Association Between Bariatric Surgery and Long-term Health Care Expenditures Among Veterans With Severe Obesity.

Importance: Bariatric surgery has been associated with improvements in health in patients with severe obesity; however, it is unclear whether these health benefits translate into lower health care expenditures. Objective: To examine 10-year health care expenditures in a large, multisite retrospective cohort study of veterans with severe obesity who did and did not undergo bariatric surgery. Design, Setting, and Participants: A total of 9954 veterans with severe obesity between January 1, 2000, and September 30, 2011, were identified from veterans affairs (VA) electronic health records. Of those, 2498 veterans who underwent bariatric surgery were allocated to the surgery cohort. Sequential stratification was used to match each patient in the surgery cohort with up to 3 patients who had not undergone bariatric surgery but were of the same sex, race/ethnicity, diabetes status, and VA regional network and were closest in age, body mass index (calculated as weight in kilograms divided by height in meters squared), and comorbidities. A total of 7456 patients were identified and allocated to the nonsurgery (control) cohort. The VA health care expenditures among the surgery and nonsurgery cohorts were estimated using regression models. Data were analyzed from July to August 2018 and in April 2019. Interventions: The bariatric surgical procedures (n = 2498) included in this study were Roux-en-Y gastric bypass (1842 [73.7%]), sleeve gastrectomy (381 [15.3%]), adjustable gastric banding (249 [10.0%]), and other procedures (26 [1.0%]). Main Outcomes and Measures: The study measured total, outpatient, inpatient, and outpatient pharmacy expenditures from 3 years before surgery to 10 years after surgery, excluding expenditures associated with the initial bariatric surgical procedure. Results: Among 9954 veterans with severe obesity, 7387 (74.2%) were men; the mean (SD) age was 52.3 (8.8) years for the surgery cohort and 52.5 (8.7) years for the nonsurgery cohort. Mean total expenditures for the surgery cohort were $5093 (95% CI, $4811-$5391) at 7 to 12 months before surgery, which increased to $7448 (95% CI, $6989-$7936) at 6 months after surgery. Postsurgical expenditures decreased to $6692 (95% CI, $6197-$7226) at 5 years after surgery, followed by a gradual increase to $8495 (95% CI, $7609-$9484) at 10 years after surgery. Total expenditures were higher in the surgery cohort than in the nonsurgery cohort during the 3 years before surgery and in the first 2 years after surgery. The expenditures of the 2 cohorts converged 5 to 10 years after surgery. Outpatient pharmacy expenditures were significantly lower among the surgery cohort in all years of follow-up ($509 lower at 3 years before surgery and $461 lower at 7 to 12 months before surgery), but these cost reductions were offset by higher inpatient and outpatient (nonpharmacy) expenditures. Conclusions and Relevance: In this cohort study of 9954 predominantly older male veterans with severe obesity, total health care expenditures increased immediately after patients underwent bariatric surgery but converged with those of patients who had not undergone surgery at 10 years after surgery. This finding suggests that the value of bariatric surgery lies primarily in its associations with improvements in health and not in its potential to decrease health care costs.

Biological Mesh Implants for Abdominal Hernia Repair: US Food and Drug Administration Approval Process and Systematic Review of Its Efficacy.

