Magnetic Sphincter Augmentation Superior to Proton Pump Inhibitors for Regurgitation in a 1-Year Randomized Trial.

BACKGROUND & AIMS: Regurgitative gastroesophageal reflux disease (GERD) refractive to medical treatment is common and caused by mechanical failure of the anti-reflux barrier. We compared the effects of magnetic sphincter augmentation (MSA) with those of proton-pump inhibitors (PPIs) in a randomized trial. METHODS: Patients with moderate to severe regurgitation (assessed by the foregut symptom questionnaire) despite once-daily PPI therapy (n = 152) were randomly assigned to groups given twice-daily PPIs (n = 102) or laparoscopic MSA (n = 50) at 20 sites, from July 2015 through February 2017. Patients answered questions from the foregut-specific reflux disease questionnaire and GERD health-related quality of life survey about regurgitation, heartburn, dysphagia, bloating, diarrhea, flatulence, and medication use, at baseline and 6 and 12 months after treatment. Six months after PPI therapy, MSA was offered to patients with persistent moderate to severe regurgitation and excess reflux episodes during impedance or pH testing on medication. Regurgitation, foregut scores, esophageal acid exposure, and adverse events were evaluated at 1 year. RESULTS: Patients in the MSA group and those who crossed over to the MSA group after PPI therapy (n = 75) had similar outcomes. MSA resulted in control of regurgitation in 72/75 patients (96%); regurgitation control was independent of preoperative response to PPIs. Only 8/43 patients receiving PPIs (19%) reported control of regurgitation. Among the 75 patients who received MSA, 61 (81%) had improvements in GERD health-related quality of life improvement scores (greater than 50%) and 68 patients (91%) discontinued daily PPI use. Proportions of patients with dysphagia decreased from 15% to 7% (P < .005), bloating decreased from 55% to 25%, and esophageal acid exposure time decreased from 10.7% to 1.3% (P < .001) from study entry to 1-year after MSA (Combined P < .001). Seventy percent (48/69) of patients had pH normalization at study completion. MSA was not associated with any peri-operative events, device explants, erosions, or migrations. CONCLUSIONS: In a prospective study, we found MSA to reduce regurgitation in 95% of patients with moderate to severe regurgitation despite once-daily PPI therapy. MSA is superior to twice-daily PPIs therapy in reducing regurgitation. Relief of regurgitation is sustained over 12 months. ClinicalTrials.gov no: NCT02505945.

Magnetic sphincter augmentation: a viable rescue therapy for symptomatic reflux following bariatric surgery.

INTRODUCTION: Laparoscopic sleeve gastrectomy (LSG) and laparoscopic Roux-en-Y gastric bypass (LRYGB) are commonly performed bariatric procedures in obesity management. Gastroesophageal reflux disease (GERD) in this population has reported rates of 23-100%. GERD after LSG has been noted with recent studies demonstrating de novo reflux or symptom exacerbation despite weight loss. Fundoplication is not an option, and medically refractory GERD after LSG is usually treated with conversion to RYGB. GERD post-RYGB is a unique entity, and management poses a clinical and technical challenge. We evaluate safety and effectiveness of magnetic sphincter augmentation after bariatric surgery. MATERIALS AND METHODS: A retrospective review of a prospectively maintained database was performed identifying patients that underwent LINX placement for refractory GERD after LSG, LRYGB, or duodenal switch across three institutions. Outcomes included complications, length of stay, PPI use, GERD-HRQL scores, and patient overall satisfaction. RESULTS: From March 2014 through June 2018, 13 identified patients underwent LINX placement after bariatric surgery: 8 LSG, 4 LRYGB, and 1 duodenal switch. The patients were 77% female, with mean age 43 and average BMI 30.1. Average pre-operative DeMeester score was 24.8. Pre-operatively, 5 patients were on daily PPI, 6 on BID PPI, and 1 on PPI + H2 blocker. We noted decreased medication usage post-operatively, with 4 patients taking daily PPI, and 9 off medication completely. A GERD-HRQL score was obtained pre- and post-operatively in 6 patients with average reduction from 25 to 8.5 (p value 0.002). Two patients experienced complications requiring endoscopic dilation after LINX placement. 100% of patients reported overall satisfaction post procedure. CONCLUSION: LINX placement is a safe, effective treatment option for surgical management of refractory GERD after bariatric surgery. It can relieve symptoms and obviate the requirement of high-dose medical management. Magnetic lower esophageal sphincter augmentation should be another tool in the surgeon's toolbox for managing reflux after bariatric surgery in select patients.

