- Email: [email protected]
Preliminary outcomes of laparoscopic sleeve gastrectomy in a Veterans Affairs medical center
The American Journal of Surgery (2012) 204, e1– e6
Association of VA Surgeons
Preliminary outcomes of laparoscopic sleeve gastrectomy in a Veterans Affairs medical center Daniel Saul, M.D., Daniel Stephens, M.D.*, Rita de Cássia Hofstätter, M.D., Leaque Ahmed, M.D., F.A.C.S., Erik Langhoff, M.D., Tomas M. Heimann, M.D., F.A.C.S. Department of Surgery, James J. Peters VA Medical Center, 130 West Kingsbridge Rd., Bronx, NY 10468, USA; The Mount Sinai School of Medicine, New York, NY, USA KEYWORDS: Bariatric surgery; Morbid obesity; Laparoscopic sleeve gastrectomy; Vertical gastrectomy; Staple line reinforcement; Diabetes; Veterans Affairs
Abstract BACKGROUND: Preliminary results of a new bariatric surgery program in a VA Medical Center using laparoscopic sleeve gastrectomy (LSG). METHODS: Prospective review of the first 50 patients who underwent LSG. Percentage change in body mass index (BMI), comorbidities, serum glucose, glycosylated hemoglobin (HbA1c), lipid profiles, and medications were recorded. RESULTS: Mean age was 52 years. Average BMI was 46 kg/m2. There were no mortalities or staple line leaks. The percentage excess BMI loss was 47% and 54% at 6 and 12 months, respectively. After 6 months, fasting glucose level decreased from 127 to 93 mg/dL, and mean glycosylated hemoglobin decreased from 6.8% to 5.7%. At 1-year follow-up evaluation, serum cholesterol decreased from 182 to 168 mg/dL, mean triglycerides from 179 to 93 mg/dL, low-density lipoprotein from 110 to 94 mg/dL, and high-density lipoprotein increased from 42 to 50 mg/dL. CONCLUSIONS: Laparoscopic sleeve gastrectomy is safe and effective for morbidly obese VA patients and resulted in significant discontinuation of medication for hypertension, diabetes and hyperlipidemia. Published by Elsevier Inc.
Obesity is becoming an endemic disease in the United States,1 and in this setting, bariatric surgery has become the treatment of choice for morbidly obese patients with comorbidities who are unable to lose weight with diet, exercise, and behavior modification. Sleeve gastrectomy originally was described as a firststage surgery in high-risk morbidly obese patients, resulting in significant weight loss with low complication rates.2,3 Presented at the 36th Annual Meeting of the Association of VA Surgeons, April 1-3, 2012, Miami Beach, FL. * Corresponding author. Tel.: ⫹1-718-584-9000; fax: ⫹1-718-741-4621. E-mail address: [email protected] Manuscript received April 5, 2012; revised manuscript July 10, 2012
0002-9610/$ - see front matter Published by Elsevier Inc. http://dx.doi.org/10.1016/j.amjsurg.2012.07.005
Currently, laparoscopic sleeve gastrectomy (LSG) is used more frequently as a standalone surgery for obese patients, reserving the second stage for the few patients with inadequate weight loss after LSG.4 Although LSG is a restrictive procedure,5 removing the gastric fundus, the primary site of ghrelin production, appears to have a hormonal effect, enhancing weight loss by reducing appetite.6,7 Several studies also have shown that bariatric surgery results in resolution or improvement of obesity-related comorbidities, cardiovascular risk, and reduction of the need for medication for diabetes, dyslipidemia, and hypertension.8 –14 The aim of this study was to assess the early outcomes of laparoscopic sleeve gastrectomy in a popula-
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tion of primarily male, high-risk, Veterans Affairs patients and to compare our results with those published in the literature.
Materials and Methods Fifty consecutive morbidly obese patients undergoing laparoscopic sleeve gastrectomy at the James J. Peters VA Medical Center (Bronx, NY) were studied. These patients underwent surgery between April 2010 and November 2011 and were analyzed prospectively. To qualify for bariatric surgery, patients were required to have a body mass index (BMI) of 40 kg/m2 or more, or a BMI of 35 kg/m2 to 40 kg/m2 with comorbidities related to their obesity. Data were collected at 3, 6, and 12 months before the surgery, and at 1, 2, 3, 6, and 12 months after the surgery. The data collected included patient demographics, length of stay, early complications, incidence of hiatus hernia repair, preoperative weight loss, comorbidities, medications, fasting blood glucose level, glycosylated hemoglobin (HbA1c) level, blood pressure, and serum lipid profile. Weight loss was expressed as a decrease in BMI and a percentage change in BMI. The percentage of excess BMI loss (% EBL) was calculated using the following formula: % EBL ⫽ (preoperative BMI – current BMI)/(preoperative BMI – 25) ⫻ 100.15 The medication information was obtained from the VA pharmacy records, which contain information on the medications filled, the dosage, and days of supply. The patients were considered cured if all medications for diabetes mellitus, hypertension, or dyslipidemia were discontinued, and considered improved with discontinuation or decreasing the dose of one or more drugs but not all. Diabetic patients on insulin were considered improved if they were able to discontinue insulin. Patients considered cured had to be taken off medications within 1 year of surgery with no refills until the end point of the study.
Statistical analyses Data analysis was performed using the chi-square test for categoric data, and analysis of variance or paired t test for
Table 1
continuous data. Continuous analyses were reported as mean, standard deviation (SD), and range. Categoric variables were reported as numbers and percentages. A P value less than .05 was considered statistically significant and a P value less than .01 was considered highly significant. SPSS Statistics version 20 (IBM, Armonk, NY) was used to perform the statistical analyses.
Surgical procedure LSG was performed laparoscopically in every case. A 5-trocar technique is performed with the Nathanson liver retractor (Richard Wolf Medical Instruments Corporation, Vernon Hills, IL) in the subxyphoid position. The gastric dissection begins at a point directly inferior to the angularis incisura. The LigaSure 5 mm Blunt Tip Laparoscopic Instrument (Covidien, Boulder, CO) is used to divide the gastrocolic ligament from the greater curvature of the stomach. The lesser sac is entered and the dissection proceeds along the greater curvature toward the proximal stomach and spleen. The short gastric vessels then are transected with care to avoid injury to the splenic capsule. Once the stomach is fully mobilized, the sleeve is created with an endoscopic stapler reinforced with Gore SeamGuard bioabsorbable material (W.L. Gore & Associates, Inc, Newark, DE). A 34F bougie is used to determine the diameter of the sleeve.
