Pulsed-field ablation for atrial fibrillation

NICE did a rapid review of the published literature on the efficacy and safety of this procedure. This comprised a comprehensive literature search and detailed review of the evidence from 12 sources, which was discussed by the committee. The evidence included 2 systematic reviews and meta-analyses, 1 non-inferiority randomised controlled trial, 4 single-arm trials, an EU retrospective analysis of a prospective registry, a centre-level study done across 101 centres in the EU and Israel, a study that combined 2 single-arm trials, a prospective case series and a retrospective case series. It is presented in the summary of key evidence section in the interventional procedures overview. Other relevant literature is in the appendix of the overview.

The professional experts and the committee considered the key efficacy outcomes to be: return to normal sinus rhythm, recurrence of arrhythmia, improved quality of life, reintervention rate, and long-term outcomes including reduction in stroke.

The professional experts and the committee considered the key safety outcomes to be: injury to oesophagus or phrenic nerve, pericardial tamponade, perforation, effusion and bleeding.

Sixteen commentaries from people who have had this procedure and a submission from a patient organisation were discussed by the committee.

There are different types of catheter and generators with varying amounts of evidence. The evidence may not be transferable between technologies because of their differences.

People may have to continue taking anticoagulation medication after the procedure.

Results may be different for paroxysmal atrial fibrillation and persistent atrial fibrillation.

The procedure may need to be repeated.

The procedure is most commonly done under general anaesthesia in the UK.

The procedure may be associated with less post-procedure discomfort than other types of ablation.