Machine learning prediction of major adverse cardiac events after elective bariatric surgery.

BACKGROUND: Machine learning (ML) is an emerging technology with the potential to predict and improve clinical outcomes including adverse events, based on complex pattern recognition. Major adverse cardiac events (MACE) after bariatric surgery have an incidence of 0.1% but carry significant morbidity and mortality. Prior studies have investigated these events using traditional statistical methods, however, studies reporting ML for MACE prediction in bariatric surgery remain limited. As such, the objective of this study was to evaluate and compare MACE prediction models in bariatric surgery using traditional statistical methods and ML. METHODS: Cross-sectional study of the MBSAQIP database, from 2015 to 2019. A binary-outcome MACE prediction model was generated using three different modeling methods: (1) main-effects-only logistic regression, (2) neural network with a single hidden layer, and (3) XGBoost model with a max depth of 3. The same set of predictor variables and random split of the total data (50/50) were used to train and validate each model. Overall performance was compared based on the area under the receiver operating curve (AUC). RESULTS: A total of 755,506 patients were included, of which 0.1% experienced MACE. Of the total sample, 79.6% were female, 47.8% had hypertension, 26.2% had diabetes, 23.7% had hyperlipidemia, 8.4% used tobacco within 1 year, 1.9% had previous percutaneous cardiac intervention, 1.2% had a history of myocardial infarction, 1.1% had previous cardiac surgery, and 0.6% had renal insufficiency. The AUC for the three different MACE prediction models was: 0.790 for logistic regression, 0.798 for neural network and 0.787 for XGBoost. While the AUC implies similar discriminant function, the risk prediction histogram for the neural network shifted in a smoother fashion. CONCLUSION: The ML models developed achieved good discriminant function in predicting MACE. ML can help clinicians with patient selection and identify individuals who may be at elevated risk for MACE after bariatric surgery.

Presence of SARS-CoV-2 in abdominal tissues and biologic fluids during abdominal surgery: a systematic review.

BACKGROUND: Viral transmission to healthcare providers during surgical procedures was a major concern at the outset of the COVID-19 pandemic. The presence of the severe acute respiratory disease syndrome coronavirus (SARS-CoV-2), the virus responsible for COVID-19, in the abdominal cavity as well as in other abdominal tissues which surgeons are exposed has been investigated in several studies. The aim of the present systematic review was to analyze if the virus can be identify in the abdominal cavity. METHODS: We performed a systematic review to identify relevant studies regarding the presence of SARS-CoV-2 in abdominal tissues or fluids. Number of patients included as well as patient's characteristics, type of procedures, samples and number of positive samples were analyzed. RESULTS: A total of 36 studies were included (18 case series and 18 case reports). There were 357 samples for detection of SARS-CoV-2, obtained from 295 individuals. A total of 21 samples tested positive for SARS-CoV-2 (5.9%). Positive samples were more frequently encountered in patients with severe COVID-19 (37.5% vs 3.8%, p < 0.001). No health-care provider related infections were reported. CONCLUSION: Although a rare occurrence, SARS-CoV-2 can be found in the abdominal tissues and fluids. It seems that the presence of the virus in the abdominal tissues or fluids is more likely in patients with severe disease. Protective measures should be employed in the operating room to protect the staff when operating patients with COVID-19.

Primary single anastomosis duodeno-ileal bypass with sleeve gastrectomy (SADI-S) versus sleeve gastrectomy to SADI conversions: a comparison study of prevalence and safety.

