Insights from the FARADISE registry, studying real-world outcomes from more than 1,000 patients to have undergone catheter ablation for paroxysmal and non-paroxysmal atrial fibrillation (AF) using the Farapulse pulsed field ablation (PFA) system (Boston Scientific) “reinforce the safety, efficacy and efficiency” of the device, researchers say.
Findings of FARADISE, a global, prospective, post-market registry study to demonstrate the safety and effectiveness of the Farapulse PFA system, which uses an over-the-wire catheter with variable distal shapes (basket and flower), were presented at the Heart Rhythm Society (HRS) annual meeting (16–19 May, Boston, USA).
At three and six months after ablation in patients with paroxysmal and non-paroxysmal AF, researchers did not observe any reported deaths or certain serious complications, including coronary spasm, persistent phrenic nerve palsy, atrio-oesophageal fistula, or pulmonary vein stenosis.
Compared to traditional thermal catheter ablation, the Farapulse PFA system requires a significantly shorter duration of energy application, they reported. Pulmonary vein isolation (PVI) procedure, left atrial dwell, and fluoroscopy times were 51, 32, and 12 minutes, respectively. For patients with additional ablation beyond PVI, average procedure, left atrial dwell, and fluoroscopy times were 68, 42, and 16 minutes, respectively.
“Acute outcomes presented from more than 1,000 patients in the global FARADISE registry reinforce the safety, efficacy and efficiency profile of the FARAPULSE PFA system for the treatment of atrial fibrillation, with no reports of coronary spasm, pulmonary vein stenosis, persistent phrenic nerve palsy or oesophageal fistula,” said Lucas Boersma (St Antonius Hospital, Nieuwegein, The Netherlands), lead investigator of the FARADISE registry. “We look forward to gathering long-term evidence from this registry for this particular PFA therapy, which continues to generate promising outcomes in real-world use.”
