Insurance Status and Outcomes in Laparoscopic Adjustable Gastric ...

ORIGINAL ARTICLE

Insurance Status and Outcomes in Laparoscopic Adjustable Gastric Banding Paul R. Balash, MD,* Nicole A. Wilson, PhD,* Nicholas E. Bruns, BA, MD,* Minh B. Luu, MD,* Amanda B. Francescatti, BA, MS,* Basile Maroulis, BA,* Khristi M. Autajay, RD,* and Jonathan A. Myers, MD*w

Background: Laparoscopic adjustable gastric banding (LAGB) is a proven method for achieving long-term weight loss, but there has been controversy regarding how pay status impacts outcomes after surgery. Objectives: To compare outcomes of LAGB with respect to percentage excess weight loss (%EWL), perioperative complications, and number of band adjustments between insured and self-financed patients. Methods: Retrospective analysis of data (n = 108) including demographics, comorbidities, operative complications, and %EWL for 5 years postsurgery. Results: There were no demographic differences between the Insured Group and the Self-financed Group, except mean preoperative BMI (P = 0.049). There were no complications reported and no differences in %EWL between the groups. Conclusions: This is the first study assessing outcomes and complication rates with respect to pay status in an outpatient surgery center bariatric patient population. These results demonstrate that self-financed patients did not achieve greater weight loss compared with privately insured patients undergoing LAGB. Key Words: bariatric surgery, gastric banding, weight loss

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besity is currently the second leading cause of preventable death in the United States and continues to be a major problem affecting approximately one third of the US population.1–3 Studies have shown that surgical treatment of obesity is superior to nonsurgical treatment plans in terms of not only weight loss, but also in reduction and resolution of comorbid conditions.1,3 Compared with many other bariatric techniques, laparoscopic adjustable gastric banding (LAGB) is a reversible, less morbid technique that has been adopted by many in the bariatric community.1,3 The National Institutes of Health Consensus Development Conference panel (1991) has recommended that bariatric surgery be considered for motivated and wellinformed patients that are diagnosed with morbid obesity Received for publication April 1, 2013; accepted April 11, 2013. From the *Department of General Surgery, Rush University Medical Center; and wDay One Health, The Surgery Center, 900 North Michigan Surgery Center, Chicago, IL. The authors declare no conflicts of interest. Reprints: Jonathan A. Myers, MD, Rush University Medical Center, 1725 West Harrison Street, Suite 810, Chicago, IL 60612 (e-mail: [email protected]) Copyright r 2013 by Lippincott Williams & Wilkins

Surg Laparosc Endosc Percutan Tech

and are of acceptable operative risk.3,4 Because of the high cost of bariatric surgery most patients rely on health care insurance to finance the procedure. For those that do not qualify for coverage under their specific health care policy or do not have health care insurance, self-finance options exist for the procedure. The primary aim of this study was to compare the outcomes of LAGB in terms of demographics, comorbidities, overall excess weight loss (EWL), perioperative outcomes, number of band adjustments, and complications between insured and self-financed patients. We postulated that, based on financial incentive, self-financed patients would have increased weight loss compared with those patients whose procedures were covered by insurance.

MATERIALS AND METHODS A retrospective study was performed including data from 108 individuals (88 women, 20 men; age range, 23 to 70 y; mean ± SD age, 41 ± 11 y) who underwent LAGB, performed by a single surgeon at the 900 North Michigan Surgery Center (Day One Health) between January 2007 and December 2008. Of the 108 patients identified, 102 met the criteria proposed by the National Institutes of Health Consensus Panel.4 Six patients with BMI < 35 kg/m2 did not meet NIH consensus criteria and were offered “offlabel” band placement. All included patients were divided into 2 groups based on how they financed the operation: insured patients (n = 61) used health care insurance, whereas self-financed patients (n = 47) paid for the procedure out-of-pocket. This project was Institutional Review Board approved in accordance with the requirements of the Code of Federal Regulations on the Protection of Human Subjects. Retrospective analysis was conducted using the patient medical records. Data collected included patient demographic information [ie, age, sex, ethnicity, height, weight, BMI (calculated), and comorbidities], perioperative data (ie, OR time, estimated blood loss, length of stay, and readmission within 30 d of the initial operation), operative complications (ie, number of band adjustments, portrevisions, leaks, and rate of band slippage), and postoperative data (ie, weight loss at yearly intervals for 5 y postsurgery). Weight loss was expressed as the percent of EWL with excess weight defined as that above the median weight for height.5 Statistical analyses were performed to evaluate differences between the 2 groups (insured and self-financed) using either an unpaired t test or Fisher exact test, as appropriate (SPSS, Version 11.5; IBM Inc., Armonk, NY). Changes in EWL (%) over time for the 2 groups were

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analyzed using ANOVA with repeated measures. The threshold for statistical significance was set at P < 0.05 for all comparisons. Data were expressed as mean ± SD.

