Yalini Vigneswaran, Michelle Campbell, Alex W Lois, Lawrence J Gottlieb, Mustafa Hussain
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.
OBJECTIVE: 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.
BACKGROUND: 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.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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.