Objective Evidence of Reflux Control After Magnetic Sphincter Augmentation: One Year Results From a Post Approval Study.

OBJECTIVE: To report 1-year results from a 5-year mandated study. SUMMARY BACKGROUND DATA: In 2012, the United States Food and Drug Administration approved magnetic sphincter augmentation (MSA) with the LINX Reflux Management System (Torax Medical, Shoreview, MN), a novel device for the surgical treatment of gastroesophageal reflux disease (GERD). Continued assessment of safety and effectiveness has been monitored in a Post Approval Study. METHODS: Multicenter, prospective study of patients with pathologic acid reflux confirmed by esophageal pH testing undergoing MSA. Predefined clinical outcomes were assessed at the annual visit including a validated, disease-specific questionnaire, esophagogastricduodenoscopy and esophageal pH monitoring, and use of proton pump inhibitors. RESULTS: A total of 200 patients (102 males, 98 females) with a mean age of 48.5 years (range 19.7-71.6) were treated with MSA between March 2013 and August 2015. At 1 year, the mean total acid exposure time decreased from 10.0% at baseline to 3.6%, and 74.4% of patients had normal esophageal acid exposure time (% time pH<4 ≤5.3%). GERD Health-Related Quality of Life scores improved from a median score of 26.0 at baseline to 4.0 at 1 year, with 84% of patients meeting the predefined success criteria of at least a 50% reduction in total GERD Health-Related Quality of Life score compared with baseline. The device removal rate at 1 year was 2.5%. One erosion and no serious adverse events were reported. CONCLUSIONS: Safety and effectiveness of magnetic sphincter augmentation has been demonstrated outside of an investigational setting to further confirm MSA as treatment for GERD.

Laparoscopic magnetic sphincter augmentation versus double-dose proton pump inhibitors for management of moderate-to-severe regurgitation in GERD: a randomized controlled trial.

BACKGROUND AND AIMS: GERD patients frequently complain of regurgitation of gastric contents. Medical therapy with proton-pump inhibitors (PPIs) is frequently ineffective in alleviating regurgitation symptoms, because PPIs do nothing to restore a weak lower esophageal sphincter. Our aim was to compare effectiveness of increased PPI dosing with laparoscopic magnetic sphincter augmentation (MSA) in patients with moderate-to-severe regurgitation despite once-daily PPI therapy. METHODS: One hundred fifty-two patients with GERD, aged ≥21 years with moderate-to-severe regurgitation despite 8 weeks of once-daily PPI therapy, were prospectively enrolled at 21 U.S. sites. Participants were randomized 2:1 to treatment with twice-daily (BID) PPIs (N = 102) or to laparoscopic MSA (N = 50). Standardized foregut symptom questionnaires and ambulatory esophageal reflux monitoring were performed at baseline and at 6 months. Relief of regurgitation, improvement in foregut questionnaire scores, decrease in esophageal acid exposure and reflux events, discontinuation of PPIs, and adverse events were the measures of efficacy. RESULTS: Per protocol, 89% (42/47) of treated patients with MSA reported relief of regurgitation compared with 10% (10/101) of the BID PPI group (P < .001) at the 6-month primary endpoint. By intention-to-treat analysis, 84% (42/50) of patients in the MSA group and 10% (10/102) in the BID PPI group met this primary endpoint (P < .001). Eighty-one percent (38/47) of patients with MSA versus 8% (7/87) of patients with BID PPI had ≥50% improvement in GERD-health-related quality of life scores (P < .001), and 91% (43/47) remained off of PPI therapy. A normal number of reflux episodes and acid exposures was observed in 91% (40/44) and 89% (39/44) of MSA patients, respectively, compared with 58% (46/79) (P < .001) and 75% (59/79) (P = .065) of BID PPI patients at 6 months. No significant safety issues were observed. In MSA patients, 28% reported transient dysphagia; 4% reported ongoing dysphagia. CONCLUSION: Patients with GERD with moderate-to-severe regurgitation, especially despite once-daily PPI treatment, should be considered for minimally invasive treatment with MSA rather than increased PPI therapy. (Clinical trial registration number: NCT02505945.).

