European Contegra multicentre study: 7-year results after 165 valved bovine jugular vein graft implantations

Thorac Cardiovasc Surg. 2009 Aug;57(5):257-69. doi: 10.1055/s-0029-1185513. Epub 2009 Jul 23.

Abstract

Objective: The valved bovine conduit "Contegra" for RVOT reconstruction became available for clinical use within a 100 % source data monitored and echo core lab controlled prospective European Multicentre Study, carried out from 1999 to 2006. We present the results of this study.

Methods: A total of 165 Contegras were implanted in 8 centres. The mean patient age was 3.9 years (2 days - 18 years, median 2.0). Total follow-up was 687 patient years. Diagnoses included: tetralogy of Fallot (64 patients, 39 %), truncus arteriosus (50, 30 %), double outlet right ventricle (16, 10 %), aortic valve disease/Ross procedure (11, 7 %), pulmonary valve atresia (10, 6 %), transposition of the great arteries (10, 6 %), 4 other malformations (2 %). Previous procedures were: 82 patients (50 %) - none; 37 (22 %) - valved conduit implantation; 14 (8 %) aortopulmonary shunt; 6 (4 %) catheter intervention. Follow-up appointments which included standardised echocardiography investigations were scheduled at 1, 3, 6, and 12 months, then annually. We evaluated freedom from death, explantation, intervention, stenosis, insufficiency, and degeneration. Results were stratified by age, diagnosis group and conduit size.

Results: The 5-year freedom-from rates were: explantation - 90 % (for patients aged 1 to 10 years) and 68 % (for younger patients); endocarditis - over 92 %; catheter intervention - 74 % (patients with congenital malformations); stenosis - 75 % and more (any group); insufficiency - 50 % (12 and 14 mm diameter conduits); any event - 13 % (patients under 1 year), 58 % (1 to 10 years), 82 % (> 10 years). Trace or mild insufficiency was a frequent, but not progressive finding. Mild calcification was detected in only 8 examinations.

Conclusions: The performance of the Contegra conduit compares well with that of homografts when used to reconstruct paediatric right ventricular outflow tracts.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Animals
  • Calcinosis / etiology
  • Calcinosis / therapy
  • Cardiac Catheterization
  • Cardiac Surgical Procedures* / adverse effects
  • Cardiac Surgical Procedures* / mortality
  • Cattle
  • Child
  • Child, Preschool
  • Endocarditis / etiology
  • Endocarditis / therapy
  • Europe
  • Female
  • Graft Occlusion, Vascular / etiology
  • Graft Occlusion, Vascular / therapy
  • Heart Defects, Congenital / mortality
  • Heart Defects, Congenital / surgery*
  • Humans
  • Infant
  • Infant, Newborn
  • Jugular Veins / diagnostic imaging
  • Jugular Veins / transplantation*
  • Kaplan-Meier Estimate
  • Male
  • Proportional Hazards Models
  • Prospective Studies
  • Reoperation
  • Risk Assessment
  • Risk Factors
  • Time Factors
  • Transplantation, Heterologous
  • Treatment Outcome
  • Ultrasonography
  • Ventricular Outflow Obstruction / diagnostic imaging
  • Ventricular Outflow Obstruction / surgery*