Hijazi Z M, Geggel R L, Aronovitz M J, Marx G R, Rhodes J, Fulton D R
Department of Pediatrics, Boston Floating Hospital For Children, New England Medical Center, Tufts University School of Medicine, Boston, Massachusetts 02111, USA.
J Invasive Cardiol. 1994 Jul-Aug;6(6):209-12.
To evaluate the safety and efficacy of a new low profile balloon septostomy catheter in neonatal animals as well as in one newborn infant.
Balloon atrial septostomy remains one of the most commonly performed palliative procedures in pediatric cardiology. The currently available septostomy catheter requires a large introducer sheath (6 or 7F), does not have an end hole for confirmation of position or pressure measurement and is limited in patients with a small left atrium due to its large balloon inflated diameter.
Four neonatal piglets (average weight 3.9 kg) underwent percutaneous balloon atrial septostomy using the new balloon catheter inflated to 1 cc via a 5F sheath in the femoral vein. Two other piglets (average weight 4.9 kg) underwent septostomy with the conventional catheter inflated to 3.5 cc via a 6 or 7F sheath in the femoral vein. All animals underwent transthoracic echocardiography pre and post septostomy. All animals were sacrificed after the procedure and the size of the atrial defect created was measured. One neonate with Taussig-Bing anomaly underwent septostomy with the new balloon catheter.
The left atrium was entered in all piglets. It was easier to enter the left atrium with an end hole catheter which was exchanged over a wire with the septostomy catheter. Septostomy was performed with the new or conventional catheters without complications. Echocardiography demonstrated a very small patent foramen ovale prior to the procedure and a large atrial defect after septostomy. The average size of the defect created by the new catheter was 11.3 x 10 mm in diameter and 11 x 10 mm using the conventional catheter. A 10 x 10 mm atrial communication was created in the neonate.
This study demonstrates the safety and efficacy of this new catheter. This catheter will be of potential importance in patients with a small left atrium and in small neonates with congenital heart disease requiring septostomy.
评估一种新型低轮廓球囊房间隔造口导管在新生动物以及一名新生儿中的安全性和有效性。
球囊房间隔造口术仍然是小儿心脏病学中最常用的姑息性手术之一。目前可用的房间隔造口导管需要一个大的导入鞘（6或7F），没有用于确认位置或测量压力的端孔，并且由于其大的球囊膨胀直径，在左心房小的患者中受到限制。
四只新生仔猪（平均体重3.9千克）通过股静脉中的5F鞘使用充气至1立方厘米的新型球囊导管进行经皮球囊房间隔造口术。另外两只仔猪（平均体重4.9千克）通过股静脉中的6或7F鞘使用充气至3.5立方厘米的传统导管进行房间隔造口术。所有动物在房间隔造口术前和术后均接受经胸超声心动图检查。所有动物在手术后被处死，并测量所形成的房间隔缺损的大小。一名患有陶西格-宾畸形的新生儿使用新型球囊导管进行了房间隔造口术。
所有仔猪均成功进入左心房。使用带有端孔的导管并通过导丝与房间隔造口导管交换后更容易进入左心房。使用新型或传统导管进行房间隔造口术均无并发症。超声心动图显示术前卵圆孔未闭非常小，房间隔造口术后出现大的房间隔缺损。新型导管造成的缺损平均直径为11.3×10毫米，传统导管造成的缺损为11×10毫米。该新生儿形成了10×10毫米的房间隔交通。
本研究证明了这种新型导管的安全性和有效性。这种导管对于左心房小的患者以及需要进行房间隔造口术的先天性心脏病的小新生儿可能具有重要意义。
