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.

High-Risk Features of Esophageal Adenocarcinoma Following Neoadjuvant Chemoradiation: Patients for Whom Surgery Should Not Be Delayed.

OBJECTIVE: Clinical predictors of pathological complete response have not reliably identified patients for whom an organ-sparing approach following neoadjuvant chemoradiation be undertaken for esophageal cancer patients. We sought to identify high-risk predictors of residual carcinoma that may preclude patients from a selective surgical approach. BACKGROUND: Patients treated with neoadjuvant chemoradiation followed by esophagectomy for esophageal adenocarcinoma were identified. PATIENTS AND METHODS: Correlation between clinical and pathologic complete responses were examined. Regression models and recursive partitioning were utilized to identify features associated with residual carcinoma. External validation of these high-risk factors was performed on a data set from an independent institution. RESULTS: A total of 326 patients were identified, in whom clinical complete response was noted in 104/326 (32%). Pathologic complete response was noted in only 33/104 (32%) of these clinical complete responders. Multivariable analysis identified that the presence of stricture ( P =0.011), positive biopsy ( P =0.010), and signet ring cell histology ( P =0.019) were associated with residual cancer. Recursive partitioning corroborated a 94% probability of residual disease, or greater, for each of these features. The positive predictive value was >90% for these characteristics. A SUV max >5.4 at the esophageal primary in the absence of esophagitis was also a high-risk factor for residual carcinoma. External validation confirmed these high-risk factors to be implicated in the finding of residual carcinoma. CONCLUSIONS: Clinical parameters of response are poor predictors of complete pathologic response leading to challenges in selecting candidates for active surveillance. However, we characterize several high-risk features for residual carcinoma which indicate that esophagectomy should not be delayed.

Improving the Diagnostic Yield of High-Resolution Esophageal Manometry for GERD: The "Straight Leg-Raise" International Study.

BACKGROUND & AIMS: The straight leg raise (SLR) maneuver during high-resolution manometry (HRM) can assess esophagogastric junction (EGJ) barrier function by measuring changes in intraesophageal pressure (IEP) when intra-abdominal pressure is increased. We aimed to determine whether increased esophageal pressure during SLR predicts pathologic esophageal acid exposure time (AET). METHODS: Adult patients with persistent gastroesophageal reflux disease (GERD) symptoms undergoing HRM and pH-impedance or wireless pH study off proton pump inhibitor were prospectively studied between July 2021 and March 2022. After the HRM Chicago 4.0 protocol, patients were requested to elevate 1 leg at 45º for 5 seconds while supine. The SLR maneuver was considered effective when intra-abdominal pressure increased by 50%. IEPs were recorded 5 cm above the lower esophageal sphincter at baseline and during SLR. GERD was defined as AET greater than 6%. RESULTS: The SLR was effective in 295 patients (81%), 115 (39%) of whom had an AET greater than 6%. Hiatal hernia (EGJ type 2 or 3) was seen in 135 (46%) patients. Compared with patients with an AET less than 6%, peak IEP during SLR was significantly higher in the GERD group (29.7 vs 13.9 mm Hg; P < .001). Using receiver operating characteristic analysis, an increase of 11 mm Hg of peak IEP from baseline during SLR was the optimal cut-off value to predict an AET greater than 6% (area under the receiver operating characteristic curve, 0.84; sensitivity, 79%; and specificity, 85%), regardless of the presence of hiatal hernia. On multivariable analysis, an IEP pressure increase during the SLR maneuver, EGJ contractile integral, EGJ subtype 2, and EGJ subtype 3, were found to be significant predictors of AET greater than 6% CONCLUSIONS: The SLR maneuver can predict abnormal an AET, thereby increasing the diagnostic value of HRM when GERD is suspected. CLINICALTRIALS: gov ID: NCT04813029.

Evolution in the treatment of gastroesophageal reflux disease over the last century: from a crural-centered to a lower esophageal sphincter-centered approach and back.

