Evaluation of postoperative esophagram following peroral endoscopic myotomy (POEM).

INTRODUCTION: The routine use of post-operative esophogram has come under evaluation for multiple upper GI surgeries such as with bariatric surgery and gastric resections. A major complication following Per Oral Endoscopic Myotomy (POEM) is a leak from the myotomy site. A post-operative contrast esophogram is often utilized to evaluate the presence of a leak, however it is not a standardized care practice for all patients. Presently it is selectively performed depending on physician assessment intra-operatively. This project will evaluate the necessity of post-operative contrast esophogram following POEM. MATERIALS AND METHODS: We retrospectively reviewed 277 patients diagnosed with achalasia who underwent POEM by two surgeons from 2011 to 2022. 173 patients met the inclusion criteria. A post-operative esophogram was used for the evaluation of a leak. Post-operative esophagram were selectively performed on day 1 following surgery using a water-soluble material. Data was evaluated using Stata. RESULTS: There were 3 detected leaks in the group that underwent esophagrams compared to the non-esophagram group in the early post-operative period. The overall complication rate was 5.5% in the non-esophagram versus 7.9% in the esophagram group. Length of stay was 1.48 days in the non-UGI vs 1.76 days in the esophagram group. Readmission rate was 10.9% in non-esophagram versus 8.7% in esophagram group. CONCLUSION: There was no statistically significant difference in outcomes in patients undergoing POEM who received post-operative esophagram verses patients who did not receive post-operative esophagram. The routine use of a contrast esophogram to detect a leak following POEM may not be justified. This study suggests that esophagrams should be performed depending on the clinical signs/symptoms post-operatively that would warrant imaging and intervention.

Does preoperative symptom duration affect outcomes following per oral endoscopic myotomy (POEM)?

BACKGROUND: Per oral endoscopic myotomy (POEM) is a safe therapy for the treatment of achalasia. Long-term effects of untreated achalasia include worsening dysmotility and disruptions in esophageal anatomy, i.e., tortuosity and dilation. We hypothesize that long-standing achalasia prior to intervention will have worse outcomes following POEM than in patients with symptoms for shorter duration. METHODS: We retrospectively analyzed achalasia patients who underwent POEM at our institution from 2011 to 2023, categorizing them into symptom duration cohorts (< 1 year, 1-3 years, 4-10 years, > 10 years). Inclusion criteria comprised patients with documented achalasia diagnosis who received POEM treatment at our facility. Exclusion criteria encompassed individuals lacking data pertaining to achalasia diagnosis, the time frame before intervention, or those missing pre and postoperative Eckardt scores. POEM failure was defined as symptom recurrence, necessity for repeat intervention, or high postoperative Eckardt score. We compared demographic, preoperative, and postoperative outcomes across these cohorts, and employed multivariable logistic regression to explore the link between symptom duration and POEM response. RESULTS: During the study period, in our increased cohort 234 patients met inclusion criteria. 75 patients had symptoms for < 1 year, 78 patients had symptoms from 1 to 3 years, 47 patients had symptoms from 4 to 10 years, and 34 patients had symptoms > 10 years. Patient demographics such as age, sex, BMI, Charleson-Deyo-Comorbidity-Index, and diabetes did not differ amongst cohorts. High-resolution manometry data, including achalasia type, Median IRP, LES residual pressure, and Basal LES pressure did not differ between groups. Preoperative Eckardt scores ranged from 4 to 5 across groups (p 0.24). Patients endorsed an average of three total preoperative symptoms across groups (p 0.13). Patients with symptoms greater than 4 years had significantly more endoscopic interventions prior to POEM (37% vs, 68% p .001). There was no significant difference in post-procedure mean Eckardt scores between cohorts. All cohorts experienced the same number of post-POEM symptoms. Post-POEM manometric measurements remained consistent across cohorts. Similarly, there were no significant differences in terms of symptom recurrence, requirement for repeat interventions, or repeat POEM among the cohorts. Multivariable logistic regression analysis determined achalasia symptoms greater than a decade did not result in increased odds of having a higher postoperative Eckardt score, worse dysphagia, regurgitation, or weight loss. CONCLUSIONS: In this increased cohort, this data once again suggests that longer symptom duration is not associated with increased rates of POEM failure.

Does practice make perfect? Studying the relationship between surgeon experience and patient outcomes for paraesophageal hernia repairs.

