The Impact of Ineffective Esophageal Motility on Patients Undergoing Magnetic Sphincter Augmentation.

OBJECTIVE: To evaluate and characterize outcomes of MSA in patients with IEM. SUMMARY BACKGROUND DATA: MSA improves patients with gastroesophageal reflux and normal motility. However, many patients have IEM, which could impact the outcomes of MSA and discourage use. METHODS: An international, multi-institutional case control study of IEM patients undergoing MSA matched to normal patients was performed. Primary outcomes were new onset dysphagia and need for postoperative interventions. RESULTS: A total of 105 IEM patients underwent MSA with matching controls. At 1 year after MSA: GERD-Health Related Quality of Life was similar; DeMeester scores in IEM patients improved to 15.7 and 8.5 in controls ( P = 0.021); and normalization of the DeMeester score for IEM = 61.7% and controls = 73.1% ( P = 0.079).In IEM patients, 10/12 (83%) with preop dysphagia had resolution; 11/66 (17%) had new onset dysphagia and 55/66 (83%) never had dysphagia. Comparatively, in non-IEM patients, 22/24 (92%) had dysphagia resolve; 2/24 (8%) had persistent dysphagia; 7/69 (10%) had new onset dysphagia, and 62/69 (90%) never had dysphagia.Overall, 19 (18%) IEM patients were dilated after MSA, whereas 12 (11%) non-IEM patients underwent dilation ( P = 0.151). Nine (9%) patients in both groups had their device explanted. CONCLUSIONS: Patients with IEM undergoing MSA demonstrate improved quality of life and reduction in acid exposure. Key differences in IEM patients include lower rates of objective GERD resolution, lower resolution of existing dysphagia, higher rates of new onset dysphagia and need for dilation. GERD patients with IEM should be counselled about these possibilities.

Is systematic formal crural repair mandatory at the time of magnetic sphincter augmentation implantation?

Laparoscopic placement of the LINX Magnetic Sphincter Augmentation (MSA) device has become an accepted alternative to fundoplication in appropriate patients. Initial studies of MSA targeted to patients with 'early' disease allowed for the most minimal dissection of the esophagus to place the device, without hiatal dissection or repair (NoHHR), in patients with no or minimal hernia findings at surgery. Subsequent studies have compared systematic formal hiatal dissection and repair (Formal HHR) with the original minimal dissection technique. Review of published literature on MSA includes discussion on treatment of hiatal hernia at the time of implantation, accompanying the review of the physiology of the crural diaphragm. Formal hiatal hernia repair at the time of MSA implantation results in better control of reflux with less dysphagia and risk of postoperative hernia than NoHHR, regardless of the presence or size of hiatal hernia. Systematic crural repair should accompany any MSA implantation regardless of the presence or size of hiatal hernia.

Loosening the belt on magnetic sphincter augmentation indications: does body mass index matter?

BACKGROUND: Magnetic sphincter augmentation (MSA) is an effective treatment for gastroesophageal reflux disease (GERD). However, the impact of obesity on MSA outcomes is unknown. The objective of this study was to evaluate the effectiveness of MSA in patients with GERD and obesity. METHODS: A retrospective cohort study was performed of consecutive patients who underwent laparoscopic MSA at three high-volume centers from 2016 to 2019. Patients were grouped into four cohorts according to the World Health Organization body mass index (BMI) classification: BMI < 25 (normal weight), BMI 25-29.9 (overweight), BMI 30-34.9 (obese class I), and BMI > 35 (obese class II-III). Preoperative, operative, and postoperative data were compared between groups. RESULTS: A total of 621 patients underwent laparoscopic MSA during the study period. Follow-up with endoscopy or video esophagram was available for 361 patients (58%) with a median follow-up of 15.4 months. Baseline characteristics of the groups were similar except the BMI > 35 group had more females and a higher preoperative median DeMeester score. There were no significant differences in outcomes between normal weight, overweight, and obese patient groups undergoing MSA. All groups experienced significant reductions in acid suppressive medication use, low GERD-HRQL scores, low DeMeester scores, few intraoperative and postoperative complications, and low rates of hiatal hernia recurrence after MSA. CONCLUSIONS: Magnetic sphincter augmentation is safe and effective in improving GERD symptoms, reducing esophageal acid exposure, and preventing hiatal hernia recurrence, irrespective of patient BMI. MSA should be considered an acceptable treatment option for obese patients with GERD.

