Prospective study of zero-fluoroscopy laser balloon pulmonary vein isolation for the management of atrial fibrillation.

BACKGROUND

In recent years, there has been increased focus on the development of safe and effective strategies to minimize and ultimately eliminate fluoroscopy use in the electrophysiology lab due to the inherent risks to patients and staff associated with this imaging source. However, studies examining these innovative fluoroless strategies for pulmonary vein isolation (PVI) using catheters without direct 3D mapping system integration are lacking. We sought to develop a method to perform zero-fluoroscopy laser balloon PVI for patients with atrial fibrillation (AF), and to test the safety and efficacy of this approach.

METHODS

We developed a standardized method for performing PVI using the X3 laser balloon (LB) system, 3-dimensional electroanatomic mapping (3D-EAM) and intracardiac echocardiography (ICE) in a cohort of patients with symptomatic AF. The primary endpoint of the study was the ability to perform PVI without the use of fluoroscopy. Secondary outcomes were rate of successful transseptal puncture on first attempt, first pass isolation of target PVs, mean procedural time, active laser time to achieve PVI, need for use of supplemental energy sources, and procedural complication rates.

RESULTS

Two hundred consecutive patients undergoing PVI were recruited in the study. In the zero-fluoroscopy group, LB PVI was successfully performed in 100% of participants (n = 100) without the need for fluoroscopy. Transseptal access was achieved in 100% of cases on the first attempt. Successful first pass PVI was achieved in 360 of the 387 pulmonary veins attempted (93%). Mean procedural time was 68.2 ± 16.2 min in the zero-fluoroscopy group versus 67.5 ± 17.0 min in the conventional fluoroscopy group. PVI was able to be achieved in 100% of cases in both groups without need for use of supplemental energy sources. In the zero-fluoroscopy group there were minimal complications, with 3% of all cases having groin complications and 1 patient with a pericardial effusion noted post-procedure which was managed conservatively.

CONCLUSIONS

We demonstrated that successful zero-fluoroscopy LB PVI could be performed at a single high-volume center by experienced operators in an effective manner, without significant complications.