Eighteen months follow-up of the clinical efficacy of the high density mesh ablator (HDMA) in patients with atrial fibrillation after pulmonary vein isolation.

Purpose: The high density mesh ablator (HDMA), a mesh electrode catheter using radiofrequency delivery for pulmonary vein isolation (PVI) in patients with atrial fibrillation (AF), has been shown to have a high acute ablation success rate. The primary endpoint of our study was the efficacy of HDMA to maintain sinus rhythm (SR), and the secondary endpoint is its efficacy to reduce AF burden in an 18-month follow-up.

Methods: Forty-two patients with AF [25 patients with paroxysmal AF (PAF, 59.5%), 17 patients with persistent AF (persAF, 40.5%)], were followed up with 7-day Holter monitoring and anamnestic survey at 6 and 12 months after PVI. To evaluate symptomatic AF episodes after 12 months, we used data from further hospital stays or information given by phone.

Results: In 42 patients at intervals of 6 and 12 months, stable SR was documented in 7-day Holter monitoring in 18 patients (42.9%, 10/25 and 9/25 for PAF and 8/17 and 9/17 for persAF, respectively). Symptomatic episodes of AF were reported in 31 patients (73.8%, 18/25 for PAF and 13/17 for persAF). Re-ablation was performed in seven patients (3/25 for PAF and 4/17 for persAF) not yielding to stable SR. At an 18-month follow-up (12-29 months), AF recurrence persisted in all 42 patients; in four patients, a permanent pacemaker was implanted (9.5%). No complications attributable to the HDMA occurred in this series.

Conclusions: Our findings suggest that the PVI using the HDMA is a safe method but yields to a high AF recurrence rate at long-term follow-up even after a second procedure with the same tool.