The surgical management of gastroesophageal reflux disease (GERD) has evolved significantly over the past century, driven by increased understanding of the physiology of the reflux barrier, its anatomic components, and surgical innovation. Initially, emphasis was on reduction of hiatal hernias and crural closure as the etiology behind GERD was felt to be solely related to the anatomic alterations caused by hiatal hernias. With persistence of reflux-related changes in some patients despite crural closure, along with the development of what is now modern manometry and the discovery of a high-pressure zone at the distal esophagus, focus evolved to surgical augmentation of the lower esophageal sphincter (LES). With this transition to an LES-centric approach, attention shifted to reconstruction of the angle of His, ensuring sufficient intra-abdominal esophageal length, development of the now commonly employed Nissen fundoplication, and creation of devices that directly augment the LES such as magnetic sphincter augmentation. More recently, the role of crural closure in antireflux and hiatal hernia surgery has again received renewed attention due to the persistence of postoperative complications including wrap herniation and high rates of recurrences. Rather than simply preventing transthoracic herniation of the fundoplication as was originally thought, diaphragmatic crural closure has been documented to have a key role in re-establishing intra-abdominal esophageal length and contributing to the restoration of normal LES pressures. This progression from a crural-centric to a LES-centric approach and back has evolved along with our understanding of the reflux barrier and will continue to do so as more advances are made in the field. In this review, we will discuss the evolution of surgical techniques over the past century, highlighting key historical contributions that have shaped our management of GERD today.

The Nissen-Hill Hybrid Repair: Experience With the First 500.

INTRODUCTION: A new repair for gastroesophageal reflux and hiatal hernia, the Nissen-Hill hybrid repair, was developed to combine the relative strengths of its component repairs with the aim of improved durability. In several small series, it has been shown to be safe, effective, and durable for paraesophageal hernia, Barrett esophagus, and gastroesophageal reflux disease. This study represents our experience with the first 500 consecutive repairs for all indications. METHODS: Retrospective study of prospectively collected data for the first 500 consecutive Nissen-Hill hybrid repairs from March 2006 to December 2016, including all indications for surgery. Three quality of life metrics, manometry, radiographic imaging, and pH testing were administered before and at defined intervals after repair. RESULTS: Five hundred patients were included, with a median follow-up of 6.1 years. Indications for surgery were gastroesophageal reflux disease in 231 (46.2%), paraesophageal hernia in 202 (40.4%), and reoperative repair in 67 (13.4%). The mean age was 59, with body mass index of 30 and 63% female. A minimally invasive approach was used in 492 (98%). Thirty-day operative mortality was 1 (0.2%), with a 4% major complication rate and a median length of stay of 2 days. Preoperative to postoperative pH testing was available for 390 patients at a median follow-up of 7.3 months, with the median DeMeester score improving from 45.9 to 2.7. At long-term follow-up (229 responses), all median quality of life scores improved: Quality Of Life in Reflux And Dyspepsia 4 to 6.9, Gastroesophageal Reflux Disease-Health Related Quality of Life 22 to 3, and Swallowing 37.5 to 45 and proton pump inhibitor use dropped from 460 (92%) to 50 (10%). Fourteen (2.8%) underwent reoperation for failure. CONCLUSION: The combined Nissen-Hill hybrid repair is safe and effective in achieving excellent symptomatic and objective outcomes and low recurrence rates beyond 5 years.

Retrospective multicenter study on endoscopic treatment of upper GI postsurgical leaks.

BACKGROUND AND AIMS: Therapeutic endoscopy plays a critical role in the management of upper GI (UGI) postsurgical leaks. Data are scarce regarding clinical success and safety. Our aim was to evaluate the effectiveness of endoscopic therapy for UGI postsurgical leaks and associated adverse events (AEs) and to identify factors associated with successful endoscopic therapy and AE occurrence. METHODS: This was a retrospective, multicenter, international study of all patients who underwent endoscopic therapy for UGI postsurgical leaks between 2014 and 2019. RESULTS: Two hundred six patients were included. Index surgery most often performed was sleeve gastrectomy (39.3%), followed by gastrectomy (23.8%) and esophagectomy (22.8%). The median time between index surgery and commencement of endoscopic therapy was 16 days. Endoscopic closure was achieved in 80.1% of patients after a median follow-up of 52 days (interquartile range, 33-81.3). Seven hundred seventy-five therapeutic endoscopies were performed. Multimodal therapy was needed in 40.8% of patients. The cumulative success of leak resolution reached a plateau between the third and fourth techniques (approximately 70%-80%); this was achieved after 125 days of endoscopic therapy. Smaller leak initial diameters, hospitalization in a general ward, hemodynamic stability, absence of respiratory failure, previous gastrectomy, fewer numbers of therapeutic endoscopies performed, shorter length of stay, and shorter times to leak closure were associated with better outcomes. Overall, 102 endoscopic therapy-related AEs occurred in 81 patients (39.3%), with most managed conservatively or endoscopically. Leak-related mortality rate was 12.4%. CONCLUSIONS: Multimodal therapeutic endoscopy, despite being time-consuming and requiring multiple procedures, allows leak closure in a significant proportion of patients with a low rate of severe AEs.

