Table 1.
Baseline Characteristics
| Total (N = 3,082) | Death, Stroke, and SE (–) (n = 2,949) |
Death, Stroke, and SE (+) (n = 133) |
P Value | |
|---|---|---|---|---|
| Demographic characteristics | ||||
| Age, y | 69.1 ± 9.4 | 68.93 ± 9.3 | 73.26 ± 9.2 | <0.001 |
| ≥75 y | 908 (29.5) | 842 (28.6) | 66 (49.6) | <0.001 |
| Male | 1,771 (57.5) | 1,689 (57.3) | 82 (61.7) | 0.363 |
| Body mass index, kg/m2 | 24.83 ± 3.5 | 24.85 ± 3.5 | 24.34 ± 4.0 | 0.122 |
| Heart rate, beats/min | 81.91 ± 20.4 | 81.85 ± 20.4 | 83.35 ± 22.2 | 0.408 |
| Diabetes | 714 (23.2) | 669 (22.7) | 45 (33.8) | 0.004 |
| Previous stroke or TIA | 1,411 (45.8) | 1,331 (45.1) | 80 (60.2) | 0.001 |
| Ischemic stroke or TIA | 1,373 (44.5) | 1,297 (44.0) | 76 (57.1) | 0.004 |
| Hemorrhagic stroke | 106 (3.4) | 101 (3.4) | 5 (3.8) | 0.524 |
| Hypertension | 2,120 (68.8) | 2,012 (68.2) | 108 (81.2) | 0.007 |
| Coronary artery disease | 875 (28.4) | 833 (28.2) | 42 (31.6) | 0.464 |
| Previous PCI | 326 (10.6) | 303 (10.3) | 23 (17.3) | 0.023 |
| Previous CABG | 46 (1.5) | 41 (1.4) | 5 (3.8) | 0.066 |
| Vascular diseasea | 1,674 (54.3) | 1,589 (53.9) | 85 (63.9) | 0.029 |
| Current smoker | 333 (10.8) | 318 (10.8) | 15 (11.3) | 0.923 |
| Alcohol abuse | 168 (5.5) | 163 (5.5) | 5 (3.8) | 0.494 |
| Chronic heart failure | 462 (15.0) | 429 (14.5) | 33 (24.8) | 0.002 |
| LVEF, % | 60.05 ± 8.3 | 60.12 ± 8.3 | 58.53 ± 9.6 | 0.040 |
| Abnormal thyroidal function | 132 (4.3) | 132 (4.5) | 0 (0.0) | 0.057 |
| Abnormal renal function | 72 (2.3) | 61 (2.1) | 11 (8.3) | <0.001 |
| Abnormal liver function | 51 (1.7) | 46 (1.6) | 5 (3.8) | 0.110 |
| Bleeding history or predispositionb | 313 (10.2) | 293 (9.9) | 20 (15.0) | 0.079 |
| Concomitant use of drugs | 1,034 (33.5) | 975 (33.1) | 59 (44.4) | 0.009 |
| Classification of AF | 0.743 | |||
| Paroxysmal | 1,245 (40.4) | 1,196 (40.6) | 49 (36.8) | |
| Persistent | 1,270 (41.2) | 1,211 (41.1) | 59 (44.4) | |
| Long-standing persistent (>1 y)/permanent | 567 (18.4) | 542 (18.4) | 25 (18.8) | |
| CHADS2 score | 2.3 ± 1.4 | 2.3 ± 1.4 | 3.1 ± 1.4 | <0.001 |
| CHA2DS2-VASc score | 4.0 ± 1.8 | 3.9 ± 1.8 | 4.9 ± 1.8 | <0.001 |
| HAS-BLED score | 2.4 ± 1.2 | 2.4 ± 1.2 | 3.1 ± 1.1 | <0.001 |
| ATRIA score | 6.2 ± 3.0 | 6.2 ± 3.0 | 7.6 ± 2.5 | <0.001 |
| Procedural characteristics | ||||
| Recaptured (≥2 times) before release | 252 (8.2) | 240 (8.1) | 12 (9.0) | 0.840 |
| Devices used | 3,187 (1.03 per patient) | 3,053 (1.04 per patient) | 134 (1.01 per patient) | 0.003 |
| Device size, mm | ||||
| 21 | 188 (6.1) | 180 (6.1) | 8 (6.0) | |
| 24 | 634 (20.6) | 615 (20.9) | 19 (14.3) | |
| 27 | 918 (29.8) | 877 (29.7) | 41 (30.8) | |
| 30 | 714 (23.2) | 679 (23.0) | 35 (26.3) | |
| 33 | 633 (20.5) | 603 (20.4) | 30 (22.6) | |
| Anesthesia | 0.111 | |||
| General anesthesia | 1,799 (58.4) | 1,712 (58.1) | 87 (65.4) | |
| Moderate sedation | 1,283 (41.6) | 1,237 (41.9) | 46 (34.6) | |
| Imaging guidance | 0.759 | |||
| TEE/ICE | 2,590 (84.0) | 2,480 (84.1) | 110 (82.7) | |
| Fluoroscopy | 492 (16.0) | 469 (15.9) | 23 (17.3) | |
| Combined procedures | ||||
| Radiofrequency ablation/cryoablation | 1,295 (42.0) | 1,251 (42.4) | 44 (33.1) | 0.041 |
| Cryoablation | 350 (11.4) | 337 (11.4) | 13 (9.8) | |
| Radiofrequency ablation | 945 (30.7) | 914 (31.0) | 31 (23.3) | |
| Othersc | 154 (5.0) | 150 (5.1) | 4 (3.0) | 0.383 |
Values are mean ± SD, or n (%). N = 3,082 except for body mass index (n = 2,842), LVEF (n = 2,774), CHADS2 score (n = 3,065), CHA2DS2-VASc score (n = 3,065), HAS-BLED score (n = 3,068), and ATRIA score (n = 3,068).
AF = atrial fibrillation; CABG = coronary artery bypass graft; ICE = intracardiac echocardiography; LVEF = left ventricular ejection fraction; PCI = percutaneous coronary intervention; SE = systemic embolism; TEE = transesophageal echocardiography; TIA = transient ischemic attack.
Vascular disease includes previous myocardial infarction, peripheral artery disease, or aortic plaque, defined according to the CHA2DS2-VASc score.
Bleeding history or predisposition includes previous major hemorrhage or anemia or severe thrombocytopenia, defined according to the HAS-BLED score.
Others included atrial septal defect/patent foramen ovale occlusion (n = 78), percutaneous coronary intervention/percutaneous transluminal coronary angioplasty (n = 54), pacemaker implantation (n = 8), percutaneous mitral valvuloplasty (n = 5), transcatheter aortic valve replacement (n = 2), femoral artery stent implantation (n = 1), implantation of vena cava filter (n = 1), splenic artery angiography (n = 1), renal angiography (n = 1), radiofrequency ablation of supraventricular tachycardia (n = 1), and electrocardiogram event recorder implantation (n = 1).