Comparison of procedural efficacy and biophysical parameters between two competing cryoballoon technologies for pulmonary vein isolation: Insights from an initial multicenter experience

Abstract

Introduction Recently a novel cryoballoon system (POLARx, Boston Scientific) became available for the treatment of atrial fibrillation. This cryoballoon is comparable with Arctic Front Advance Pro (AFA‐Pro, Medtronic), however, it maintains a constant balloon pressure. We compared the procedural efficacy and biophysical characteristics of both systems. Methods One hundred and ten consecutive patients who underwent first‐time cryoballoon ablation (POLARx: n = 57; AFA‐Pro: n = 53) were included in this prospective cohort study. Results Acute isolation was achieved in 99.8% of all pulmonary veins (POLARx: 99.5% vs. AFA‐Pro: 100%, p = 1.00). Total procedure time (81 vs. 67 min, p < .001) and balloon in body time (51 vs. 35 min, p < .001) were longer with POLARx. After a learning curve, these times were similar. Cryoablation with POLARx was associated with shorter time to balloon temperature −30°C (27 vs. 31 s, p < .001) and −40°C (32 vs. 54 s, p < .001), lower balloon nadir temperature (−55°C vs. −47°C, p < .001), and longer thawing time till 0°C (16 vs. 9 s, p < .001). There were no differences in time‐to‐isolation (TTI; POLARx: 45 s vs. AFA‐Pro 43 s, p = .441), however, POLARx was associated with a lower balloon temperature at TTI (−46°C vs. −37°C, p < .001). Factors associated with acute isolation differed between groups. The incidence of phrenic nerve palsy was comparable (POLARx: 3.5% vs. AFA‐Pro: 3.7%). Conclusion The novel cryoballoon is comparable to AFA‐Pro and requires only a short learning curve to get used to the slightly different handling. It was associated with faster cooling rates and lower balloon temperatures but TTI was similar to AFA‐Pro.

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

“…Tilz et al 11 demonstrated a trend toward a shorter procedure time with POLARx, potentially secondary to a combination of stable balloon size during inflation and ablation, foot pedal, slider switch, and POLARSHEATH according to the authors. In contrast, Yap et al and Kochi et al showed a longer procedure time with the POLARx system 10,12 . A learning curve effect was demonstrated by Yap et al as the procedure times between both platforms were similar in the second half of the study cohort 12 .…”

“…Besides balloon nadir temperature, other factors affecting target atrial tissue temperature are balloon–tissue contact area, balloon‐to‐PV size ratio, and ipsilateral PV blood flow. A previous study has shown that the median balloon temperature at time‐to‐isolation was lower with POLARx in comparison to AFA‐Pro (−46°C vs. −37°C; p < .001); a difference of approximately 10°C 12 . This could imply that to achieve the desired biological effect (i.e., PV isolation) a lower measured balloon temperature is needed with POLARx in comparison to AFA‐Pro.…”

“…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.…”

Technical and procedural comparison of two different cryoballoon ablation systems in patients with atrial fibrillation

“…The design of the NCB ablation system with a double-balloon layer, an internal balloon thermocouple at the shaft, and N 2 O delivery is very similar to that of the SCB. The pressure within the NCB remains stable from inflation to ablation, and the fluid flow during ablation is 7800 standard cubic centimeter per minute (sccm) compared to 7200 sccm for the SCB [10]. The sheath (POLARSHEATH, Boston Scientific) is a 12.7 French inner (15.9F outer) diameter deflectable sheath with a radiopaque marker 2.5 mm proximal to the sheath tip and a 155° angle of distal deflection.…”

Optimization of the transseptal procedural workflow using a novel integrated dilator and needle during a cryoballoon procedure

“…2 Recently, a second cryoballoon technology (POLARx, Boston Scientific) was introduced which seems to have a similar efficacy and safety as the fourth generation Arctic Front Advance Pro (Medtronic). [3][4][5][6][7] In general, during a cryoballoon procedure the transseptal access is gained through a standard 8-F transseptal sheath with the use of a transseptal needle. After placement of the guidewire in the PV, the transseptal sheath is replaced by a larger steerable sheath (15.9-F POLARSHEATH, Boston Scientific; or 15-F FlexCath, Medtronic) to accommodate the cryoballoon.…”