Gastric electric stimulator versus gastrectomy for the treatment of medically refractory gastroparesis.

BACKGROUND: Gastric electrical stimulation (GES) and laparoscopic gastrectomy (LG) are known therapeutic options for medically refractory gastroparesis (MRG) although there are limited data comparing their outcomes. We aim to compare clinical outcomes between patients undergoing GES vs upfront LG for the treatment of MRG while examining factors associated with GES failure and conversion to LG. METHODS: We retrospectively analyzed 181 consecutive patients who underwent GES or LG for MRG at our institution from January 2003 to December 2017. Data collection consisted of chart review and follow-up telephone survey. Statistical analysis utilized Chi-squared, ANOVA, and multivariable logistic regression. RESULTS: Overall, 130 (72%) patients underwent GES and 51 (28%) LG as primary intervention. GES patients were more likely to have diabetic gastroparesis (GES 67% vs LG 39%, p < 0.001), while primary LG patients were more likely to have post-surgical gastroparesis (GES 5% vs LG 43%, p < 0.001). Postoperatively, primary LG patients had higher rates of major in-hospital morbidity events (GES 5% vs LG 18%, p = 0.017) and longer hospital stays (GES 3 vs LG 9 days, p < 0.001). However, over a mean 35-month follow-up period, there were no differences in the rates of major morbidity, readmissions, or mortality. Multivariable regression analysis revealed patients undergoing GES as a primary intervention were less likely to report improvement in symptoms on follow-up compared to primary LG patients OR 0.160 (95% CI 0.048-0.532). Additionally, patients who converted to LG from GES were more likely to have post-surgical gastroparesis as the primary etiology. CONCLUSION: GES as a first-line surgical treatment of MRG was associated with worse outcomes compared to LG. Post-surgical etiology was associated with an increased likelihood of GES failure, and in such patients, upfront gastrectomy may be a superior alternative to GES. Further studies are needed to determine patient selection for operative treatment of MRG.

Postoperative Dysphagia Following Magnetic Sphincter Augmentation for Gastroesophageal Reflux Disease.

The addition of posterior cruroplasty to magnetic sphincter augmentation (MSA-PC) has been shown to be effective in treating gastroesophageal reflux disease (GERD). This study evaluates the predictors of persistent postoperative dysphagia, one of the major complaints after MSA-PC. From August 2015 to February 2018 the medical records of 118 patients (male=59, female=59) receiving MSA-PC for GERD were reviewed. Postoperative dysphagia was present in 80 patients (67.8%), with 20 (16.9%) requiring dilation for persistent dysphagia. Three patients (2.5%) had the magnetic sphincter augmentation device removed for persistent dysphagia, one was converted to a Nissen fundoplication. The median number of dilations was 1, mean time from surgery to dilation was 5.6 months, and 15/20 (75%) had symptom resolution after 1 to 2 dilations. Dilated patients were more likely than nondilated patients to have atypical GERD symptoms preoperatively (70% vs. 44.7%, P=0.042). After dilation, 93.3% of patients reported a good quality of life.

Hiatal hernia recurrence following magnetic sphincter augmentation and posterior cruroplasty: intermediate-term outcomes.

BACKGROUND: We have previously reported short-term outcomes after hiatal hernia repair (HHR) at the time of magnetic sphincter augmentation (MSA) for gastroesophageal reflux disease (GERD). Here we report intermediate-term outcomes and hernia recurrence rate after concomitant MSA and HHR. METHODS: This is a retrospective cohort study of patients who underwent repair of a hiatal hernia 3 cm or larger at the time of MSA implantation between May 2009 and December 2015. The primary endpoint was hiatal hernia recurrence identified by routine postoperative videoesophagography or endoscopy. Recurrence was defined by a 2 cm or greater upward displacement of the stomach through the diaphragmatic esophageal hiatus. Secondary endpoints included cessation of proton-pump inhibitor (PPI), persistent dysphagia requiring intervention, and GERD health-related quality-of-life (HRQL) scores 1 year from surgery. RESULTS: During the study period, 47 of 53 (89%) patients underwent concomitant MSA with HHR and complied with surveillance. Hiatal hernias ranged from 3 to 7 cm (mean 4 ± 1). Mean clinical follow-up time was 19 months (range 1-39). GERD-HRQL score decreased from 20.3 to 3.1 (p < .001), 89% of patients remained off PPIs, and 97% of patients reported improvement or resolution of symptoms. Two recurrent hiatal hernias were identified on surveillance imaging for a recurrence rate of 4.3% at a mean 18 (± 10) months after initial operation. Persistent dysphagia occurred in 13% (6/47) over the first year, which resolved after a single balloon dilation in 67% (4/6). Two patients elected for device removal due to dilation-refractory dysphagia and persistent reflux symptoms. CONCLUSION: Concomitant magnetic sphincter augmentation and hiatal hernia repair in patients with gastroesophageal reflux disease and a moderate-sized hiatal hernia demonstrates durable subjective reflux control and an acceptable hiatal hernia recurrence rate at 1- to 2-year follow-up.

