This section describes efficacy outcomes from the published literature that the committee considered as part of the evidence about this procedure. For more detailed information on the evidence, see the interventional procedure overview.
4.1 In a randomised controlled trial of 342 patients with atrial fibrillation (AF) treated by laser balloon pulmonary vein isolation or radiofrequency ablation, 61% and 62% of patients (actual numbers not reported) respectively (p=0.003 for non‑inferiority) did not have protocol‑defined treatment failure (documented symptomatic AF of 1 minute or more; ablation‑induced left atrial flutter or atrial tachycardia; failure to acutely isolate all pulmonary veins; use of any anti‑arrhythmic drug; or left heart ablation or surgery or implantable cardioverter‑defibrillator placement for AF) at 12‑month follow‑up. The percentage of patients who were drug‑free at 12 months and free from symptomatic AF or atypical atrial flutter or atrial tachycardia was 64% (106/167 and 106/166) in both treatment groups (p=0.94). In a case series of 200 patients, 60% (95% confidence interval [CI] 53% to 67%) of patients were free from AF and were off anti‑arrhythmic drugs (class I or III) at 12‑month follow‑up.
4.2 In a non‑randomised comparative study of 140 patients treated by laser balloon pulmonary vein isolation or cryoballoon ablation, AF recurred between 90 and 365 days after the procedure in 27% (18/68) and 37% (24/65) of patients respectively (p=0.18). In a non‑randomised comparative study of 80 patients with early persistent AF treated by laser balloon pulmonary vein isolation or radiofrequency ablation, AF recurred in 28% (11/40) and 23% (9/40) of patients respectively (p=0.79) after a single procedure at 12‑month follow‑up. In a case series of 194 patients, 82% (130/158) of patients with paroxysmal AF and 75% (9/12) of patients with persistent AF were free from AF at 12‑month follow‑up. For patients with paroxysmal AF, 76%, 76% and 75% of patients were free from AF at 24‑, 36‑ and 48‑month follow‑up respectively.
4.3 In the non‑randomised comparative study of 80 patients, 25% (10/40) and 23% (9/40) of patients treated by laser balloon pulmonary vein isolation or radiofrequency ablation respectively had a repeat procedure. In the case series of 194 patients, 6% (11/194) of patients had a repeat procedure.
4.4 The specialist advisers listed key efficacy outcomes as persistent isolation of pulmonary veins, freedom from AF, freedom from atrial arrhythmias, freedom from atrial arrhythmias when off anti‑arrhythmic drug therapy, the single or multiple procedure success rate and improvement in quality of life.
4.5 Sixteen commentaries from patients who had experience of this procedure were received, which were discussed by the committee. The commentaries supported the procedure and reported improved quality of life after the procedure.