BACKGROUND: It has been reported that higher surgeon experience leads to better patient outcomes. In this study, we look at surgeon experience and its association with postoperative outcomes and variation among the practice of surgeons performing paraesophageal hernia repairs (PEH). METHOD: This was a retrospective study of 1155 patients who underwent PEH repair at a single institution (2010-2023). Surgeon experience was defined as the number of surgeries performed per surgeon and was split using the median surgeries (n = 100), with surgeons performing at or above the median categorized as high-experience and below the median as low-experience surgeons. A multivariable logistic regression model was used to test correlation between surgeon experience and variables, including demographics and intra- and post-operative outcomes. RESULTS: High-experience surgeons performed more elective cases (93.4% vs 85.5%), but low-experience surgeons operated more on emergent (2.7% vs 0.9%), semi-elective (2.3% vs 1.4%), and urgent cases (9.5% vs 4.3%). Low-experience surgeons operated more on patients who were older (67.5 vs 63.2 years, p < 0.001) and had an increased risk of CVD (72.9% vs 61.5%, p < 0.001). Intraoperative OR time was considerably less for high-experience surgeons (115.8 vs 172.9 min, p < 0.001). Low-experience surgeons had increased risk of intra-operative complications (4.5% vs 1.8%, p = 0.021) and post-op pneumonia within 30 days (1.8% vs 0.3%). However, long-term outcomes such as hernia recurrence (OR: 1.10, CI: 0.78-1.54) and redo-operations for hiatal hernia (OR: 1.10, CI: 0.65-1.75) were similar for both groups. CONCLUSION: High-experience surgeons perform more complex revisional surgeries in less time with fewer complications. Low-experience surgeons operated more on patients with higher comorbidities but had significantly higher OR times. Long-term results of recurrence and redo-operations were comparable. These variations suggest that high-experience surgeons are more efficient while operating on more complex cases. These findings have pivotal implications to facilitate mentorship and education among less-experienced surgeons.

Elevated preoperative lower esophageal sphincter pressure predicts improved clinical outcomes after per oral endoscopic myotomy (POEM).

BACKGROUND: Although per oral endoscopic myotomy (POEM) has shown to be beneficial for the treatment of achalasia, it can be difficult to predict who will have a robust and long-lasting response. Historically, it has been shown that higher lower esophageal sphincter pressures have been associated with poorer responses to alternative endoscopic therapies such as Botox therapy and pneumatic dilation. This study was designed to evaluate if modern preoperative manometric data could similarly predict response to therapy after POEM. METHODS: This was a retrospective study of 237 patients who underwent POEM at a single institution over a period of 13 years (2011-2023) and who had a high-resolution manometry performed preoperatively and an Eckardt symptom score performed both preoperative and postoperatively. The achalasia type and integrated relaxation pressures (IRP) were tested for potential correlation with the need for any further achalasia interventions postoperatively as well as the degree of Eckardt score reduction using a linear regression model. RESULTS: The Achalasia type on preoperative manometry was not predictive for further interventions or degree of Eckardt score reduction (p = 0.76 and 0.43, respectively). A higher IRP was not predictive of the need for further interventions, however, it was predictive of a greater reduction in postoperative Eckardt scores (p = 0.03) as shown by the non-zero regression slope. CONCLUSION: In this study, achalasia type was not a predictive factor in the need for further interventions or the degree of symptom relief. Although IRP was not predictive of the need for further interventions, a higher IRP did predict better symptomatic relief postoperatively. This result is opposite that of other endoscopic treatment modalities (Botox and pneumatic dilation). Therefore, patients with higher IRP on preoperative high-resolution manometry would likely benefit from POEM which provides significant symptomatic relief postoperatively.

Symptom duration is not associated with per oral endoscopic myotomy (POEM) failure.