Strategies for surgical remediation of the multi-fundoplication failure patient.

BACKGROUND: Outcomes are not well studied in patients undergoing remediation for multi-fundoplication failure, that is, two or more prior failed fundoplications. Re-operation must balance reflux control and restoration of the ability to eat with the challenge of reconstructing a distorted hiatus and GE junction. The purpose of this study is to present our experience with surgical remediation for multi-fundoplication failure. METHODS: Medical records were retrospectively reviewed of 91 patients who underwent third time or more esophagogastric operation for fundoplication failure at a single institution from 2007 to 2016. Dysphagia was present in 56% and heartburn in 51%. Median number of prior operations was 2 with range up to 6. Anatomic failure consisted of slipped wrap in 26 cases, wrap herniation in 23, hiatal stenosis in 24, hiatal mesh complication in 8, and wrap dehiscence in 10. Operative approaches generally followed an institutional algorithm and consisted of hiatal hernia repair with: re-do fundoplication in 55%, takedown of fundoplication alone in 24%, Roux-en-Y gastrojejunostomy in 14%, and GE junction resection in 7%. Laparoscopic approach was successful in 81%. RESULTS: Mean duration of operations was 217 min and median length of stay was 3 days. The complication rate was 13%, with 7% undergoing unplanned early re-operation. Patients were followed for mean 11 months, and recurrent hiatal hernia was detected in 13%. Late re-operation was performed in 6% for recurrent hiatal hernia. Recurrent reflux symptomatology resolved in 93%. Dysphagia resolved in 84%. There were no significant differences in outcomes with regard to number of prior operations, operative approach, BMI, or age. CONCLUSIONS: There is no single best approach to remediation in the multi-fundoplication failure patient. Re-do fundoplication is appropriate in over half of patients. Reoperation for multi-fundoplication failure can be performed via minimally invasive approach with excellent remediation of symptoms, low morbidity, and low recurrence rates.

Totally endoscopic implant to effect a gastric bypass: 12-month safety and efficacy outcomes.

BACKGROUND: Only a small percentage of candidates for bariatric surgery ever undergo a procedure for weight loss. Devices duplicating key effects of bariatric surgeries with removable, fully trans-oral implants could extend their benefits to patients unwilling to undergo anatomy-altering abdominal surgeries. METHODS: Thirty-two obese subjects (mean BMI: 42.3) were enrolled in a prospective, multicenter, single-arm, feasibility trial of the first fully trans-oral endoscopic gastrointestinal bypass device. The device is a cuff attached to the distal esophagus by transmural anchors and connected to a 120-cm sleeve diverting undigested nutrients to the jejunum. Bodyweight, vital signs, adverse events, medications, HbA1c, fasting glucose, and lipids were collected at baseline and follow-up visits. Device status was endoscopically assessed every 6 months. RESULTS: The fully trans-oral procedure was successful in all subjects without intraoperative adverse events or postoperative infections. Twenty-eight of 32 subjects (88%) remained implanted with continuing follow-up beyond their 12-month visit. At 12 months, the 32 subjects had lost an average of 44.8% of excess body weight, 17.6% of total body weight, 20.8 kg, and 7.5 BMI points. Weight loss depended on capture of ingesta by the esophageal cuff, with 18 of 32 subjects without visible gaps around their cuffs at the 6 month endoscopy having significantly greater EWL (53.6 vs. 33.4% in the remaining subjects, p < 0.002). Mean HbA1c and fasting glucose declined by 1.1% points and 29 mg/dL in type 2 diabetic subjects, 80% of whom had remission of their diabetes at 12 months. CONCLUSION: This study demonstrates the feasibility, safety, and efficacy of a fully trans-oral gastrointestinal bypass implant. This purely endoscopic device may provide a valuable addition to the armamentarium of treatment available for the management of morbid obesity.

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.).

Long-term Outcomes of Patients Receiving a Magnetic Sphincter Augmentation Device for Gastroesophageal Reflux.

