1 Introduction
2 Methods
2.1 Study design
2.2 Patient population
2.3 Outcome measures
2.4 Assessments and statistical analysis
3 Results
3.1 Study population
Western Europe | Eastern Europe | North America | Asia | |
---|---|---|---|---|
Patients ablated, n | 329 | 57 | 141 | 108 |
Age, mean, years (SD) | 58.7 (10.0) | 56.9 (9.1) | 61.4 (10.8) | 59.0 (11.2) |
< 65 years, n (%) | 232 (70.5) | 45 (78.9) | 80 (56.7) | 69 (63.9) |
65 to < 75 years, n (%) | 84 (25.5) | 12 (21.1) | 45 (31.9) | 35 (32.4) |
≥ 75 years, n (%) | 13 (4.0) | 0 (0.0) | 16 (11.3) | 4 (3.7) |
Male sex, n (%) | 242 (73.6) | 38 (66.7) | 100 (70.9) | 95 (88.0) |
Body mass index, mean (SD), kg/m2 | 28.5 (5.1) | 28.9 (4.2) | 32.5 (7.9) | 24.0 (3.3) |
CHA2DS2-VASc score, mean (SD) | 1.8 (1.2) | 2.2 (1.1) | 2.6 (1.8) | 2.0 (1.1) |
0, n (%) | 27 (8.2) | 3 (5.3) | 11 (7.8) | 2 (1.9) |
1, n (%) | 120 (36.5) | 11 (19.3) | 31 (22.0) | 37 (34.3) |
2, n (%) | 94 (28.6) | 22 (38.6) | 39 (27.7) | 42 (38.9) |
> 2, n (%) | 88 (26.7) | 21 (36.8) | 60 (42.6) | 27 (25.0) |
Medical history, n (%) | ||||
Ejection fraction*, mean, ml (SD) | 60.0 (7.4) | 63.4 (7.2) | 55.9 (11.5) | 60.6 (9.7) |
Left atrial size†, mean, mm (SD) | 41.8 (6.3) | 42.4 (4.4) | 41.7 (6.9) | 38.9 (5.4) |
Atrial flutter | 55 (16.7) | 5 (8.8) | 46 (32.6) | 6 (5.6) |
Congestive heart failure | 8 (2.4) | 23 (40.4) | 29 (20.6) | 5 (4.6) |
Coronary artery disease | 26 (7.9) | 8 (14.0) | 41 (29.1) | 5 (4.6) |
Diabetes mellitus | 27 (8.2) | 1 (1.8) | 26 (18.4) | 10 (9.3) |
Hypertension | 158 (48.0) | 43 (75.4) | 92 (65.2) | 50 (46.3) |
Previous MI‡ | 11 (3.3) | 1 (1.8) | 12 (8.5) | 1 (0.9) |
Stroke | 7 (2.1) | 3 (5.3) | 4 (2.8) | 5 (4.6) |
Previous stroke, hemorrhagic | 0 (0.0) | 0 (0.0) | 0 (0.0) | 2 (1.9) |
Previous stroke, ischemic | 7 (2.1) | 2 (3.5) | 1 (0.7) | 3 (2.8) |
Previous stroke, uncertain | 0 (0.0) | 1 (1.8) | 3 (2.1) | 0 (0.0) |
Systemic embolism | 1 (0.3) | 1 (1.8) | 3 (2.1) | 0 (0.0) |
TIA | 5 (1.5) | 1 (1.8) | 7 (5.0) | 1 (0.9) |
Atrial fibrillation, n (%) | ||||
Paroxysmal | 241 (73.3) | 44 (77.2) | 87 (61.7) | 60 (55.6) |
Persistent | 80 (24.3) | 11 (19.3) | 46 (32.6) | 30 (27.8) |
Long-standing persistent | 8 (2.4) | 2 (3.5) | 8 (5.7) | 18 (16.7) |
3.2 Patient characteristics
3.3 Ablation procedure
Procedural variable | Western Europe | Eastern Europe | North America | Asia |
---|---|---|---|---|
Patients ablated, n | 329 | 57 | 141 | 108 |
PVI only, n (%) | 255 (77.5) | 47 (82.5) | 121 (85.8) | 81 (75.0) |
PVI plus, n (%) | 72 (21.9) | 5 (8.8) | 18 (12.8) | 26 (24.1) |
Energy source RF, n (%) | 207 (62.9) | 37 (64.9) | 104 (73.8) | 81 (75.0) |
Energy source cryoballoon, n (%) | 116 (35.3) | 15 (26.3) | 27 (19.1) | 10 (9.3) |
Individual mean ACT during ablation, s | ||||
