Table 1. Baseline Characteristics of Patients.
| Characteristic | Patients, No. (%) | P value | |
|---|---|---|---|
| Women (n = 20 388) | Men (n = 28 969) | ||
| Demographic information | |||
| Age, mean (SD), y | 76.5 (7.9) | 75.8 (8.2) | <.001 |
| Race/ethnicity | |||
| White | 18 701 (91.7) | 27 068 (93.4) | <.001 |
| Black | 1130 (5.5) | 1187 (4.1) | <.001 |
| Asian | 338 (1.7) | 434 (1.5) | .16 |
| Othera | 108 (0.5) | 135 (0.5) | .32 |
| Hispanic | 789 (3.9) | 1024 (3.6) | .06 |
| Insurance payer | |||
| Private | 12 301 (60.3) | 18 444 (63.7) | <.001 |
| Medicare | 17 681 (86.7) | 24 553 (84.8) | <.001 |
| Medicaid | 1411 (6.9) | 1121 (3.9) | <.001 |
| State-specific plan | 185 (0.9) | 200 (0.7) | .007 |
| Other | 792 (3.9) | 1392 (4.8) | <.001 |
| Admitted for LAAO procedure | 19 617 (96.5) | 27 942 (96.8) | .08 |
| Patient history and risk factors | |||
| CHA2DS2-VASc score, mean (SD) | 5.3 (1.5) | 4.5 (1.4) | <.001 |
| Congestive heart failure | 7025 (34.5) | 11 493 (39.7) | <.001 |
| NYHA class I | 1759 (8.6) | 2903 (10.0) | <.001 |
| NYHA class II | 3247 (15.9) | 5280 (18.2) | <.001 |
| NYHA class III | 1458 (7.2) | 2433 (8.4) | <.001 |
| NYHA class IV | 84 (0.4) | 167 (0.6) | .01 |
| Hypertension | 18 736 (92.0) | 26 719 (92.3) | .28 |
| Type 1 or 2 diabetes | 7088 (34.8) | 11 468 (39.7) | <.001 |
| Prior stroke | 5288 (26.0) | 7104 (24.6) | < 001 |
| Prior transient ischemic attack | 3044 (15.0) | 3900 (13.5) | <.001 |
| Prior thromboembolic event | 3855 (19.0) | 4919 (17.0) | <.001 |
| Vascular disease | 7530 (37.0) | 15 357 (53.1) | <.001 |
| Prior myocardial infarction | 2829 (13.9) | 6619 (22.8) | <.001 |
| Peripheral arterial disease | 2402 (11.8) | 4331 (15.0) | <.001 |
| Known aortic plaque | 646 (3.2) | 1216 (4.2) | <.001 |
| HAS-BLED score, mean (SD) | 2.96 (1.1) | 3.04 (1.1) | <.001 |
| Uncontrolled hypertension | 5953 (29.3) | 7722 (26.7) | <.001 |
| Abnormal renal function | 2431 (12.0) | 4455 (15.4) | <.001 |
| Abnormal liver function | 616 (3.0) | 957 (3.3) | .08 |
| Prior stroke | 5584 (27.5) | 7588 (26.3) | .003 |
| Ischemic | 3203 (57.6) | 4163 (55.1) | .005 |
| Hemorrhagic | 1286 (23.1) | 2131 (28.2) | <.001 |
| Undetermined | 1324 (23.8) | 1738 (23.0) | .28 |
| Prior bleeding | 14 245 (70.0) | 20 287 (70.1) | .76 |
| Labile INR | 2290 (11.3) | 3071 (10.6) | .03 |
| Alcohol use | 579 (2.9) | 2139 (7.4) | <.001 |
| Antiplatelet medication use | 5042 (24.8) | 8225 (28.5) | <.001 |
| Nonsteroidal anti-inflammatory drug use | 5701 (28.1) | 9072 (31.4) | <.001 |
| Indication for occlusion | |||
| Increased thromboembolic risk | 13 188 (64.7) | 18 625 (64.3) | .37 |
| History of major bleeding | 12 908 (63.3) | 18 524 (63.9) | .15 |
| High fall risk | 8111 (39.8) | 9692 (33.5) | <.001 |
| Labile INR | 1850 (9.1) | 2408 (8.3) | .003 |
| Patient preference | 6924 (34.0) | 10 165 (35.1) | .01 |
| Noncompliance with anticoagulation therapy | 686 (3.4) | 931 (3.2) | .35 |
| Other history and risk factors | |||
| Clinically relevant prior bleeding | 13 922 (68.4) | 19 881 (68.8) | .36 |
| Intracranial | 2138 (10.5) | 3555 (12.3) | <.001 |
| Epistaxis | 1260 (6.2) | 1877 (6.5) | .18 |
| Gastrointestinal | 8874 (43.5) | 11 484 (39.6) | <.001 |
| Other | 2808 (13.8) | 4582 (15.8) | <.001 |
| Fall risk | 9012 (44.4) | 10 709 (37.1) | <.001 |
| Genetic coagulopathy | 197 (1.0) | 232 (0.8) | .05 |
| Cardiomyopathy | 2924 (14.4) | 7307 (25.3) | <.001 |
| Ischemic | 1010 (5.0) | 4138 (14.3) | <.001 |
| Nonischemic | 1267 (6.2) | 2331 (8.0) | <.001 |
| Restrictive | 21 (0.1) | 35 (0.1) | .56 |
| Hypertrophic | 216 (1.1) | 218 (0.8) | < 001 |
| Other | 399 (2.0) | 649 (2.2) | .03 |
| Chronic lung disease | 4524 (22.2) | 6006 (20.8) | < 001 |
| Coronary artery disease | 7137 (35.0) | 16 122 (55.7) | <.001 |
| Sleep apnea | 4194 (20.6) | 8596 (29.7) | <.001 |
| Sleep apnea treatment | 2906 (71.2) | 6144 (73.4) | .01 |
| AF classification | |||
| Paroxysmal | 12 029 (59.0) | 14 488 (50.0) | <.001 |
