Hybrid angioplasty-catheter placement procedure performed in a hemodialysis patient with central venous obstruction disease. Presentation of a case.

Obstruction or occlusion of the central veins (Central venous disease, CVD) represents a major complication in hemodialysis patients (HD) limiting central venous access available for a central venous catheter placement. Endovascular treatment with percutaneous transluminal angioplasty (PTA) is the first therapeutic option to restore patency and gain access. This case presents our initial experience of a HD patient with CVD treated with a combination therapy of a balloon PTA to the left brachiocephalic trunk, through the right hepatic vein and standard catheter placement technique to the previously occluded junction of the left internal jugular vein to the left subclavian vein.

The Elipse Balloon, a swallowable gastric balloon for weight loss not requiring sedation, anesthesia or endoscopy: a pilot study with 12-month outcomes.

BACKGROUND: The Elipse Balloon is a swallowable gastric balloon for weight loss that can be deployed without the use of endoscopy or anesthesia. This study aims to report on 12-month safety and efficacy outcomes. SETTING: Private hospital, Athens, Greece. METHODS: This was a prospective, nonrandomized open trial. Twelve patients between 18 and 64 years of age with a body mass index (BMI) of 27.0 to 40.0 kg/m2 were enrolled. The Elipse capsule is swallowed with water and its location in the stomach is confirmed by x-ray. All patients received diet and exercise counseling only during the therapy period (0-4 mo). Eight months later they were seen in clinic to assess 12-month outcomes. RESULTS: There were 7 (58.3%) females and 5 (41.7%) males. The mean age was 41 years, mean BMI was 35.9 kg/m2, mean weight was 103.5±15.8 kg, and mean waist circumference was 117.6±14.9 cm. All patients swallowed the balloon. Eleven (91.7%) balloons were filled and were included in subsequent analysis. All balloons were excreted safely, and no serious adverse events were reported. Accommodative symptoms were not severe and of very short duration. Mean excess weight loss percentage and total weight loss percentage were 50.2% and 14.6% at balloon excretion and 17.6% and 5.9% at 12 months, respectively. There was a statistically significant improvement in patients' weight, BMI, body fat, waist circumference, diastolic blood pressure, HbA1C, cholesterol, thyroid stimulating hormone, aspartate transaminase, and alanine transaminase at balloon excretion. Quality of life was significantly improved at excretion and 12 months. CONCLUSIONS: This study is the first to demonstrate 12-month efficacy and performance outcomes of the Elipse Balloon.

Elipse, the first procedureless gastric balloon for weight loss: a prospective, observational, open-label, multicenter study.

Background and study aims Conventional gastric balloons for weight loss require endoscopy for placement and removal. The Elipse device is swallowed, resides in the stomach for 4 months, and is then expelled. The objectives of this study were to assess the safety of Elipse and to measure its effects on weight loss, metabolic parameters, and quality of life. Methods Each participant swallowed one Elipse device, which was filled with 550 mL of filling fluid through a thin delivery catheter that was then removed. Weight was measured every 2 weeks, and metabolic parameters and quality of life were assessed at baseline and at trial exit. Results 34 patients, with a mean body mass index of 34.8 kg/m2, were enrolled. All 34 patients successfully swallowed the Elipse device. All adverse events were either self-limiting or resolved with medication. All balloons were safely excreted. At 4 months, the mean percent total body weight loss was 10 %. Mean waist circumference was reduced by 8.4 cm. Improvements were also seen in hemoglobin A1c, triglycerides, low density lipoprotein, and blood pressure. At trial exit, quality of life measures had improved across all domains. Conclusion These results demonstrate clinically significant weight loss with the Elipse, the first procedureless gastric balloon. The weight loss was similar to that seen in previous studies of endoscopically placed balloons. In addition, Elipse therapy led to improvements in waist circumference, several metabolic parameters, and overall quality of life.ClinicalTrials.gov identifier: NCT 02802007.

Prospective 30-Day Outcome Evaluation of a Fast-Track Protocol for 23-Hour Ambulatory Primary and Revisional Laparoscopic Roux-en-Y Gastric Bypass in 820 Consecutive Unselected Patients.

