- Email: [email protected]
Safety, efficacy, and durability of laparoscopic adjustable gastric banding in a single surgeon U.S. community practice
Surgery for Obesity and Related Diseases 7 (2011) 140 –144
Original article
Safety, efficacy, and durability of laparoscopic adjustable gastric banding in a single surgeon U.S. community practice James B. Ray, M.D., F.A.C.S.*, Shahla Ray, Ph.D. Center for Advanced Laparoscopic and Bariatric Surgery, Bloomington, Indiana Received February 19, 2010; accepted August 9, 2010
Abstract
Background: Although laparoscopic adjustable gastric banding (LAGB) has been increasing in popularity, controversy is ongoing in regard to its efficacy, safety and durability. Particular concern exists now that this technique is being adapted in the community setting. We report a single surgeon’s experience of LAGB in a community practice serving a medium-size Midwest town in the United States. Methods: From March 30, 2004 to December 2, 2009, 442 patients underwent LAGB (77% women; mean age 47 years, range 18 –71; mean body mass index 47 kg/m2, range 35–78). The maximal number of primary procedures performed in a 12-month period was 105. Follow-up information was available for 94% of patients. Results: The perioperative mortality rate was 0%. The average percentage of excess weight loss was 27% at 6 months (n ⫽ 384), 38% at 12 months (n ⫽ 301), 44% at 18 months (n ⫽ 260), 48% at 24 months (n ⫽ 190), 51% at 36 months (n ⫽ 135), 58% at 48 months (n ⫽ 66), and 60% at 60 months (n ⫽ 31). By 60 months, 10% had failed to lose ⱖ25% of their excess body weight. The explantation rate was 1.8%. Gastric prolapse occurred in 2.0% of patients and erosion in 0.4% of patients. Conclusion: LAGB can be done safely in a community setting with acceptable weight loss and low failure rates. LAGB is less technical than other procedures; however, the results depend heavily on meticulous long-term follow-up. We have proposed a strategy that has been effective in the community setting. (Surg Obes Relat Dis 2011;7:140 –144.) © 2011 American Society for Metabolic and Bariatric Surgery. All rights reserved.
Keywords:
Laparoscopic adjustable gastric banding; Bariatric surgery; Follow-up; Failure rate; Community practice; Five-year follow-up
Although a consensus has been growing regarding the superiority of surgery compared with nonoperative treatment of obesity, debate continues regarding the use of laparoscopic adjustable gastric banding (LAGB). LAGB is an attractive option for several reasons. It is minimally invasive, reversible and relatively easy to perform. More importantly, because it does not require division of the gastrointestinal tract, many of the severe complications seen in other weight loss procedures are avoided. This has led to a relative increase in LAGB [1]. Few would argue its safety.
*Correspondence: James B. Ray, M.D., F.A.C.S., Center for Advanced Laparoscopic and Bariatric Surgery, 502 West Second Street, Bloomington, IN 47403. E-mail: [email protected]
Questions have been raised, however, regarding its efficacy in terms of weight loss and durability. DeMaria et al. [2] reported on the results from the Food and Drug Administration “A trial.” In that trial, 37 patients underwent gastric banding. They reported an explantation rate ⬎40% after 2 years and a percentage of excess weight loss (%EWL) of only 38% [2]. In a recent European study, Suter et al. [3] also reported a 40% 5-year failure rate. Failure was defined as a %EWL ⬍25% or band removal; 22% required band removal. The patients who retained their band maintained a stable %EWL of 50 – 60% [3]. Two recent prospective randomized studies compared banding and gastric bypass. Nguyen et al. [4] found an advantage of Roux-en-Y gastric bypass (RYGB) compared
1550-7289/11/$ – see front matter © 2011 American Society for Metabolic and Bariatric Surgery. All rights reserved. doi:10.1016/j.soard.2010.08.011
J. B. Ray & S. Ray / Surgery for Obesity and Related Diseases 7 (2011) 140 –144
with LAGB at 4 years for both weight loss and failure. The LAGB patients in that study only lost 45% of excess body weight at 4 years and had a failure rate of 16% [4]. Angrisani and Borrelli [5] reported the results from a randomized prospective trial with 5 years of follow-up. A total of 51 patients were randomized to LAGB or RYGB. The 27 LAGB patients lost 47% excess body weight at 5 years compared with 66% excess body weight lost by the 24 RYGB patients at 5 years. They reported a 34% failure rate for the LAGB group, as defined by a final body mass index (BMI) ⬎35 kg/m2 [5]. Reports such as these have tended to discredit gastric banding as a viable option. A recent meta-analysis in the American Journal of Medicine recommended RYGB as the primary bariatric procedure in the United States [6]. Guller et al. [7] made an even stronger statement claiming that placement of a gastric band is a “disservice to many morbidly obese patients” and that “its use can no longer be justified.” Such a conclusion, however, would ignore an equally large body of evidence supporting the use of LAGB. Many investigators have reported excellent results with banding. O’Brien et al. [8] reported a %EWL of 52% at 2 years and this had improved to 57% at 6 years, with no evidence of weight regain. Ponce and Dixon [9] reported 61% EWL at 36 months. Parikh et al. [10] reported a 36-month %EWL of 52%. They also reported that 11% failed to lose 25% of their excess