Prevalence, Indications, and Complications of Conversional Surgery After Vertical Banded Gastroplasty: A MBSAQIP Analysis.

PURPOSE: Vertical banded gastroplasty (VBG) was once the most popular bariatric procedure in the 1980's, with many patients subsequently requiring conversional surgery. However, knowledge regarding the prevalence and outcomes of these procedures remains limited. This study aims to determine the prevalence, indications, rate of 30-day serious complications, and mortality of conversional surgery after VBG. MATERIALS AND METHODS: A retrospective analysis of the MBSAQIP database from 2020 to 2022 was conducted. Individuals undergoing conversional or revisional surgery after VBG were included. The primary outcomes were 30-day serious complications and mortality. RESULTS: Of 716 VBG conversions, the common procedures included 660 (92.1%) Roux-en-Y gastric bypass (RYGB) and 56 (7.9%) sleeve gastrectomy (SG). The main indication for conversion was weight gain for RYGB (31.0%) and for SG (41.0%). RYGB had longer operative times than SG (223.7 vs 130.5 min, p < 0.001). Although not statistically significant, serious complications were higher after RYGB (14.7% vs 8.9%, p = 0.2). Leak rates were higher after SG (5.4 vs 3.5%) but this was not statistically significant (p = 0.4). Mortality was similar between RYGB and SG (1.2 vs 1.8%, p = 0.7). Multivariable regression showed higher body mass index, longer operative time, previous cardiac surgery and black race were independently associated with serious complications. Conversion to RYGB was not predictive of serious complications compared to SG (OR 0.96, 95%CI 0.34-2.67, p = 0.9). CONCLUSIONS: Conversional surgery after VBG is uncommon, and the rate of complications and mortality remains high. Patients should be thoroughly evaluated and informed about these risks before undergoing conversion from VBG.

Revisional Procedures after Sleeve Gastrectomy for Weight Recurrence or Inadequate Weight Loss: An Analysis of the MBSAQIP Database.

INTRODUCTION: The safety of conversional bariatric procedures after sleeve gastrectomy (SG) for weight recurrence (WR) or inadequate weight loss (IWL) is debated due to limited evidence. Conversion options include Roux-en-Y gastric bypass (RYGB), single anastomosis duodeno-ileal bypass (SADI), and biliopancreatic diversion with duodenal switch (BPD-DS). We aimed to compare serious complications and mortality rates between these procedures within 30 days. METHODS: Using the 2020 and 2021 MBSAQIP databases, we identified patients who underwent a conversion from SG to RYGB, SADI, or BPD-DS. We performed a multivariable logistic regression to assess predictors of 30-day complications and mortality. RESULTS: Among 7388 patients (77.6% RYGB, 8.7% SADI, 13.7% BPD-DS), those undergoing SADI and BPD-DS had higher preoperative body mass index. Conversion reasons included WR (63.0%) and IWL (37.0%). SADI and BPD-DS patients had longer operative times (p < 0.001) and higher leak rates (p = 0.001). Serious complications, reoperations, readmissions, and 30-day mortality were similar across groups. Conversion procedure type was not an independent predictor of complications. CONCLUSION: RYGB was the most performed conversional procedure after SG. The study indicated a similar safety profile for revisional RYGB, SADI, and BPD-DS, with comparable 30-day complications and mortality rates. However, SADI and BPD-DS patients had longer operative time and higher leak rates.

Safety and Efficacy of Metabolic Surgery in Patients with Type 2 Diabetes in the Middle East and North Africa Region: An Analysis of Primary Roux-en-Y Gastric Bypass and Sleeve Gastrectomy Outcomes.

