Shahin Ayazi, MD, Kirsten Newhams, MD, Ali H Zaidi, MD, Tameka Scott, DO, Jonathan Levy, MD, Yoshihiro Komatsu, MD, Kristy Chovanec, BS, Fahim Habib, MD, Adam Alleyne, Ping Zheng, MD, Toshitaka Hoppo, MD, Blair A Jobe, MD. The Esophageal and Lung Institute, Allegheny Health Network
Introduction: Magnetic sphincter augmentation (MSA) is an effective treatment for patients with gastroesophageal reflux disease. In early studies, patients with a hiatal hernia (HH) ≥3cm were excluded from consideration for implantation and initially the FDA considered its use as “precautionary” in this context. This early approach has led to an attitude of hesitance among some surgeons to offer this therapy to patients with HH. This study was designed to evaluate the impact of HH status on the outcome of MSA.
Methods and procedures: This is a retrospective review of prospectively collected data of patients who underwent MSA between June 2013 and August 2017. Baseline clinical and objective data were collected. Patients were divided into 4 groups based on HH status: no HH, small HH (<3cm), large HH (≥ 3cm) and paraesophageal hernia (PEH). Patient satisfaction, GERD-HRQL data, freedom from PPI, need for postoperative dilation, length of hospitalization, 90-day readmission rate, and need for device removal were compared between groups.
Results: There were 350 patients [60% female, mean (SD) age: 53.5 (13.8)] who underwent MSA. There were 65 (18.6%) with no HH, 205 (58.6%) with small HH (<3cm), 58 (16.6%) with large HH (≥ 3cm) and 22 (6.2%) with PEH. At a mean follow up of 13.6 (10.4) months, the rate of outcome satisfaction was similar between the groups (86%, 87.9%, 92.2% and 93.8%, p=0.72). This was also true for GERD-HRQL total score clinical improvement (79.1%, 77.8%, 82% and 87.5%, p= 0.77). The rate of postoperative dysphagia (p=0.33) and freedom from PPIs (p=0.96) were similar among the four groups.
Duration of hospitalization was higher among those with a large HH or PEH, and only PEH patients had a higher 90-day readmission rate (p=0.0004). There was no difference between the need for dilation among groups (p= 0.13). The need for device replacement (2.3% overall) or removal (5% overall) was similar between the four groups (p=0.28). The rate of asymptomatic HH recurrence was 4.8% in all groups combined. This rate increased in a stepwise fashion with an increase in HH size at baseline (0%, 2.7%, 10.3 and 25%, p=0.014).
Conclusion: In the largest series of MSA implantation, we demonstrate that the outcome and satisfaction after MSA are independent of the presence or size of HH. Despite higher rates of asymptomatic recurrence in PEH and large HH patients, the rate of device removal is similar to those with no or small HH.
Presented at the SAGES 2017 Annual Meeting in Houston, TX.
Abstract ID: 94195
Program Number: S022
Presentation Session: Foregut I
Presentation Type: Podium