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Weight loss and early and late complications—the international experience
The American Journal of Surgery 184 (2002) 42S– 45S
Weight loss and early and late complications—the international experience Paul E. O’Brien, M.D.*, John B. Dixon, M.B.B.S. Monash University Department of Surgery and the Alfred Hospital, Commercial Road, Melbourne, Victoria 3181, Australia
Abstract Following its introduction in 1993, the LAP-BAND (INAMED Health, Santa Barbara, CA) has been used extensively across the world for the treatment of obesity, and data on safety and effectiveness are now available. This review draws on the literature and our own clinical patient base to provide an overview of the early and late problems associated with LAP-BAND placement and its effects on weight loss. It has proved to be a remarkably safe procedure. A report analyzing international data on laparoscopic adjustable gastric bands identified 3 deaths in 5,827 patients (approximately 1 in 2,000). In our series of 1,120 patients, there have been no deaths and no life-threatening perioperative complications. Significant early complications occurred in 17 (1.5%) of our patients; late problems have been more common, particularly during our early experience. Prolapse of the stomach through the band occurred in 125 (25%) of our first 500 patients but has occurred in only 28 (4.7%) of our last 600 patients. Erosion of the band into the stomach occurred in 34 patients (3%); all occurred in the first 500 patients. No erosions have occurred in the last 600 patients. Both problems are treated laparoscopically by removal and replacement. Combined international data show that weight loss after LAP-BAND placement is characterized by steady progressive weight loss over a 2- to 3-year period, followed by stable weight out to 6 years. This pattern reflects the benefit of adjustability. For the international series, the percent excess weight loss (%EWL) at 2 years has been between 52% and 65%. In our series, %EWL at 5 years and 6 years was 54% and 57%, respectively. The LAP-BAND is proving to be extremely safe, able to facilitate good weight loss, and able to maintain weight loss over time. © 2002 Excerpta Medica Inc. All rights reserved.
The LAP-BAND (INAMED Health, Santa Barbara, CA) has now been placed in more than 80,000 people. Data on its safety and effectiveness are accumulating to the point where its potential impact on health can be measured and comparative analyses with alternative treatments are possible. To date, there have been no randomized controlled trials of its effectiveness in comparison with optimal medical therapy or with traditional surgical approaches. The quality of comparative published data is marred by inconsistent measures of outcome, incompleteness of data, and frequent lack of measures of dispersion of the data about the mean. The Australian Safety and Efficacy Register of New Interventional Procedures–Surgical (ASERNIP-S) recently analyzed existing international data regarding laparoscopic adjustable gastric banding and 55 selected papers covering vertical banded gastroplasty (VBG) and Rouxen-Y gastric bypass (RYGBP) [1]. The literature search included all randomized controlled studies, controlled clinical trials, and prospective case series of laparoscopic ad-
* Corresponding author: Tel.: ⫹61-3-9903-0608; fax: ⫹61-3-9510-3365 E-mail address: [email protected]
justable gastric banding worldwide contained in the databases of Current Contents, Medline, Embase, Healthstar, and the Cochrane Library up to September 2001. This article draws on details from our research group’s published reports combined with data from the systematic ASERNIP-S review. The outcomes covered include perioperative mortality and morbidity, weight loss over time after surgery, and late events that have required additional procedures. The changes in the health of the patients in association with weight loss are covered in a separate article (see Dixon and O’Brien [2]). Perioperative mortality There have been no deaths in our series, which now includes more than 1,100 patients. In the overall international experience, LAP-BAND surgery has shown similar low mortality rates. The ASERNIP-S review of the world literature to September 2001 reported 3 deaths in 5,827 cases (approximately 1 in 2,000 or 0.05%). This is significantly fewer than occurred after RYGBP, where the ASERNIP-S review noted 25 deaths in 7,232 cases (0.3%). In a
0002-9610/02/$ – see front matter © 2002 Excerpta Medica Inc. All rights reserved. doi:10.1016/S0002-9610(02)01179-0
P.E. O’Brien and J.B. Dixon / The American Journal of Surgery 184 (2002) 42S– 45S Table 1 Early complications after laparoscopic placement of LAP-BAND (N ⫽ 1,120) Infection at access port Delayed emptying through band Deep venous thrombosis Hepatotoxicity (causes questionable) Bile leak from liver Total
10 4 1 1 1 17 (1.5%)
large RYGBP series [3] not included in the ASERNIP-S review, 21 of 1,976 patients (⬎1%) died.
