Publications by authors named "Blair A Jobe"

132 Publications

Acquired Morgagni hernia following coronary artery bypass graft (CABG) with successful robotic repair of hernia.

Int J Surg Case Rep 2022 May 4;94:107164. Epub 2022 May 4.

Esophageal Institute, Department of Surgery, Allegheny Health Network, Pittsburgh, PA, United States; Department of Surgery, Drexel University, Philadelphia, PA, United States.

Introduction And Importance: Morgagni hernia is an uncommon type of diaphragmatic hernia and commonly presents as a congenital disease. Acquired Morgagni hernias following open cardiac surgery are exceedingly rare and only reported in the pediatric population.

Case Presentation: The patient is a 70-year-old female who presented with complaints of shortness of breath and cough one year following a coronary artery bypass graft (CABG). A chest CT scan showed a large Morgagni type diaphragmatic hernia with herniated transverse colon occupying the anterior mediastinum as well as the right hemi-thorax. This hernia was successfully repaired using transabdominal robotic approach with complete resolution of patient's symptoms.

Clinical Discussion: This is the first reported case of acquired Morgagni type diaphragmatic hernia in an adult following open cardiac surgery. The potential etiologies for this hernia include distal extension of the median sternotomy and involvement of the anterior diaphragm, iatrogenic injury to the attenuated anterior diaphragm during pericardial window creation, or pericardial drain placement. Operative repair is the mainstay of treatment and is usually performed with a transabdominal approach since it is thought to be less challenging and allows for evaluation of the entire abdominal cavity. If primary repair cannot be achieved, then synthetic mesh may be needed to obtain a tension free and durable repair.

Conclusion: We present a case of acquired Morgagni type diaphragmatic hernia in an adult following open cardiac surgery that was successfully repaired using a transabdominal robotic approach.
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http://dx.doi.org/10.1016/j.ijscr.2022.107164DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9097635PMC
May 2022

Esophageal retention cyst: Esophagogastric junction outflow obstruction (EGJOO) as a potential etiology and management with endoscopic mucosal resection (EMR).

Int J Surg Case Rep 2022 Jun 11;95:107194. Epub 2022 May 11.

Esophageal Institute, Department of Surgery, Allegheny Health Network, Pittsburgh, PA, United States; Department of Surgery, Drexel University, Philadelphia, PA, United States.

Introduction And Importance: Esophageal retention cysts are acquired cysts with no known etiology. They are characterized by dilation of the submucosal glands. Symptomatic cysts are traditionally managed by surgical resection.

Case Presentation: We present a case of progressive dysphagia and chest pain secondary to esophageal retention cysts in the mid and distal esophagus with associated esophagogastric junction outflow obstruction (EGJOO) and jackhammer esophagus on high resolution manometry (HRM). The patient underwent staged endoscopic mucosal resection (EMR) with subsequent improvement in her symptoms. However, EGJOO persisted after resection, suggesting it was the primary pathology and not a consequence of the obstruction from the cysts.

Clinical Discussion: Esophageal retention cysts are rarely reported in the literature with most descriptions coming from incidental post-mortems. The presented case suggests EGJOO as a potential etiology of retention cysts. The proposed mechanism is that a significant rise in esophageal intraluminal pressure creates a state of stasis in the esophagus, ideal for the development of these cysts. Symptomatic or malignant retention cysts should be resected. We demonstrate the feasibility of EMR as an alternative to surgical resection.

Conclusion: Esophageal retention cyst is a rare entity, which may arise as a result of EGJOO. The natural history and malignant potential of these cysts are unknown, and no formal guidelines have been established for follow-up for patients with asymptomatic retention cysts. Endoscopic mucosal resection can be used to successfully manage these cysts.
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http://dx.doi.org/10.1016/j.ijscr.2022.107194DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9112123PMC
June 2022

CSF-1R inhibitor, pexidartinib, sensitizes esophageal adenocarcinoma to PD-1 immune checkpoint blockade in a rat model.

Carcinogenesis 2022 May 12. Epub 2022 May 12.

Allegheny Health Network, Allegheny Health Network Cancer Institute, Pittsburgh, PA, USA.

Esophageal adenocarcinoma (EAC) is a leading cause of cancer deaths. Pexidartinib, a multi-gene tyrosine kinase inhibitor, through targeting CSF-1R, down modulates macrophage mediated pro-survival tumor signaling. Previously, CSF-1R inhibitors have successfully shown to enhance antitumor activity of PD-1/PD-L1 inhibitors by suppressing tumor immune evasion, in solid tumors. In this study, we investigated the antitumor activity of pexidartinib alone or in combination with blockade of PD-1 in a de novo EAC rat model. Here, we showed limited toxicity with significant tumor shrinkage in pexidartinib treated animals compared to controls, single agent and in combination with a PD-1 inhibitor, AUNP-12. Suppression of CSF-1/CSF-1R axis resulted in enhanced infiltration of CD3+CD8+ T cells with reduced M2 macrophage polarization, in the tumor microenvironment (TME). Endpoint tissue gene expression in pexidartinib treated animals demonstrated upregulation of BAX, Cas3, TNFα, IFNγ and IL6 and downregulation of Ki67, IL13, IL10, TGFβ and Arg1 (p<0.05). Additionally, among the pexidartinib treated animals responders compared to non-responders demonstrated a significant upregulation of pre-treatment CSF-1 gene, confirming that tumor associated macrophage suppression directly translates to clinical benefit. Moreover, a post-treatment serum cytokine assay exhibited similar systemic trends as the gene expression in the TME, depicting increases in pro-inflammatory cytokines and decreases in anti-inflammatory cytokines. In conclusion, our study established a promising combinatorial strategy using a CSF-1R inhibitor to overcome resistance to PD-1/PD-L1 axis blockade in an EAC model, providing the rationale for future clinical strategies.
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http://dx.doi.org/10.1093/carcin/bgac043DOI Listing
May 2022

The Impact of Magnetic Sphincter Augmentation (MSA) on Esophagogastric Junction (EGJ) and Esophageal Body Physiology and Manometric Characteristics.

Ann Surg 2021 Oct 8. Epub 2021 Oct 8.