INTRODUCTION: Type 2 diabetes (T2D) is a chronic medical condition that results in significant health implications and reduced life expectancy. The International Diabetes Federation (IDF) estimated that in 2021, 51.8% of all deaths of people under 60 years old in the Middle East and North Africa (MENA) region were related to diabetes. Bariatric surgery has been demonstrated to be a safe and effective treatment for T2D in different populations worldwide, though few specific data exist on outcomes of procedures in the MENA region. The aim of this study was to compare the safety and postoperative outcomes between patients with and without T2D undergoing primary bariatric surgery at a tertiary referral academic medical center in the United Arab Emirates. METHODS: All patients who underwent primary metabolic surgery between September 2015 and July 2020 were retrospectively reviewed from a prospective database. Group 1 included patients with T2D, and Group 2 included patients without T2D. Patients undergoing revisional or correctional operations were excluded. The procedure performed was based on surgeon discretion in discussion with a multidisciplinary team and the patient. Demographics as well as perioperative and postoperative results were examined. RESULTS: Our study included 542 patients, 160 (29.5%) with T2D and 382 (70.5%) with non-T2D. Mean age was 44.5 years (range 16-70) in the T2D group and 33.3 years (range 15-63) in the non-T2D group; median BMI was 41.8 ± 7.3 and 43.2 ± 7.2, respectively. The T2D group was 37.5% male and 62.5% female, and the non-T2D group was 38.7% male and 61.3% female. There were no significant differences in comorbidities. In the T2D group, 45.6% of patients underwent Roux-en-Y gastric bypass and 54.4% sleeve gastrectomy. In the non-TD2 group, 42.7% of patients received Roux-en-Y gastric bypass and 57.3% sleeve gastrectomy. There were no statistically significant differences in postoperative ED visits (21.8% vs. 24.3%, p = 0.21), minor complications within 30 days (4.3% vs. 5.2%, p = 0.67), readmission rates (5.6% vs. 4.9%, p = 0.77), re-operation rates (3.7% vs. 1.5%, p = 0.11), median hospital stay (2.0 days vs. 3.0, p = 0.05), or complications after 30 days (6.2% vs. 11.2%, p = 0.07). There were no deaths either group. CONCLUSIONS: In this cohort of patients from the MENA region, bariatric surgery in T2D patients is safe and effective, with perioperative outcomes comparable to those of non-T2D patients. To the best of our knowledge, our postoperative findings, which are the first report in the MENA region, are consistent with studies published in North America and Europe.

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 findings do not predict per-oral pyloromyotomy (POP) response.

INTRODUCTION: Gastroparesis is a life-altering diagnosis caused by the stomach's inability to function in the absence of a mechanical obstruction. The primary causes are idiopathic, diabetic, and postoperative. Our first-line treatment for medical refractory gastroparesis is the endoscopic per-oral pyloromyotomy (POP) procedure. Predicting clinical response cost effectively remains elusive. METHODS: All patients who underwent a POP procedure at our institution by a single surgical endoscopist from January 1, 2019 to June 30, 2020 were retrospectively reviewed. All endoscopic data were prospectively collected. The patients were followed by a survey including the Gastroparesis Cardinal Symptom Index (GCSI) and other relevant postoperative measures. The primary endpoint was clinical response defined as ≥ 1.0 decrease in the GCSI from preoperative to the time of survey. Secondary outcome was normalization of the gastric emptying study (GES). RESULTS: Our patient population is 85% female and has an average age of 44.8 years. The diagnosis of gastroparesis is 71% iatrogenic, 19% postoperative, and 10% diabetic. On endoscopy, 30% had bile in the stomach and 65% had any degree of pylorospasm. The primary outcome measure of clinical response was 39% at an average of 697 ± 151 days post-POP, but 66% of patients attested to an improvement in their symptoms. Of 68 postoperative gastric emptying studies 50% normalized at an average of 145 ± 98 days. Following univariate and multivariate analyses of preoperative data and endoscopic findings, there were no significant predictors of clinical response. A preoperative GCSI ≥ 2.6 trends toward significance (OR 6.87, p = 0.058). CONCLUSION: Endoscopic findings at the time of POP do not correlate with clinical response. The GCSI model currently used to measure clinical response may not accurately capture the full clinical picture. The long-term durability of endoscopic myotomy to treat medical refractory gastroparesis needs to be studied further to improve patient selection.

