Neethling W.M.L., Strange G., Firth L., Smit F.E.
Fremantle Heart Institute, Fremantle Hospital, University of Western Australia, Fremantle WA, Australia; Department of Cardiothoracic Surgery, Fremantle Hospital, Alma Street, Fremantle 6959, WA, Australia; Department of Cardiothoracic Surgery, University of Free State, Bloemfontein, South Africa; Department of Cardiology, Royal Prince Alfred Hospital, Sydney, NSW, Australia; UWA Centre for Applied Statistics, School of Mathematics and Statistics, University of Western Australia, Crawley WA, Australia
Neethling, W.M.L., Fremantle Heart Institute, Fremantle Hospital, University of Western Australia, Fremantle WA, Australia, Department of Cardiothoracic Surgery, Fremantle Hospital, Alma Street, Fremantle 6959, WA, Australia, Department of Cardiothoracic Surgery, University of Free State, Bloemfontein, South Africa; Strange, G., Department of Cardiology, Royal Prince Alfred Hospital, Sydney, NSW, Australia; Firth, L., UWA Centre for Applied Statistics, School of Mathematics and Statistics, University of Western Australia, Crawley WA, Australia; Smit, F.E., Department of Cardiothoracic Surgery, University of Free State, Bloemfontein, South Africa
OBJECTIVESThis study evaluated the safety, efficacy and clinical performance of the tissue-engineered ADAPT® bovine pericardial patch (ABPP) in paediatric patients with a range of congenital cardiac anomalies.METHODSIn this single-centre, prospective, non-randomized clinical study, paediatric patients underwent surgery for insertion of the ABPP. Primary efficacy measures included early (<30 day) morbidity; incidence of device-related complications; haemodynamic performance derived from echocardiography assessment at 6- and 12-month follow-up and magnetic resonance imaging findings in 10 randomly selected patients at 12 months. Secondary measures included device-handling characteristics; shape and sizing characteristics and perioperative implant complications. The Aristotle complexity scoring system was used to score the complexity level of all surgical procedures. Patients completing the 12-month study were eligible to enter a long-term evaluation study.RESULTSBetween April 2008 and September 2009, the ABPP was used in 30 paediatric patients. In the 30-day postoperative period, no graft-related morbidity was observed. In total, there were 5 deaths (2 in the 30-day postoperative period and 3 within the first 6 postoperative months). All deaths were deemed due to comorbid non-graft-related events. Echocardiography assessment at 6 and 12 months revealed intact anatomical and haemodynamically stable repairs without any visible calcification of the patch. Magnetic resonance imaging assessment in 10 patients at 12 months revealed no signs of calcification. Fisher's exact test demonstrated that patients undergoing more complex, higher risk surgical repairs (Aristotle complexity score >8) were significantly more likely to die (P = 0.0055, 58% survival compared with 100% survival for less complex surgical repairs). In 19 patients, echocardiographic data were available at 18-36 months with no evidence of device calcification, infection, thromboembolic events or device failure.CONCLUSIONSThis study demonstrates the safety and efficacy of this engineered bovine pericardial patch as a cardiovascular substitute for surgical repair of both simple and more complex congenital cardiac defects. © The Author 2013. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.
article; atrioventricular septal defect; biocompatibility; bovine pericardial patch; child; clinical effectiveness; clinical trial; comorbidity; congenital heart malformation; coronary hemodynamics; death; device safety; echocardiography; female; follow up; heart atrium septum defect; heart right ventricle outflow tract; heart ventricle septum defect; high risk patient; human; incidence; infant; male; morbidity; nuclear magnetic resonance imaging; pericardial patch; peroperative complication; post treatment survival; postoperative complication; priority journal; prospective study; school child; surgical risk; survival rate; thrombogenicity; Bovine; Pericardium; Tissue-engineered; Xenograft; Adolescent; Animals; Cardiac Surgical Procedures; Cattle; Child; Child, Preschool; Feasibility Studies; Female; Heart Defects, Congenital; Hemodynamics; Heterografts; Humans; Infant; Infant, Newborn; Magnetic Resonance Imaging; Male; Pericardium; Postoperative Complications; Prospective Studies; South Africa; Time Factors; Tissue Engineering; Treatment Outcome
