Massimo A Padalino1, Andrea Quarti2, Emanuela Angeli3, Anna C Frigo4, Vladimiro L Vida5, Marco Pozzi2, Gaetano Gargiulo3, Giovanni Stellin5. 1. Pediatric and Congenital Cardiac Surgery, Department of Cardiac, Thoracic and Vascular Sciences, University of Padova Medical School, Padova, Italy massimo.padalino@unipd.it. 2. Pediatric and Congenital Cardiac Surgery and Cardiology, Ospedali Riuniti di Ancona, Ancona, Italy. 3. Pediatric and Congenital Cardiac Surgery, University of Bologna Medical School, Bologna, Italy. 4. Section of Biomedical Statistics, Department of Cardio-Thoracic and Vascular Sciences, University of Padova Medical School, Padova, Italy. 5. Pediatric and Congenital Cardiac Surgery, Department of Cardiac, Thoracic and Vascular Sciences, University of Padova Medical School, Padova, Italy.
Abstract
OBJECTIVES: The aim of this multicentric study was to outline surgical indications and evaluate mid-term outcomes of porcine extracellular matrix (ECM) in surgery for congenital heart disease (CHD). METHODS: The use of ECM was categorized into four major groups: A, valve repair; B, septal reconstruction; C, arterial plasty; D, other use. Primary endpoints of analysis were reintervention (either surgical or interventional) when related to ECM, and functional ECM failure. Secondary endpoints were evidence of calcification and of persistent inflammation at follow-up. RESULTS: One hundred and three patients (M/F = 61/42, median age 19.7 months, 1 day-62 years) underwent surgical repair for CHD. Among ECM use categories, 38 patients were in Group A, 16 in Group B, 71 in Group C and 7 in Group D. There were neither complications nor deaths related to ECM. At a median follow-up of 23.3 months (0.3-55.2), 19 patients underwent reoperation (ECM-related in 6); 11 patients underwent interventional cardiology procedures (ECM-related in 8). Reinterventions were significantly more frequent on the aortic valve (surgical, P = 0.0056) and pulmonary arteries (interventional, P = 0.0159). In addition, interventional procedures on pulmonary arteries were significantly more frequent in infants <12 months (P = 0.0474). No calcifications were detected. CONCLUSIONS: Surgical use of ECM in CHD repair is characterized by a suboptimal functional late performance on reconstruction of valve leaflet or pulmonary artery wall. Longer follow-up and larger clinical experience may support these preliminary results on mid-term outcomes, so as to assess the optimal indication for an ECM graft.
OBJECTIVES: The aim of this multicentric study was to outline surgical indications and evaluate mid-term outcomes of porcine extracellular matrix (ECM) in surgery for congenital heart disease (CHD). METHODS: The use of ECM was categorized into four major groups: A, valve repair; B, septal reconstruction; C, arterial plasty; D, other use. Primary endpoints of analysis were reintervention (either surgical or interventional) when related to ECM, and functional ECM failure. Secondary endpoints were evidence of calcification and of persistent inflammation at follow-up. RESULTS: One hundred and three patients (M/F = 61/42, median age 19.7 months, 1 day-62 years) underwent surgical repair for CHD. Among ECM use categories, 38 patients were in Group A, 16 in Group B, 71 in Group C and 7 in Group D. There were neither complications nor deaths related to ECM. At a median follow-up of 23.3 months (0.3-55.2), 19 patients underwent reoperation (ECM-related in 6); 11 patients underwent interventional cardiology procedures (ECM-related in 8). Reinterventions were significantly more frequent on the aortic valve (surgical, P = 0.0056) and pulmonary arteries (interventional, P = 0.0159). In addition, interventional procedures on pulmonary arteries were significantly more frequent in infants <12 months (P = 0.0474). No calcifications were detected. CONCLUSIONS: Surgical use of ECM in CHD repair is characterized by a suboptimal functional late performance on reconstruction of valve leaflet or pulmonary artery wall. Longer follow-up and larger clinical experience may support these preliminary results on mid-term outcomes, so as to assess the optimal indication for an ECM graft.
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