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.

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.

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.).

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.

The Spectrum of Surgical Remediation of Transoral Incisionless Fundoplication-Related Failures.

AIM: To evaluate outcomes of surgical remediation for symptomatic or anatomic failure after a transoral incisionless fundoplication (TIF). METHODS: This retrospective study was performed on 11 patients who underwent a remedial operation following TIF failure between June 2011 and September 2016 at the Mayo Clinic in Florida for persistent foregut symptoms. Upper gastrointestinal workup characterized 1 patient as having normal post-TIF anatomy and 10 as having anatomic failure. Ambulatory pH testing was performed in 7 patients and was abnormal in all. All patients underwent a laparoscopic takedown of the prior endoscopic fundoplication and removal of all accessible polypropylene T-fasteners. RESULTS: All patients had esophageal salvage and have not required a reoperation. Anatomical findings included hiatal hernia (7), esophageal diverticulum (2), hiatal mesh erosion of esophagus (1), long-segment esophageal stricture (1), and normal anatomy (1). Remedial operations included laparoscopic explant of fasteners in all patients with conversion to fundoplication (7), resection/imbrication of esophageal diverticulum (2), Heller myotomy (1), and mesh explant and complex esophageal repair (1). Mean operative time was 177 minutes and median length of stay 3 days (range 2-13 days). At mean follow-up of 10.7 months (range 1-42 months), 7 patients had persistent complaints. Esophagogastroduodenoscopy was repeated in these 7 patients and was normal (n = 3), mild stenosis requiring dilation (n = 2), Los Angeles grade B esophagitis (n = 1), and Barrett's esophagus (n = 1). CONCLUSION: Anatomic distortion of the distal esophagus after TIF can be significant, making subsequent operations complex. After remedial surgery, few patients will continue to have troublesome symptoms such as dysphagia.

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.

Lower Esophageal Sphincter Augmentation for Gastroesophageal Reflux Disease: The Safety of a Modern Implant.

INTRODUCTION: Use of the magnetic sphincter augmentation device (MSAD) for gastroesophageal reflux disease (GERD) is increasing. As this innovative treatment for GERD gains widespread use and adoption, an assessment of its safety since U.S. market introduction is presented. METHODS: Events were collected from the Manufacturer and User Facility Device Experience (MAUDE) database, which reports events submitted to the Food and Drug Administration (FDA) of suspected device-associated deaths, serious injuries, and malfunctions. The reporting period was from March 22, 2012 (FDA approval) through May 31, 2016, and included only events occurring in the United States. Additional information was provided by the manufacturer, allowing calculation of implant rates and durations. RESULTS: An estimated 3283 patients underwent magnetic sphincter augmentation (165 surgeons at 191 institutions). The median implant duration was 1.4 years, with 1016 patients implanted for at least 2 years. No deaths, life-threatening events, or device malfunctions were reported. The overall rate of device removal was 2.7% (89/3283). The most common reasons for device removal were dysphagia (52/89) and persistent reflux symptoms (19/89). Removal for erosion and migration was 0.15% (5/3283) and 0% (0/3283), respectively. There were no perforations. Of the device removals, 57.3% (51/89) occurred <1 year after implant, 30.3% (27/89) between 1 and 2 years, and 12.4% (11/89) >2 years after implant. The rate of device removal and erosion with an implant duration >2 years were 1.1% (11/1016) and 0.1% (1/1016), respectively. All device removals and erosions were managed nonemergently, with no complications or long-term consequences. CONCLUSIONS: During a 4-year period in more than 3000 patients, no unanticipated MSAD complications have emerged, and there is no data to suggest a trend of increased events over time. The presentation and management of device-related issues have been less complicated than revisions for laparoscopic fundoplication or other interventions for GERD. MSAD is considered safe for the widespread treatment of GERD.

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.

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.

Esophageal strictures and diverticula.

Esophageal disease and dysfunction of the lower esophageal sphincter (LES) manifesting as gastroesophageal reflux disease (GERD) particularly, is the most common of all gastrointestinal conditions impacting patients on a day-to-day basis. LES dysfunction can lead to anatomic changes to the distal esophagus, with GERD-mediated changes being benign stricture or progression of GERD to Barrett's esophagus and even esophageal cancer, and LES hypertension impairing esophageal emptying with subsequent development of pulsion esophageal diverticulum. This article details the causes, clinical presentation, workup, and treatment of esophageal stricture and epiphrenic esophageal diverticulum. Other types of esophageal diverticula (Zenker's and midesophageal) are also covered.

