Data Sheet 1_Evaluation of the novel multi-points surface thermometry cryoballoon in the treatment of paroxysmal atrial fibrillation.pdf

BackgroundCryoballoon ablation (CBA) is extensively utilized to treat paroxysmal atrial fibrillation (PAF). The IceMagicTM Cardiac CryoAblation System (CryoMST, MicroPort EP MedTech CO., Ltd, Shanghai, China) has recently been introduced.
ObjectivesTo evaluate the clinical efficiency and potential benefits of CryoMST in PAF.
MethodsA propensity-score matched study compared 16 patients with PAF undergoing initial CBA with CryoMST against cohorts treated with Arctic Front Advance™ (n = 48), radiofrequency ablation (RFA, n = 48), and pulsed-field ablation (PFA, n = 16). Peri-procedural and 12-month outcome data were compared among the four groups to assess the efficacy and safety of the CryoMST.
ResultsThe CryoMST cohort showed significant reductions in total procedure time [83.00 (Q1, Q3: 75.00, 89.25) vs. 102.00 (Q1, Q3: 85.00, 127.75) min], ablation time [20.00 (Q1, Q3: 18.74, 21.00) vs. 46.00 (Q1, Q3: 38.00, 55.75) min], fluoroscopy time [12.93 (Q1, Q3: 11.15, 16.96) vs. 17.85 (Q1, Q3: 12.35, 23.38) min], fluoroscopy dose [81.80 (Q1, Q3: 69.93, 96.03) vs. 200.00 (Q1, Q3: 134.75, 311.50) mGy], and contrast agent volume [16.00 (Q1, Q3: 11.00, 22.00) vs. 52.50 (Q1, Q3: 45.00, 57.00) mL] compared to the Arctic Front Advance™ group (P < 0.05). CryoMST accurately predicted pulmonary vein occlusion, showing high concordance with pulmonary vein angiograph (sensitivity 89.3%, specificity 100.0%, Kappa value = 0.87, p < 0.001). At 12-month follow-up, rates of arrhythmia recurrence and complications did not differ among the groups.
ConclusionsThe CryoMST system demonstrates excellent diagnostic accuracy for pulmonary vein occlusion, obviating the need for routine venography. It significantly reduces procedure time, radiation exposure, and contrast use compared to conventional CBA, while maintaining comparable 12-month efficacy and safety to established ablation modalities for PAF.