body weight and 1.5% required explantation [10]. A recent meta-analysis reviewed 1703 patients from 43 reports with follow-up to 10 years. The pooled data revealed that the %EWL stabilized for both RYGB and LAGB at 50 – 60%, with no difference between the 2 groups after the second year [11]. We report a single surgeon’s experience with gastric banding in the United States during a 5-year period. Methods From March 30, 2004 to December 2, 2009, 442 underwent LAGB. All bands were placed by a single surgeon in a community-based practice using a standardized technique. All patients met the National Institutes of Health criteria for bariatric surgery. A retrospective review was performed using a prospectively obtained database. Operative technique All the bands were placed using a laparoscope utilizing previously described techniques [12]. Hiatal hernias were repaired when encountered. A pars flaccida technique was routinely used and band fixation was routinely performed. Postoperative care The patients were given clear liquids after surgery and then advanced to full liquids the day after surgery. Routine fluoroscopy was not used after the first 50 patients. The
141
patients were released when they were able to tolerate liquids, able to ambulate and their pain was adequately controlled. Follow-up care Follow-up examinations were performed in the office. Adjustments were made according to weight loss, level of satiety and hunger. Fluoroscopy was only used for ports that were not palpable. Patients were seen 2 weeks postoperatively and then every 6 weeks for the first year, every 3 months for the second year and twice yearly thereafter. Additional follow-up visits were tailored to the patients’ needs. The results are reported from the weights measured in the office for all patients who continued in follow-up. Follow-up by mail or telephone was obtained for patients not actively participating in the follow-up program. Results Demographics A total of 442 patients underwent LAGB from March 30, 2004 to December 2, 2009. Of the 442 patients, 77% were women. The mean age was 47 years (range 18 –71). The mean starting weight was 291 lb (132 kg). The mean initial BMI was 47 kg/m2 (range 35–78 kg/m2). The BMI distribution was 35–39 kg/m2 in 13%, 40 – 49 kg/m2 in 54%, 50 –59 kg/m2 in 26%, 60 – 69 kg/m2 in 6%, and ⱖ70 kg/m2 in 1%. The maximal number of primary cases within a 12-month period was 105. Follow-up Follow-up information was available for 94.3% of our patients during the 5-year study period and always remained ⱖ80% (60 months, 95%; 48 months, 80%; 36 months, 90%; 24 months, 89%; and 12 months 100%). Active participation in follow-up was defined as having been seen in the office within the previous 12 months. Of the 442 patients, 91% were actively participating in follow-up, and 13 additional patients had responded to telephone calls or letters. Three patients had died of causes unrelated to their band, each more than 3 years after LAGB. In each case, the cause of death was determined not to be band related by either autopsy or surgical findings. A total of 25 patients (5.6%) were lost to follow-up. Weight loss The %EWL was 27% at 6 months (n ⫽ 384), 38% at 12 months (n ⫽ 301), 44% at 18 months (n ⫽ 260), 48% at 24 months (n ⫽ 190), 51% at 36 months (n ⫽ 135), 58% at 48 months (n ⫽ 66), and 60% at 60 months (n ⫽ 31) (Fig. 1). Complications Of the 442 patients, 12 (2.7%) were readmitted within 30 days of the index procedure and 4 patients (0.9%) required
J. B. Ray & S. Ray / Surgery for Obesity and Related Diseases 7 (2011) 140 –144
reoperation within 30 days. Long term complications were band slippage in 9 (2.0%), port problems in 14 (3.1%) and band erosion in 2 (0.4%). A total of 41 (9.2%) band-related reoperations was required. The mortality rate was 0%. Failure Failure was defined as losing ⬍25% of excess body weight or explantation without band replacement. The percentage of patients who lost ⬍25% of their excess body weight decreased almost continuously, until a nadir of 10% was reached at 60 months (Fig. 2). A total of 8 patients (1.8%) underwent band explantation without band replacement. Three patients had had their bands removed at an outside institution (Fig. 2). Discussion Our patients fared well in terms of weight loss, failure, and complications. Our weight loss of 60% EWL at 60 months compares quite favorably with that of other reported series (Fig. 1). In addition, our patients’ weight loss was maintained over time with no evidence of weight regain. We defined failure as either weight loss ⬍25% EWL or explantation without band replacement. In terms of weight loss ⬍25% EWL, we found that our results improved during the first 4 years and then stabilized at approximately 10%. Had we considered only our results at 12 months, one third of our patients would have classified as having treatment failure. It is open for debate whether a point in time exists at which one would declare failure; however, from our findings, acceptable weight loss can still be achieved after 4 years. Regarding safety, we had no deaths, even among our high-risk patients. Pouch dilations were included in our slippage data and a rate of 2% was lower than that of most reported results. We believe that a slippage rate of 2% is an obtainable standard. Our erosion rate was also lower than that reported by Suter et al. [3]. However, other investigators [9] have reported that erosions are becoming rare.