Esophageal Institute, Allegheny Health Network, Pittsburgh, PA Department of Surgery, Drexel University, Philadelphia, PA.

Objective: To evaluate the impact of MSA on lower esophageal sphincter (LES) and esophageal body using high resolution impedance manometry.

Background: MSA is an effective treatment in patients with gastroesophageal reflux disease, but there is limited data on its impact on esophageal functional physiology.

Methods: Patients who underwent MSA were approached 1-year after surgery for objective foregut testing consists of upper endoscopy, esophagram, high resolution impedance manometry, and esophageal pH-monitoring. Postoperative data were then compared to the preoperative measurements.

Results: A total of 100 patients were included in this study. At a mean follow up of 14.9(10.1) months, 72% had normalization of esophageal acid exposure. MSA resulted in an increase in mean LES resting pressure [29.3(12.9) vs 25(12.3), P < 0.001]. This was also true for LES overall length [2.9(0.6) vs 2.6(0.6), P = 0.02] and intra-abdominal length [1.2(0.7) vs 0.8(0.8), P < 0.001]. Outflow resistance at the EGJ increased after MSA as demonstrated by elevation in intrabolus pressure (19.6 vs 13.5 mmHg, P < 0.001) and integrated relaxation pressure (13.5 vs 7.2, P < 0.001). MSA was also associated with an increase in distal esophageal body contraction amplitude [103.8(45.4) vs 94.1(39.1), P = 0.015] and distal contractile integral [2647.1(2064.4) vs 2099.7(1656.1), P < 0.001]. The percent peristalsis and incomplete bolus clearance remained unchanged (P = 0.47 and 0.08, respectively).

Conclusions: MSA results in improvement in the LES manometric characteristics. Although the device results in an increased outflow resistance at the EGJ, the compensatory increase in the force of esophageal contraction will result in unaltered esophageal peristaltic progression and bolus clearance.
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http://dx.doi.org/10.1097/SLA.0000000000005239DOI Listing
October 2021

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

Ann Surg 2022 Jan 25. Epub 2022 Jan 25.

Swedish Cancer Institute, Seattle Washington Institute of Esophageal and Reflux Surgery, Englewood, CO University of Milano, IRCCS Policlinico San Donato, Milan, Italy Esophageal and Lung Institute, Canonsburg, PA Medical University of Vienna, Vienna, Austria University of Southern California, Los Angeles, CA The Oregon Clinic, Portland, OR.

Objective: To evaluate and characterize outcomes of magnetic sphincter augmentation (MSA) in patients with ineffective esophageal motility (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-HRQL was similar; DeMeester scores in IEM patients improved to 15.7 and to 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, while 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.
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http://dx.doi.org/10.1097/SLA.0000000000005369DOI Listing
January 2022

Agrin Loss in Barrett's Esophagus-Related Neoplasia and Its Utility as a Diagnostic and Predictive Biomarker.

Clin Cancer Res 2022 03;28(6):1167-1179

David H. Koch Institute for Integrative Cancer Research, Massachusetts Institute of Technology, Cambridge, Massachusetts.

Purpose: There is an unmet need for identifying novel biomarkers in Barrett's esophagus that could stratify patients with regards to neoplastic progression. We investigate the expression patterns of extracellular matrix (ECM) molecules in Barrett's esophagus and Barrett's esophagus-related neoplasia, and assess their value as biomarkers for the diagnosis of Barrett's esophagus-related neoplasia and to predict neoplastic progression.

Experimental Design: Gene-expression analyses of ECM matrisome gene sets were performed using publicly available data on human Barrett's esophagus, Barrett's esophagus-related dysplasia, esophageal adenocarcinoma (ADCA) and normal esophagus. Immunohistochemical expression of basement membrane (BM) marker agrin (AGRN) and p53 was analyzed in biopsies of Barrett's esophagus-related neoplasia from 321 patients in three independent cohorts.

Results: Differential gene-expression analysis revealed significant enrichment of ECM matrisome gene sets in dysplastic Barrett's esophagus and ADCA compared with controls. Loss of BM AGRN expression was observed in both Barrett's esophagus-related dysplasia and ADCA. The mean AGRN loss in Barrett's esophagus glands was significantly higher in Barrett's esophagus-related dysplasia and ADCA compared with non-dysplastic Barrett's esophagus (NDBE; P < 0.001; specificity = 82.2% and sensitivity = 96.4%). Loss of AGRN was significantly higher in NDBE samples from progressors compared with non-progressors (P < 0.001) and identified patients who progressed to advanced neoplasia with a specificity of 80.2% and sensitivity of 54.8%. Moreover, the combination of AGRN loss and abnormal p53 staining identified progression to Barrett's esophagus-related advanced neoplasia with a specificity and sensitivity of 86.5% and 58.7%.

Conclusions: We highlight ECM changes during Barrett's esophagus progression to neoplasia. BM AGRN loss is a novel diagnostic biomarker that can identify patients with NDBE at increased risk of developing advanced neoplasia.
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http://dx.doi.org/10.1158/1078-0432.CCR-21-2822DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8923984PMC
March 2022

Normative Ambulatory Reflux Monitoring Metrics for Laryngopharyngeal Reflux: A Systematic Review of 720 Healthy Individuals.

Otolaryngol Head Neck Surg 2022 05 27;166(5):802-819. Epub 2021 Jul 27.

Department of Otorhinolaryngology-Head & Neck Surgery, Medical College of Wisconsin, Milwaukee, Wisconsin, USA.

Objectives: To review the normative data for acid, weakly acid, and nonacid proximal esophageal (PRE) and hypopharyngeal reflux (HRE) events in diagnosing laryngopharyngeal reflux (LPR) using ambulatory reflux monitoring.

Data Sources: PubMed, Cochrane Library, and Scopus.

Review Methods: A literature search was conducted about the normative data for PRE and HRE on multichannel intraluminal impedance-pH monitoring (MII-pH), hypopharyngeal-esophageal MII-pH (HEMII-pH), or oropharyngeal pH monitoring using PICOTS (population, intervention, comparison, outcome, timing, and setting) and PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) statements. Outcomes reviewed included device characteristics, impedance/pH sensor placements, study duration, number/average and percentiles of PRE or HRE occurrence, and the event characteristics (pH, composition, and position).