BACKGROUND: Conversion from sleeve gastrectomy (SG) to single anastomosis duodeno-ileal bypass (SADI) is becoming increasingly common, but data regarding safety is of these conversions is scarce. As such, the objective of this study was to compare the 30-day rate of serious complications and mortality of primary SADI (p-SADI-S) with SG to SADI (SG-SADI) conversions. METHODS: This retrospective cohort study analyzed the MBSAQIP database. Patients undergoing p-SADI-S and SG-SADI were included. Data collection was limited to 2020 and 2021. A multivariable logistic regression analysis was performed between groups to determine if SG-SADI was an independent predictor of 30-day serious complications or mortality. RESULTS: A total of 783 patients were included in this study, 488 (62.3%) underwent p-SADI-S and 295 (37.6%) underwent SG-SADI. The mean body mass index (BMI) at the time of surgery was lower in the SG-SADI cohort (45.1 vs 51.4 kg/m2, p < 0.001). Indications for revision in the SG-SADI cohort included weight recurrence (50.8%), inadequate weight loss (41.0%), other (3.0%), GERD (2.7%), and persistent comorbidities (2.5%). SG-SADI had longer operative times (156.7 vs 142.1 min, p < 0.001) and was not associated with a higher rate of serious complications (5.7 vs 6.9%, p = 0.508) compared to p-SADI-S. p-SADI-S was associated with a higher rate of pneumonia (1.2 vs 0.0%, p < 0.001), and SG-SADI was not correlated with higher rates of reoperation (3.0 vs 3.2%, p = 0.861), readmission (5.4 vs 5.5%, p = 0.948) and death (0.0 vs 0.2%, p = 0.437). On multivariable analysis, SG-SADI was not independently predictive of serious complications (OR 0.81, 95% CI 0.43 to 1.52, p = 0.514) when adjusting for age, sex, BMI, comorbidities, and operative time. CONCLUSIONS: The prevalence of SG-SADI is high, representing 37.6% of SADI-S procedures. Conversion from sleeve to SADI, is safe, and as opposed to other studies of revisional bariatric surgery, has similar 30-day complication rates to primary SADI-S.

Endoscopic mucosal incision and muscle interruption (MIMI) for the treatment of Zenker's diverticulum.

BACKGROUND: In peroral endoscopic myotomy for Zenker's diverticulum (Z-POEM), the cricopharyngeus muscle is divided within a submucosal tunnel started in the hypopharynx. We aimed to evaluate the safety and preliminary outcomes in patients who underwent a modified version of the Z-POEM where the tunnel is made directly overlying the cricopharyngeus, the mucosal incision and muscular interruption (MIMI) approach, and to compare these with patients who underwent a non-tunneled flexible endoscopic approach. METHODS: All patients with ZD who were treated by flexible endoscopy at our institution between January 2015 and February 2020 were identified by a retrospective chart review. Dysphagia symptoms were assessed using a validated scoring system. RESULTS: Nineteen patients with ZD underwent MIMI (mean age 76.1 years, 68.1% male) and seven patients underwent non-tunneled flexible endoscopic approach (mean age 64.4 years, 85.7% male) during the study period. Mean ZD size was 2.8 cm in the MIMI group and 1.9 cm in the non-tunneled group (p = 0.03). Clinical success was achieved in 17/19(89.5%) MIMI patients and 7/7(100%) of non-tunneled flexible endoscopic patients (p = 0.101). Dysphagia scores improved in both groups, although this difference was only significant in the MIMI group (p ≤ 0.001). Recurrence occurred in 2/17(11.7%) MIMI patients and 3/7(42.9%) non-tunneled flexible endoscopic patients (p = 0.096). There were 4 complications, including one pharyngeal perforation requiring open surgical repair in a patient with a small ZD with an associated cricopharyngeal bar in the MIMI group. Median length of follow-up was 290 [142; 465] days in the MIMI group and 1056 [258; 1206] days in the non-tunneled group (p = 0.094). CONCLUSIONS: MIMI is a technically feasible and effective treatment for ZD. Care should be taken in patients with a cricopharyngeal bar and small ZD, as this may increase the risk of perforation. Larger studies with long-term follow-up are needed to determine if MIMI reduces the risk of symptom recurrence when compared to non-tunneled flexible endoscopic approaches.

Gastrectomy versus stomach left in situ with Roux-en-Y reconstruction for the treatment of gastroparesis.

