Table 5.
Adverse events
| Cryo or RF energy | p | Cryo energy | p | RF energy | p | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Total | Adenosine | No adenosine | Total | Adenosine | No adenosine | RF | Adenosine | No adenosine | ||||
| Cardiovascular | ||||||||||||
| Cardiac arrest | 3/3430 (0.1%) | 0/360 (0.0%) | 3/3070 (0.1%) | 1.000(NS)† | 0/543 (0.0%) | 0/74 (0.0%) | 0/469 (0.0%) | NA | 3/2887 (0.1%) | 0/286 (0.0%) | 3/2601 (0.1%) | 1.000(NS)† |
| Air embolism | 8/3430 (0.2%) | 1/360 (0.3%) | 7/3070 (0.2%) | 0.589(NS)† | 3/543 (0.6%) | 0/74 (0.0%) | 3/469 (0.6%) | 1.000(NS)† | 5/2887 (0.2%) | 1/286 (0.3%) | 4/2601 (0.2%) | 0.407(NS)† |
| Endocarditis | 0/3430 (0.0%) | 0/360 (0.0%) | 0/3070 (0.0%) | NA | 0/543 (0.0%) | 0/74 (0.0%) | 0/469 (0.0%) | NA | 0/2887 (0.0%) | 0/286 (0.0%) | 0/2601 (0.0%) | NA |
| Myocardial infarction | 0/3430 (0.0%) | 0/360 (0.0%) | 0/3070 (0.0%) | NA | 0/543 (0.0%) | 0/74 (0.0%) | 0/469 (0.0%) | NA | 0/2887 (0.0%) | 0/286 (0.0%) | 0/2601 (0.0%) | NA |
| Cardiac perforation | 46/3430 (1.3%) | 1/360 (0.3%) | 45/3070 (1.5%) | 0.084(NS)† | 7/543 (1.3%) | 0/74 (0.0%) | 7/469 (1.5%) | 0.601(NS)† | 39/2887 (1.4%) | 1/286 (0.3%) | 38/2601 (1.5%) | 0.174(NS)† |
| Bradycardia requiring pacemaker | 5/3431 (0.1%) | 0/360 (0.0%) | 5/3071 (0.2%) | 1.000(NS)† | 0/543 (0.0%) | 0/74 (0.0%) | 0/469 (0.0%) | NA | 5/2888 (0.2%) | 0/286 (0.0%) | 5/2602 (0.2%) | 1.000(NS)† |
| Cardiac thromboembolic event | 2/3430 (0.1%) | 1/360 (0.3%) | 1/3070 (0.0%) | 0.199(NS)† | 1/543 (0.2%) | 0/74 (0.0%) | 1/469 (0.2%) | 1.000(NS)† | 1/2887 (0.0%) | 1/286 (0.3%) | 0/2601 (0.0%) | 0.099(NS)† |
| Heart valve damage | 1/3430 (0.0%) | 0/360 (0.0%) | 1/3070 (0.0%) | 1.000(NS)† | 0/543 (0.0%) | 0/74 (0.0%) | 0/469 (0.0%) | NA | 1/2887 (0.0%) | 0/286 (0.0%) | 1/2601 (0.0%) | 1.000(NS)† |
| Pericarditis | 26/3431 (0.8%) | 6/360 (1.7%) | 20/3071 (0.7%) | 0.048(S)† | 0/543 (0.0%) | 0/74 (0.0%) | 0/469 (0.0%) | NA | 26/2888 (0.9%) | 6/286 (2.1%) | 20/2602 (0.8%) | 0.038(S)† |
| Other | 50/3434 (1.5%) | 8/360 (2.2%) | 42/3074 (1.4%) | 0.200(NS) | 3/543 (0.6%) | 0/74 (0.0%) | 3/469 (0.6%) | 1.000(NS)† | 47/2891 (1.6%) | 8/286 (2.8%) | 39/2605 (1.5%) | 0.132(NS)† |
| General | ||||||||||||