Predicting serious complications following bariatric surgery in geriatric patients: development of the GeriBari scoring tool using the MBSAQIP database.

BACKGROUND: Geriatric patients have a greater risk of complications after bariatric surgery. The objective of this study was to develop a tool to predict serious complications in geriatric patients after minimally invasive bariatric surgery. OBJECTIVES: To develop a predictive model, GeriBari, for serious complications in geriatric patients after bariatric surgery. SETTING: Multiple accredited bariatric surgery centers in the United States and Canada. METHODS: This was a retrospective cohort study of the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program database, which collects 30-day bariatric surgery outcomes from 868 accredited centers. Geriatric patients defined as those ≥65 years old who underwent primary laparoscopic Roux-en-Y gastric bypass (LRYGB) or laparoscopic sleeve gastrectomy (LSG) were included. Characteristics associated with serious complications were identified using univariate and multivariable analyses. A predictive model, GeriBari, was derived using a forward selection algorithm from operative years 2015, 2017, and 2019. GeriBari's robustness was tested against a validation cohort of subjects from operative years 2016 and 2018. RESULTS: A total of 40,199 geriatric patients underwent LRYGB (27.7%) or LSG (72.3%). Overall, 1866 (4.6%) experienced a complication, which included bleeding (1.6%), reoperation (1.6%), reintervention (1.3%), unplanned intubation (.4%), and pneumonia (.4%). Mortality was higher in the geriatric patients than that in younger patients (.27% versus .08%). GeriBari consists of 12 factors that predicted serious complications and stratified individuals into high- (>6%) and low-risk (<6%) groups. This tool accurately predicted events in the validation cohort with sensitivity of 46.0% and specificity of 100%. CONCLUSIONS: GeriBari enables preoperative risk stratification for 30-day serious complications in geriatric patients undergoing bariatric surgery. Stratifying low- and high-risk geriatric patients for adverse events allows for informed clinical decision-making prior to bariatric surgery.

Real-time intraoperative functioning lumen imaging probe during endoscopic per-oral pyloromyotomy (pop).

BACKGROUND: Endoscopic per-oral pyloromyotomy (POP) has emerged as a safe and effective first line option in medically refractory gastroparesis. Determining the appropriate extent of the pyloromyotomy continues to present a challenge as there are no standardized tools for measuring changes in pyloric distensibility during the procedure. The objective of this study was to evaluate the utility of using impedance planimetry with endoscopic functional luminal imaging probe (FLIP) to measure changes in pyloric distensibility after POP, and to compare these changes with improvement in symptoms and objective gastric emptying. METHODS: Patients with medically refractory gastroparesis underwent POP with FLIP measurements of the pylorus (EndoFLIP®, Medtronic, Fridley MN). FLIP measurements, as well as changes in symptoms measured by the validated gastroparesis cardinal symptom index (GCSI) and scintigraphic gastric emptying studies (GES), were evaluated before and after POP. RESULTS: A total of 14 patients underwent measurement with FLIP during POP, 12 of whom had pre- and post-POP measurements. Mean pyloric diameter increased by 1.4 mm, from 13.9 mm to 15.3 mm (p = 0.0012). Mean distensibility index increased from 6.2 mm2/mmHg to 9.1 mm2/mmHg (p = 0.0074). Successful division of the pylorus was achieved in 100% of patients with a mean operative time of 36 min and no perioperative complications. The mean length of stay was 0.7 days (0-3 days). Post-POP mean GCSI score improved from 2.97 to 2.28 at a mean follow-up time of 27 days (p < 0.001). Objective improvement in gastric emptying was observed in 80% of patients with scintigraphic GES, with mean four-hour retention decreasing from 46.3% to 32.4% (p < 0.007). CONCLUSIONS: FLIP is a safe and feasible tool to provide objective measurements during POP. Larger cohorts with longer follow-up are required to determine if measured improvements in pyloric diameter and distensibility are predictive of sustained improvements in GCSI and GES.

Gastroparesis with concomitant gastrointestinal dysmotility is not a contraindication for per-oral pyloromyotomy (POP).

