الفهرس 
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Abstract
Background: Repair of complex congenital heart disease frequently requires usage of a patch as an anatomical substitute. The study’s aim is to evaluate the use, effectiveness and safety of utilizing small intestine submucosa extracellular matrix (SIS-ECM) patches in a congenital cardiac surgery program.
Methods: This is a single-center, retrospective, cohort study of surgeries utilizing SIS-ECM between 2012–2019. The SIS-ECM data was categorized by usage and type (4-ply and 2-ply). All re-interventions/complications were reviewed by an independent surgeon, a practicing congenital heart surgeon and a pediatric cardiologist.
Results: 408 SIS-ECM patches were used in 309 patients (M/F=188/121; median age 8.5months). The usage consisted of 314 (77%) arterioplasties, 22 (5.4%) venoplasties, 63 (15.4%) intracardiac repairs, and 9 (2.2%) valve repairs. The most common usage was pulmonary artery repair (n=181; 44.4%). Median follow-up time was 3.9 years (range: 3days–7.4years). Ten (2.5%) patches required surgical (2 in first 30-days and 5 in 1st year) and 27 (6.6%) required percutaneous re-interventions (2 in first 30-days and 22 in 1st year). Between 4-ply (n=376) and 2-ply (n=32) SIS-ECM, rate of surgical (2.1% (n=8) vs 6.3% (n=2); p=0.18) or percutaneous re-interventions (6.4% (n=24) vs 9.4% (n=3); p=0.46) was not different. There were no deaths related to the SIS-ECM patch or reports of calcification.
Conclusions: SIS-ECM is a viable patch option that can be used in various cardiac and vascular reconstructive surgeries with low risk of failure and calcification. Long-term, positive outcomes may be maximized by consistent techniques and understanding appropriate applications of the patch.