Results Fifty consecutive patients underwent LSG. The mean follow-up period was 10.3 months. One hundred percent of the patients had 6 months of follow-up evaluation and 72% had 1 year of follow-up evaluation. Preoperative characteristics of the patients are shown in Table 1. Ninety percent of the patients were men, the mean age was 52 ⫾ 11 years (range, 26 –77 y), and the mean preoperative BMI was 46 ⫾ 6 kg/m2 (range, 36 – 66 kg/m2). A total of 64% of the patients had hypertension, 42% had type 2 diabetes mellitus, and 40% had hyperlipidemia. The mean preoperative fasting blood glucose level was 127 ⫾ 52 mg/dL (range, 62–
Preoperative patient demographics
Average age, y (range) Average BMI, kg/m2 (range) Length of stay, d (range) Hiatus hernia, % (n) Hypertension, % (n) T2DM, % (n) Hyperlipidemia, % (n) T2DM ⫽ type 2 diabetes mellitus.
Male (n ⫽ 45)
Female (n ⫽ 5)
Total (n ⫽ 50)
52 46 2.1 8 64 42 38
44 49.8 4 2 0 0 2
52 46 2.1 10 64 42 40
(26–77) (36–66) (2–5) (4) (32) (21) (19)
(31–52) (37–43) (2) (1) (0) (0) (1)
(26–77) (36–66) (2–5) (5) (32) (21) (20)
D. Saul et al. Table 2
Laparoscopic sleeve gastrectomy in veterans
e3
Outcomes after a laparoscopic sleeve gastrectomy at 6 months (mean ⫾ SD; N ⫽ 50) Preoperative
BMI, kg/m2 %EBL Systolic BP, mm Hg Diastolic BP, mm Hg Glycemia, mg/dL HbA1c, % Cholesterol, mg/dL LDL, mg/dL HDL, mg/dL Triglycerides, mg/dL
46 0 133 75 127 6.8 182 110 42 179
⫾6 ⫾ ⫾ ⫾ ⫾ ⫾ ⫾ ⫾ ⫾
18 10 52 1.0 47 44 11 100
Postoperative 36 47 123 69 93 5.7 171 103 48 115.3
⫾ ⫾ ⫾ ⫾ ⫾ ⫾ ⫾ ⫾ ⫾ ⫾
6 17 16 7 16 .7 32 33 10 56
Mean change
95% CI*
P value†
8.2 ⫺46.9 9.5 5.7 28.8 1.1 14.9 10.8 ⫺5.1 51.7
5.1–11.2 ⫺53.0 to ⫺40.8 ⫺.4 to 19.4 1.3–10.1 12.3–45.2 .6–1.6 ⫺6.3 to 36.1 ⫺11.0 to 32.7 ⫺9.5 to ⫺.6 14.0–89.3
⬍.01 ⬍.01 NS (.06) ⬍.05 ⬍.01 ⬍.01 NS NS ⬍.05 ⬍.01
BP ⫽ blood pressure. *95% Confidence interval (CI) of mean difference. †Paired t test was used to assess the variation from baseline.
336 mg/dL), and the mean HbA1c value was 6.8% ⫾ 1.0% (range, 5.2%–9.9%). The preoperative lipid profile showed a mean cholesterol level of 182 ⫾ 47 mg/dL (range, 118 – 337 mg/dL), mean triglyceride level of 179 ⫾ 100 mg/dL (range, 70 –572 mg/dL), mean low-density lipoprotein (LDL) level of 110 ⫾ 44 mg/dL (range, 37–235 mg/dL), and mean high-density lipoprotein (HDL) level of 42 ⫾ 11 mg/dL (range, 24 – 80 mg/dL). None of the patients required conversion to open surgery, and there were no mortalities. A hiatal hernia was diagnosed on preoperative endoscopy and was repaired in 5 patients (10%) during LSG. One patient had postoperative bleeding, presumably from the staple line, requiring transfusion of 3 units of packed red blood cells. He was discharged home on postoperative day 5. One patient with hepatitis C had a transient hepatic transaminase increase that resolved by discharge on postoperative day 5. There were no staple line leaks. All patients had a postoperative upper-gastrointestinal barium study on postoperative day 1. The mean length of stay in the hospital was 2 ⫾ .6 days (range, 2–5 d). Patients were followed up for up to 1 year after surgery. Outcomes at 6 months after surgery are shown in Table 2. The percentage change in BMI and the mean % EBL are shown in Figs. 1 and 2. For all patients, the mean fasting blood glucose values decreased to 110, 104, 93, and 86 mg/dL at 1, 3, 6, and 12
Figure 1
months (P ⬍ .01), respectively. In the same period, the mean HbA1c value decreased to 6.1%, 5.9%, 5.7%, and 5.4% (P ⬍ .01). The mean serum cholesterol level at 6 months before the surgery was 182 mg/dL, and 6 months postoperatively decreased to 171 mg/dL (not significant, P ⫽ .16). The serum LDL cholesterol level decreased from 110 to 103 mg/dL (not significant, P ⫽ .32) and the HDL cholesterol level increased from 42 to 48 mg/dL from 6 months before surgery to 6 months after surgery (P ⬍ .05). The triglyceride levels were 179 at 6 months before the LSG and decreased to 115 mg/dL at 6 months after surgery (P ⬍ .01). For the patients who were diabetic preoperatively the mean preoperative fasting blood glucose level was 141.2 mg/dL and decreased to 99.2 and 84.2 at 6 and 12 months (P ⬍ .01), respectively. For the patients who were not diabetic preoperatively the mean preoperative fasting blood glucose level was 116.2 mg/dL and decreased to 87.6 and 87.6 at 6 and 12 months (P ⬍ .01), respectively. For the patients who were diabetic preoperatively the mean preoperative HbA1c value was 7.3% and decreased to 6.1% and 5.6% at 6 and 12 months (P ⬍ .01), respectively. For the patients who were not diabetic preoperatively the mean preoperative HbA1c value was 6.3% and decreased to 5.4% and 5.3% at 6 and 12 months (P ⬍ .01), respectively. For the patients who were hypertensive preoperatively the mean
Percentage change in BMI 1 year before laparoscopic sleeve gastrectomy and 12 months postoperatively.