Number of reflux episodes on pH-impedance monitoring associates with improved symptom outcome and treatment satisfaction in gastro-oesophageal reflux disease (GERD) patients with regurgitation.

OBJECTIVE: Number of reflux episodes, an adjunctive metric on pH-impedance monitoring, is incompletely studied. We aimed to determine if number of reflux episodes associates with therapeutic outcome in regurgitation predominant gastro-oesophageal reflux disease (GERD). DESIGN: We performed post hoc analysis of postintervention pH-impedance data from adult patients with moderate/severe regurgitation despite QD proton pump inhibitor (PPI), randomised to either two times a day PPI or magnetic sphincter augmentation (MSA) in 2:1 allocation. After 6 and 12 months, symptom response was defined by improvement in Foregut Symptom Questionnaire (FSQ) regurgitation score to none or minimal, ≥50% reduction in GERD health-related quality of life (HRQL) score and satisfaction with therapy. Univariate and multivariate analyses were performed to determine predictors of symptom improvement. RESULTS: Of 152 randomised patients, 123 (age 46.9±1.2 year, 43% female) had complete data. Symptom and satisfaction scores significantly improved after MSA compared with two times a day PPI. Both acid exposure time (13.4%±0.7% to 1.3±0.2%, p<0.001) and reflux episodes (86±4 to 48±4, p<0.001) declined with therapy. Reduction to <40 reflux episodes was significantly more frequent in those with symptom response by FSQ regurgitation score, GERD HRQL score and satisfaction with therapy (p≤0.03 for each); <35 episodes performed better on receiver operating characteristic analysis. On multivariate analysis, improvement in regurgitation score remained independently predictive of satisfaction with therapy (p<0.001 for each). In patients crossing over to MSA, >80 episodes pretreatment predicted improvement. CONCLUSIONS: Reduction of reflux episodes on pH-impedance to physiological levels associates with improved outcomes, while pathological levels predict improvement with MSA in regurgitation predominant GERD. TRAIL REGISTRATION NUMBER: ClinicalTrials.gov: NCT02505945.

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.

Management of regurgitation in patients with gastroesophageal reflux disease.

PURPOSE OF REVIEW: Precision treatment of medically-refractory regurgitation differs from that of heartburn. Regurgitation is an often-overlooked symptom characterized as a bitter taste in the mouth or a sense of fluid moving up from the stomach occurring in approximately 80% of gastroesophageal reflux disease (GERD) patients with varying severity. Its response to standard medical therapy is significantly less than heartburn while significantly lessening quality of life in 10-20% of GERD patients. RECENT FINDINGS: The therapeutic gain of proton pump inhibitors (PPIs) above placebo averages 17% for regurgitation compared with 41% for heartburn. Increased dosing of medication is commonly, yet futilely, used. The symptom is probably mediated more by fluid volume than by the acidity of the refluxate. PPIs significantly decrease gastric acid secretion and to some extent volume of gastric juice. Significantly, doubling the PPI dose does not incrementally decrease gastric juice volume though it may decrease gastric acid secretion further. Studies on refractory regurgitation using some of the newer antireflux procedures (magnetic sphincter augmentation and transoral fundoplication) demonstrated success in over 85% of patients whereas increased PPI dosing helped in approximately 15%. SUMMARY: Precision care of regurgitation should recognize the low-therapeutic impact of acid control, while antireflux procedures are very successful.

Surgical and endoscopic management options for patients with GERD based on proton pump inhibitor symptom response: recommendations from an expert U.S. panel.

BACKGROUND AND AIMS: The objective of this study was to examine expert opinion and agreement on the treatment of distinct GERD profiles from surgical and therapeutic endoscopy perspectives. METHODS: We used the RAND/University of California, Los Angeles Appropriateness Method over 6 months (July 2018 to January 2019) to assess the appropriateness of antireflux interventions among foregut surgeons and therapeutic gastroenterologists. Patients with primary atypical or extraesophageal symptoms were not considered. Patient scenarios were grouped according to their symptom response to proton pump inhibitor (PPI) therapy. The primary outcome was appropriateness of an intervention. RESULTS: Antireflux surgery with laparoscopic fundoplication (LF) and magnetic sphincter augmentation (MSA) were ranked as appropriate for all complete and partial PPI responder scenarios. Transoral incisionless fundoplication was ranked as appropriate in complete and partial PPI responders without a hiatal hernia. Radiofrequency energy was not ranked as appropriate for complete or partial responders. There was lack of agreement between surgery and interventional gastroenterology groups on the appropriateness of LF and MSA for PPI nonresponders. Rankings for PPI nonresponders were similar when results from impedance-pH testing on PPI therapy were available, except that LF and MSA were not ranked as appropriate for PPI nonresponders if the impedance-pH study was negative. CONCLUSIONS: This work highlights areas of agreement for invasive therapeutic approaches for GERD and provides impetus for further interdisciplinary collaboration and trials to compare and generate novel and effective treatment approaches and care pathways, including the role of impedance-pH testing in PPI nonresponders.

