Table 6.
Adverse events at 1 year follow-up
| Cryo or RF energy | p | Cryo energy | p | RF energy | p | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Total | Adenosine | No adenosine | Total | Adenosine | No adenosine | RF | Adenosine | No adenosine | ||||
| Permanent pacemaker implantation | 23/131 (17.6%) | 1/15 (6.7%) | 22/116 (19.0%) | 0.468(NS) | 0/24 (0.0%) | 0/5 (0.0%) | 0/19 (0.0%) | NA | 23/107 (21.5%) | 1/10 (10.0%) | 22/97 (22.7%) | 0.686(NS) |
| Cardiovascular | 31/3057 (1.0%) | 3/314 (1.0%) | 28/2743 (1.0%) | 1.000(NS) | 3/494 (0.6%) | 0/71 (0.0%) | 3/423 (0.7%) | 1.000(NS) | 28/2563 (1.1%) | 3/243 (1.2%) | 25/2320 (1.1%) | 0.744(NS) |
| Cardiac Arrest | 0/3057 (0.0%) | 0/314 (0.0%) | 0/2743 (0.0%) | NA | 0/494 (0.0%) | 0/71 (0.0%) | 0/423 (0.0%) | NA | 0/2563 (0.0%) | 0/243 (0.0%) | 0/2320 (0.0%) | NA |
| Air Embolism | 1/3057 (0.0%) | 0/314 (0.0%) | 1/2743 (0.0%) | 1.000(NS) | 0/494 (0.0%) | 0/71 (0.0%) | 0/423 (0.0%) | NA | 1/2563 (0.0%) | 0/243 (0.0%) | 1/2320 (0.0%) | 1.000(NS) |
| Endocarditis | 1/3057 (0.0%) | 0/314 (0.0%) | 1/2743 (0.0%) | 1.000(NS) | 0/494 (0.0%) | 0/71 (0.0%) | 0/423 (0.0%) | NA | 1/2563 (0.0%) | 0/243 (0.0%) | 1/2320 (0.0%) | 1.000(NS) |
| Myocardial Infarction | 2/3057 (0.1%) | 0/314 (0.0%) | 2/2743 (0.1%) | 1.000(NS) | 0/494 (0.0%) | 0/71 (0.0%) | 0/423 (0.0%) | NA | 2/2563 (0.1%) | 0/243 (0.0%) | 2/2320 (0.1%) | 1.000(NS) |
| Cardiac perforation | 6/3057 (0.2%) | 0/314 (0.0%) | 6/2743 (0.2%) | 1.000(NS) | 1/494 (0.2%) | 0/71 (0.0%) | 1/423 (0.2%) | 1.000(NS) | 5/2563 (0.2%) | 0/243 (0.0%) | 5/2320 (0.2%) | 1.000(NS) |
| Bradycardia Requiring Pacemaker | 5/3057 (0.2%) | 0/314 (0.0%) | 5/2743 (0.2%) | 1.000(NS) | 0/494 (0.0%) | 0/71 (0.0%) | 0/423 (0.0%) | NA | 5/2563 (0.2%) | 0/243 (0.0%) | 5/2320 (0.2%) | 1.000(NS) |
| Cardiac Thromboembolic Event | 0/3057 (0.0%) | 0/314 (0.0%) | 0/2743 (0.0%) | NA | 0/494 (0.0%) | 0/71 (0.0%) | 0/423 (0.0%) | NA | 0/2563 (0.0%) | 0/243 (0.0%) | 0/2320 (0.0%) | NA |
| Heart Valve Damage | 1/3057 (0.0%) | 0/314 (0.0%) | 1/2743 (0.0%) | 1.000(NS) | 0/494 (0.0%) | 0/71 (0.0%) | 0/423 (0.0%) | NA | 1/2563 (0.0%) | 0/243 (0.0%) | 1/2320 (0.0%) | 1.000(NS) |
| Pericarditis | 4/3057 (0.1%) | 1/314 (0.3%) | 3/2743 (0.1%) | 0.352(NS) | 0/494 (0.0%) | 0/71 (0.0%) | 0/423 (0.0%) | NA | 4/2563 (0.2%) | 1/243 (0.4%) | 3/2320 (0.1%) | 0.329(NS) |
| Other | 14/3057 (0.5%) | 2/314 (0.6%) | 12/2743 (0.4%) | 0.648(NS) | 1/494 (0.2%) | 0/71 (0.0%) | 1/423 (0.2%) | 1.000(NS) | 13/2563 (0.5%) | 2/243 (0.8%) | 11/2320 (0.5%) | 0.353(NS) |
| General | 3/3057 (0.1%) | 1/314 (0.3%) | 2/2743 (0.1%) | 0.278(NS) | 1/494 (0.2%) | 1/71 (1.4%) | 0/423 (0.0%) | 0.144(NS) | 2/2563 (0.1%) | 0/243 (0.0%) | 2/2320 (0.1%) | 1.000(NS) |
