Abstract 13991: Acute Procedural and Clinical Outcome Comparison Using the First and Second-Generation Cryoballoon: Inside a Large Cohort of Data Derived From Real World Multicentric Experience
Introduction: Limited data are available on safety and efficacy of second-generation cryoballoon (CB2) for cryoablation of atrial fibrillation (CBA).
Hypothesis: To evaluate in a large cohort of patients treated in real world clinical settings, demographics, procedural data and outcomes comparing CB2 to first-generation cryoballoon (CB1).
Methods: Between 2012 and 2014, 581 patients (74% men, 59±10 years, 78% paroxysmal AF, LA diameter: 41±6 mm) suffering from AF and undergoing pulmonary veins (PV) CBA were prospectively enrolled in ClinicalService® framework One Shot TO Pulmonary vein isolation (1STOP) project. The cohort was divided into 2 groups according to the cryoballoon used in standard clinical practice: 120 (21%) CB1 and 461 (79%) CB2.
Results: Clinical and demographic characteristics were similar in the two cohorts; procedure, fluoroscopy and ablation time were significantly lower in CB2 respect to CB1 (141±40 vs 166±50 min, p<.001; 35±15 vs 41±15 min, p<.001; 27±17 vs 41±26 min, p<.001) with comparable acute success rate (97.8 vs 97.4%, p=ns); 22 patients (3.8%) experienced procedural complications. The most frequent acute procedural complication was transient diaphragmatic paralysis, significantly lower in CB2 vs CB1 (0.7 vs 3.3%, p=.016). Data at a minimum FU of 6 months were available for 237 (41%) patients: annual rate of follow-up complications was significantly lower in CB2 vs CB1 (Rate*100 pt/years: 5.74 vs 17.92, Incidence Rate Ratio - IRR: 0.32; 95% CI 0.17- 0.60; p<.001) as well as CB2 was associated with lower PV reconnection rate causing redo ablation (Rate*100 pt/years: 0.64 vs 4.98; IRR: 0.13; 95% CI 0.05-0.30; p<.001); 25 complications in 16 patients have been reported during FU, 21 (84%) of which for AF recurrence.
Kaplain Meier analysis showed that freedom from AF at 12 months for patients with paroxysmal indication, considering a blanking period of 3 months, was 67.8% (95% CI 53.1-78.8%) in CB1 group and 77.8% (95% CI 68.6-84.7%) in CB2.
Conclusions: The novel cryoballoon Arctic Front Advance (CB2) has proven to achieve, in a large clinical standard setting, significantly faster CBA times in comparison with the first-generation balloon, results also in lower acute procedural complication rates and a 78% 1-year freedom from AF.
Author Disclosures: L. Padeletti: None. G. Arena: None. C. Tondo: None. S. Fumagalli: None. M. Lunati: None. S. Porcellini: None. D. Catanzariti: None. L. Sciarra: None. L. Leoni: None. G. Senatore: None. A. Curnis: None.
- © 2015 by American Heart Association, Inc.