研究目的:继发孔型房间隔缺损的经典外科治疗已有50余年的历史,临床结果证明了其安全性及有效性。房间隔缺损外科微创封堵术作为一种新的房间隔缺损封堵方法,自2000年应用于临床至今,经过了近10年。为系统探讨这一新术式的安全性及有效性,我们对其适应症及临床效果进行了回顾性的分析。通过比较房间隔缺损大小、相对位置和手术效果,短-中期预后与已有的国内外相应文献报告的关系,评价新术式的安全性及有效性。 方法:对外科微创封堵术的临床数据(缺损大小,缺损相对位置,手术时间,住院时间等)和临床预后(生活质量,心功能分级等)进行描述性研究。 结果:病例组共入选61例,平均年龄30.2±18.4岁(1~68岁)。其中50岁以上10例,3岁以内3例。单发房间隔缺损59例,平均直径22.4±8.3㎜ (6~39㎜),植入封堵器平均直径28.4± 8.6㎜ (10~44㎜),平均手术时间106.3±31.0分钟(55~180分钟),术后气管插管时间8.7±6.9小时(2.5~43小时),平均住院天数12.9±7.5日。围术期死亡率0,并发症发生率4.8%。 结论:外科微创封堵法封堵单纯房间隔缺损的有效性及中期安全性不次于现有的经典外科治疗或导管介入治疗。 [关键词]:房间隔缺损,外科微创治疗,安全性,有效性。
Objective: Surgical closure of secundum atrial septal defects (ASDs) has a history of over 50 years and a proved safety and efficacy. As a brand-new minimally invasive technique of atrial septal defect closure, surgical intraoperative device closure of ASD had been in clinical practice for nearly 10 years. To testify its safety and efficacy, we analyzed its adaptations and clinical outcomes retrospectively. Evaluate its safety and efficacy by comparing the size of ASDs, margins, operational parameters, short/mid-term outcomes with current companions inside and outside the country. Methods: Descriptively study the clinical results (including size of ASDs, its margins, procedure duration, hospital stay et. al.) and outcomes (quality of life, New York Heart Association class). Results:61 cases were enrolled in the study with an average age of 30. 2 year (range 1-68), among them 10 above 50-years-old and 3 below 3. The average size of the 59 single ASDs was 22.4㎜ (range 6-39), the size (diameter) of the occluder implanted ranged from 10 to 44㎜ with an average of 28. 4mm. The mean duration of anesthesia time and tracheal intubation time was 106.3 minutes and 8. 7 hours respectively. Average hospital stay was 12.9 days. The total complication rate was 4. 8%. without any perioperative mortality, and t Conclusion: The safety and efficacy of the new minimally invasive surgical intraoperative device on closing ASDs is no inferior to classic surgical procedure or the transcatheter ones [Keywords]: atrial septal defect, minimal invasive, surgical closure, device closure, safety, efficacy.