Results: Of 154 identified studies, 18 met criteria for analysis, including 720 healthy individuals. HEMII-pH, MII-pH, and oropharyngeal pH monitoring were used in 7, 6, and 5 studies, respectively. The definition and inclusion/exclusion criteria of healthy individuals varied substantially across studies, with 6 studies considering only digestive symptoms to exclude potential LPR patients. Substantial heterogeneity across studies was noted, including impedance/pH sensor placements/configurations and definitions of composition (liquid, gas, mixed) and type (acid, weakly acid, nonacid) of PRE/HRE. The 95th percentile thresholds were 10 to 73 events for PRE, 0 to 10 events for HRE on HEMII-pH, and 40 to 128 for events with pH <6.0 on oropharyngeal pH monitoring. Most HREs were nonacid and occurred upright. The mean HRE among healthy individuals was 1.

Conclusion: The low number of studies and the heterogeneity in inclusion criteria, definitions, and characterization of PRE and HRE limit the establishment of consensual normative criteria for LPR on ambulatory reflux monitoring. Future large multicenter studies are needed.
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http://dx.doi.org/10.1177/01945998211029831DOI Listing
May 2022

Multifactorial dysphagia: Azygos vein aneurysm (AVA) and esophagogastric junction outflow obstruction (EGJOO).

Int J Surg Case Rep 2021 Jun 26;83:106017. Epub 2021 May 26.

Esophageal Institute, Department of Surgery, Allegheny Health Network, Pittsburgh, PA, United States of America.

Introduction: Vascular impingement of the esophagus is a rare cause of dysphagia, and is most commonly due to aortic arch anomalies such as arterial lusoria. Dysphagia resultant from venous compression is even further less likely.

Presentation Of Case: We present a highly unusual case of dysphagia secondary to a large aneurysm of the azygous vein near its confluence with the superior vena cava, which was managed with endovascular modalities. Despite initial treatment success, patient reported some intermittent solid food dysphagia, and was also found to have esophagogastric junction outflow obstruction (EGJOO) on high resolution impedance manometry (HRIM) which was successfully managed with surgical myotomy and partial fundoplication.

Discussion: The azygos vein has an intimate anatomic relationship with the esophagus as it traverses the posterior mediastinum. Because of this anatomic association, the azygos vein may present a point of esophageal obstruction in the setting of significant pathology.

Conclusion: This case highlights the possibility of multifactorial causes of dysphagia, and that HRIM is a key aspect of this workup. Additionally we discuss the pertinent anatomy, diagnosis, and treatments for azygos vein aneurysm and EGJOO.
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http://dx.doi.org/10.1016/j.ijscr.2021.106017DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8188362PMC
June 2021

Swallow-induced syncope after magnetic sphincter augmentation: a case report and physiologic explanation.

Clin J Gastroenterol 2021 Oct 29;14(5):1318-1323. Epub 2021 May 29.

Esophageal Institute, Allegheny Health Network, 4815 Liberty Avenue, Suite 439, Pittsburgh, PA, 15224, USA.

Swallow-induced syncope is a rare cause of syncope that occurs during or immediately after swallowing. This phenomenon has been reported in association with few esophageal pathologies and the likely explanation is a vagal reflex during deglutition that results in inhibition of the cardiac conduction system. This report describes a case of swallow-induced syncope related to the implantation of a magnetic sphincter augmenting (MSA) device. Two episodes of syncope after food bolus occurred with the device in place and upon removal of the device, the patient had no further episodes of syncope. Vagal stimulation from distention of the esophagus or vagus nerve contact irritation by the implant are the potential explanation for syncope in this patient. Although this is an extremely rare complication of magnetic sphincter device augmentation, it is one that physicians should be cognizant of given the dangers of syncope events.
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http://dx.doi.org/10.1007/s12328-021-01448-wDOI Listing
October 2021

Gastric remnant mesentero-axial volvulus following Roux-en-Y esophagojejunostomy: A rare complication.

Int J Surg Case Rep 2021 May 7;82:105873. Epub 2021 Apr 7.

Esophageal Institute, Allegheny Health Network, Pittsburgh, PA, United States. Electronic address:

Introduction: Acute gastric volvulus is a surgical emergency with a mortality as high as 15-20%. The rarity of gastric volvulus requires high index of clinical suspicion especially in the patients with altered anatomy, to allow immediate surgical intervention and reduce the morbidity and mortality.

Presentation Of Case: We present an unusual case of gastric remnant volvulus several months following Roux-en-Y esophagojejunostomy performed in an obese patient for severe, recurrent gastroesophageal reflux disease (GERD) and failed prior fundoplication. The patient was treated with gastropexy and Stamm gastrostomy tube.

Discussion: Gastric volvulus is a rare phenomenon, in which the stomach rotates around the short (mesentero-axial) or longitudinal (organo-axial) axes. Diagnosis of gastric volvulus is challenging due to non-specific presentation and rarity of this clinical condition. The diagnosis of volvulus in patients with altered anatomy is even more challenging, requiring a high index of suspicion, and heavily relies on cross sectional imaging.

Conclusion: Extensive gastric mobilization is a key step in several foregut and bariatric surgeries, this will leave the stomach with no attachments posteriorly and along the greater curvature and increases the likelihood of volvulus.
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http://dx.doi.org/10.1016/j.ijscr.2021.105873DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8079269PMC
May 2021

Intratumoral immunotherapy with STING agonist, ADU-S100, induces CD8+ T-cell mediated anti-tumor immunity in an esophageal adenocarcinoma model.

Oncotarget 2021 Feb 16;12(4):292-303. Epub 2021 Feb 16.

Esophageal and Lung Institute, Allegheny Health Network, Pittsburgh, PA, USA.

Background: Esophageal adenocarcinoma (EAC) is a deadly disease with limited treatment options. STING is a transmembrane protein that activates transcription of interferon genes, resulting in stimulation of APCs and enhanced CD8+ T-cell infiltration. The present study evaluates STING agonists, alone and in combination with radiation to determine durable anticancer activity in solid tumors.

