Preliminary Experience With Cardiac Reconstruction Using Decellularized Porcine Extracellular Matrix Scaffold: Human Applications in Congenital Heart Disease

Abstract

An ideal material for repair of congenitally malformed hearts would encourage tissue regeneration with growth potential. Decellularized porcine small intestinal submucosa extracellular matrix (SIS-ECM) promotes tissue regeneration in animal models and noncardiac human applications. This retrospective review evaluates SIS-ECM for reconstruction of congenital heart defects. From June 2007 to May 2009, SIS-ECM patches were used in 43 operations on 40 patients aged 2 days to 13 years. In 16 cases, the SIS-ECM was used for pericardial closure. The SIS-ECM was used for cardiac or great vessel repair in 37 cases: atrial septal defect repair in 11, pulmonary arterioplasty in 10, right ventricular outflow tract patch in 6, pulmonary monocusp valve creation in 5, superior vena cava patch in 2 and aortoplasty in 2, valve leaflet augmentation in 2, and repair of unroofed coronary sinus in 1. Follow-up was complete. There were 5 deaths, all unrelated to the SIS-ECM. Mean follow-up was 7.85 months (0.5-24 months). No pericardial effusions or intracardiac or intravascular thromboses occurred related to the SIS-ECM. The patches did not shrink or calcify. Four of 5 monocusp valves were competent and none were stenotic. One patient who underwent tricuspid valve anterior leaflet augmentation with SIS-ECM required tricuspid valve replacement 4 months later for severe regurgitation following a catheter-based procedure. Explanted tissue showed resorption of the SIS-ECM, replacement with organized collagen, and re-endothelialization. Repair of congenital heart defects using SIS-ECM is feasible and safe. In valve reconstruction, this procedure shows potential for replacement by autologous tissue. Longer-term follow-up is required to assess the potential for growth.

Biologic Scaffolds

“…The investigators concluded that CorMatrix facilitates a favorable clinical outcome for patients undergoing cardiac reconstructive surgery, because only 12 of the 532 required explantation; however, the lack of availability for biopsy and histologic examination prevented any conclusion regarding sitespecific constructive remodeling (Woo et al 2016). Use of SIS-ECM for repair of congenital heart defects in a different study did show regeneration with favorable outcomes (Scholl et al 2010).…”

Editorial Comment: Do not throw away anything from the pig

“…School reported four unicusp valves implanted in pulmonary outflow tract reconstruction with three of them competent at an average follow-up of 9 months: too short to be of significance [4]. Quarti reported 26 cases treated with SIS-ECM patch reconstruction, nine of which were cusp extension valvular repairs: five aortic, two tricuspid, one mitral and one pulmonary valve.…”

Feasibility and Early Effectiveness of a Custom, Hand-Made Systemic Atrioventricular Valve Using Porcine Extracellular Matrix (CorMatrix) in a 4-Month-Old Infant

“…To our knowledge, this is the first report of successful placement of a custom valve made with extracellular matrix material on the systemic side of the heart. This is particularly exciting because there is evidence for resorption of the SIS-ECM, replacement with organized collagen, and reendothelialization in tissues that have been explanted from cardiac patients [7]. Other reports have demonstrated the early success of creating handmade valved conduits on the pulmonary side with the use of similar material [8], but as with our case, these reports have very short-term follow-up.…”