80%
50
Failure
70%
45 40
60%
35
50%
30
40%
25
30%
20 15
20%
10
10%
Number of Explantaons
Fig. 1. Graph showing our results compared with results from other prominent publications.
Our overall explantation rate was 1.5%. The events leading to explantation appeared to occur randomly and the risks did not appear to increase with time (Fig. 2). Because 3 bands were removed at an outside hospital, it was impossible to know whether these bands could have been salvaged. These failure rates were quite similar to those reported by O’Brien et al. [8] and Parikh et al. [10] but markedly different from the 40% failure rate reported by Suter et al. [3], DeMaria et al. [2], and others. Our results were notably different from those reported in many series in regards to weight loss, failures and complications. The reasons for this disparity are unclear. The potential sources of these differences include patient selection, technical factors and postoperative care strategies. Patient selection is the first variable to examine. Because LAGB is the only bariatric operation we offer, the selection bias should have been minimized. Our series represents relatively older patients with a greater BMI and a lower percentage of female patients compared with other series. Therefore, patient selection probably did not play a significant role. The second variable is operative technique. Since the Food and Drug Administration “A trial”, significant changes in technique and band design have been made. The introduction of the pars flaccida technique, high placement of the band, routine repair of hiatal hernias and the introduction of low-pressure bands could explain many of the differences between our findings and the findings of these older studies. In recent years, however, the procedure has become much more standardized. Therefore, it would be difficult to attribute the differences between our results and those from contemporary studies to purely technical factors. Finally, differences in the long-term follow-up care must be examined. Bariatric surgery is unique among the surgical specialties in that the outcomes rely on both the operative technique and the long-term postoperative care. This is particularly true for LAGB. The possibility must be raised
EWL < 25%
142
5
0%
0 3
6
12
18
24
36
48
60
Months
Fig. 2. Graph showing failure rates. Solid line indicates weight loss ⬍25% excess body weight. Bar graph indicates band loss (explantation). Each bar indicates incidence of bands lost and interval between surgery and band loss (i.e., 1 band was removed at 3 months postoperatively, 1 at 6 months, and 3 at 18 months, etc.)
J. B. Ray & S. Ray / Surgery for Obesity and Related Diseases 7 (2011) 140 –144
that the differences in outcome resulted from differences in aftercare strategies. Our follow-up rate has been relatively high. The rate of patients for whom we have data was, however, perhaps less important than the rate of patients actively participating in our follow-up program. The specific strategy used for aftercare could also have contributed to the observed differences in outcomes. In our practice, we have used the strategy outlined in Figure 3. The strategy we have used has several advantages. It allows the bariatric team to interact with the patients at frequent intervals. Band adjustments are obviously an important intervention. However, frequent visits also allow one to provide ongoing education, positive re-enforcement of healthy behavior and encouragement. Many, if not
143
most, patients have experienced a lifetime of failed attempts to lose weight. The weight loss after LAGB is known to be relatively slow. Many patients will frequently become frustrated at the pace and require ongoing encouragement. Another advantage is that it allows for flexibility. Some patients will lose more slowly than others. We have set a benchmark of 40% EWL at 1 year. If a patient has not reached that benchmark, we continue to see them every 4 – 6 weeks until they have reached that benchmark. This “failure is not an option” strategy also demonstrates to the patient that the bariatric team is committed to their success. It should also be emphasized that this schedule represents the minimal interval between visits. Patients should be encouraged to come in sooner if they feel excessive restric-
Fig. 3. Strategy used in our practice.