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Figure 2
Percentage EBL 1 year before the surgery and 12 months postoperatively.
preoperative blood pressure was 131/73 and decreased to 124/71 and 120/71 at 6 and 12 months (P ⬍ .01), respectively. For the patients who were not hypertensive preoperatively, the mean preoperative blood pressure was 125/77 and decreased to 117/68 and 107/58 at 6 and 12 months (P ⬍ .01), respectively. Change in medication status also was analyzed (Fig. 3). Preoperatively, 32 patients were on antihypertensive medication, 21 patients were on hypoglycemic medication, and 20 patients were on statins. At 6 months after surgery, 22 patients were on hypertension medication (P ⬍ .01), 11 patients were on hypoglycemic medication (P ⬍ .01), and 9 patients were using statins (P ⬍ .01). There was discontinuation of medication in 31%, 47%, and 55% of patients with hypertension, diabetes, and hyperlipidemia, respectively. Also, the number of diabetic patients using insulin decreased from 10 (20%) preoperatively to 5 (10%) patients 6 months after surgery.
Comments LSG is a safe and effective procedure for the treatment of morbid obesity and obesity-related comorbidities in VA
Figure 3 Number of patients on medications preoperatively and 6 months postoperatively.
patients. Our patients are mostly male and older than non-VA patients undergoing bariatric surgery. In our study the percentage of female patients was only 10% and the mean age was 52 years old, whereas in 5 other studies of patients undergoing LSG the mean percentage of women was 71% and the mean age was 10 years younger at 42 years.5,11,13,16,17 Nevertheless, LSG can be accomplished with a low rate of complications, and without conversions to open surgery or reoperations. There were no mortalities and only 2 complications (4%) in our series. Other recent studies showed mortality rates ranging from 0% to 3.3%.16,18 –21 We had no staple line leaks. This complication was found in .7% and 1.8% of patients reported by Arias et al22 and Deitel et al,20 respectively. Our current study was a prospective series of LSG as a primary bariatric surgery in VA patients. A PubMed literature search for bariatric surgery in VA hospitals found only one series of LSG.23 In this study, however, LSG was intended as an initial weight loss procedure for high-risk patients to be followed by laparoscopic Roux-en-Y gastric bypass (LRYGB). There have been 5 studies that examined the results of LRYGB in VA patients and showed LRYGB is a safe and effective surgery in this population.24 –28 Two cost analyses showed that bariatric surgery reduces obesityrelated expenditures and use of health care resources.29,30 Another analysis indicated that bariatric surgery in VA patients does not achieve a reduction in health care expenditures 3 years after the procedure.31 We did not address cost in our study, and this is an area of future research. Our early findings of a mean % EBL of 54% at 12 months is comparable with other published studies.13,17 The recent report from the American College of Surgeons21 showed a mean BMI loss at 1 year for patients undergoing LSG of 11.8 kg/m2, compared with our study with an 11.3 kg/m2 BMI loss. At the Third International Summit for LSG, a questionnaire was completed by 88 attendees with a total number of 19,605 LSGs performed, 86% of which were intended as the sole operation. After 1 year of follow-up evaluation there was a mean of 63% ⫾ 29% EBL,
D. Saul et al.
Laparoscopic sleeve gastrectomy in veterans
and at 5 years there was a mean of 62% ⫾ 12% EBL.20 These results suggest a similar trend to that seen in our patients. Compared with other bariatric procedures, our weight loss results are between those seen in LRYGB and laparoscopic adjustable gastric banding (LAGB).21,32 In the current study, LSG significantly improved our patients’ comorbidities. The report from the American College of Surgeons shows a resolution or improvement of 55% for patients with diabetes, 68% for patients with hypertension, and 35% resolution for patients with hyperlipidemia. Our results compare favorably with values at 76% and 50% for improved or resolved diabetes and hypertension, respectively, and 70% resolution of hyperlipidemia. Also, it has been reported that resolution of diabetes is present in 44% of patients for LAGB and in 83% for Roux-en-Y gastric bypass (RYGB). Resolution of hypertension was seen in 44% for LAGB and in 79% for RYGB, and resolution for hyperlipidemia was seen in 33% for LAGB and in 66% for RYGB.21 Our results are comparable,11–13 and the results for improvement or resolution of diabetes and hypertension are between those seen with RYGB and LAGB.21 Six months after LSG, fasting glucose and HbA1c values significantly decreased as has been shown in other studies.16,33,34 A total of 98.8% of patients achieved HbA1c less than 6.5% compared with 85.7% reported by Vidal et al,12 and 75.6% in our series achieved HbA1c less than 6% compared with 65.2% reported by DePaula et al.35 Analyzing the lipid profile changes, we could observe statistically significant improvement of HDL cholesterol and triglyceride levels. Zhang et al36 reported similar results in their study. We found a statistically significant decrease in triglyceride levels and increase in HDL cholesterol, but the decreases in LDL and total cholesterol were not statistically significant. There is no general consensus regarding the use of staple line reinforcement versus oversewing the staple line versus no reinforcement. Dapri et al37 compared 3 techniques in LSG (without reinforcement, with Gore SeamGuard, and with staple line oversewing). They concluded that there were no differences in postoperative leak rates, and that reinforcement with Gore SeamGuard reduced bleeding. However, this study included only 75 patients among the 3 groups and did not have sufficient power to detect differences considering the known rate of leaks. Another study concluded that the reduction of leaks may not necessarily be owing to staple line reinforcement because the rate was so low that nearly 10,000 procedures would be needed to reach statistical significance.38 A recent, nonrandomized study was consistent with our results, showing no leaks and one bleed in 116 consecutive patients.39 In summary, LSG appears to be a safe and effective surgical procedure for morbidly obese VA patients. Significant weight loss and improvement of comorbidities related to obesity such as hypertension, diabetes, and hyperlipidemia, and discontinuation of medications used to treat these disorders is seen within 6 to 12 months in most patients.