INTRODUCTION: Per-oral pyloromyotomy (POP or G-POEM) provides significant short-term improvements in symptoms and objective emptying for patients with medically refractory gastroparesis, but it is unclear if patients with gastroparesis and co-existing dysmotility (small bowel or colonic delay) also benefit. In this study, we used wireless motility capsule (WMC) data to measure outcomes in patients with isolated gastroparesis (GP) and gastroparesis with co-existing dysmotility (GP + Dys) who underwent POP. METHODS: We retrospectively analyzed patients who had POP and completed WMC data during their evaluation of intestinal dysmotility. WMC data were reviewed to identify patients who demonstrated isolated GP or GP + Dys. Each patient's pre-op and post-op Gastroparesis Cardinal Symptom Index (GCSI) and 4-h solid-phase scintigraphy gastric emptying studies (GES) scores were compared to evaluate improvement. RESULTS: Of the entire cohort (n = 73), 89% were female with a mean age of 47.0 ± 15.0 years old. Gastroparesis etiologies were divided among idiopathic (54.8%), diabetic (26%), postsurgical (8.2%), autoimmune (5.5%), and multifactorial (5.5%). Forty-one patients (56%) had GP and 32 patients (44%) had GP + Dys. GCSI improved after POP whether the patient had isolated GP (- 12.31, p < 0.001) or GP + Dys (- 9.58, p < 0.001); however, there was no significant difference in total GCSI improvement between the two groups. A subset of patients had postoperative GES available (n = 47). In the isolated GP and GP + Dys cohorts, 15/28 (54%) and 12/19 (63%) patients had normal post-op 4-h GES, respectively, but no statistical difference between the two groups. CONCLUSION: Patients with medically refractory gastroparesis with and without concomitant gastrointestinal dysmotility show short-term subjective and objective improvement after POP. Concomitant small bowel or colonic dysmotility should not deter physicians from offering POP in carefully selected patients with gastroparesis.

Gastric Mass: Intramural Hematoma.

Gastric masses can be challenging to diagnose pre-operatively due to their heterogeneity in presentation and work-up. One must be cautious that a seemingly benign mass may be malignant and vice versa. Some of the more common gastric masses include peptic ulcer, adenocarcinoma, and gastrointestinal stromal tumour. These diagnoses have vastly different management strategies despite similar presentations. The case presented here is an example of this management, highlighting a patient with a gastric bleeding mass initially thought to be a gastrointestinal stromal tumour. However, on final pathology, the mass was determined to be benign, an ulcerated hematoma.

Spontaneous Chest Wall Herniation in Centrally Obese Patients: A Single-Center Experience of a Rare Problem.

BACKGROUND: Spontaneous rib fractures, especially in association with chest wall herniation, represent an uncommon pathology. As such, there are little data analyzing approaches to treatment or regarding the success of intervention. The goal of this study was to analyze our cumulative experience with this unusual condition. METHODS: A case series of 12 patients was gathered from a single institution based on outpatient visits between February 2015 and October 2018. Each chart was retrospectively reviewed with particular attention to age, gender, BMI, area of injury, and smoking history. Patients presented with complaints of dyspnea or pain related to rib fractures with or without intercostal neuralgia. Each of these patients was noted to have rib fractures with lung herniation either on imaging, outside hospital records, or physical exam. A thorough medical history was obtained with attempts to find common predisposing factors as well as data regarding any previous surgical intervention for their herniation. RESULTS: Nine of the 12 patients reviewed had recent or prior surgical intervention. Every patient seen in the clinic with a spontaneous fracture and herniation incidentally had a BMI >30 and was therefore classified as obese. Additionally, every patient who had a recurrence after their first surgical attempt at repair had a BMI greater than or equal to 35. All 12 patients seen at our institution were males. The failure rate of operative intervention was 66%. CONCLUSIONS: Obesity was a prevalent comorbidity in the patient population we reviewed. Given the role obesity plays in abdominal and hiatal hernia repair success rates, it should be considered that obesity is a significant contributor to chest wall herniation if rib fractures occur. With 66% chest wall repair failure, patient selection is critical in the success of surgical intervention. Perhaps additional patient optimization, especially weight loss, should be considered prior to surgery.

