Purpose: This study aims to investigate whether the use of a novel inner lumen circular mapping catheter (IMC) can shorten the procedural duration and fluoroscopic exposure of the single transseptal big cryoballoon (CB) pulmonary vein isolation (PVI) procedures in patients with atrial fibrillation (AF).
Methods: This is a prospective non-randomized case-control study. Forty-two patients (28 men, mean age 55.7 ± 12.1) with drug-refractory paroxysmal or persistent AF and underwent CB PVI procedures were divided into Group A (conventional single transseptal big CB approach, n = 21) and Group B (IMC-facilitated approach, n = 21). They were compared in the co-primary endpoints: (1) procedural duration and (2) fluoroscopic exposure and secondary endpoints: (1) 6-month AF-free survival and (2) number of cryo-applications.
Results: Both the procedural duration (162 ± 26 vs. 215 ± 25 min; p < 0.001) and fluoroscopic exposure (44.1 ± 10.4 vs. 56.8 ± 11.7 min; p = 0.001) were significantly shorter in Group B than Group A patients. With multivariate stepwise regression, only the use of IMC was an independent predictor for procedural duration (β = -59; 95 % CI, -84.1 to -33.8; p < 0.001) and fluoroscopic exposure (β = -16.9; 95 % CI, -28.4 to -5.4; p = 0.006). The number of cryo-applications was significantly fewer in Group B than Group A patients (median 8 vs. 11; p = 0.001). There was no significant difference in the 6-month AF-free survival between the two approaches (57 % vs. 71 %; p = 0.351).
Conclusions: Compared to conventional single transseptal big CB PVI procedures, the use of IMC may reduce procedural duration, fluoroscopic exposure and the number of cryo-applications with comparable mid-term efficacy.