| Allergic Reaction | 2/3057 (0.1%) | 1/314 (0.3%) | 1/2743 (0.0%) | 0.195(NS) | 1/494 (0.2%) | 1/71 (1.4%) | 0/423 (0.0%) | 0.144(NS) | 1/2563 (0.0%) | 0/243 (0.0%) | 1/2320 (0.0%) | 1.000(NS) |
| Sepsis | 0/3057 (0.0%) | 0/314 (0.0%) | 0/2743 (0.0%) | NA | 0/494 (0.0%) | 0/71 (0.0%) | 0/423 (0.0%) | NA | 0/2563 (0.0%) | 0/243 (0.0%) | 0/2320 (0.0%) | NA |
| Gastrointestinal | 4/3057 (0.1%) | 1/314 (0.3%) | 3/2743 (0.1%) | 0.352(NS) | 2/494 (0.4%) | 1/71 (1.4%) | 1/423 (0.2%) | 0.267(NS) | 2/2563 (0.1%) | 0/243 (0.0%) | 2/2320 (0.1%) | 1.000(NS) |
| Esophageal Fistula or perforation | 0/3057 (0.0%) | 0/314 (0.0%) | 0/2743 (0.0%) | NA | 0/494 (0.0%) | 0/71 (0.0%) | 0/423 (0.0%) | NA | 0/2563 (0.0%) | 0/243 (0.0%) | 0/2320 (0.0%) | NA |
| Esophageal ulceration | 0/3057 (0.0%) | 0/314 (0.0%) | 0/2743 (0.0%) | NA | 0/494 (0.0%) | 0/71 (0.0%) | 0/423 (0.0%) | NA | 0/2563 (0.0%) | 0/243 (0.0%) | 0/2320 (0.0%) | NA |
| Neurological | 8/3057 (0.3%) | 3/314 (1.0%) | 5/2743 (0.2%) | 0.041(S) | 3/494 (0.6%) | 2/71 (2.8%) | 1/423 (0.2%) | 0.055(NS) | 5/2563 (0.2%) | 1/243 (0.4%) | 4/2320 (0.2%) | 0.393(NS) |
| Stroke | 1/3057 (0.0%) | 0/314 (0.0%) | 1/2743 (0.0%) | 1.000(NS) | 0/494 (0.0%) | 0/71 (0.0%) | 0/423 (0.0%) | NA | 1/2563 (0.0%) | 0/243 (0.0%) | 1/2320 (0.0%) | 1.000(NS) |
| TIA | 5/3057 (0.2%) | 1/314 (0.3%) | 4/2743 (0.1%) | 0.419(NS) | 1/494 (0.2%) | 0/71 (0.0%) | 1/423 (0.2%) | 1.000(NS) | 4/2563 (0.2%) | 1/243 (0.4%) | 3/2320 (0.1%) | 0.329(NS) |
| Phrenic Nerve Damage | 2/2973 (0.1%) | 2/304 (0.7%) | 0/2669 (0.0%) | 0.010(S) | 2/480 (0.4%) | 2/68 (2.9%) | 0/412 (0.0%) | 0.020(S) | 0/2493 (0.0%) | 0/236 (0.0%) | 0/2257 (0.0%) | NA |
| Vagal nerve injury | 0/3057 (0.0%) | 0/314 (0.0%) | 0/2743 (0.0%) | NA | 0/494 (0.0%) | 0/71 (0.0%) | 0/423 (0.0%) | NA | 0/2563 (0.0%) | 0/243 (0.0%) | 0/2320 (0.0%) | NA |
| Peripheral nerve injury | 0/3057 (0.0%) | 0/314 (0.0%) | 0/2743 (0.0%) | NA | 0/494 (0.0%) | 0/71 (0.0%) | 0/423 (0.0%) | NA | 0/2563 (0.0%) | 0/243 (0.0%) | 0/2320 (0.0%) | NA |
| Peripheral-vascular | 21/3057 (0.7%) | 1/314 (0.3%) | 20/2743 (0.7%) | 0.717(NS) | 5/494 (1.0%) | 0/71 (0.0%) | 5/423 (1.2%) | 1.000(NS) | 16/2563 (0.6%) | 1/243 (0.4%) | 15/2320 (0.6%) | 1.000(NS) |
| AV fistula | 8/2973 (0.3%) | 0/304 (0.0%) | 8/2669 (0.3%) | 1.000(NS) | 3/480 (0.6%) | 0/68 (0.0%) | 3/412 (0.7%) | 1.000(NS) | 5/2493 (0.2%) | 0/236 (0.0%) | 5/2257 (0.2%) | 1.000(NS) |
| DVT | 2/3057 (0.1%) | 0/314 (0.0%) | 2/2743 (0.1%) | 1.000(NS) | 0/494 (0.0%) | 0/71 (0.0%) | 0/423 (0.0%) | NA | 2/2563 (0.1%) | 0/243 (0.0%) | 2/2320 (0.1%) | 1.000(NS) |
