title: Intravascular stents in congenital heart disease: short- and long-term results from a large single-center experience.
abstract: OBJECTIVE
  This report describes the results of the Food and Drug Administration's phase 1 and 2 clinical trials of intravascular stents at Texas Children's Hospital.
  
  
  BACKGROUND
  Since the late 1980s, intravascular stent implantation for the treatment of arterial and venous stenoses in congenital heart disease has been highly successful.
  
  
  METHODS
  Stents were placed in postoperative pulmonary artery (PA) stenoses, congenital PA stenoses or stenoses of systemic veins/venous anastomoses. Prospective collection of data according to protocol was done before intervention, after stent implantation and at follow-up catheterization.
  
  
  RESULTS
  At stent implantation, pressure gradients decreased significantly in all three groups (mean +/- SD): from 46 +/- 25 to 10 +/- 13 mm Hg in postoperative PA stenoses (p < 0.001); from 71 +/- 45 to 15 +/- 21 mm Hg in congenital PA stenoses (p < 0.001); and from 7 +/- 6 to 1 +/- 2 mm Hg in stenoses of systemic veins/venous anastomoses stenoses (p < 0.001). Vessel diameters markedly increased: from 6 +/- 3 to 12 +/- 3 mm in postoperative PA stenoses (p < 0.001); from 3 + 1 to 9 + 1 mm in congenital PA stenoses (p < 0.001); and from 3 +/- 4 to 12 +/- 4 mm in stenoses of systemic veins/venous anastomoses (p < 0.001). In the postoperative and congenital PA stenoses groups, right ventricular pressure decreased (right ventricular pressure indexed to femoral artery pressure ratio): from 0.63 +/- 0.2 to 0.41 +/- 0.02 (p < 0.001) and from 0.71 +/- 0.3 to 0.55 +/- 0.35 (p = 0.04), respectively. Perfusion to a single affected lung increased from 31 +/- 17% to 46 +/- 14% (p < 0.001). On recatheterization (mean 14 months), results varied minimally. Repeat angioplasty of residual stent stenoses was safe and effective. Complications included four early patients with stent migration, three with stent thrombosis and two deaths. There were no late complications. Significant restenosis occurred in only three patients.
  
  
  CONCLUSIONS
  Intravascular stents for the treatment of vascular stenoses in congenital heart disease provide excellent immediate and long-term results.
authors.affiliation: Department of Pediatrics, Baylor College of Medicine and Texas Children's Hospital, Houston 77030, USA.
authors.forename: K M
authors.initials: KM
authors.lastname: Shaffer
authors.forename: C E
authors.initials: CE
authors.lastname: Mullins
authors.forename: R G
authors.initials: RG
authors.lastname: Grifka
authors.forename: M P
authors.initials: MP
authors.lastname: O'Laughlin
authors.forename: W
authors.initials: W
authors.lastname: McMahon
authors.forename: F F
authors.initials: FF
authors.lastname: Ing
authors.forename: M R
authors.initials: MR
authors.lastname: Nihill
mesh_terms: D000293:Adolescent; D000328:Adult; D002648:Child; D002675:Child, Preschool; D003251:Constriction, Pathologic; D005260:Female; D005548:Foreign-Body Migration / Q000209:etiology; D006330:Heart Defects, Congenital / Q000601:surgery*; D006801:Humans; D007223:Infant; D008297:Male; D011651:Pulmonary Artery / Q000002:abnormalities* / Q000601:surgery*; D015607:Stents / Q000009:adverse effects; D013927:Thrombosis / Q000209:etiology; D016896:Treatment Outcome