Safety and efficacy outcomes in patients undergoing pulmonary vein isolation with second-generation cryoballoon†.
OBJECTIVE
The second-generation cryoballoon (Arctic Front Advance™) (Arc-Adv-CB) has a redesigned injection system which distributes the refrigerant homogenously to the frontal balloon surface. The aim of this study was to compare the efficacy and safety of the Arc-Adv-CB and its predecessor (Arctic Front™) (Arc-CB) in patients who underwent pulmonary vein isolation (PVI) for atrial fibrillation (AF).


RESULTS
Three hundred and six patients (55.35 ± 10.60 years, 47.05% male) were included in the study. A total of 1205 pulmonary veins were attempted for PVI with either Arc-CB or Arc-Adv-CB. The follow-up durations were 30 (23-38) and 10 (8-13) months in Arc-CB and Arc-Adv-CB groups, respectively (P < 0.001). When the blanking period was considered, freedom from AF after a single ablation procedure was 68.53 and 90.83% in patients undergoing PVI with Arc-CB and Arc-Adv-CB, respectively. The most frequent complication was transient phrenic nerve palsy (PNP) which occurred in five(2.54%) and nine(8.26%) of patients undergoing PVI with Arc-CB and Arc-Adv-CB, respectively (P = 0.040). Left atrial (LA) diameter (hazard ratio, HR: 3.552, 95% CI: 2.034-6.201, P < 0.001), smoking history (HR:1.643, 95% CI: 1.011-2.671, P = 0.045), persistent AF (HR:1.725, 95% CI: 1.021-2.915, P = 0.041), duration of AF (HR:1.039, 95% CI: 1.000-1.080, P = 0.047), and early AF recurrence (HR:2.399, 95% CI: 1.443-3.989, P < 0.001) were associated with increased late AF recurrence. On the other hand, intraprocedural vagal reactions (HR: 0.550, 95% CI: 0.331-0.915, P = 0.021) and Arc-Adv-CB use (HR: 0.441, 95% CI: 0.225-0.866, P = 0.017) were associated with lower late AF recurrence. Left atrial diameter (HR: 3.072, 95% CI: 1.646-5.732, P < 0.001), early AF recurrence (HR: 1.906, 95% CI: 1.103-3.291, P = 0.021), and Arc-Adv-CB use (HR: 0.472, 95% CI: 0.239-0.931, P = 0.030) were independent predictors for late AF recurrence.


CONCLUSIONS
Our study has shown that Arc-Adv-CB use is associated with lower late AF recurrences at the cost of an increased risk for PNP.
Faculty of Medicine, Department of Cardiology, Hacettepe University, 06100 Sıhhiye, Ankara, Turkey.
Kudret
K
Aytemir
Faculty of Medicine, Department of Cardiology, Hacettepe University, 06100 Sıhhiye, Ankara, Turkey kmuratg@yahoo.com.
Kadri Murat
KM
Gurses
Faculty of Medicine, Department of Cardiology, Hacettepe University, 06100 Sıhhiye, Ankara, Turkey.
Muhammed Ulvi
MU
Yalcin
Faculty of Medicine, Department of Cardiology, Hacettepe University, 06100 Sıhhiye, Ankara, Turkey.
Duygu
D
Kocyigit
Faculty of Medicine, Department of Cardiology, Hacettepe University, 06100 Sıhhiye, Ankara, Turkey.
Muhammet
M
Dural
Faculty of Medicine, Department of Cardiology, Hacettepe University, 06100 Sıhhiye, Ankara, Turkey.
Banu
B
Evranos
Faculty of Medicine, Department of Cardiology, Hacettepe University, 06100 Sıhhiye, Ankara, Turkey.
Hikmet
H
Yorgun
Department of Cardiology, Samsun Education and Research Hospital, 55100 Samsun, Turkey.
Ahmet Hakan
AH
Ates
Faculty of Medicine, Department of Cardiology, Hacettepe University, 06100 Sıhhiye, Ankara, Turkey.
Mehmet Levent
ML
Sahiner
Faculty of Medicine, Department of Cardiology, Hacettepe University, 06100 Sıhhiye, Ankara, Turkey.
Ergun Baris
EB
Kaya
Faculty of Medicine, Department of Cardiology, Hacettepe University, 06100 Sıhhiye, Ankara, Turkey.
Mehmet Ali
MA
Oto
D000328:Adult; D000368:Aged; D001281:Atrial Fibrillation / Q000601:surgery*; D003452:Cryosurgery / Q000009:adverse effects / Q000379:methods*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D061646:Operative Time; D010523:Peripheral Nervous System Diseases / Q000209:etiology; D010791:Phrenic Nerve / Q000293:injuries; D011183:Postoperative Complications / Q000453:epidemiology; D011667:Pulmonary Veins / Q000601:surgery*; D016896:Treatment Outcome
Ablation; Atrial fibrillation; Cryoballoon; Efficacy; Safety