| Peripheral thromboembolic event | 1/3057 (0.0%) | 0/314 (0.0%) | 1/2743 (0.0%) | 1.000(NS) | 0/494 (0.0%) | 0/71 (0.0%) | 0/423 (0.0%) | NA | 1/2563 (0.0%) | 0/243 (0.0%) | 1/2320 (0.0%) | 1.000(NS) |
| Pseudoaneurysm | 9/2973 (0.3%) | 1/304 (0.3%) | 8/2669 (0.3%) | 1.000(NS) | 3/480 (0.6%) | 0/68 (0.0%) | 3/412 (0.7%) | 1.000(NS) | 6/2493 (0.2%) | 1/236 (0.4%) | 5/2257 (0.2%) | 0.450(NS) |
| Hematoma or bleeding requiring evacuation or transfusion | 3/3057 (0.1%) | 0/314 (0.0%) | 3/2743 (0.1%) | 1.000(NS) | 0/494 (0.0%) | 0/71 (0.0%) | 0/423 (0.0%) | NA | 3/2563 (0.1%) | 0/243 (0.0%) | 3/2320 (0.1%) | 1.000(NS) |
| Bleeding requiring transfusion | 0/3057 (0.0%) | 0/314 (0.0%) | 0/2743 (0.0%) | NA | 0/494 (0.0%) | 0/71 (0.0%) | 0/423 (0.0%) | NA | 0/2563 (0.0%) | 0/243 (0.0%) | 0/2320 (0.0%) | NA |
| Pulmonary | 10/3057 (0.3%) | 1/314 (0.3%) | 9/2743 (0.3%) | 1.000(NS) | 2/494 (0.4%) | 1/71 (1.4%) | 1/423 (0.2%) | 0.267(NS) | 8/2563 (0.3%) | 0/243 (0.0%) | 8/2320 (0.3%) | 1.000(NS) |
| Hemotorax | 0/3057 (0.0%) | 0/314 (0.0%) | 0/2743 (0.0%) | NA | 0/494 (0.0%) | 0/71 (0.0%) | 0/423 (0.0%) | NA | 0/2563 (0.0%) | 0/243 (0.0%) | 0/2320 (0.0%) | NA |
| Pneumotorax | 3/3057 (0.1%) | 0/314 (0.0%) | 3/2743 (0.1%) | 1.000(NS) | 0/494 (0.0%) | 0/71 (0.0%) | 0/423 (0.0%) | NA | 3/2563 (0.1%) | 0/243 (0.0%) | 3/2320 (0.1%) | 1.000(NS) |
| Pulmonary vein damage/dissection | 0/3057 (0.0%) | 0/314 (0.0%) | 0/2743 (0.0%) | NA | 0/494 (0.0%) | 0/71 (0.0%) | 0/423 (0.0%) | NA | 0/2563 (0.0%) | 0/243 (0.0%) | 0/2320 (0.0%) | NA |
| Pulmonary vein stenosis | 4/3057 (0.1%) | 0/314 (0.0%) | 4/2743 (0.1%) | 1.000(NS) | 0/494 (0.0%) | 0/71 (0.0%) | 0/423 (0.0%) | NA | 4/2563 (0.2%) | 0/243 (0.0%) | 4/2320 (0.2%) | 1.000(NS) |
| Pleural Effusion | 0/3057 (0.0%) | 0/314 (0.0%) | 0/2743 (0.0%) | NA | 0/494 (0.0%) | 0/71 (0.0%) | 0/423 (0.0%) | NA | 0/2563 (0.0%) | 0/243 (0.0%) | 0/2320 (0.0%) | NA |
| Pulmonary embolism | 0/3057 (0.0%) | 0/314 (0.0%) | 0/2743 (0.0%) | NA | 0/494 (0.0%) | 0/71 (0.0%) | 0/423 (0.0%) | NA | 0/2563 (0.0%) | 0/243 (0.0%) | 0/2320 (0.0%) | NA |
| Pulmonary vein thrombosis | 0/3057 (0.0%) | 0/314 (0.0%) | 0/2743 (0.0%) | NA | 0/494 (0.0%) | 0/71 (0.0%) | 0/423 (0.0%) | NA | 0/2563 (0.0%) | 0/243 (0.0%) | 0/2320 (0.0%) | NA |
| Pneumonia | 3/3057 (0.1%) | 1/314 (0.3%) | 2/2743 (0.1%) | 0.278(NS) | 2/494 (0.4%) | 1/71 (1.4%) | 1/423 (0.2%) | 0.267(NS) | 1/2563 (0.0%) | 0/243 (0.0%) | 1/2320 (0.0%) | 1.000(NS) |
| Other | 48/3057 (1.6%) | 6/314 (1.9%) | 42/2743 (1.5%) | 0.628(NS) | 9/494 (1.8%) | 1/71 (1.4%) | 8/423 (1.9%) | 1.000(NS) | 39/2563 (1.5%) | 5/243 (2.1%) | 34/2320 (1.5%) | 0.411(NS) |
AV arteriovenous, DVT deep vein thrombosis, NA not applicable, NS non significant, RF radio frequency, S significant, TIA transient ischemic attack