 8577 (64.7%) | N(Yes%) | 242 (63.9%) | <.0001 |
| High fall risk | N(Yes%) | 13637 (36.2%) | N(Yes%) | 4614 (34.8%) | N(Yes%) | 130 (34.3%) | 0.0147 |
| labileINR | N(Yes%) | 3150 (8.4%) | N(Yes%) | 1087 (8.2%) | N(Yes%) | 31 (8.2%) | 0.8486 |
| Patient preference | N(Yes%) | 13807 (36.6%) | N(Yes%) | 4596 (34.7%) | N(Yes%) | 125 (33.0%) | 0.0001 |
| Non-compliance with anticoagulation therapy | N(Yes%) | 1219 (3.2%) | N(Yes%) | 431 (3.3%) | N(Yes%) | 11 (2.9%) | 0.9302 |
| Device ResidualLeak | Mean(std) | 0.1 (0.5) | Mean(std) | 0.2 (0.8) | Mean(std) | 0.5 (1.5) | <.0001 |
| Range | 0.0 – 10.0 | Range | 0.0 – 10.0 | Range | 0.0 – 9.0 | ||
| Observations | 36989 (98.1%) | Observations | 13016 (98.2%) | Observations | 374 (98.7%) | ||
| Guidance Method | |||||||
| Fluoroscopy | N(Yes%) | 34667 (92.0%) | N(Yes%) | 12134 (91.5%) | N(Yes%) | 356 (93.9%) | 0.0929 |
| Intracardia | N(Yes%) | 447 (1.2%) | N(Yes%) | 149 (1.1%) | N(Yes%) | 1 (0.3%) | 0.2217 |
| TEE | N(Yes%) | 2132 (5.7%) | N(Yes%) | 831 (6.3%) | N(Yes%) | 19 (5.0%) | 0.0279 |
| Cumulative Air kerma | Mean(std) | 743.2 (1599.1) | Mean(std) | 746.3 (1530.8) | Mean(std) | 933.9 (2431.9) | 0.1035 |
| Range | 1.0 – 50000.0 | Range | 1.0 – 50000.0 | Range | 4.0 – 36875.0 | ||
| Observations | 32026 (85.0%) | Observations | 11314 (85.3%) | Observations | 318 (83.9%) | ||
| Contrast Volume | Mean(std) | 63.0 (47.3) | Mean(std) | 62.6 (46.9) | Mean(std) | 67.9 (47.1) | 0.0996 |
| Range | 0.0 – 751.0 | Range | 0.0 – 636.0 | Range | 0.0 – 320.0 | ||
| Observations | 36498 (96.8%) | Observations | 12754 (96.2%) | Observations | 368 (97.1%) | ||
| Procedure Adjudicated Major Event Occurred | |||||||
| Pericadial effusion | N(Yes%) | 334 (0.9%) | N(Yes%) | 138 (1.0%) | N(Yes%) | 3 (0.8%) | 0.2672 |
| Device Systemic Ebolism | N(Yes%) | 4 (0.0%) | N(Yes%) | 1 (0.0%) | N(Yes%) | 0 (0.0%) | 0.9361 |
| Cardiac Arrest | N(Yes%) | 24 (0.1%) | N(Yes%) | 15 (0.1%) | N(Yes%) | 0 (0.0%) | 0.178 |
| Myocardial Infarction | N(Yes%) | 15 (0.0%) | N(Yes%) | 3 (0.0%) | N(Yes%) | 0 (0.0%) | 0.6193 |
| Ischemic Stroke | N(Yes%) | 32 (0.1%) | N(Yes%) | 11 (0.1%) | N(Yes%) | 0 (0.0%) | 0.8503 |
| Hemorrhagic Stroke | N(Yes%) | 1 (0.0%) | N(Yes%) | 0 (0.0%) | N(Yes%) | 0 (0.0%) | 0.8345 |
| Undetermined Stroke | N(Yes%) | 2 (0.0%) | N(Yes%) | 0 (0.0%) | N(Yes%) | 0 (0.0%) | 0.6964 |
| TIA | N(Yes%) | 10 (0.0%) | N(Yes%) | 4 (0.0%) | N(Yes%) | 0 (0.0%) | 0.9269 |
| major bleeding | N(Yes%) | 510 (1.4%) | N(Yes%) | 193 (1.5%) | N(Yes%) | 3 (0.8%) | 0.4224 |
| major vascular complcation | N(Yes%) | 59 (0.2%) | N(Yes%) | 11 (0.1%) | N(Yes%) | 1 (0.3%) | 0.1178 |