| Allergic reaction | 9/3435 (0.3%) | 1/360 (0.3%) | 8/3075 (0.3%) | 1.000(NS)† | 3/543 (0.6%) | 0/74 (0.0%) | 3/469 (0.6%) | 1.000(NS)† | 6/2892 (0.2%) | 1/286 (0.3%) | 5/2606 (0.2%) | 0.465(NS)† |
| Sepsis | 1/3436 (0.0%) | 0/360 (0.0%) | 1/3076 (0.0%) | 1.000(NS)† | 0/543 (0.0%) | 0/74 (0.0%) | 0/469 (0.0%) | NA | 1/2893 (0.0%) | 0/286 (0.0%) | 1/2607 (0.0%) | 1.000(NS)† |
| Gastrointestinal | ||||||||||||
| Esophageal ulceration | 2/3437 (0.1%) | 1/360 (0.3%) | 1/3077 (0.0%) | 0.199(NS)† | 0/543 (0.0%) | 0/74 (0.0%) | 0/469 (0.0%) | NA | 2/2894 (0.1%) | 1/286 (0.3%) | 1/2608 (0.0%) | 0.188(NS)† |
| Esophageal fistula or perforation | 1/3437 (0.0%) | 0/360 (0.0%) | 1/3077 (0.0%) | 1.000(NS)† | 0/543 (0.0%) | 0/74 (0.0%) | 0/469 (0.0%) | NA | 1/2894 (0.0%) | 0/286 (0.0%) | 1/2608 (0.0%) | 1.000(NS)† |
| Neurological | ||||||||||||
| Stroke | 1/3437 (0.0%) | 0/360 (0.0%) | 1/3077 (0.0%) | 1.000(NS)† | 0/543 (0.0%) | 0/74 (0.0%) | 0/469 (0.0%) | NA | 1/2894 (0.0%) | 0/286 (0.0%) | 1/2608 (0.0%) | 1.000(NS)† |
| TIA | 8/3436 (0.2%) | 1/360 (0.3%) | 7/3076 (0.2%) | 0.588(NS)† | 3/543 (0.6%) | 0/74 (0.0%) | 3/469 (0.6%) | 1.000(NS)† | 5/2893 (0.2%) | 1/286 (0.3%) | 4/2607 (0.2%) | 0.406(NS)† |
| Phrenic nerve damage | 13/3436 (0.4%) | 4/360 (1.1%) | 9/3076 (0.3%) | 0.039(S)† | 11/543 (2.0%) | 4/74 (5.4%) | 7/469 (1.5%) | 0.050(S)† | 2/2893 (0.1%) | 0/286 (0.0%) | 2/2607 (0.1%) | 1.000(NS)† |
| Vagal nerve injury | 0/3436 (0.0%) | 0/360 (0.0%) | 0/3076 (0.0%) | NA | 0/543 (0.0%) | 0/74 (0.0%) | 0/469 (0.0%) | NA | 0/2893 (0.0%) | 0/286 (0.0%) | 0/2607 (0.0%) | NA |
| Peripheral nerve injury | 0/3436 (0.0%) | 0/360 (0.0%) | 0/3076 (0.0%) | NA | 0/543 (0.0%) | 0/74 (0.0%) | 0/469 (0.0%) | NA | 0/2893 (0.0%) | 0/286 (0.0%) | 0/2607 (0.0%) | NA |
| Peripheral/vascular | ||||||||||||
| AV fistula | 14/3435 (0.4%) | 2/360 (0.6%) | 12/3075 (0.4%) | 0.652(NS)† | 1/542 (0.2%) | 0/74 (0.0%) | 1/468 (0.2%) | 1.000(NS)† | 13/2893 (0.4%) | 2/286 (0.7%) | 11/2607 (0.4%) | 0.373(NS)† |
| DVT | 0/3433 (0.0%) | 0/360 (0.0%) | 0/3073 (0.0%) | NA | 0/542 (0.0%) | 0/74 (0.0%) | 0/468 (0.0%) | NA | 0/2891 (0.0%) | 0/286 (0.0%) | 0/2605 (0.0%) | NA |
| Peripheral thromboembolic event | 0/3433 (0.0%) | 0/360 (0.0%) | 0/3073 (0.0%) | NA | 0/542 (0.0%) | 0/74 (0.0%) | 0/468 (0.0%) | NA | 0/2891 (0.0%) | 0/286 (0.0%) | 0/2605 (0.0%) | NA |