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.).

Favorable results from a prospective evaluation of 200 patients with large hiatal hernias undergoing LINX magnetic sphincter augmentation.

INTRODUCTION: Magnetic sphincter augmentation (MSA) of the lower esophageal sphincter restores the antireflux barrier in patients with hiatal hernias ≤3 cm. We performed a prospective study in patients undergoing MSA with the LINX device during repair of paraesophageal and hernias over 3 cm axial component. METHODS AND PROCEDURES: Multicenter, prospective study of consecutive patients treated with MSA at the time of repair of hiatal hernias >3 cm. RESULTS: 200 patients (110 female) were treated between March 2014 and February 2017 via laparoscopic hernia repair and MSA. Mean age was 59.5 years, mean BMI 29.4. 40% had esophagitis, 20% intestinal metaplasia, 72 of 77 tested had abnormal pH studies. Preoperative PPI use was reported by 87%. Eighteen patients had prior hiatal hernia/fundoplication. All had normal function. 78% of patients had axial hiatal hernia ≥5 cm or large paraesophageal component. Mean operative time was 81 min (38-193), EBL was 10 cc. Non-permanent mesh reinforcement of hiatal repair was performed in 83% of the patients. There were two readmissions for dehydration; 2 patients with pulmonary embolism, and 1 patient with cardiac ischemia. Nineteen patients required dilation. 156 pts were followed at a median of 8.6 months. GERD-HRQL scores improved from 26 preoperatively to 2 postoperatively. Complete PPI independence was achieved in 94% (147/156). Videoesophagram in 51 patients at median 11 months found 3 asymptomatic hernias <3 cm. One symptomatic patient underwent successful repair of the hernia without MSA manipulation. There have been no device explants, erosions, or migrations to date. CONCLUSIONS: This prospective study of 200 patients with >3 cm hernias undergoing MSA with hiatoplasty resulted in favorable outcomes with median of 9 months follow-up. Comparing this to published reports of MSA in patients with <3 cm hernias, the safety and clinical efficacy of MSA are independent of initial hernia size.

Efficacy of transoral fundoplication vs omeprazole for treatment of regurgitation in a randomized controlled trial.

BACKGROUND & AIMS: Transoral esophagogastric fundoplication (TF) can decrease or eliminate features of gastroesophageal reflux disease (GERD) in some patients whose symptoms persist despite proton pump inhibitor (PPI) therapy. We performed a prospective, sham-controlled trial to determine if TF reduced troublesome regurgitation to a greater extent than PPIs in patients with GERD. METHODS: We screened 696 patients with troublesome regurgitation despite daily PPI use with 3 validated GERD-specific symptom scales, on and off PPIs. Those with at least troublesome regurgitation (based on the Montreal definition) on PPIs underwent barium swallow, esophagogastroduodenoscopy, 48-hour esophageal pH monitoring (off PPIs), and high-resolution esophageal manometry analyses. Patients with GERD and hiatal hernias ≤2 cm were randomly assigned to groups that underwent TF and then received 6 months of placebo (n = 87), or sham surgery and 6 months of once- or twice-daily omeprazole (controls, n = 42). Patients were blinded to therapy during follow-up period and reassessed at 2, 12, and 26 weeks. At 6 months, patients underwent 48-hour esophageal pH monitoring and esophagogastroduodenoscopy. RESULTS: By intention-to-treat analysis, TF eliminated troublesome regurgitation in a larger proportion of patients (67%) than PPIs (45%) (P = .023). A larger proportion of controls had no response at 3 months (36%) than subjects that received TF (11%; P = .004). Control of esophageal pH improved after TF (mean 9.3% before and 6.3% after; P < .001), but not after sham surgery (mean 8.6% before and 8.9% after). Subjects from both groups who completed the protocol had similar reductions in GERD symptom scores. Severe complications were rare (3 subjects receiving TF and 1 receiving the sham surgery). CONCLUSIONS: TF was an effective treatment for patients with GERD symptoms, particularly in those with persistent regurgitation despite PPI therapy, based on evaluation 6 months after the procedure. Clinicaltrials.gov no: NCT01136980.