INTRODUCTION: Per oral endoscopic myotomy (POEM) is a relatively novel technique to address achalasia; however, little is known about the efficacy of POEM for patients with long-standing achalasia. We hypothesize that patients with long-standing achalasia prior to intervention will be more recalcitrant to POEM than patients with symptoms for a short duration. METHODS: We performed a retrospective analysis of patients with achalasia who received a POEM at a single institution from 2012 to 2022. Patients were grouped into cohorts based on the time of symptom duration: < 1 year, 1-3 years, 4-10 years, > 10 years. POEM failure was defined as need for repeat intervention, symptom recurrence, and a high postoperative Eckart score. Demographic and clinical data were compared between cohorts. Measures of failure multivariable logistic regression analyzed the association between symptom duration and response to POEM. RESULTS: During the study period, 132 patients met inclusion criteria. Patient age at surgery, sex, BMI, Charleston-Deyo Comorbidity Index, and patients with diabetes with and without end organ complications, connective tissue diseases, and patients with ulcer diseases did not differ among cohorts. Patients who have had symptoms for greater than 10 years had significantly more endoscopic interventions prior to their POEM (30% vs, 60% p = 0.002). Patients in all cohorts experienced the same number of symptoms post-POEM. Manometric measurements did not vary across cohorts after POEM. Symptom recurrence, need for repeat endoscopic intervention, repeat surgical intervention, or repeat POEM also did not vary across cohorts. Having symptoms of achalasia > 10 years did not increase the odds POEM failure on multivariable logistical regression. CONCLUSIONS: These data suggest that longer symptom duration is not associated with increased rates of POEM failure. This is promising as clinicians should not exclude patients for POEM eligibility based on duration of symptoms alone.

Do preoperative endoscopic interventions predict symptom recurrence or reintervention after peroral endoscopic myotomy?

BACKGROUND: Studies assessing outcomes of patients undergoing peroral endoscopic myotomy (POEM) after botulinum injection or dilation have had various results with respect to failure, although this has not been differentiated between lack of clinical response and recurrence. We hypothesize that patients with previous endoscopic intervention(s) are more likely to recur than treatment-naïve patients. METHODS: This is a retrospective cohort study of patients that underwent POEM for achalasia at a single tertiary care center between 2011 and 2022. Patients were excluded if they had previous myotomy (POEM or Heller). The remaining patients were stratified into treatment-naïve patients (TN), those with previous botulinum injection (BTX), those with previous dilatation (BD), and those with both previous endoscopic interventions (BOTH). Primary outcome was recurrence indicated by clinical symptoms or need for repeat endoscopic intervention or surgery after originally having clinical resolution (Eckardt ≤ 3). Multivariate logistic regression using preoperative and intraoperative factors was completed to assess odds of recurrence. RESULTS: A total of 164 patients were included in the analysis, 90 TN, 34 BD, 28 BTX, and 12 BOTH. There were no other significant differences in demographics or in preoperative Eckardt score (p = 0.53). There was no difference in the proportion of patients that had postoperative manometry (p = 0.74), symptom recurrence (p = 0.59), surgical intervention (p = 0.16). BTX (14.3%) and BOTH (16.7%) patients had a higher rate of repeat endoscopic intervention than BD and TN patients (5.9% and 1.1%). In the logistic regression analysis, there was no association among the BTX, BD, or BOTH groups compared to the TN group. No odds ratios achieved statistical significance. CONCLUSIONS: There were no increased likelihood of recurrence with botulinum injection or dilatation prior to POEM, implying that they are similarly good candidates compared to treatment-naïve patients.

Enhanced gastric decompression for palliation of malignant bowel obstruction.

BACKGROUND: Malignant bowel obstruction (MBO) is a sequela of advanced intraabdominal cancer and has a profound impact on quality of life. Common therapy is endoscopic decompressive gastrostomy tube placement. Standard gastrostomy tubes are poorly designed to completely evacuate the dependent portions of the stomach due to their location on the anterior gastric wall. In our institution we have begun placing the ASPIRE Assist gastrostomy tube (ASPIRE Bariatrics, Exton, PA) which includes a 15 cm long, 30Fr fenestrated gastric tube extension for enhanced gastric decompression. This tube is FDA indicated for gastric decompression and marketed for endoscopic weight loss. The purpose of this study is to review our experience managing MBO utilizing the ASPIRE Assist tube. METHODS: This is a retrospective analysis of outcomes at a single institution. All decompressive endoscopic gastrostomy tubes placed by two surgeons between November 2019 and July 2021 were reviewed. Endoscopic placement was performed utilizing standard safe tract and Ponsky pull techniques. RESULTS: Fourteen patients were identified (10F:4 M), mean age 70 (range 35-89). Primary cancer diagnoses included gynecologic (8), colorectal (3), bladder (1), small bowel (1), peritoneal serous (1). During the 12 months before decompressive gastrostomy tube placement, mean number of hospital admissions for MBO was 1.6 (range 1-3). Following tube placement, twelve patients had no further hospital admissions for MBO over their lifespan of mean 270 days (range 8-679 days). One patient had 1 admission for MBO in the 12 months before tube placement and 3 admissions in the 4 months after placement. A second patient had 2 admissions in the 12 months before tube placement and 1 admission in their 54-day lifespan after placement. There were no major complications. CONCLUSIONS: Endoscopic placement of the ASPIRE Assist gastrostomy tube is safe for palliation of MBO and may improve gastric decompression compared with standard endoscopic gastrostomy tubes. Enhanced gastric decompression can better manage symptoms, reduce hospital encounters, and improve quality of life. Further study is needed, however, our initial data appears promising.