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become infrequent (15 [2.5%] in the last 600 patients) in association with improvement in design of the tubing and in the technique of its placement. The breaks are generally easily repaired because the port is in a subcutaneous position. Other problems have been uncommon. Symptomatic gallstone disease led to cholecystectomy in 55 patients (5%). Eleven patients (1%) had the band removed because they could not cope with the effect. Esophageal dilatation was common when a prolapse occurred or the band was adjusted excessively. There has been no instance of persistence of the esophageal dilatation after removal of fluid from the band or treatment of the prolapse. There has been no symptomatic esophageal dysmotility noted in our series.
Perioperative and late morbidity International experience Authors’ experience For our 1,120 patients, we have kept a prospective database of all perioperative and late complications that either delayed discharge or required readmission or reoperation. For patients treated laparoscopically, the overall perioperative complication rate was 1.5% (Table 1). No serious complication has occurred. No patient in our series has required admission to intensive care. Late complications requiring reoperation were a major issue, particularly in our early experience, with the problems of prolapse and, less commonly, erosions and tubing breaks. Each of these problems has become much less frequent with time and evolution of our technique. Gastric prolapse/slippage has been the most common problem. There were 125 episodes in our first 500 patients (25%) and, thus far, 28 episodes in the last 600 patients (4.7%). Almost all have been posterior prolapse and reflect the placement of the band across the apex of the lesser sac, a feature of the perigastric approach. We have had no episodes of posterior prolapse since adopting the pars flaccida approach (see Fielding and Allen, [4]). Posterior prolapse is treated by laparoscopic removal of the band and placement of a new band along the pars flaccida pathway. Anterior prolapse has generally been treated by laparoscopic reduction and refixation. Erosion of the band into the lumen of the stomach occurred in 34 (3%) of 1,120 patients; all occurred in the first 500 patients treated. To date, we have had no erosions in our last 600 patients. Aspects of the particular technique of anterior fixation we used initially probably were a significant factor in most erosions. Various treatment strategies have been used. The current preferred approach is for laparoscopic removal of the band, repair of the gastric wall, and placement of a new LAP-BAND in a single operation. We have used this approach in 12 patients thus far; no complications have occurred, and the patients remain on track with weight loss or weight maintenance. Tubing breaks or other problems with the access port occurred in 61 (5.4%) of 1,120 patients. These have now
The literature is patchy and anecdotal in covering the perioperative complications of laparoscopic adjustable gastric banding. Most reviews address the incidence of complications as a secondary outcome measure, and the validity of the counting cannot be easily established. The morbidity rates reported in the literature vary widely, reflecting differing views as to what is regarded as reportable, variations in technique, and level of skill and the “learning curve” in LAP-BAND placement. The ASERNIP-S review struggled to find an appropriate method for bringing together the data relating to postoperative events because of the data and reporting quality issues noted. The group pooled perioperative complications and late events that required reoperation or further procedures, such as prolapse, erosion, or tubing breaks related to laparoscopic adjustable gastric banding, and stenoses, obstructions, hernia, and so on related to stapling procedures. The report noted an overall morbidity rate of 11.3% for laparoscopic adjustable gastric banding, 23.6% for VBG, and 25.7% for RYGBP. Consistent with these results, the Italian Collaborative Study Group documented an 11.3% rate of LAP-BAND– related complications [5], including gastric pouch dilatation (5.2%), port-tube complications (4.2%), and band erosion (1.9%). Of 830 LAP-BAND patients with up to 7 years of follow-up, Favretti and colleagues reported major complications requiring reoperation in 3.9% [6]. Early