The second-generation cryoballoon for pulmonary vein isolation resulted in a 2.8% rate of persistent phrenic nerve palsy compared to 1.9% with the first-generation balloon (P=0.63).
Observational (n=360)
Does the second-generation cryoballoon alter the incidence and characteristics of phrenic nerve palsy compared to the first-generation cryoballoon in patients undergoing pulmonary vein isolation for atrial fibrillation?
While the incidence of phrenic nerve palsy is similar between first- and second-generation cryoballoons, the second-generation device is associated with a significantly longer time to nerve function recovery.
Absolute Event Rate: 2.8% vs 1.9%
p-value: p=0.63
AIMS: The second-generation cryoballoon (CB2) with increased surface cooling has recently become available. The aim was to investigate the incidence and characteristics of phrenic nerve palsy (PNP) during pulmonary vein isolation (PVI) using the CB2 as compared with the first-generation balloon (CB1). METHODS AND RESULTS: A total of 360 consecutive patients with atrial fibrillation underwent PVI with the CB1 (106 patients) or the CB2 (254 patients). Right PN function was monitored by continuous stimulation and palpation during septal PV ablation. Persistent PNP (present at discharge) occurred in 2.8 and 1.9% (P = 0.63) of patients, transient PNP (full recovery before discharge) in 5.9 and 3.8% (P = 0.41) of patients in the CB2 and CB1 group, respectively. Phrenic nerve palsy during ablation at the right inferior PV was observed in 0% (CB1) and 4.3% (CB2, P = 0.03) of patients. Using the CB2, a trend of reduced incidence of persistent PNP over quartiles of consecutive patients was observed 4.8% (Q1) vs. 0% (Q4); P = 0.077. At the culprit PV, PNP occurred after 3.5 ± 2.1 (CB1) and 1.1 ± 0.4 applications (CB2; P = 0.036). Complete recovery of PN function occurred after 29 ± 11 (CB1) and 259 ± 137 days (CB2; P = 0.004). CONCLUSIONS: The rate of transient/persistent PNP associated with the use of the CB2 was 5.9 and 2.8%, respectively. Time to restitution of PN function was longer using the CB2.
Fürnkranz et al. (2015) conducted an observational in Atrial fibrillation (n=360). Second-generation cryoballoon (CB2) vs. First-generation cryoballoon (CB1) was evaluated on Persistent phrenic nerve palsy (present at discharge) (p=0.63). The second-generation cryoballoon for pulmonary vein isolation resulted in a 2.8% rate of persistent phrenic nerve palsy compared to 1.9% with the first-generation balloon (P=0.63).
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