Laparoscopic anti-reflux revision surgery after transoral incisionless fundoplication is safe and effective.

BACKGROUND: Transoral incisionless fundoplication (TIF) treats gastroesophageal reflux disease (GERD) by creating a full-thickness esophagogastric plication using transmural fasteners. If unsuccessful, revision laparoscopic anti-reflux surgery (rLARS) may be performed. This study evaluated operative findings and clinical outcomes of rLARS in 28 patients with prior primary TIF. METHODS: Intraoperative findings, complications, and symptomatic outcomes with GERD health-related quality of life (GERD-HRQL) were evaluated prospectively in patients having rLARS after TIF. Results are median with interquartile range (IQR). RESULTS: Between 03/2009 and 08/2013, 28 patients underwent rLARS at 14 (13-50) months post-TIF for recurrent symptoms after initial improvement. Pre-rLARS endoscopies found hiatal hernia (9) and wrap disruption (12). All revisions were completed laparoscopically in 88 (70-90) min. Eight patients underwent partial fundoplication, the rest Nissen. No intraoperative or postoperative complications occurred. Operative findings included: No axial hernia in 65%; Dense adhesions in 14%; Fasteners incorporating the lateral crus in 95%; Traction diverticuli from esophagus to crura in 21%. Residual plication was noted anteriorly in 75%, posteriorly in 0%. Operative approaches: (1) Areas where the TIF fundoplication remained were left intact. This necessitated rolling the fundoplication over the fused area to prevent an endoscopic appearance of 'fold'. (2) Fasteners were cut and left to migrate into the lumen, rather than being pulled out. (3) In 8 patients with fusion of the lateral crus to TIF fundoplication and no axial hernia, revision fundoplication was performed without mediastinal mobilization but with posterior hernia repair. One patient required subsequent surgery for small paraesophageal hernia, one for refractory gas-bloat after rLARS. Dysphagia in 2 patients resolved with dilation. GERD-HRQL improved from a median of 20 (8-27) pre-TIF and 10 (1-20) pre-rLARS to 3 (0-4) at 28 months (12-40) post-rLARS (p = 0.020 for pre-rLARS to post-rLARS). CONCLUSION: rLARS after TIF can be performed safely with excellent clinical outcomes.

Univariate and multivariate analyses of preoperative factors influencing symptomatic outcomes of transoral fundoplication.

BACKGROUND: Preoperative factors predicting symptomatic improvement after transoral fundoplication (TF) in chronic gastroesophageal reflux disease (GERD) patients with persistent symptoms on proton-pump inhibitors (PPIs) therapy have not been elucidated fully. METHODS: Univariate and multivariate logistic regression analyses were performed on data from 158 consecutive patients who underwent TF with the EsophyX device between January 2010 and June 2012 in 14 community centers. Variables included age, gender, body mass index, GERD duration, PPIs therapy duration, presence of hiatal hernia, esophagitis, Hill grade, quality of life scores (QOL) on PPIs, % total time pH < 4, and DeMeester score on reflux testing off PPIs. RESULTS: All patients suffered from typical GERD symptoms. Additionally, 78% (124/158) of patients suffered from atypical symptoms. Six percent (10/158) with recurrent GERD symptoms refractory to PPI therapy underwent revisional procedure (9 laparoscopic Nissen, 1 TF). Median follow-up was 22 (range 10-43) months. For patients with typical symptoms, univariate analyses revealed 4 preoperative factors predictive of successful outcomes: age ≥ 50 [odds ratio (OR) = 2.4, 95% confidence interval (CI) = 1.2-4.8, p = 0.014], GERD Health-related Quality of Life score (GERD-HRQL) ≥ 15 on PPIs (OR = 6.0, CI = 1.2-29.4, p = 0.026, Reflux Symptom Index score > 13 on PPIs (OR = 2.4, CI = 1.1-5.2, p = 0.027), and Gastroesophageal Reflux Symptom Score ≥ 18 on PPIs (OR = 2.6, CI = 1.2-5.8, p = 0.018). Age and GERD-HRQL score remained significant predictors by multivariate analysis. For patients with atypical symptoms, only GERD-HRQL score ≥ 15 on PPIs (OR = 9.9, CI = 0.9-4.6, p = 0.036) was associated with successful outcomes. CONCLUSIONS: Elevated preoperative QOL scores on PPIs and age ≥ 50 were most closely associated with successful outcome of TF in patients with persistent symptoms despite medical therapy.