Risk factors for adverse outcomes following paraesophageal hernia repair among obese patients.

BACKGROUND: Although obesity is an established risk factor for adverse outcomes after paraesophageal hernia repair (PEHR), many obese patients nonetheless receive PEHR. The purpose of this study was to explore risk factors for adverse outcomes of PEHR among this high-risk cohort. We hypothesized that obese patients may have other risk factors for adverse outcomes following PEHR. METHODS: A retrospective study of adult obese patients who underwent minimally invasive PEHR from 2017 to 2019 was performed. Patients were excluded for BMI < 30 or if they had concomitant bariatric surgery at time of PEHR. The primary outcome of interest was a composite adverse outcome (CAO) defined as having any of the four following outcomes after PEHR: persistent GERD > 30 d, persistent dysphagia > 30 d, recurrence, or reoperation. Chi-square and t-test analysis was used to compare demographic and clinical characteristics. Multivariable logistic regression analysis was used to evaluate independent predictors of CAO. RESULTS: In total, 139 patients met inclusion criteria with a median follow-up of 19.7 months (IQR 8.8-81). Among them, 51/139 (36.7%) patients had a CAO: 31/139 (22.4%) had persistent GERD, 20/139 (14.4%) had persistent dysphagia, 24/139 (17.3%) had recurrence, and 6/139 (4.3%) required reoperation. On unadjusted analysis, patients with a CAO were more likely to have a history of prior abdominal surgery (86.3% vs 70.5%, p = 0.04) and were less likely to have undergone a preoperative CT scan (27.5% vs 45.5%, p = 0.04). On multivariable analysis, previous abdominal surgery was independently associated with an increased likelihood of CAO whereas age and preoperative CT scan had a decreased likelihood of CAO. CONCLUSIONS: Although there were adverse outcomes among obese patients, minimally invasive PEHR may be feasible in a subset of patients at specialized centers. These findings may help guide the appropriate selection of obese patients for PEHR.

Multi-society consensus conference and guideline on the treatment of gastroesophageal reflux disease (GERD).

BACKGROUND: Gastroesophageal reflux disease (GERD) is one of the most common diseases in North America and globally. The aim of this guideline is to provide evidence-based recommendations regarding the most utilized and available endoscopic and surgical treatments for GERD. METHODS: Systematic literature reviews were conducted for 4 key questions regarding the surgical and endoscopic treatments for GERD in adults: preoperative evaluation, endoscopic vs surgical or medical treatment, complete vs partial fundoplication, and treatment for obesity (body mass index [BMI] ≥ 35 kg/m2) and concomitant GERD. Evidence-based recommendations were formulated using the GRADE methodology by subject experts. Recommendations for future research were also proposed. RESULTS: The consensus provided 13 recommendations. Through the development of these evidence-based recommendations, an algorithm was proposed for aid in the treatment of GERD. Patients with typical symptoms should undergo upper endoscopy, manometry, and pH-testing; additional testing may be required for patients with atypical or extra-esophageal symptoms. Patients with normal or abnormal findings on manometry should consider undergoing partial fundoplication. Magnetic sphincter augmentation or fundoplication are appropriate surgical procedures for adults with GERD. For patients who wish to avoid surgery, the Stretta procedure and transoral incisionless fundoplication (TIF 2.0) were found to have better outcomes than proton pump inhibitors alone. Patients with concomitant obesity were recommended to undergo either gastric bypass or fundoplication, although patients with severe comorbid disease or BMI > 50 should undergo Roux-en-Y gastric bypass for the additional benefits that follow weight loss. CONCLUSION: Using the recommendations an algorithm was developed by this panel, so that physicians may better counsel their patients with GERD. There are certain patient factors that have been excluded from included studies/trials, and so these recommendations should not replace surgeon-patient decision making. Engaging in the identified research areas may improve future care for GERD patients.