TABLE 2. Perioperative Outcomes

Outcomes

RESULTS Demographics Between January 2007 and December 2008, 108 patients underwent LAGB at a single surgery center (Table 1). For all patients combined, comorbidities included hypertension (44%), gastroesophageal reflux disease (44%), obstructive sleep apnea (22%), arthritis (20%), diabetes (17%), depression (15%), dyslipidemia (12%), asthma (10%), joint pain (9%), menstrual irregularity (7%), and back pain (2%). Before surgery the mean BMI was 43.1 ± 5.9 kg/m2 (range, 30.5 to 59 kg/m2) and the mean body weight was 120.6 ± 23.4 kg (range, 78.0 to 198.7 kg). The ethnic distribution for all included patients was 65.7% white, 26.7% African American, 7.6% Hispanic, and 2.8% other. The insured group consisted of 61 patients (47 women, 14 men; age range, 23 to 59 y; mean age, 39 ± 9.5 y) and the self-financed group consisted of 47 patients (41 women, 6 men; age range, 25 to 70 y; mean age, 42 ± 12.6 y). The mean BMI was higher in the insured (44.1 ± 5.17 kg/m2) compared with the self-financed group (41.9 ± 6.56 kg/m2, P = 0.049). Age, height, weight, sex, and number of comorbidities were similar between the 2 groups (Table 1).

Perioperative Data and Complications For all patients combined, the mean number of band adjustments was 7.0. There was no significant difference in the number of band adjustments between the insured (7.0 ± 5.9) and the self-financed group (7.0 ± 4.4, P = 0.991). All band adjustments in the insured group were covered by health care insurance. The mean operating time, estimated blood loss, and length of stay were similar between the 2 groups (Table 2). No patients from either group were readmitted within 30 days of operation. There were no conversions to an open procedure.

Weight Loss At 1 year, the EWL was 30.75% ± 18.0% for the insured group and 34.8% ± 20.0% for the self-financed group. At 2 years, the EWL was 42.5% ± 17.8% for the insured group and 42.5% ± 20.7% for the self-financed group. At 3 years, the EWL was 37.4% ± 22.7% for the insured group and 39.2% ± 22.3% for the self-financed

TABLE 1. Patient Demographics

Characteristics Age (y) Sex: % female Preoperative height (cm) Preoperative weight (kg) BMI (kg/m2) # Comorbidities

Insured (n = 61)

Self-Financed (n = 47)

P

39.1 ± 9.5 77.0 (n = 47) 167.1 ± 9.1

42.4 ± 12.6 87.2 (n = 41) 166.1 ± 7.6

0.141 0.217 0.503

124.3 ± 24.2

115.8 ± 21.7

0.062

44.1 ± 5.2 2.0 ± 1.6

41.9 ± 6.6 2.1 ± 1.2

0.049* 0.641

*P < 0.05.

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Operative time (min) Estimated blood loss (mL) Length of hospital stay (d) 30 d readmission (n)

Insured (n = 61)

Self-Financed (n = 47)

P

42.5 ± 12.2 10.7 ± 4.2

44.2 ± 14.3 11.0 ± 3.7

0.504 0.699

0

0

N/A

0

0

N/A

N/A statistical test not applicable.

group. At 4 years, the EWL was 41.1% ± 22.7% for the insured group and 47.0% ± 25.3% for the self-financed group. At 5 years, the EWL was 37.1% ± 19.9% for the insured group and 40.0% ± 22.5% for the self-financed group (Table 3). There were no significant differences in %EWL between the groups at yearly follow- up. As shown in the table, follow-up ranged from 60/61 for the insured group (98%) and 47/47 (100%) for the self-financed group in the first year and dropped to 11/61 (18%) for the insured group and 11/47 (23%) for the self-financed group as the years progressed.