Efficacy of magnetic sphincter augmentation in patients with large hiatal hernias.

BACKGROUND: Magnetic sphincter augmentation (MSA) has demonstrated long-term safety and efficacy in the treatment of patients with gastroesophageal reflux (GERD), but its efficacy in patients with large hiatal hernias has yet to be proven. The aim of our study was to assess outcomes of MSA in patients with hiatal hernias ≥3 cm. METHODS: We retrospectively reviewed all patients who underwent MSA at our institutions over a 6-year period. Information obtained consisted of patient demographics, symptoms of GERD, preoperative GERD Health-Related Quality-of-Life (HRQL) scores, perioperative details, and implantation of the MSA device. Primary endpoints included postoperative GERD-HRQL scores, proton-pump inhibitor (PPI) use, symptom change, and procedure-related complications. A large hiatal hernia was defined as a hernia measuring ≥3 cm by intraoperative measurement. RESULTS: A total of 192 patients were reviewed. Median follow-up was 20 months (3-75 months). Mean GERD-HRQL scores in the overall population before and after MSA were 18.9 and 5.0, respectively (p < 0.001). In the majority of patients symptoms improved or resolved (N = 177, p < 0.001). Fifty-two patients (27.0 %) had a hiatal hernia ≥3 cm (range 3-7 cm). Their mean GERD-HRQL score decreased from 20.5 to 3.6 (p < 0.001) following MSA. When compared to patients with smaller hernias, patients with large hiatal hernias had decreased postoperative PPI requirement (9.6 vs. 26.6 %, p = 0.011) and lower mean postoperative GERD-HRQL scores (3.6 vs. 5.6, p = 0.027). The percent of patients requiring postoperative intervention for dysphagia was similar (13.5 vs. 17.9 %, p = 0.522), as was the incidence of symptom resolution or improvement (98.1 vs. 91.3 %, p = 0.118). CONCLUSION: MSA in patients with large hiatal hernias demonstrates decreased postoperative PPI requirement and mean GERD-HRQL scores compared to patients with smaller hernias. The incidence of symptom resolution or improvement and the percentage of patients requiring intervention for dysphagia are similar. Short-term outcomes of MSA are encouraging in patients with gastroesophageal reflux disease and large hiatal hernias.

Multi-institutional outcomes using magnetic sphincter augmentation versus Nissen fundoplication for chronic gastroesophageal reflux disease.

BACKGROUND: Magnetic sphincter augmentation (MSA) has emerged as an alternative surgical treatment of gastroesophageal reflux disease (GERD). The safety and efficacy of MSA has been previously demonstrated, although adequate comparison to Nissen fundoplication (NF) is lacking, and required to validate the role of MSA in GERD management. METHODS: A multi-institutional retrospective cohort study of patients with GERD undergoing either MSA or NF. Comparisons were made at 1 year for the overall group and for a propensity-matched group. RESULTS: A total of 415 patients (201 MSA and 214 NF) underwent surgery. The groups were similar in age, gender, and GERD-HRQL scores but significantly different in preoperative obesity (32 vs. 40 %), dysphagia (27 vs. 39 %), DeMeester scores (34 vs. 39), presence of microscopic Barrett's (18 vs. 31 %) and hiatal hernia (55 vs. 69 %). At a minimum of 1-year follow-up, 354 patients (169 MSA and 185 NF) had significant improvement in GERD-HRQL scores (pre to post: 21-3 and 19-4). MSA patients had greater ability to belch (96 vs. 69 %) and vomit (95 vs. 43 %) with less gas bloat (47 vs. 59 %). Propensity-matched cases showed similar GERD-HRQL scores and the differences in ability to belch or vomit, and gas bloat persisted in favor of MSA. Mild dysphagia was higher for MSA (44 vs. 32 %). Resumption of daily PPIs was higher for MSA (24 vs. 12, p = 0.02) with similar patient-reported satisfaction rates. CONCLUSIONS: MSA for uncomplicated GERD achieves similar improvements in quality of life and symptomatic relief, with fewer side effects, but lower PPI elimination rates when compared to propensity-matched NF cases. In appropriate candidates, MSA is a valid alternative surgical treatment for GERD management.

