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Multicenter Study
Favorable results from a prospective evaluation of 200 patients with large hiatal hernias undergoing LINX magnetic sphincter augmentation.
- F P Buckley, Bell Reginald C W RCW SurgOne Foregut Institute, 401 W Hampden Place Suite 230, Englewood, CO, 80110, USA. reg@sofisite.com., Kate Freeman, Stephanie Doggett, and Rachel Heidrick.
- The Heartburn & Acid Reflux Center, Baylor Scott & White Healthcare, Round Rock, TX, USA.
- Surg Endosc. 2018 Apr 1; 32 (4): 1762-1768.
IntroductionMagnetic sphincter augmentation (MSA) of the lower esophageal sphincter restores the antireflux barrier in patients with hiatal hernias ≤3 cm. We performed a prospective study in patients undergoing MSA with the LINX device during repair of paraesophageal and hernias over 3 cm axial component.Methods And ProceduresMulticenter, prospective study of consecutive patients treated with MSA at the time of repair of hiatal hernias >3 cm.Results200 patients (110 female) were treated between March 2014 and February 2017 via laparoscopic hernia repair and MSA. Mean age was 59.5 years, mean BMI 29.4. 40% had esophagitis, 20% intestinal metaplasia, 72 of 77 tested had abnormal pH studies. Preoperative PPI use was reported by 87%. Eighteen patients had prior hiatal hernia/fundoplication. All had normal function. 78% of patients had axial hiatal hernia ≥5 cm or large paraesophageal component. Mean operative time was 81 min (38-193), EBL was 10 cc. Non-permanent mesh reinforcement of hiatal repair was performed in 83% of the patients. There were two readmissions for dehydration; 2 patients with pulmonary embolism, and 1 patient with cardiac ischemia. Nineteen patients required dilation. 156 pts were followed at a median of 8.6 months. GERD-HRQL scores improved from 26 preoperatively to 2 postoperatively. Complete PPI independence was achieved in 94% (147/156). Videoesophagram in 51 patients at median 11 months found 3 asymptomatic hernias <3 cm. One symptomatic patient underwent successful repair of the hernia without MSA manipulation. There have been no device explants, erosions, or migrations to date.ConclusionsThis prospective study of 200 patients with >3 cm hernias undergoing MSA with hiatoplasty resulted in favorable outcomes with median of 9 months follow-up. Comparing this to published reports of MSA in patients with <3 cm hernias, the safety and clinical efficacy of MSA are independent of initial hernia size.
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