complications included 1 gastric perforation requiring band removal and 1 gastric prolapse treated by band repositioning. Late complications included gastric prolapse in 17 patients (12 repositioned and 5 removed), malpositioned band in 9 (all repositioned), erosions in 4 (all removed), psychological intolerance in 3 (all removed), and human immunodeficiency virus in 1 (removed). Reservoir leakage, which the authors regarded as a minor complication requiring reoperation, occurred in 91 patients (11%). Belachew and colleagues in Belgium reported a need to convert to laparotomy in 10 of their 763 LAP-BAND patients (1.3%) [7]. Reoperations were necessary in 80 patients (10.5%). Of these 80, 71 (88.8%) were readily cor-
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P.E. O’Brien and J.B. Dixon / The American Journal of Surgery 184 (2002) 42S– 45S
Table 2 Weight loss after LAP-BAND expressed as percent excess weight loss Months after surgery Study
N
12
Belachew et al, 2002 [7] O’Brien et al, 2002 [10] Cadiere et al, 2000 [11] Vertruyen, 2002 [8] Dargent, 1999 [12] Toppino et al, 1999 [13] Fielding et al, 1999 [14] Paganelli et al, 2000 [15] Niville and Dams, 1999 [16] Berrevoet et al, 1999 [17]
763 706 652 543 500 361 335 156 126 120
40 47 38 38 56 42 52 43 48 46
18 51
24 50 52 62 61 65
36
48
60
72
53
52
50–60* 54
57
62 64
58
53
84
52†
62 58 53
* Percentage reduction of excess weight for patients with greater than 5-year follow-up. † Percentage shown was at 86 months.
rected by laparoscopy. Early complications included 4 cases of gastric perforation (0.5%), 1 case of large-bowel perforation (0.1%), 1 case of severe bleeding (0.1%), and 1 port infection (0.1%). Late complications included 7 cases of band erosion (0.9%), 59 cases of total and irreversible food intolerance related to pouch dilatation or gastric slippage (8%), and 20 port-related complications (2.5%). Vertruyen in Belgium reported a conversion to laparotomy in 6 of 543 patients (1.1%) [8]. Perioperative and early complications occurred in 8 patients.The most common late complication was total and irreversible food intolerance caused by distal pouch dilatation, which occurred in 24 patients (4.6%). Laparoscopic reoperation was performed in 6 patients (1.1%) who required band removal and 17 patients (3.1%) who required band repositioning. Port or tube problems were seen in 16 patients (2.9%). Weiner and colleagues in Germany reported a postoperative complication rate of approximately 9% [9], which included port-related complications (3.2%), prolapse (2.2%), and erosions (1.1%). In their series of 184 LAPBAND patients, 6.4% required reoperation.
Weight loss after LAP-BAND surgery Studies of weight loss in bariatric surgery will generally express the outcomes in terms of percent excess weight lost (%EWL) or as change in body mass index (⌬BMI). To derive meaningful analysis reflecting “steady-state” practice, and because there are numerous reports with small numbers or short follow-up, we have included in Tables 2 [7,8,10 –17] and 3 [5–9,18 –23] only studies in which 100 or more patients were treated, with a 1-year follow-up for at least some of the patients. The pattern of weight loss shown in these tables is significant. There is progression of weight loss over several years. Adjustability permits a gentle progression rather than the severe early effect of RYGBP or other nonadjustable procedures. We generally expect that most of the weight loss will occur in the first 3 years after LAP-BAND placement. However, further small progression from there is still possible. Patient loss to follow-up can be an important factor in missing bad outcomes and has made the assessment of
Table 3 Weight loss after LAP-BAND expressed as reduction in body mass index* Months after surgery Study
N
Base
12
18
24
36
48
60
72
84
Angrisani et al, 2001 [5] Favretti et al, 2002 [6] Belachew et al, 2002 [7] Vertruyen, 2002 [8] Abu-Abeid and Szold, 1999 [18] Belachew et al, 1998 [19] Hauri et al, 2000 [20] Furbetta et al, 1999 [21] Weiner et al, 1999 [9] Gambinotti et al, 1998 [22] Nowara, 2001 [23]
1,265 830 763 543 391 350 207 201 184 162 108
44 46 42 44 43 43 43 43 48 43 49
35 37 32 33.2 32 30 35 35 32 32
33
30 36 30 31.3
32 37
32 37 30 31.4
36 ⬍30† 31.2
40
29
30
33 30
33 28 35
3
* Body mass index is calculated as weight (kg)/height (m ). † Reduction for patients with ⬎5 years follow-up. ‡ Reduction shown was at 86 months.