Spontaneous Hemoperitoneum From a Ruptured Gastrointestinal Stromal Tumor.

This is a case report of a ruptured gastrointestinal stromal tumor (GIST) presenting as spontaneous hemoperitoneum. The patient was a 63-year-old female with a past medical history of hypertension and ulcerative colitis who presented to the emergency department with worsening epigastric pain. The patient denied history of trauma, previous surgeries, or forceful vomiting. She was not on anticoagulation. Vital signs at presentation were stable. A CT scan of abdomen/pelvis revealed a large amount of fluid in the upper abdomen with high attenuation material adjacent to the greater curvature of the stomach concerning for hemoperitoneum. Diagnostic laparoscopy revealed a significant amount of blood along the upper abdominal viscera. The procedure was converted to an upper midline laparotomy after identifying a necrotic, extremely friable 7 x 6 x 3 cm pedunculated mass with active hemorrhage on the posterior aspect of the greater curvature. A wedge resection was performed to remove the mass with grossly negative margins. An intraoperative frozen section revealed a stromal tumor with spindle cells. Final pathology revealed a pT3N0M0 stromal tumor with histologic spindle cells and a high mitotic rate (24/5 mm2) consistent with a high-grade GIST. Given tumor rupture at presentation, the patient was started on imatinib therapy for a minimum duration of three years. GISTs are often asymptomatic or cause mild abdominal pain or GI bleeding. Rarely, an exophytic GIST may rupture leading to intraperitoneal bleeding. Surgical resection with negative margins is the mainstay of treatment although patients presenting with tumor rupture are at higher risk of dissemination and recurrence.

Emergent Management of a Tracheoinnominate Fistula in the Community Hospital Setting.

Tracheoinnominate fistula is a rare but highly lethal complication of tracheostomy. Early recognition and interventions are key to patient survival. A 63-year-old woman had undergone tracheostomy for respiratory failure secondary to disseminated histoplasmosis. She presented to the community hospital intensive care unit from a long-term acute care facility for presumed gastrointestinal bleeding. A tracheoinnominate fistula was suspected when there was bleeding around the tracheostomy. The patient underwent a median sternotomy with innominate artery ligation. The article will discuss the presentation, evaluation, and emergent management of this lethal complication of tracheostomies. The patient survival is dependent on high clinical suspicion, rapid diagnosis, and emergent surgical management.

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.

Completion Gastrectomy with Esophagojejunostomy for Management of Complications of Benign Foregut Surgery.

BACKGROUND: With the worldwide epidemic of obesity, an increasing number of bariatric operations and antireflux fundoplications are being performed. Despite low morbidity of the primary foregut surgery, completion gastrectomy may be necessary as a definitive procedure for complications of prior foregut surgery; however, the literature evaluating outcomes after completion gastrectomy with esophagojejunostomy (EJ) for benign diseases is limited. We present our experience of completion gastrectomy with Roux-en-Y EJ in the setting of benign disease at a single tertiary center. METHODS AND PROCEDURES: All patients who underwent total, proximal, or completion gastrectomy with EJ for complications of benign foregut surgery from January 2006 to December 2015 were retrospectively identified. All cancer operations were excluded. RESULTS: There were 23 patients who underwent gastrectomy with EJ (13 laparoscopic EJ [LEJ] and 10 open EJ). The index operations included 12 antireflux, 9 bariatric, and 2 peptic ulcer disease surgeries. Seventy-eight percent of patients had surgical or endoscopic interventions before EJ, with a median of one prior intervention and a median interval from the index operation to EJ of 25 months (interquartile range 9-87). The 30-day perioperative complication rate was 30% with 17% classified being major (Clavien-Dindo ≥ III) and no 30-day perioperative mortality. Comparing laparoscopic and open approaches showed similar operative times, estimated blood loss, and overall complication rate. LEJ was associated with a shorter length of stay (LOS) (P < .001), fewer postoperative ICU days (P = .002), fewer 6-month complication rates (P < .007), and decreased readmission rate (P = .024). CONCLUSION: Our series demonstrates that EJ is a reasonable option for reoperative foregut surgery. The laparoscopic approach appears to be associated with decreased LOS and readmissions.

