Steven G. Leeds M.D.

Ward, M.A., Whitfield, E.P., Hasan, S.S., Ogola, G.O. and Leeds, S.G. (2020). “Objectively Confirmed Gastroesophageal Reflux Disease Following Per Oral Endoscopic Myotomy Higher in Obese Patients (BMI>30).” Surg Laparosc Endosc Percutan Tech Sep 2. [Epub ahead of print.].

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INTRODUCTION: Per oral endoscopic myotomy (POEM) is a promising minimally invasive therapy in the treatment of achalasia and other esophageal motility disorders. A concern surrounding POEM is the development of gastroesophageal reflux disease (GERD) postoperatively. This study was designed to report outcomes and identify risk factors for the development of postoperative GERD. METHODS: Patients who underwent POEM between January 1, 2015 and December 12, 2019 were prospectively followed in an Institutional Review Board approved database. All patients were invited for a full comprehensive workup 6 months post-POEM including symptom scores, pH testing, manometry and esophagogastroduodenoscopy. In a retrospective review of this database, those who developed postoperative GERD were compared with those who did not. RESULTS: There were 82 patients that met study criteria (median age 59). Indications for POEM include 35 type I achalasia, 16 type II achalasia, 21 type III achalasia and other spastic esophageal motility disorders, and 10 esophagogastric junction outflow obstruction. Mean Eckardt scores post-POEM were 2.67 compared with 6.79 pre-POEM (P<0.05). Mean integrated relaxation pressure improvement decreased from 27 to 13.1 (P<0.05). The presence of postoperative GERD was defined as an abnormal DeMeester score (>14.7) with pH testing off-medications or the presence of Grade C/D esophagitis on endoscopy. Thirty-five percent (29/82) of patients developed postoperative GERD following POEM. Negative predictive factors for the development of postoperative GERD include myotomy length and normal body mass index (BMI). Obesity (BMI>30) was a positive predictive risk factor in the development of GERD (P=0.029). CONCLUSIONS: POEM provides symptomatic relief and reduced Eckardt scores in patient with achalasia and other esophageal motility disorders. Patients who undergo POEM are at risk for developing gastroesophageal reflux disease especially in obese patients.

Ward, M.A., Ebrahim, A., Clothier, J.S., Prajapati, P.K., Ogola, G.O., Davis, D.G. and Leeds, S.G. (2020). “Factors that promote successful endoscopic management of laparoscopic sleeve gastrectomy leaks.” Surg Endosc Aug 11. [Epub ahead of print.].

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INTRODUCTION: Staple line leaks following laparoscopic sleeve gastrectomy (LSG) are associated with significant morbidity and mortality. Endoluminal techniques, including stent placement and endoluminal vacuum therapy (EVAC), have become viable options to treat these patients without the need for additional surgery. The purpose of this study was to define the conditions where certain endoscopic therapies are most likely to succeed compared to surgery. METHODS: An IRB approved prospectively maintained database was retrospectively reviewed for all patients treated for gastrointestinal leaks from July 2013 to March 2019. All patients who were treated for gastrointestinal leaks following LSG were included. Endpoints include success of leak closure and hospital-related morbidity for the patients treated solely by endoscopic only methods (EP) compared to the additional surgery group (SP). RESULTS: There were 39 patients (33 females; 6 males) with a median age of 45.9 years. The EP group included 23 patients (59%), whereas SP included 16 patients (31%). On average, the SP had longer days from sentinel surgery to our hospital admission (70 vs 41), a higher percentage of previous bariatric surgery prior to sentinel LSG (50% vs 17%), and a higher readmission rates following discharge (50% vs 39%). Total length of stay was also higher in the SP compared to the EP (45.4 vs 11). Using this data, a treatment algorithm was developed to optimally treat future patients who suffer from gastrointestinal leaks following LSG. CONCLUSIONS: Endoscopic therapies, such as EVAC, stent placement, internal drainage, and over-the-scope clips, have a higher chance of success if performed earlier to their sentinel surgery and if patients have had no prior bariatric surgeries. Patients who require additional surgery tend to have longer hospital stays and readmission rates. Using the treatment algorithm provided can help determine when endoscopic therapies are likely to succeed.

Leeds, S. G., A. Ebrahim, E. M. Potter, J. S. Clothier, P. Prajapati, G. O. Ogola and M. A. Ward (2020). “The role of preoperative workup in predicting dysphagia, dilation, or explantation after magnetic sphincter augmentation.” Surg Endosc May 27. [Epub ahead of print].