Materials And Methods: Esophagojejunostomy was performed on rats to induce reflux leading to the development of EAC. At 32 weeks post operatively, rats received intratumorally either 50 μg STING (ADU-S100) or placebo (PBS), +/- 16Gy radiation. Drug activity was evaluated by pre- and post- treatment MRI, histology, immunofluorescence and RT-PCR.

Results: Mean MRI tumor volume decreased by 30.1% and 50.8% in ADU-S100 and ADU-S100 + radiation animals and increased by 76.7% and 152.4% in placebo and placebo + radiation animals, respectively ( < 0.0001). Downstream gene expression, pre- to on- and post- treatment, demonstrated significant upregulation of IFNβ, TNFα, IL-6, and CCL-2 in the treatment groups vs. placebo. On- or post- treatment, radiation alone, ADU-S100 alone, and ADU-S100 + radiation groups demonstrated enhanced PD-LI expression, induced by upregulation of CD8+ T-cells ( < 0.01).

Conclusions: ADU-S100 +/- radiation exhibits potent antitumor activity and a promising immunomodulatory profile in a EAC.
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http://dx.doi.org/10.18632/oncotarget.27886DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7899550PMC
February 2021

Pneumothorax as the presenting manifestation of COVID-19.

J Thorac Dis 2020 Dec;12(12):7488-7493

Esophageal and Lung Institute, Department of Surgery, Allegheny Health Network, Pittsburgh, PA, USA.

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http://dx.doi.org/10.21037/jtd-20-1687DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7797865PMC
December 2020

Efficacy of Magnetic Sphincter Augmentation Across the Spectrum of GERD Disease Severity.

J Am Coll Surg 2021 03 30;232(3):288-297. Epub 2020 Dec 30.

Esophageal Institute, Allegheny Health Network, Pittsburgh, PA.

Background: The performance and durability of various types of fundoplication are variable when stratified by disease severity. To date, magnetic sphincter augmentation (MSA) has not been evaluated in this context. We designed this study to determine the efficacy of MSA in the treatment of severe GERD.

Study Design: Guided by previous studies, a DeMeester score (DMS) ≥ 50 was used as a cutoff point to define severe reflux disease. Subjects were divided into 2 groups using this cutoff, and outcomes of severe cases were compared with those with less severe disease (DMS < 50).

Results: A total of 334 patients underwent MSA. Patients with severe disease had a higher mean preoperative DMS compared with those with mild to moderate GERD (79.2 [53.2] vs 22.8 [13.7], p < 0.0001). At a mean postoperative follow-up of 13.6 (10.4) months, there was no difference between the mean GERD Health-Related Quality of Life (HRQL) total scores in patients with severe disease compared with those with less severe GERD (8.8 [10] vs 9.2 [10.8], p = 0.9204). Postoperative mean DMS was not different between groups (17.3[23.0] vs 14.1[33.9], p = 0.71), and there was no difference in the prevalence of esophagitis (p = 0.52). Patients with severe disease were less likely to be free from use of proton pump inhibitors after surgery (85% vs 93.1%, p = 0.041). There were similar rates of postoperative dysphagia (10% vs 14%, p = 0.42) and need for device removal (3% vs 5%, p = 0.7463).

Conclusions: MSA is an effective treatment in patients with severe GERD and leads to significant clinical improvement across the spectrum of disease severity, with few objective outcomes being superior in patients with mild-to-moderate reflux disease.
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http://dx.doi.org/10.1016/j.jamcollsurg.2020.11.012DOI Listing
March 2021

Measurement of outflow resistance imposed by magnetic sphincter augmentation: defining normal values and clinical implication.

Surg Endosc 2021 10 13;35(10):5787-5795. Epub 2020 Oct 13.

Esophageal Institute, Allegheny Health Network, 4815 Liberty Avenue, Suite 439, Pittsburgh, PA, 15224, USA.

Introduction: No manometric criteria have been defined to select patients for magnetic sphincter augmentation (MSA). The first step to establish such criteria is to measure the outflow resistance at esophagogastric junction (EGJ) imposed by MSA. This resistance needs to be overcome by the esophageal contraction in order for the esophagus to empty and to avoid postoperative dysphagia. This study was designed to measure the outflow resistance caused by MSA in patients free of postoperative dysphagia.

Methods: Records of the patients who underwent MSA in our institution were reviewed. A group of MSA patients with excellent functional outcome, who were free of clinically significant postoperative dysphagia, were selected. These patients then underwent high-resolution impedance manometry (HRIM) at a target date of 1 year after surgery. The outflow resistance was measured by the esophageal intrabolus pressure (iBP) recorded 2 cm proximal to the lower esophageal sphincter (LES).

Results: The study population consisted of 43 patients. HRIM was performed at mean of 20.4 (10.4) months after surgery. The mean (SD) amplitude of the iBP was 13.5 (4.3) before surgery and increased to 19.1 (5.6) after MSA (p < 0.0001). Patients with a smaller size LINX device (≤ 14 beads) had a similar iBP when compared to those with a larger device (> 15 beads) [19.7 (4.5) vs. 18.4 (5.9), p = 0.35]. There was a significant correlation between the iBP and % incomplete bolus clearance [Spearman R: 0.44 (95% CI 0.15-0.66), p = 0.0032]. The 95th percentile value for iBP after MSA was 30.4 mmHg.

Conclusion: The EGJ outflow resistance measured by iBP is increased after MSA. The upper limit of normal for iBP is 30 mmHg in this cohort of patients who were free of dysphagia after MSA. This degree of resistance needs to be overcome by distal esophageal contraction and will likely be requisite to prevent persistent postoperative dysphagia.
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http://dx.doi.org/10.1007/s00464-020-08068-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8437925PMC
October 2021

Esophagitis dissecans superficialis (EDS) secondary to esophagogastric junction outflow obstruction (EGJOO): a case report and literature review.

Clin J Gastroenterol 2021 Feb 1;14(1):26-31. Epub 2020 Oct 1.

Esophageal Institute, Allegheny Health Network, 4815 Liberty Avenue, Suite 439, Pittsburgh, PA, 15224, USA.

