Favorable results from a prospective evaluation of 200 patients with large hiatal hernias undergoing LINX magnetic sphincter augmentation

Abstract

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.

Systematic review of the introduction and evaluation of magnetic augmentation of the lower oesophageal sphincter for gastro-oesophageal reflux disease

“…). A total of 39 full‐text papers, published between 2008 and 2019, were finally included. The 39 articles consisted of one RCT, five comparative cohort studies (2 prospective and 3 retrospective), three comparative case–control studies, 25 case series (14 prospective, 11 retrospective) and five case reports ( Fig .…”

“…Twenty‐one followed the FDA eligibility criteria for MSA insertion. Seven, comprising a total of 427 patients and published after FDA approval, extended these criteria to include patients with a hiatus hernia greater than 3 cm or previous gastrointestinal surgery, to assess whether the device could be used in this population.…”

Magnetic sphincter augmentation (MSA) in patients with hiatal hernia: clinical outcome and patterns of recurrence

“…This early approach has led to an attitude of hesitance among some surgeons to offer this therapy to patients with HH, and a minimal dissection approach (no mediastinal dissection or cruralplasty) was recommended. Recent studies have demonstrated encouraging results in the use of MSA in patients with a larger size hiatal hernia [17,18]. However, there remains a paucity of data on the overall impact of hiatal hernia on the outcome of MSA.…”

Magnetic sphincter augmentation is an effective option for refractory duodeno-gastro-oesophageal reflux following Billroth II gastrectomy

“…Device erosions have rarely occurred and have been managed without sequelae 9 10. More recently, the MSA procedure has been successfully performed in patients with large hiatus hernia11 and in those presenting de novo GERD after sleeve gastrectomy 12…”