Mean | 341.3 | 304.3 | 330.5 | 341.4 |
Median | 332.2 | 310.0 | 324.8 | 340.6 |
Q1 | 301.8 | 274.3 | 289.4 | 298.8 |
Q3 | 362.8 | 324.0 | 364.1 | 370.1 |
Western Europe | Eastern Europe | North America | Asia | |||||
---|---|---|---|---|---|---|---|---|
AF type and type of ablation | Dabigatran | Warfarin | Dabigatran | Warfarin | Dabigatran | Warfarin | Dabigatran | Warfarin |
Mean length of ablation, min | 175.9 | 175.9 | 117.8 | 117.8 | 227.5 | 227.5 | 131.5 | 131.5 |
Paroxysmal, n | 118 | 123 | 22 | 22 | 41 | 46 | 32 | 28 |
Mean length of ablation, mean (SD), min | 179.8 (114.8) | 164.1 (103.3) | 122.1 (44.5) | 99.9 (40.8) | 215.7 (112.3) | 196.9 (96.9) | 126.9 (55.2) | 122.0 (29.5) |
PVI only, n (%) | 100 (84.7) | 104 (84.6) | 17 (77.3) | 19 (86.4) | 34 (82.9) | 39 (84.8) | 20 (62.5) | 22 (78.6) |
PVI plus, n (%) | 17 (14.4) | 19 (15.5) | 2 (9.1) | 1 (4.5) | 5 (12.2) | 7 (15.2) | 11 (34.4) | 6 (21.4) |
Persistent, n | 39 | 41 | 4 | 7 | 22 | 24 | 21 | 9 |
Mean length of ablation, mean (SD), min | 173.5 (78.9) | 201.4 (111.5) | 120.0 (23.5) | 136.6 (45.5) | 239.2 (79.3) | 267.9 (109.2) | 139.4 (47.7) | 125.9 (39.5) |
PVI only, n (%) | 27 (69.2) | 22 (53.7) | 4 (100.0) | 6 (85.7) | 19 (86.4) | 22 (91.7) | 16 (76.2) | 9 (100.0) |
PVI plus, n (%) | 11 (28.2) | 19 (46.3) | 0 | 1 (14.3) | 3 (13.6) | 2 (8.3) | 5 (23.8) | 0 |
Longstanding persistent, n | 6 | 2 | 1 | 1 | 2 | 6 | 9 | 9 |
Mean length of ablation, mean (SD), min | 188.5 (103.6) | 153.0 (29.7) | 205.0 (−) | 190.0 (−) | 340.0 (18.4) | 302.0 (30.9) | 142.3 (44.7) | 153.8 (42.6) |
PVI only, n (%) | 2 (33.3) | 0 (0.0) | 0 (0.0) | 1 (100.0) | 2 (100.0) | 5 (83.3) | 7 (77.8) | 7 (77.8) |
PVI plus, n (%) | 4 (66.7) | 2 (100.0) | 1 (100.0) | 0 | 0 | 1 (16.7) | 2 (22.2) | 2 (22.2) |
3.4 Outcomes
Western Europe | Eastern Europe | North America | Asia | |||||
---|---|---|---|---|---|---|---|---|
Patients | Dabigatran | Warfarin | Dabigatran | Warfarin | Dabigatran | Warfarin | Dabigatran | Warfarin |
Patients ablated, n | 163 | 166 | 27 | 30 | 65 | 76 | 62 | 46 |
ISTH major bleeds, n (%) | 1 (0.6) | 10 (6.0) | 0 (0.0) | 4 (13.3) | 3 (4.6) | 7 (9.2) | 1 (1.6) | 1 (2.2) |
Minor bleeds, n (%) | 34 (20.9) | 35 (21.1) | 1 (3.7) | 0 | 11 (16.9) | 10 (13.2) | 13 (21.0) | 9 (19.6) |
Bleeds requiring medical attention, n (%) | 14 (8.6) | 24 (14.5) | 1 (3.7) | 4 (13.3) | 6 (9.2) | 11 (14.5) | 12 (19.4) | 6 (13.0) |
Patients treated*, n | 173 | 177 | 33 | 36 | 67 | 78 | 65 | 47 |
Patients with any AE, n (%) | 129 (74.6) | 124 (70.1) | 14 (42.4) | 18 (50.0) | 43 (64.2) | 62 (79.5) | 39 (60.0) | 38 (80.9) |
Composite of stroke, systemic embolism, or TIA | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (1.3%) | 0 (0.0) | 0 (0.0) |