Esophageal dissecans superficialis (EDS) is a rare disease with endoscopic findings of sloughing squamous tissue with underlying normal mucosa and had no known cause. The literature does support possible causality between the presence of an esophageal stricture and EDS however there has been no association to date between EDS and esophagogastric junction outflow obstruction (EGJOO). We present a case of newly diagnosed EGJOO in a patient with long standing gastroesophageal reflux disease who presented with dysphagia. Evaluation identified endoscopically normal mucosa and a diagnosis of esophagogastric junction outflow obstruction on high resolution impedance manometry. A month later, repeat endoscopy identified diffusely sloughing mucosa consistent with EDS. Endoscopic dilation followed by a robotic Heller myotomy with Dor fundoplication to relive the outflow obstruction resulted in resolution of EDS in this case.
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http://dx.doi.org/10.1007/s12328-020-01247-9DOI Listing
February 2021

Esophageal Squamous Cell Carcinoma After Radiofrequency Catheter Ablation Thermal Injury.

Ann Thorac Surg 2021 03 24;111(3):e185-e187. Epub 2020 Aug 24.

Esophageal and Lung Institute, Allegheny Health Network, Pittsburgh, Pennsylvania. Electronic address:

Radiofrequency ablation is a common treatment for atrial fibrillation, and esophageal complications are exceedingly rare. This report describes the case of a patient with no other known cancer risk factors who had esophageal squamous cell carcinoma that developed at the site of esophageal thermal injury, which occurred during a radiofrequency catheter ablation procedure.
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http://dx.doi.org/10.1016/j.athoracsur.2020.06.050DOI Listing
March 2021

COVID-19 outbreak and surgical practice: The rationale for suspending non-urgent surgeries and role of testing modalities.

World J Gastrointest Surg 2020 Jun;12(6):259-268

Esophageal and Lung Institute, Department of Surgery, Allegheny Health Network, Pittsburgh, PA 15224, United States.

One-hundred years after the 1918-19 H1N1 flu pandemic and 10 years after the 2009 H1N1 flu pandemic, another respiratory virus has now inserted itself into the human population. Severe acute respiratory syndrome coronavirus has become a critical challenge to global health with immense economic and social disruption. In this article we review salient aspects of the coronavirus disease 2019 (COVID-19) outbreak that are relevant to surgical practice. The emphasis is on considerations during the pre-operative and post-operative periods as well as the utility and limitations of COVID-19 testing. The focus of the media during this pandemic is centered on predictive epidemiologic curves and models. While epidemiologists and infectious disease physicians are at the forefront in the fight against COVID-19, this pandemic is also a "stress test" to evaluate the capacity and resilience of our surgical community in dealing with the challenges imposed to our health system and society. As recently pointed out by Dr. Anthony Fauci, the virus decides the timelines in the models. However, the models can also change based on our decisions and behavior. It is our role as surgeons, to make every effort to bend the curves against the virus' will.
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http://dx.doi.org/10.4240/wjgs.v12.i6.259DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7385513PMC
June 2020

COVID-19 outbreak and endoscopy: Considerations in patients encountered in a foregut surgery practice.

World J Gastrointest Surg 2020 May;12(5):197-202

Esophageal and Lung Institute, Department of Surgery, Allegheny Health Network, Pittsburgh, PA 15224, United States.

Severe acute respiratory syndrome coronavirus has become a critical challenge to global health. Since the arrival of coronavirus disease 2019 in the United States, several government agencies and professional societies have issued guidelines to healthcare systems and medical providers. Endoscopy is a substantial portion of the practice of many general surgeons in the United States. With upper endoscopy, manipulation of the upper aerodigestive tract can turn the droplets to an aerosolized form and increase the likelihood of transmission and therefore is considered a high-risk procedure. In this article we review some aspects of the coronavirus disease 2019 outbreak that are relevant to practice of surgical endoscopy. The emphasis of this communication is on the mode of transmission, previous experiences during other coronavirus outbreaks and society guidelines. We then highlight the changes that we have made to our practice to incorporate these factors to improve the safety of patients, health care providers, and community as a whole.
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http://dx.doi.org/10.4240/wjgs.v12.i5.197DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7289649PMC
May 2020

Development of pseudoachalasia following magnetic sphincter augmentation (MSA) with restoration of peristalsis after endoscopic dilation.

Clin J Gastroenterol 2020 Oct 29;13(5):697-702. Epub 2020 May 29.

Esophageal and Lung Institute, Allegheny Health Network, 4815 Liberty Avenue, Suite 439, Pittsburgh, PA, 15224, USA.

Pseudoachalasia is mimicking clinical and physiologic manifestations of idiopathic achalasia but results from alternative etiologies that infiltrate or obstruct the esophagogastric junction (EGJ). Anti-reflux surgery is one of the potential etiologies of pseudoachalasia. The majority of cases with persistent dysphagia after a tightly constructed Nissen fundoplication results from EGJ outlet obstruction (EGJOO) and in rare cases progresses to pseudoachalasia. In these extreme cases, endoscopic dilation is not a sufficient treatment and take down of fundoplication would be necessary. In this case report, we present a patient with long-standing GERD symptoms that underwent magnetic sphincter augmentation (MSA) with complete resolution of his reflux symptoms. He did not have dysphagia prior to surgery and his preoperative manometry showed normal peristaltic progression of esophageal contractions. He developed pseudoachalasia 14 months after surgery. Repeated endoscopic dilation in this case resulted in resolution of dysphagia and complete restoration of peristaltic contractions.
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http://dx.doi.org/10.1007/s12328-020-01140-5DOI Listing
October 2020

Clinical Outcomes and Predictors of Favorable Result after Laparoscopic Magnetic Sphincter Augmentation: Single-Institution Experience with More than 500 Patients.

J Am Coll Surg 2020 05 17;230(5):733-743. Epub 2020 Feb 17.

Esophageal and Lung Institute, Allegheny Health Network, Pittsburgh, PA. Electronic address:

Background: Magnetic sphincter augmentation (MSA) is a promising surgical treatment for patients with GERD. The aim of this study was to evaluate the outcomes of MSA in a large cohort of patients with GERD and to determine the factors predicting a favorable outcome.

Methods: This was a retrospective review of prospectively collected data of 553 patients who underwent MSA at our institution in a 5-year period. Preoperative clinical, endoscopic, manometric, and pH data were used in a univariate analysis. This was followed by a regression multivariable analysis to determine the factors predicting a favorable outcome. Favorable outcome was defined as freedom from proton pump inhibitors and ≥50% improvement in Gastroesophageal Reflux Disease-Health-Related Quality of Life (GERD-HRQL) total score.