Allograft dermal matrix hiatoplasty during laparoscopic primary fundoplication, paraesophageal hernia repair, and reoperation for failed hiatal hernia repair.

BACKGROUND: Hiatal repair failure is the nemesis of laparoscopic paraesophageal hernia repair as well as the major cause of failure of primary fundoplication and reoperation on the hiatus. Biologic prosthetics offer the promise of reinforcing the repair without risks associated with permanent prosthetics. DESIGN: Retrospective evaluation of safety and relative efficacy of laparoscopic hiatal hernia repair using an allograft (acellular dermal matrix) onlay. Patients with symptomatic failures underwent endoscopic or radiographic assessment of hiatal status. RESULTS: Greater than 6-month follow-up was available for 252 of 450 consecutive patients undergoing laparoscopic allograft-reinforced hiatal hernia repair between January 2007 and March 2011. No erosions, strictures, or persisting dysphagia were encountered. Adhesions were minimal in cases where reoperation was required. Failure of the hiatal repair at median 18 months (6-51 months) was significantly (p < 0.005) different between groups: group A (primary fundoplication with axial hernia ≤ 2 cm), 3.7 %; group B (primary fundoplication with axial hernia 2-5 cm), 7.1 %; group G (giant/paraesophageal), 8.8 %; group R (reoperative), 23.4 %. Additionally, mean time to failure was significantly shorter in group R (247 days) compared with the other groups (462-489 days). CONCLUSIONS: Use of allograft reinforcement to the hiatus is safe at 18 months median follow-up. Reoperations had a significantly higher failure rate and shorter time to failure than the other groups despite allograft, suggesting that primary repairs require utmost attention and that additional techniques may be needed in reoperations. Patients with hiatal hernias >2 cm axially had a recurrence rate equal to that of patients undergoing paraesophageal hiatal hernia repair, and should be treated similarly.

Revision of failed traditional fundoplication using EsophyX transoral fundoplication.

BACKGROUND: Laparoscopic revision of failed traditional fundoplication is difficult and involves risk of gastric, esophageal, and vagal nerve injury that is higher than that of the primary fundoplication. This study assessed feasibility and clinical outcomes of the transoral approach to revision of loose Nissen. METHODS: Between November 2009 and August 2011, a total of 11 patients underwent transoral repair as opposed to 70 patients who underwent laparoscopic or open revision of a failed fundoplication. Subjective and objective outcomes were evaluated with the GERD health-related quality of life (GERD-HRQL) questionnaire and the reflux symptom index (RSI) questionnaire and ambulatory pH testing. The competency of the new antireflux barrier was evaluated by endoscopy. Wilcoxon signed-rank test was used to compare pre- and postoperative variables. RESULTS: All 11 patients evidenced loosening of the Nissen fundoplication without evidence of hiatal failure. Mean age was 57 years, BMI was 25.1 kg/m(2), and 4 of 11 (36 %) were female. Indications for operation were abnormal pH-metry off PPIs (6), impedance/pH on PPIs (3), esophagitis (1), and evidence of free reflux on barium swallow (1). One patient developed a postoperative bleed requiring transfusion. Two patients had laparoscopic revision at 6 and 8 months after the transoral procedure. At a median follow-up of 14 (range = 6-28) months, 8/10 patients reported resolution of their primary symptoms. Eight patients had pH testing off PPIs both pre- and postoperatively; median % time with pH <4 improved by dropping from 8.1 % (21-4.8 %) to 0.6 % (13.4-0.01 %) (p = 0.008). Esophageal acid exposure normalized in 5/6 patients. Mean GERD-HRQL score improved significantly by dropping from 28.6 (10.6) preoperatively to 6.7 (6.1) post-TIF (p = 0.016). Mean RSI score improved more than 50 % in 5/7 patients. CONCLUSION: Transoral revision of failed traditional fundoplication without herniation is technically feasible. It results in symptomatic and objective improvement of GERD without the risks of laparoscopic dissection for a majority of patients.

