Table-1.
Baseline Characteristic of the Study Cohort
| Baseline Characteristic | Leak= 0 mm (N=37,696) | Leak= >0–5 mm (N=13,258) | Leak >5 mm (N= 379) | p-value |
|---|---|---|---|---|
| Male | 22135 (58.7%) | 7678 (57.9%) | 235 (62.0%) | 0.102 |
| Race | ||||
| White | 35207 (93.4%) | 12241 (92.3%) | 347 (91.6%) | <.0001 |
| Black | 1634 (4.3%) | 658 (5.0%) | 21 (5.5%) | 0.007 |
| Asian | 493 (1.3%) | 228 (1.7%) | 7 (1.8%) | 0.002 |
| Hispanic | 1297 (3.5%) | 387 (3.0%) | 15 (4.0%) | 0.014 |
| Insurance payer | ||||
| Private | 23397 (62.1%) | 8561 (64.6%) | 239 (63.1%) | <.0001 |
| Medicare | 32262 (85.6%) | 11471 (86.5%) | 328 (86.5%) | 0.027 |
| Medicaid | 1896 (5.0%) | 664 (5.0%) | 18 (4.7%) | 0.966 |
| State-Specific plan | 293 (0.8%) | 91 (0.7%) | 6 (1.6%) | 0.105 |
| Other | 1799 (4.8%) | 546 (4.1%) | 19 (5.0%) | 0.008 |
| Patient Risk Factors | ||||
| CHA2DS2-VASc Score; median (IQR) | 4.8 (1.5) | 4.9 (1.5) | 4.9 (1.5) | <.0001 |
| Congestive heart failure | 13794 (36.6%) | 5174 (39.0%) | 126 (33.3%) | <.0001 |
| NYHA Class I | 3724 (9.9%) | 1338 (10.1%) | 29 (7.7%) | 0.260 |
| NYHA Class II | 6399 (17.0%) | 2452 (18.5%) | 61 (16.1%) | 0.0003 |
| NYHA Class III | 2753 (7.3%) | 1013 (7.6%) | 29 (7.7%) | 0.434 |
| NYHA Class IV | 169 (0.4%) | 59 (0.4%) | 2 (0.5%) | 0.972 |
| Hypertension | 34773 (92.3%) | 12225 (92.3%) | 358 (94.5%) | 0.281 |
| Diabetes | 14299 (37.9%) | 4924 (37.2%) | 130 (34.3%) | 0.109 |
| Stroke | 9069 (24.1%) | 3415 (25.8%) | 104 (27.5%) | 0.000 |
| Transient ischemic attack | 5141 (13.6%) | 1814 (13.7%) | 58 (15.3%) | 0.631 |
| Prior thromboembolic event | 6505 (17.3%) | 2390 (18.0%) | 79 (20.9%) | 0.030 |
| Vascular disease | 18267 (48.5%) | 6417 (48.4%) | 188 (49.6%) | 0.900 |
| Prior myocardial infarction | 6913 (18.3%) | 2523 (19.0%) | 75 (19.8%) | 0.173 |
| Peripheral arterial disease | 4836 (12.8%) | 1794 (13.5%) | 52 (13.7%) | 0.109 |
| Known aortic plaque | 1293 (3.4%) | 449 (3.4%) | 11 (2.9%) | 0.835 |
| HAS-BLED Score; median (IQR) | 3.0 (1.1) | 3.0 (1.1) | 3.0 (1.1) | 0.299 |
| Uncontrolled hypertension | 10962 (29.1%) | 3570 (27.0%) | 115 (30.3%) | <.0001 |
| Abnormal renal function | 5129 (13.6%) | 1780 (13.4%) | 53 (14.0%) | 0.86 |
| Abnormal liver function | 1142 (3.0%) | 420 (3.2%) | 11 (2.9%) | 0.71 |
| Prior stroke | 9641 (25.6%) | 3614 (27.3%) | 114 (30.1%) | 0.00 |
| Ischemic stroke | 5546 (57.6%) | 2083 (57.7%) | 58 (50.9%) | 0.35 |
| Hemorrhagic stroke | 2431 (25.2%) | 952 (26.4%) | 37 (32.5%) | 0.10 |
| Undetermined stroke | 2179 (22.6%) | 800 (22.2%) | 26 (22.8%) | 0.86 |
| Prior bleeding | 26042 (69.1%) | 9455 (71.4%) | 257 (67.8%) | <.0001 |
| Labile INR | 3889 (10.3%) | 1432 (10.8%) | 38 (10.0%) | 0.271 |
| Alcohol use | 2073 (5.5%) | 756 (5.7%) | 28 (7.4%) | 0.202 |
| Antiplatelet medication use | 9949 (26.4%) | 3258 (24.6%) | 92 (24.3%) | 0.000 |
| NSAID | 11649 (30.9%) | 4071 (30.8%) | 112 (29.6%) | 0.803 |
| Other Risk Factors | ||||
| Clinically relevant prior bleeding | 25061 (66.6%) | 9172 (69.3%) | 253 (66.8%) | <.0001 |
| Intracranial | 4191 (11.1%) | 1575 (11.9%) | 65 (17.2%) | 0.000 |
| Epistaxis | 2415 (6.4%) | 825 (6.2%) | 20 (5.3%) | 0.523 |
| Gastrointestinal | 14929 (39.6%) | 5521 (41.6%) | 151 (39.8%) | 0.000 |
| Other | 5629 (14.9%) | 2002 (15.1%) | 41 (10.8%) | 0.069 |
