title: Early and mid-term clinical experience with extracellular matrix scaffold for congenital cardiac and vascular reconstructive surgery: a multicentric Italian study.
abstract: OBJECTIVE
  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.
authors.affiliation: Pediatric and Congenital Cardiac Surgery, Department of Cardiac, Thoracic and Vascular Sciences, University of Padova Medical School, Padova, Italy massimo.padalino@unipd.it.
authors.forename: Massimo A
authors.initials: MA
authors.lastname: Padalino
authors.affiliation: Pediatric and Congenital Cardiac Surgery and Cardiology, Ospedali Riuniti di Ancona, Ancona, Italy.
authors.forename: Andrea
authors.initials: A
authors.lastname: Quarti
authors.affiliation: Pediatric and Congenital Cardiac Surgery, University of Bologna Medical School, Bologna, Italy.
authors.forename: Emanuela
authors.initials: E
authors.lastname: Angeli
authors.affiliation: Section of Biomedical Statistics, Department of Cardio-Thoracic and Vascular Sciences, University of Padova Medical School, Padova, Italy.
authors.forename: Anna C
authors.initials: AC
authors.lastname: Frigo
authors.affiliation: Pediatric and Congenital Cardiac Surgery, Department of Cardiac, Thoracic and Vascular Sciences, University of Padova Medical School, Padova, Italy.
authors.forename: Vladimiro L
authors.initials: VL
authors.lastname: Vida
authors.affiliation: Pediatric and Congenital Cardiac Surgery and Cardiology, Ospedali Riuniti di Ancona, Ancona, Italy.
authors.forename: Marco
authors.initials: M
authors.lastname: Pozzi
authors.affiliation: Pediatric and Congenital Cardiac Surgery, University of Bologna Medical School, Bologna, Italy.
authors.forename: Gaetano
authors.initials: G
authors.lastname: Gargiulo
authors.affiliation: Pediatric and Congenital Cardiac Surgery, Department of Cardiac, Thoracic and Vascular Sciences, University of Padova Medical School, Padova, Italy.
authors.forename: Giovanni
authors.initials: G
authors.lastname: Stellin
mesh_terms: D000293:Adolescent; D000328:Adult; D000818:Animals; D001705:Bioprosthesis; D001706:Biopsy; D001807:Blood Vessel Prosthesis; D019917:Blood Vessel Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation*; D002648:Child; D002675:Child, Preschool; D005109:Extracellular Matrix / Q000637:transplantation*; D005260:Female; D006330:Heart Defects, Congenital / Q000175:diagnosis / Q000503:physiopathology / Q000601:surgery*; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation*; D064593:Heterografts; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D007558:Italy; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications / Q000601:surgery; D011446:Prospective Studies; D011474:Prosthesis Design; D011475:Prosthesis Failure; D012086:Reoperation; D012307:Risk Factors; D013552:Swine; D013997:Time Factors; D054457:Tissue Scaffolds; D016896:Treatment Outcome; D055815:Young Adult
keywords: Congenital heart disease; Extracellular matrix; Outcomes; Scaffold; Small intestine submucosa; Surgery