Ineffective esophageal motility is not a contraindication to total fundoplication.

INTRODUCTION: Ineffective esophageal motility (IEM) is a physiologic diagnosis and is a component of the Chicago Classification. It has a strong association with gastroesophageal reflux and may be found during work-up for anti-reflux surgery. IEM implies a higher risk of post-op dysphagia if a total fundoplication is done. We hypothesized that IEM is not predictive of dysphagia following fundoplication and that it is safe to perform total fundoplication in appropriately selected patients. METHODS: Retrospective chart review of patients who underwent total fundoplication between September 2012 and December 2018 in a single foregut surgery center and who had IEM on preoperative manometry. We excluded patients who had partial fundoplication, previous foregut surgery, other causes of dysphagia or an esophageal lengthening procedure. Dysphagia was assessed using standardized Dakkak score ≤ 40 and GERD-HRQL question 7 ≥ 3. RESULTS: Two hundred patients were diagnosed with IEM and 31 met the inclusion criteria. Median follow-up: 706 days (IQR 278-1348 days). No preoperative factors, including subjective dysphagia, transit on barium swallow, or individual components of manometry showed statistical correlation with postoperative dysphagia. Of 9 patients with preoperative dysphagia, 2 (22%) had persistent postoperative dysphagia and 7 had resolution. Of 22 patients without preoperative dysphagia, 3 (14%) developed postoperative dysphagia; for a combined rate of 16%. No patient needed re-intervention beyond early recovery or required reoperation for dysphagia during the follow-up period. CONCLUSION: In appropriately selected patients, when total fundoplication is performed in the presence of preoperative IEM, the rate of long-term postoperative dysphagia is similar to the reported rate of dysphagia without IEM. With appropriate patient selection, total fundoplication may be performed in patients with IEM without a disproportionate increase in postoperative dysphagia. The presence of preoperative IEM should not be rigidly applied as a contraindication to a total fundoplication.

Safety and efficacy of magnetic sphincter augmentation dilation.

BACKGROUND: The magnetic sphincter augmentation device (MSA) provides effective relief of gastroesophageal reflux symptoms. Dysphagia after MSA implantation sometimes prompts endoscopic dilation. The manufacturer's instructions are that it be performed 6 or more weeks after implantation under fluoroscopic guidance to not more than 15 mm keeping 3 or more beads closed. The purpose of this study was to assess adherence to these recommendations and explore the techniques used and outcomes after MSA dilation. METHODS AND PROCEDURES: We conducted a multicenter retrospective review of patients undergoing dilation for dysphagia after MSA placement from 2012 to 2018. RESULTS: A total of 144 patients underwent 245 dilations. The median size of MSA placed was 14 beads (range 12-17) and the median time to dilation was 175 days. A second dilation was performed in 67 patients, 22 patients had a third dilation and 7 patients underwent 4 or more dilations. In total, 17 devices (11.8%) were eventually explanted. The majority of dilations were performed with a balloon dilator (81%). The median dilator size was 18 mm and 73.4% were done with a dilator larger than 15 mm. There was no association between dilator size and need for subsequent dilation. Fluoroscopy was used in 28% of cases. There were no perforations or device erosions related to dilation. DISCUSSION: There is no clinical credence to the manufacturer's recommendation for the use of fluoroscopy and limitation to 15 mm when dilating a patient for dysphagia after MSA implantation. Use of a larger size dilator was not associated with perforation or device erosion, but also did not reduce the need for repeat dilation. Given this, we would recommend that the initial dilation for any size MSA device be done using a 15 mm through-the-scope balloon dilator. Dysphagia prompting dilation after MSA implantation is associated with nearly a 12% risk of device explantation.