| Persistent | 3920 (19.2) | 6452 (22.3) | <.001 |
| Longstanding persistent | 1585 (7.8) | 2789 (9.6) | <.001 |
| Permanent | 2773 (13.6) | 5104 (17.6) | <.001 |
| Valvular | 116 (0.6) | 144 (0.5) | .28 |
| Attempt at AF termination | 8089 (39.7) | 11 614 (40.1) | .35 |
| Pharmacologic cardioversion | 4258 (53.1) | 5382 (46.7) | <.001 |
| Direct current cardioversion | 4080 (50.8) | 6820 (59.1) | <.001 |
| Catheter ablation | 3216 (39.9) | 4611 (39.8) | .92 |
| Surgical ablation | 87 (1.1) | 182 (1.6) | .004 |
| Atrial flutter | 2354 (11.6) | 4474 (15.5) | <.001 |
| Typical | 1511 (7.4) | 3047 (10.5) | <.001 |
| Atypical | 644 (3.2) | 1124 (3.9) | <.001 |
| Attempt at atrial flutter termination | 1591 (68.3) | 3108 (69.7) | .21 |
| Pharmacologic cardioversion | 463 (29.3) | 801 (25.9) | .01 |
| Direct current cardioversion | 508 (32.2) | 1103 (35.7) | .02 |
| Ablation | 1242 (78.3) | 2483 (80.1) | .15 |
| Previous cardiac structural intervention | 1316 (6.5) | 2312 (8.0) | <.001 |
| LAA orifice maximal width, mean (SD) | 21.3 (4.2) | 21.7 (4.5) | <.001 |
| Physical examination and laboratory results, mean (SD) | |||
| Body mass indexb | 30.3 (13.8) | 29.9 (8.3) | <.001 |
| Hemoglobin level, g/dL | 12.3 (1.8) | 13.0 (2.2) | <.001 |
| INR | 1.4 (1.0) | 1.4 (0.9) | .01 |
| Creatinine, mg/dL | 1.2 (0.9) | 1.4 (1.2) | <.001 |
| Albumin, g/dL | 3.8 (0.5) | 3.8 (0.5) | .10 |
| Platelet count, ×103/µL | 225 647 (74 004) | 194 924 (67 272) | <.001 |
| Preimplant medications | |||
| Direct oral anticoagulant only | 3264 (11.3) | 2584 (12.7) | <.001 |
| Warfarin only | 2801 (9.7) | 2217 (10.9) | <.001 |
| Single antiplatelet agent | 7051 (24.3) | 4589 (22.5) | <.001 |
| Dual antiplatelet therapy | 1136 (3.9) | 663 (3.3) | <.001 |
| Triple therapy | 461 (1.6) | 182 (0.9) | <.001 |
| Oral anticoagulant agent plus single antiplatelet agent | 6153 (21.2) | 3589 (17.6) | <.001 |
| Other | 8103 (28.0) | 6564 (32.2) | <.001 |
| Procedural characteristics | |||
| Intraprocedural anticoagulation | 20 059 (98.4) | 28 463 (98.3) | .31 |
| Heparin | 19 945 (99.5) | 28 303 (99.5) | .88 |
| Bivalirudin | 92 (0.5) | 127 (0.4) | .84 |
| Other | 737 (3.7) | 1113 (3.9) | .18 |
| Anticoagulation reversal | 12 168 (61.0) | 16 940 (59.8) | .01 |
| Hospital characteristics | |||
| Hospital location | |||
| Rural | 1601 (7.9) | 2283 (7.9) | .91 |
| Suburban | 5500 (27.0) | 8009 (27.6) | .10 |
| Urban | 13 287 (65.2) | 18 677 (64.5) | .11 |
| US Region | |||
| Northeast | 3282 (16.1) | 5259 (18.2) | <.001 |
| West | 4510 (22.1) | 6381 (22.0) | .80 |
| Midwest | 4617 (22.6) | 6291 (21.7) | .01 |
| South | 7968 (39.1) | 11 030 (38.1) | .02 |
| Type of facility | |||
| Government | 231 (1.1) | 328 (1.1) | .10 |
| Private | 16 168 (79.3) | 22 381 (77.3) | <.001 |
| University | 3989 (19.6) | 6260 (21.6) | <.001 |
| Teaching hospital | 12 927 (63.4) | 18 922 (65.3) | <.001 |
| Hospital No. of certified beds, median (range) | 500 (341-683) | 500 (341-691) | .25 |
| Annual LAAO procedure volume, median (range) | 26 (1-60) | 26.0 (1-60) | .45 |
Abbreviations: AF, atrial fibrillation; CHA2DS2-VASc, (cardiac failure or dysfunction, hypertension, age 65-74 [1 point] or ≥75 years [2 points], diabetes mellitus, and stroke, transient ischemic attack or thromboembolism [2 points]–vascular disease, and sex category [female]); HAS-BLED, hypertension, abnormal renal/liver function, stroke, bleeding history or predisposition, labile INR, elderly, drugs/alcohol concomitantly; INR, international normalized ratio; LAAO, left atrial appendage occlusion; NYHA, New York Heart Association.
SI conversion factors: To convert hemoglobin to grams per liter, multiply by 10.0; creatinine to micromoles per liter, multiply by 88.4; albumin to grams per liter, multiply by 10.0; and platelets to ×109/L, multiply by 1.0.
a
Other races include American Indian or Alaskan Native, Pacific Islander, or multiple origins.
b
Calculated as weight in kilograms divided by height in meters squared.