144
J. B. Ray & S. Ray / Surgery for Obesity and Related Diseases 7 (2011) 140 –144
tion, inadequate restriction or have any concerns that they are experiencing an adverse event. Although this strategy is simple in design, its implementation is not trivial. Each patient who undergoes surgery will require a minimum of 12 visits within the first 2 years. This is in addition to the multiple preoperative visits required for adequate preparation. Therefore, even with a modest patient volume, adequate physical space and staffing is a prerequisite. Patients should have access to the team 5 days a week. A dedicated clinic day will not be sufficient. Physician extenders have become commonplace and we have found ours to be invaluable. However, the surgeon must remain closely involved and will need to avoid the temptation to delegate all postoperative care to other providers. Finally, and perhaps most importantly, is the establishment of a culture in the practice that promotes long-term care to what must be described as a lifelong condition. We have established an ongoing relationship, much like a primary care physician. We keep an “open door policy” for our LAGB patients. We are not judgemental if they have failed to lose weight. We believe that this environment is essential to success. Many different protocols and strategies are in current use, and we do not suggest that our strategy is the only path to success. However, our approach is similar to that of other published strategies by successful practices such as O’Brien et al. [13] and Ren et al. [12]. We believe it is not coincidental that our outcomes were also similar (Fig. 1). This suggests that, not only are excellent results obtainable, but that they are also reproducible.
Conclusion We found LAGB to be both a safe and an effective procedure with a low long-term failure rate. LAGB should continue to be considered a viable option for the treatment of morbid obesity. It must be understood that the weight loss tends to be slow but progressive. Long-term follow-up must be emphasized. We have proposed a strategy that has been effective in a community setting.
Disclosures The authors have no commercial associations that might be a conflict of interest in relation to this article. References [1] Hinojosa MW, Varela JE, Parikh D, Smith BR, Nguyen XM, Nguyen NT. National trends in use and outcome of laparoscopic adjustable gastric banding. Surg Obes Relat Dis 2009;5:150 –5. [2] DeMaria EJ, Sugerman HJ, Meador JG, et al. High failure rate after laparoscopic adjustable silicone gastric banding for treatment of morbid obesity. Ann Surg 2001;233:809 –18. [3] Suter M, Calmes JM, Paroz A, Giusti V. A 10-year experience with laparoscopic gastric banding for morbid obesity: high long-term complication and failure rates. Obes Surg 2006;16:829 –35. [4] Nguyen NT, Sloan JA, Nguyen XM, Hartman JS, Hoyt DB. A prospective randomized trial of laparoscopic gastric bypass versus laparoscopic adjustable gastric banding for the treatment of morbid obesity: outcomes, quality of life, and costs. Ann Surg 2009;250:631– 41. [5] Angrisani LA, Borrelli VA. Laparoscopic adjustable gastric banding versus Roux-en-Y gastric bypass: 5-year results of a prospective randomized trial. Surg Obes Relat Dis 2007;3:127–32. [6] Tice JA, Karliner L, Walsh J, Peterson AJ, Feldman MD. Gastric banding or bypass? A systematic review comparing the two most popular bariatric procedures. Am J Med 2008;121:885–93. [7] Guller U, Klein LV, Hagen JA. Safety and effectiveness of bariatric surgery: Roux-en-Y gastric bypass is superior to gastric banding in the management of morbidly obese patients. Patient Saf Surg 2009; 3:10. [8] O’Brien PE, Dixon JB, Brown W, et al. The laparoscopic adjustable gastric band (Lap-Band): a prospective study of medium-term effects on weight, health and quality of life. Obes Surg 2002;12:652– 60. [9] Ponce J, Dixon J. Laparoscopic adjustable gastric banding. Surg Obes Relat Dis 2005;1:310 –16. [10] Parikh MS, Fielding GA, Ren CJ. U.S. experience with 749 laparoscopic adjustable gastric bands: intermediate outcomes. Surg Endosc 2005;19:1631–5. [11] O’Brien PE, McPhail T, Chaston TB, Dixon JB. Systematic review of medium-term weight loss after bariatric operations. Obes Surg 2006; 16:1032– 40. [12] Ren CJ, Weiner M, Allen JW. Favorable early results of gastric banding for morbid obesity: the American experience. Surg Endosc 2004;18:543– 6. [13] O’Brien PE, Dixon JB, Laurie C, et al. Treatment of mild to moderate obesity with laparoscopic adjustable gastric banding or an intensive medical program: a randomized trial. Ann Intern Med 2006;144:625–33.