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References 1. Deitel M. The obesity epidemic. Obes Surg 2006;16:377– 8. 2. Cottam D, Qureshi FG, Mattar SG, et al. Laparoscopic sleeve gastrectomy as an initial weight-loss procedure for high-risk patients with morbid obesity. Surg Endosc 2006;20:858 – 63. 3. Mognol P, Chosidow D, Marmuse JP. Laparoscopic sleeve gastrectomy as an initial bariatric operation for high-risk patients: initial results in 10 patients. Obes Surg 2005;15:1030 –3. 4. Frezza EE. Laparoscopic vertical sleeve gastrectomy for morbid obesity. The future procedure of choice? Surg Today 2007;37:275– 81. 5. Melissas J, Koukouraki S, Askoxylakis J, et al. Sleeve gastrectomy: a restrictive procedure? Obes Surg 2007;17:57– 62. 6. Langer FB, Reza Hoda MA, Bohdjalian A, et al. Sleeve gastrectomy and gastric banding: effects on plasma ghrelin levels. Obes Surg 2005;15:1024 –9. 7. Ariyasu H, Takaya K, Tagami T, et al. Stomach is a major source of circulating ghrelin, and feeding state determines plasma ghrelin-like immunoreactivity levels in humans. J Clin Endocrinol Metab 2001; 86:4753– 8. 8. Arterburn D, Schauer DP, Wise RE, et al. Change in predicted 10-year cardiovascular risk following laparoscopic Roux-en-Y gastric bypass surgery. Obes Surg 2009;19:184 –9. 9. Sjöström L, Lindroos AK, Peltonen M, et al. Lifestyle, diabetes, and cardiovascular risk factors 10 years after bariatric surgery. N Engl J Med 2004;351:2683–93. 10. Maciejewski ML, Livingston EH, Kahwati LC, et al. Discontinuation of diabetes and lipid-lowering medications after bariatric surgery at Veterans Affairs Medical Centers. Surg Obes Relat Dis 2010;6:601–7. 11. Sánchez-Santos R, Masdevall C, Baltasar A, et al. Short- and mildterm outcomes of sleeve gastrectomy for morbid obesity: the experience of the Spanish national registry. Obes Surg 2009;19:1203–10. 12. Vidal J, Ibarzabal A, Nicolau J, et al. Short-term effects of sleeve gastrectomy on type 2 diabetes mellitus in severely obese subjects. Obes Surg 2007;17:1069 –74. 13. Hamoui N, Anthone GJ, Kaufman HS, et al. Sleeve gastrectomy in the high-risk patient. Obes Surg 2006;16:1445–9. 14. Zlabek JA, Grimm MS, Larson CJ, et al. The effect of laparoscopic gastric bypass surgery on dyslipidemia in severely obese patients. Surg Obes Relat Dis 2005;1:537– 42. 15. Deitel M, Gawdat K, Melissas J. Reporting weight loss 2007. Obes Surg 2007;17:565– 8. 16. Angrisani L, Cutolo PP, Buchwald JN, et al. Laparoscopic reinforced sleeve gastrectomy: early results and complications. Obes Surg 2011; 21:783–93. 17. Fuks D, Verhaeghe P, Brehant O, et al. Results of laparoscopic sleeve gastrectomy: a prospective study in 135 patients with morbid obesity. Surgery 2009;145:106 –13. 18. Brethauer SA, Hammel JP, Schauer PR. Systematic review of sleeve gastrectomy as staging and primary bariatric procedure. Surg Obes Relat Dis 2009;5:469 –75. 19. Shi X, Karmali S, Sharma AM, et al. A review of laparoscopic sleeve gastrectomy for morbid obesity. Obes Surg 2010;20:1171–7. 20. Deitel M, Gagner M, Erickson AL, et al. Third international summit: current status of sleeve gastrectomy. Surg Obes Relat Dis 2011;7:749 –59. 21. Hutter MM, Schirmer BD, Jones DB, et al. First report from the American College of Surgeons Bariatric Surgery Center Network: laparoscopic sleeve gastrectomy has morbidity and effectiveness positioned between the band and the bypass. Ann Surg 2011;254: 410 –20. 22. Arias E, Martínez P, Ka M, et al. Mid-term follow-up after sleeve gastrectomy as a final approach for morbid obesity. Obes Surg 2009; 195:544 – 8. 23. Cottam D, Qureshi FG, Mattar SG, et al. Laparoscopic sleeve gastrectomy as an initial weight-loss procedure for high-risk patients with morbid obesity. Surg Endosc 2006;20:859 – 63.
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24. Hauser DL, Titchner RL, Wilson MA, et al. Long-term outcomes of laparoscopic Roux-en-Y gastric bypass in US veterans. Obes Surg 2010;20:283–9. 25. Alami RS, Morton JM, Sanchez BR, et al. Laparoscopic Roux-en-Y gastric bypass at a Veterans Affairs and high-volume academic facilities: a comparison of institutional outcomes. Am J Surg 2005;190: 821–5. 26. Safadi BY, Kieran JA, Hall RG, et al. Introducing laparoscopic Rouxen-Y gastric bypass at a Veterans Affairs medical facility. Am J Surg 2004;188:606 –10. 27. Livingston EH, Liu CY, Glantz G, et al. Characteristics of bariatric surgery in an integrated VA Health Care System: follow-up and outcomes. J Surg Res 2003;109:138 – 43. 28. Maciejewski ML, Livingston EH, Kahwati LC, et al. Discontinuation of diabetes and lipid-lowering medications after bariatric surgery at Veterans Affairs Medical Centers. Surg Obes Relat Dis 2010;6:601–7. 29. Ghiassi S, Morton J, Bellatorre N, et al. Short-term medication cost savings for treating hypertension and diabetes after gastric bypass. Surg Obes Relat Dis 2011;8:269 –74. 30. Gallagher SF, Banasiak M, Gonzalvo JP, et al. The impact of bariatric surgery on the Veterans Administration healthcare system: a cost analysis. Obes Surg 2003;13:245– 8. 31. Maciejewski ML, Smith VA, Livingston EH, et al. Health care utilization and expenditure changes associated with bariatric surgery. Med Care 2010;48:989 –98.
