Esophageal sphincter device for gastroesophageal reflux disease

BACKGROUND Patients with gastroesophageal reflux disease who have a partial response to proton-pump inhibitors often seek alternative therapy. We evaluated the safety and effectiveness of a new magnetic device to augment the lower esophageal sphincter. METHODS We prospectively assessed 100 patients with gastroesophageal reflux disease before and after sphincter augmentation. The study did not include a concurrent control group. The primary outcome measure was normalization of esophageal acid exposure or a 50% or greater reduction in exposure at 1 year. Secondary outcomes were 50% or greater improvement in quality of life related to gastroesophageal reflux disease and a 50% or greater reduction in the use of proton-pump inhibitors at 1 year. For each outcome, the prespecified definition of successful treatment was achievement of the outcome in at least 60% of the patients. The 3-year results of a 5-year study are reported. RESULTS The primary outcome was achieved in 64% of patients (95% confidence interval [CI], 54 to 73). For the secondary outcomes, a reduction of 50% or more in the use of proton-pump inhibitors occurred in 93% of patients, and there was improvement of 50% or more in quality-of-life scores in 92%, as compared with scores for patients assessed at baseline while they were not taking proton-pump inhibitors. The most frequent adverse event was dysphagia (in 68% of patients postoperatively, in 11% at 1 year, and in 4% at 3 years). Serious adverse events occurred in six patients, and in six patients the device was removed. CONCLUSIONS In this single-group evaluation of 100 patients before and after sphincter augmentation with a magnetic device, exposure to esophageal acid decreased, reflux symptoms improved, and use of proton-pump inhibitors decreased. Follow-up studies are needed to assess long-term safety. (Funded by Torax Medical; ClinicalTrials.gov number, NCT00776997.

Laparoscopic Transhiatal Esophagectomy for Invasive Esophageal Adenocarcinoma.

BACKGROUND: Esophagectomy is a fundamental step to achieve long-term disease-free survival in esophageal cancer. While various approaches have been described, there is no consensus on the single best technique to optimize operative and oncologic outcomes. We aim to report the modern experience with laparoscopic transhiatal esophagectomy (LTHE) for invasive adenocarcinoma. METHODS: We reviewed all patients who underwent LTHE with extended lymph node dissection for distal esophageal adenocarcinoma (EAC) at our institution between 2007 and 2016. Pre-operative characteristics, operative details, postoperative complications, and long-term outcomes were tracked by review of the electronic medical record and patient surveys. Survival rates were calculated with Kaplan-Meier curves. RESULTS: Eighty-two EAC patients underwent LTHE during the study period (84% male, mean age 65, mean BMI 27.8, large). Most patients were clinical stage III (42.7%) and 68.3% had received neoadjuvant chemoradiation (nCRT). Laparoscopy was successful in 93.9%, with five cases requiring conversion to open (6.1%). The median lymph node harvest was 19. Overall complication rate (major and minor) was 45.5% and ninety-day mortality was 4%. Overall 5-year survival was 52% (77% for stage 1, 57% for stage 2, 37% for stage 3). CONCLUSIONS: Laparoscopic transhiatal esophagectomy has an important role in current esophageal cancer treatment and can be performed with curative intent in patients with distal esophageal tumors. In addition to the well-known advantages of laparoscopy, the increased mediastinal visibility and a modern focus on oncologic principles seem to have a positive impact on cancer survival compared to the open transhiatal approach

Abnormal response after multiple rapid swallow provocation is not predictive of post-operative dysphagia following a tailored fundoplication approach.

INTRODUCTION: The aim was to evaluate the clinical significance of multiple rapid swallows (MRS) during high-resolution manometry (HRM) prior to fundoplication. Despite pre-operative HRM, up to 38% of patients report post-fundoplication dysphagia. Suggestion that MRS improves prediction of dysphagia after fundoplication has not been investigated when using a tailored approach. We hypothesize response to MRS is predictive of dysphagia after tailored fundoplication. METHODS: A retrospective cohort study was performed on patients undergoing HRM with MRS provocation 5/2019-7/2021 at a single institution. Patients who underwent subsequent index laparoscopic fundoplication, without peptic stricture or achalasia, were included. After performing standard 10-swallow HRM, MRS provocation was performed. Patient-reported dysphagia frequency scores were collected at initial consultation and post-operative follow-up. At least weekly symptoms were considered clinically significant. Normal MRS response was defined as adequate deglutitive inhibition and MRS contractile response. Fundoplications were tailored based on standard HRM values. RESULTS: HRM was performed in 1201 patients, 220 met inclusion criteria. Clinically significant pre-operative dysphagia was reported by 85 (38.6%). Patients undergoing partial fundoplication (n = 123, 55.9%) had lower mean distal contractile integer, distal esophageal contraction amplitude, and percent peristalsis (p \u3c 0.005). Post-operatively, 120 (54.5%) were without dysphagia, 59 (26.8%) had improved dysphagia, 26 (11.8%) had unchanged dysphagia, and 15 (6.8%) reported new dysphagia. There was no statistical difference in early or late dysphagia outcome between tailored fundoplication groups (p = 0.69). On univariate and multivariate analysis, neither MRS response, nor standard HRM metrics were significantly associated with post-operative dysphagia. Younger age (OR 0.96, 95% CI 0.94-0.986, p = 0.042) and the presence of pre-operative dysphagia (OR 2.54, 95% CI 1.17-5.65, p = 0.015) were significant predictors of post-operative dysphagia. CONCLUSION: The risk of clinically significant dysphagia post-fundoplication is low when using a tailored approach based on standard HRM metrics. Additional data provided by MRS does not add to surgical decision-making using the investigated approach

Robotic-assisted versus laparoscopic unilateral inguinal hernia repair: a comprehensive cost analysis.

BACKGROUND: Cost-effectiveness of robotic-assisted surgery is still debatable. Robotic-assisted inguinal hernia repair has no clear clinical benefit over laparoscopic repair. We performed a comprehensive cost-analysis comparison between the two approaches for evaluation of their cost-effectiveness in a large healthcare system in the Western United States. METHODS: Health records in 32 hospitals were queried for procedural costs of inguinal hernia repairs between January 2015 and March 2017. Elective robotic-assisted or laparoscopic unilateral inguinal hernia repairs were included. Cost calculations were done using a utilization-based costing model. Total cost included: fixed cost, which comprises medical device and personnel costs, and variable cost, which comprises disposables and reusable instruments costs. Other outcome measures were length of stay (LOS), conversion to open, and operative times. Statistics were done using t test for continuous variables and χ RESULTS: A total of 2405 cases, 734 robotic-assisted (633 Primary: 101 recurrent) and 1671 laparoscopic (1471 Primary: 200 recurrent), were included. The average total cost was significantly higher (p \u3c 0.001) in the robotic-assisted group ($5517) compared to the laparoscopic group ($3269). However, the average laparoscopic variable cost ($1105) was significantly higher (p \u3c 0.001) than the robotic-assisted cost ($933). Whereas there was no significant difference between the two groups for LOS and conversion to open, average operative times were significantly higher in the robotic-assisted group (p \u3c 0.001). Subgroup analysis for primary and recurrent inguinal hernias matched the overall results. CONCLUSIONS: Robotic-assisted inguinal hernia repair has a significantly higher cost and significantly longer operative times, compared to the laparoscopic approach. The study has shown that only fixed cost contributes to the cost difference between the two approaches. Medical device cost plus the longer operative times are the main factors driving the cost difference. Laparoscopic unilateral inguinal hernia repair is more cost-effective compared to a robotic-assisted approach