BACKGROUND: Results from validated national databases suggest that a 1-day length of stay (LOS) is not only unattainable in more than 20% of primary laparoscopic Roux-en-Y gastric bypass (LRYGB) operations, but it is also associated with an increased 30-day mortality risk. There are no published data regarding the feasibility and safety of 1-day LOS after revisional LRYGB. STUDY DESIGN: We reviewed 1 surgeon's experience after implementation of a 1-day fast-track protocol (FTP) in 784 primary and 36 revisional consecutive LRYGB patients. Patient demographics, comorbidities, preoperative laboratory values, diagnostic work-up, operative characteristics, LOS, 30-day outcomes, and patient satisfaction scores were prospectively collected in a deidentified registry. Predictors of longer hospitalization were assessed by univariate and multiple regression analysis. RESULTS: One-day LOS was accomplished in 71.9% primary and 58.3% revisional LRYGBs. Median LOS was 1 day for primary and revisional LRYGB and mean lengths of stay were 1.34 and 1.63 days, respectively. "Excellent" or "very good" satisfaction ratings were reported regarding the FTP education provided (95.3%), surgeon's accessibility (98.3%), and hospital care (86.5%). Only 0.34% of patients who had a 1-day LOS indicated that they would benefit from an additional in-hospital stay. In multivariate analysis, independent predictors of longer hospitalization included prolonged operative time, hemoglobin reduction, reoperation for primary LRYGB, and operative time for revisional LRYGB. CONCLUSIONS: A 1-day FTP can be successfully implemented in the majority of primary and revisional LRYGB patients regardless of preoperative patient characteristics without increasing the risk of 30-day morbidity, mortality, reoperations, readmissions, emergency department or outpatient fluid visits, or reducing patient satisfaction.

Protein intake compliance of morbidly obese patients undergoing bariatric surgery and its effect on weight loss and biochemical parameters.

BACKGROUND: Grade D evidence supports a daily protein intake (DPI) of >60 g/d after Roux-en-Y gastric bypass. However, the physiologic effects of this recommendation have yet to be elucidated. The primary aim of the present study was to assess the effects of DPI after laparoscopic Roux-en-Y gastric bypass on weight loss, leptin levels, and albumin levels. The setting was a 617-acute inpatient bed university-affiliated teaching hospital. METHODS: The data from 427 consecutive bariatric surgery patients were prospectively collected from December 2007 to April 2011. The data were analyzed using Pearson's correlation, the chi-square test, the paired t test, analysis of covariance, and hierarchical linear regression analysis. RESULTS: Of the 427 patients, 167 (39.1%) had complete data at 3, 6, and 12 months of follow-up and were used for the present analysis. Of the 427 patients, 140 (83.8%) were women with a mean age and preoperative body mass index (BMI) of 42.7 ± 11 years and 47.3 ± 8.1 kg/m(2), respectively. Of the 427 patients, 71.3% were compliant with a DPI of ≥1 g/kg/d at 12 months postoperatively. The patients had a mean percentage of excess weight loss of 74.9% ± 16.7% and a mean BMI of 29.4 ± 5.4 kg/m2 at 12 months. When controlling for the preoperative BMI, carbohydrate violations, and exercise increase, DPI was associated with a greater percentage of excess weight loss (P = .001), BMI change (P < .0001), and percentage of lean mass (P = .003), and a lower percentage of body fat (P < .0001) at 12 months. CONCLUSION: Excellent compliance with a DPI of ≥1 g/kg/d at 12 months after laparoscopic Roux-en-Y gastric bypass is feasible and might result in the benefits of increased weight loss, a decreased percentage of body fat, and improved percentage of lean mass.

Effect of mood and eating disorders on the short-term outcome of laparoscopic Roux-en-Y gastric bypass.

BACKGROUND: We examined whether patients with a history of mood and eating disorders (MED) had less weight loss and poorer treatment compliance after laparoscopic Roux-en-Y gastric bypass (LRYGBP) than patients with a history of either mood (MD) or eating disorders (ED), or no history of mood or eating disorders (ND). METHODS: Consecutive LRYGBP patients (n = 196; 43.6 +/- 10.9 years; BMI 47.2 +/- 7.4 kg/m(2); 83.2% female, 91.8% Caucasian) underwent a preoperative psychological evaluation. At 6 months post-surgery, body mass index (BMI), % excess weight loss (%EWL), hospital readmissions, and adherence to behavioral recommendations were assessed. RESULTS: Of the patients, 10.2% had MED, 36.7% had ED only, 24.0% had MD only, and 29.1% of patients had ND. MED patients fared worse than all other groups in dietary violations (p = 0.03), exercise habits (p = 0.05), and readmission rates (p = 0.06) but there were no group differences in either BMI change or %EWL. CONCLUSIONS: MED patients are at-risk for poor treatment compliance following LRYGBP; however, they achieve similar weight losses 6 months postoperatively.

The effect of extended post-discharge chemical thromboprophylaxis on venous thromboembolism rates after bariatric surgery: a prospective comparison trial.

BACKGROUND: The effect of extended post-discharge thromboprophylaxis (ETP) on venous thromboembolism (VTE) rates following bariatric surgery (BS) is unknown. METHODS: 308 consecutive patients who underwent BS between 2003 and 2007 and who had > 1 month of follow-up were included. In-hospital-only VTE prophylaxis (group A), or extended 10-day ETP (group B) was used in 132 and 176 patients, respectively. All patients underwent bilateral lower extremity venous Doppler studies (BLEVDS) prior to discharge. Primary endpoint was the incidence of VTE within 30 days postoperatively. VTE was defined as a clinically evident deep vein thrombosis or pulmonary embolism documented by positive BLEVDS, or computed chest tomography. The primary safety endpoint was bleeding associated with > or = 2 g/dL decrease in hemoglobin compared with baseline, transfusion or reoperation. RESULTS: The incidence of VTE was 1.9% (6/308); 66.6% (4/6) of cases occurred after cessation of thromboprophylaxis. There were no deaths in either group. With the exception of percentage open surgical approach (A: 3% versus B: 0%, p = 0.03), percentage conversions (A: 0 versus B: 3.8%, p = 0.01), and hospital stay (A: 3 versus B: 2.2 days, p < 0.0001), the two groups were comparable in relation to age, sex, body mass index, percentage revision surgery, operative time, and history of VTE. VTE rate was significantly higher in group A (A: 4.5% versus B: 0%, p = 0.006). Although morbidity was higher in group A (A: 12.1% versus B: 1.1%, p < 0.0001), no VTE event occurred in patients who had other complications. The incidence of significant bleeding was lower in group B (A: 5.3% versus B: 0.56%, p = 0.02). CONCLUSIONS: ETP is safe and effective in reducing the incidence of VTE as compared with in-hospital thromboprophylaxis only.

Laparoscopic revision of Nissen fundoplication to Roux-en-Y gastric bypass in morbidly obese patients.

BACKGROUND: We present a case of a morbidly obese patient with previous laparoscopic Nissen fundoplication (LNF) who was successfully treated by revision to a laparoscopic Roux-en-Y gastric bypass (RYGB) and discuss our collective experience. METHODS: Between June 2000 and April 2006 seven morbidly obese patients with mean body mass index (BMI) of 39.4 kg/m(2) underwent laparoscopic revision of LNF to RYGB by our group. Important steps of the revision include lysis of all adhesions between the liver and the stomach, dissection of the diaphragmatic crura and gastroesophageal fat pad, reduction and repair of hiatal hernia and complete take-down of the wrap to avoid stapling over the fundoplication which can create an obstructed, septated pouch. RESULTS: There was one (14.3%) conversion. Mean operative time (OT) was 324 (206-419) minutes and length of stay was 4.9 (3-8) days. Early complications occurred in 3/7 (42.9%) patients including a staple line hemorrhage without a need for re-exploration, a small pulmonary embolism without hemodynamic instability and a small-bowel obstruction due to a pre-existing incisional ventral hernia that was not repaired on original operation. There were no anastomotic leaks or deaths. At a mean follow-up of 32.9 (12-39) months, mean percentage excess weight loss was 79.5% and 18/28 (64.3%) comorbid conditions were improved or resolved. Gastroesophageal reflux disease (GERD) evaluation with the GERD health-related quality of life (GERD-HRQL) scale showed a significant reduction of GERD scores postoperatively (16.7 versus 4.4). CONCLUSIONS: Although laparoscopic RYGB after antireflux surgery is technically difficult and carries higher morbidity, it is feasible and effective in the treatment of recurrent GERD in morbidly obese patients.

Should completely intracorporeal anastomosis be considered in obese patients who undergo laparoscopic colectomy for benign or malignant disease of the colon?

BACKGROUND: The outcome of laparoscopic colectomy with completely intracorporeal anastomosis (LCIA) in obese and nonobese patients is assessed. METHODS: Forty-five consecutive patients who underwent LCIA for benign or malignant disease of the right and proximal left colon were reviewed prospectively. Obesity was defined as a body mass index of >30 kg/m(2). RESULTS: There were 24 men (53%) and 21 women (47%) with a mean age of 67 years (46-84 years). The mean body mass index was 27 kg/m(2) (16-38 kg/m(2)); 13 patients (29%) were obese. One procedure was converted to a laparoscopic-assisted colectomy. The mean operative time, estimated blood loss, and duration of stay were 218 minutes (110-420 minutes), 82 mL (50-250 mL), and 5 days (2-11 days), respectively. The mean length of the larger incision (extraction site) and the sum of all port incisions was 4 cm (3-8 cm) and 7 cm (6-10 cm), respectively. Complications occurred in 8 of 45 patients (18%), with no deaths. The mean number of harvested lymph nodes per specimen was 11 (3-30 lymph nodes). Obesity had no effect on operative time (obese patients, 232 minutes; nonobese patients, 213 minutes), incision length (obese patients, 4 cm; nonobese patients, 4 cm) estimated blood loss (obese patients, 100 mL; nonobese patients, 76 mL), complications (obese patients, 15%; nonobese patients, 19%), duration of stay (obese patients, 5 days; nonobese patients, 5 days), or number of harvested lymph nodes (obese patients, 11 lymph nodes; nonobese patients, 11 lymph nodes). There were no port-site hernias or metastases during a mean follow-up period of 5 months (1-18 months). CONCLUSIONS: LCIA can offer smaller incisions, improved cosmesis, and low conversion rates while oncologic principles are preserved. LCIA is a feasible and safe technique with equally successful outcomes in thin and obese patients.

Outcomes of Roux-en-Y gastric bypass stratified by a body mass index of 70 kg/m2: a comparative analysis of 825 procedures.

We compared the safety, excess weight loss (EWL), and improvement in comorbidities after Roux-en-Y gastric bypass (RYGB) in morbidly obese and superobese patients (body mass index, <70 kg/m2 or >or=70 kg/m2). Of 825 patients who underwent RYGB by our group between 1995 and 2003, 79 (9.6%) were superobese (group A) and 746 were morbidly obese (group B). There were significant differences in age (A, 40.8 years; B, 43.2 years; P=0.01), gender (males: A, 40.5%; B, 17.6%; P<0.0001), and type of access (laparoscopic RYGB: A, 4.1%; B, 34.2%; P<0.0001). Sleep apnea (A, 57%; B, 31.4%; P<0.0001) and venous insufficiency (A, 16.5%; B, 2.4%; P<0.0001) were more common in superobese patients. Hospital stay was similar (A, 6.3 days; B, 5.3 days) with adjustment for differences in type of access. Although morbidity was comparable, mortality was higher in the superobese group (A, 2.5%; B, 0.5%; P<0.05). At a comparable follow-up (A, 17.7 months; B, 18.25 months), percent EWL at 1 year was lower in the superobese group (A, 54.6%; B, 64.3%; P<0.0001), but it became similar at 3 years (A, 66.5%; B, 60.7%). Postoperative improvement of comorbidities was equally dramatic in both groups with the exception of venous insufficiency. In conclusion, complications are not increased in the superobese, but they are more often fatal. Superobese patients achieve their maximum weight loss in a longer period of time and reach their nadir at year 3.

Acute, complete proximal small bowel obstruction after laparoscopic gastric bypass due to intraluminal blood clot formation.

BACKGROUND: To report the presentation and management of early complete proximal small bowel obstruction from intraluminal clot after laparoscopic Roux-en-Y gastric bypass. METHODS: We performed a retrospective chart review of 5 female patients who developed small bowel obstruction at the jejunojejunostomy (JJ) secondary to intraluminal clot from January 2001 to January 2003. We analyzed the signs and symptoms, etiology of bowel obstruction, and operative treatment. RESULTS: From January 2001 to January 2003, 5 patients who had undergone successful laparoscopic Roux-en-Y gastric bypass developed proximal small bowel obstruction from a solid intraluminal clot secondary to staple line bleeding. All patients were women, with an average age and body mass index of 37 years and 43.41 kg/m(2), respectively. All patients underwent an upper gastrointestinal series on postoperative day 1, which revealed no leak, and all became symptomatic on postoperative day 2. Tachycardia and a "sense of impending doom" were both observed in 80% of the patients with this clinical syndrome. The intraoperative findings consistently revealed intraluminal clot obstructing the JJ. After reexploration and anastomotic revision, all patients had an uneventful recovery, with an average hospital length of stay of 9.8 days (range 8-11). CONCLUSION: Staple line bleeding potentially exacerbated by perioperative subcutaneous heparin use can cause proximal small bowel obstruction at the JJ after laparoscopic Roux-en-Y gastric bypass. It presents on postoperative day 2 most commonly as tachycardia and a "sense of impending doom." Prompt recognition and immediate reexploration will lead to an uneventful recovery. The need for complete anastomotic JJ revision is discussed.

Laparoscopic gastric bypass after antireflux surgery for the treatment of gastroesophageal reflux in morbidly obese patients: initial experience.

BACKGROUND: Laparoscopic Roux-en-Y gastric bypass (LRYGBP) has been proven effective against gastroesophageal reflux disease (GERD) in morbidly obese patients. We present our experience with revision of antireflux procedures to LRYGBP in obese patients with recurrent GERD, weight gain or a combination of both and discuss the indications and technical considerations involved. METHODS: Between June 2000 and December 2003, 7 morbidly obese patients with a mean BMI of 37.5 kg/m(2) underwent revision of an antireflux procedure to LRYGBP by our group. Important steps of the revision include dissection of the diaphragmatic crura and gastroesophageal fat pad, reduction and repair of hiatal hernia, and complete take-down of the wrap to avoid stapling over the fundoplication which can create an obstructed, septated pouch. RESULTS: Mean operative time was 6 hr 12 min and length of stay was 4.8 days. There were 3 major complications postoperatively and no deaths. During follow-up, 5 patients developed anastomotic strictures and 2 patients were re-explored for gastric remnant herniation and intestinal obstruction. At a mean follow-up of 24 (3-44) months, mean excess weight loss was 70.7% and 14/20 (70%) co-morbid conditions were improved or resolved. GERD evaluation with the GERD-HRQL scale showed a significant reduction of GERD scores postoperatively (P =0.006). CONCLUSIONS: Although LRYGBP after antireflux surgery is a technically more difficult procedure with a higher morbidity, it is feasible and effective for the treatment of recurrent GERD and worsening obesity with the additional advantage of weight loss and improvement of co-morbidities.

Comparison of open and laparoscopic prosthetic repair of large ventral hernias.

BACKGROUND AND OBJECTIVES: Open ventral hernia repair is associated with significant morbidity and high recurrence rates. Recently, the laparoscopic approach has evolved as an attractive alternative. Our objective was to compare open with laparoscopic ventral hernia repairs. METHODS: Fifty laparoscopic and 22 open ventral hernia repairs were included in the study. All patients underwent a tension-free repair with retromuscular placement of the prosthesis. No significant difference between the 2 groups was noted regarding patient demographics and hernia characteristics except that the population in the open group was relatively older (59.4 vs 47.82, P < 0.003). RESULTS: We found no significant difference in the operative time between the 2 groups (laparoscopic 132.7 min vs open 152.7 min). Laparoscopic repair was associated with a significant reduction in the postoperative narcotic requirements (27 vs 58.95 mg i.v. morphine, P < 0.002) and the lengths of nothing by mouth (NPO) status (10 vs 55.3 hrs. P < 0.001), and hospital stay (1.88 vs 5.38 days, P < 0.001). The incidence of major complications (1 vs 4, P < 0.028), the hernia recurrence (1 vs 4, P < 0.028), and the time required for return to work (25.95 vs 47.8, P < 0.036) were significantly reduced in the laparoscopic group. CONCLUSIONS: Laparoscopic ventral hernioplasty offers significant advantages and should be considered for repair of primary and incisional ventral hernias.

Outcome of laparoscopic ventral hernia repair in correlation with obesity, type of hernia, and hernia size.

BACKGROUND: The morbidity and overall recovery time of ventral hernia repair can vary significantly depending on the hernia type or size and on other factors, such as the body mass index (BMI). The purpose of our study was to investigate the effects of type of hernia, hernia size, and BMI on the outcome of laparoscopic ventral hernia repair. METHODS: Fifty patients who underwent laparoscopic ventral hernia repair were retrospectively reviewed and stratified according to hernia type (incisional, IVH/primary, PVH), hernia size, and BMI. These subgroups were compared in regard to operative time, resumption of diet, hospital stay, pain control, and complication rate. RESULTS: Laparoscopic IVH repair was associated with a longer operative time (143 vs. 98 minutes, p = .02) and length of stay (2.2 vs. 0.6 days, p = .03) than PVH repair. The narcotic requirements were higher in the IVH group, but the difference did not reach statistical significance. Larger hernias were associated with a longer operative time (p = .04) and increased narcotic requirement (p = .03). The morbidity of the laparoscopic repair was not significantly affected by the hernia type or size. The BMI did not significantly alter any of the parameters examined. CONCLUSIONS: Laparoscopic repair of incisional and larger hernias is a technically demanding procedure that requires a longer operative time. In contrast to PVH repair, laparoscopic IVH repair usually cannot be performed on an outpatient basis. Surgeons need not be discouraged from recommending the laparoscopic approach for patients with large IVHs or with severe obesity because the morbidity remains low.