| Pseudoaneurysm | 16/3433 (0.5%) | 1/360 (0.3%) | 15/3073 (0.5%) | 1.000(NS)† | 3/542 (0.6%) | 0/74 (0.0%) | 3/468 (0.6%) | 1.000(NS)† | 13/2891 (0.4%) | 1/286 (0.3%) | 12/2605 (0.5%) | 1.000(NS)† |
| Hematoma or bleeding requiring evacuation or transfusion | 12/3434 (0.3%) | 0/360 (0.0%) | 12/3074 (0.4%) | 0.627(NS)† | 4/543 (0.7%) | 0/74 (0.0%) | 4/469 (0.9%) | 1.000(NS)† | 8/2891 (0.3%) | 0/286 (0.0%) | 8/2605 (0.3%) | 1.000(NS)† |
| Bleeding requiring transfusion | 4/3433 (0.1%) | 2/360 (0.6%) | 2/3073 (0.1%) | 0.057(NS)† | 1/542 (0.2%) | 1/74 (1.4%) | 0/468 (0.0%) | 0.137(NS)† | 3/2891 (0.1%) | 1/286 (0.3%) | 2/2605 (0.1%) | 0.268(NS)† |
| Pulmonary | ||||||||||||
| Hemothorax | 1/3437 (0.0%) | 0/360 (0.0%) | 1/3077 (0.0%) | 1.000(NS)† | 0/543 (0.0%) | 0/74 (0.0%) | 0/469 (0.0%) | NA | 1/2894 (0.0%) | 0/286 (0.0%) | 1/2608 (0.0%) | 1.000(NS)† |
| Pneumothorax | 2/3437 (0.1%) | 0/360 (0.0%) | 2/3077 (0.1%) | 1.000(NS)† | 0/543 (0.0%) | 0/74 (0.0%) | 0/469 (0.0%) | NA | 2/2894 (0.1%) | 0/286 (0.0%) | 2/2608 (0.1%) | 1.000(NS)† |
| Pulmonary vein damage/dissection | 0/3437 (0.0%) | 0/360 (0.0%) | 0/3077 (0.0%) | NA | 0/543 (0.0%) | 0/74 (0.0%) | 0/469 (0.0%) | NA | 0/2894 (0.0%) | 0/286 (0.0%) | 0/2608 (0.0%) | NA |
| Pulmonary vein stenosis | 3/3437 (0.1%) | 2/360 (0.6%) | 1/3077 (0.0%) | 0.031(S)† | 0/543 (0.0%) | 0/74 (0.0%) | 0/469 (0.0%) | NA | 3/2894 (0.1%) | 2/286 (0.7%) | 1/2608 (0.0%) | 0.027(S)† |
| Pleural effusion | 5/3437 (0.1%) | 1/360 (0.3%) | 4/3077 (0.1%) | 0.425(NS)† | 1/543 (0.2%) | 0/74 (0.0%) | 1/469 (0.2%) | 1.000(NS)† | 4/2894 (0.1%) | 1/286 (0.3%) | 3/2608 (0.1%) | 0.341(NS)† |
| Pulmonary embolism | 0/3437 (0.0%) | 0/360 (0.0%) | 0/3077 (0.0%) | NA | 0/543 (0.0%) | 0/74 (0.0%) | 0/469 (0.0%) | NA | 0/2894 (0.0%) | 0/286 (0.0%) | 0/2608 (0.0%) | NA |
| Pulmonary vein thrombosis | 0/3437 (0.0%) | 0/360 (0.0%) | 0/3077 (0.0%) | NA | 0/543 (0.0%) | 0/74 (0.0%) | 0/469 (0.0%) | NA | 0/2894 (0.0%) | 0/286 (0.0%) | 0/2608 (0.0%) | NA |
| Pneumonia | 0/3437 (0.0%) | 0/360 (0.0%) | 0/3077 (0.0%) | NA | 0/543 (0.0%) | 0/74 (0.0%) | 0/469 (0.0%) | NA | 0/2894 (0.0%) | 0/286 (0.0%) | 0/2608 (0.0%) | NA |
| Other | 54/3436 (1.6%) | 10/360 (2.8%) | 44/3076 (1.4%) | 0.052(NS) | 7/543 (1.3%) | 2/74 (2.7%) | 5/469 (1.1%) | 0.245(NS)† | 47/2893 (1.6%) | 8/286 (2.8%) | 39/2607 (1.5%) | 0.131(NS)† |