Procedural Maturation and Midterm Durability of the Posterior Rectus Sheath Flap for Hiatal Augmentation in Complex Paraesophageal Hernias.

Abstract

To evaluate procedural maturation, donor-site morbidity, and midterm durability of posterior rectus sheath flap for hiatal augmentation (PoRSHA) within an IDEAL Phase 2b framework. Large paraesophageal hernia repair remains limited by high recurrence rates associated with structural weakness of the diaphragmatic crura. Existing reinforcement strategies remain limited by inconsistent long-term durability. PoRSHA, a vascularized autologous tissue technique developed for complex hiatal repair, previously demonstrated early feasibility and promising early outcomes in IDEAL Phase 2a evaluation. This prospective single-center IDEAL Phase 2b study included 104 consecutive patients undergoing PoRSHA between 2021 and 2026. The analytic cohort consisted of patients with primary type III/IV (n=71) and recurrent paraesophageal hernias (n=23). Radiologic recurrence (>2 cm) was assessed using Kaplan-Meier analysis to account for variable imaging follow-up. Secondary outcomes included symptomatic recurrence requiring reoperation, postoperative dysphagia, and donor-site morbidity. Estimated radiologic recurrence in the overall analytic cohort was 1.4% at 12 months and 13.8% at 24 months (95% CI, 5.7%-31.3%), remaining stable at 18.1% through 48 months. After exclusion of the procedural maturation phase (n=16), estimated radiologic recurrence improved to 9.2% at both 24 months and 36 months (95% CI, 2.9%-27.4%), with no additional recurrences during follow-up. Recurrences were small and did not result in reoperation. Donor-site morbidity was infrequent. Following procedural maturation, PoRSHA demonstrated favorable midterm durability with limited donor-site morbidity. These findings support continued multicenter evaluation of vascularized autologous tissue augmentation for complex paraesophageal hernia repair.