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Aims Cryoballoon (CB) pulmonary vein isolation (PVI) is an accepted ablation strategy for rhythm control in atrial fibrillation (AF). We describe efficacy and safety in a high volume centre with a long experience in the use of the second-generation CB (CB2). Methods and results Consecutive paroxysmal AF (PAF) or persistent AF (persAF) patients undergoing CB2-PVI were enrolled. Procedural data, efficacy, and safety issues were systematically collected. The 28 mm CB2 was used in combination with an inner lumen spiral catheter, a luminal oesophageal temperature (LET) probe was used with a cut-off of 15°C, the phrenic nerve (PN) monitored during septal PVs ablation. Freeze duration was mainly set at 240 s with a bonus application in case of delayed time-to-isolation (TTI > 75 s). A total of 1017 CB2 procedures were analysed (58% male, 66 ± 12 years old, 70% with PAF). 3964 PVs were identified, 99.8% PVs isolated using solely the 28 mm CB. Mean procedure time was 69 ± 25 min, TTI during the first application was recorded in 77% of PVs after a mean of 48 ± 31 s. We recorded 0.2% cardiac tamponade, 4.8% PN injury (1.6% of PN palsy), and 19% of LET < 15°C. Among 725 patients with follow-up data, 84% with PAF and 75% with persAF were in stable SR at 1 year. Shorter freezing duration and longer TTI were procedural predictors for recurrence. Conclusion Cryoballoon procedures are fast and associated with a benign safety profile. Shorter TTI and longer freeze durations are associated with sinus rhythm during follow-up.

AimsSystematic data on phrenic nerve palsy (PNP) associated with contemporary balloon ablation techniques (cryoballoon [CBA] vs laser balloon [LBA]) are sparse. We aimed to investigate the incidence, characteristics, and clinical recovery course in patients with PNP who underwent CBA or LBA.Methods and ResultsA total of 2433 consecutive patients who underwent balloon‐based pulmonary vein isolation (CBA: n = 1720 and LBA: n = 713) were retrospectively identified. PNP was classified into (a) transient (recovery before discharge) or (b) persistent (within 6 months, 6‐12 months, and >12 months) according to clinical recovery course. In general, PNP occurred significantly more often in CBA 71/1720 (4.2%) than LBA 11/713 (1.5%) (P = .003). The rate of transient PNP was significantly higher in CBA (3.0%, n = 45) than LBA (0.1%, n = 1, P = .004). The rate of persistent PNP did not significantly differ between two groups (CBA: 1.2% vs LBA: 1.4%, P = .89). The rate of persistent PNP which recovered within 6 months was similar (CBA: 17.4% vs LBA 18.2%, P = 1.000). However, the rates of persistent PNP which recovered within 6 to 12 months (CBA: 2.9% vs LBA 27.3%, P = .0171) and more than 12 months (CBA: 7.3% vs LBA 45.5%, P = .0034) were significantly higher in LBA.ConclusionPNP occurred more often in CBA than LBA, however, the majority of PNP in CBA was transient whereas the majority of PNP in LBA was persistent. Either balloon technology is not superior in terms of long‐term PNP.

Background - Pulmonary vein isolation (PVI) represents the cornerstone in atrial fibrillation ablation. Cryoballoon (CB) and laser balloon (LB) catheters have emerged as promising devices but lack randomized comparisons. Therefore, we sought to compare efficacy and safety comparing both balloons in patients with persistent and paroxysmal AF. Methods - Symptomatic AF patients (n=200) were prospectively randomized (1:1) to receive either CB or LB PVI (CB: n=100: 50 PAF + 50 persistent AF vs. LB: n=100: 50 PAF + 50 persistent AF). All antiarrhythmic drugs (AAD) were stopped after ablation. Follow-up included 3-day Holter-ECG recordings and office visits at 3, 6 and 12 months. Primary efficacy endpoint was defined as freedom from atrial tachyarrythmia (ATa) between 90 and 365 days after a single ablation. Secondary endpoints included procedural parameters and peri-procedural complications. Results - Patient baseline parameters were not different between both groups. In all (n=200) complete PVI was obtained and the entire follow-up accomplished. Balloon only PVI was obtained in 98% (CB) vs. 95% (LB) requiring focal touch up in 2 and 5 patients, respectively. Procedure but not fluoroscopy time was significantly shorter in the CB group (50.9±21.0min vs. 96.0±20.4 min; p<0.0001 and 7.4±4.4 min vs. 8.4±3.2min, p=0.083). Overall, the primary endpoint of no ATa reccurence was met in 79% (CB: 80.0% vs LB: 78.0%, p=ns). No death, atrio-esophageal fistula, tamponade or vascular laceration requiring surgery occurred. In the CB group, 8 transient but no persistent phrenic nerve palsy (PNP) were noted compared to 2 persistent PNP and 1 TIA in the LB group. Conclusions - Both balloon technologies represent highly effective and safe tools for PVI resulting in similar favorable rhythm outcome after 12 months. Use of the cryoballoon is associated with significantly shorter procedure but not fluoroscopy time.