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.

How I Do It: Per-Oral Pyloromyotomy (POP).

INTRODUCTION: Several surgical treatments exist for treatment of gastroparesis, including gastric electrical stimulation, pyloroplasty, and gastrectomy. Division of the pylorus by means of endoscopy, Per-Oral Pyloromyotomy (POP), is a newer, endoluminal therapy that may offer a less invasive, interventional treatment option. METHODS: We describe and present a video of our step by step technique for POP using a lesser curvature approach. The following are technical steps to complete the POP procedure from the lesser curve approach. CONCLUSION: In our experience, these methods provide promising initial results with low operative risks, although long-term outcomes remain to be determined.

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.

The LargPAD Trial: Phase IIA evaluation of l-arginine infusion in patients with peripheral arterial disease.

OBJECTIVE: Endothelial function is improved by l-arginine (l-arg) supplementation in preclinical and clinical studies of mildly diseased vasculature; however, endothelial function and responsiveness to l-arg in severely diseased arteries is not known. Our objective was to evaluate the acute effects of catheter-directed l-arg delivery in patients with chronic lower extremity ischemia secondary to peripheral arterial disease. METHODS: The study enrolled 22 patients (45% male) with peripheral arterial disease (mean age, 62 years) requiring lower extremity angiography. Endothelium-dependent relaxation of patent but atherosclerotic superficial femoral arteries was measured using a combination of intravascular ultrasound (IVUS) imaging and a Doppler FloWire (Volcano Corporation, Rancho Cordova, Calif) during the infusion of incremental acetylcholine (10-6 to 10-4 molar concentration) doses. Patients received 50 mg (n = 3), 100 mg (n = 10), or 500 mg (n = 9) l-arg intra-arterially, followed by repeat endothelium-dependent relaxation measurement (limb volumetric flow). IVUS-derived virtual histology of the culprit vessel was also obtained. Endothelium-independent relaxation was measured using a nitroglycerin infusion. Levels of nitrogen oxides and arginine metabolites were measured by chemiluminescence and mass spectrometry, respectively. RESULTS: Patients tolerated limb l-arg infusion well. Serum arginine and ornithine levels increased by 43.6% ± 13.0% and 23.2% ± 10.3%, respectively (P < .005), and serum nitrogen oxides increased by 85% (P < .0001) after l-arg infusion. Average vessel area increased by 6.8% ± 1.3% with l-arg infusion (acetylcholine 10-4; P < .0001). Limb volumetric flow increased in all patients and was greater with l-arg supplementation by 130.9 ± 17.6, 136.9 ± 18.6, and 172.1 ± 24.8 mL/min, respectively, for each cohort. Maximal effects were seen with l-arg at 100 mg (32.8%). Arterial smooth muscle responsiveness to nitroglycerin was intact in all vessels (endothelium-independent relaxation, 137% ± 28% volume flow increase). IVUS-derived virtual histology indicated plaque volume was 14 ± 1.3 mm3/cm, and plaque stratification revealed a predominantly fibrous morphology (46.4%; necrotic core, 28.4%; calcium, 17.4%; fibrolipid, 6.6%). Plaque morphology did not correlate with l-arg responsiveness. CONCLUSIONS: Despite extensive atherosclerosis, endothelial function in diseased lower extremity human arteries can be enhanced by l-arg infusion secondary to increased nitric oxide bioactivity. Further studies of l-arg as a therapeutic modality in patients with endothelial dysfunction (ie, acute limb ischemia) are warranted.

Dextran or Saline Can Replace Contrast for Intravascular Optical Coherence Tomography in Lower Extremity Arteries.

