Purpose: We aimed to evaluate the incidence, characteristics and outcome of PNI during after CB2 based-PVI in a large patients population.
Methods: From July 2012 to August 2018 a total of 5371 patients received CB2 based-PVI in nine EP centers (Germany: 6, Turkey: 1, Japan: 1, USA: 1).
Resuls: A total of 209 (3.9%) of patients experienced PNI during treatment of the right superior (82%) or inferior (18%) pulmonary vein. The mean time to PNI was 124±48 seconds and the mean temperature at the time of PNI was -48.7±8 °C. The applications were interrupted using double-stop technique in 189/209 (90%). In 146/209 (70%) a CMAP was utilized. At the end of the procedure PNI persistent in 42.6% of patients. Fluoroscopic or sonographic evaluation of PNI was performed 1-3 days after the procedure and revealed persistent PNI in 28.2% of patients. Dyspnea before discharge was reported in 10% of patients with persistent PNI. Patients follow up at 1-3, and 6-12 months included fluoroscopy and a visit in an outpatient clinic. After 1-3 months 12% of patients showed persistent PNI including 6.7% of patients complaining of dyspnea. After 6-12 months of follow-up including fluoroscopic evaluation PNI was persistent in 3.3% of patients while dyspnea was reported by 1.4% patients. Overall permanent PNI after 6-12 months was evaluated in 0.13% of patients. Only 0.06% of the overall population of 5371 patients showed permanent and symptomatic PNI.
Clonclusion: The incidence of PNI during CB2-based PVI is low. About 57.4% of PNI recovered until the end of the procedure. Most of PNI resulting from CB2-based PVI recovered after 12 months. Symptomatic permanent PNI is very rare in patients after CB2-based PVI.