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.

How Many Nodes Need to be Removed to Make Esophagectomy an Adequate Cancer Operation, and Does the Number Change When a Patient has Chemoradiotherapy Before Surgery?

INTRODUCTION AND DESIGN: Node dissection during esophagectomy is an important aspect of esophageal cancer staging. Controversy remains as to how many nodes need to be resected in order to properly stage a patient and whether the removal of more nodes carries a stage-independent survival benefit. A review of the literature performed by a group of experts in the subject may help define a minimum accepted number of lymph nodes to be resected in both primary surgery and post-induction therapy scenarios. RESULTS AND CONCLUSIONS: The existing evidence generally supports the goal of obtaining a minimum of 15 lymph nodes for pathological examination in both primary surgery and post-induction therapy scenarios.

Use of a report card to evaluate outcomes of achalasia surgery: beyond the Eckardt score.

BACKGROUND: Achalasia outcome is primarily defined using the Eckardt score with failure recognized as > 3. However, patients experience many changes after myotomy including new onset GERD, swallowing difficulties, and potential need for additional treatment. We aim to devise a comprehensive assessment tool to demonstrate the extent of patient-reported outcomes, objective changes, and need for re-interventions following myotomy. METHODS: We performed a retrospective chart review of surgically treated primary achalasia patients. We identified 185 patients without prior foregut surgery who underwent either per oral endoscopic myotomy (POEM) or Heller myotomy from 2005 to 2017. Eight outcome measures in subjective, objective, and interventional categories formulated a global postoperative assessment tool. These outcomes included Eckardt score, Dakkak Dysphagia score, GERD-HRQL score, normalization of pH scores and IRP, esophagitis, timed barium clearance at 5 min, and the most invasive re-intervention performed. RESULTS: Of 185 patients, achalasia subtypes included Type I = 42 (23%), II = 109 (59%), and III = 34 (18%). Patients underwent minimally invasive myotomy in 114 (62%), POEM in 71 (38%). Median proximal myotomy length was 4 cm (IQR 4-5) and distal 2 cm (IQR 2-2.5). Based on postoperative Eckardt score, 135/145 (93%) had successful treatment of achalasia. But, only 47/104 (45%) reported normal swallowing, and 78/108 (72%) had GERD-HRQL score ≤ 10. Objectively, IRP was normalized in 48/60 (80%), whereas timed barium clearance occurred in 51/84 (61%). No evidence of esophagitis was documented in 82/115 (71%). Postoperative normal DeMeester scores occurred in 38/76 (50%). No additional treatments were required in 110/139 (79%) of patients. CONCLUSIONS: Use of the Eckardt score alone to assess outcomes after achalasia surgery shows outstanding results. Using patient-reported outcomes, objective measurements, re-intervention rates, organized into a report card provides a more comprehensive and informative view.

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.).

Large Cell Neuroendocrine Tumor Size >3 cm Negatively Impacts Long-Term Outcomes After R0 Resection.

BACKGROUND: Minimal knowledge exists regarding the outcome, prognosis and optimal treatment strategy for patients with pulmonary large cell neuroendocrine carcinomas (LCNEC) due to their rarity. We aimed to identify factors affecting survival and recurrence after resection to inform current treatment strategies. METHODS: We retrospectively reviewed 72 patients who had undergone a curative resection for LCNEC in 8 centers between 2000 and 2015. Univariable and multivariable analyses were performed to identify the factors influencing recurrence, disease-specific survival and overall survival. These included age, gender, previous malignancy, ECOG performance status, symptoms at diagnosis, extent of resection, extent of lymphadenectomy, additional chemo- and/or radiotherapy, tumor location, tumor size, pT, pleural invasion, pN and pStage. RESULTS: Median follow-up was 47 (95%CI 41-79) months; 5-year disease-specific and overall survival rates were 57.6% (95%CI 41.3-70.9) and 47.4% (95%CI 32.3-61.1). There were 22 systemic recurrences and 12 loco-regional recurrences. Tumor size was an independent prognostic factor for systemic recurrence [HR: 1.20 (95%CI 1.01-1.41); p = 0.03] with a threshold value of 3 cm (AUC = 0.71). For tumors ≤3 cm and >3 cm, 5-year freedom from systemic recurrence was 79.2% (95%CI 43.6-93.6) and 38.2% (95%CI 20.6-55.6) (p < 0.001) and 5-year disease-specific survival was 60.7% (95%CI 35.1-78.8) and 54.2% (95%CI 32.6-71.6) (p = 0.31), respectively. CONCLUSIONS: A large proportion of patients with surgically resected LCNEC will develop systemic recurrence after resection. Patients with tumors >3 cm have a significantly higher rate of systemic recurrence suggesting that adjuvant chemotherapy should be considered after complete resection of LCNEC >3 cm, even in the absence of nodal involvement.