IMPORTANCE: Expensive biological mesh materials are increasingly used to reinforce abdominal wall hernia repairs. The clinical and cost benefit of these materials are unknown. OBJECTIVES: To review the published evidence on the use of biological mesh materials and to examine the US Food and Drug Administration (FDA) approval history for these devices. EVIDENCE ACQUISITION: Search of multiple electronic databases (Ovid, MEDLINE, EMBASE, Cochrane Systematic Reviews, Cochrane Database of Abstracts of Reviews of Effects, Cochrane Central Register of Controlled Trials, and Cochrane National Health Service Economic Evaluation Database) to identify articles published between 1948 and June 30, 2015, on the use of biological mesh materials used to reinforce abdominal wall hernia repair. Keywords searched included surgical mesh, abdominal hernia, recurrence, infection, fistula, bioprosthesis, biocompatible materials, absorbable implants, dermis, and collagen. The FDA online database for 510(k) clearances was reviewed for all commercially available biological mesh materials. The median national price for mesh materials was established by a benchmarking query through several Integrated Delivery Network and Group Purchasing Organization tools. EVIDENCE SYNTHESIS: Of 274 screened articles, 20 met the search criteria. Most were case series that reported results of convenience samples of patients at single institutions with a variety of clinical problems. Only 3 of the 20 were comparative studies. There were no randomized clinical trials. In total, outcomes for 1033 patients were described. Studies varied widely in follow-up time, operative technique, meshes used, and patient selection criteria. Reported outcomes and clinical outcomes, such as fistula formation and infection, were inconsistently reported across studies. Conflicts of interest were not reported in 16 of the 20 studies. Recurrence rates ranged from 0% to 80%. All biological mesh devices were approved by the FDA based on substantial equivalence to a group of nonbiological predicate devices that, on average, were one-third less costly. CONCLUSIONS AND RELEVANCE: There is insufficient evidence to determine the extra costs associated with or the clinical efficacy of biological mesh materials for the repair of abdominal wall hernia.

Impact of bariatric surgery on life expectancy in severely obese patients with diabetes: a decision analysis.

OBJECTIVE: To create a decision analytic model to estimate the balance between treatment risks and benefits for severely obese patients with diabetes. BACKGROUND: Bariatric surgery leads to many desirable metabolic changes, but long-term impact of bariatric surgery on life expectancy in patients with diabetes has not yet been quantified. METHODS: We developed a Markov state transition model with multiple Cox proportional hazards models and logistic regression models as inputs to compare bariatric surgery versus no surgical treatment for severely obese diabetic patients. The model is informed by data from 3 large cohorts: (1) 159,000 severely obese diabetic patients (4185 had bariatric surgery) from 3 HMO Research Network sites; (2) 23,000 subjects from the Nationwide Inpatient Sample; and (3) 18,000 subjects from the National Health Interview Survey linked to the National Death Index. RESULTS: In our main analyses, we found that a 45-year-old woman with diabetes and a body mass index (BMI) of 45 kg/m gained an additional 6.7 years of life expectancy with bariatric surgery (38.4 years with surgery vs 31.7 years without surgery). Sensitivity analyses revealed that the gain in life expectancy decreased with increasing BMI, until a BMI of 62 kg/m is reached, at which point nonsurgical treatment was associated with greater life expectancy. Similar results were seen for both men and women in all age groups. CONCLUSIONS: For most severely obese patients with diabetes, bariatric surgery seems to improve life expectancy; however, surgery may reduce life expectancy for the super obese with BMIs over 62 kg/m.

Global comparators project: international comparison of hospital outcomes using administrative data.

OBJECTIVE: To produce comparable risk-adjusted outcome rates for an international sample of hospitals in a collaborative project to share outcomes and learning. DATA SOURCES: Administrative data varying in scope, format, and coding systems were pooled from each participating hospital for the years 2005-2010. STUDY DESIGN: Following reconciliation of the different coding systems in the various countries, in-hospital mortality, unplanned readmission within 30 days, and "prolonged" hospital stay (>75th percentile) were risk-adjusted via logistic regression. A web-based interface was created to facilitate outcomes analysis for individual medical centers and enable peer comparisons. Small groups of clinicians are now exploring the potential reasons for variations in outcomes in their specialty. PRINCIPAL FINDINGS: There were 6,737,211 inpatient records, including 214,622 in-hospital deaths. Although diagnostic coding depth varied appreciably by country, comorbidity weights were broadly comparable. U.S. hospitals generally had the lowest mortality rates, shortest stays, and highest readmission rates. CONCLUSIONS: Intercountry differences in outcomes may result from differences in the quality of care or in practice patterns driven by socio-economic factors. Carefully managed administrative data can be an effective resource for initiating dialog between hospitals within and across countries. Inclusion of important outcomes beyond hospital discharge would increase the value of these analyses.

Health expenditures among high-risk patients after gastric bypass and matched controls.