The relationship of depression, alcohol and marijuana with treatment for LUTS/BPH.

INTRODUCTION: Despite widespread usage, research on the relationship of marijuana use to disease is sorely lacking. We sought to test the relationship of LUTS/BPH treatment and endocannabinoid agonist usage, as well as alcohol usage and depression, with treatment for LUTS/BPH in our health system. MATERIALS AND METHODS: We queried our hospital system database of nearly three million patients in a marijuana-legalized region for data from the electronic medical record between January 2011 and October 2018. Men over the age of 45 on medical therapy for LUTS (selective alpha blockade and/or finasteride) were included. Exclusions were diagnosis of bladder or prostate malignancy and men with only one visit. Alcohol and marijuana (MJ) use were found from diagnosis code and/or social history text. Medical diagnoses were based on ICD-9/10 codes. Multiple logistic regression was used to control for confounders. We considered all men over the age of 45 who had any of these features: depression, obesity or metabolic syndrome (MetS), hypertension (HTN), erectile dysfunction (ED), hypogonadism, diabetes (DM) and calculated the odds ratio of also receiving medical therapy for LUTS. Univariable and multivariable analyses were employed, multiple logistic regression was used to control for confounders. RESULTS: A total of 173,469 patients were identified meeting criteria with 20,548 (11.9%) on medical treatment for LUTS. After adjusting for confounding variables, MJ and depression remained associated with an increased risk of LUTS medication, within the context of verifying previously established relationships of ED, Obesity/MetS, DM, HTN and hypogonadism. CONCLUSIONS: Men with depression and MJ usage were more likely to be treated for LUTS/BPH in our system. Better understanding of the causality of this relationship and potential interaction of LUTS/BPH with the endocannabinoid system is desirable.

Management of patients after failed peroral endoscopic myotomy: a multicenter study.

BACKGROUND: Although peroral endoscopic myotomy (POEM) is highly effective for the management of achalasia, clinical failures may occur. The optimal management of patients who fail POEM is not well known. This study aimed to compare the outcomes of different management strategies in patients who had failed POEM. METHODS: This was an international multicenter retrospective study at 16 tertiary centers between January 2012 and November 2019. All patients who underwent POEM and experienced persistent or recurrent symptoms (Eckardt score > 3) were included. The primary outcome was to compare the rates of clinical success (Eckardt score ≤ 3) between different management strategies. RESULTS : 99 patients (50 men [50.5 %]; mean age 51.4 [standard deviation (SD) 16.2]) experienced clinical failure during the study period, with a mean (SD) Eckardt score of 5.4 (0.3). A total of 29 patients (32.2 %) were managed conservatively and 70 (71 %) underwent retreatment (repeat POEM 33 [33 %], pneumatic dilation 30 [30 %], and laparoscopic Heller myotomy (LHM) 7 [7.1 %]). During a median follow-up of 10 (interquartile range 3 - 20) months, clinical success was highest in patients who underwent repeat POEM (25 /33 [76 %]; mean [SD] Eckardt score 2.1 [2.1]), followed by pneumatic dilation (18/30 [60 %]; Eckardt score 2.8 [2.3]), and LHM (2/7 [29 %]; Eckardt score 4 [1.8]; P = 0.12). A total of 11 patients in the conservative group (37.9 %; mean Eckardt score 4 [1.8]) achieved clinical success. CONCLUSION : This study comprehensively assessed an international cohort of patients who underwent management of failed POEM. Repeat POEM and pneumatic dilation achieved acceptable clinical success, with excellent safety profiles.

SAGES guidelines for the use of peroral endoscopic myotomy (POEM) for the treatment of achalasia.

BACKGROUND: Peroral endoscopic myotomy (POEM) is increasingly used as primary treatment for esophageal achalasia, in place of the options such as Heller myotomy (HM) and pneumatic dilatation (PD) OBJECTIVE: These evidence-based guidelines from the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) intend to support clinicians, patients and others in decisions about the use of POEM for treatment of achalasia. RESULTS: The panel agreed on 4 recommendations for adults and children with achalasia. CONCLUSIONS: Strong recommendation for the use of POEM over PD was issued unless the concern of continued postoperative PPI use remains a key decision-making concern to the patient. Conditional recommendations included the option of using either POEM or HM with fundoplication to treat achalasia, and favored POEM over HM for achalasia subtype III.