Tunneled pleural catheter use for pleural palliation does not increase infection rate in patients with treatment-related immunosuppression.

PURPOSE: Concerns for infections resulting from antineoplastic therapy-associated immunosuppression may deter referral for symptom palliation with a tunneled pleural catheter (TPC) in patients with malignant/para-malignant pleural effusions (MPE/PMPE). While rates of TPC-related infections range from 1 to 21%, those in patients receiving antineoplastic therapy with correlation to immune status has not been established. We aimed to assess TPC-related infection rates in patients on antineoplastic therapy, determine relation to immune system competency, and assess impact on the patient. METHODS: Patients with a MPE/PMPE undergoing TPC management associated with antineoplastic therapy, from 2008 to 2016, were reviewed and categorized into those with an immunocompromised versus immunocompetent immune status. RESULTS: Of the 150 patients, a TPC-related infection developed in 13 (9%): pleural space in 11 (7%) and superficial in 2 (1%). Ninety-three percent (139/150) were identified to be immunocompromised during their antineoplastic therapy. No difference in TPC-related infections was seen in patients with an immunocompromised (9%, 12/139) versus immunocompetent status (9%, 1/11); p = 0.614. The presence of a catheter-related infection did not negatively impact overall survival over a median follow-up of 144 days (interquartile range 41-341); p = 0.740. CONCLUSIONS: These results suggest that antineoplastic therapy may not significantly increase the overall risk of TPC-related infections, as the rate remains low and comparable to rates in patients not undergoing antineoplastic therapy. Regardless of immune status, the presence of a catheter-related infection did not negatively impact overall survival. These results should reassure clinicians that the need to initiate antineoplastic therapy should not delay definitive pleural palliation with a TPC.

Laparoscopic Hill repair: 25-year follow-up.

BACKGROUND: The open Hill repair for gastroesophageal reflux disease and hiatal hernia is remarkably durable, with a median 10-year reoperation rate of only 3% and satisfaction of 93%. No long-term data exist for the laparoscopic Hill repair (LHR). METHODS: Patients who underwent primary LHR at Swedish Medical Center for reflux and/or hiatal hernia at least 5 years earlier (1992-2010) were identified from an IRB-approved database. There were 727 patients who met inclusion criteria, including 648 undergoing repair for reflux and 79 for paraesophageal hernia. Two questionnaires were administered via mail to evaluate long-term quality of life using validated GERD-HRQL, Swallowing score, and global satisfaction score. Outcomes were defined by GERD-HRQL score, Swallowing score, resumption of proton pump inhibitor (PPI) therapy, need for reoperation, and global satisfaction with overall results. RESULTS: Two hundred forty-two patients completed and returned the survey (226 lost to follow-up, 90 deceased, 3 denied undergoing LHR, 166 non-responders), of which 52% were male. The average age at the time of surgery was 49.5 years. Median follow-up was 18.5 years (range 6.2-24.7). The average GERD-HRQL score (7.1) and the average Swallowing score (39.9) both indicated excellent symptomatic outcomes. 30% of patients are using daily PPIs. 24 patients (9.9%) required reoperation for failure during the follow-up period, 21 in the reflux group and 3 in the paraesophageal hernia group. Overall, 85% reported good to excellent results, and 76% would recommend the operation. CONCLUSION: LHR shows excellent long-term durability and quality of life similar to the open Hill repair, with 85% good to excellent results at a median follow-up of 19 years and a reoperation rate under 10%. It is surmised that Hill suture fixation of the gastroesophageal junction to the preaortic fascia may confer unique structural integrity compared to other repairs.

