A comparison of acute procedural outcomes within four generations of cryoballoon catheters utilized in the real‐world multicenter experience of 1STOP

Abstract

Introduction Four generations of the cryoballoon (CB) catheter were retrospectively evaluated in a real‐world examination of patients with atrial fibrillation (AF). Methods and Results Four hundred eighty patients (27% female and 60 ± 10 years) suffering from AF, underwent pulmonary vein (PV) ablation with one‐of‐four generations of the CB catheter. The total cohort was divided into four groups of patients: 120 with first‐generation (CB‐1); 120 with second‐generation (CB‐2); 120 with third‐generation (CB‐3); and 120 with fourth‐generation (CB‐4). Equal group sizes were achieved by examining the last 120 patients treated in each cohort, attempting to minimize the effect of a learning curve between the generations of CB catheter. Baseline clinical and patient characteristics were similar between the four cohorts, excepting age and the number of tested antiarrhythmic drugs. Procedure, fluoroscopy, and left atrial dwell times were significantly lower in the CB‐4 cohort compared to previous generations of the CB catheters, while the acute procedural success rate was comparable across all catheter groups (>99%). Total acute procedural complications were low (2.5%), and acute complications were comparable within the CB‐2, CB‐3, and CB‐4 groups (0.8% reported in each cohort). The rate of time‐to‐isolation (TTI) visualization increased with later generations of the CB catheters. Conclusions The novel CB‐4 achieved significantly faster procedural ablation times in comparison to the previous generations, while still maintaining a low rate of acute complications. Also, the rate of TTI visualization was observed to be higher with the CB‐4 catheter. Further long‐term evaluation is necessary, including an assessment of AF recurrence and PV reconnection(s).

Cryoballoon atrial fibrillation ablation: Single‐center safety and efficacy data using a novel cryoballoon technology compared to a historical balloon platform

“…A real‐world study evaluating 480 patients, 120 in each generation group, found a progressive reduction in procedural duration (150 min, 95 min, 90 min, and 75 min, from CB‐1 to CB‐4, as well as a reduction in fluoroscopy time and ablation duration, with the same success rate. This denotes that even if reaching a higher success was not possible, the evolution in balloon architecture improved the handling, making the procedure easier 11 …”

“…The Arctic Front Advance ST™ (CB‐3; Medtronic) had a shorter distal nose‐tip on the balloon, which facilitated the real‐timed assessment of pulmonary vein potentials 10 . Currently, most AF cryoablations are performed using the Arctic Front Advance PRO™ system (Medtronic), the 4th generation device, characterized by better catheter maneuverability and ergonomics, achieving shorter procedural times 11 …”

Strategies to Improve the Outcome of Cryoballoon Ablation in the Treatment of Atrial Fibrillation

“…Recently, an interesting study evaluated four generations of CBG in the treatment of AF. The CBG4 application showed a higher rate of TTI visualization, faster procedural ablation times, and a lower rate of acute complications in comparison to the previous generations [22], while the long-term outcomes associated with CBG4 are still unclear.…”

Radiofrequency Versus Cryoablation

“…PV isolation with cryoballoon ablation has gained wide acceptance due to its high rate of success and simplicity of the technique. When successful, a single application of ≤240 s can be applied to isolate a vein, and single-shot procedures (1 application for all veins) are common (25-45%) [19,20]. Currently, there are two manufacturers (Medtronic Inc., Minneapolis,…”