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USE OF HUMAN AMNION/CHORION MEMBRANE (HACM) ALLOGRAFTS IN COLORECTAL SURGERY ARE ASSOCIATED WITH SIGNIFICANT DECREASES IN HOSPITAL READMISSIONS AND ANASTOMOTIC LEAKS
Bidhan Das
*2, Nezar Jrebi
3, Dennis Choat
4, Matthew Bardin
11STC Clinical, LLC, Tampa, FL; 2Southwest Surgical Associates, Houston, TX; 3North Texas Surgical Specialists, Ft. Worth, TX; 4Piedmont Physicians Colon and Rectal Surgery of Fayetteville, Fayetteville, GA
Introduction:Rising healthcare costs in colorectal (CR) surgery are driven by complex procedures and frequent hospital readmissions due to complications, most notably anastomotic leaks (AL). Reduced reimbursements and penalties for high readmission rates, highlight the need for strategies to improve surgical outcomes and control costs. Data from the Premier Healthcare Database (PHD) estimates the 30-day readmission rate to be 11.1% and incidence of AL at 6.2% following colectomy.
1 National Surgical Quality Improvement Program (NSQIP) data, which uses a stricter definition of AL, estimates an AL incidence of 3.8%, with similar 30-day readmissions at 10.6%.
2 Human amnion/chorion membrane (HACM) allografts are FDA-regulated, commercially available, non-viable cellular allografts derived from donated human placentas.
3 This tissue is rich in cytokines and growth factors critical in wound healing and tissue growth.
4 Animal models have demonstrated the benefits of these grafts for anastomotic healing in terms of increased bursting pressures, neoangiogenesis, fibroblast activity, collagenization, and epithelialization, as well as decreased inflammation.
5 Furthermore, accounts of HACM in patients undergoing colonic resections report decreased rates of AL.
6,7 This study reviewed real-world AL outcomes in CR patients receiving HACM compared to without following colectomy.
Methods:Chart review of consecutive adults with a primary colectomy who received HACM directly applied to a CR anastomosis without a protective ostomy between 01JAN16 and 30JUN24. The primary endpoint was the incidence of any hospital readmission within 30-days of CR surgery. The secondary endpoint of AL was defined to match those used by the control studies: 1) minor leak requiring percutaneous intervention or major leak requiring laparotomy
2 or 2) reoperation, reanastomosis, stent, colostomy, drainage, and/or abscess from day 2 up to 30 days post-op.
1 The study was granted an IRB Exemption.
Results:566 patients received HACM applied to a CR anastomosis without a protective ostomy. HACM use was associated with significant reductions in 30-day readmissions (5.7%) and AL (1.9-2.3%, depending on definition
1,2).
Figure 1 describes the study cohort and comparative outcomes.
Discussion:This study found HACM used as a protective barrier to support the healing process, for risk-mitigation in CR surgery, was associated with significant reductions in 30-day readmissions and AL compared to historical controls. This is similar to previous reports demonstrating low AL rates in patients receiving HACM for CR anastomoses.
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7. Jrebi.
Am J Gastroenterol,2024:S225
Figure 1. Patient Demographics and Outcomes
Figure 2. Example of HACM and Placement on Anastomosis
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