BACKGROUND: Gastroparesis is a debilitating functional disorder of the stomach marked by delayed gastric emptying in the absence of mechanical obstruction. Patients with severe, refractory symptoms may ultimately be managed with Roux-en-Y reconstruction; however, it is unclear whether the stomach should be left in situ, similar to a conventional gastric bypass, or resected as in gastrectomy. METHODS: All patients undergoing Roux-en-Y for the treatment of gastroparesis (GP) at our institution from September 2010 through March 2018 were retrospectively reviewed. Patients with prior gastric resection or whose primary operative indication was not gastroparesis were excluded from analysis. RESULTS: Twenty-six patients underwent Roux-en-Y with stomach left in situ (RY-SIS) and twenty-seven patients underwent gastrectomy with Roux-en-Y reconstruction during the study period. The mean age was 49.7 years in the RY-SIS cohort and 48.5 years in the gastrectomy cohort. Etiology of GP was similar between the two cohorts. Patients undergoing gastrectomy were more likely to have previous interventions for GP (63.0% vs. 26.9%). RY-SIS was associated with a shorter operative time (155 vs. 223 min), less blood loss (24 vs. 130 mL), and shorter length of stay (4.0 vs. 7.2 days). Twelve patients (44.4%) had complications within 30 days following gastrectomy compared to two patients (7.7%) following RY-SIS (p = 0.001). Patients in the RY-SIS cohort were more likely to require further subsequent surgical intervention for GP (23.1% vs. 3.7%, p = 0.04). At last follow-up, there were no differences in reported GP symptoms or symptom scoring. CONCLUSIONS: Gastrectomy was associated with greater perioperative morbidity compared to leaving the stomach in situ. Symptomatic improvement at intermediate follow-up was equivalent following either procedure. However, patients undergoing RY-SIS were more likely to require subsequent surgical intervention, suggesting that gastrectomy may be a more definitive operation for the management of medically refractory gastroparesis.

Minimally invasive Roux-en-Y reconstruction as a salvage operation after failed nissen fundoplication.

BACKGROUND: Conversion of Nissen fundoplication to Roux-en-Y (RnY) anatomy may be indicated in patients with post-surgical complications or who fail to achieve durable control of their disease. Herein we describe the largest series of patients at a single institution who underwent minimally invasive conversion of Nissen fundoplication to RnY reconstruction. METHODS: All patients with prior Nissen fundoplication which were converted to RnY anatomy at our institution from March 2009 through November 2017 were retrospectively reviewed and analyzed. Patients were identified based on CPT codes and the description of the operation performed. All cases with attempted minimally invasive approach were included for analysis. RESULTS: Fifty patients underwent conversion from prior Nissen fundoplication to RnY anatomy during the study period. The cohort was 84.0% female with a mean age of 53.5 years and a median body mass index of 36.7 kg/m2. Thirteen patients (26.0%) had multiple prior foregut operations. Complications from fundoplication that warranted revision included recurrent hiatal hernia (n = 16), post-surgical gastroparesis (n = 10), and mechanical complications from the wrap (n = 8). An additional fourteen patients underwent conversion to RnY for metabolic disease. The mean operative time and estimated blood loss were 266 min and 132 mL, respectively, with all but one (98.0%) completed with a minimally invasive approach. The median length of stay was 5 days. Complications included marginal ulcer (n = 2), superficial surgical site infection (n = 2), anastomotic leak (n = 2), and one case each of pulmonary embolism, small bowel obstruction, and gastrointestinal bleeding. There were no mortalities at a median follow-up of 12.4 months. CONCLUSIONS: Conversion of prior Nissen fundoplication to RnY anatomy is technically challenging, although it is safe and feasible even in the setting of multiple prior foregut operations. A minimally invasive approach should be offered to patients by surgeons with experience in revisional foregut and bariatric surgery.

Enhanced recovery outcomes following per-oral pyloromyotomy (POP): a comparison of safety and cost with same-day discharge versus inpatient recovery.

BACKGROUND: While per-oral pyloromyotomy (POP) has shown promise as a novel endoscopic procedure to treat medically refractory gastroparesis, standardized care pathways are not well-defined. We aimed to compare the safety and cost of same-day discharge (SDD) after POP with inpatient stay overnight or longer. METHODS: All patients with SDD after POP between January 2016 and May 2018 were retrospectively identified from a prospectively maintained registry. Propensity scores considering gender, age, gastroparesis etiology, and American Society of Anesthesiologists (ASA) class were used to match a comparison group which stayed overnight or longer. Statistical tests included two-sample t tests for continuous variables, Fisher's exact test for categorical variables, and paired sample t tests for within-group comparisons with repeated measures. RESULTS: Fifty-four patients who underwent POP with SDD during the study period were propensity-matched with 54 patients with inpatient recovery. The SDD cohort was 85.2% female with a mean age of 44.8 years and median ASA class 3. The etiology of gastroparesis was idiopathic in 53.7% (n = 29), diabetic in 29.6% (n = 16), and post-surgical in 11.1% (n = 6). Operative time was shorter in the SDD cohort (25.4 vs. 31.3 min, p = 0.02). The mean post-procedure recovery time was 4 h in patients with SDD and 29.3 h in the inpatient cohort (p < 0.001). There was a trend towards less readmissions with SDD (7.4% vs. 18.5%, p = 0.08). There was no increased risk of complications with SDD (1.9% vs. 3.7%, p = 0.57). Compared to inpatient recovery, the average total cost for the procedure, recovery, and all subsequent care within 30 days was 26.0% less with SDD (p < 0.001). CONCLUSIONS: Following POP, patients can be safely discharged the same day with low risk of both complications and readmission. Total costs in the complete perioperative period are significantly less with SDD compared to inpatient recovery.

