Key result
Cryoballoon pulmonary vein isolation carries a ~2% major complication rate, with mostly transient phrenic nerve injury.
Why the study?
What is the incidence and what are the predictors of complications during cryoballoon pulmonary vein isolation for atrial fibrillation?
Cohort (n=450)
No
What is the incidence and what are the predictors of complications during cryoballoon pulmonary vein isolation for atrial fibrillation?
Cryoballoon pulmonary vein isolation in a contemporary cohort exhibits a low (2.2%) major complication rate, with older age and 23-mm balloon use increasing the risk of mostly transient phrenic nerve injury.
Supports cryoballoon PVI safety in real-world cohorts; leaves open whether age or balloon size warrant procedural adjustments.
BACKGROUND: 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). METHODS AND RESULTS: 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. CONCLUSIONS: 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.
No takes yet. Share an insight, caveat, or question.
Guhl et al. (2016) conducted a cohort in Atrial fibrillation (n=450). Cryoballoon pulmonary vein isolation was evaluated on Predefined major complications (persistent phrenic nerve injury, symptomatic pericardial effusion, deep vein thrombosis, arteriovenous fistula, atrioesophageal fistula, major bleeding, stroke, or death). Cryoballoon pulmonary vein isolation resulted in a 2.2% rate of major complications, with phrenic nerve injury occurring in 10.8% of patients (mostly transient) and predicted by older age and 23-mm balloon use.
Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context: