Severe complications after pulmonary vein isolation for atrial fibrillation: a worldwide collaborative registry

FUNDING ACKNOWLEDGEMENTS: Type of funding sources: Foundation. Main funding source(s): Swiss Heart Foundation BACKGROUND: Pulmonary vein isolation (PVI) is the most commonly performed electrophysiological procedure. Severe complications such as tamponade, stroke, cardiac arrest and death are believed to be uncommon but detailed assessment of these complications in very large worldwide cohorts is lacking. PURPOSE: To investigate the incidence, predictors, patient characteristics, management details and outcome of severe complications (cardiac tamponade, stroke, cardiac arrest, death) after PVI in a large worldwide collaborative registry with comprehensive patient-level data. METHODS: We contacted electrophysiologists from an established PVI-collaborative network and invited further center to participate, thereby gathering individual patient-data from 23 centers worldwide. Few datapoints were collected for the overall patients and exhaustive details were entered in a dedicated database for patients experiencing a severe complication. RESULTS: From the 23 participating centers a total of 33,889 procedures could be collected (median age 63 y.o., 30% female, 27% cryoballoon ablations). The incidence of severe complications was low (tamponade 0.7% (7/1000 PVIs), stroke 0.089% (<1/1000 PVIs) or cardiac arrest (0.035%, <1/1000PVIs)), and death was extremely rare (1.18/10,000 PVIs), Figure panel A). Female sex (OR 1.7 95%-CI [1.3-2.2], p<0.001), a dilated left atrium (OR 1.9 95%-CI [1.4-2.8], p<0.001) and the use of radiofrequency (OR 1.8 95%-CI [1.3-2.7], p=0.002) appeared as strong predictors for the composite endpoint of all severe complications (Figure panel B). Critical steps during the ablation were transseptal puncture and energy delivery and 14% of all tamponades led to procedure abortion (Figure panel C). Among the patients experiencing a tamponade, 13% required cardiac surgery and perforations were predominantly found in the left atrial appendage and in the PVs during surgery (Figure panel D). Patient outcomes despite a severe complication were good with 93% of patients discharged directly home after a median length of stay of 5 days (IQR 3-7). CONCLUSION: This very large worldwide collaborative study highlighted that tamponade, stroke, cardiac arrest or death are rare after PVI. Female sex and the use of radiofrequency catheters were associated with a higher risk of severe complications. A non-negligible percentage of patients required cardiac surgery after tamponade, where a perforation was most commonly found in the left atrial appendage and PVs. [Figure: see text] [Figure: see text]