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BACKGROUND: Magnetic sphincter augmentation (MSA) is a surgical treatment for gastroesophageal reflux disease using a ring of titanium beads to improve the function of the lower esophageal sphincter. Prior to implantation, a comprehensive preoperative esophageal workup is required to determine patient candidacy in an effort to reduce the dysphagia, dilation, and explantation rate of the device. This study was designed to assess the best predictors for these endpoints. METHODS: A prospectively maintained IRB-approved database was retrospectively reviewed for patients undergoing MSA implantation. Patients were divided into 3 groups, those that needed no intervention, those that needed medical intervention with oral steroids for reported dysphagia, and surgical intervention, which included endoscopic dilation and/or surgical explantation. Primary endpoints included preoperative objective and subjective testing from a comprehensive esophageal workup including intraoperative notation of number of beads on the device. RESULTS: There were 99 patients eligible for the study with a mean age of 52 and mean follow-up of 10.2 months. Mean BMI was 27 and 59% were female. The no-intervention group had 59 patients, medical intervention group had 25 patients, and surgical intervention group had 15 patients. Preoperative esophageal manometry findings, pH testing off medications, endoscopic and radiologic evaluation showed no difference between the 3 groups. No differences were seen in preoperative subjective evaluations based on GERD-HRQL or RSI scores. There was no difference in average number of beads on the device between the 3 groups. CONCLUSION: A comprehensive esophageal workup is important to confirm the presence of gastroesophageal reflux disease and rule out other esophageal pathology. However, this study shows that a preoperative comprehensive esophageal workup does not predict which patients will develop dysphagia or require either medical or surgical interventions following MSA implantation.

Sankaranarayanan, G., C. A. Odlozil, K. O. Wells, S. G. Leeds, S. Chauhan, J. W. Fleshman, D. B. Jones and S. De (2020). “Training with cognitive load improves performance under similar conditions in a real surgical task.” Am J Surg Feb 10. [Epub ahead of print].

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BACKGROUND: Enhancing cognitive load while performing a bimanual surgical task affects performance. Whether repeated training under this condition could benefit performance in an operating room was tested using a virtual reality simulator with cognitive load applied through two-digit math multiplication questions. METHOD: 11 subjects were randomized to Control, VR and VR + CL groups. After a pre-test, VR and VR + CL groups repeated the peg transfer task 150 times over 15 sessions with cognitive load applied only for the last 100 trials. After training, all groups took a post-test and two weeks later the retention test with and without cognitive load and the transfer task on a pig intestine of 150 cm long under cognitive load. RESULTS AND CONCLUSION: Mixed ANOVA analysis showed significant differences between the control and VR and VR + CL groups (p = 0.013, p = 0.009) but no differences between the VR + CL and the VR groups (p = 1.0). GOALS bimanual dexterity score on transfer test show that VR + CL group outperformed both Control and VR groups (p = 0.016, p = 0.03). Training under cognitive load benefitted performance on an actual surgical task under similar conditions.

Ward, M. A., T. Hassan, J. S. Burdick and S. G. Leeds (2019). “Endoscopic vacuum assisted wound closure (EVAC) device to treat esophageal and gastric leaks: assessing time to proficiency and cost.” Surg Endosc 33(12): 3970-3975.

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BACKGROUND: Endoluminal vacuum therapy (EVAC) is an emerging procedure used to treat anastomotic leaks and/or perforations that would otherwise require surgery. The aim of this study was to determine time to proficiency in EVAC and the cost effectiveness of the procedure. METHODS: We retrospectively reviewed a prospectively maintained IRB approved database for all patients undergoing EVAC after esophageal and gastric complications between October 2013 and December 2017. Proficiency was determined by obtaining predicted estimates and analyzing the point at which average procedure time plateaued based on case volume. Total cost was calculated based on supplies and location where the procedure was performed. RESULTS: There were 50 patients (17 males, 33 female), with a mean age of 52.1 years. EVAC was placed in 23 (46%) patients with esophageal injuries and 28 (56%) with gastric injuries. Two advanced endoscopists performed all EVAC procedures in this study (1 surgeon, 1 gastroenterologist). The average procedure time for all patients was 43.5 min and the average wheel in/wheel out time for all patients was 75.6 min. Analysis of the trend based on average procedure times for EVAC revealed that proficiency was obtained after 10 cases. Total cost of the procedure is significantly lower in the GI lab compared to the operating room ($4528 vs. $11889). The majority of EVAC were performed in the GI lab (62%) compared to the operating room (38%). CONCLUSION: Successful outcomes in managing anastomotic leaks or intestinal perforations non-operatively has led to an increased interest in EVAC. For advanced endoscopists, time to proficiency is approximately 10 cases. Performing the procedure in the GI lab has a 2.5 reduction in total cost compared to the operating room.