Decline of open surgical experience for general surgery residents.

BACKGROUND: Minimally invasive surgery is now preferred to open in many surgical procedures. This has led to changes in training to ensure skills acquisition and education in minimally invasive technique. There have been limited data regarding the effect of the number of open procedures being performed in training. The aim of this paper is to examine the relationship in trends for open and laparoscopic procedures performed by general surgery residents. METHODS: A retrospective review of the Accreditation Council for Graduate Medical Education publicly available resident case log statistical reports for the academic years from 1999-2000 to 2017-2018 was performed for laparoscopic and open anti-reflux surgery, appendectomy, colectomy, splenectomy, and inguinal hernia repair. The data were grouped by time period and compared to evaluate changes in operative patterns. RESULTS: The mean number for all (open and MIS) of the selected procedures increased from 159.1 in 2000 to 223.8 in 2018 (40.7%). The mean number of laparoscopic cases increased from 23.6 to 135.6 (462%), and open decreased from 135.5 to 88.2 (- 34.9%). There was a significant decrease in the average number of open procedures performed in each period among anti-reflux operations (3.4, 1.8, 1.5, 0.7, p < 0.01), appendectomy (30.7, 23.4, 13.6, 6.8, p < 0.01), and splenectomy (3.0, 2.0, 1.6, 1.4, p < 0.05); the number of open colectomies decreased significantly from Period 2 to Period 4 (46.1, 38.5, 33.4, p < 0.02). There was a significant increase in the number of laparoscopic procedures performed in each period among appendectomy (13.1, 28.3, 48.9, 58.4, all p < 0.02), colectomy (2.9, 10.1, 19.1, 23.4, all p < 0.01), and inguinal hernia repair (9.7, 14.9, 25.6, 34.1, all p < 0.01). CONCLUSION: The number of open procedures performed by general surgery residents continues to decline despite an increase in total cases reported. The reduction in open surgical experience may result in surgeons who lack technical skills to safely complete open procedures.

ASGE EndoVators Summit: simulators and the future of endoscopic training.

Interest in the use of simulation for acquiring, maintaining, and assessing skills in GI endoscopy has grown over the past decade, as evidenced by recent American Society for Gastrointestinal Endoscopy (ASGE) guidelines encouraging the use of endoscopy simulation training and its incorporation into training standards by a key accreditation organization. An EndoVators Summit, partially supported by a grant from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of the National Institutes of Health, (NIH) was held at the ASGE Institute for Training and Technology from November 19 to 20, 2017. The summit brought together over 70 thought leaders in simulation research and simulator development and key decision makers from industry. Proceedings opened with a historical review of the role of simulation in medicine and an outline of priority areas related to the emerging role of simulation training within medicine broadly. Subsequent sessions addressed the summit's purposes: to review the current state of endoscopy simulation and the role it could play in endoscopic training, to define the role and value of simulators in the future of endoscopic training and to reach consensus regarding priority areas for simulation-related education and research and simulator development. This white paper provides an overview of the central points raised by presenters, synthesizes the discussions on the key issues under consideration, and outlines actionable items and/or areas of consensus reached by summit participants and society leadership pertinent to each session. The goal was to provide a working roadmap for the developers of simulators, the investigators who strive to define the optimal use of endoscopy-related simulation and assess its impact on educational outcomes and health care quality, and the educators who seek to enhance integration of simulation into training and practice.

Cyclodextrin Polymer Preserves Sirolimus Activity and Local Persistence for Antifibrotic Delivery over the Time Course of Wound Healing.

