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国产Snare-Ⅱ抓捕器用于室间隔缺损介入治疗的临床研究 被引量:4

Clinical study of domestic Snare Ⅱ generation products in treatment of rentnicular septal defect
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摘要 目的探讨抓捕器-Ⅱ(Snare-Ⅱ)在室间隔缺损(VSD)介入治疗中的实用性和安全性。方法将接受单纯膜周型VSD介入封堵术的患者按照第三方提供的密封随机信封分组,最终98例患者入选,分别为对照组46例和试验组52例;对照组使用SnareⅠ抓捕器,试验组使用Snare-Ⅱ抓捕器,对比分析两组患者终点指标、效果指标和安全指标。结果与对照组比较,试验组导丝抓捕时间短[(3.97±1.02)s比(24.83±2.84)s]、照射X线时间显著减少[(16.0±5.2)s比(65.1±13.6)s]、抓捕次数中位数少[2(1,4)比5(4,6)]、放射量少[(6.6±1.9)u Sv比(35.7±6.9)u Sv],差异均有统计学意义(P<0.001)。试验组中绝大多数患者1次抓捕成功,较对照组优势显著。抓捕器撤回时间试验组用时略短于对照组[(4.2±0.8)s比(4.4±0.9)s],差异无统计学意义(P=0.186)。两组患者抓捕器送达肺动脉时间、并发症、总手术时间方面比较,差异无统计学意义(P>0.05)。结论介入治疗VSD时,采用Snare-Ⅱ,实用性和安全性更高。 Objective To investigate the practicability and safety of domestic Snare H generation products in the treatment of perimembranous VSD. Methods Ninety-eight patients who underwent interventional occlusion for simple perimembranous VSD were randomized into two groups: 46 patients were treated with the Snare- Ⅰ (first-generation product) and 52 patients were treated with the Snare-Ⅱ (second- generation product) . Clinical endpoints including procedural success rates, eomplication rates, successful delivery rates of devices and safety were compared between the 2 groups. Results The capture time was shorter with the Snare- H ( 24. 8 ± 2. 8 ) s than the Snare- Ⅰ [ (4. 0 ± 1.0) s, P 〈 0. 001 ] . X-ray exposure time was shorter in the Snare Ⅱ group ( 16.0 ± 5.2) s than in the Snare I group (65.1 ± 13.6) s (P 〈0. 001 ) . Median capture counts were lower in the Snare I group [2 ( 1, 4) ] than in the Snare Ⅱ group [5 (4, 6)] (P 〈 0. 001 ) . Radiation quantity was less in the Snare Ⅱ group (6. 6 ± 1.9) uSv than in the Snare I group (35.7±6.9) uSv (P 〈0.001) . In the Snare Ⅱ group, most captures required only one catch. Withdrawal time was slightly longer in the Snare Ⅱ group than in the Snare I group [ (4.4±0.9) s vs. (4.2 ±0.8) s, P= 0.186] . Intergroup differences were not statistically significant in fields of delivery time to the pulmonary artery, complications and total surgical time. Conclusions Interventional therapy using the Snare-Ⅱ for VSD offers practicality and greater security.
出处 《中国介入心脏病学杂志》 2015年第7期361-365,共5页 Chinese Journal of Interventional Cardiology
基金 湖北省卫生厅科研项目(JX6B90) 湖北省卫生局科研项目(WX13C47)
关键词 抓捕器 先天性心脏病 室间隔缺损 Snare Congenital heart disease Ventricular septal defect
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