32. Lee CM, Cirangle PT, Jossart GH. Vertical gastrectomy for morbid obesity in 216 patients: report of two-year results. Surg Endosc 2007; 21:1810 – 6. 33. Rizzello M, Abbatini F, Casella G, et al. Early postoperative insulinresistance changes after sleeve gastrectomy. Obes Surg 2010;20:50 –5. 34. Rosenthal R, Li X, Samuel S, et al. Effect of sleeve gastrectomy on patients with diabetes mellitus. Surg Obes Relat Dis 2009;5:429 –34. 35. DePaula AL, Macedo AL, Mota BR, et al. Laparoscopic ileal interposition associated to a diverted sleeve gastrectomy is an effective operation for the treatment of type 2 diabetes mellitus patients with BMI 21–29. Surg Endosc 2009;23:1313–20. 36. Zhang F, Strain GW, Lei W, et al. Changes in lipid profiles in morbidly obese patients after laparoscopic sleeve gastrectomy (LSG). Obes Surg 2011;21:305–9. 37. Dapri G, Cadière GB, Himpens J. Reinforcing the staple line during laparoscopic sleeve gastrectomy: prospective randomized clinical study comparing three different techniques. Obes Surg 2010;20:462–7. 38. Chen B, Kiriakopoulos A, Tsakayannis D, et al. Reinforcement does not necessarily reduce the rate of staple line leaks after sleeve gastrectomy. A review of the literature and clinical experiences. Obes Surg 2009;19:166 –72. 39. Gill RS, Switzer N, Driedger M, et al. Laparoscopic sleeve gastrectomy with staple line buttress reinforcement in 116 consecutive morbidly obese patients. Obes Surg 2012;22:560 – 4.
Association of VA Surgeons
Preliminary outcomes of laparoscopic sleeve gastrectomy in a Veterans Affairs medical center Daniel Saul, M.D., Daniel Stephens, M.D.*, Rita de Cássia Hofstätter, M.D., Leaque Ahmed, M.D., F.A.C.S., Erik Langhoff, M.D., Tomas M. Heimann, M.D., F.A.C.S. Department of Surgery, James J. Peters VA Medical Center, 130 West Kingsbridge Rd., Bronx, NY 10468, USA; The Mount Sinai School of Medicine, New York, NY, USA KEYWORDS: Bariatric surgery; Morbid obesity; Laparoscopic sleeve gastrectomy; Vertical gastrectomy; Staple line reinforcement; Diabetes; Veterans Affairs
Abstract BACKGROUND: Preliminary results of a new bariatric surgery program in a VA Medical Center using laparoscopic sleeve gastrectomy (LSG). METHODS: Prospective review of the first 50 patients who underwent LSG. Percentage change in body mass index (BMI), comorbidities, serum glucose, glycosylated hemoglobin (HbA1c), lipid profiles, and medications were recorded. RESULTS: Mean age was 52 years. Average BMI was 46 kg/m2. There were no mortalities or staple line leaks. The percentage excess BMI loss was 47% and 54% at 6 and 12 months, respectively. After 6 months, fasting glucose level decreased from 127 to 93 mg/dL, and mean glycosylated hemoglobin decreased from 6.8% to 5.7%. At 1-year follow-up evaluation, serum cholesterol decreased from 182 to 168 mg/dL, mean triglycerides from 179 to 93 mg/dL, low-density lipoprotein from 110 to 94 mg/dL, and high-density lipoprotein increased from 42 to 50 mg/dL. CONCLUSIONS: Laparoscopic sleeve gastrectomy is safe and effective for morbidly obese VA patients and resulted in significant discontinuation of medication for hypertension, diabetes and hyperlipidemia. Published by Elsevier Inc.
Obesity is becoming an endemic disease in the United States,1 and in this setting, bariatric surgery has become the treatment of choice for morbidly obese patients with comorbidities who are unable to lose weight with diet, exercise, and behavior modification. Sleeve gastrectomy originally was described as a firststage surgery in high-risk morbidly obese patients, resulting in significant weight loss with low complication rates.2,3 Presented at the 36th Annual Meeting of the Association of VA Surgeons, April 1-3, 2012, Miami Beach, FL. * Corresponding author. Tel.: ⫹1-718-584-9000; fax: ⫹1-718-741-4621. E-mail address: [email protected] Manuscript received April 5, 2012; revised manuscript July 10, 2012
0002-9610/$ - see front matter Published by Elsevier Inc. http://dx.doi.org/10.1016/j.amjsurg.2012.07.005
Currently, laparoscopic sleeve gastrectomy (LSG) is used more frequently as a standalone surgery for obese patients, reserving the second stage for the few patients with inadequate weight loss after LSG.4 Although LSG is a restrictive procedure,5 removing the gastric fundus, the primary site of ghrelin production, appears to have a hormonal effect, enhancing weight loss by reducing appetite.6,7 Several studies also have shown that bariatric surgery results in resolution or improvement of obesity-related comorbidities, cardiovascular risk, and reduction of the need for medication for diabetes, dyslipidemia, and hypertension.8 –14 The aim of this study was to assess the early outcomes of laparoscopic sleeve gastrectomy in a popula-
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The American Journal of Surgery, Vol 204, No 5, November 2012
tion of primarily male, high-risk, Veterans Affairs patients and to compare our results with those published in the literature.
Materials and Methods Fifty consecutive morbidly obese patients undergoing laparoscopic sleeve gastrectomy at the James J. Peters VA Medical Center (Bronx, NY) were studied. These patients underwent surgery between April 2010 and November 2011 and were analyzed prospectively. To qualify for bariatric surgery, patients were required to have a body mass index (BMI) of 40 kg/m2 or more, or a BMI of 35 kg/m2 to 40 kg/m2 with comorbidities related to their obesity. Data were collected at 3, 6, and 12 months before the surgery, and at 1, 2, 3, 6, and 12 months after the surgery. The data collected included patient demographics, length of stay, early complications, incidence of hiatus hernia repair, preoperative weight loss, comorbidities, medications, fasting blood glucose level, glycosylated hemoglobin (HbA1c) level, blood pressure, and serum lipid profile. Weight loss was expressed as a decrease in BMI and a percentage change in BMI. The percentage of excess BMI loss (% EBL) was calculated using the following formula: % EBL ⫽ (preoperative BMI – current BMI)/(preoperative BMI – 25) ⫻ 100.15 The medication information was obtained from the VA pharmacy records, which contain information on the medications filled, the dosage, and days of supply. The patients were considered cured if all medications for diabetes mellitus, hypertension, or dyslipidemia were discontinued, and considered improved with discontinuation or decreasing the dose of one or more drugs but not all. Diabetic patients on insulin were considered improved if they were able to discontinue insulin. Patients considered cured had to be taken off medications within 1 year of surgery with no refills until the end point of the study.