Laparoscopic pyloroplasty versus endoscopic per-oral pyloromyotomy for the treatment of gastroparesis.

BACKGROUND: Gastroparesis is a debilitating functional disorder of the stomach characterized by delayed gastric emptying absent an obstructive etiology. Surgical or endoscopic disruption of the pylorus has been utilized to treat this disease, but there is little evidence comparing laparoscopic pyloroplasty (LP) with endoscopic per-oral pyloromyotomy (POP). Herein we describe our experience at our institution using a propensity-matched cohort study to compare outcomes between these procedures. METHODS: All patients who underwent LP for the treatment of gastroparesis from October 2014 through September 2017 at our institution were retrospectively reviewed. Propensity scoring was used to match these patients 1:1 to patients undergoing POP during this time period based on gender, age, and etiology of gastroparesis. Symptom scores using the Gastroparesis Cardinal Symptom Index (GCSI), scintigraphic gastric emptying studies (GES), and perioperative outcomes were compared between matched cohorts. Thirty patients underwent LP for gastroparesis during the study period which were matched 1:1 with patients undergoing POP. The etiology of gastroparesis was 63.3% idiopathic (n = 19), 20.0% post-surgical (n = 6), and 16.7% diabetic (n = 5) in both cohorts. RESULTS: Patients who underwent LP had a longer average length of stay (4.6 vs. 1.4 days, p = 0.003), operative time (99.3 vs. 33.9 min, p < 0.001), and estimated blood loss (12.9 vs. 0.4 mL, p < 0.001). There were more complications in the LP cohort (16.7 vs. 3.3%, p = 0.086), which included surgical site infection (6.7 vs. 0%, p = 0.153), pneumonia (6.7 vs. 0.0%, p = 0.153), and unplanned ICU admission (10.0 vs. 0.0%, p = 0.078). LP and POP both resulted in similar, significant improvements in both in GCSI scores and objective gastric emptying. CONCLUSIONS: Per-oral endoscopic pyloromyotomy (POP) is safe and effective for the treatment of medical refractory gastroparesis. POP has less perioperative morbidity compared to LP with comparative functional outcomes.

Common bile duct dilation after bariatric surgery.

BACKGROUND: Biliary dilation suggests obstruction and prompts further work up. Our experience with endoscopic ultrasound and endoscopic retrograde cholangiopancreatography in the symptomatic post-bariatric surgery population revealed many patients with radiographically dilated bile ducts, but endoscopically normal studies. It is unclear if this finding is phenomenological or an effect of surgery. Additionally, it is unknown whether the type of bariatric surgery alters biliary pathophysiology. Thus, we studied whether a change occurs in biliary diameter following Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy (SG). METHODS: A single-center retrospective study assessing biliary diameter before and after RYGB or SG based on radiographic imaging. All adult patients undergoing RYGB or SG from January 2010 to December 2013 who had imaging studies before and > 3 months after surgery were included. Those with known obstructive etiologies and those without post-operative imaging were excluded. Common bile duct (CBD) diameter was re-read by a radiologist at the same location in the CBD for pre- and post-operative imaging. Baseline clinical factors and cholecystectomy status were collected. RESULTS: 269 patients met inclusion criteria (193 RYGB;76 SG). Between the groups, there were no significant differences in pre-operative characteristics. Average time from surgery to repeat imaging was 24.1 months. After adjusting for pre-operative factors, subjects who underwent an RYGB had an increase in CBD diameter of 1.4 mm (95% CI 0.096, 0.18), which was greater than the change following SG 0.5 mm(95% CI - 0.007, 0.11). The magnitude of this change did not depend on prior cholecystectomy in the RYGB cohort. Within the SG group, for patients without a prior cholecystectomy, there was a significant increase in post-operative CBD diameter of 0.8 mm(95% CI 0.02, 0.14). CONCLUSION: Bariatric surgery results in CBD dilation, with changes more pronounced after RYGB. Biliary dilation occurs irrespective of cholecystectomy status. Further work is necessary to determine the cause and clinical implications of this phenomenon.

