No esophageal complications, pulmonary vein stenosis, persistent phrenic palsy observed; stroke was rare and death even rarer
By Elana Gotkine HealthDay Reporter
THURSDAY, July 11, 2024 (HealthDay News) — For patients with atrial fibrillation (AF), pulsed field ablation (PFA) demonstrates a favorable safety profile, according to a study published online July 8 in Nature Medicine.
Emmanuel Ekanem, M.D., from the Icahn School of Medicine at Mount Sinai in New York City, and colleagues examined the safety of PFA by studying postapproval use. Data were obtained from 106 centers performing postapproval PFA with a pentaspline catheter (17,642 patients undergoing PFA).
The researchers found there were no reports of esophageal complications, pulmonary vein stenosis, or persistent phrenic palsy (transient palsy reported in 0.06 percent of patients). About 1 percent of patients reported major complications, including pericardial tamponade and vascular events (0.36 and 0.30 percent, respectively). Stroke and death were rare (0.12 and 0.03 percent, respectively). Coronary arterial spasm and hemolysis-related acute renal failure necessitating hemodialysis were unexpected complications of PFA and occurred in 0.14 and 0.03 percent of patients, respectively.
“In a ‘real-world’ setting of an unselected AF patient population, PFA demonstrated a safety profile consistent with an important degree of preferentiality to myocardial tissue ablation, with no evidence of esophageal complications, and with a low rate of major complications,” the authors write.
Several authors disclosed ties to the biopharmaceutical industry.
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