Statistical analyses Data analysis was performed using the chi-square test for categoric data, and analysis of variance or paired t test for
Table 1
continuous data. Continuous analyses were reported as mean, standard deviation (SD), and range. Categoric variables were reported as numbers and percentages. A P value less than .05 was considered statistically significant and a P value less than .01 was considered highly significant. SPSS Statistics version 20 (IBM, Armonk, NY) was used to perform the statistical analyses.
Surgical procedure LSG was performed laparoscopically in every case. A 5-trocar technique is performed with the Nathanson liver retractor (Richard Wolf Medical Instruments Corporation, Vernon Hills, IL) in the subxyphoid position. The gastric dissection begins at a point directly inferior to the angularis incisura. The LigaSure 5 mm Blunt Tip Laparoscopic Instrument (Covidien, Boulder, CO) is used to divide the gastrocolic ligament from the greater curvature of the stomach. The lesser sac is entered and the dissection proceeds along the greater curvature toward the proximal stomach and spleen. The short gastric vessels then are transected with care to avoid injury to the splenic capsule. Once the stomach is fully mobilized, the sleeve is created with an endoscopic stapler reinforced with Gore SeamGuard bioabsorbable material (W.L. Gore & Associates, Inc, Newark, DE). A 34F bougie is used to determine the diameter of the sleeve.
Results Fifty consecutive patients underwent LSG. The mean follow-up period was 10.3 months. One hundred percent of the patients had 6 months of follow-up evaluation and 72% had 1 year of follow-up evaluation. Preoperative characteristics of the patients are shown in Table 1. Ninety percent of the patients were men, the mean age was 52 ⫾ 11 years (range, 26 –77 y), and the mean preoperative BMI was 46 ⫾ 6 kg/m2 (range, 36 – 66 kg/m2). A total of 64% of the patients had hypertension, 42% had type 2 diabetes mellitus, and 40% had hyperlipidemia. The mean preoperative fasting blood glucose level was 127 ⫾ 52 mg/dL (range, 62–
Preoperative patient demographics
Average age, y (range) Average BMI, kg/m2 (range) Length of stay, d (range) Hiatus hernia, % (n) Hypertension, % (n) T2DM, % (n) Hyperlipidemia, % (n) T2DM ⫽ type 2 diabetes mellitus.
Male (n ⫽ 45)
Female (n ⫽ 5)
Total (n ⫽ 50)
52 46 2.1 8 64 42 38
44 49.8 4 2 0 0 2
52 46 2.1 10 64 42 40
(26–77) (36–66) (2–5) (4) (32) (21) (19)
(31–52) (37–43) (2) (1) (0) (0) (1)
(26–77) (36–66) (2–5) (5) (32) (21) (20)
D. Saul et al. Table 2
Laparoscopic sleeve gastrectomy in veterans
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Outcomes after a laparoscopic sleeve gastrectomy at 6 months (mean ⫾ SD; N ⫽ 50) Preoperative
BMI, kg/m2 %EBL Systolic BP, mm Hg Diastolic BP, mm Hg Glycemia, mg/dL HbA1c, % Cholesterol, mg/dL LDL, mg/dL HDL, mg/dL Triglycerides, mg/dL
46 0 133 75 127 6.8 182 110 42 179
⫾6 ⫾ ⫾ ⫾ ⫾ ⫾ ⫾ ⫾ ⫾
18 10 52 1.0 47 44 11 100
Postoperative 36 47 123 69 93 5.7 171 103 48 115.3
⫾ ⫾ ⫾ ⫾ ⫾ ⫾ ⫾ ⫾ ⫾ ⫾
6 17 16 7 16 .7 32 33 10 56
Mean change
95% CI*
P value†
8.2 ⫺46.9 9.5 5.7 28.8 1.1 14.9 10.8 ⫺5.1 51.7
5.1–11.2 ⫺53.0 to ⫺40.8 ⫺.4 to 19.4 1.3–10.1 12.3–45.2 .6–1.6 ⫺6.3 to 36.1 ⫺11.0 to 32.7 ⫺9.5 to ⫺.6 14.0–89.3
⬍.01 ⬍.01 NS (.06) ⬍.05 ⬍.01 ⬍.01 NS NS ⬍.05 ⬍.01
BP ⫽ blood pressure. *95% Confidence interval (CI) of mean difference. †Paired t test was used to assess the variation from baseline.
