Table 2. Effectiveness and Safety Outcomes and Comparison.
| Outcome | SMART-AF Analysis | Reproduction Analysis | ||
|---|---|---|---|---|
| No. | % (95% CI) | No. | % (95% CI) | |
| Effectiveness cohort outcomes | ||||
| 12-mo freedom from arrhythmiaa | 122 | 74.0 (66.0-82.0) | 124 | 76.4 (68.7-84.1) |
| Success rateb | 77 | 65.8 (56.7-74.3) | 90 | 75.6 (67.2-82.5) |
| Reason for failure | ||||
| AF recurrence post-blanking | 31 | 26.5 (NR) | 23 | 19.3 (12.8-27.4) |
| Repeat ablation | 6 | 5.1 (NR) | 6 | 5.0 (1.9-10.5) |
| Taking new AAD at 12 mo | 4 | 3.4 (NR) | 0 | 0.0 (0.0-2.9) |
| Safety cohort outcomesc | ||||
| Cardiac tamponade | 4 | 2.5 (NR) | 4 | 2.5 (0.7-6.2) |
| Heart block | 1 | 0.6 (NR) | 1 | 0.6 (0.0-3.4) |
| Pericarditis | 3 | 1.9 (NR) | 4 | 2.5 (0.7-6.2) |
| Vascular access problem | 4 | 2.5 (NR) | 5 | 3.1 (1.0-7.1) |
| Pericardial effusion | NR | (NR) | 3 | 1.9 (0.4-5.4) |
Abbreviations: AAD, antiarrhythmic drug; AF, atrial fibrillation; NR, not reported; SMART-AF, THERMACOOL SMARTTOUCH Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation..
a
Reported results are for symptomatic atrial arrhythmia as displayed in Figure 2 in the primary study report by Natale et al; No. = initial at risk population for Kaplan-Meier analysis.
b
n = 117 for SMART-AF analysis (5 lost to follow-up) and n = 119 for reproduction analysis (5 lost to follow-up).
c
n = 161 for SMART-AF analysis and n = 162 for reproduction analysis.