Results: At a mean (SD) follow-up of 10.3 (10.6) months after MSA, 92.7% of the patients were free of proton pump inhibitor use and 84% reported at least 50% improvement in their GERD-HRQL total score. The GERD-HRQL total score was improved from a mean (SD) baseline value of 33.8 (18.7) to 7.2 (9.0) (p < 0.001) and 76.1% of the patients had normalization of their esophageal acid exposure. Independent predictors of a favorable outcome after MSA included age younger than 45 years (odds ratio [OR] 4.2; 95% CI, 1.1 to 15.2; p = 0.0305), male sex (OR 2.5; 95% CI, 1.1 to 5.7; p = 0.0301), GERD-HRQL total score >15 (OR 7.5; 95% CI, 3.3 to 16.8; p < 0.0001), and abnormal DeMeester score (OR, 2.6; 95% CI, 1.1 to 5.7; p = 0.0225).

Conclusions: In this largest single-institution series, we demonstrate that MSA implantation is associated with very good clinical and objective outcomes. Age younger than 45 years, male sex, GERD-HRQL total score >15, and abnormal DeMeester score are the 4 preoperative factors predicting a favorable outcome and can be used in patient counseling and MSA use.
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http://dx.doi.org/10.1016/j.jamcollsurg.2020.01.026DOI Listing
May 2020

Magnetic Sphincter Augmentation and Postoperative Dysphagia: Characterization, Clinical Risk Factors, and Management.

J Gastrointest Surg 2020 01 6;24(1):39-49. Epub 2019 Aug 6.

Esophageal and Lung Institute, Allegheny Health Network, 4815 Liberty Avenue, Suite 439, Pittsburgh, PA, 15224, USA.

Introduction: Magnetic sphincter augmentation (MSA) results in less severe side effects compared with Nissen fundoplication, but dysphagia remains the most common side effect reported by patients after MSA. This study aimed to characterize and review the management of postoperative dysphagia and identify the preoperative factors that predict persistent dysphagia after MSA.

Material And Methods: This is a retrospective review of prospectively collected data of patients who underwent MSA between 2013 and 2018. Preoperative objective evaluation included upper endoscopy, esophagram, high-resolution impedance manometry (HRIM), and esophageal pH testing. Postoperative persistent dysphagia was defined as a postoperative score of > 3 for the dysphagia-specific item within the GERD-HRQL at a minimum of 3 months following MSA. A timeline of dysphagia and dilation rates was constructed and correlated with the evolution of our patient management practices and modifications in surgical technique.

Results: A total of 380 patients underwent MSA, at a mean (SD) follow up of 11.5 (8.7) months, 59 (15.5%) patients were experiencing persistent dysphagia. Thirty-one percent of patients required at least one dilation for dysphagia or chest pain and the overall response rate to this procedure was 67%, 7 (1.8%) patients required device removal specifically for dysphagia. Independent predictors of persistent dysphagia based on logistic regression model included (1) absence of a large hernia (OR 2.86 (95% CI 1.08-7.57, p = 0.035)); (2) the presence of preoperative dysphagia (OR 2.19 (95% CI 1.05-4.58, p = 0.037)); and (3) having less than 80% peristaltic contractions on HRIM (OR 2.50 (95% CI 1.09-5.73, p = 0.031)). Graded cutoffs of distal contractile integral (DCI), mean wave amplitude, DeMeester score, sex, and body mass index were evaluated within the model and did not predict postoperative dysphagia. Frequent eating after surgery, avoidance of early dilation, and increase in the size of the LINX device selected decreased the need for dilation.

Conclusion: In a large cohort of patients who underwent MSA, we report 15.5% rate of persistent postoperative dysphagia. The overall response rate to dilation therapy is 67%, and the efficacy of dilation with each subsequent procedure reduces. Patients with normal hiatal anatomy, significant preoperative dysphagia, and less than 80% peristaltic contractions of the smooth muscle portion of the esophagus should be counseled that they have an increased risk for persistent postoperative dysphagia.
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http://dx.doi.org/10.1007/s11605-019-04331-9DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6987054PMC
January 2020

Comparison of surgical payer costs and implication on the healthcare expenses between laparoscopic magnetic sphincter augmentation (MSA) and laparoscopic Nissen fundoplication (LNF) in a large healthcare system.

Surg Endosc 2020 05 2;34(5):2279-2286. Epub 2019 Aug 2.

Esophageal and Lung Institute, Allegheny Health Network, 4815 Liberty Avenue, Suite 439, Pittsburgh, PA, 15224, USA.

Introduction: Magnetic sphincter augmentation (MSA) is a promising antireflux surgical treatment. The cost associated with the device may be perceived as a drawback by payers, which may limit the adoption of this technique. There are limited data regarding the cost of MSA in the management of reflux disease. The aims of the study were to report the clinical outcome and quality of life measures in patients after MSA and to compare the pharmaceutical and procedure payer costs and the disease-related and overall expense of MSA compared to laparoscopic Nissen fundoplication (LNF) from a payer perspective.

Methods And Procedures: This prospective observational study was performed in conjunction with the region's largest health insurance company. Data were collected on patients who underwent MSA over a 2-year period beginning in September 2015 at the study network hospitals. The LNF comparison group was procured from members' claims data of the payer. Inclusion was predicated by patients having continuous coverage during study period. The total procedural reimbursement and the disease-related and overall medical claims submitted up to 12 months prior to surgery and up to 12 months following surgery were obtained. The payer reimbursement data are presented as allowed cost per member per month (PMPM). These values were then compared between groups.

