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Frontiers in cardiovascular medicine · 2025

Evaluation of the novel multi-points surface thermometry cryoballoon in the treatment of paroxysmal atrial fibrillation.

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Bai Lu, Jia Ruikun, Sun Xiaochi, Chan Juan, Wang Xinmeng, Wang Shijie, Liu Ming, Shen Yue, Sun Jiayu, Cui Kaijun

Аннотация

BACKGROUND: Cryoballoon 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.

OBJECTIVES: To evaluate the clinical efficiency and potential benefits of CryoMST in PAF.

METHODS: A 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.

RESULTS: The 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.

CONCLUSIONS: The 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.

ИП Урсолов Владлен Сергеевич

ИНН 500118482352 · ОГРНИП 314500117700049

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