318 * EARLY AND MID-TERM CLINICAL EXPERIENCE WITH EXTRACELLULAR MATRIX GRAFT FOR CONGENITAL CARDIAC AND VASCULAR RECONSTRUCTIVE SURGERY: A MULTICENTRE ITALIAN STUDY

Abstract

Objectives: A multicentre study to outline surgical indications and evaluate mid-term outcomes of porcine extracellular matrix (ECM) in surgery for congenital heart disease (CHD). Methods: Use of ECM was categorised in 4 major groups: A, valve repair; B, septal reconstruction; C, arterial plasty; D, other use. Primary endpoints of analysis were death related to ECM or reintervention (either surgical or interventional). Secondary endpoints were functional ECM failure, defined as significant regurgitation/stenosis (A), residual shunt or inflow stenosis (B), vessel stenosis or aneurysm (C), any adverse event (D); evidence of calcification. Results: One hundred and three patients (M/F = 60/43, median age 19.7 months, 0.03–62 years) underwent surgical repair for CHD. Among ECM use categories, 37 patients were in Group A, 9 in Group B, 53 in Group C and 4 in Group D. There were neither complications nor deaths related to ECM. At a median follow up of 21.5 months (0.2 months to 4.6 years), there was no significant difference in incidence of overall reintervention among Groups (P = 0.64), even if it occurred mostly in Groups A and C. Nineteen patients underwent reoperation (ECM-related in 6 patients, 5.9%); 9 patients required interventional cardiology procedures. Overall, ECM functional failure occurred in 25 patients (24.3%). No calcification was detected. In group A, late outcome seems to be related to surgical technique. Conclusion: Surgical use of ECM in CHD repair is characterised by suboptimal late outcome in valve repair, according to technique. Longer follow-up and larger clinical experience are needed, so as to outline the optimal indication for ECM graft.