Factors influencing the outcome of magnetic sphincter augmentation for chronic gastroesophageal reflux disease.

OBJECTIVES: Magnetic sphincter augmentation (MSA) is a surgical treatment option for patients with gastroesophageal reflux disease (GERD). MSA consistently improves quality of life, maintains freedom from PPIs, and objectively controls GERD. However, up to 24% of patients did not achieve these outcomes. We sought to identify factors predicting outcomes after MSA placement with the aim of refining selection criteria. METHODS: We retrospectively analyzed clinical, endoscopic, manometric, pH data, and intraoperative factors from two databases: Pivotal Trial (N = 99) and our prospectively maintained esophageal database (N = 71). A priori outcomes were defined as excellent (GERD-HRQL <5, no PPI, no esophagitis), good (GERD-HRQL 6-15, no PPI, grade A esophagitis), fair (GERD-HRQL 16 to 25, PPI use, grade B esophagitis), and poor (GERD-HRQL >25, PPI use, grade C/D esophagitis). Univariable and multivariable logistic regression analyses were performed to determine predictors of achieving an excellent/good outcome. RESULTS: A total of 170 patients underwent MSA with a median age of 53 years, [43-60] and a median BMI of 27 (IQR = 24-30). At baseline, 93.5% of patients experienced typical symptoms and 69% atypical symptoms. Median DeMeester score was 37.9 (IQR 27.9-51.2) with a structurally intact sphincter in 47%. Esophagitis occurred in 43%. At 48 [19-60] months after MSA, excellent outcomes were achieved in 47%, good in 28%, fair in 22%, and poor in 3%. Median DeMeester score was 15.6 (IQR = 5.8-26.6), esophagitis in 17.6% and daily PPI use in 17%. At univariable analysis, excellent/good outcomes were negatively impacted by BMI, preoperative LES residual pressure, Hill grade, and hiatal hernia. At multivariable analysis, BMI >35 (OR = 0.05, 0.003-0.78, p = 0.03), structurally defective LES (OR = 0.37, 0.13-0.99, p = 0.05), and preoperative LES residual pressure (OR = 0.89, 0.80-0.98, p = 0.02) were independent negative predictors of excellent/good outcome. CONCLUSIONS: Magnetic sphincter augmentation results in excellent/good outcomes in most patients but a higher BMI, structurally defective sphincter, and elevated LES residual pressure may prevent this goal.

Manometric Changes to the Lower Esophageal Sphincter After Magnetic Sphincter Augmentation in Patients With Chronic Gastroesophageal Reflux Disease.

OBJECTIVE: To evaluate the manometric changes, function, and impact of magnetic sphincter augmentation (MSA) on the lower esophageal sphincter (LES). BACKGROUND: Implantation of a MSA around the gastroesophageal junction has been shown to be a safe and effective therapy for gastroesophageal reflux disease, but its effect on the LES has not been elucidated. METHODS: Retrospective case control study (n = 121) evaluating manometric changes after MSA. Inclusion criteria consisted of a confirmed diagnosis of gastroesophageal reflux disease by an abnormal esophageal pH study (body mass index <35 kg/m, hiatal hernia <3 cm, and absence of endoscopic Barrett disease). Manometric changes, pH testing, and proton pump inhibitor use were assessed preoperatively and 6 and 12 months after MSA. RESULTS: MSA was associated with an overall increase in the median LES resting pressure (18 pre-MSA vs 23 mm Hg post-MSA; P = 0.0003), residual pressure (4 vs 9 mm Hg; P < 0.0001), and distal esophageal contraction amplitude (80 vs 90 mm Hg; P = 0.02). The percent peristalsis remained unaltered (94% vs 87%; P = 0.71).Overall, patients with a manometrically defective LES were restored 67% of the time to a normal sphincter with MSA. Those with a structurally defective or severely defective LES improved to a normal LES in 77% and 56% of patients, respectively. Only 18% of patients with a normal preoperative manometric LES deteriorated to a lower category. CONCLUSION: MSA results in significant manometric improvement of the LES without apparent deleterious effects on the esophageal body. A manometrically defective LES can be restored to normal sphincter, whereas a normal LES remains stable.

