1 Introduction
2 Methods
2.1 Study population
2.2 Periprocedural management
2.3 Ablation procedure
2.4 Fluoroscopy settings
2.5 Follow-up
2.6 Endpoints
2.7 Statistical analysis
3 Results
3.1 Study population
Group A (N = 46) | Group B (n = 44) | P value | |
---|---|---|---|
Age (years) | 60 ± 10 | 57 ± 11 | 0.16 |
Female gender | 7 (15%) | 20 (46%) | 0.002 |
BMI (kg/m2) | 28 ± 3 | 27 ± 3 | 0.42 |
Obesity (BMI ≥ 30 kg/m2) | 11 (24%) | 9 (20%) | 0.69 |
Hypertension | 23 (50%) | 16 (36%) | 0.19 |
Diabetes mellitus | 1 (2%) | 2 (5%) | 0.61 |
Prior stroke/TIA | 2 (4%) | 2 (5%) | 1.00 |
CHA2DS2-VASc score | 0.40 | ||
- 0 | 13 (28%) | 14 (32%) | |
- 1 | 13 (28%) | 12 (27%) | |
- 2 | 16 (35%) | 13 (30%) | |
- 3 | – | 3 (7%) | |
- 4 | 4 (9%) | 2 (5%) | |
HAS-BLED score | 0.43 | ||
- 0 | 26 (57%) | 30 (68%) | |
- 1 | 18 (39%) | 12 (27%) | |
- 2 | 1 (2%) | 2 (5%) | |
- 3 | 1 (2%) | – | |
LA diameter (mm) | 42 ± 5 | 38 ± 6 | 0.003 |
Ischemic cardiomyopathy | 1 (2%) | 0 (0%) | 1.00 |
Type of AF | 0.44 | ||
- Paroxysmal AF | 41 (89%) | 42 (96%) | |
- Persistent AF | 4 (9%) | 2 (5%) | |
- Long-standing persistent AF | 1 (2%) | 0 (0%) | |
Presence of common ostium | 1 (2%) | 3 (7%) | 0.36 |
General anesthesia | 10 (22%) | 11 (25%) | 0.72 |
3.2 Primary endpoints
Group A (N = 46) | Group B (n = 44) | P value | |
---|---|---|---|
Total number of PVs | 183 | 173 | |
Electrical isolation of all PVs | 45 (98%) | 39 (89%) | 0.11 |
Left superior PV | |||
- Electrical isolation | 44/45 (98%) | 41/41 (100%) | 1.00 |
- Number of applications | |||
- 1 application | 35 (78%) | 31 (76%) | 0.81 |
- 180 s application | 20 (44%) | 17 (41%) | 0.78 |
- 2 applications | 5 (11%) | 7 (17%) | |
- > 2 applications | 5 (11%) | 3 (7%) | |
- Minimal balloon temperature (°Celsius) | − 46 (− 51, − 43) | − 47 (− 51, − 44) | 0.36 |
- Time to isolation (sec)* | 55 (41, 77) | 38 (32, 55) | 0.13 |
Left inferior PV | |||
- Electrical isolation | 44/45 (98%) | 39/41 (95%) | 0.60 |
- Number of applications: | |||
- 1 application | 26 (58%) | 25 (61%) | 0.76 |
- 180 s application | 16 (36%) | 11 (27%) | 0.38 |
- 2 applications | 10 (22%) | 10 (24%) | |
- > 2 applications | 9 (20%) | 6 (15%) | |
- Minimal balloon temperature (°Celsius) | − 42 (− 45, − 38) | − 42 (− 47, − 40) | 0.34 |
- Time to isolation (sec)* | 58 (33, 102) | 86 (48, 104) | 0.31 |
Right superior PV | |||
- Electrical isolation | 46/46 (100%) | 41/44 (93%) | 0.11 |
- Number of applications: | |||
- 1 application | 34 (74%) | 32 (73%) | 0.90 |
- 180 s application | 25 (54%) | 21 (48%) | 0.53 |
- 2 applications | 11 (24%) | 9 (20%) | |
- > 2 applications | 1 (2%) | 3 (7%) | |
- Minimal balloon temperature (°Celsius) | − 48 (− 54, − 44) | − 52 (− 55, − 49) | 0.08 |
- Time to isolation (sec)* | 34 (28, 100) | 45 (22, 60) | 1.00 |
Right inferior PV | |||
- Electrical isolation | 45/46 (98%) | 42/44 (96%) | 0.61 |
- Number of applications: | |||
- 1 application | 34 (74%) | 30 (68%) | 0.55 |
- 180 s application | 21 (46%) | 14 (32%) | 0.18 |
- 2 applications | 7 (15%) | 8 (18%) | |
- > 2 applications | 5 (11%) | 6 (14%) | |
- Minimal balloon temperature (°Celsius) | − 45 (− 52, − 40) | − 43 (− 48, − 39) | 0.21 |
- Time to isolation (sec)* | 45 (31, 61) | 48 (37, 65) | 0.66 |
Left common PV | |||
- Electrical isolation | 1 (100%) | 2/3 (67%) | 1.00 |
- Number of applications | |||
- 1 application | – | 1 (33%) | 1.00 |
- > 2 applications | 1 (100%) | 2 (66%) | |
- Minimal balloon temperature (°Celsius) | − 34 | − 40 (− 41, − 39) | 1.00 |
Group A (N = 46) | Group B (n = 44) | P value | |
---|---|---|---|
Total dose area product (cGycm2) | 3232 (2108, 5046) | 1393 (827, 2842) | < 0.001 |
Total effective dose (mSv) | 6.5 (4.2, 10.1) | 2.8 (1.7, 5.7) | < 0.001 |
Total fluoroscopy time (min) | 24 (19, 30) | 19 (12, 23) | < 0.001 |
Total dose (mGy) | 194 (123, 279) | 84 (55, 157) | < 0.001 |
Procedure duration (min) | 108 ± 30 | 99 ± 22 | 0.13 |
Group A (N = 46) | Group B (n = 44) | P value | |
---|---|---|---|
Freedom from AF, without antiarrhythmic drugs | 33 (72%) | 34 (77%) | 0.55 |
Freedom from AF, with or without antiarrhythmic drugs | 34 (74%) | 34 (77%) | 0.71 |
Freedom from atrial arrhythmia, without antiarrhythmic drugs | 32 (70%) | 33 (75%) | 0.57 |
Freedom from atrial arrhythmia, with or without antiarrhythmic drugs | 33 (72%) | 33 (75%) | 0.73 |
Second ablation procedure | 7 (15%) | 5 (11%) | 0.59 |