Original article
Safety, efficacy, and durability of laparoscopic adjustable gastric banding in a single surgeon U.S. community practice James B. Ray, M.D., F.A.C.S.*, Shahla Ray, Ph.D. Center for Advanced Laparoscopic and Bariatric Surgery, Bloomington, Indiana Received February 19, 2010; accepted August 9, 2010
Abstract
Background: Although laparoscopic adjustable gastric banding (LAGB) has been increasing in popularity, controversy is ongoing in regard to its efficacy, safety and durability. Particular concern exists now that this technique is being adapted in the community setting. We report a single surgeon’s experience of LAGB in a community practice serving a medium-size Midwest town in the United States. Methods: From March 30, 2004 to December 2, 2009, 442 patients underwent LAGB (77% women; mean age 47 years, range 18 –71; mean body mass index 47 kg/m2, range 35–78). The maximal number of primary procedures performed in a 12-month period was 105. Follow-up information was available for 94% of patients. Results: The perioperative mortality rate was 0%. The average percentage of excess weight loss was 27% at 6 months (n ⫽ 384), 38% at 12 months (n ⫽ 301), 44% at 18 months (n ⫽ 260), 48% at 24 months (n ⫽ 190), 51% at 36 months (n ⫽ 135), 58% at 48 months (n ⫽ 66), and 60% at 60 months (n ⫽ 31). By 60 months, 10% had failed to lose ⱖ25% of their excess body weight. The explantation rate was 1.8%. Gastric prolapse occurred in 2.0% of patients and erosion in 0.4% of patients. Conclusion: LAGB can be done safely in a community setting with acceptable weight loss and low failure rates. LAGB is less technical than other procedures; however, the results depend heavily on meticulous long-term follow-up. We have proposed a strategy that has been effective in the community setting. (Surg Obes Relat Dis 2011;7:140 –144.) © 2011 American Society for Metabolic and Bariatric Surgery. All rights reserved.
Keywords:
Laparoscopic adjustable gastric banding; Bariatric surgery; Follow-up; Failure rate; Community practice; Five-year follow-up
Although a consensus has been growing regarding the superiority of surgery compared with nonoperative treatment of obesity, debate continues regarding the use of laparoscopic adjustable gastric banding (LAGB). LAGB is an attractive option for several reasons. It is minimally invasive, reversible and relatively easy to perform. More importantly, because it does not require division of the gastrointestinal tract, many of the severe complications seen in other weight loss procedures are avoided. This has led to a relative increase in LAGB [1]. Few would argue its safety.
*Correspondence: James B. Ray, M.D., F.A.C.S., Center for Advanced Laparoscopic and Bariatric Surgery, 502 West Second Street, Bloomington, IN 47403. E-mail: [email protected]
Questions have been raised, however, regarding its efficacy in terms of weight loss and durability. DeMaria et al. [2] reported on the results from the Food and Drug Administration “A trial.” In that trial, 37 patients underwent gastric banding. They reported an explantation rate ⬎40% after 2 years and a percentage of excess weight loss (%EWL) of only 38% [2]. In a recent European study, Suter et al. [3] also reported a 40% 5-year failure rate. Failure was defined as a %EWL ⬍25% or band removal; 22% required band removal. The patients who retained their band maintained a stable %EWL of 50 – 60% [3]. Two recent prospective randomized studies compared banding and gastric bypass. Nguyen et al. [4] found an advantage of Roux-en-Y gastric bypass (RYGB) compared
1550-7289/11/$ – see front matter © 2011 American Society for Metabolic and Bariatric Surgery. All rights reserved. doi:10.1016/j.soard.2010.08.011
J. B. Ray & S. Ray / Surgery for Obesity and Related Diseases 7 (2011) 140 –144
with LAGB at 4 years for both weight loss and failure. The LAGB patients in that study only lost 45% of excess body weight at 4 years and had a failure rate of 16% [4]. Angrisani and Borrelli [5] reported the results from a randomized prospective trial with 5 years of follow-up. A total of 51 patients were randomized to LAGB or RYGB. The 27 LAGB patients lost 47% excess body weight at 5 years compared with 66% excess body weight lost by the 24 RYGB patients at 5 years. They reported a 34% failure rate for the LAGB group, as defined by a final body mass index (BMI) ⬎35 kg/m2 [5]. Reports such as these have tended to discredit gastric banding as a viable option. A recent meta-analysis in the American Journal of Medicine recommended RYGB as the primary bariatric procedure in the United States [6]. Guller et al. [7] made an even stronger statement claiming that placement of a gastric band is a “disservice to many morbidly obese patients” and that “its use can no longer be justified.” Such a conclusion, however, would ignore an equally large body of evidence supporting the use of LAGB. Many investigators have reported excellent results with banding. O’Brien et al. [8] reported a %EWL of 52% at 2 years and this had improved to 57% at 6 years, with no evidence of weight regain. Ponce and Dixon [9] reported 61% EWL at 36 months. Parikh et al. [10] reported a 36-month %EWL of 52%. They also reported that 11% failed to lose 25% of their excess body weight and 1.5% required explantation [10]. A recent meta-analysis reviewed 1703 patients from 