Results: There were 195 patients who underwent MSA and 1131 that had LNF. MSA results in comparable symptom control, PPI elimination rate, and quality of life measures compared to values reported for LNF in the literature. The median (IQR) reimbursement of surgery was $13,522 (13,195-14,439) for those who underwent MSA and $13,388 (9951-16,261) for patients with LNF, p = 0.02. In patients who underwent MSA, the median reimbursement related to the upper gastrointestinal disease was $ 305 PMPM, at 12 months prior to surgery and $ 104 at 12 months after surgery, representing 66% decrease in cost. These values were $ 233 PMPM and $126 PMPM for patients who underwent LNF, representing a 46% decrease (p = 0.0001). At 12 months following surgery, the reimbursement for overall medical expenses had decreased by 10.7% in the MSA group and 1.4% in the LNF group when compared to the preoperative baseline reimbursement. The reimbursement for PPI use after surgery showed a 95% decrease in the MSA group and 90% among LNF group when compared to the preoperative baseline (p = 0.10).

Conclusion: When compared with LNF, MSA results in a reduction of disease-related expenses for the payer in the year following surgery. While MSA is associated with a higher procedural payer cost compared to LNF, payer costs may offset due to reduction in the expenses after surgery.
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http://dx.doi.org/10.1007/s00464-019-07021-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7113225PMC
May 2020

Prognostic immune markers for recurrence and survival in locally advanced esophageal adenocarcinoma.

Oncotarget 2019 Jul 16;10(44):4546-4555. Epub 2019 Jul 16.

Esophageal and Lung Institute, Allegheny Health Network, Pittsburgh, PA, USA.

Treatment options and risk stratification for esophageal adenocarcinomas (EAC) currently rely on pathological criteria such as tumor staging. However, with advancement in immune modulated treatments, there is a need for accurate predictive biomarkers that will help identify high-risk patients and provide novel therapeutic targets. Hence, we analyzed as prognostic classifiers a host of histopathological parameters in conjunction with novel immune biomarkers. Specifically, gene expression levels for CXCL9, IDO1, LAG3, and TIM3 were established in treatment naïve samples. Additionally, PD-L1 and CD8 positivity was determined by immunohistochemical staining. Based on our finding, a Cox model consisting of pathological complete response (CR), LAG3, and CXCL9 provided improved predictability for disease-free survival (DFS) compared to CR alone, and it demonstrated statistical significance for predictability of recurrence (p=0.0001). Likewise, for overall survival (OS), a Cox model constituted of TIM3, CR, and IDO1 performed better than CR alone, and it demonstrated statistical significance for predictability of survival (p = 0.0004). TIM3 was identified as the best predictor for OS (HR=4.43, p=0.0023). In conclusion, given the paucity of treatment options for EAC, evaluation of these biomarkers early in the disease course will lead to better risk stratification of patients and much needed alternatives for improved therapy.
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http://dx.doi.org/10.18632/oncotarget.27052DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6642049PMC
July 2019

Magnetic sphincter augmentation (MSA) in patients with hiatal hernia: clinical outcome and patterns of recurrence.

Surg Endosc 2020 04 8;34(4):1835-1846. Epub 2019 Jul 8.

Esophageal and Lung Institute, Allegheny Health Network, 4815 Liberty Avenue, Suite 439, Pittsburgh, PA, 15224, USA.

Introduction: Magnetic sphincter augmentation (MSA) is an effective treatment for patients with gastroesophageal reflux disease. In early studies, patients with a hiatal hernia (HH) ≥ 3 cm were excluded from consideration for implantation and initially the FDA considered its use as "precautionary" in this context. This early approach has led to an attitude of hesitance among some surgeons to offer this therapy to patients with HH. This study was designed to evaluate the impact of HH status on the outcome of MSA and to report the rate of HH recurrence after MSA.

Methods And Procedures: This is a retrospective review of prospectively collected data of patients who underwent MSA between June 2013 and August 2017. Baseline clinical and objective data were collected. Patients were divided into four groups based on HH status: no HH, small HH (< 3 cm), large HH (≥ 3 cm), and paraesophageal hernia (PEH). Patient satisfaction, GERD-HRQL and RSI data, freedom from PPI, need for postoperative dilation, length of hospitalization, 90-day readmission rate, need for device removal, and HH recurrence was compared between groups.

Results: There were 350 patients [60% female, mean (SD) age: 53.5 (13.8)] who underwent MSA. There were 65 (18.6%) with no HH, 205 (58.6%) with small HH (< 3 cm), 58 (16.6%) with large HH (≥ 3 cm) and 22 (6.2%) with PEH. At a mean follow-up of 13.6 (10.4) months, the rate of outcome satisfaction was similar between the groups (86%, 87.9%, 92.2% and 93.8%, p = 0.72). This was also true for GERD-HRQL total score clinical improvement (79.1%, 77.8%, 82% and 87.5%, p = 0.77). The rate of postoperative dysphagia (p = 0.33) and freedom from PPIs (p = 0.96) were similar among the four groups. Duration of hospitalization was higher among those with a large HH or PEH, and only PEH patients had a higher 90-day readmission rate (p = 0.0004). There was no difference between the need for dilation among groups (p = 0.13). The need for device removal (5% overall) was similar between the four groups (p = 0.28). HH recurrence was 10% in all groups combined, and only 7 of 240 (2.9%) patients required reoperation; the majority of these patients underwent a minimal dissection approach (no hernia repair) at the index operation. The incidence of recurrent HH increased in direct correlation with the preoperative HH size (0%, 10.1%, 16.6 and 20%, p = 0.032).

Conclusion: In the largest series of MSA implantation, we demonstrate that the excellent outcomes and high degree of satisfaction after MSA are independent of the presence or size of HH. Despite higher rates of hernia recurrence in large HH and PEH patients, the rates of postoperative endoscopic intervention, and device removal is similar to those with no or small HH. The minimal dissection approach to MSA should be abandoned.
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http://dx.doi.org/10.1007/s00464-019-06950-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7093380PMC
April 2020

The Potential Clinical Utility of Circulating Tumor DNA in Esophageal Adenocarcinoma: From Early Detection to Therapy.

Front Oncol 2018 11;8:610. Epub 2018 Dec 11.

Esophageal and Lung Institute, Allegheny Health Network, Pittsburgh, PA, United States.