OBJECTIVE: To determine whether bariatric surgery is associated with reduced health care expenditures in a multisite cohort of predominantly older male patients with a substantial disease burden. DESIGN: Retrospective cohort study of bariatric surgery. Outpatient, inpatient, and overall health care expenditures within Department of Veterans Affairs (VA) medical centers were examined via generalized estimating equations in the propensity-matched cohorts. SETTING: Bariatric surgery programs in VA medical centers. PARTICIPANTS: Eight hundred forty-seven veterans who were propensity matched to 847 nonsurgical control subjects from the same 12 VA medical centers. INTERVENTION: Bariatric surgical procedures. MAIN OUTCOME MEASURE: Health expenditures through December 2006. RESULTS: Outpatient, inpatient, and total expenditures trended higher for bariatric surgical cases in the 3 years leading up to the procedure and then converged back to the lower expenditure levels of nonsurgical controls in the 3 years after the procedure. CONCLUSIONS: Based on analyses of a cohort of predominantly older men, bariatric surgery does not appear to be associated with reduced health care expenditures 3 years after the procedure.

Little effect of insurance status or socioeconomic condition on disparities in minority appendicitis perforation rates.

OBJECTIVE: To estimate how much of the gap in appendicitis perforation rates between minority and white children is explained by differences in socioeconomic and insurance factors. DESIGN: Observational analysis of hospital discharge information. SETTING: The Healthcare Cost and Utilization Project database. PARTICIPANTS: Appendicitis perforation rates determined from the Healthcare Cost and Utilization Project database of hospital discharges from 2001 to 2008. MAIN OUTCOME MEASURES: The proportion of the gap between perforation rates explained by various patient- and hospital-level variables. RESULTS: There were no disparities observed in adult appendicitis perforation rates. The perforation rate for white children was 26.7%; black children, 35.5%; and Latino children, 36.5%. Gap analysis showed that only 12.0% of the difference in perforation rates between black and white children was explained by insurance status and only 12.7% of the difference between Latino and white children was explained. Income level only accounted for 7.2% of the gap for black children and 6.1% for Latino children. Age explained one-third of the gap for Latino children and one-third was not accounted for by measurable variables. Two-thirds of the difference between appendicitis perforation rates between black and white children was not explained by measurable factors. CONCLUSIONS: A very small amount of the gap between minority and white children's appendicitis rates is explained by the proxy factors for health insurance and poverty status that might relate to health care access. Appendicitis perforation rates are not an appropriate indicator of health care access.

Health care utilization and expenditure changes associated with bariatric surgery.

CONTEXT: Bariatric surgery provides significant reductions in weight and comorbidity, and has the potential to reduce health care utilization. It is unknown whether health care utilization and expenditures are reduced for veterans after bariatric surgery. OBJECTIVES: To examine health care utilization and expenditures of severely obese individuals before and after bariatric surgery within the Veterans Health Administration. DESIGN, SETTING, AND PATIENTS: We conducted a retrospective, longitudinal cohort study of health care use and expenditures among all veterans who underwent bariatric surgery in 1 of 12 approved Department of Veterans Affairs bariatric centers from 2000 to 2006. Bariatric patients were identified via Current Procedural Terminology-4 codes from a database of major surgical procedures maintained by the National Surgical Quality Improvement Program. MAIN OUTCOME MEASURE: The main outcomes of interest for our analysis were multivariable adjusted inpatient and outpatient health care utilization and expenditures in the 3 years prior to surgery and in the 3 years after surgery. RESULTS: Between 2000 and 2006, 846 veterans had bariatric surgery, 25% of whom underwent a laparoscopic procedure. The mean initial body mass index was 48.5, the mean age was 51; and 73% were male. In multivariable models including all years of data, outpatient, inpatient, and overall expenditures significantly decreased in the years after surgery because of higher clinical resources required in the months before and during surgery. When excluding the 6 months leading up to surgery and the 6 months just after surgery, outpatient expenditures remained lower in the postsurgical period, but inpatient and overall expenditures were significantly higher. CONCLUSION: Our analyses indicate that this cohort of older, male bariatric surgery patients does not achieve a reduction in health care expenditures 3 years after their procedure. These results are at variance from other, similar published studies and may reflect differences in study populations or systems of care.