Fibrosis and dysphagic stricture of the esophagus is a major unaddressed problem often accompanying endoscopic removal of esophageal cancers and precancerous lesions. While weekly injections of antiproliferative agents show potential for improved healing, repeated injections are unlikely clinically and may alternatively be replaced by creating an esophageal drug delivery system. Affinity-based polymers have previously shown success for continuous delivery of small molecules for weeks to months. Herein, we explored the potential of an affinity-based microparticle to provide long-term release of an antiproliferative drug, sirolimus. In molecular docking simulations and surface plasmon resonance experiments, sirolimus was found to have suitable affinity for beta-cyclodextrin, while dextran, as a low affinity control, was validated. Polymerized beta-cyclodextrin microparticles exhibited 30 consecutive days of delivery of sirolimus during in vitro release studies. In total, the polymerized beta-cyclodextrin microparticles released 36.9 mg of sirolimus per milligram of polymer after one month of incubation in vitro. Taking daily drug release aliquots and applying them to PT-K75 porcine mucosal fibroblasts, we observed that cyclodextrin microparticle delivery preserved bioactivity of sirolimus inhibiting proliferation by 27-67% and migration of fibroblasts by 28-100% of buffer treated controls in vitro. Testing for esophageal injection site losses, no significant loss was incurred under simulated saliva flow for 10 min, and 16.7% of fluorescently labeled polymerized cyclodextrin microparticle signal was retained at 28 days after submucosal injection in esophageal tissue ex vivo versus only 4% of the initial amount remaining for free dye molecules injected alone. By combining affinity-based drug delivery for continuous long-term release with a microparticle platform that is injectable yet remains localized in tissue interstitium, this combination platform demonstrates promise for preventing esophageal fibrosis and stricture.

Benign Prostatic Hyperplasia and Lower Urinary Tract Symptoms: What Is the Role and Significance of Inflammation?

PURPOSE OF REVIEW: The purpose of this review is to summarize the role and significance of inflammation as a putative additional factor contributing to lower urinary tract symptoms and the progression of benign prostatic hyperplasia. We review (1) the histologic definition of prostatic inflammation and its prevalence, (2) the effects inflammation in the prostate including on risk of acute urinary retention, and (3) the effects of systemic inflammation on the prostate and on voiding. RECENT FINDINGS: Inflammation is a highly prevalent finding in the prostate, both on a histological and biochemical level. Men with inflammation have higher IPSS scores and increased prostate size; however, these differences appear to be imperceptibly small. Men with inflammation do experience a significantly increased risk of developing acute urinary retention, an event that is associated with significant morbidity. Recently, attempts have been made to identify more specific biochemical markers of local inflammation, and to identify regional patterns of inflamed tissue within the prostate which may be associated with higher IPSS scores, accelerated progression, and AUR. The effects of systemic inflammatory states, most notably MetS, and their role in LUTS have also been examined. Inflammation is a common finding in prostates of aging men, but its contribution to lower urinary tract symptoms and benign prostatic hyperplasia progression appears to be small when considered as a clinically relevant entity. Advances in the understanding of different forms of inflammation, and their impact when experienced in different locations within the prostate, may refine this knowledge. Systemic inflammation affects voiding, including in the absence of a prostate, but again significant effects of systemic inflammation on the prostate itself are also difficult to demonstrate. Prostatic inflammation is associated with a significantly increased risk of acute urinary retention.

POEM is a cost-effective procedure: cost-utility analysis of endoscopic and surgical treatment options in the management of achalasia.

BACKGROUND: Achalasia is a rare motility disorder of the esophagus. Treatment is palliative with the goal of symptom remission and slowing the progression of the disease. Treatment options include per oral endoscopic myotomy (POEM), laparoscopic Heller myotomy (LM) and endoscopic treatments such as pneumatic dilation (PD) and botulinum toxin type A injections (BI). We evaluate the economics and cost-effectiveness of treating achalasia. METHODS: We performed cost analysis for POEM, LM, PD and BI at our institution from 2011 to 2015. Cost of LM was set to 1, and other procedures are presented as percentage change. Cost-effectiveness was calculated based on cost, number of interventions required for optimal results for dilations and injections and efficacy reported in the current literature. Incremental cost-effectiveness ratio was calculated by a cost-utility analysis using quality-adjusted life year gained, defined as a symptom-free year in a patient with achalasia. RESULTS: Average number of interventions required was 2.3 dilations or two injections for efficacies of 80 and 61 %, respectively. POEM cost 1.058 times the cost of LM, and PD and BI cost 0.559 and 0.448 times the cost of LM. Annual cost per cure over a period of 4 years for POEM, and LM were consistently equivalent, trending the same as PD although this has a lower initial cost. The cost per cure of BI remains stable over 3 years and then doubles. CONCLUSION: The cost-effectiveness of POEM and LM is equivalent. Myotomy, either surgical or endoscopic, is more cost-effective than BI due to high failure rates of the economical intervention. When treatment is being considered BI should be utilized in patients with less than 2-year life expectancy. Pneumatic dilations are cost-effective and are an acceptable approach to treatment of achalasia, although myotomy has a lower relapse rate and is cost-effective compared to PD after 2 years.