336 mg/dL), and the mean HbA1c value was 6.8% ⫾ 1.0% (range, 5.2%–9.9%). The preoperative lipid profile showed a mean cholesterol level of 182 ⫾ 47 mg/dL (range, 118 – 337 mg/dL), mean triglyceride level of 179 ⫾ 100 mg/dL (range, 70 –572 mg/dL), mean low-density lipoprotein (LDL) level of 110 ⫾ 44 mg/dL (range, 37–235 mg/dL), and mean high-density lipoprotein (HDL) level of 42 ⫾ 11 mg/dL (range, 24 – 80 mg/dL). None of the patients required conversion to open surgery, and there were no mortalities. A hiatal hernia was diagnosed on preoperative endoscopy and was repaired in 5 patients (10%) during LSG. One patient had postoperative bleeding, presumably from the staple line, requiring transfusion of 3 units of packed red blood cells. He was discharged home on postoperative day 5. One patient with hepatitis C had a transient hepatic transaminase increase that resolved by discharge on postoperative day 5. There were no staple line leaks. All patients had a postoperative upper-gastrointestinal barium study on postoperative day 1. The mean length of stay in the hospital was 2 ⫾ .6 days (range, 2–5 d). Patients were followed up for up to 1 year after surgery. Outcomes at 6 months after surgery are shown in Table 2. The percentage change in BMI and the mean % EBL are shown in Figs. 1 and 2. For all patients, the mean fasting blood glucose values decreased to 110, 104, 93, and 86 mg/dL at 1, 3, 6, and 12
Figure 1
months (P ⬍ .01), respectively. In the same period, the mean HbA1c value decreased to 6.1%, 5.9%, 5.7%, and 5.4% (P ⬍ .01). The mean serum cholesterol level at 6 months before the surgery was 182 mg/dL, and 6 months postoperatively decreased to 171 mg/dL (not significant, P ⫽ .16). The serum LDL cholesterol level decreased from 110 to 103 mg/dL (not significant, P ⫽ .32) and the HDL cholesterol level increased from 42 to 48 mg/dL from 6 months before surgery to 6 months after surgery (P ⬍ .05). The triglyceride levels were 179 at 6 months before the LSG and decreased to 115 mg/dL at 6 months after surgery (P ⬍ .01). For the patients who were diabetic preoperatively the mean preoperative fasting blood glucose level was 141.2 mg/dL and decreased to 99.2 and 84.2 at 6 and 12 months (P ⬍ .01), respectively. For the patients who were not diabetic preoperatively the mean preoperative fasting blood glucose level was 116.2 mg/dL and decreased to 87.6 and 87.6 at 6 and 12 months (P ⬍ .01), respectively. For the patients who were diabetic preoperatively the mean preoperative HbA1c value was 7.3% and decreased to 6.1% and 5.6% at 6 and 12 months (P ⬍ .01), respectively. For the patients who were not diabetic preoperatively the mean preoperative HbA1c value was 6.3% and decreased to 5.4% and 5.3% at 6 and 12 months (P ⬍ .01), respectively. For the patients who were hypertensive preoperatively the mean
Percentage change in BMI 1 year before laparoscopic sleeve gastrectomy and 12 months postoperatively.
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Figure 2
Percentage EBL 1 year before the surgery and 12 months postoperatively.
preoperative blood pressure was 131/73 and decreased to 124/71 and 120/71 at 6 and 12 months (P ⬍ .01), respectively. For the patients who were not hypertensive preoperatively, the mean preoperative blood pressure was 125/77 and decreased to 117/68 and 107/58 at 6 and 12 months (P ⬍ .01), respectively. Change in medication status also was analyzed (Fig. 3). Preoperatively, 32 patients were on antihypertensive medication, 21 patients were on hypoglycemic medication, and 20 patients were on statins. At 6 months after surgery, 22 patients were on hypertension medication (P ⬍ .01), 11 patients were on hypoglycemic medication (P ⬍ .01), and 9 patients were using statins (P ⬍ .01). There was discontinuation of medication in 31%, 47%, and 55% of patients with hypertension, diabetes, and hyperlipidemia, respectively. Also, the number of diabetic patients using insulin decreased from 10 (20%) preoperatively to 5 (10%) patients 6 months after surgery.
Comments LSG is a safe and effective procedure for the treatment of morbid obesity and obesity-related comorbidities in VA
Figure 3 Number of patients on medications preoperatively and 6 months postoperatively.
patients. Our patients are mostly male and older than non-VA patients undergoing bariatric surgery. In our study the percentage of female patients was only 10% and the mean age was 52 years old, whereas in 5 other studies of patients undergoing LSG the mean percentage of women was 71% and the mean age was 10 years younger at 42 years.5,11,13,16,17 Nevertheless, LSG can be accomplished with a low rate of complications, and without conversions to open surgery or reoperations. There were no mortalities and only 2 complications (4%) in our series. Other recent studies showed mortality rates ranging from 0% to 3.3%.16,18 –21 We had no staple line leaks. This complication was found in .7% and 1.8% of patients reported by Arias et al22 and Deitel et al,20 respectively. Our current study was a prospective series of LSG as a primary bariatric surgery in VA patients. A PubMed literature search for bariatric surgery in VA hospitals found only one series of LSG.23 In this study, however, LSG was intended as an initial weight loss procedure for high-risk patients to be followed by laparoscopic Roux-en-Y gastric bypass (LRYGB). There have been 5 studies that examined the results of LRYGB in VA patients and showed LRYGB is a safe and effective surgery in this population.24 –28 Two cost analyses showed that bariatric surgery reduces obesityrelated expenditures and use of health care resources.29,30 Another analysis indicated that bariatric surgery in VA patients does not achieve a reduction in health care expenditures 3 years after the procedure.31 We did not address cost in our study, and this is an area of future research. Our early findings of a mean % EBL of 54% at 12 months is comparable with other published studies.13,17 The recent report from the American College of Surgeons21 showed a mean BMI loss at 1 year for patients undergoing LSG of 11.8 kg/m2, compared with our study with an 11.3 kg/m2 BMI loss. At the Third International Summit for LSG, a questionnaire was completed by 88 attendees with a total number of 19,605 LSGs performed, 86% of which were intended as the sole operation. After 1 year of follow-up evaluation there was a mean of 63% ⫾ 29% EBL,