Feasibility and Efficacy of Magnetic Sphincter Augmentation for the Management of Gastroesophageal Reflux Disease Post-Sleeve Gastrectomy for Obesity.

BACKGROUND: Patients with medically intractable GERD after laparoscopic sleeve gastrectomy (LSG) have limited surgical options. Fundoplication is difficult post-LSG. Roux-en-Y gastric bypass may be used as a conversion procedure but is more invasive with potential for serious complications. Magnetic sphincter augmentation (MSA) is a less invasive GERD treatment alternative. The objective of this study was to assess safety and efficacy outcomes of MSA after LSG. METHODS: The primary outcome of this observational, multicenter, single-arm prospective study was the rate of serious device and/or procedure-related adverse events (AEs). The efficacy of the LINX device was measured comparing baseline to 12-month post-implant reductions in distal acid exposure, GERD-HRQL score, and average daily PPI usage. RESULTS: Thirty subjects who underwent MSA implantation were followed 12 months post-implant. No unanticipated adverse device effects were observed. There were two adverse events deemed serious (dysphagia, pain, 6.7%) which resolved without sequelae. GERD-HRQL scores showed significant improvement (80.8%, P < 0.001), and reduction in daily PPI usage was seen (95.8%, P < 0.001). Forty-four percent of subjects demonstrated normalization or > = 50% reduction of total distal acid exposure time (baseline 16.2%, 12 months 11%; P = 0.038). CONCLUSIONS: Post-LSG, MSA showed an overall improvement of GERD symptoms, and reduction in PPI use with explants within anticipated range along with improvement in distal esophageal acid exposure time.

Randomized double-blind placebo-controlled study of the efficacy of continuous infusion of local anesthetic to the diaphragm closure following laparoscopic hiatal hernia repair.

BACKGROUND: Laparoscopic repair of hiatal hernia can result in significant postoperative pain requiring use of narcotics and patient dissatisfaction. A catheter-based delivery method that has demonstrated effectiveness and safety in other laparoscopic and open procedures (ON-Q, I Flow Corporation) was used to deliver pain medicine. This randomized double-blind, placebo-controlled study evaluated the efficacy of continuous infusion of local anesthetic to the diaphragm closure post laparoscopic hiatal hernia repair. METHODS: After obtaining Institutional Review Board approval, qualifying patients undergoing laparoscopic repair of hiatal hernia voluntarily consented to the study protocol. Standard techniques for routine closure of hiatal hernia repair were used. The ON-Q pain pump catheter was placed adjacent to the sutures used to repair the hiatal hernia, so that it rested between the diaphragm and the collagen patch used to reinforce the hernia repair. The pump infused either bupivacaine 0.5% or NaCl 0.9% at 2 cc/h for 5 days postoperatively. Patients kept a daily diary for pain scores, number of narcotic pain pills taken, and number of nausea pills taken. RESULTS: Of the 46 patients enrolled in the study, seven were dropped for adverse events or noncompliance; 20 were given placebo (0.9% NaCl) and 19 were given 0.5% bupivacaine. CONCLUSION: This randomized double-blind, placebo-controlled trial showed no advantage in using the ON-Q pain pump in terms of providing measurable reduction of pain or concomitant narcotic or nausea medication use. Further studies are indicated to determine alternatives for reducing postoperative pain after laparoscopic hiatal hernia repair.

Clinical and pH-metric outcomes of transoral esophagogastric fundoplication for the treatment of gastroesophageal reflux disease.

