Key result
Cryoballoon ablation adverse events are most frequently phrenic nerve palsy, accounting for ~48% of reports.
Why the study?
Real-world clinical data on adverse events related to the use of cryoballoon catheters for pulmonary vein isolation remain limited.
What are the most common procedure-related adverse events associated with Arctic Front cryoballoon catheter ablation for pulmonary vein isolation reported in the FDA MAUDE database?
Observational (n=320)
What are the most common procedure-related adverse events associated with Arctic Front cryoballoon catheter ablation for pulmonary vein isolation reported in the FDA MAUDE database?
Real-world FDA MAUDE surveillance demonstrates that phrenic nerve palsy and cardiac perforation are the most frequently reported complications of cryoballoon AF ablation, with cardiac perforation accounting for all reported intra-procedural deaths and underscoring the need for on-site surgical backup.
MAUDE data flag phrenic nerve palsy and perforation risks in cryoballoon ablation; extends trial signals but leaves open true incidence due to voluntary reporting.
Background: Real-world clinical data on the adverse events related to the use of cryoballoon catheter for pulmonary vein isolation remains limited. Objective: To report and describe the adverse events related to the use of Artic Front cryoballoon catheters (Arctic Front, Arctic Front Advance, and Arctic Front Advance Pro) reported in the Food and Drug Administration's (FDA) Manufacturers and User Defined Experience (MAUDE) database. Methods: We reviewed all the adverse events reported to the FDA MAUDE database over a 10.7-year study period from January 01, 2011 to September 31, 2021. All events were independently reviewed by two physicians. Results: During the study period, a total of 320 procedural-related adverse events reported in the MAUDE database were identified. The most common adverse event was transient or persistent phrenic nerve palsy (PNP), accounting for 48% of all events. This was followed by cardiac perforation (15%), pulmonary vein stenosis (8%), transient ischemic attack or stroke (6%), vascular injury (4%), transient or persistent ST-elevation myocardial infarction (3%), hemoptysis (2%), pericarditis (2%), and esophageal ulcer or fistula (1%). There were six reported intra-procedural death events as a result of cardiac perforation. Conclusion: The two most common procedural adverse events associated with cryoballoon ablation were PNP and cardiac perforation. All cases of procedural mortality were due to cardiac perforation.
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Tan et al. (2023) conducted an observational in Atrial fibrillation undergoing cryoballoon ablation for pulmonary vein isolation (n=320). Arctic Front cryoballoon catheter (Arctic Front, Arctic Front Advance, and Arctic Front Advance Pro) was evaluated on Transient or persistent phrenic nerve palsy (most common reported procedural-related adverse event). Cryoballoon ablation adverse events in the FDA MAUDE database (n=320) were most commonly phrenic nerve palsy (48%) and cardiac perforation (15%), which caused all 6 (1.9%) intra-procedural deaths.
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