BACKGROUND & AIMS: Based on results from year 2 of a 5-year trial, in 2012 the US Food and Drug Administration approved the use of a magnetic device to augment lower esophageal sphincter function in patients with gastroesophageal reflux disease (GERD). We report the final results of 5 years of follow-up evaluation of patients who received this device. METHODS: We performed a prospective study of the safety and efficacy of a magnetic device in 100 adults with GERD for 6 months or more, who were partially responsive to daily proton pump inhibitors (PPIs) and had evidence of pathologic esophageal acid exposure, at 14 centers in the United States and The Netherlands. The magnetic device was placed using standard laparoscopic tools and techniques. Eighty-five subjects were followed up for 5 years to evaluate quality of life, reflux control, use of PPIs, and side effects. The GERD-health-related quality of life (GERD-HRQL) questionnaire was administered at baseline to patients on and off PPIs, and after placement of the device; patients served as their own controls. A partial response to PPIs was defined as a GERD-HRQL score of 10 or less on PPIs and a score of 15 or higher off PPIs, or a 6-point or more improvement when scores on vs off PPI were compared. RESULTS: Over the follow-up period, no device erosions, migrations, or malfunctions occurred. At baseline, the median GERD-HRQL scores were 27 in patients not taking PPIs and 11 in patients on PPIs; 5 years after device placement this score decreased to 4. All patients used PPIs at baseline; this value decreased to 15.3% at 5 years. Moderate or severe regurgitation occurred in 57% of subjects at baseline, but only 1.2% at 5 years. All patients reported the ability to belch and vomit if needed. Bothersome dysphagia was present in 5% at baseline and in 6% at 5 years. Bothersome gas-bloat was present in 52% at baseline and decreased to 8.3% at 5 years. CONCLUSIONS: Augmentation of the lower esophageal sphincter with a magnetic device provides significant and sustained control of reflux, with minimal side effects or complications. No new safety risks emerged over a 5-year follow-up period. These findings validate the long-term safety and efficacy of the magnetic sphincter augmentation device for patients with GERD. ClinicalTrials.gov no: NCT00776997.

Revisional surgery after failed esophagogastric myotomy for achalasia: successful esophageal preservation.

BACKGROUND: Treatment failure with recurrent dysphagia after Heller myotomy occurs in fewer than 10 % of patients, most of whom will seek repeat surgical intervention. These reoperations are technically challenging, and as such, there exist only limited reports of reoperation with esophageal preservation. METHODS: We retrospectively reviewed the records of patients who sought operative intervention from March 1998 to December 2014 for obstructed swallowing after esophagogastric myotomy. All patients underwent a systematic approach, including complete hiatal dissection, takedown of prior fundoplication, and endoscopic assessment of myotomy. Patterns of failure were categorized as: fundoplication failure, inadequate myotomy, fibrosis, and mucosal stricture. RESULTS: A total of 58 patients underwent 65 elective reoperations. Four patients underwent esophagectomy as their initial reoperation, while three patients ultimately required esophagectomy. The remainder underwent reoperations with the goal of esophageal preservation. Of these 58, 46 were first-time reoperations; ten were second time; and two were third-time reoperations. Forty-one had prior operations via a trans-abdominal approach, 11 via thoracic approach, and 6 via combined approaches. All reoperations at our institution were performed laparoscopically (with two conversions to open). Inadequate myotomy was identified in 53 % of patients, fundoplication failure in 26 %, extensive fibrosis in 19 %, and mucosal stricture in 2 %. Intraoperative esophagogastric perforation occurred in 19 % of patients and was repaired. Our postoperative leak rate was 5 %. Esophageal preservation was possible in 55 of the 58 operations in which it was attempted. At median follow-up of 34 months, recurrent dysphagia after reoperation was seen in 63 % of those with a significant fibrosis versus 28 % with inadequate myotomy, 25 % with failed wrap, and 100 % with mucosal stricture (p = 0.10). CONCLUSIONS: Laparoscopic reoperation with esophageal preservation is successful in the majority of patients with recurrent dysphagia after Heller myotomy. The pattern of failure has implications for relief of dysphagia with reoperative intervention.

Prospective evaluation of 24-hour urine profiles following bariatric surgery in a modern comprehensive care bariatric clinic.