| Indication for occlusion | ||||
| Increased thromboembolic risk | 24184 (64.2%) | 8620 (65.0%) | 235 (62.0%) | 0.129 |
| History of major bleeding | 23357 (62.0%) | 8577 (64.7%) | 242 (63.9%) | <.0001 |
| High fall risk | 13637 (36.2%) | 4614 (34.8%) | 130 (34.3%) | 0.015 |
| labile INR | 3150 (8.4%) | 1087 (8.2%) | 31 (8.2%) | 0.849 |
| Patient preference | 13807 (36.6%) | 4596 (34.7%) | 125 (33.0%) | 0.000 |
| Non-compliance with anticoagulation | 1219 (3.2%) | 431 (3.3%) | 11 (2.9%) | 0.930 |
| Fall risk | 15063 (40.1%) | 5107 (38.6%) | 136 (36.0%) | 0.005 |
| Genetic coagulopathy | 298 (0.8%) | 102 (0.8%) | 1 (0.3%) | 0.503 |
| Cardiomyopathy | 7432 (19.8%) | 2924 (22.1%) | 91 (24.0%) | <.0001 |
| Ischemic | 3692 (9.8%) | 1425 (10.7%) | 42 (11.1%) | 0.006 |
| Non-ischemic | 2617 (6.9%) | 1065 (8.0%) | 33 (8.7%) | <.0001 |
| Restrictive | 42 (0.1%) | 21 (0.2%) | 1 (0.3%) | 0.312 |
| Hypertrophic | 313 (0.8%) | 141 (1.1%) | 7 (1.8%) | 0.007 |
| Other | 800 (2.1%) | 287 (2.2%) | 8 (2.1%) | 0.958 |
| LVEF; mean (SD) | 54.2% (9.9%) | 54.0% (10.3%) | 53.8% (10.5%) | 0.119 |
| Chronic lung disease | 7981 (21.2%) | 2781 (21.0%) | 69 (18.3%) | 0.348 |
| Coronary artery disease | 17710 (47.0%) | 6229 (47.0%) | 171 (45.2%) | 0.788 |
| Sleep apnea | 10214 (27.1%) | 3683 (27.8%) | 108 (28.6%) | 0.269 |
| Atrial fibrillation classification | ||||
| Paroxysmal | 21357 (56.7%) | 6863 (51.8%) | 175 (46.2%) | <.0001 |
| Persistent | 7722 (20.5%) | 2911 (22.0%) | 98 (25.9%) | <.0001 |
| Long standing persistent | 2998 (8.0%) | 1141 (8.6%) | 36 (9.5%) | 0.038 |
| Permanent | 5462 (14.5%) | 2290 (17.3%) | 68 (17.9%) | <.0001 |
| Attempt at AF termination | 15321 (40.7%) | 5622 (42.4%) | 149 (39.4%) | 0.001 |
| Pharmacologic cardioversion | 7550 (49.6%) | 2684 (48.0%) | 82 (55.4%) | 0.040 |
| DC cardioversion | 8343 (54.8%) | 3254 (58.2%) | 91 (61.5%) | <.0001 |
| Catheter ablation | 6183 (40.5%) | 2330 (41.6%) | 67 (45.0%) | 0.216 |
| Surgical ablation | 197 (1.3%) | 77 (1.4%) | 3 (2.0%) | 0.687 |
| Atrial flutter | 5234 (13.9%) | 2070 (15.6%) | 64 (16.9%) | <.0001 |
| Prior structural intervention | 2661 (7.1%) | 1017 (7.7%) | 31 (8.2) | 0.050 |
| Hospital Characteristics | ||||
| Rural | 3101 (8.2%) | 1178 (8.9%) | 18 (4.7%) | 0.002 |
| Suburban | 10422 (27.6%) | 3697 (27.9%) | 108 (28.5%) | 0.822 |
| Urban | 24173 (64.1%) | 8383 (63.2%) | 253 (66.8%) | 0.093 |
| U.S. Region | ||||
| Northeast | 5991 (15.9%) | 2894 (21.8%) | 91 (24.0%) | <.0001 |
| West | 8196 (21.7%) | 2465 (18.6%) | 76 (20.1%) | <.0001 |
| Midwest | 8584 (22.8%) | 3283 (24.8%) | 97 (25.6%) | <.0001 |
| South | 14904 (39.5%) | 4614 (34.8%) | 115 (30.3%) | <.0001 |
| Patients treated at teaching hospitals | 23445 (62.2%) | 8860 (66.8%) | 272 (71.8%) | <.0001 |
| LAAO procedure volume (Can we remove this?) I think this is important info and prefer to keep | ||||
| Mean (SD) | 58.4 (65.2) | 54.5 (58.8) | 56.8 (57.8) | <.0001 |
| Median (IQR) | 45.0 (2.0 – 84.0) | 41.0 (0.0 – 79.0) | 46.0 (12.0 – 80.0) | 0.0001 |
NYHA; New York heart association, INR; international normalized ratio, DC; direct current, NSAID; nonsteroidal inflammatory drug use, LV; left ventricular, AF; atrial fibrillation, LVEF; left ventricular ejection fraction, LAAO; left atrial appendage occlusion, SD; standard deviation, IQR; interquartile range