Original Cardiovascular
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Risk Factors for Distal Contegra Stenosis: Results of a Prospective European Multicentre Study Dietmar Boethig 1 Christian Schreiber 2 Mark Hazekamp 3 Ute Blanz 4 Rene Prêtre 5 Ruben Greco 7 Vladimir Alexi-Meskishvili 8 Arturo Gonçalves 9 Thomas Breymann 10
Medical School, Hannover, Germany 2 Department of Cardiac Surgery, Deutsches Herzzentrum München, München, Germany 3 Department of Cardiac Surgery, University Medical Center, Leiden, The Netherlands 4 Department of Cardiovascular Surgery, Heart and Diabetes Centre North-Rhine Westphalia, Bad Oeynhausen, Germany 5 Division of Congenital Cardiovascular Surgery, University Children's Hospital, Zürich, Switzerland 6 Department of Paediatric, Thoracic, and Cardiovascular Surgery, German Paediatric Heart Institute, Sankt Augustin, Germany 7 Department of Pediatric Surgery, Hospital Infantil Gregorio Marañon, Madrid, Spain 8 Department of Cardiothoracic and Vascular Surgery, Deutsches Herzzentrum Berlin, Berlin, Germany 9 Department of Cardiac Surgery, Hospital Valle de Hebrón, Barcelona, Spain 10 Department for Cardiac, Thoracic, Transplant and Vascular Surgery, Hannover Medical School, Hannover, Germany
Address for correspondence and reprint requests Dietmar Boethig, M.D., Ph.D., M.Sc., MHH - OE 6730, Carl-Neuberg-Str. 1, Hannover 30625, Germany (e-mail:
[email protected])
Thorac Cardiovasc Surg 2012;60:195–204.
Abstract
Keywords
► pulmonary valve ► congenital heart disease ► CHD ► xenograft ► heart valve surgery ► cardiac
received July 1, 2011 accepted after revision August 22, 2011 published online January 7, 2012
Objectives The EUCon study was designed to identify risk factors for distal anastomotic stenosis after bovine jugular vein (Contegra) implantation in children. Methods Between March 2006 and August 2008, 104 devices were implanted in nine European centers. Preoperative, intraoperative, and follow-up data (at discharge, 6, 12, 24 months) including standardized echocardiography were prospectively registered, source data verified and collected in a central database. Main endpoint was distal stenosis (either postvalvular gradient of 50 mm Hg or need for intervention for distal stenosis). Eight potential risk factors (age < 2 years, diagnosis, running suture, use of glue, flapless anastomosis, oversizing less than þ 2 z, anticoagulation, implantation site) were investigated. Cox regression, decision tree analyses, and “Clustering by Response” were applied. Results Patient age ranged from 0 to18 years, mean 6.0 6.1, median 3.2 years. Implantation reasons: 88% congenital malformations, 12% Ross operations. Follow-up was 88.3% complete. Durability (freedom from death, reoperation, degeneration, endocarditis, and explantation) compared well to corresponding homograft literature. Sixteen patients reached study endpoints. Age
