| Trials | N | Age | Inclusions | Atrial Arrhythmias Outcome (Ablation vs. AAD) | Ablation Better? |
|---|---|---|---|---|---|
| RAAFT-1 | 70 | 54 | Symptomatic AF (97% parox) Monthly episodes > 3mos |
Recurrence symp AF 13% vs. 63% at 1yr; P<0.001 (Quarterly event recorder) |
Yes, but N was small. |
| MANTRA PAF | 294 | 55 | Symptomatic Parox AF 2+ episodes in 6mos No episode > 7d |
AF Burden 13% vs. 19% at 24mos; P=0.10 (Quarterly holter) |
No |
| RAAFT-2 | 127 | 55 | Symptomatic Parox AF <4 episodes in 6mos |
Recurrence Atrial Arrhythmias 54.5 vs. 72.1% at 24mos; P=0.02 (Biweekly transtelephonic) |
Yes, but not by much. |
| Adverse Events | RFA (N = 167) | CBA (N = 135) | PFA (N = 305) |
|---|---|---|---|
| Procedure related SERIOUS adverse events | 7 (4.2%) | 2 (1.5%) | 20 (6.6%) |
| Any procedure related adverse events | 58 (34.7%) | 36 (26.7%) | 97 (31.8%) |
|
CBA: Cryoballoon ablation; PFA: Pulsed field ablation; RFA: Radiofrequency ablation
Ref: ADVENT Trial
|
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| Adverse Event | Incidence N (%) | ||
|---|---|---|---|
| Procedure-related SERIOUS adverse events | 100 (3.4%) | ||
| Recurrences Atrial Arrhythmias | 25 (0.9%) | ||
| Groin Complication | 20 (0.7%) | ||
| Phrenic Nerve Injury | 15 (0.5%) | ||
| Cardiac Tamponade or effusion | 11 (0.4%) | ||
| Stroke/TIA | 5 (0.2%) | ||
| Death within 30d | 3 (0.1%) | ||
| Ref: Cryo AF Global Registry | |||
| Variable | Immediate Recovery (n=455) | Early Recovery (n=127) | Delayed Recovery (n=109) | P Value |
|---|---|---|---|---|
| Age (y) | 64 (54–72) | 65 (57–73) | 66 (58–71) | 0.212 |
| Body Mass Index (kg/m²) | 26.0 (23.9–29.5) | 24.5 (22.6–27.4) | 26.7 (23.3–30.7) | 0.002 |
| Temperature at PNI (°C) | −47.3±8.5 | −49.6±6.0 | −50.1±6.4 | <0.001 |
| Time to PNI (s) | 136.8±58.6 | 137.5±50.1 | 121.5±51.5 | 0.037 |
| Bonus Freeze Protocol n (%) | 191 (41.9) | 39 (30.7) | 22 (20.2) | 0.001 |
| Utilization of CMAP n (%) | 226 (49.7) | 81 (63.8) | 66 (60.6) | 0.006 |
| CMAP Amplitude Loss >30% n (%) | 90 (20.2) | 36 (28.6) | 46 (42.2) | <0.001 |
| Double-stop Technique at Time of PNI n (%) | 450 (98.9) | 122 (96.1) | 103 (94.5) | 0.009 |
| PV Diameter (mm) | 19.3 (17.4–22.1) | 22.1 (18.2–24.6) | 20.1 (17.2–21.5) | 0.019 |
|
Immediate recovery=recovery until discharge. Early recovery=recovery within 3 mo. Delayed recovery=recovery >3 mo. CMAP indicates compound motor action potential; PNI = Phrenic Nerve Injury
Ref: YETI Registry
|
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