Vol.:(0123456789) 1 3
Journal of Interventional Cardiac Electrophysiology
https://doi.org/10.1007/s10840-022-01262-5
Comparison of the 1‑year clinical outcome of a novel cryoballoon
to an established cryoballoon technology
Sing‑Chien Yap
1
· Ante Anic
2
· Toni Breskovic
2
· Annika Haas
3
· Rohit E. Bhagwandien
1
· Zrinka Jurisic
2
·
Tamas Szili‑Torok
1
· Armin Luik
3
Received: 7 May 2022 / Accepted: 27 May 2022
© The Author(s) 2022
1 Introduction
Mid 2020, a novel cryoballoon was introduced, the POLARx
(Boston Scientific, Marlborough, MA, USA). The design of
this cryoballoon is comparable to Arctic Front (Medtronic,
Minneapolis, MN, USA), except it has a lower balloon pres-
sure during freezing making it more compliant. Previous
studies have compared the procedural outcome of POLARx
to Arctic Front Advance Pro (AFA-Pro) [1–5]. The aim of
the present study was to compare the 1-year clinical out-
come between POLARx and AFA-Pro of our original study
cohort.
2 Methods
We prospectively included consecutive patients who under-
went cryoballoon ablation (CBA) for the treatment of AF
between May and October 2020 in 3 centers. The periproce-
dural management of our patients was described extensively
previously [5]. A time-to-isolation (TTI)-based cryodosing
was employed. The primary outcome was the freedom from
atrial arrhythmias between 90 and 365 days after the pro-
cedure. The primary outcome between both groups was
compared using log-rank statistics. A P value of < 0.05 was
considered statistically significant.
3 Results
We enrolled 110 patients in the study period (POLARx:
n = 57; AFA-Pro: n = 53). The POLARx group had less
hypertension (31.6% vs. 58.5%, P = 0.007), had more
use of direct acting oral anticoagulants (100% vs. 90.6%,
P = 0.02), and used less antiarrhythmic drugs (52.6% vs.
75.5%, P = 0.02) in comparison to the AFA-Pro group.
Most patients had paroxysmal AF (POLARx: 75.4% ver-
sus AFA-Pro: 75.5%, P = 1.00). The rate of PV isola-
tion was similar between groups (POLARx: 99.5% of
all PVs versus AFA-Pro: 100% of all PVs, P = 1.00).
The POLARx group had a longer procedure time
(median 81 min versus 67 min, P < 0.001) and longer
balloon in body time (median, 51 min versus 35 min,
P < 0.001). There was no difference in the magnitude of
PV occlusion (grade 4 occlusion: POLARx: 81.6% ver-
sus AFA-Pro 77.3%, P = 0.21). Balloon nadir tempera-
tures and temperatures at TTI were lower with POLARx
(median − 55 °C versus − 47 °C, P < 0.001; − 46 °C ver-
sus − 37 °C, P < 0.001), but the timing of TTI was simi-
lar between groups (median 45 s versus 43 s, P = 0.44).
In both groups, 2 patients had phrenic nerve palsy (PNP)
at hospital discharge ( P = 1.00). During a follow-up of
1 year, there was no difference in freedom from atrial
arrhythmias after a blanking period of 90 days (Fig. 1).
The 1-year freedom from atrial arrhythmias was 82%
and 87% for the POLARx and AFA-Pro group, respec-
tively (log-rank P = 0.60). The rate of redo procedures
in the first year was similar between groups (POLARx:
7% versus AFA-Pro: 0%, log-rank P = 0.12). Of the 4
patients in the POLARx group undergoing a redo proce-
dure, all had at least one reconnected PV. The PV recon-
nection rate was 33% (5 of 15 PVs). Of the 4 patients
with PNP, all recovered.
* Sing-Chien Yap
s.c.yap@erasmusmc.nl
1
Department of Cardiology, Erasmus MC, University
Medical Center Rotterdam, Dr. Molewaterplein 40,
3015 GD Rotterdam, the Netherlands
2
Department of Cardiology, Clinical Hospital Center Split,
Split, Croatia
3
Medizinische Klinik IV, Städtisches Klinikum Karlsruhe,
Academic Teaching Hospital of the University of Freiburg,
Karlsruhe, Germany