The Use of Mesh in Laparoscopic Large Hiatal Hernia Repair: A Survey of European Surgeons.

PURPOSE: The aim of this study was to evaluate the current opinion of the individual European surgeons on the use of mesh in large hiatal hernia repair. METHODS: A Web-based questionnaire was e-mailed to European upper gastrointestinal surgeons identified by the European Association for Endoscopic Surgery. RESULTS: The questionnaire was completed by 165 surgeons. Mesh is routinely applied by 24 respondents (14.5%), selectively by 128 (77.6%), never used by 11 (6.7%), and 2 failed to respond. A polypropylene mesh is used by 81 (52.6%), polyester by 24 (15.6%), PTFE by 12 (7.8%), ePTFE by 49 (31.8%), and biomesh by 43 respondents (27.9%). A vast variation in mesh configuration and positioning is used. Esophageal erosions were encountered by 33 (20.0%) and esophageal stenosis due to dense fibrosis by 34 (20.6%). CONCLUSIONS: The results of this survey are very instructive for the individual surgeons throughout the world as these illustrate how colleagues in Europe handle the controversial issues in large hiatal hernia repair.

Introduction of mechanical sphincter augmentation for gastroesophageal reflux disease into practice: early clinical outcomes and keys to successful adoption.

BACKGROUND: A new device for mechanical sphincter augmentation (MSA) of the lower esophageal sphincter was approved by the FDA on March 22, 2012. We report early experience with MSA, specifically addressing postoperative management. STUDY DESIGN: Between October 1, 2011 and June 1, 2013, 150 patients were evaluated for MSA. Of these, 66 patients underwent device implantation; the first implant was April 10, 2012. All patients had objectively confirmed gastroesophageal reflux disease (GERD) with pH testing, acceptable esophageal motility, and no significant hiatal hernia (>3 cm). All patients experienced clinical improvement on antisecretory medication, but incomplete symptom control or medication intolerance. RESULTS: All patients were successfully implanted without intra- or perioperative complications. Average length of hospital stay was 0.7 days. At an average follow-up of 5.8 months (range 1 to 18.6 months), 92% of patients are satisfied or neutral with their GERD condition, and 83% are proton pump inhibitor free. The GERD-Health-Related Quality of Life (HRQL) scores are similar to those of patients without GERD. There were no device ulcers or erosions and no devices explanted. Thirteen patients underwent additional testing for dysphagia or persistent symptoms. Calls with questions and nursing involvement in the first 6 months postoperatively were 3 times what is typical for fundoplication patients. Dysphagia and regurgitation were the most common concerns. All these symptoms were improving over time. CONCLUSIONS: Single-center early results are promising and parallel those from a multicenter trial. There is significant interest in MSA, with referrals and direct patient appointments specifically for MSA. Outcomes improve over time after implantation. The surgeon learning curve is different than with the Nissen, both in operative technique and postoperative management. This is a promising new offering for patients with GERD, and surgeons will need to learn how to integrate this into their practices.

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.

Laparoscopic cholecystectomy in patients with HeartMate II left ventricular assist devices.

INTRODUCTION: With an expanding population of patients requiring ventricular assist devices, it is inevitable that these patients will require noncardiac surgery. Ventricular assist devices provide mechanical support for a failing heart either as a bridge to transplant or now as a long-term support if transplant is not available, so-called destination therapy. These devices can add significant technical challenges to abdominal surgery, in that the power supply and drivelines crossing the abdomen can potentially be damaged. The use of preoperative or intraoperative imaging may aid in locating these devices and increase patient safety. MATERIALS AND METHODS: We describe a laparoscopic cholecystectomy in two patients supported with HeartMate(®) II (Thoratec Corp., Pleasanton, CA) left ventricular assist devices. Our use of fluoroscopic guidance in port placement is also described. A literature review was performed to assess the frequency of laparoscopic procedures performed on patients with similar ventricular assist devices and of complications associated with the device and other comorbidities. RESULTS: Laparoscopic cholecystectomy was performed without significant intraoperative hemodynamic changes. The use of imaging, such as fluoroscopy, can identify the location of the ventricular assist device and its associated drive wires to assure they are not damaged intraoperatively. CONCLUSIONS: Laparoscopic cholecystectomy can be performed safely on patients with ventricular assist devices. Complications due to damage to the device can be avoided with the assistance of fluoroscopy to identify the implanted abdominal portions of the ventricular assist device. Each laparoscopic procedure performed on these patients presents the surgeon with unique obstacles in which careful operative planning and intraoperative monitoring are essential.