First experience of POLARx™ versus Arctic Front Advance™: An early technology comparison

Abstract

Introduction Cryoballoon ablation is an established technique to achieve pulmonary vein isolation in patients with atrial fibrillation (AF). Recently, a new manufacturer of cryoballoon achieved regulatory CE marking (POLARx™; Boston Scientific). We describe our early experience of using this new market entrant of the technology and describe procedural aspects in comparison to the incumbent Medtronic Arctic Front Advance™. Methods We assessed the first 40 AF ablations performed with the POLARx catheter at the Barts Heart Centre. These patients were compared with a contemporaneous series of patients undergoing ablation by the same operators using the Arctic Front Advance. Procedural metrics were prospectively recorded. Results A total of four operators undertook 40 cases using the POLARx catheter, compared with 40 cases using the Arctic Front Advance. Procedure times (60.0 vs. 60.0 min) were similar between the two technologies, however left atrial dwell time (35.0 vs 39.0 min) and fluoroscopy times (3.3 vs. 5.2 min) were higher with the POLARx. Measured nadir and isolation balloon temperatures were significantly lower with POLARx. Almost all veins were isolated with a median freezing time of 16.0 (POLARx) versus 15.0 (Arctic Front Advance) min. The rate of procedural complications was low in both groups. Conclusion The POLARx cryoballoon is effective for pulmonary vein isolation. Measured isolation and nadir temperatures are lower compared with the predicate Arctic Front Advance catheter. The technology appears similar in acute efficacy and has a short learning curve, but formal dosing studies may be required to prove equivalence of efficacy.

Key characteristics for effective acute pulmonary vein isolation when using a novel cryoballoon technology: insights from the CHARISMA registry

“…Recently, a new CB technology (POLARx™; Boston Scientific) has come onto the market. Preliminary data [3][4][5] have shown that its acute safety and efficacy are similar to those of the Arctic Front Advance™ CB. However, the behavior of the biophysical parameters associated with cooling seems different between the two systems [3][4][5].…”

“…Preliminary data [3][4][5] have shown that its acute safety and efficacy are similar to those of the Arctic Front Advance™ CB. However, the behavior of the biophysical parameters associated with cooling seems different between the two systems [3][4][5]. The aim of this study was to evaluate procedural and biophysical parameters resulting in acute PV isolation when using this new CB.…”

Comparison of procedural efficacy, balloon nadir temperature, and incidence of phrenic nerve palsy between two cryoballoon technologies for pulmonary vein isolation: A systematic review and meta‐analysis

“…One of the unique features of this cryoballoon is that it maintains a uniform pressure and size during inflation and cryoablation. Several centers have published their initial clinical experience with this POLARx cryoablation system and have compared it with the fourth‐generation Arctic Front Advance Pro (AFA‐Pro) cryoballoon (Medtronic) 9–12 . Most of these studies are limited by their small sample size, observational design, and single‐center design.…”

A tale of two balloons: technical and procedural difference between cryoballoon systems

“…One comparative study comparing Arctic Advance and POLARx demonstrated shorter TTI in the POLARx group (44.8 s vs 39 s) [ 19 ]. Another study by Creta et al suggested increased ablation time in the right-sided PV, contradicting the assumption the more maneuverable POLARSHEATH would ease access to these veins [ 20 ▪ ]. This early clinical data also shows some increased procedural time, LA dwell time, and increased fluoroscopy when using the POLARx system, which could be attributed to operators adapted to the use of new devices.…”