Abstract 3507: Long-Term Single-Procedure Clinical Results with an Endoscopic Balloon Ablation Catheter for Pulmonary Vein Isolation in Patients with Atrial Fibrillation
Background: During catheter ablation of AF, placing contiguous point ablation lesions to electrically-isolate the PVs can be technically challenging. A novel balloon catheter (Endoscopic Ablation System (EAS); Cardiofocus, Inc.) which utilizes an endoscope for real-time visualization during ablation has been developed. This system employs arcs of light-energy that are adjustable (rotating, advancing, retracting) independent of the ballon to aim energy to the PV-LA ostial region. This report details long-term follow-up results from a prospective, multicenter study.
Methods: In this three-center study, 26 patients with a history of symptomatic drug-resistant paroxysmal AF were studied: Sex: M/F = 23(88.5%) / 3 (11.5%); Age 53 ±12 years (28–73); AF duration: 6.5±5.0 years (range 1.2–24.1); LA diameter: 4.2±0.5 cm (range 3.1–4.9); LVEF 66.4±8.4% (range 45–86). A single treatment consisting of isolation of the pulmonary vein ostia was delivered using the EAS. There were no exclusion criteria related to shape/number of PVs.
Results: Electrical PV isolation was achieved in 89% (83/93) of the targeted PVs. An average of 13 energy deliveries/PV were delivered (range 2–40). One patient experienced pericardial tamponade (not device-related); one patient experienced a prolonged reversible ischemic event, and one other patient experienced reversible phrenic nerve paralysis. Following a 60-day blanking period, 75% (15/20) of patients were free from symptomatic AF episodes >1 min at 6-month follow-up, and 80% (4/5) were free from symptomatic AF episodes lasting >1 minute through one-year follow-up. At the 6-month follow-up visit, 9/70 veins (12.9%) had mild stenosis present (20–50% narrowing) and none had moderate or worse stenosis (>50% narrowing). At the 12-month follow-up visit, 1/8 veins (12.5%) had mild stenosis present (20–50% narrowing) and none had moderate or worse stenosis (>50% narrowing).
Conclusions: A single treament with EAS ablation of paroxysmal AF appears feasible, safe and efficacious.