AIMS: To prospectively examine the effect of modern bariatric surgery on 24-hour urine parameters in a comprehensive care bariatric practice (CCBP). MATERIALS AND METHODS: 47 consecutive patients in our CCBP underwent serum and 24-hour urine analysis pre-operatively, and 30 returned at 12 months for repeat testing. Paired comparisons for serum metabolite and 24-hour urine measures were performed using a Wilcoxon signed-rank test for continuous variables and McNemar's test for categorical variables. Statistical tests were two-sided, with threshold of significance set at p = 0.05. RESULTS: All 30 patients with pre-operative and 12-month follow-up analysis were free of stone events. 20 (67%) had Roux-en-Y gastric bypass (RYGB), 6 (20%) had laparoscopic gastric banding (LGB), and 4 (13%)h ad laparoscopic sleeve gastrectomy (LSG). 24-hour urinary parameters were available for 27 patients. Median urine oxalate (mmol) was 0.29 pre-operatively and 0.21 at 12 months (p = 0.048). Median urine calcium (mg) was 143 pre-operatively and 180 at 12 months (p = 0.11). Median citrate excretion was 527 pre-operatively and 782 at 12 months (p = 0.22). Median serum creatinine was 0.7 pre-operatively and 0.8 at 12 months (p < 0.001). These trends were preserved with the exclusion of LGB and LSG patients. CONCLUSIONS: Modern bariatric surgery (RYGB, LGB, and LSG) as part of a CCBP can still demonstrate alterations of select urinary parameters (particularly oxalate and citrate) in select patients associated with an increased risk of urolithiasis at 1 year follow-up.

Variability of NSQIP-assessed surgical quality based on age and disease process.

BACKGROUND: Recent national attention has focused on improving upon the surgical quality of hospitals across the United States. The American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP) database includes expected morbidity probability for each surgical patient. We sought to investigate the accuracy of this probability across the spectrum of general surgical operations and assess the variability based on the age and disease process. MATERIALS AND METHODS: Using the 2008 ACS-NSQIP database, we identified 190,929 operations that would be in the scope of practice of a modern general surgeon; the four most common included breast resection (n = 22,175; 11.6%), colon resection (n = 21,363; 11.2%), cholecystectomy (n = 20,889; 10.9%), and inguinal hernia repair (n = 11,709; 6.1%). We calculated the surgical observed versus expected morbidity rates (O/E) of each operation type and compared them by decile of patient age. We then determined the effect of case mix and patient age on theoretical hospitals performing at the NSQIP average. RESULTS: There is substantial variability in O/E ratios when comparing these disease processes across deciles of age. For patients undergoing breast resections, 67.2% of morbidities were solely attributed to 30-d reoperations; colon resections had an O/E ratio greater than 1 for all age deciles except over 90 y old. For cholecystectomies and the majority of patients undergoing inguinal hernia repairs, there was a lower morbidity rate than expected. Case mix and patient age were found to independently affect assessment of hospital quality. CONCLUSIONS: It is conceivable that general surgery case mix and patient age could independently affect the quality assessment of a hospital. This variability may have implications for overall quality measures.

Technical and perioperative outcomes of minimally invasive esophagectomy in the prone position.

BACKGROUND: Minimally invasive esophagectomy (MIE) is performed through various approaches, including using video-assisted thoracoscopic surgery for mediastinal esophageal dissection. The prone technique allows for gravity-aided retraction of the lung. The aim of this study was to examine perioperative outcomes after prone MIE in relation to patient preoperative comorbidities. METHODS: A retrospective cohort study from our single tertiary-care center is presented. Between January 2007 and August 2010, a total of 42 patients underwent three-field prone MIE. The majority of patients were male (37 vs. 5 female), with an average age of 68 years (range = 37-87). The diagnoses for patients who underwent MIE were 35 adenocarcinoma, four Barrett's esophagus with high-grade dysplasia, two achalasia, and one squamous cell carcinoma. Neoadjuvant chemotherapy with or without radiotherapy was administered to 16 (38 %) patients. Preoperative comorbidities were quantified using the Modified Charlson Comorbidity Index; low risk was defined as a score of 0-2 (23 patients), moderate risk 3-4 (14 patients), and high risk 5 or higher (five patients). Postoperative complications were stratified using the Clavien Classification Scale; minor complications were grades 1 and 2 and major complications were grades 3-5. RESULTS: Median length of hospital stay was 8 days (range = 6-51) and median ICU stay was 2 days (range = 1-26). Average prone surgical time was 108 min (range = 67-198). Thirty-seven of 42 patients (88 %) were extubated on the day of operation. Postoperatively, all five high-risk patients had a complication, three of which were major. Eight of the 14 moderate-risk patients had a complication and three were major, and 17 of the 23 low-risk group had a complication with nine being major. There was a total of 15 major complications. Predominant complications were arrhythmias (15) and pneumonia (five), with four anastomotic leaks and two postoperative 30-day mortalities. CONCLUSIONS: This series supports using prone MIE. Despite a clinical pathway, including immediate extubation postoperatively, there is still a risk of pulmonary complications that appears to correlate with higher preoperative comorbidity scores.