Per-oral Pyloromyotomy (POP) for Medically Refractory Gastroparesis: Short Term Results From the First 100 Patients at a High Volume Center.

OBJECTIVE: For patients with gastroparesis, temporary pyloric disruption has been shown to improve symptoms and gastric emptying. Per-oral pyloromyotomy (POP) is an innovative endoscopic procedure to divide the pylorus from within a submucosal tunnel, as a corollary to surgical pyloromyotomy. Here we evaluate subjective and objective outcomes 12-weeks after POP at a high volume center. METHODS: The first 100 consecutive patients undergoing POP were included, with procedure dates between January 2016 and October 2017. Patients were evaluated using the Gastroparesis Cardinal Symptom Index (GCSI), and 4-hour solid-phase scintigraphic gastric emptying studies (GES) prior to procedure and at 90 days post-POP RESULTS:: The study cohort was 85% female with a mean age of 45.0 ±â€Š14.6 years. Gastroparesis etiologies were divided among idiopathic (56%), diabetic (21%), postsurgical (19%), and other in 4%. There were 67% of the patients who had previous endoscopic or surgical interventions for gastroparesis. Most POP procedures were performed in the operating room (97%) and were completed in an average of 33 minutes. Ten patients incurred complications (10%), which included 1 diagnostic laparoscopy and 2 cases of gastrointestinal bleeding. Overall GCSI improved from a preoperative mean of 3.82 ±â€Š0.86 to 2.54 ±â€Š1.2 (P < 0.001). The improvement in each GCSI subscore was also highly statistically significant. Among the patients with postoperative GES available, 78% had objectively better 4-hour emptying with a mean improvement in retention by 23.6% (P < 0.001). This included 57% of patients with normal gastric emptying post-POP. CONCLUSION: For patients with medically refractory gastroparesis, POP results in both subjective and objective improvement in the majority of patients. Prior intervention does not obviate POP as a therapeutic option. POP should be included along the treatment algorithm for patients with gastroparesis as an organ-sparing procedure.

Multicenter evaluation of the clinical utility of laparoscopy-assisted ERCP in patients with Roux-en-Y gastric bypass.

BACKGROUND AND AIMS: The obesity epidemic has led to increased use of Roux-en-Y gastric bypass (RYGB). These patients have an increased incidence of pancreaticobiliary diseases, yet standard ERCP is not possible because of surgically altered gastroduodenal anatomy. Laparoscopy-assisted ERCP (LA-ERCP) has been proposed as an option, but supporting data are derived from single-center small case series. Therefore, we conducted a large multicenter study to evaluate the feasibility, safety, and outcomes of LA-ERCP. METHODS: This is a retrospective cohort study of adult patients with RYGB who underwent LA-ERCP in 34 centers. Data on demographics, indications, procedure success, and adverse events were collected. Procedure success was defined when all the following were achieved: reaching the papilla, cannulating the desired duct, and providing endoscopic therapy as clinically indicated. RESULTS: A total of 579 patients (median age, 51; 84% women) were included. Indication for LA-ERCP was biliary in 89%, pancreatic in 8%, and both in 3%. Procedure success was achieved in 98%. Median total procedure time was 152 minutes (interquartile range [IQR], 109-210), with a median ERCP time of 40 minutes (IQR, 28-56). Median hospital stay was 2 days (IQR, 1-3). Adverse events were 18% (laparoscopy related, 10%; ERCP related, 7%; both, 1%) with the clear majority (92%) classified as mild/moderate, whereas 8% were severe and 1 death occurred. CONCLUSIONS: Our large multicenter study indicates that LA-ERCP in patients with RYGB is feasible with a high procedure success rate comparable with that of standard ERCP in patients with normal anatomy. The ERCP-related adverse events rate is comparable with conventional ERCP, but the overall adverse event rate was higher because of the added laparoscopy-related events.

An Odyssey of complications from band, to sleeve, to bypass; definitive laparoscopic completion gastrectomy with distal esophagectomy and esophagojejunostomy for persistent leak.