DISCUSSION Obesity is a multifactorial condition that affects a heterogenous cross-section of the US population. Although a myriad of factors impact successful weight loss after bariatric surgery, many physicians and surgeons believe that a primary determinant of success is patient motivation.6 Furthermore, socioeconomic disparities and their impact on outcomes after surgical intervention are well documented.7 The results of this study suggest that pay status does not affect the perioperative complication rate or amount of excess weight lost within the first 5 years after LAGB surgery. LAGB is a proven method for achieving long-term weight loss.8–11 For example, the patients included in this study lost an average of 42% of their excess weight within the first 5 years after undergoing LAGB. This degree of weight loss is consistent with previous studies, including a large meta-analysis by Buchwald et al,12 which reported a mean EWL of 47.45% after gastric banding, based on >1800 patients. However, not all patients are successful in achieving this degree of weight loss after bariatric surgery and it is important to identify those at risk for poor outcomes so that more effective interventions can be designed.13

TABLE 3. Excess Weight Loss of Insured and Self-Financed patients

Follow-Up (y) 1 2 3 4 5

Insured (n) 30.75% ± 18.0% 42.5% ± 17.8% 37.4% ± 22.7% 41.1% ± 22.7% 37.1% ± 19.9%

r

Self-Financed (n) (60) (31) (30) (23) (11)

34.8% ± 20.0% 42.5% ± 20.7% 39.2% ± 22.3% 47.0% ± 25.3% 40.0% ± 22.5%

(47) (25) (18) (9) (11)

P 0.271 0.996 0.777 0.529 0.751

2013 Lippincott Williams & Wilkins



There has been considerable controversy in the literature regarding how patient pay status impacts outcomes after bariatric surgery. Several early studies suggested that patients with publically funded coverage (eg, Medicaid and VA benefits) had poorer weight loss outcomes and increased perioperative complication rates compared with patients with private insurance.14,15 Although, with a few exceptions, more recent studies suggest that other factors are more important than pay status when predicting weight loss and complication rates after bariatric surgery.6,13,16,17 From 1998 to 2002, the patient population that underwent bariatric surgery was predominantly female, privately insured, and from the highest income bracket.18 Interestingly, most literature investigating outcome disparities with regard to socioeconomic or pay status has focused on differences between patients with publically funded insurance coverage and those with private insurance. A unique aspect of the current study is the contrast between patients with private insurance and those that paid for the procedure out-of-pocket (self-financed). Patients with Medicaid and/or Medicare were not included in this series. Inclusion of the self-financed payer category allows further characterization of the patients that undergo these procedures. A national survey of bariatric surgeons found that surgeons preferred patients with private insurance to either self-financed patients or those with public insurance.19 Although outcomes analysis from single-institution centers should be considered carefully because demographic differences may impact outcomes and prospective data are needed to properly risk-adjust outcomes after bariatric surgery, the results of this study are consistent with previously published studies showing that insurance status did not predict weight loss after bariatric surgery.6,13,17 The current research supports previous findings and suggests that insurance status is, at best, an imperfect indicator of socioeconomic status and is a poor predictor of outcomes after LAGB surgery. The population included in this series represents a relatively homogenous patient population that reflects the demographics of bariatric surgery patients that present to an outpatient surgery center for care. A majority of the patients in this study were female (81.5%), were privately insured (56.5%), and were affluent (based on a median household income of $73,088 in the immediate catchment area of the surgery center20). The hypothesis of this study was based on the assumption that self-financed patients would have increased personal incentive for weight loss compared with those who financed the procedure through private insurance coverage. However, the homogenous, affluent nature of the patient population may have contributed to the lack of differences between these 2 groups. Most studies investigating bariatric surgery outcomes with respect to pay status have used pay status as an indirect assessment of socioeconomic status. Therefore these studies have assessed the difference between a relatively affluent population (privately insured) and a lower socioeconomic population (publically funded coverage). It is possible that no such socioeconomic stratification exists between the 2 groups included in the current study. Durable weight loss after bariatric surgery is mainly contingent on patient compliance with prescribed dietary restrictions and maintenance of behavior modifications over time.6 A limitation of this study is the drop-off of follow-up and the assumption of that these patients may have done poorly in terms of EWL. This phenomenon was r


Insurance and Outcomes in Gastric Banding

undoubtedly exacerbated by the economic downturn which occurred in 2008. Elective adjustments were likely deferred by many affected during this time. It is possible that differences in EWL could arise between the 2 groups with inclusion of more complete long-term follow-up. In addition, the mean BMI before surgery was significantly different between the 2 groups. This difference was likely due to selection bias inherent in insurance coverage. At the time of the study, for patients with a BMI < 35 kg/m2, LAGB surgery was considered “off-label” by the FDA.21 However, the protocol at our institution offers LAGB to qualified patients with a BMI > 30 kg/m2. The selection bias arose because patients with a BMI of 30 to 35 kg/m2 were included in the self-financed group, as they were not eligible for inclusion in the insured group. Recent changes in FDA guidelines have lowered the required BMI to 30 kg/m2 with a related comorbid condition.22