Chasing zero: the drive to eliminate surgical site infections.

OBJECTIVES: It is estimated that healthcare associated infections (HAI) account for 1.7 million infections and 99,000 associated deaths each year, with annual direct medical costs of up to $45 billion. Surgical Site Infections (SSI) account for 17% of HAIs, an estimated annual cost of $3.5 to 10 billion for our country alone. This project was designed to pursue elimination of SSIs and document results. METHODS: Starting in 2009 a program to eliminate SSIs was undertaken at a nationally recognized academic health center. Interventions already outlined by CMS and IHI were utilized, along with additional interventions based on literature showing relationships with SSI reduction and best practices. Rapid deployment of multiple interventions (SSI Bundle) was undertaken. Tactics included standardized order sets, a centralized preoperative evaluation (POE) clinic, high compliance with intraoperative interventions, and widespread monthly reporting of compliance and results. Data from 2008 to 2010 were collected and analyzed. RESULTS: Between May 1, 2008 and June 30, 2010, all patients with Class I and Class II wounds were tracked for SSIs. Baseline data (May-June 2008) was obtained showing a Class I surgical site infection rate of 1.78%, Class II of 2.82% (total surgical volume: 4160 cases). As of the second quarter 2010, those rates have dropped to 0.51% and 1.44%, respectively (P < 0.001 and P = 0.013; total surgical cases: 2826). This represents a 57% decrease in the SSI rate with an estimated institution specific cost savings of nearly $1 million during the study period. CONCLUSION: Committed leadership, aggressive assurance of high compliance with multiple known interventions (SSI Bundle), transparency to achieve high levels of staff engagement, and centralization of critical surgical activities result in significant declines in SSIs with resulting substantial cost savings.

Video: transcervical videoscopic esophageal dissection in minimally invasive esophagectomy.

BACKGROUND: Minimally invasive esophagectomy (MIE) may involve video-assisted thoracoscopic surgery (VATS) for mediastinal esophageal dissection. Usually, VATS requires single-lung ventilation and has associated cardiopulmonary morbidity [1-3]. Alternatively, transhiatal dissection can be performed, although its complications include vocal cord palsy [4], cardiac arrythmias [5], and increased bleeding [5, 6], the latter associated with mortality after esophagectomy [2]. Therefore, the feasibility of MIE using transcervical videoscopic esophageal dissection (TVED) in swine was investigated. A simultaneous laparoscopic and TVED approach may decrease operative time and blood loss while improving visualization and avoiding single-lung ventilation. METHODS: Two pigs (Sus domesticus) underwent two similar procedures. The methods were approved by the authors' Institutional Animal Care and Use Committee (no. A24209) under United States Department of Agriculture guidelines. Steps included a cervical incision to accommodate a modified hand-assist access device. The cervical esophagus was dissected. Trocars were placed through the modified access device, and pneumomediastinum was established. The tracheoesophageal plane was dissected into the thorax and beyond the mid esophagus, on which the pleura of the separate mediastinal compartment inserts itself. Vagal nerves were identified and divided distal to recurrent branches. Standard laparoscopic techniques were used for esophagogastric dissection. After specimen extraction, the animals were euthanized. RESULTS: A full circumferential dissection of the mediastinal esophagus was successfully accomplished in two animals using a single-incision TVED for MIE. CONCLUSIONS: A novel technique for mediastinal esophageal dissection using a TVED approach performed with instruments designed for single-port surgery is described. Fortunately, the human lacks the swine's separate mediastinal compartment, and this unique difference should facilitate the human version of this dissection. This approach may avoid the potential morbidity of VATS while providing better visualization and facilitating dissection of the upper mediastinal esophagus compared with either the transhiatal approach or the previously attempted rigid mediastinoscopic approaches [7-9].