The incidence of bariatric surgery has plateaued in the U.S.

BACKGROUND: Estimates of the procedure incidence for bariatric surgery have been derived primarily from surveys of bariatric surgeons or from inpatient data sources. New population-representative databases of outpatient surgery are available that enable accurate estimations of bariatric surgery case volumes. METHODS: The 2006 National Hospital Discharge Survey, National Inpatient Sample, and National Survey of Ambulatory Surgery were assessed for bariatric surgery procedures. Data were compared with inpatient data from 1993 to 2007. Procedure costs were estimated. RESULTS: The incidence of bariatric surgery has plateaued at approximately 113,000 cases per year. Open gastric bypass now constitutes only 3% of all cases but costs $4,800 less than laparoscopic procedures. Laparoscopic gastric banding is performed in 37% of all bariatric surgery cases and costs the same as laparoscopic gastric bypass to perform. Complication rates have fallen from 10.5% in 1993 to 7.6% of all cases in 2006. Bariatric surgery costs the health economy at least $1.5 billion annually. CONCLUSIONS: Despite predictions of continued growth of bariatric surgery, it appears that the annual incidence for these operations has remained stable since 2003. Most operations are performed laparoscopically, but open gastric bypass is substantially less costly than laparoscopic operations. Despite its simplicity, laparoscopic gastric banding costs the same as gastric bypass. There is no cost savings associated with ambulatory bariatric surgery.

Relative capacities of time-gated versus continuous-wave imaging to localize tissue embedded vessels with increasing depth.

Surgeons often cannot see major vessels embedded in adipose tissue and inadvertently injure them. One such example occurs during surgical removal of the gallbladder, where injury of the nearby common bile duct leads to life-threatening complications. Near-infrared imaging of the intraoperative field may help surgeons localize such critical tissue-embedded vessels. We have investigated how continuous-wave (CW) imaging performs relative to time-gated wide-field imaging, presently a rather costly technology, under broad Gaussian beam-illumination conditions. We have studied the simplified case of an isolated cylinder having bile-duct optical properties, embedded at different depths within a 2-cm slab of adipose tissue. Monte Carlo simulations were preformed for both reflectance and transillumination geometries. The relative performance of CW versus time-gated imaging was compared in terms of spatial resolution and contrast-to-background ratio in the resulting simulated images. It was found that time-gated imaging offers superior spatial resolution and vessel-detection sensitivity in most cases, though CW transillumination measurements may also offer satisfactory performance for this tissue geometry at lower cost. Experiments were performed in reflectance geometry to validate simulation results, and potential challenges in the translation of this technology to the clinic are discussed.

Decision modeling to estimate the impact of gastric bypass surgery on life expectancy for the treatment of morbid obesity.

OBJECTIVE: To create a decision analytic model to estimate the balance between treatment risks and benefits for patients with morbid obesity. DESIGN: Decision analytic Markov state transition model with multiple logistic regression models as inputs. Data from the 2005 National Inpatient Survey were used to calculate in-hospital mortality risk associated with bariatric surgery and then adjusted for 30-day mortality. To calculate excess mortality associated with obesity, we used the 1991-1996 National Health Interview Survey linked to the National Death Index. Bariatric surgery was assumed to influence mortality only through its impact on the excess mortality associated with obesity, and the efficacy of surgery was estimated from a recent large observational trial. INTERVENTION: Gastric bypass surgery. Main Outcome Measure Life expectancy. RESULTS: Our base case, a 42-year-old woman with a body mass index of 45, gained an additional 2.95 years of life expectancy with bariatric surgery. No surgical treatment was favored in our base case when the 30-day surgical mortality exceeded 9.5% (baseline 30-day mortality, 0.2%) or when the efficacy of bariatric surgery for reducing mortality decreased to 2% or less (baseline efficacy, 53%). CONCLUSIONS: The optimal decision for individual patients varies based on the balance of risk between perioperative mortality, excess annual mortality risk associated with increasing body mass index, and the efficacy of surgery; however, for the average morbidly obese patient, gastric bypass improves life expectancy.

