TY - JOUR
T1 - More Than 400 Uses of an Intestinal Submucosal Extracellular Matrix Patch in a Congenital Heart Program
AU - Haney, Li Cai
AU - Ahmed, Hosam F.
AU - Dani, Alia
AU - Chin, Peter
AU - Thangappan, Karthik
AU - Madsen, Nicolas
AU - Zafar, Farhan
AU - Tweddell, James S.
AU - Morales, David L.S.
N1 - Publisher Copyright:
© 2021 The Society of Thoracic Surgeons
PY - 2021
Y1 - 2021
N2 - Background: Repair of complex congenital heart disease frequently requires use of a patch as an anatomic substitute. The study's aim is to evaluate the use, effectiveness, and safety of using small intestine submucosal extracellular matrix (SIS-ECM) patches in a congenital cardiac surgery program. Methods: This is a single-center, retrospective, cohort study of surgeries using SIS-ECM between 2012 and 2019. The SIS-ECM data were categorized by use and type (four-ply and two-ply). All reinterventions and complications were reviewed by an independent surgeon, a practicing congenital heart surgeon, and a pediatric cardiologist. Results: In all, 408 SIS-ECM patches were used in 309 patients (188 male, 121 female; median age 8.5 months). Use of the patches consisted of 314 arterioplasties (77%), 22 venoplasties (5.4%), 63 intracardiac repairs (15.4%), and 9 valve repairs (2.2%). The most common use was for pulmonary artery repair (n = 181; 44.4%). Median follow-up time was 3.9 years (range, 3 days to 7.4 years). Ten patches (2.5%) required surgical reintervention (2 in the first 30 days and 5 in the first year) and 27 (6.6%) required percutaneous reinterventions (2 in the first 30 days and 22 in the first year). Between four-ply (n = 376) and two-ply (n = 32) SIS-ECM, the rate of surgical (2.1% [n = 8] vs 6.3% [n = 2], P = .18) or percutaneous reinterventions (6.4% [n = 24] vs 9.4% [n = 3], P = .46) was not different. There were no deaths related to the SIS-ECM patch or reports of calcification. Conclusions: The 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 using consistent techniques and understanding the appropriate applications of the patch.
AB - Background: Repair of complex congenital heart disease frequently requires use of a patch as an anatomic substitute. The study's aim is to evaluate the use, effectiveness, and safety of using small intestine submucosal extracellular matrix (SIS-ECM) patches in a congenital cardiac surgery program. Methods: This is a single-center, retrospective, cohort study of surgeries using SIS-ECM between 2012 and 2019. The SIS-ECM data were categorized by use and type (four-ply and two-ply). All reinterventions and complications were reviewed by an independent surgeon, a practicing congenital heart surgeon, and a pediatric cardiologist. Results: In all, 408 SIS-ECM patches were used in 309 patients (188 male, 121 female; median age 8.5 months). Use of the patches consisted of 314 arterioplasties (77%), 22 venoplasties (5.4%), 63 intracardiac repairs (15.4%), and 9 valve repairs (2.2%). The most common use was for pulmonary artery repair (n = 181; 44.4%). Median follow-up time was 3.9 years (range, 3 days to 7.4 years). Ten patches (2.5%) required surgical reintervention (2 in the first 30 days and 5 in the first year) and 27 (6.6%) required percutaneous reinterventions (2 in the first 30 days and 22 in the first year). Between four-ply (n = 376) and two-ply (n = 32) SIS-ECM, the rate of surgical (2.1% [n = 8] vs 6.3% [n = 2], P = .18) or percutaneous reinterventions (6.4% [n = 24] vs 9.4% [n = 3], P = .46) was not different. There were no deaths related to the SIS-ECM patch or reports of calcification. Conclusions: The 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 using consistent techniques and understanding the appropriate applications of the patch.
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U2 - 10.1016/j.athoracsur.2021.06.087
DO - 10.1016/j.athoracsur.2021.06.087
M3 - Article
C2 - 34375649
AN - SCOPUS:85113177235
SN - 0003-4975
JO - Annals of Thoracic Surgery
JF - Annals of Thoracic Surgery
ER -