Esophageal adenocarcinoma (EAC) is a lethal cancer requiring improved screening strategies and treatment options due to poor detection methods, aggressive progression, and therapeutic resistance. Emerging circulating tumor DNA (ctDNA) technologies may offer a unique non-invasive strategy to better characterize the highly heterogeneous cancer and more clearly establish the genetic modulations leading to disease progression. The presented review describes the potential advantages of ctDNA methodologies as compared to current clinical strategies to improve clinical detection, enhance disease surveillance, evaluate prognosis, and personalize treatment. Specifically, we describe the ctDNA-targetable genetic markers of prognostic significance to stratify patients into risk of progression from benign to malignant disease and potentially offer cost-effective screening of established cancer. We also describe the application of ctDNA to more effectively characterize the heterogeneity and particular mutagenic resistance mechanisms in real-time to improve prognosis and therapeutic monitoring strategies. Lastly, we discuss the inconsistent clinical responses to currently approved therapies for EAC and the role of ctDNA to explore the dynamic regulation of novel targeted and immunotherapies to personalize therapy and improve patient outcomes. Although there are clear limitations of ctDNA technologies for immediate clinical deployment, this review presents the prospective role of such applications to potentially overcome many of the notable hurdles to treating EAC patients. A deeper understanding of complex EAC tumor biology may result in the progress toward improved clinical outcomes.
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http://dx.doi.org/10.3389/fonc.2018.00610DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6297385PMC
December 2018

Enhancing the Detection of Barrett Esophagus.

Thorac Surg Clin 2018 Nov;28(4):453-464

Esophageal and Lung Institute, Allegheny Health Network, Western Pennsylvania Hospital, Suite 158, Mellon Pavilion, 4815 Liberty Avenue, Pittsburgh, PA 15224, USA. Electronic address:

In Western countries, the incidence of esophageal adenocarcinoma has increased rapidly in parallel with its premalignant condition, Barrett esophagus (BE). Unlike colonoscopy, endoscopic screening for BE is not currently recommended for all patients; however, surveillance endoscopy is advocated for patients with established BE. Novel imaging and sampling techniques have been developed and investigated for the purpose of improving the detection of Barrett esophagus, dysplasia, and neoplasia. This article discusses several screening and surveillance techniques, including Seattle protocol, chromoendoscopy, electronic chromoendoscopy, wide area transepithelial sampling with 3-dimensional analysis, nonendoscopic sampling devices, and transnasal endoscopy.
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http://dx.doi.org/10.1016/j.thorsurg.2018.07.011DOI Listing
November 2018

Extracellular Matrix Degradation Products Downregulate Neoplastic Esophageal Cell Phenotype.

Tissue Eng Part A 2019 03;25(5-6):487-498

2 McGowan Institute for Regenerative Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania.

Impact Statement: Extracellular matrix (ECM) biomaterials were used to treat esophageal cancer patients after cancer resection and promoted regrowth of normal mucosa without recurrence of cancer. The present study investigates the mechanisms by which these materials were successful to prevent the cancerous phenotype. ECM downregulated neoplastic esophageal cell function (proliferation, metabolism), but normal esophageal epithelial cells were unaffected , and suggests a molecular basis (downregulation of PI3K-Akt, cell cycle) for the promising clinical results. The therapeutic effect appeared to be enhanced using homologous esophageal ECM. This study suggests that ECM can be further investigated to treat cancer patients after resection or in combination with targeted therapy.
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http://dx.doi.org/10.1089/ten.TEA.2018.0105DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6450457PMC
March 2019

Serial Endoscopic Evaluation of Esophageal Disease in a Cancer Model: A Paradigm Shift for Esophageal Adenocarcinoma (EAC) Drug Discovery and Development.

Cancer Invest 2018 24;36(7):363-370. Epub 2018 Aug 24.

a Esophageal and Lung Institute , Allegheny Health Network , Pittsburgh , PA , USA.

A rat model of surgically induced reflux recapitulates the development and progression of human esophageal adenocarcinoma (EAC). In this study, reflux was induced in rats followed by postoperative endoscopy with biopsy, to diagnose and monitor disease progression. Overall, percentage agreement between visual endoscopy and gold standard histology was 95%, with disease-specific classification accuracies of 100% and 75% for Barrett's with dysplasia and EAC, respectively. Additionally, the percentage agreement for biopsy in tumors >4 mm was 75%. Thereby, establishing endoscopic evaluation as a reliable tool to assess disease progression and provide biopsies for downstream correlates in a de novo EAC model.
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http://dx.doi.org/10.1080/07357907.2018.1499029DOI Listing
October 2018

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

Ann Surg 2019 08;270(2):302-308

Department of Surgery, Medical College of Wisconsin, Milwaukee, WI.

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.
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http://dx.doi.org/10.1097/SLA.0000000000002789DOI Listing
August 2019

Worldwide Experience with Erosion of the Magnetic Sphincter Augmentation Device.

J Gastrointest Surg 2018 08 17;22(8):1442-1447. Epub 2018 Apr 17.

Department of Surgery, Keck Medicine of USC, University of Southern California, 1510 San Pablo St. #514, Los Angeles, CA, 90033, USA.

Background: The magnetic sphincter augmentation device continues to become a more common antireflux surgical option with low complication rates. Erosion into the esophagus is an important complication to recognize and is reported to occur at very low incidences (0.1-0.15%). Characterization of this complication remains limited. We aim to describe the worldwide experience with erosion of the magnetic sphincter augmentation device including presentation, techniques for removal, and possible risk factors.

Materials And Methods: We reviewed data obtained from the device manufacturer Torax Medical, Inc., as well as the Manufacturer and User Facility Device Experience (MAUDE) database. The study period was from February 2007 through July 2017 and included all devices placed worldwide.

Results: In total, 9453 devices were placed and there were 29 reported cases of erosions. The median time to presentation of an erosion was 26 months with most occurring between 1 and 4 years after placement. The risk of erosion was 0.3% at 4 years after device implantation. Most patients experienced new-onset dysphagia prompting evaluation. Devices were successfully removed in all patients most commonly via an endoscopic removal of the eroded portion followed by a delayed laparoscopic removal of the remaining beads. At a median follow-up of 58 days post-removal, there were no complications and 24 patients have returned to baseline. Four patients reported ongoing mild dysphagia.

Conclusions: Erosion of the LINX device is an important but rare complication to recognize that has been safely managed via minimally invasive approaches without long-term consequences.
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http://dx.doi.org/10.1007/s11605-018-3775-0DOI Listing
August 2018
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