Arrhythmias & electrophysiology
Pulsed Field Ablation to Treat Paroxysmal Atrial Fibrillation: Safety and Effectiveness in the AdmIRE Pivotal Trial
Authors' conclusion
AdmIRE confirmed the safety and effectiveness of the variable-loop PFA catheter, with short procedure and PFA application times and low fluoroscopy exposure.
Study context
- Population
- US patients with drug-refractory symptomatic paroxysmal AF undergoing pulmonary vein isolationpivotal cohort
- Participants
- 277 patients
- Outcome
- Safety: primary adverse event within 7 days of ablation; effectiveness: composite including freedom from documented atrial tachyarrhythmia, failure to achieve PVI, nonstudy catheter use, repeat procedure, new/failed class I or III antiarrhythmic drug at higher dose or DC cardioversion after blanking
- Follow-up
- 7 days (safety); 12 months (effectiveness)
Methodological detailsmulticentre, FDA investigational device exemption study, 30 centres
- Multicentre
- FDA investigational device exemption study
- 30 centres
Main finding
As reported in the abstract
Primary effectiveness composite end point · 12 months
12-month primary effectiveness end point
74.6%
Further findings
Freedom from AF, atrial tachycardia or atrial flutter recurrence after blanking · 1 year
- 1-year freedom from AF, atrial tachycardia or atrial flutter recurrence after blanking
- 75.4%
Quality of life and health care use · 3 months
- Substantial improvements in quality of life as early as 3 months, with reduction in multiple health care use measures
Safety
Primary adverse event within 7 days of ablation (primary safety end point)
- Primary adverse event rate (8 of 272)
- 2.9%
- Most common complication: pericardial tamponade
Original publication
Pulsed Field Ablation to Treat Paroxysmal Atrial Fibrillation: Safety and Effectiveness in the AdmIRE Pivotal Trial. Circulation. Published 11 September 2024. doi:10.
Summarised from the published abstract; every number is checked against it