43 reports with follow-up to 10 years. The pooled data revealed that the %EWL stabilized for both RYGB and LAGB at 50 – 60%, with no difference between the 2 groups after the second year [11]. We report a single surgeon’s experience with gastric banding in the United States during a 5-year period. Methods From March 30, 2004 to December 2, 2009, 442 underwent LAGB. All bands were placed by a single surgeon in a community-based practice using a standardized technique. All patients met the National Institutes of Health criteria for bariatric surgery. A retrospective review was performed using a prospectively obtained database. Operative technique All the bands were placed using a laparoscope utilizing previously described techniques [12]. Hiatal hernias were repaired when encountered. A pars flaccida technique was routinely used and band fixation was routinely performed. Postoperative care The patients were given clear liquids after surgery and then advanced to full liquids the day after surgery. Routine fluoroscopy was not used after the first 50 patients. The
141
patients were released when they were able to tolerate liquids, able to ambulate and their pain was adequately controlled. Follow-up care Follow-up examinations were performed in the office. Adjustments were made according to weight loss, level of satiety and hunger. Fluoroscopy was only used for ports that were not palpable. Patients were seen 2 weeks postoperatively and then every 6 weeks for the first year, every 3 months for the second year and twice yearly thereafter. Additional follow-up visits were tailored to the patients’ needs. The results are reported from the weights measured in the office for all patients who continued in follow-up. Follow-up by mail or telephone was obtained for patients not actively participating in the follow-up program. Results Demographics A total of 442 patients underwent LAGB from March 30, 2004 to December 2, 2009. Of the 442 patients, 77% were women. The mean age was 47 years (range 18 –71). The mean starting weight was 291 lb (132 kg). The mean initial BMI was 47 kg/m2 (range 35–78 kg/m2). The BMI distribution was 35–39 kg/m2 in 13%, 40 – 49 kg/m2 in 54%, 50 –59 kg/m2 in 26%, 60 – 69 kg/m2 in 6%, and ⱖ70 kg/m2 in 1%. The maximal number of primary cases within a 12-month period was 105. Follow-up Follow-up information was available for 94.3% of our patients during the 5-year study period and always remained ⱖ80% (60 months, 95%; 48 months, 80%; 36 months, 90%; 24 months, 89%; and 12 months 100%). Active participation in follow-up was defined as having been seen in the office within the previous 12 months. Of the 442 patients, 91% were actively participating in follow-up, and 13 additional patients had responded to telephone calls or letters. Three patients had died of causes unrelated to their band, each more than 3 years after LAGB. In each case, the cause of death was determined not to be band related by either autopsy or surgical findings. A total of 25 patients (5.6%) were lost to follow-up. Weight loss The %EWL was 27% at 6 months (n ⫽ 384), 38% at 12 months (n ⫽ 301), 44% at 18 months (n ⫽ 260), 48% at 24 months (n ⫽ 190), 51% at 36 months (n ⫽ 135), 58% at 48 months (n ⫽ 66), and 60% at 60 months (n ⫽ 31) (Fig. 1). Complications Of the 442 patients, 12 (2.7%) were readmitted within 30 days of the index procedure and 4 patients (0.9%) required
J. B. Ray & S. Ray / Surgery for Obesity and Related Diseases 7 (2011) 140 –144
reoperation within 30 days. Long term complications were band slippage in 9 (2.0%), port problems in 14 (3.1%) and band erosion in 2 (0.4%). A total of 41 (9.2%) band-related reoperations was required. The mortality rate was 0%. Failure Failure was defined as losing ⬍25% of excess body weight or explantation without band replacement. The percentage of patients who lost ⬍25% of their excess body weight decreased almost continuously, until a nadir of 10% was reached at 60 months (Fig. 2). A total of 8 patients (1.8%) underwent band explantation without band replacement. Three patients had had their bands removed at an outside institution (Fig. 2). Discussion Our patients fared well in terms of weight loss, failure, and complications. Our weight loss of 60% EWL at 60 months compares quite favorably with that of other reported series (Fig. 1). In addition, our patients’ weight loss was maintained over time with no evidence of weight regain. We defined failure as either weight loss ⬍25% EWL or explantation without band replacement. In terms of weight loss ⬍25% EWL, we found that our results improved during the first 4 years and then stabilized at approximately 10%. Had we considered only our results at 12 months, one third of our patients would have classified as having treatment failure. It is open for debate whether a point in time exists at which one would declare failure; however, from our findings, acceptable weight loss can still be achieved after 4 years. Regarding safety, we had no deaths, even among our high-risk patients. Pouch dilations were included in our slippage data and a rate of 2% was lower than that of most reported results. We believe that a slippage rate of 2% is an obtainable standard. Our erosion rate was also lower than that reported by Suter et al. [3]. However, other investigators [9] have reported that erosions are becoming rare.
