Five-Year Outcomes from a Prospective Study on Safety and Efficacy of Phasix ST Mesh Use at the Hiatus During Paraesophageal Hernia Repair.

Background: Laparoscopic paraesophageal hernia (PEH) repair has a high hernia recurrence rate. The aim of this study was to assess the 5-year hernia recurrence rate after PEH repair using a combination of bioresorbable mesh and advanced surgical techniques to address tension as needed in a prospective group of patients.

Study Design: In 2016, a prospective database was established for 50 patients undergoing primary, elective PEH repair with a new bioresorbable mesh (Phasix ST). Intraoperatively, tension was addressed with Collis gastroplasty and diaphragm relaxing incisions as needed. All 50 patients from the initial study were tracked and asked to return for objective follow-up. Recurrence was considered present for any hernia more than 2 cm in size.

Results: Objective follow-up was conducted in 27 of the original 50 (54%) patients at a median of 5.25 years after their PEH repair. Before the 5-year follow-up, 5 patients had a known recurrent hernia. Objective evaluation at 5 years identified an additional 3 recurrences, for a total recurrence rate of 25% (8 of 32 patients). The hernia recurrence rate in patients with a Collis gastroplasty was significantly lower than in those without a Collis (7% vs 54%, p = 0.008). Two patients underwent reoperation for hernia recurrence. No patient had a mesh infection or mesh erosion.

Conclusions: The combination of Phasix ST Mesh and tension-reducing techniques during PEH repair led to a 25% hernia recurrence rate at 5 years. The addition of a Collis gastroplasty led to significantly fewer hernia recurrences and is indicative of the potential for esophageal shortening in many patients with a PEH. The long-term safety and efficacy of Phasix ST Mesh in combination with surgical technique for PEH repair is confirmed.