Table 2.
Efficacy and Safety End Points
| Variable | Total Sample (n=2497) | Normal Weight (n=711) | Pre‐Obese (n=1092) | Obese (n=508) | Morbidly Obese (n=186) | Overall P Value |
|---|---|---|---|---|---|---|
| Efficacy | ||||||
| Pulmonary vein isolation | 99.0% (2473) | 99.3% (706) | 98.9% (1080) | 99.0% (503) | 98.9% (184) | 0.863 |
| Relapse during blanking | 25.0% (504) | 24.1% (141) | 22.6% (194) | 28.1% (119) | 34.7% (50) | 0.007 |
| Relapse during first 12 mo | 38.1% (916) | 35.2% (241) | 35.7% (374) | 43.6% (216) | 48.0% (85) | <0.001 |
| Safety | ||||||
| Per‐procedural complications | 6.1% (151) | 7.0% (49) | 5.9% (64) | 5.3% (27) | 5.9% (11) | 0.680 |
| Cardiac tamponade | 0.7% (18) | 0.3% (2) | 0.9% (10) | 0.8% (4) | 1.1% (2) | 0.414 |
| TIA | 0.1% (3) | 0.1% (1) | 0.2% (2) | 0% (0) | 0% (0) | 0.748 |
| Stroke | 0.2% (6) | 0.1% (1) | 0.3% (3) | 0.4% (2) | 0% (0) | 0.730 |
| Transient phrenic nerve palsy | 1.5% (37) | 1.5% (11) | 1.5% (16) | 0.8% (4) | 3.2% (6) | 0.134 |
| Major vascular complications | 2.6% (65) | 3.5% (25) | 2.5% (27) | 2.4% (12) | 0.5% (1) | 0.130 |
| Procedure‐related deatha | 0.1% (1) | 0% (0) | 0.1% (1) | 0% (0) | 0% (0) | 0.732 |
| Other complicationsb | 0.8% (21) | 1.3% (9) | 0.5% (5) | 1.0% (5) | 1.1% (2) | 0.295 |
| Other complications | ||||||
| Esophageal fistula | 0.1% (2) | 0% (0) | 0% (0) | 0.2% (1) | 0.5% (1) | 0.067 |
| Gastroparesis | 0.1% (2) | 0.1% (1) | 0% (0) | 0.1% (1) | 0% (0) | 0.529 |
| Esophageal ulcer | 0.1% (1) | 0.1% (1) | 0% (0) | 0% (0) | 0% (0) | 0.473 |
| Non‐access related bleeds | 0.2% (6) | 0.6% (4) | 0.1% (1) | 0.1% (1) | 0% (0) | 0.206 |
| Bradyarrhythmic complications | 0.2% (5) | 0.1% (1) | 0.3% (3) | 0.2% (1) | 0% (0) | 0.849 |
| Anaphylaxis | 0.1% (1) | 0%(0) | 0.1% (1) | 0% (0) | 0% (0) | 0.732 |
| Transient myocardial stunning | 0.1% (1) | 0% (0) | 0% (0) | 0.2% (1) | 0% (0) | 0.271 |
| PV stenosis | 0.1% (1) | 0.1% (1) | 0% (0) | 0% (0) | 0% (0) | 0.473 |
| Air embolism | 0.1% (1) | 0.1% (1) | 0% (0) | 0% (0) | 0% (0) | 0.473 |
| Acute pulmonary edema | 0.1% (1) | 0% (0) | 0% (0) | 0% (0) | 0.5% (1) | 0.006 |
Values are given as number and (%), and incidence and (95% CI). TIA indicates transient ischemic attack.
Death occurred as a result of diffuse lung bleed without identifiable source.
Other complications are as follows: normal weight patients: haemothorax and haemomediastinum (n=1), upper gastrointestinal bleed (n=1), haematuria (n=1), haemoptysis (n=1), gastroparesis (n=1), esophageal ulcer (n=1), and complete atrioventricular block (n=1), PV stenosis (n=1), and air embolism into coronary artery (n=1); Pre‐obese patients: upper gastrointestinal bleed (n=1), sinus node dysfunction requiring permanent pacemaker implant (n=2), reversible period of complete atrioventricular block (n=1), and anaphylactic shock (n=1); Obese: haemoptysis (n=1), sinus node dysfunction requiring permanent pacemaker implant (n=1), esophageal fistula (n=1), temporary myocardial stunning with transient drop in left ventricular ejection fraction (n=1), and gastroparesis (n=1); Mordibly obese: esophageal fistula (n=1), and acute pulmonary edema (n=1). PV indicates pulmonary vein.