INTRODUCTION: Anastomotic leaks are uncommon yet potentially devastating complications after bariatric surgery. While the initial management includes resuscitation and sepsis control, the definitive management often requires endoscopic or surgical interventions. Surgical revision of the initial surgery may be necessary for chronic non-healing fistula. PATIENTS AND METHODS: The patient is a 45-year-old female with history of laparoscopic adjustable gastric banding who underwent band removal and conversion to a sleeve gastrectomy (SG) due to her failed weight loss, which resulted in a leak at gastroesophageal junction. She underwent multiple attempted endoluminal treatments without success and then SG was converted to Roux-en-Y gastric bypass (RYGB). However, this failed and the persistent leak led to a gastro-pleural fistula requiring left chest decortication. After addressing nutritional deficiencies, she underwent laparoscopic completion gastrectomy and Roux-en-Y esophagojejunostomy reconstruction. RESULTS: Five ports and a liver retractor were placed. Dissection was carried down posteriorly to free up the Roux limb and then to the right crus. There was an abscess cavity around the left crus. The esophagus was circumferentially mobilized and the abscess cavity was debrided. The proximal Roux limb was disconnected with a linear stapler. Upper endoscopy was used to identify the leak. The healthy tissue was confirmed above the leak and the distal esophagus was transected. Esophageal stump was mobilized up into the middle mediastinum. Esophagojejunostomy was completed with 25 mm circular stapler. A linear stapler was used to close the candy cane. The procedure took 2 h and 40 min. Estimated blood loss was 100 ml. Her postoperative course was uncomplicated. CONCLUSION: We present a video of the complex surgical revision of a leak after through the gamut of bariatric surgery: band to sleeve, failed endoluminal therapy and conversion of SG to RYGB. Durable success was achieved by a completion gastrectomy, distal esophagectomy with Roux-en-Y esophagojejunostomy.

Erratum to: First human use of hybrid synthetic/biologic mesh in ventral hernia repair: a multicenter trial.

Some values in the pages 1, 3, and 5 of the original article are corrected and also an updated Table 5 is displayed.

Surgical management of gastroesophageal reflux disease in patients with systemic sclerosis.

BACKGROUND: Systemic sclerosis (scleroderma) is frequently associated with both gastroesophageal reflux disease (GERD) and simultaneous esophageal dysmotility. Anti-reflux procedures in this patient population must account for the existing physiology of each patient and likely disease progression. We aim to compare perioperative and intermediate outcomes of fundoplication versus gastric bypass for the treatment of GERD. METHODS: After IRB approval, patients with systemic sclerosis undergoing fundoplication or gastric bypass for the treatment of GERD from 2004 to 2016 were identified. Demographics, perioperative data, immediate complications, and symptom improvement were retrieved and analyzed. RESULTS: Fourteen patients with systemic sclerosis underwent surgical treatment of GERD during the defined study period. Average body mass index was 26 kg/m2. Seven fundoplications (2 Nissens, 4 Toupets, and 1 Dor) and 7 Roux-en-Y gastric bypasses (RYGB) were performed. No 30-day mortality was observed in either group. Median follow-up was 97 months for the fundoplication group (range 28-204 months), and 19 months for the RYGB group (range 1-164 months). Preoperatively, dysphagia, heartburn, and regurgitation were present in 71% (n = 10), 86% (n = 12), and 64% (n = 9) of patients, respectively. Eleven patients had pH study prior to surgical intervention, and 91% of them had abnormal acid exposure. Esophagitis was evident in 85% (n = 11) of patients during preoperative upper endoscopy, and two patients had Barrett's esophagus. Impaired esophageal motility was present in all RYGB patients and 71% of fundoplication patients. Of the patients who had assessment of their GERD symptoms at follow-up, all five patients in the RYGB group and only 3 (50%) patients in the fundoplication group reported symptom improvement or resolution. CONCLUSIONS: Laparoscopic RYGB as an anti-reflux procedure is safe and may provide an alternative to fundoplication in the treatment of GERD for systemic sclerosis patients with esophageal dysmotility.

First human use of hybrid synthetic/biologic mesh in ventral hernia repair: a multicenter trial.