Bariatric surgery outcomes at designated centers of excellence vs nondesignated programs.

OBJECTIVE: To compare outcomes of patients undergoing bariatric procedures in hospitals designated as centers of excellence compared with nondesignated hospitals. DESIGN: The 2005 National Inpatient Survey was used to compare outcomes at designated vs nondesignated hospitals. In addition to conventional null-hypothesis statistical testing to assess differences, effect sizes were calculated to estimate the clinical significance for observed differences. RESULTS: Centers of excellence performed substantially more operations than nondesignated centers. Despite this, outcomes were equivalent at centers of excellence and hospitals without this designation. Volume-outcome modeling attempting to identify the optimal number for a minimum volume threshold for bariatric operations revealed that annual procedure volume has a weak effect on outcomes. Similarly, many variables that were statistically significantly different between centers and noncenters proved to be clinically unimportant by effect size analysis. Risk adjustment was effectively achieved by using the Agency for Healthcare Research and Quality-supplied variables all-payer severity-adjusted diagnostic related group expected charges and deaths. CONCLUSIONS: Designation as a bariatric surgery center of excellence does not ensure better outcomes. Neither does high annual procedure volume. Extra expenses associated with center of excellence designation may not be warranted.

Trends in thyroid cancer demographics and surgical therapy in the United States.

BACKGROUND: The incidence of thyroid cancer is increasing. Our objective was to characterize the demographic pattern of this increase and to examine trends in surgical therapy for thyroid cancer. METHODS: Analysis of the SEER and NHDS databases was performed from 1974 to 2000 and from 1979 to 2004, respectively. Thyroid-related diagnoses were extracted, and thyroid cancer (ICD 193.X) were analyzed using the SAS statistical package. We compared the population-adjusted incidence of thyroid cancer and examined regional variations in the operative therapy for thyroid cancer. RESULTS: The incidence of thyroid cancer has increased during the past 26 years. This increase occurred predominantly in women and in the Northeastern and Southern United States, whereas there has been a decrease in thyroid cancers in the Midwest. Papillary cancer accounts for most of this increase. Total thyroidectomy (TT) is now the most common operation for thyroid cancer. No differences in the use of TT were observed based on hospital size or insurance status. CONCLUSION: The increasing incidence of thyroid cancer in the United States is predominantly in women. These results suggest that women are a high-risk group for developing thyroid cancer although men have higher stage disease.

When policy meets statistics: the very real effect that questionable statistical analysis has on limiting health care access for bariatric surgery.

HYPOTHESIS: Bariatric surgery for Medicare patients must be performed in an accredited hospital that performs at least 125 cases per year. We assessed the validity of this volume threshold and its policy implications. DESIGN: Using the 2001-2003 National Inpatient Survey, the effect of hospital volume on in-hospital mortality was statistically modeled and the effect of a 125-case per year threshold on access to bariatric surgery was calculated. We performed Monte Carlo modeling to investigate the effect random sampling has on the apparently high mortality rate for low-volume hospitals. SETTING: US inpatient hospitals. PATIENTS: Patients with hospital discharge codes indicating bariatric surgery. Main Outcome Measure In-house mortality. RESULTS: The observed in-hospital mortality distribution as a function of hospital volume was similar to the expected frequency attributable to random sampling alone. A small number of excess deaths in very low-volume facilities cause statistically significant results for volume-outcome studies. Although 74% of all bariatric surgeries are performed in high-volume centers, 73% of all hospitals currently offering these services are now classified as low volume. CONCLUSIONS: When the results of statistical analysis are used for policy determination, the consequences for patient care may be substantial. Most studies of volume-outcome relationships rely on statistical methods that tend to amplify the effects and few fully characterize their statistical models. Despite the weak evidence for a volume-outcome relationship for bariatric surgery, a 125-case per year threshold has been set for center-of-excellence status, which eliminates most hospitals currently providing these services and disproportionately restricts access for the poor and underinsured.