Industry relationships between physicians and professional medical associations: corrupt or essential?

Congress and others have called into question the propriety of relationships between professional medical associations (PMAs) and industry. These relationships are critical to the continued development of new and better devices and procedures for patients. Better guidelines are needed to help guide these relationships. Overrestrictive regulatory oversight risks overconstraint of these relationships and hindrance to medical progress.

Hiatal mesh is associated with major resection at revisional operation.

BACKGROUND: Mesh-assisted hiatal closure during foregut surgery is increasing. Our aim was to evaluate the complications that follow revisional foregut surgery. Specifically, we compared surgical indications and perioperative outcomes between patients with and without prior hiatal mesh (PHM). METHODS: We conducted an institutional review board (IRB)-approved retrospective cohort study from a single tertiary-care referral center. Over 37 months, 91 patients underwent revisional foregut surgery. We excluded 13 cases including operations performed primarily for obesity or achalasia. Of the remaining 78 patients, 10 had PHM and 68 were nonmesh patients (NM). RESULTS: The groups were similar in terms of age, body mass index (BMI), American Society of Anesthesiologists (ASA) classification, and rates and types of anatomic failure. Compared with NM patients, PHM patients had increased estimated blood loss (410 vs. 127 ml, p < 0.01) and operative time (4.07 vs. 2.89 h, p < 0.01). The groups had no difference in perioperative blood transfusion or length of stay. Complete fundoplication was more commonly created in NM patients (2/10 vs. 42/68, p = 0.03). Three of the 10 PHM patients and 3 of the 68 NM patients required major resection. Therefore, PHM patients had 6.8-fold increased risk of major resection compared with NM patients [95% confidence interval (CI) = 1.585, 29.17; p = 0.05]. The NM patients with multiple prior hiatal operations had 4.6-fold increased risk of major resection compared with those with one prior operation (95% CI = 2.919, 7.384; p = 0.03). In PHM patients, however, the number of prior hiatal operations was not associated with major resection. CONCLUSIONS: PHM is associated with increased risk of major resection at revision. The pattern of failure was not different in patients with hiatal mesh, suggesting that hiatal mesh does not eliminate the potential for revision. When performing hiatal herniorrhaphy, the increased risk of recurrence without mesh must be weighed against the potential risk for subsequent major resection when using mesh.

Use of endoluminal antireflux therapies for obese patients with GERD.

BACKGROUND: Obese patients with gastroesophageal reflux disease (GERD) refractory to medical therapy are a challenging patient population as obesity is a preoperative predictor of failure after antireflux surgery. We therefore sought to evaluate outcomes using one of two commercially available endoluminal therapies in this population. METHODS: Consecutive obese patients (body mass index (BMI)>30) with GERD (DeMeester>14.5) undergoing either Plicator (NDO) or Stretta (Curon) were identified in our single-institution prospective database. Outcomes assessed were: (1) failure rate (absolutely no symptomatic improvement after procedure and/or need for subsequent antireflux surgery), (2) postoperative vs. preoperative symptom (heartburn, chest pain, regurgitation, dysphagia, cough, hoarseness, and asthma) scores, and (3) proton-pump inhibitor (PPI) medication use. RESULTS: Twenty-two patients each underwent an endoluminal therapy (ten Plicator patients and 12 Stretta patients) with mean follow-up of 1.5 years. There were no treatment-associated complications. Mean BMI was not different between Plicator and Stretta groups (39.6 vs. 38.6, respectively, p=0.33). The failure rate for the entire cohort was 28% (10% Plicator vs. 42% Stretta, p=0.11). The proportion of patients reporting moderate/severe symptoms postop was significantly less than preop: chest pain 9% vs. 13% (p=0.04), cough 22% vs. 36% preop (p=0.025), voice changes 9% vs. 36% preop (p=0.012), and dysphagia 9% vs. 32% preop (p=0.04). The proportion of patients on PPI medications postop was also less than preop (45% vs. 81%, p=0.1) CONCLUSION: Endoluminal treatment can provide a safe means of improving GERD symptoms for some obese patients, though many will continue to require medication therapy also. Further work aimed at understanding optimal candidates for endoluminal therapy in this patient population is warranted.