80%
50
Failure
70%
45 40
60%
35
50%
30
40%
25
30%
20 15
20%
10
10%
Number of Explantaons
Fig. 1. Graph showing our results compared with results from other prominent publications.
Our overall explantation rate was 1.5%. The events leading to explantation appeared to occur randomly and the risks did not appear to increase with time (Fig. 2). Because 3 bands were removed at an outside hospital, it was impossible to know whether these bands could have been salvaged. These failure rates were quite similar to those reported by O’Brien et al. [8] and Parikh et al. [10] but markedly different from the 40% failure rate reported by Suter et al. [3], DeMaria et al. [2], and others. Our results were notably different from those reported in many series in regards to weight loss, failures and complications. The reasons for this disparity are unclear. The potential sources of these differences include patient selection, technical factors and postoperative care strategies. Patient selection is the first variable to examine. Because LAGB is the only bariatric operation we offer, the selection bias should have been minimized. Our series represents relatively older patients with a greater BMI and a lower percentage of female patients compared with other series. Therefore, patient selection probably did not play a significant role. The second variable is operative technique. Since the Food and Drug Administration “A trial”, significant changes in technique and band design have been made. The introduction of the pars flaccida technique, high placement of the band, routine repair of hiatal hernias and the introduction of low-pressure bands could explain many of the differences between our findings and the findings of these older studies. In recent years, however, the procedure has become much more standardized. Therefore, it would be difficult to attribute the differences between our results and those from contemporary studies to purely technical factors. Finally, differences in the long-term follow-up care must be examined. Bariatric surgery is unique among the surgical specialties in that the outcomes rely on both the operative technique and the long-term postoperative care. This is particularly true for LAGB. The possibility must be raised
EWL < 25%
142
5
0%
0 3
6
12
18
24
36
48
60
Months
Fig. 2. Graph showing failure rates. Solid line indicates weight loss ⬍25% excess body weight. Bar graph indicates band loss (explantation). Each bar indicates incidence of bands lost and interval between surgery and band loss (i.e., 1 band was removed at 3 months postoperatively, 1 at 6 months, and 3 at 18 months, etc.)
J. B. Ray & S. Ray / Surgery for Obesity and Related Diseases 7 (2011) 140 –144
that the differences in outcome resulted from differences in aftercare strategies. Our follow-up rate has been relatively high. The rate of patients for whom we have data was, however, perhaps less important than the rate of patients actively participating in our follow-up program. The specific strategy used for aftercare could also have contributed to the observed differences in outcomes. In our practice, we have used the strategy outlined in Figure 3. The strategy we have used has several advantages. It allows the bariatric team to interact with the patients at frequent intervals. Band adjustments are obviously an important intervention. However, frequent visits also allow one to provide ongoing education, positive re-enforcement of healthy behavior and encouragement. Many, if not
143
most, patients have experienced a lifetime of failed attempts to lose weight. The weight loss after LAGB is known to be relatively slow. Many patients will frequently become frustrated at the pace and require ongoing encouragement. Another advantage is that it allows for flexibility. Some patients will lose more slowly than others. We have set a benchmark of 40% EWL at 1 year. If a patient has not reached that benchmark, we continue to see them every 4 – 6 weeks until they have reached that benchmark. This “failure is not an option” strategy also demonstrates to the patient that the bariatric team is committed to their success. It should also be emphasized that this schedule represents the minimal interval between visits. Patients should be encouraged to come in sooner if they feel excessive restric-
Fig. 3. Strategy used in our practice.