Efficacy of endoscopic management of leak after foregut surgery with endoscopic covered self-expanding metal stents (SEMS).

INTRODUCTION: Anastomotic or staple-line leak after foregut surgery presents a formidable management challenge. In recent years, with advancement of endoscopy, self-expanding covered stents have been gaining popularity. In this study, we aimed to determine the safety and effectiveness of self-expanding covered stents in management of leak after foregut surgery. METHODS: Consecutive patients who received a fully covered self-expandable metal stent (SEMS) due to an anastomotic leak after upper gastrointestinal surgery between 2009 and 2014 were retrospectively reviewed. Demographic data, stent placement and removal, clinical success, time to resolution, and complications were collected. Predictive factors for clinical success rate were assessed. RESULTS: A total of 20 consecutive patients underwent placement of fully covered SEMS for anastomotic leak, following esophagectomy (n = 5), esophageal diverticulectomy (n = 1), gastric sleeve (n = 4), gastric bypass (n = 3), partial gastrectomy (n = 4), and total gastrectomy (n = 3). All the stents were removed successfully, and clinical resolution was achieved in 18 patients (90 %) after a median of two (range 1-3) procedures and a mean of 6.2 weeks (range 0.4-14). Complications presented in 12 patients (60 %), including stent migration (n = 8), mucosal friability (n = 4), tissue integration (n = 2), and bleeding (n = 2). Two (10 %) patients' treatment was complicated by aorto-esophageal fistula formation resulting in one death. Demographic factors, comorbidities, and type of surgery were not predictive of clinical success rate or time to resolution. CONCLUSION: SEMS are effective tools for the management of leaks after foregut surgery. The biggest challenge with this approach is stent migration. Caution is warranted due to the risk of fatal complications such as aorto-esophageal fistula formation. No type of surgery or particular patient factor, including age, sex, BMI, albumin, history of radiation, malignancy, and comorbid diabetes or coronary artery disease, appeared to be correlated with success rate. Larger studies are needed to determine factors predictive of clinical success.

Changing attitudes and improving skills: demonstrating the value of the SAGES flexible endoscopy course for fellows.

BACKGROUND: The purpose of this study was to examine the effectiveness of the SAGES flexible endoscopy course in improving fellows' attitudes, confidence, and skills related to implementing endoscopy in practice. METHODS: Fellows participated in a 2-day course consisting of case presentations, expert panels, and hands-on laboratory training. Before and after the course, fellows completed a questionnaire assessing demographics, experiences in residency, practice plans, plans to implement flexible endoscopy in practice, and level of confidence performing 15 endoscopic procedures. Half of the fellows were randomly assigned to complete pre- and post-skills testing using a previously validated endoscopic targeting model. RESULTS: Fifty-four fellows (90 %; age 33.5 ± 2.8; 58 % male) completed the pre- and post-questionnaire. All MIS fellowship types were represented. Almost half (48 %) reported none or very little flexible endoscopy in their current fellowship. The average prior case volume among those completing an ACGME-approved residency (42/54) was 76 upper and 75 lower endoscopies with one-third reporting no experience in therapeutic EGD (33 %) or polypectomy (31 %). Intentions to implement flexible endoscopy in practice significantly improved after the course overall (3.72 ± .85-3.92 ± .69, p < 0.05; 1 = never; 5 = very frequently). Prior to the course, 39 % of fellows reported plans to use endoscopy in practice "occasionally" or "rarely." After, this decreased to 28 with 72 % planning to implement "frequently" or "very frequently." Mean levels of confidence performing all 15 endoscopic tasks improved significantly after the course. Skills performance for the 27 fellows improved significantly as well; participants decreased their time to perform the targeting task by 40 % (222.3 ± 119.8-133.0 ± 70.1 s; p < 0.001) and decreased errors by 49 % (2.9 ± 1.7-1.5 ± 1.5; p < 0.001). CONCLUSIONS: These results indicate that the SAGES flexible endoscopy course increases fellow confidence to implement endoscopic techniques, expands the ways in which they plan to include endoscopy in practice, and enhances their endoscopic skills.