Novel cryoballoon effective, safe in real-world ablation use for AF
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In a real-world setting, a novel cryoballoon for atrial fibrillation ablation generated effective pulmonary vein isolation with relatively short procedure times, researchers reported.
“Cryoballoon ablation has been shown to be very effective for pulmonary vein isolation and it is associated with low complication rates; furthermore, it has been demonstrated to be as effective as pulmonary vein isolation with radiofrequency ablation,” Claire A. Martin, MD, PhD, of the Royal Papworth Hospital NHS Foundation Trust in Cambridge, U.K., and colleagues wrote. “POLARx was introduced to market in Europe in 2020 by Boston Scientific. Observational studies, mostly single-center studies, suggest that POLARx may have similar procedural efficacy and safety to Arctic Front Advance Pro (Medtronic). However, one limitation of these smaller studies is generalizability of the data. The POLAR ICE study was designed to collect prospective real-world data on the safety and effectiveness of the POLARx cryoballoon for pulmonary vein isolation to treat paroxysmal AF.”
Image: Adobe Stock
The POLAR ICE study enrolled 399 patients across 19 European centers; data were collected from 372 de novo pulmonary vein isolation procedures (n = 2,190 ablations). Researchers assessed time to isolation, cryoablations per pulmonary vein, balloon nadir temperature and occlusion grade. Pulmonary vein isolation was confirmed with entrance block testing.
The findings were published in the Journal of Cardiovascular Electrophysiology.
Complete pulmonary vein isolation was achieved in 96.8% of pulmonary veins.
Mean procedure and fluoroscopy times were 68.2 minutes and 15.6 minutes, respectively. Mean left atrial dwell time was 46.6 minutes. Grade 3 or 4 occlusion was achieved in 98.2% of pulmonary veins reported, and 71.2% of pulmonary vein isolations required only a single cryoablation.
Among all cryo-applications, 83% had a duration of at least 120 seconds. The average nadir temperature of ablations was –56.3°C.
Researchers noted that there were six persistent phrenic nerve palsy events; two events resolved within 3 months of the procedure.
“Pulmonary vein isolation with POLARx is effective, safe, and relatively fast in experienced cryoballoon centers,” the researchers wrote. “While it is notable that this acute real-world data showed relatively low rates of phrenic nerve palsy, further study is necessary to determine if these real-world adverse event rates generalize to other treatment centers.”
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