Largest Real-World Patient Registry (N=17,642)1
Center-level data was collected across 106 EU sites and 413 operators spanning a 2-year period (3/2021–3/2023); 91.4% of commercial centers reported.
STUDY DESIGN
Multicenter, retrospective, observational study
PATIENT POPULATION
Drug–refractory paroxysmal AFib
REPORTED OUTCOMES
Safety
Clinicians worldwide have confirmed the safety of FARAPULSE.
reports of esophageal fistula or dysmotility, pulmonary vein stenosis, or persistent phrenic nerve injury
major adverse event rate with the most common complication being pericardial tamponade (0.36%)*
Low rates of pulsed field energy-specific adverse events
- 0.06% transient phrenic nerve paresis
- 0.14% coronary spasm
- 0.03% hemolysis/renal failure
Key Takeaways
- Safety profile remained strong as FARAPULSE use expanded across centers
- Major adverse event rate was <1%, with no severe complications reported
- Only two rare events identified: coronary spasm and hemolysis
Next: See how FARAPULSE PFA compared to thermal ablation
References:
1. Ekanem E, Neuzil P, Reichlin T, et al. Safety of pulsed field ablation in more than 17,000 patients with atrial fibrillation in the MANIFEST-17K study. Nat Med. 2024;30:2020–2029. https://doi.org/10.1038/s41591-024-03114-3
*In a clinical trial the major adverse event rate was 0.98% (N=17,642). Due to the retrospective nature of the registry, the adverse event rate was not reported at a prespecified time point. Serious adverse events include atrioesophageal fistula, pulmonary vein stenosis, or persistent phrenic nerve injury.