Pulmonary vein isolation (PVI) has evolved as a safe and effective treatment for drug-refractory paroxysmal atrial fibrillation (PAF). PVI can be performed using single-tip (ST) radiofrequency catheters with contact force as Gold standard or with the second-generation multielectrode Phased RF ablation Catheter (PVAC Gold).
To evaluate the 30-day periprocedural efficacy and safety in patients with symptomatic drug-refractory PAF randomized in the GOLD FORCE trial (PVI using ST RF or multielectrode phased RF).
The GOLD FORCE trial is a multicenter, non-inferiority randomized controlled study evaluating safety and efficacy of PVI using single tip with contact force or multielectrode PVAC Gold in patients with symptomatic drug-refractory PAF.
Baseline and periprocedural data up to 30 days were available for 194 subjects (97 assigned to single tip RF ablation, 97 assigned to multielectrode phased RF ablation) and are shown in Table 1. Mean age was 61±9; CHA2DS2-VASc 1.0[1.0-2.0], and 73% were male. Pulmonary vein isolation was achieved in 98% of patients and in 99% of PV’s. The mean total procedure time was shorter in the multielectrode phased RF group than in the single tip group (78 vs 109 minutes, p<0.001), as was the left atrial dwell time (55 vs 80 minutes, p<0.001) and radiofrequency time (21 vs 32 minutes, p<0.001). Eight AE’s in 8 patients were reported up to 30 days, consisting mostly of minor groin complications and chest pain. The 30-day complication rates did not significantly differ between both groups (4% vs 4%, p=1.00) No periprocedural TIA/stroke, atrio-esophageal fistulae, PV stenosis or deaths were observed. Median Length of hospital stay was equal in both groups (1 day in 98% of patients).
In this multicentre randomized clinical trial, ablation with single tip RF ablation and multielectrode phased RF had similar rates of acute PVI with low (S)AE rates in both groups. Multielectrode phased RF had significantly shorter procedure and RF times.