A combined thoracoscopic and laparoscopic approach for high epiphrenic diverticula and the importance of complete myotomy.

BACKGROUND: The traditional approach to epiphrenic diverticula is thoracotomy and diverticulectomy, together with myotomy ± partial fundoplication to address underlying dysmotility. A laparoscopic approach has been advocated but access to more proximal diverticula is problematic. We propose the selective addition of a thoracoscopic approach to overcome these challenges and reviewed our results. METHODS: A retrospective review from 2004 to 2015 identified 17 patients with an epiphrenic diverticulum who underwent surgery. Patients were grouped according to height of the diverticular neck (HDN) above the GEJ: group A < 5 cm, group B > 5 cm. Preoperative evaluation and type of surgery performed were recorded. Postoperative complications, mortality, and clinical outcomes using quality of life metrics and objective testing were assessed. RESULTS: The mean size of the diverticulum was 3.3 cm (2-6 cm) with a mean height above the GEJ of 5.5 cm (0-12 cm). A motility disorder was identified in 15/17. Group A, 9 patients, underwent laparoscopic diverticulectomy, myotomy, and partial fundoplication. For group B, 8 patients, the intended procedure was thoracoscopic diverticulectomy followed by laparoscopic myotomy and partial fundoplication, but this was only completed in 5. In 3 the myotomy was aborted or incomplete with subsequent staple line leaks resulting in 1 death. At a mean follow-up of 21 months, improvement of median QOLRAD scores from 3.42 to 6.2 (p = 0.18); GERD-HRQL from 23 to 1 (p = 0.05), swallowing score from 17.5 to 30 (p = 0.22), and Eckardt scores from 5 to 0 (p < 0.05) were observed. CONCLUSIONS: A minimally invasive strategy for epiphrenic diverticula based HDN above the GEJ and selective thoracoscopy for higher diverticula is feasible and appropriate, and resulted in improved quality of life. Incomplete myotomy was associated with a substantially higher complication rate. Laparoscopic myotomy should precede diverticulectomy for all cases, especially for high diverticula.

Impact of prior interventions on outcomes during per oral endoscopic myotomy.

BACKGROUND: Per oral endoscopic myotomy (POEM) is performed by accessing the submucosal space of the esophagus. This space may be impacted by prior interventions such as submucosal injections, dilations or previous myotomies. These interventions could make POEM more difficult and may deter surgeons during their initial experience. We sought to determine the impact of prior interventions on our early experience. METHODS: Prospective, single-center study of consecutive patients undergoing POEM. Patients were grouped according to their anticipated complexity: Group A: no prior interventions (N = 19); Group B: prior interventions such as submucosal injections and/or dilations (N = 11) and  Group C: sigmoidal esophagus, prior esophageal surgery, balloon dilation >30 mm (N = 8). We compared operative times, inadvertent mucosotomy rates, complications and short-term outcomes between groups. RESULTS: A total of 38 patients underwent POEM for achalasia subtypes: I (N = 9), II (N = 19) and III (N = 7). Three had other dysmotility disorders. Patients between the groups were similar. Operative times were similar between Group A and Group B but significantly longer for Group C (133 vs. 132 vs. 210 min, p = 0.001). Mucosotomy rates were highest in Group A (6/19) with 1 each in Group B/C (p = 0.46). One patient in Group A required an esophageal stent. Eckardt scores improved in all groups (6-1; 8-2; 6-0.5, p = 0.73), and postoperative GERD-HRQL scores were similar. One patient underwent laparoscopic myotomy for persistent symptoms with no improvement, and one patient underwent esophagectomy for a sigmoid esophagus and persistent symptoms despite adequate myotomy. CONCLUSION: A prior intervention does not seem to impact short-term clinical outcomes with POEM. Patients who had submucosal injections or small caliber dilations are similar to patients with no prior inventions; however, patients with a sigmoid-shaped esophagus and/or a prior myotomy require nearly double the operative time. Endoscopists undertaking POEM should consider these during their learning curve.