BACKGROUND: Mesh options for reinforcement of ventral/incisional hernia (VIH) repair include synthetic or biologic materials. While each material has known advantages and disadvantages, little is understood about outcomes when these materials are used in combination. This multicenter study reports on the first human use of a novel synthetic/biologic hybrid mesh (Zenapro® Hybrid Hernia Repair Device) for VIH repair. METHODS: This prospective, multicenter post-market clinical trial enrolled consecutive adults who underwent elective VIH repair with hybrid mesh placed in the intraperitoneal or retromuscular/preperitoneal position. Patients were classified as Ventral Hernia Working Group (VHWG) grades 1-3 and had clean or clean-contaminated wounds. Outcomes of ventral and incisional hernia were compared using appropriate parametric tests. RESULTS: In all, 63 patients underwent VIH repair with hybrid mesh. Most were females (54.0%), had a mean age of 54.8 ± 10.9 years and mean body mass index of 34.5 ± 7.8 kg/m2, and classified as VHWG grade 2 (87.3%). Most defects were midline (92.1%) with a mean area of 106 ± 155 cm2. Cases were commonly classified as clean (92.1%) and were performed laparoscopically (60.3%). Primary fascial closure was achieved in 82.5% with 28.2% requiring component separation. Mesh location was frequently intraperitoneal (69.8%). Overall, 39% of patients available for follow-up at 12 months suffered surgical site events, which were generally more frequent after incisional hernia repair. Of these, seroma (23.7%) was most common, but few (8.5%) required procedural intervention. Other surgical site events that required procedural intervention included hematoma (1.7%), wound dehiscence (1.7%), and surgical site infection (3.4%). Recurrence rate was 6.8% (95% CI 2.2-16.6%) at 12-months postoperatively. CONCLUSION: Zenapro® Hybrid Hernia Repair Device is safe and effective in VHWG grade 1-2 patients with clean wounds out to 12 months. Short-term outcomes and recurrence rate are acceptable. This hybrid mesh represents a novel option for reinforcement during VIH repair.

Magnetic surgery: first U.S. experience with a novel device.

INTRODUCTION: Magnet-assisted surgery is a new platform within minimally invasive surgery. The Levita™ Magnetic Surgical System, the first magnetic surgical system to receive Food and Drug Administration (FDA) approval, includes a deployable, magnetic grasper and an external magnet that is used to manipulate the grasper within the peritoneal cavity. This system is currently approved for patients undergoing laparoscopic cholecystectomy with a body mass index (BMI) between 21 and 34 kg/m2. Herein, we detail the first United States experience with the Levita™ Magnetic Surgical System during laparoscopic cholecystectomy. METHODS: The Levita™ Magnetic Surgical System was used on consecutive patients undergoing laparoscopic cholecystectomy at our institution from June 2016 through November 2016. Only patients undergoing elective surgery and those with a body mass index (BMI) between 21 and 34 kg/m2 were included. Baseline patient characteristics, operative time, and perioperative details were collected. RESULTS: A total of ten patients underwent laparoscopic cholecystectomy with the Levita™ Magnetic Surgical System during the defined study period. The mean age at the time of surgery was 49.0 years and the average BMI of the cohort was 27.6 kg/m2. The average operative time was 64.4 min. There were no perioperative complications. Seven (70.0%) patients were discharged to home on the day of surgery, while the remaining three (30.0%) patients were discharged to home on postoperative day number one. Surgeons reported that the magnetic grasper was easy to use and provided adequate tissue retraction and exposure. CONCLUSIONS: The Levita™ Magnetic Surgical System is safe and feasible to use in patients undergoing laparoscopic cholecystectomy. Routine use of this system may facilitate a reduction in the total number of laparoscopic trocars used, leading to less tissue trauma and improved cosmesis. Additional studies are needed to determine the applicability and utility of this system for other general surgery cases.

Comparison of laparoscopic jejunostomy tube to percutaneous endoscopic gastrostomy tube with jejunal extension: long-term durability and nutritional outcomes.