PURPOSE: To examine the hypothesis that alternative flush media could be used for lower extremity optical coherence tomography (OCT) imaging in long lesions that would normally require excessive use of contrast. METHODS: The OPTical Imaging Measurement of Intravascular Solution Efficacy (OPTIMISE) trial was a single-center, prospective study (ClinicalTrials.gov identifier NCT01743872) that enrolled 23 patients (mean age 68±11 years; 14 men) undergoing endovascular intervention involving the superficial femoral artery. Four flush media (heparinized saline, dextran, carbon dioxide, and contrast) were used in succession in random order for each image pullback. Quality was defined as ≥270° visualization of vessel wall layers from each axial image. Mean proportions (± standard deviation) of image quality for each flush medium were assessed using 1-way analysis of variance and are reported with the 95% confidence intervals (CI). RESULTS: Four OCT catheters failed, leaving 19 patients who completed the OCT imaging protocol; from this cohort, 51 highest quality runs were selected for analysis. Average vessel diameter was 3.99±1.01 mm. OCT imaging allowed 10- to 15-µm resolution of the lumen border, with diminishing quality as vessel diameter increased. Plaque characterization revealed fibrotic lesions. Mean proportions of image quality were dextran 87.2%±12% (95% CI 0.81 to 0.94), heparinized saline 74.3%±24.8% (95% CI 0.66 to 0.93), contrast 70.1%±30.5% (95% CI 0.52 to 0.88), and carbon dioxide 10.0%±10.4% (95% CI 0.00 to 0.26). Dextran, saline, and contrast provided better quality than carbon dioxide (p<0.001). CONCLUSION: OCT is feasible in peripheral vessels <5 mm in diameter. Dextran or saline flush media can allow lesion characterization, avoiding iodinated contrast. Carbon dioxide is inadequate for peripheral OCT imaging. Axial imaging may aid in enhancing durability of peripheral endovascular interventions.

Elevated Peak Systolic Velocity and Velocity Ratio from Duplex Ultrasound are Associated with Hemodynamically Significant Lesions in Arteriovenous Access.

BACKGROUND: Duplex ultrasound (DUS) is reliably used to detect lesions in the peripheral and carotid arterial beds and venous system. Although commonly used in clinical practice, duplex criteria to define lesions in arteriovenous access are not well characterized. This study will define the optimal Doppler-derived peak systolic velocity (PSV) and velocity ratio (VR) to identify >50% lesions in arteriovenous fistulas (AVF) and arteriovenous grafts (AVG). METHODS: This retrospective analysis includes patients with both DUS and fistulogram within 30 days. DUS-derived PSV and VR were recorded for 3 segments of each access and compared with fistulograms of the same 3 segments of each AV access. Receiver operating characteristic (ROC) was used to determine the optimal DUS criteria for diagnosis of >50% stenosis. RESULTS: Fifty pairs of imaging in 40 patients were available for analysis. Mean PSV and VR for segments with greater than 50% stenosis were significantly greater than those without; mean PSV of 480 cm/sec vs. 297 cm/sec (P < 0.001) and mean VR of 3.81 vs. 2.09 (P < 0.001). The ROC analysis demonstrated an optimal PSV of 404 and VR of 2.2 to diagnose >50% stenosis with area under the curve of 0.825 and 0.821 for PSV and VR, respectively. PSV of 500 had sensitivity (Se) of 0.60, specificity (Sp) of 0.86, positive predictive value (PPV) of 0.72, and negative predictive value (NPV) of 0.78. VR of 3.0 had Se of 0.52, Sp of 0.91, PPV of 0.77, and NPV of 0.75. CONCLUSIONS: DUS-derived PSV of 400 cm/sec and VR of 2.25 have good discrimination to predict greater than 50% stenosis in AVFs and AVGs. Given the broad range of velocities in AV accesses, a threshold of PSV greater than 500 cm/sec and VR greater than 3.0, will reliably identify graft-threatening lesions. Se and Sp of PSV 500 are 0.596 and 0.854, respectively. Se and Sp for VR 3.0 are 0.519 and 0.894, respectively.