CONCLUSIONS This is one of the first studies to assess outcome and complication rates with respect to pay status in a population representative of bariatric surgery patients presenting at an outpatient surgery center. These results demonstrate that self-financed patients did not achieve greater weight loss compared with privately insured patients undergoing LAGB. REFERENCES 1. Ogden CL, Carroll MD, Curtin LR, et al. Prevalence of overweight and obesity in the United States, 1999–2004. JAMA. 2006;295:1549–1555. 2. Martin LF, Hunter SM, Lauve RM, et al. Severe obesity: expensive to society, frustrating to treat, but important to confront. South Med J. 1995;88:895–902. 3. Flegal KM, Carroll MD, Ogden CL, et al. Prevalence and trends in obesity among US adults, 1999-2000. JAMA. 2002;288:1723–1727. 4. National Institutes of Health Consensus Development Panel. Gastrointestinal surgery for severe obesity. Ann Intern Med. 1991;115:956–961. 5. 1983 Metropolitan height and weight tables. Stat Bull Metrop Life Insur Co. 1984;64:2–9, Available at: http://www.ncbi.nlm. nih.gov/pubmed/6623350. 6. Durkin AJ, Bloomston M, Murr MM, et al. Financial status does not predict weight loss after bariatric surgery. Obes Surg. 1999;9:524–526. 7. El-Sayed AM, Ziewacz JE, Davis MC, et al. Insurance status and inequalities in outcomes after neurosurgery. World Neurosurg. 2011;76:459–466. 8. Sjo¨stro¨m L, Narbro K, Sjo¨stro¨m CD, et al. Effects of bariatric surgery on mortality in Swedish obese subjects. N Engl J Med. 2007;357:741–752. 9. Adams TD, Gress RE, Smith SC, et al. Long-term mortality after gastric bypass surgery. N Engl J Med. 2007;357:753–761. 10. Mason EE, Printen KJ, Blommers TJ, et al. Gastric bypass for obesity after ten years experience. Int J Obes. 1978;2:197–206. 11. Higa KD, Boone KB, Ho T. Complications of the laparoscopic Roux-en-Y gastric bypass: 1040 patients-what have we learned? Obes Surg. 2000;10:509–513. 12. Buchwald H, Avidor Y, Braunwald E, et al. Bariatric surgery: a systematic review and meta-analysis. JAMA. 2004;292:1724–1737. 13. Melton GB, Steele KE, Schweitzer MA, et al. Suboptimal weight loss after gastric bypass surgery: correlation of demographics, comorbidities, and insurance status with outcomes. J Gastrointest Surg. 2008;12:250–255. 14. Renquist KE, Mason EE, Tang S, et al. Pay status as a predictor of outcome in surgical treatment of obesity. Obes Surg. 1996;6:224–232.

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15. Martin LF, Tan TL, Holmes PA, et al. Preoperative insurance status influences postoperative complication rates for gastric bypass. Am J Surg. 1991;161:625–634. 16. Dallal RM, Bailey L, Guenther L, et al. Comparative analysis of short-term outcomes after bariatric surgery between two disparate populations. Surg Obes Relat Dis. 2008;4: 110–114. 17. Alexander JW, Goodman HR, Martin Hawver LR, et al. The impact of Medicaid status on outcome after gastric bypass. Obes Surg. 2008;18:1241–1245. 18. Santry HP, Gillen DL, Lauderdale DS. Trends in bariatric surgical procedures. JAMA. 2005;294:1909–1917.

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19. Santry HP, Lauderdale DS, Cagney KA, et al. Predictors of patient selection in bariatric surgery. Ann Surg. 2007;245:59–67. 20. Urban Mapping Inc. Available at: http://www.city-data.com/ neighborhood/Magnificent-Mile-Chicago-IL.html. Accessed October 27, 2012. 21. Gastrointestinal surgery for severe obesity. National Institutes of Health consensus development conference statement. Am J Clin Nutr. 1992;55S:615–619. 22. US Department of Health and Human Service, FDA. Center for Devices and Radiologic Health Medical Devices Advisory Committee. Gastroenterology and Urology Devices Panel. December 3, 2010.

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