A budget impact analysis of a magnetic sphincter augmentation device for the treatment of medication-refractory mechanical gastroesophageal reflux disease: a United States payer perspective.

BACKGROUND: Medication-refractory gastroesophageal reflux disease (GERD) is sometimes treated with laparoscopic Nissen fundoplication (LNF); however, this is a non-reversible procedure associated with important side effects and the need for repeat surgery. Removable magnetic sphincter augmentation (MSA) devices are an alternative, effective, and safe treatment option for such patients who have some lower esophageal sphincter function. The objective of this study was to assess the economic impact of introducing MSA technology (i.e., LINX Reflux Management System) into current practice from a US-payer perspective. METHODS: An economic budget impact model was developed over a 1-year time horizon that compared current treatment of GERD patients who are medically managed (but refractory) or receiving LNF to future treatment of GERD patients that included a mix of patients treated with medical management only, LNF, or MSA. Resources included within the analyses were index procedures (inpatient and outpatient use), reoperations (revisions and removals), readmissions, healthcare visits, diagnostic tests, procedures, and medications. Medicare payment rates were typically used to inform unit costs. RESULTS: Assuming a hypothetical commercial insurance population of 1 million members, the base-case analysis estimated a net cost savings of $111,367 with introduction of the MSA. This translates to a savings of $0.01 per member per month. Results were largely driven by avoided inpatient procedures with use of the MSA device. Alternative analyses exploring the potential impact of increasing surgical volumes predicted that results would remain cost saving if the proportion of MSA market share taken from LNF was ≥ 90%. CONCLUSIONS: This study predicts that the introduction of the MSA device would lead to favorable budget impact results for the treatment of medication-refractory mechanical GERD for commercial payers. Future analyses will benefit from inclusion of middle-ground treatments as well as longer time horizons.

Intraoperative assessment of the effects of laparoscopic sleeve gastrectomy on the distensibility of the lower esophageal sphincter using impedance planimetry.

BACKGROUND: Laparoscopic sleeve gastrectomy (LSG) has emerged as an effective weight-loss procedure for morbid obesity that is also effective for treating comorbidities such as diabetes. However, it has been associated with the development of GERD postoperatively. The pathophysiology of post-LSG GERD is unknown, and current studies have shown conflicting results. The aim of our study is to shed light on this issue by investigating the effect of LSG on the lower esophageal sphincter (LES) function and the relationship of LES function to GERD symptoms. METHODS: A prospective study of patients undergoing LSG from 10/2013 to 8/2014 at a single academic tertiary referral center was carried out. Patients undergoing a concomitant procedure such as hiatal hernia repair or laparoscopic gastric band removal were excluded. Distensibility of the LES was measured after pneumoperitoneum and after LSG. Baseline GERD-HRQL was obtained with follow-up GERD-HRQL and weight at 3 and 6 months. The primary outcomes measured were LES distensibility and GERD-HRQL scores after LSG. Our secondary outcome was a correlation between LES distensibility and GERD-HRQL scores after LSG. RESULTS: Fifteen subjects were enrolled (5M/10F). Mean age was 51 years (30-71 years), and mean BMI 45 kg/m2 (30-58). We were able to obtain follow-up data for all patients at 3 months. Mean LES distensibility increased from 1.2 before LSG to 2.2 after LSG (p = 0.017). Median GERD-HRQL was 0 before LSG and remained essentially negative at 1 and 0 (3 and 6 months postoperatively, respectively). Three (27 %) of the patients had de novo GERD at 3 months following LSG. One (25 %) patient had remission of GERD. There was no correlation between LES distensibility and GERD symptoms. CONCLUSION: While LSG weakens the LES immediately, it does not predictably affect postoperative GERD symptoms; therefore, distensibility is not the only factor affecting development of postoperative GERD, confirming the multifactorial nature of post-LSG GERD.

Charges, outcomes, and complications: a comparison of magnetic sphincter augmentation versus laparoscopic Nissen fundoplication for the treatment of GERD.

BACKGROUND: Magnetic sphincter augmentation (MSA) is approved for uncomplicated GERD. Multiple studies have shown MSA to compare favorably to laparoscopic Nissen fundoplication (LNF) in terms of symptom control with results out to 5 years. The MSA device itself, however, is an added cost to an anti-reflux surgery, and direct cost comparison studies have not been done between MSA and LNF. The aim of the study was to compare charges, complications, and outcome of MSA versus LNF at 1 year. METHODS: This is a retrospective analysis of all patients who underwent MSA or LNF for the treatment of GERD between January 2010 and June 2013. Patient charges were collected for the surgical admission. We also collected data on 30-day complications and symptom control at 1 year assessed by GERD-HRQL score and PPI use. RESULTS: There were 119 patients included in the study, 52 MSA and 67 LNF. There was no significant difference between the mean charges for MSA and LNF ($48,491 vs. $50,111, p = 0.506). There were significant differences in OR time (66 min MSA vs. 82 min LNF, p < 0.01) and LOS (17 h MSA vs. 38 h LNF, p < 0.01). At 1-year follow-up, mean GERD-HRQL was 4.3 for MSA versus 5.1 for LNF (p = 0.47) and 85 % of MSA patients versus 92 % of LNF patients were free from PPIs (p = 0.37). MSA patients reported less gas bloat symptoms (23 vs. 53 %, p ≤ 0.01) and inability to belch (10 vs. 36 %, p ≤ 0.01) and vomit (4 vs. 19 %, p ≤ 0.01). CONCLUSION: The side effect profile of MSA is better than LNF as evidenced by less gas bloat and increase ability to belch and vomit. LNF and MSA are comparable in symptom control, safety, and overall hospital charges. The charge for the MSA device is offset by less charges in other categories as a result of the shorter operative time and LOS.

