Table 2B.
Data from included publication concerning the cryoballoon ablation success rate.
| Publication | Freedom of AF after multiple proc. | Complication | Follow-up within 1-year FU | Follow-up after 1-year FU | Quality score |
|---|---|---|---|---|---|
| Neumann T. et al. (2008, GER) | nd | Pericardial tamponade (n=2) | Clinical visit, ECG, 7-day Holter-monitor at 1,3,6,12 month | Clinical visit, ECG, 7-day Holter-monitor annually | 8 |
| Neumann T. et al. (2013, GER) | nd | Pericardial effusion (n=3), Femoral pseudoanerysm (n=2) Femoral arterio-venous fistula (n=1) Transient PNP (11%) TIA (n=1) Transient air embolism (n=2) Groin hematoma (n=5) | Clinical visit, ECG, 7-day Holter-monitor at 1,3,6,12 month | Clinical visit, ECG, 7-day Holter-monitor annually | 8 |
| Wojczik M. et al. (2013, POL, GER) | nd | Pericardial tamponade (n=1) Transient PNP (n=5) Pericardial effusion (n=1) | Clinical visit, ECG,7-day Holter-monitor at 1,3,6,12 month | Clinical visit, ECG, 7-day Holter-monitor annually | 6 |
| Rao J.Y. et al. (2013, BEL) | nd | Pericardial tamponade (n=1) PNP (n=3) | Clinical visit, ECG, Holter-monitor at 1,3,6,12 month Five-day Holter-monitor at 3 or 5 month |
Clinical visit, ECG 6 monthly | 6 |
| Metzner A. et al. (2014, GER) | nd | Transient PNP (n=1) | Clinical visit, Holter-monitor at 3, 6, 12 month | - | 6 |
| Metzner A. et al. (2015, GER) | 88% * | Transient PNP (n=2) | Clinical visit, Holter-monitor at 3, 6, 12, 24 month | - | 6 |
| Bohó A. et al. (2015, SV) | nd | Transient PNP (n=7) Persistent PNP (n=7) Embolic complication (n=3) TIA (n= 2) Vascular complication (n=9) Pericardial tamponade (n=2) |
Clinical visit, Holter-monitor at 3,6,9,12 month | Clinical visit, Holter-monitor 6 monthly | 8 |
ECG=electrocardiogram, n=number, nd=no data, PNP= phrenic nerve palsy, TIA= transient ischaemic attack, *=freedom from AF after not-only PVI.
rate as the percentage of patients who remained free of atrial fibrillation and/or atrial flutter or atrial tachycardia with or without anti-arrhythmic drug (AAD) therapy following a 3-months blanking period or those not requiring redo procedures. All studies observed a gradual decrease in arrhythmia-free survival rate over time. Among the observational studies, no studies were judged to be at low risk of bias, six studies were at medium risk of bias, and six studies were evaluated to be at high risk of bias. The quality assessment of the involved studies is reported in Supplement Tables S1 and S2. The only one RCT included in this review demonstrated a medium risk of bias within one or more areas of study quality using Cochrane Collaboration’s tool (Supplement Table S3).