Catheter Ablation -> Atrial Fibrillation & Atrial Flutter: -> Quality Measures & Complications D-PO05 - Poster Session V (ID 39) Poster

D-PO05-128 - Incidence And Sequelae Of Atrioesophageal Fistula Following Cryoballoon Ablation In Greater Than 500,000 Cases (ID 1271)

Abstract

Background: Incidence of complications associated with the Arctic Front (Medtronic, Inc.) cryoballoon ablation catheters has been reported over the last 10 years; however, data on the rare complication of atrioesophageal fistula (AEF) following cryoballoon AF ablation are limited.
Objective: To report the global incidence rate and sequelae of AEF associated with cryoballoon ablation for the treatment of patients with atrial fibrillation using both manufacturer and MAUDE database data.
Methods: User-reported complications cataloged in the manufacturer database that occurred between July 1, 2009 and March 31, 2019 were reviewed for cases of AEF. A global event rate of AEF was calculated by dividing the event count by the number of catheters sold (a surrogate for the number of patients) over the study period. Data on symptoms upon presentation and time of onset, patient sequelae are reported to provide insight into the clinical course of these events.
Results: In total, over 500,000 Arctic Front cryoballoon catheters (Arctic Front, Arctic Front Advance, Arctic Front Advance ST, and Arctic Front Advance Pro, Medtronic Inc) were distributed globally during the 9.75-year period. During this time, 18 confirmed AEF events, 1 unconfirmed case, and 1 pericardial esophageal fistula(PEF) were identified. A 28 mm balloon was used in all but one instance. The nadir temperatures were less than -700 Celsius in one case, less than -600 Celsius in 5 cases, and less than -500 Celsius in 5 other cases when the temperatures were reported. The global incidence of AEF and PEF associated with cryoballoon ablation was 0.00396%. The available data records that the most common clinical presentation is fever (88.2%), neurological symptoms(55%) and initial symptoms were reported from day 3 to 6 weeks following the procedure with a mean reported symptom presentation of 20±15 days after the ablation. While exceedingly rare, the development of AEF resulted in death in 69% (n=11/16) of patients with known outcomes.
Conclusion: AEF is an extremely rare complication of cryoballoon ablation with an estimated rate of 1 in every 25,000 patients treated. Nadir temperatures should be closely monitored both at 30 seconds and throughout the ablation period to avoid this dreaded complication.
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