Short-Term Outcomes Predict Long-Term Satisfaction in Patients Undergoing Laparoscopic Magnetic Sphincter Augmentation.

INTRODUCTION: Laparoscopic magnetic sphincter augmentation (MSA) has been shown to be efficacious therapy for gastroesophageal reflux disease (GERD) refractory to maximal medical management. Herein, we present our experience with this procedure and an analysis of our outcomes. MATERIALS AND METHODS: Medical records were retrospectively reviewed of 98 patients who underwent laparoscopic MSA for GERD at a single institution from 2012 to 2016. Symptoms were assessed with gastroesophageal reflux disease-health-related quality of life (GERD-HRQL) questionnaire. Objective testing included pH testing, manometry, endoscopy, and upper GI series. Postimplantation interventions were recorded. Median follow-up was 46 months. RESULTS: Median preoperative DeMeester score was 32 (interquartile range 21-46). Esophagitis was present in 18%. Hiatal hernia was present in 59%. Operation required full hiatal dissection in 16%. There were no intraoperative complications. Mean hospital stay postimplantation was 18 hours. Reoperative intervention with device explant was necessary in 5 cases, one of which was for intraluminal device erosion. Median GERD-HRQL scores were 25 preoperatively, 8 in short-term follow-up at median 1 month, and 5 in long-term follow-up at median 46 months. Improvement in GERD-HRQL scores was statistically significant with both short and long term compared with preoperative (P < .05), but no different between short- and long-term follow-up. Daily bothersome dysphagia was present in 19 patients preoperatively and in 9 at long-term follow-up. CONCLUSIONS: Laparoscopic MSA is associated with excellent outcomes with decrease in GERD-HRQL scores in short term that are durable to longer term follow-up, and with low rates of new-onset dysphagia.

Increases in adiponectin predict improved liver, but not peripheral, insulin sensitivity in severely obese women during weight loss.

Obesity-related glucose intolerance is a function of hepatic (homeostatic model assessment-insulin resistance [HOMA-IR]) and peripheral insulin resistance (S(i)) and beta-cell dysfunction. We determined relationships between changes in these measures, visceral (VAT) and subcutaneous (SAT) adipose tissue, and systemic adipocytokine biomarkers 1 and 6 months after surgical weight loss. HOMA-IR decreased significantly (-50%) from baseline by 1 month and decreased further (-67%) by 6 months, and S(i) was improved by 6 months (2.3-fold) weight loss. Plasma concentrations of leptin decreased and adiponectin increased significantly by 1 month, and decreases in interleukin-6, C-reactive protein (CRP), and tumor necrosis factor-alpha were observed at 6 months of weight loss. Longitudinal decreases in CRP (r = -0.53, P < 0.05) were associated with increases in S(i), and decreases in HOMA-IR were related to increases in adiponectin (r = -0.37, P < 0.05). Decreases in VAT were more strongly related to increases in adiponectin and decreases in CRP than were changes in general adiposity or SAT. Thus, in severely obese women, specific loss of VAT leads to acute improvements in hepatic insulin sensitivity mediated by increases in adiponectin and in peripheral insulin sensitivity mediated by decreases in CRP.

A comprehensive appraisal of the surgical treatment of diffuse esophageal spasm.

Diffuse esophageal spasm is a motility disorder of undetermined cause. The optimal treatment remains controversial, and evidence-based data are lacking. Several medical treatment modalities have been proposed, but none has emerged as the treatment of choice. Patients who do not respond to medical therapy may be considered for surgical treatment. The surgical treatment of diffuse esophageal spasm is based on similar principles to the treatment of achalasia. A long esophageal myotomy is done to divide the hypertrophied circular muscle that is frequently noted in diffuse esophageal spasm. To protect against postoperative reflux, an antireflux procedure may be added. However, the surgical treatment of diffuse esophageal spasm has not been subjected to randomized clinical trials. The purpose of this article is to provide a review of the available literature regarding the surgical management of the diffuse esophageal spasm. In particular, we offer an appraisal of surgical outcomes, the effects of surgery on manometric and radiologic parameters (when available), complications, and mortality.