Magnetic sphincter augmentation with the LINX device for gastroesophageal reflux disease after U.S. Food and Drug Administration approval.

Magnetic sphincter augmentation (MSA) of the gastroesophageal junction with the LINX Reflux Management System is an alternative to fundoplication for gastroesophageal reflux disease (GERD) that was approved by the U.S. Food and Drug Administration (FDA) in March 2012. This is a prospective observational study of all patients who underwent placement of the LINX at two institutions from April 2012 to December 2013 to evaluate our clinical experience with the LINX device after FDA approval. There were no intraoperative complications and only four mild postoperative morbidities: three urinary retentions and one readmission for dehydration. The mean operative time was 60 minutes (range, 31 to 159 minutes) and mean length of stay was 11 hours (range, 5 to 35 hours). GERD health-related quality-of-life scores were available for 83 per cent of patients with a median follow-up of five months (range, 3 to 14 months) and a median score of four (range, 0 to 26). A total of 76.9 per cent of patients were no longer taking proton pump inhibitors. The most common postoperative complaint was dysphagia, which resolved in 79.1 per cent of patients with a median time to resolution of eight weeks. There were eight patients with persistent dysphagia that required balloon dilation with improvement in symptoms. MSA with LINX is a safe and effective alternative to fundoplication for treatment of GERD. The most common postoperative complaint is mild to moderate dysphagia, which usually resolves within 12 weeks.

Minimally invasive surgical approach for the treatment of gastroparesis.

BACKGROUND: Gastroparesis is a chronic disorder resulting in decreased quality of life. The gastric electrical stimulator (GES) is an alternative to gastrectomy in patients with medically refractory gastroparesis. The aim of this study was to analyze the outcomes of patients treated with the gastric stimulator versus patients treated with laparoscopic subtotal or total gastrectomy. METHODS: A retrospective chart review was performed of all patients who had surgical treatment of gastroparesis from January 2003 to January 2012. Postoperative outcomes were analyzed and symptoms were assessed with the Gastroparesis Cardinal Symptom Index (GCSI). RESULTS: There were 103 patients: 72 patients (26 male/46 female) with a GES, implanted either with laparoscopy (n = 20) or mini-incision (n = 52), and 31 patients (9 male/22 female) who underwent laparoscopic subtotal (n = 27), total (n = 1), or completion gastrectomy (n = 3). Thirty-day morbidity rate (8.3% vs. 23%, p = 0.06) and in-hospital mortality rate (2.7% vs. 3%, p = 1.00) were similar for GES and gastrectomy. There were 19 failures (26%) in the group of GES patients; of these, 13 patients were switched to a subtotal gastrectomy for persistent symptoms (morbidity rate 7.7%, mortality 0). In total, 57% of patients were treated with GES while only 43% had final treatment with gastrectomy. Of the GES group, 63% rated their symptoms as improved versus 87% in the primary gastrectomy group (p = 0.02). The patients who were switched from GES to secondary laparoscopic gastrectomy had 100% symptom improvement. The median total GCSI score did not show a difference between the procedures (p = 0.12). CONCLUSION: The gastric electrical stimulator is an effective treatment for medically refractory gastroparesis. Laparoscopic subtotal gastrectomy should also be considered as one of the primary surgical treatments for gastroparesis given the significantly higher rate of symptomatic improvement with acceptable morbidity and comparable mortality. Furthermore, the gastric stimulator patients who have no improvement of symptoms can be successfully treated by laparoscopic subtotal gastrectomy.