Intraoperative Assessment of Perfusion of the Gastric Graft and Correlation With Anastomotic Leaks After Esophagectomy.

OBJECTIVE: The aim of the study was to evaluate laser-assisted fluorescent-dye angiography (LAA) to assess perfusion in the gastric graft and to correlate perfusion with subsequent anastomotic leak. BACKGROUND: Anastomotic leaks are a major source of morbidity after esophagectomy with gastric pull-up (GPU). In large part, they occur as a consequence of poor perfusion in the gastric graft. METHODS: Real-time intraoperative perfusion was assessed using LAA before bringing the graft up through the mediastinum. When there was a transition from rapid and bright to slow and less robust perfusion, this site was marked with a suture. The location of the anastomosis relative to the suture was noted and the outcome of the anastomosis ascertained by retrospective record review. RESULTS: Intraoperative LAA was used to assess graft perfusion in 150 consecutive patients undergoing esophagectomy with planned GPU reconstruction. An esophagogastric anastomosis was performed in 144 patients. A leak was found in 24 patients (16.7%) and were significantly less likely when the anastomosis was placed in an area of good perfusion compared with when the anastomosis was placed in an area of less robust perfusion by LAA (2% vs 45%, P < 0.0001). By multivariate analysis perfusion at the site of the anastomosis was the only significant factor associated with a leak. CONCLUSIONS: Intraoperative real-time assessment of perfusion with LAA correlated with the likelihood of an anastomotic leak and confirmed the critical relationship between good perfusion and anastomotic healing. The use of LAA may contribute to reduced anastomotic morbidity.

The value of high-resolution manometry in the assessment of the resting characteristics of the lower esophageal sphincter.

INTRODUCTION: High-resolution manometry (HRM) is faster and easier to perform than conventional water perfused manometry. There is general acceptance of its usefulness in evaluating upper esophageal sphincter and esophageal body. There has been less emphasis on the use of HRM to evaluate the lower esophageal sphincter (LES) resting pressure and length, both factors important in LES barrier function. The aim of this study was to compare the resting characteristics of the LES determined by HRM and conventional manometry in the same patients. METHODS: We performed both HRM and conventional manometry including a slow motorized pull-through technique in 55 patients with foregut symptoms. The characteristics of the LES analyzed were: resting pressure, total length, and abdominal length. Four available modes of HRM analysis were used to assess resting characteristics of the LES: spatiotemporal mode using both abrupt color change and isobaric contour, line tracing, and pressure profile. The values obtained from these four HRM modes were then compared to the conventional manometry measurements. RESULTS: High-resolution manometry and conventional manometry did not differ in their measurement of LES resting pressure. LES overall and abdominal length were consistently overestimated by HRM. A variability up to 4 cm in overall length was observed and was greatest in patients with hiatal hernia (1.8 vs. 0.9 cm, p = 0.027). CONCLUSION: The current construction of the catheter and software analysis used in high-resolution manometry do not allow precise measurement of LES length. Errors in the identification of the upper border of the sphincter may compromise accurate positioning of a pH probe.

Laparoscopic Nissen fundoplication assessment: task analysis as a model for the development of a procedural checklist.

BACKGROUND: Learning an advanced laparoscopic procedure is a complex process that requires clinical exposure, direct teaching, and deliberate practice. Expert surgeons automate their knowledge, making it difficult to teach incremental steps. Our aim was to deconstruct the steps of a laparoscopic Nissen fundoplication (LNF) and develop a procedural checklist assessment instrument. METHODS: A behavioral task analysis was conducted with five experts using the Delphi technique to identify all steps of a LNF. The Delphi survey included video analysis of expert performance, two electronic iterative rounds and final group interview to reach consensus. The created checklist was then used to assess the performance of 14 general surgery residents. Participants viewed a brief instructional video and performed a LNF on a porcine model. Laparoscope video recordings were evaluated by a blinded investigator using the created LNF checklist. RESULTS: The task analysis produced a 65-step procedural checklist with six major components (patient positioning and port placement, dissection of crura and esophagus, closure of crura, mobilization of fundus, orientation of fundoplication, and creation of fundoplication). Thirteen of 14 participants completed the procedure. Median score for all residents was 31 (range 13-38) with senior residents (36, 34-38) having significantly higher scores than junior residents (30, 13-36) (p = 0.0162). Most residents attempted the major components of the procedure; 13 of 14 dissected the crura and created the fundoplication, 12 closed the crura, and 11 mobilized the fundus. However, residents frequently failed to complete key elements such as protection of the vagus nerve or mediastinal mobilization of the esophagus. CONCLUSIONS: The task analysis and Delphi technique was successful in reaching expert consensus on the procedural steps of a LNF and in creating a valid checklist. By capturing automated knowledge in a checklist form, we can scaffold resident learning and improve feedback for an advanced laparoscopic case.