Nir-David Yifat, Mainzer Gur, Tal Roie, Lorber Avraham
Department of Pediatrics, Carmel Medical Center, Haifa, Israel.
Department of Pediatric Cardiology and Adults with Congenital Heart Disease, Meyer Children's Hospital, Rambam Health Care Campus, Haifa, Israel.
Isr Med Assoc J. 2017 Sep;19(9):557-561.
The closure of an atrial septal defect is procedure that is frequently performed in both adults and children. Currently, the most commonly used devices are the Amplatzer® and Occlutech® Figulla® atrial septal occluders. Studies conducted in adults have shown that these devices all have similar performance efficiency for the closure of secundum atrial septal defects. No study to date has examined their performance in the pediatric population.
To evaluate and compare the performance of Amplatzer® and Occlutech® Figulla® atrial septal occluders in the pediatric population.
A consecutive retrospective study of exclusively pediatric patients who underwent percutaneous closure of atrial septal defect with these devices was conducted at our institute.
The study comprised 110 children, 50 in the Amplatzer® device group and 60 in the Occlutech® Figulla® device group. The groups had similar demographic and defect characteristics, except for defect size per transesophageal echocardiography (TEE), which was 2.1 mm larger in the Amplatzer® device group (P = 0.02). No adverse events were recorded in either of the study groups. Complete defect closure at 12 months follow-up (procedural success) was achieved in all but one of the patients in the Amplatzer® group and all but two in the Figulla® group (P = 1). The residual shunt rates of fenestrated defects were similar in the two groups.
For children with an isolated secundum atrial septal defect, percutaneous closure is equally safe and effective with either Amplatzer® or Occlutech® Figulla® devices.
房间隔缺损封堵术在成人和儿童中都经常进行。目前，最常用的装置是Amplatzer®和Occlutech® Figulla®房间隔封堵器。在成人中进行的研究表明，这些装置在封堵继发孔房间隔缺损方面都具有相似的性能效率。迄今为止，尚无研究考察它们在儿科人群中的性能。
评估和比较Amplatzer®和Occlutech® Figulla®房间隔封堵器在儿科人群中的性能。
在我们研究所对仅使用这些装置进行经皮房间隔缺损封堵术的儿科患者进行了连续回顾性研究。
该研究包括110名儿童，Amplatzer®装置组50名，Occlutech® Figulla®装置组60名。除经食管超声心动图（TEE）测量的缺损大小外，两组的人口统计学和缺损特征相似，Amplatzer®装置组的缺损大小大2.1mm（P = 0.02）。两个研究组均未记录到不良事件。在Amplatzer®组中，除1名患者外，其余所有患者在12个月随访时均实现了缺损完全闭合（手术成功）；在Figulla®组中，除2名患者外，其余所有患者也实现了缺损完全闭合（P = 1）。两组中筛孔状缺损的残余分流率相似。
对于孤立性继发孔房间隔缺损的儿童，使用Amplatzer®或Occlutech® Figulla®装置进行经皮封堵同样安全有效。