INTRODUCTION: Enteral access through the jejunum is indicated when patients cannot tolerate oral intake or gastric feeding. While multiple approaches for feeding jejunal access exist, few studies have compared the efficacy of these techniques. The purpose of this study was to investigate the long-term durability, re-intervention rates, and nutritional outcomes following percutaneous endoscopic gastrostomy tubes with jejunal extension tubes (PEG-JET) versus laparoscopic jejunostomy tubes (j-tubes). METHODS: Retrospective chart review was performed on all patients who underwent PEG-JET or laparoscopic jejunostomy tube placement from January 2005 through December 2015 at our institution. Thirty-day and long-term outcomes were compared between the two groups. RESULTS: A total of 105 patients underwent PEG-JET and 307 patients underwent laparoscopic j-tube placement during the defined study period. In terms of 30-day outcomes, patients who underwent PEG-JET placement were significantly more likely to experience a tube dislodgement event (p = 0.005) and undergo a re-intervention (p < 0.001). Patients who had a laparoscopic j-tube placed were significantly more likely to meet their enteral feeding goals (p = 0.002) and less likely to require nutritional supplementation with total parenteral nutrition (TPN) (p < 0.001). With regard to long-term outcomes, patients who underwent PEG-JET placement were significantly more likely to experience tube occlusion (p < 0.001) and require an endoscopic or surgical tube re-intervention (p < 0.001). Patients who underwent laparoscopic j-tube placement were significantly more likely to experience a tube site leak (p = 0.015) but were less likely to require nutritional supplementation with TPN (p = 0.001). CONCLUSION: Laparoscopic jejunostomy tubes provide more durable long-term enteral access compared to PEG-JET. Consideration should be given to laparoscopic jejunostomy tube placement in eligible patients who cannot tolerate oral intake or gastric enteral feeding.

Optimal injection solution for endoscopic submucosal dissection: A randomized controlled trial of Western solutions in a porcine model.

BACKGROUND AND AIM: When carrying out endoscopic submucosal dissection (ESD), procedural safety increases with greater tissue elevation and efficiency increases with longer-lasting submucosal cushion. Fluids specifically developed for ESD in Asia are not commercially available in the West, leaving endoscopists to use a variety of injectable fluids off-label. To determine the optimal fluid available in the West, we compared commonly used fluids for Western ESD. METHODS: All phases were carried out in an ex vivo porcine stomach model. Phase 1 compared tissue elevation and duration of submucosal cushions produced by various standard volumes of various injectable solutions used for ESD. The two best-performing solutions used off-label were tested head-to-head in ESD in Phase 2. Phase 3 compared the best solution from Phase 2 to Eleview® , currently the only submucosal injection fluid approved in the USA. In Phases 2 and 3, five ESD were carried out with each solution. The solutions were randomized and the endoscopist blinded to the solution. RESULTS: The best-performing solutions in Phase 1 were 0.4% hyaluronic acid, 6% hydroxyethyl starch (HES), and Eleview® . Phase 2 compared 6% HES and hydroxypropyl methylcellulose (HPMC), showing that ESD with 6% HES was easier (P = 0.007), faster (P = 0.041) and required less injection volume (P = 0.003). In Phase 3, resection speed, ease of ESD and total volume per area resected were comparable between 6% HES and Eleview® . CONCLUSIONS: Of the submucosal injection fluids currently available in the West, Eleview® and 6% HES are the best-performing solutions for ESD in a porcine model.

Per oral endoscopic pyloromyotomy for refractory gastroparesis: initial results from a single institution.

INTRODUCTION: Gastroparesis is a debilitating disease characterized by delayed gastric emptying in the absence of mechanical obstruction. A new intramural technique, per oral endoscopic pyloromyotomy (POP), has been proposed as an alternative to surgical pyloroplasty for the management of medical refractory gastroparesis. Herein, we detail the short-term results of POP at our institution. METHODS: POP was first performed at our institution in January 2016. All patients undergoing POP for management of gastroparesis from January 2016 through January 2017 were prospectively followed. All patients underwent a 4-h, non-extrapolated gastric emptying scintigraphy study and were asked to rate their symptoms using the Gastroparesis Cardinal Symptom Index (GCSI) at their pre-procedure visit and at 3 months post-procedure. RESULTS: A total of 47 patients underwent POP during the defined study period. Twenty-seven (57.4%) patients had idiopathic gastroparesis, 12 (25.6%) had diabetic gastroparesis, and eight (17.0%) had post-surgical gastroparesis. Forty-one (87.2%) patients had at least one previous intervention (i.e., enteral feeding tube, gastric pacer, botox injection) for their gastroparesis symptoms. All patients had evidence of gastroparesis on pre-procedure gastric emptying studies. The average length of hospital stay was 1 day. One patient died within 30-days of their index procedure which was unrelated to the procedure itself. The average pre-procedure percentage of retained food at 4 h was 37% compared to an average post-procedure percentage of 20% (p < 0.03). The average pre-procedure GCSI score was 4.6 compared to an average post-procedure GCSI of 3.3 (p < 0.001). CONCLUSIONS: POP is a safe and feasible endoscopic intervention for medical refractory gastroparesis. Additional follow-up is required to determine the long-term success of this approach in alleviating gastroparesis symptoms.