Evaluation of the safety and effectiveness of crural reinforcement with bio-a<sup>®</sup> or phasix-st<sup>®</sup> mesh: results from a multicenter study.

Abstract

<h4>Background</h4>Absorbable synthetic meshes have gained increasing acceptance for crural reinforcement during hiatus hernia (HH) repair because their safety profile and the potential of reducing recurrence rates. Bio-A^® (Gore Medical, Newark, DE, USA) and Phasix-ST^® (C.R. Bard, Inc./Davol, Inc., Warwick, RI, USA) are the most commonly used meshes. While previous single-arm studies have been published, there are no articles reporting the comparison between Phasix-ST^® vs. Bio-A^®.<h4>Aim</h4>Compare safety, efficacy, recurrence rates, and quality of life after laparoscopic HH repair and cruroplasty reinforced with either Bio-A^® or Phasix-ST^® mesh.<h4>Methods</h4>Retrospective multicenter study (September 2011- December 2024). All patients that underwent minimally invasive HH repair with Phasix-ST^® or Bio-A^® reinforced cruroplasty and Toupet fundoplication were included.<h4>Results</h4>Overall, 271 patients were included. Bio-A^® reinforcement was utilized in 46.8% of patients. The median follow-up time was 94 (IQR 21) months for Bio-A^® and 51 (IQR 17) months for Phasix-ST^® mesh. Hernia recurrence was diagnosed in 10.1% of patients with similar rates for Phasix-ST^® vs. Bio-A^® (7.8% vs. 12.6%; p = 0.28). The regression analysis showed that Phasix-ST^® (HR 0.66), 'keyhole' configuration (HR 0.81), hernia type III-IV (HR 1.38), and recurrent HH (HR 1.27) were not independent predictor or protective factors for recurrence. The 55-month recurrence free probability for Bio-A^® vs. Phasix-ST^® was comparable (86.2% vs. 91.8%; p = 0.132).<h4>Conclusions</h4>This study shows that Bio-A^® and Phasix-ST^® are equally safe for crural reinforcement during HH repair. Due to the longer absorption rate, Phasix ST^® might presumably confer enhanced hiatal protection early in the course of the follow-up.