D. Saul et al.
Laparoscopic sleeve gastrectomy in veterans
and at 5 years there was a mean of 62% ⫾ 12% EBL.20 These results suggest a similar trend to that seen in our patients. Compared with other bariatric procedures, our weight loss results are between those seen in LRYGB and laparoscopic adjustable gastric banding (LAGB).21,32 In the current study, LSG significantly improved our patients’ comorbidities. The report from the American College of Surgeons shows a resolution or improvement of 55% for patients with diabetes, 68% for patients with hypertension, and 35% resolution for patients with hyperlipidemia. Our results compare favorably with values at 76% and 50% for improved or resolved diabetes and hypertension, respectively, and 70% resolution of hyperlipidemia. Also, it has been reported that resolution of diabetes is present in 44% of patients for LAGB and in 83% for Roux-en-Y gastric bypass (RYGB). Resolution of hypertension was seen in 44% for LAGB and in 79% for RYGB, and resolution for hyperlipidemia was seen in 33% for LAGB and in 66% for RYGB.21 Our results are comparable,11–13 and the results for improvement or resolution of diabetes and hypertension are between those seen with RYGB and LAGB.21 Six months after LSG, fasting glucose and HbA1c values significantly decreased as has been shown in other studies.16,33,34 A total of 98.8% of patients achieved HbA1c less than 6.5% compared with 85.7% reported by Vidal et al,12 and 75.6% in our series achieved HbA1c less than 6% compared with 65.2% reported by DePaula et al.35 Analyzing the lipid profile changes, we could observe statistically significant improvement of HDL cholesterol and triglyceride levels. Zhang et al36 reported similar results in their study. We found a statistically significant decrease in triglyceride levels and increase in HDL cholesterol, but the decreases in LDL and total cholesterol were not statistically significant. There is no general consensus regarding the use of staple line reinforcement versus oversewing the staple line versus no reinforcement. Dapri et al37 compared 3 techniques in LSG (without reinforcement, with Gore SeamGuard, and with staple line oversewing). They concluded that there were no differences in postoperative leak rates, and that reinforcement with Gore SeamGuard reduced bleeding. However, this study included only 75 patients among the 3 groups and did not have sufficient power to detect differences considering the known rate of leaks. Another study concluded that the reduction of leaks may not necessarily be owing to staple line reinforcement because the rate was so low that nearly 10,000 procedures would be needed to reach statistical significance.38 A recent, nonrandomized study was consistent with our results, showing no leaks and one bleed in 116 consecutive patients.39 In summary, LSG appears to be a safe and effective surgical procedure for morbidly obese VA patients. Significant weight loss and improvement of comorbidities related to obesity such as hypertension, diabetes, and hyperlipidemia, and discontinuation of medications used to treat these disorders is seen within 6 to 12 months in most patients.
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References 1. Deitel M. The obesity epidemic. Obes Surg 2006;16:377– 8. 2. Cottam D, Qureshi FG, Mattar SG, et al. Laparoscopic sleeve gastrectomy as an initial weight-loss procedure for high-risk patients with morbid obesity. Surg Endosc 2006;20:858 – 63. 3. Mognol P, Chosidow D, Marmuse JP. Laparoscopic sleeve gastrectomy as an initial bariatric operation for high-risk patients: initial results in 10 patients. Obes Surg 2005;15:1030 –3. 4. Frezza EE. Laparoscopic vertical sleeve gastrectomy for morbid obesity. The future procedure of choice? Surg Today 2007;37:275– 81. 5. Melissas J, Koukouraki S, Askoxylakis J, et al. Sleeve gastrectomy: a restrictive procedure? Obes Surg 2007;17:57– 62. 6. Langer FB, Reza Hoda MA, Bohdjalian A, et al. Sleeve gastrectomy and gastric banding: effects on plasma ghrelin levels. Obes Surg 2005;15:1024 –9. 7. Ariyasu H, Takaya K, Tagami T, et al. Stomach is a major source of circulating ghrelin, and feeding state determines plasma ghrelin-like immunoreactivity levels in humans. J Clin Endocrinol Metab 2001; 86:4753– 8. 8. Arterburn D, Schauer DP, Wise RE, et al. Change in predicted 10-year cardiovascular risk following laparoscopic Roux-en-Y gastric bypass surgery. Obes Surg 2009;19:184 –9. 9. Sjöström L, Lindroos AK, Peltonen M, et al. Lifestyle, diabetes, and cardiovascular risk factors 10 years after bariatric surgery. N Engl J Med 2004;351:2683–93. 10. Maciejewski ML, Livingston EH, Kahwati LC, et al. Discontinuation of diabetes and lipid-lowering medications after bariatric surgery at Veterans Affairs Medical Centers. Surg Obes Relat Dis 2010;6:601–7. 11. Sánchez-Santos R, Masdevall C, Baltasar A, et al. Short- and mildterm outcomes of sleeve gastrectomy for morbid obesity: the experience of the Spanish national registry. Obes Surg 2009;19:1203–10. 12. Vidal J, Ibarzabal A, Nicolau J, et al. Short-term effects of sleeve gastrectomy on type 2 diabetes mellitus in severely obese subjects. Obes Surg 2007;17:1069 –74. 13. Hamoui N, Anthone GJ, Kaufman HS, et al. Sleeve gastrectomy in the high-risk patient. Obes Surg 2006;16:1445–9. 14. Zlabek JA, Grimm MS, Larson CJ, et al. The effect of laparoscopic gastric bypass surgery on dyslipidemia in severely obese patients. Surg Obes Relat Dis 2005;1:537– 42. 15. Deitel M, Gawdat K, Melissas J. Reporting weight loss 2007. Obes Surg 2007;17:565– 8. 16. Angrisani L, Cutolo PP, Buchwald JN, et al. Laparoscopic reinforced sleeve gastrectomy: early results and complications. Obes Surg 2011; 21:783–93. 17. Fuks D, Verhaeghe P, Brehant O, et al. Results of laparoscopic sleeve gastrectomy: a prospective study in 135 patients with morbid obesity. Surgery 2009;145:106 –13. 18. Brethauer SA, Hammel JP, Schauer PR. Systematic review of sleeve gastrectomy as staging and primary bariatric procedure. Surg Obes Relat Dis 2009;5:469 –75. 19. Shi X, Karmali S, Sharma AM, et al. A review of laparoscopic sleeve gastrectomy for morbid obesity. Obes Surg 2010;20:1171–7. 20. Deitel M, Gagner M, Erickson AL, et al. Third international summit: current status of sleeve gastrectomy. Surg Obes Relat Dis 2011;7:749 –59. 21. Hutter MM, Schirmer BD, Jones DB, et al. First report from the American College of Surgeons Bariatric Surgery Center Network: laparoscopic sleeve gastrectomy has morbidity and effectiveness positioned between the band and the bypass. Ann Surg 2011;254: 410 –20. 22. Arias E, Martínez P, Ka M, et al. Mid-term follow-up after sleeve gastrectomy as a final approach for morbid obesity. Obes Surg 2009; 195:544 – 8. 23. Cottam D, Qureshi FG, Mattar SG, et al. Laparoscopic sleeve gastrectomy as an initial weight-loss procedure for high-risk patients with morbid obesity. Surg Endosc 2006;20:859 – 63.
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