title: A new low profile balloon atrial septostomy catheter: initial animal and clinical experience.
abstract: OBJECTIVE
  To evaluate the safety and efficacy of a new low profile balloon septostomy catheter in neonatal animals as well as in one newborn infant.
  
  
  BACKGROUND
  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.
  
  
  METHODS
  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.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Pediatrics, Boston Floating Hospital For Children, New England Medical Center, Tufts University School of Medicine, Boston, Massachusetts 02111, USA.
authors.forename: Z M
authors.initials: ZM
authors.lastname: Hijazi
authors.forename: R L
authors.initials: RL
authors.lastname: Geggel
authors.forename: M J
authors.initials: MJ
authors.lastname: Aronovitz
authors.forename: G R
authors.initials: GR
authors.lastname: Marx
authors.forename: J
authors.initials: J
authors.lastname: Rhodes
authors.forename: D R
authors.initials: DR
authors.lastname: Fulton
mesh_terms: D000818:Animals; D006328:Cardiac Catheterization / Q000295:instrumentation*; D006344:Heart Septal Defects, Atrial / Q000601:surgery*; D006346:Heart Septum / Q000601:surgery*; D006801:Humans; D007231:Infant, Newborn; D008297:Male; D013552:Swine