BACKGROUND: Transoral treatment of gastroesophageal reflux disease (GERD) using the EsophyX device enables creation of an esophagogastric fundoplication with potential for better control of reflux than gastrogastric techniques. Efficacy and safety of a rotational/longitudinal esophagogastric transoral incisionless fundoplication (TIF) was evaluated retrospectively using subjective and objective outcomes. METHODS: Thirty-seven consecutive patients on antisecretory medication and with proven gastroesophageal reflux and limited hiatal hernia underwent TIF for persistent GERD symptoms. Five patients were reoperations for failed laparoscopic fundoplication. RESULTS: Of the 37 treated patients, 57% were female. The median age was 58 (range=20-81) years and BMI was 25.5 (range=15.9-36.1) kg/m2. Sixty-eight percent indicated GERD-associated cough, asthma, or aspiration as a primary complaint and 32% complained of heartburn or regurgitation. The TIF procedures created tight wraps of 230°-330° extending 3-4 cm above the Z-line. Two complications occurred: one mediastinal abscess treated laparoscopically and one postoperative bleeding requiring transfusion. At 6 (range=3-14) months median follow-up TIF resulted in a significant improvement of both atypical and typical symptoms in 64% and 70-80% of patients, respectively, as indicated by the corresponding GERD health-related quality of life (HRQL) and reflux symptom index (RSI) score reduction by 50% or more compared to baseline on proton pump inhibitors (PPIs). No patient reported problems with dysphagia, bloating, or excess flatulence, and 82% were not taking any PPIs. Reflux characteristics were significantly improved and normalized in 61, 89, and 56% of patients in terms of acid exposure, number of refluxates, and DeMeester scores, respectively. TIF was effective in treating GERD in 75% of patients among whom 54% were in a complete "remission" and 21% were "improved." The remaining 25% were considered failures, and five (13.5%) patients underwent revision. CONCLUSION: Rotational/longitudinal esophagogastric fundoplication using the EsophyX device significantly improved symptomatic and objective outcomes in over 70% of patients at median 6-month follow-up. Post-fundoplication side effects were not reported after TIF.

Transoral rotational esophagogastric fundoplication: technical, anatomical, and safety considerations.

BACKGROUND: Gastroesophageal reflux disease (GERD) results primarily from the loss of an effective antireflux barrier, which forms a mechanical barrier against the retrograde movement of gastric content. Restoration of the incompetent antireflux barrier is possible by longitudinal and rotational advancement of the gastric fundus about the lower esophagus, creating an esophagogastric fundoplication. This article describes the technique of performing a rotational and longitudinal esophagogastric fundoplication, performed transorally using EsophyX. METHODS: The transoral incisionless fundoplication (TIF) technique enables the creation of a full-thickness esophagogastric fundoplication with fixation extending longitudinally up to 3.5 cm above the Z-line and rotationally more than 270 degrees around the esophagus. A key element of the technique involves rotating the fundus around the esophagus with a tissue mold during gastric desufflation. Anatomic considerations and use of the device's tissue invaginator to push the esophagus caudally are important to ensure safe positioning of the plications below the diaphragm. The steps of the technique are described in detail, and suggestions are given about patient selection and care, as well as prevention and management of complications.

Transoral incisionless fundoplication demonstrates durability at up to 9 years.

GOALS: To assess the long-term results of transoral incisionless fundoplication (TIF 2). BACKGROUND: TIF with the EsophyX2 is an accepted procedure to treat gastroesophageal reflux disease (GERD). Long-term data have been limited. We report clinical outcomes of 151 patients followed up to 9 years. STUDY: A single institution prospective registry of patients undergoing TIF 2 between 11/2008 and 7/2015. Outcomes were assessed by complications, re-interventions, and a mixed effect model of clinical response over time. RESULTS: A total of 151 patients (87 women), mean age 62 years (30-91), mean body mass index (BMI) 26.6 (20-36.1), 93% on daily proton pump inhibitor (PPI), underwent TIF 2 without hiatal hernia repair; 131 of the 151 patients (86%) were available for follow-up at a median of 4.92 years (0.7-9.7 years). Of 120 patients ⩾5 years post-TIF, 62 (51%) were followed for a median 6.8 years. Median GERD-health-related quality of life (HRQL) scores decreased from 21 (interquartile range (IQR) 9.5-30) off PPI and 14 (4-24) on PPI at baseline to 4 (2-8) at 4.92 years and remained at 5 (2-9) in the 62 patients 5-9 years post-TIF. Sixty-four per cent had successful (>50%) reductions in GERD-HRQL scores at 4.92 years and 68% of patients followed ⩾5 years. Median regurgitation decreased from 15 (8-20) off PPI and 11 (5-20) on PPI at baseline to 0 (0-4) at 4.92 years, remaining at 1 (0-3) in 62 patients 5-9 years post-TIF. Mixed model analyses confirmed significant and stable improvements in GERD-HRQL and regurgitation scores at all annual follow-up time points after TIF. Daily PPI use decreased from 93% to 32% at 4.92, and 22% at ⩾5 years post-TIF. Revision to laparoscopic fundoplication in 33(22%) showed comparable outcomes. Two patients recovered uneventfully after laparoscopic surgery for localized perforation. CONCLUSIONS: TIF 2 provides durable relief of GERD symptoms at up to 9 years with 69-80% of patients having a successful outcome by symptom response and PPI use.