Elimination of the negative component of the unipolar electrogram as a local procedural endpoint during paroxysmal atrial fibrillation catheter ablation using contact-force sensing: the UNIFORCE study.

PURPOSE: Elimination of the negative component of the unipolar atrial electrogram is a reliable indicator of the creation of a transmural lesion. Contact-force (CF) sensing technology has the potential to increase the durability of pulmonary vein isolation (PVI). In the present multicenter study, we assessed the 2-year sinus rhythm (SR) maintenance rate in patients with paroxysmal atrial fibrillation (PAF) after PVI guided by these two approaches.

METHODS

Two hundred fifteen consecutive PAF patients (62.1 ± 10.1 years, 65 women) were prospectively enrolled. All patients underwent PVI under CARTO guidance according to a systematic contiguous "point-by-point" approach, using radiofrequency energy, and a CF externally irrigated ablation catheter with the goal of at least 10g (ideally 20g) of force. The ablation endpoint of each individual lesion was elimination of the negative component of the unipolar atrial signal. The procedural endpoint was PVI with bidirectional block.

RESULTS

All PVs were successfully isolated. After 30 min of waiting time, 35 patients (16%) had PV reconnection and in all of them, the PVs were re-isolated. Two years after a single ablation procedure, 187 patients (87%) remained arrhythmia free, without anti-arrhythmic drugs. Of the 28 patients presenting with AF recurrence, 25 had PV reconnection and underwent repeat PVI while in the remaining 3 patients, all four PVs were isolated and extra-PV triggers were identified. There were six groin hematomas and one transient ischemic attack.

CONCLUSIONS

Unipolar atrial signal analysis combined with CF sensing ensures a robust 2-year SR maintenance rate in the treatment of PAF. Clinical trial registration-URL: http://www.clinicaltrials.gov . Unique identifier: NCT02520960.