title: Incidence and Predictors of Complications During Cryoballoon Pulmonary Vein Isolation for Atrial Fibrillation.
abstract: Cryoballoon pulmonary vein isolation (PVI) has emerged as an alternative to radiofrequency PVI for atrial fibrillation (AF). Data are lacking to define the rates and predictors of complications, particularly phrenic nerve injury (PNI).
  
  
  
  We evaluated a single-center prospective registry of 450 consecutive patients undergoing cryoballoon PVI between 2011 and 2015. Patients were 59±10 years old, 26% were women, 58% had hypertension, their mean CHA2DS2VASc score was 1.7±1.3, 30% had persistent atrial fibrillation, and 92% received a second-generation 28-mm balloon. Predefined major complications were persistent PNI, pericardial effusion, deep vein thrombosis, arteriovenous fistula, atrioesophageal fistula, bleeding requiring transfusion, stroke, and death. PNI was categorized as persistent if it persisted after discharge from the laboratory. Logistic regression was performed to identify predictors of complications and specifically PNI. We identified a major complication in 10 (2.2%) patients. In 49 (10.8%) patients, at least transient PNI was observed; only 5 persisted beyond the procedure (1.1%). All cases of PNI resolved eventually, with the longest time to resolution being 48 days. We also describe 2 cases of PNI manifesting after the index hospitalization. Regression analysis identified 23-mm balloon use (16.3% versus 5.2%, odds ratio 2.94, P=0.011) and increased age (62.8±7.7 versus 58.7±0.12 years, odds ratio 1.058, P=0.014) as independent significant predictors of PNI. There were no significant predictors of major complications.
  
  
  
  In a large contemporary cohort, cryoballoon PVI is associated with low procedural risk, including lower rates of PNI than previously reported. Older age and 23-mm balloon use were associated with PNI. Our low rate of PNI may reflect more sensitive detection methods, including compound motor action potential monitoring and forced double-deflation.
authors.affiliation: Center for Atrial Fibrillation, Heart and Vascular Institute, University of Pittsburgh Medical Center, Pittsburgh, PA.
authors.forename: Emily N
authors.initials: EN
authors.lastname: Guhl
authors.affiliation: Center for Atrial Fibrillation, Heart and Vascular Institute, University of Pittsburgh Medical Center, Pittsburgh, PA.
authors.forename: Donald
authors.initials: D
authors.lastname: Siddoway
authors.affiliation: Center for Atrial Fibrillation, Heart and Vascular Institute, University of Pittsburgh Medical Center, Pittsburgh, PA.
authors.forename: Evan
authors.initials: E
authors.lastname: Adelstein
authors.affiliation: Center for Atrial Fibrillation, Heart and Vascular Institute, University of Pittsburgh Medical Center, Pittsburgh, PA.
authors.forename: Raveen
authors.initials: R
authors.lastname: Bazaz
authors.affiliation: Center for Atrial Fibrillation, Heart and Vascular Institute, University of Pittsburgh Medical Center, Pittsburgh, PA.
authors.forename: George S
authors.initials: GS
authors.lastname: Mendenhall
authors.affiliation: Center for Atrial Fibrillation, Heart and Vascular Institute, University of Pittsburgh Medical Center, Pittsburgh, PA.
authors.forename: Jan
authors.initials: J
authors.lastname: Nemec
authors.affiliation: Center for Atrial Fibrillation, Heart and Vascular Institute, University of Pittsburgh Medical Center, Pittsburgh, PA.
authors.forename: Samir
authors.initials: S
authors.lastname: Saba
authors.affiliation: Center for Atrial Fibrillation, Heart and Vascular Institute, University of Pittsburgh Medical Center, Pittsburgh, PA.
authors.forename: David
authors.initials: D
authors.lastname: Schwartzman
authors.affiliation: Center for Atrial Fibrillation, Heart and Vascular Institute, University of Pittsburgh Medical Center, Pittsburgh, PA.
authors.forename: Andrew
authors.initials: A
authors.lastname: Voigt
authors.affiliation: Center for Atrial Fibrillation, Heart and Vascular Institute, University of Pittsburgh Medical Center, Pittsburgh, PA.
authors.forename: Norman C
authors.initials: NC
authors.lastname: Wang
authors.affiliation: Center for Atrial Fibrillation, Heart and Vascular Institute, University of Pittsburgh Medical Center, Pittsburgh, PA jainsk@upmc.edu.
authors.forename: Sandeep K
authors.initials: SK
authors.lastname: Jain
mesh_terms: D000368:Aged; D001164:Arteriovenous Fistula / Q000453:epidemiology; D001281:Atrial Fibrillation / Q000601:surgery*; D001803:Blood Transfusion; D015331:Cohort Studies; D003452:Cryosurgery; D004937:Esophageal Fistula / Q000453:epidemiology; D005260:Female; D006470:Hemorrhage / Q000453:epidemiology / Q000628:therapy; D017052:Hospital Mortality; D006801:Humans; D015994:Incidence; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D010490:Pericardial Effusion / Q000453:epidemiology; D059348:Peripheral Nerve Injuries / Q000453:epidemiology; D010791:Phrenic Nerve / Q000293:injuries; D011183:Postoperative Complications / Q000453:epidemiology*; D011667:Pulmonary Veins / Q000601:surgery*; D012042:Registries; D012189:Retrospective Studies; D012307:Risk Factors; D020521:Stroke / Q000453:epidemiology; D020246:Venous Thrombosis / Q000453:epidemiology
keywords: ablation; atrial fibrillation; catheter ablation; complications