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.
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.
Authors: Denise Guckel; Philipp Lucas; Khuraman Isgandarova; Mustapha El Hamriti; Leonard Bergau; Thomas Fink; Vanessa Sciacca; Martin Braun; Moneeb Khalaph; Guram Imnadze; Georg Nölker; Philipp Sommer; Christian Sohns Journal: J Interv Card Electrophysiol Date: 2022-06-28 Impact factor: 1.759
Authors: Denise Guckel; Philipp Lucas; Khuraman Isgandarova; Mustapha El Hamriti; Leonard Bergau; Thomas Fink; Vanessa Sciacca; Guram Imnadze; Martin Braun; Moneeb Khalaph; Georg Nölker; Philipp Sommer; Christian Sohns Journal: J Cardiovasc Dev Dis Date: 2022-01-08