Table 1. Baseline Patient Characteristics and Demographic Information.
| Baseline Characteristics | No. (%) | |||
|---|---|---|---|---|
| SMART-AF Analysis | Reproduction Analysis | |||
| Effectiveness Cohort (n = 122) |
Safety Cohort (n = 161) |
Effectiveness Cohort (n = 124) |
Safety Cohort (n = 162) |
|
| Age, mean (SD), y | 58.3 (10.9) | 58.7 (10.8) | 58.3 (10.3) | 58.8 (10.8) |
| Male sex | 87 (71.3) | 116 (72.0) | 88 (71.0) | 116 (71.6) |
| Patient history | ||||
| Atrial fibrillation duration, median (IQR), y | 4 (1-7) | 4 (2-8) | 4 (1-7) | 4 (1-7) |
| Atrial flutter | 37 (30.3) | 52 (32.3) | 37 (29.8) | 52 (32.1) |
| Hypertension | 74 (60.7) | 96 (59.6) | 74 (59.7) | 96 (59.3) |
| Diabetes | 14 (11.5) | 20 (12.4) | 14 (11.3) | 20 (12.4) |
| Structural heart disease | 15 (12.3) | 19 (11.8) | 15 (12.1) | 19 (11.7) |
| Cerebrovascular disease | 0 | 0 | 0 | 2 (1.2) |
| Transient ischemic attack | 4 (3.3) | 5 (3.1) | 4 (3.2) | 5 (3.1) |
| Prior thromboembolic events | 6 (4.9) | 10 (6.2) | 3 (2.4) | 5 (3.1) |
| NYHA functional class | ||||
| None | 101 (82.8) | 133 (82.6) | 103 (83.1) | 134 (82.7) |
| I | 15 (12.3) | 18 (11.2) | 15 (12.1) | 18 (11.1) |
| II | 5 (4.1) | 8 (5.0) | 5 (4.0) | 8 (4.9) |
| Unknown | 1 (0.8) | 2 (1.2) | 1 (0.8) | 2 (1.2) |
| LVEF, mean (SD), mm | 60.3 (7.8) | 60.2 (7.6) | 60.3 (7.8) | 60.1 (7.6) |
| LA dimension, mean (SD), mm | 38.5 (5.6) | 38.5 (5.7) | 38.3 (5.7) | 38.4 (5.8) |
Abbreviations: IQR, interquartile range; LA, left atrium; LVEF, left ventricular ejection fraction; NYHA, New York Heart Association, SMART-AF, THERMACOOL SMARTTOUCH Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation.