Assessment of empiric body mass index-based thromboprophylactic dosing of enoxaparin after bariatric surgery: evidence for dosage adjustment using anti-factor Xa in high-risk patients.

BACKGROUND: Despite thromboprophylaxis, postoperative deep vein thrombosis and pulmonary embolism occur after bariatric surgery, perhaps because of failure to achieve optimal prophylactic levels in the obese population. OBJECTIVES: The aim of this study was to evaluate the adequacy of prophylactic dosing of enoxaparin in patients with severe obesity by performing an antifactor Xa (AFXa) assay. SETTING: An academic medical center METHODS: In this observational study, all bariatric surgery cases at an academic center between December 2016 and April 2017 who empirically received prophylactic enoxaparin (adjusted by body mass index [BMI] threshold of 50 kg/m2) were studied. The AFXa was measured 3-5 hours after the second dose of enoxaparin. RESULTS: A total of 105 patients were included; 85% were female with a median age of 47 years. In total, 16 patients (15.2%) had AFXa levels outside the prophylactic range: 4 (3.8%) cases were in the subprophylactic and 12 (11.4%) cases were in the supraprophylactic range. Seventy patients had a BMI <50 kg/m2 and empirically received enoxaparin 40 mg every 12 hours; AFXa was subprophylactic in 4 (5.7%) and supraprophylactic in 6 (8.6%) of these patients. Of the 35 patients with a BMI ≥50 who empirically received enoxaparin 60 mg q12h, no AFXa was subprophylactic and 6 (17.1%) were supraprophylactic. Five patients (4.8%) had major bleeding complications. One patient developed pulmonary embolism on postoperative day 35. CONCLUSION: BMI-based thromboprophylactic dosing of enoxaparin after bariatric surgery could be suboptimal in 15% of patients with obesity. Overdosing of prophylactic enoxaparin can occur more commonly than underdosing. AFXa testing can be a practical way to measure adequacy of pharmacologic thromboprophylaxis, especially in patients who are at higher risk for venous thromboembolism or bleeding.

Bariatric Surgery as a Long-Term Treatment for Type 2 Diabetes/Metabolic Syndrome.

Metabolic surgery is increasingly becoming recognized as a more effective treatment for patients with type 2 diabetes (T2D) and obesity as compared to lifestyle modification and medical management alone. Both observational studies and clinical trials have shown metabolic surgery to result in sustained weight loss (20-30%), T2D remission rates ranging from 23% to 60%, and improvement in cardiovascular risk factors such as hypertension and dyslipidemia. Metabolic surgery is cost-effective and relatively safe, with perioperative risks and mortality comparable to low-risk procedures such as cholecystectomy, hysterectomy, and appendectomy. International diabetes and medical organizations have endorsed metabolic surgery as a standard treatment for T2D with obesity.

Cost of bariatric surgery and factors associated with increased cost: an analysis of national inpatient sample.

BACKGROUND: In the current healthcare environment, bariatric surgery centers need to be cost-effective while maintaining quality. OBJECTIVE: The aim of this study was to evaluate national cost of bariatric surgery to identify the factors associated with a higher cost. SETTING: A retrospective analysis of 2012-2013 Healthcare Cost and Utilization Project - Nationwide Inpatient Sample (HCUP-NIS). METHOD: We included all patients with a diagnosis of morbid obesity (ICD9 278.01) and a Diagnosis Related Group code related to procedures for obesity, who underwent Roux-en-Y gastric bypass (RYGB), sleeve gastrectomy (SG), or adjustable gastric banding (AGB) as their primary procedure. We converted "hospital charges" to "cost," using hospital specific cost-to-charge ratio. Inflation was adjusted using the annual consumer price index. Increased cost was defined as the top 20th percentile of the expenditure and its associated factors were analyzed using the logistic regression multivariate analysis. RESULTS: A total of 45,219 patients (20,966 RYGBs, 22,380 SGs, and 1,873 AGBs) were included. The median (interquartile range) calculated costs for RYGB, SG, and AGB were $12,543 ($9,970-$15,857), $10,531 ($8,248-$13,527), and $9,219 ($7,545-$12,106), respectively (P<.001). Robotic-assisted procedures had the highest impact on the cost (odds ratio 3.6, 95% confidence interval 3.2-4). Hospital cost of RYGB and SG increased linearly with the length of hospital stay and almost doubled after 7 days. Furthermore, multivariate analysis showed that certain co-morbidities and concurrent procedures were associated with an increased cost. CONCLUSION: Factors contributing to the cost variation of bariatric procedures include co-morbidities, robotic platform, complexity of surgery, and hospital length of stay.

Who Should Get Extended Thromboprophylaxis After Bariatric Surgery?: A Risk Assessment Tool to Guide Indications for Post-discharge Pharmacoprophylaxis.

OBJECTIVE: To determine the risk factors for 30-day postdischarge venous thromboembolism (VTE) after bariatric surgery and to identify potential indications for extended pharmacoprophylaxis. BACKGROUND: VTE is among most common causes of death after bariatric surgery. Most VTEs occur after hospital stay; still a few patients receive extended pharmacoprophylaxis postdischarge. METHODS: From American College of Surgeons-National Surgical Quality Improvement Program, we identified 91,963 patients, who underwent elective primary and revisional bariatric surgery between 2007 and 2012. Regression-based techniques were used to create a risk assessment tool to predict risk of postdischarge VTE. The model was validated using the 2013 American College of Surgeons-National Surgical Quality Improvement Program dataset (N = 20,575). Significant risk factors were used to create a user-friendly online risk calculator. RESULTS: The overall 30-day incidence of postdischarge VTE was 0.29% (N = 269). In those experiencing a postdischarge VTE, mortality increased about 28-fold (2.60% vs 0.09%; P < 0.001). Among 45 examined variables, the final risk-assessment model contained 10 categorical variables including congestive heart failure, paraplegia, reoperation, dyspnea at rest, nongastric band surgery, age ≥60 years, male sex, BMI ≥50 kg/m, postoperative hospital stay ≥3 days, and operative time ≥3 hours. The model demonstrated good calibration (Hosmer-Lemeshow goodness-of-fit test, P = 0.71) and discrimination (c-statistic = 0.74). Nearly 2.5% of patients had a predicted postdischarge VTE risk >1%. CONCLUSIONS: More than 80% of post-bariatric surgery VTE events occurred post-discharge. Congestive heart failure, paraplegia, dyspnea at rest, and reoperation are associated with the highest risk of post-discharge VTE. Routine post-discharge pharmacoprophylaxis can be considered for high-risk patients (ie, VTE risk >0.4%).

Metabolic Surgery in the Treatment Algorithm for Type 2 Diabetes: A Joint Statement by International Diabetes Organizations.

BACKGROUND: Despite growing evidence that bariatric/metabolic surgery powerfully improves type 2 diabetes (T2D), existing diabetes treatment algorithms do not include surgical options. AIM: The 2nd Diabetes Surgery Summit (DSS-II), an international consensus conference, was convened in collaboration with leading diabetes organizations to develop global guidelines to inform clinicians and policymakers about benefits and limitations of metabolic surgery for T2D. METHODS: A multidisciplinary group of 48 international clinicians/scholars (75% nonsurgeons), including representatives of leading diabetes organizations, participated in DSS-II. After evidence appraisal (MEDLINE [1 January 2005-30 September 2015]), three rounds of Delphi-like questionnaires were used to measure consensus for 32 data-based conclusions. These drafts were presented at the combined DSS-II and 3rd World Congress on Interventional Therapies for Type 2 Diabetes (London, U.K., 28-30 September 2015), where they were open to public comment by other professionals and amended face-to-face by the Expert Committee. RESULTS: Given its role in metabolic regulation, the gastrointestinal tract constitutes a meaningful target to manage T2D. Numerous randomized clinical trials, albeit mostly short/midterm, demonstrate that metabolic surgery achieves excellent glycemic control and reduces cardiovascular risk factors. On the basis of such evidence, metabolic surgery should be recommended to treat T2D in patients with class III obesity (BMI≥40 kg/m(2)) and in those with class II obesity (BMI 35.0-39.9 kg/m(2)) when hyperglycemia is inadequately controlled by lifestyle and optimal medical therapy. Surgery should also be considered for patients with T2D and BMI 30.0-34.9 kg/m(2) if hyperglycemia is inadequately controlled despite optimal treatment with either oral or injectable medications. These BMI thresholds should be reduced by 2.5 kg/m(2) for Asian patients. CONCLUSIONS: Although additional studies are needed to further demonstrate long-term benefits, there is sufficient clinical and mechanistic evidence to support inclusion of metabolic surgery among antidiabetes interventions for people with T2D and obesity. To date, the DSS-II guidelines have been formally endorsed by 45 worldwide medical and scientific societies. Health care regulators should introduce appropriate reimbursement policies.

The Socioeconomic Impact of Morbid Obesity and Factors Affecting Access to Obesity Surgery.

Bariatric surgery has been shown in many studies to be the most effective long-term treatment for severe obesity and obesity-related comorbidities. Economic analysis has demonstrated cost-effectiveness as well as cost-savings in select subgroups of patients. Despite the health and economic benefits of bariatric surgery, relatively few eligible patients receive this treatment. This disparity in access to care must be addressed by health policy decision-makers.

A Challenge between Trainee Education and Patient Safety: Does Fellow Participation Impact Postoperative Outcomes Following Bariatric Surgery?

BACKGROUND: Surgical training may potentially influence patient care. A safe, high-quality bariatric and metabolic surgery practice requires dedicated and specialized training commonly acquired during a fellowship. This study evaluates the impact of fellow participation on early postoperative outcomes in bariatric surgery. METHODS: From the American College of Surgeons (ACS-NSQIP) database, we identified all obese patients who had undergone primary laparoscopic Roux-en-Y gastric bypass (LRYGB) and sleeve gastrectomy (LSG) between 2010 and 2012. Logistic regression was used to prognosticate the surgical fellow (PGY-6, 7, or 8) participation in bariatric surgeries on perioperative outcomes, as compared to surgeries with no trainee participation. RESULTS: The study cohort consisted of 10,838 patients (8819 LRYGB, 2019 LSG, 32 % fellow participation). Fellows participated in higher-risk surgeries. Fellow involvement was associated with increased operative time in LRYGB (difference 42.4 ± 1.2 min, p < 0.001) and in LSG (difference 38.8 ± 2.5 min, p < 0.001). Multivariate regression revealed that fellow involvement in LSG did not significantly alter postoperative adverse events. Conversely, in the LRYGB group, fellow participation was independently associated with higher rates of overall complications (OR = 1.37, 95 % CI 1.16-1.63), serious complications (OR = 1.23, 95 % CI 1.00-1.52), surgical complications (OR = 1.42; 95 % CI 1.17-1.73), and reoperation (OR = 1.43, 95 % CI 1.10-1.87). On adjusted analysis, while readmission was higher with fellow involvement in both procedures, mortality rates were comparable. CONCLUSIONS: Fellow involvement resulted in a clinically appreciable increase in operative times. Fellow participation in the operating room was also independently associated with worse early postoperative outcomes following LRYGB, but was not the case for LSG. Promoting proficiency in surgical simulation laboratories and a gradual participation of fellows from LSG to LRYGB during fellowship may be associated with a reduction in postoperative complications.

Gap Between Evidence and Patient Access: Policy Implications for Bariatric and Metabolic Surgery in the Treatment of Obesity and its Complications.

Despite consistently supportive evidence of clinical effectiveness and economic advantages compared with currently available non-surgical obesity treatments, patient access to bariatric and metabolic surgery (BMS) is impeded. To address this gap and better understand the relationship between value and access, the objectives of this study were twofold: (i) identify the multidimensional barriers to adoption of BMS created by clinical guidelines, public policies, and health technology assessments; and, most importantly, (ii) develop recommendations for stakeholders to improve patient access to BMS. Updated public policies focused on treatment and clinical guidelines that reflect the demonstrated advantages of BMS, patient education on safety and effectiveness, updated reimbursement policies, and additional data on long-term BMS effectiveness are needed to improve patient access.

Assessment of the quality of Internet information on sleeve gastrectomy.

BACKGROUND: The Internet is an important source of information for morbidly obese patients who are potential candidates for bariatric procedures. Over the past few years, there is growing demand for sleeve gastrectomy because of perceived technical ease balanced with excellent outcomes. The aim of this study was to assess the quality and content of available internet information pertaining to sleeve gastrectomy. Our hypothesis is that this information is inconsistent and inaccurate. METHODS: A total of 50 websites were analyzed in September 2013. We used the search term "sleeve gastrectomy" to identify sites on the most common internet search engines: Google, Yahoo, Bing, and Ask. Based on popularity of use, 20 websites were obtained through the Google engine and 10 sites by each of the others. Websites were classified as academic, physician, health professional, commercial, social media, and unspecified. Quality of information was evaluated using the DISCERN score, the Journal of the American Medical Association (JAMA) benchmark criteria, and the Health on the Net code (HONcode) seal accreditation. The DISCERN score varies from 0-80 points and is based on 16 questions that evaluate publication quality and reliability. The JAMA benchmark criteria range from 0-4 points assessing website authorship, attribution, disclosure, and currency. HONcode certification was assessed as present or absent website accreditation. Duplicate and inaccessible websites were excluded from the analysis. RESULTS: We identified 43 websites from the United States, 6 from Mexico, and 1 from Australia. The average DISCERN and JAMA benchmark scores for all websites were 46.3±14.5 and 1.6±1.1, respectively, with a median DISCERN of 48.5 (range, 16-76) and JAMA score of 2.0 (range, 0-4). Website classification distribution was 21 physician, 11 academic, 7 commercial, 5 social media, 4 unspecified, and 2 health professional. The average DISCERN and JAMA benchmark scores were 55.4±13.4 and 2.4±1.0 in the academic group, 49.5±10.0 and 1.9±.9 in the physician group, 46.9±14.2 and .2±.4 in social media sites, 44.0±2.8 and 1.0±.0 in health professional pages, 41.3±14.2 and 1.0±1.0 in commercial sites, and 39.8±19.5 and 1.0±1.1 in the unspecified group. The HONcode seal was present in 2 (4%) of the websites analyzed. CONCLUSION: The results of this study suggest poor quality and content of information on the internet viewed by potential bariatric candidates. Only 4% of the websites demonstrated HONcode seal accreditation. The global mean DISCERN and JAMA benchmark scores reported in this study were significantly lower than one would expect. Academic and physician websites offer the best information content whereas the worst was observed in the commercial and unspecified groups.

Incidence and management of bleeding complications after gastric bypass surgery in the morbidly obese.

BACKGROUND: Bleeding after gastric bypass can be a life-threatening event and challenging to manage. With an increase in the number of bariatric procedures performed in recent years, it is important to be cognizant of the frequency, presentation, and management of this complication. The purpose of the present study was to evaluate the incidence and management of bleeding complications after gastric bypass surgery. METHODS: A review of prospectively maintained bariatric surgery databases was conducted at 2 tertiary bariatric units. All patients who presented with gastrointestinal and intra-abdominal bleeding after gastric bypass during a 10-year period were identified, and their charts were reviewed. RESULTS: A total of 4466 patients who underwent gastric bypass during the 10-year period had reliable morbidity data available and were included in the present study. Of the 4466 patients, 42 (.94%) experienced a bleeding complication postoperatively. Of these patients, 20 (47.6%) had undergone previous abdominal surgery. Bleeding occurred in the early postoperative period (<30 d) in 30 (71%); the etiology of which included bleeding from the staple lines, iatrogenic visceral injury, or mesenteric vessel bleeding. Early postoperative bleeding required operative intervention to achieve hemostasis in 43%. Late postoperative bleeding (n = 12) were usually secondary to marginal ulceration and warranted surgical intervention in 33.3%. Previously undiagnosed bleeding diatheses were identified in 14.3%. CONCLUSION: Gastrointestinal bleeding after gastric bypass, although infrequent, is a difficult clinical scenario. Nonoperative management is feasible for hemodynamically stable patients. Surgical intervention is merited for patients with hemodynamic compromise, those who do not respond to transfusion, and those in whom the bleeding source cannot be adequately identified nonoperatively.

Challenges in pulmonary risk assessment and perioperative management in bariatric surgery patients.

Bariatric surgery has serious associated medical comorbidity and procedure-related risks and is, thus, considered an intermediate-to-high-risk non-cardiac surgery. Altered respiratory mechanics, obstructive sleep apnea (OSA), and less often, pulmonary hypertension and postoperative pulmonary embolism are the major contributors to poor pulmonary outcomes in obese patients. Attention to posture and positioning is critical in patients with OSA. Suspected OSA patients requiring intravenous narcotics should be kept in a monitored setting with frequent assessments and naloxone kept at the bedside. Use of reverse Tredelenburg position, preinduction, maintenance of positive end-expiratory pressure, and use of continuous positive airway pressure can help improve oxygenation in the perioperative period.

The mini-fellowship concept: a six-week focused training program for minimally invasive bariatric surgery.

OBJECTIVE: To devise a six-week hands-on training program customized to meet the needs of practicing general surgeons. The aim of this program is to provide the required training experience that will bestow the knowledge and skill necessary to implement a successful practice in laparoscopic bariatric surgery. METHODS: Ten board-certified/board-eligible practicing general surgeons with no prior hands-on or formal training in laparoscopic bariatric surgery. We report on the participants training experience and the impact that the program had on their subsequent laparoscopic bariatric clinical activity. RESULTS: Ten surgeons completed training programs from 9/01 to 3/03. None of the trainees had prior experience in laparoscopic bariatric surgery. Program operative experience averaged 42 cases (range 29-66). Trainees were integrated into all preoperative and postoperative hospital and outpatient care on the service, including workshops and seminars. Seven graduates are in practice performing laparoscopic bariatric surgery and three are implementing new bariatric programs. The active surgeons report performing an average of 101 laparoscopic bariatric procedures (range 18-264) over a mean practice period of 10 months (range 4-16) CONCLUSION: A six-week focused mini-fellowship with hands-on operative and clinical participation enables practicing surgeons to acquire the skill and experience necessary to successfully implement a laparoscopic bariatric surgical practice.

Risks and benefits of bariatric surgery: current evidence.

Patients typically lose more than 50% of their excess weight after bariatric surgery. Obesity-related diseases markedly improve, reducing cardiovascular risk and improving life expectancy. Obese patients lose more weight with bariatric surgery than with medical weight-loss treatment.