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tion, inadequate restriction or have any concerns that they are experiencing an adverse event. Although this strategy is simple in design, its implementation is not trivial. Each patient who undergoes surgery will require a minimum of 12 visits within the first 2 years. This is in addition to the multiple preoperative visits required for adequate preparation. Therefore, even with a modest patient volume, adequate physical space and staffing is a prerequisite. Patients should have access to the team 5 days a week. A dedicated clinic day will not be sufficient. Physician extenders have become commonplace and we have found ours to be invaluable. However, the surgeon must remain closely involved and will need to avoid the temptation to delegate all postoperative care to other providers. Finally, and perhaps most importantly, is the establishment of a culture in the practice that promotes long-term care to what must be described as a lifelong condition. We have established an ongoing relationship, much like a primary care physician. We keep an “open door policy” for our LAGB patients. We are not judgemental if they have failed to lose weight. We believe that this environment is essential to success. Many different protocols and strategies are in current use, and we do not suggest that our strategy is the only path to success. However, our approach is similar to that of other published strategies by successful practices such as O’Brien et al. [13] and Ren et al. [12]. We believe it is not coincidental that our outcomes were also similar (Fig. 1). This suggests that, not only are excellent results obtainable, but that they are also reproducible.
Conclusion We found LAGB to be both a safe and an effective procedure with a low long-term failure rate. LAGB should continue to be considered a viable option for the treatment of morbid obesity. It must be understood that the weight loss tends to be slow but progressive. Long-term follow-up must be emphasized. We have proposed a strategy that has been effective in a community setting.
Disclosures The authors have no commercial associations that might be a conflict of interest in relation to this article. References [1] Hinojosa MW, Varela JE, Parikh D, Smith BR, Nguyen XM, Nguyen NT. National trends in use and outcome of laparoscopic adjustable gastric banding. Surg Obes Relat Dis 2009;5:150 –5. [2] DeMaria EJ, Sugerman HJ, Meador JG, et al. High failure rate after laparoscopic adjustable silicone gastric banding for treatment of morbid obesity. Ann Surg 2001;233:809 –18. [3] Suter M, Calmes JM, Paroz A, Giusti V. A 10-year experience with laparoscopic gastric banding for morbid obesity: high long-term complication and failure rates. Obes Surg 2006;16:829 –35. [4] Nguyen NT, Sloan JA, Nguyen XM, Hartman JS, Hoyt DB. A prospective randomized trial of laparoscopic gastric bypass versus laparoscopic adjustable gastric banding for the treatment of morbid obesity: outcomes, quality of life, and costs. Ann Surg 2009;250:631– 41. [5] Angrisani LA, Borrelli VA. Laparoscopic adjustable gastric banding versus Roux-en-Y gastric bypass: 5-year results of a prospective randomized trial. Surg Obes Relat Dis 2007;3:127–32. [6] Tice JA, Karliner L, Walsh J, Peterson AJ, Feldman MD. Gastric banding or bypass? A systematic review comparing the two most popular bariatric procedures. Am J Med 2008;121:885–93. [7] Guller U, Klein LV, Hagen JA. Safety and effectiveness of bariatric surgery: Roux-en-Y gastric bypass is superior to gastric banding in the management of morbidly obese patients. Patient Saf Surg 2009; 3:10. [8] O’Brien PE, Dixon JB, Brown W, et al. The laparoscopic adjustable gastric band (Lap-Band): a prospective study of medium-term effects on weight, health and quality of life. Obes Surg 2002;12:652– 60. [9] Ponce J, Dixon J. Laparoscopic adjustable gastric banding. Surg Obes Relat Dis 2005;1:310 –16. [10] Parikh MS, Fielding GA, Ren CJ. U.S. experience with 749 laparoscopic adjustable gastric bands: intermediate outcomes. Surg Endosc 2005;19:1631–5. [11] O’Brien PE, McPhail T, Chaston TB, Dixon JB. Systematic review of medium-term weight loss after bariatric operations. Obes Surg 2006; 16:1032– 40. [12] Ren CJ, Weiner M, Allen JW. Favorable early results of gastric banding for morbid obesity: the American experience. Surg Endosc 2004;18:543– 6. [13] O’Brien PE, Dixon JB, Laurie C, et al. Treatment of mild to moderate obesity with laparoscopic adjustable gastric banding or an intensive medical program: a randomized trial. Ann Intern Med 2006;144:625–33.