Data Sheet 2_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.

背景：冷冻球囊消融术（Cryoballoon Ablation, CBA）被广泛用于治疗阵发性心房颤动（paroxysmal atrial fibrillation, PAF）。近日，IceMagicTM心脏冷冻消融系统（CryoMST，上海微创电生理医疗科技有限公司，中国上海）已推出。
研究目的：评估CryoMST系统治疗PAF的临床有效性及潜在获益。
研究方法：本项倾向评分匹配研究纳入16例接受CryoMST初次冷冻球囊消融的PAF患者，并与接受Arctic Front Advance™（n=48）、射频消融术（Radiofrequency Ablation, RFA，n=48）及脉冲电场消融术（Pulsed-Field Ablation, PFA，n=16）的队列进行对比。通过比较四组患者的围手术期及12个月随访结局数据，评估CryoMST的有效性与安全性。
研究结果：与Arctic Front Advance™组相比，CryoMST队列的总手术时间[83.00（四分位距Q1、Q3：75.00、89.25）min vs 102.00（Q1、Q3：85.00、127.75）min]、消融时间[20.00（Q1、Q3：18.74、21.00）min vs 46.00（Q1、Q3：38.00、55.75）min]、透视时间[12.93（Q1、Q3：11.15、16.96）min vs 17.85（Q1、Q3：12.35、23.38）min]、透视剂量[81.80（Q1、Q3：69.93、96.03）mGy vs 200.00（Q1、Q3：134.75、311.50）mGy]及造影剂用量[16.00（Q1、Q3：11.00、22.00）mL vs 52.50（Q1、Q3：45.00、57.00）mL]均显著降低（P<0.05）。CryoMST可准确预测肺静脉闭塞，与肺静脉造影结果一致性极佳（灵敏度89.3%，特异度100.0%，Kappa值=0.87，P<0.001）。12个月随访期间，各组的心律失常复发率及并发症发生率无显著差异。
研究结论：CryoMST系统对肺静脉闭塞的诊断准确性优异，可无需常规行静脉造影。与传统冷冻球囊消融术相比，其可显著缩短手术时间、降低辐射暴露及造影剂用量，且在12个月随访的有效性与安全性方面，与现有治疗PAF的消融方案相当。