30.1
32.1‡
P.E. O’Brien and J.B. Dixon / The American Journal of Surgery 184 (2002) 42S– 45S
long-term outcome after RYGBP difficult. In our study shown in Table 2 [10], only 10 patients (1.4%) were lost to follow-up. Conclusion Perhaps the most attractive single feature of LAP-BAND surgery is its safety. Laparoscopic placement of the LAPBAND has proved to be one of the safest surgical procedures. This is at first glance surprising, because the patients, by being obese, are regarded as having higher anesthetic and perioperative risk, and furthermore frequently have multiple, severe comorbidities. This negative view fails to recognize the cardiac and respiratory “fitness” that is derived from the daily carriage of an extra 50 to 200 kg of excess weight. That they manage such a task could be seen as a mark of fitness that few of us could emulate. Eventually the strain takes its toll; ultimately, there is increased cardiovascular disease, reduced respiratory function, and premature wearing out of many body systems and functions. But as long as obese patients do not present late (ie, end-stage disease), we can offer a procedure that has a most impressive safety record. The pattern of weight loss that we noted after LAPBAND placement is different from that which we observed after RYGBP. The latter operation generates rapid weight loss in the first 12 months, followed by a plateau for approximately a year, and then a gradual regain of weight over time. In the Adelaide study [24], the peak weight loss of 69% EWL occurred at 12 months with a reduction in EWL to 59% at 5 years. Similarly, Pories and colleagues [25] noted a fade of effect, with 58% EWL at 5 years, 55% at 10 years, and 49% at 14 years. Systematic review of published reports of weight loss after RYGBP [1] provides data on 7 studies at 5-year follow-up, with a median of 62% EWL (range: 32% to 71%). Current data do not indicate a significant difference between LAP-BAND and RYGBP at 3 or more years after operation [1]. The weight loss that has occurred in our patients after LAP-BAND placement is gentle, progressive, and durable over an extended follow-up period of at least 6 years. This pattern of weight loss reflects the benefit of adjustability. With stapling operations, the day of the operation was the only chance to get the settings right. With the LAP-BAND, as long as the operative placement is correct, the degree of restriction can be varied according to the clinical need at any time after operation. For the surgeon looking after these patients, this is, by far, its most attractive feature. References [1] Chapman A, Kiroff G, Game P, et al. Systematic Review of Laparoscopic Adjustable Gastric Banding in the Treatment of Obesity (ASERNIP-S Report No. 31). Adelaide, South Australia: Australian Safety and Efficacy Register of New Interventional Procedures-Surgical, 2002, 18.
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[2] Dixon JB, O’Brien PE. Changes in comorbidities and improvements in quality of life after LAP-BAND placement. Am J Surg 2002;184: 51S–54S. [3] Sugerman HJ, Sugerman EL, Wolfe L, et al. Risks and benefits of gastric bypass in morbidly obese patients with severe venous stasis disease. Ann Surg 2001;234:41– 46. [4] Fielding GA, Allen JW. A step-by-step guide to placement of the LAP-BAND adjustable gastric banding system. Am J Surg 2002; 184(suppl):26S–31S. [5] Angrisani L, Alkilani M, Basso N, et al. Laparoscopic Italian experience with the LAP-BAND. Obes Surg 2001;11:307–310. [6] Favretti F, Cadiere GB, Segato G, et al. Laparoscopic banding: selection and technique in 830 patients. Obes Surg 2002;12:385–390. [7] Belachew M, Belva PH, Desaive C. Long-term results of laparoscopic adjustable gastric banding for the treatment of morbid obesity. Obes Surg 2002;12:564 –568. [8] Vertruyen M. Experience with LAP-BAND system up to 7 years. Obes Surg 2002;12:569 –572. [9] Weiner R, Wagner D, Bockhorn H. Laparoscopic gastric banding for morbid obesity. J Laparoendosc Adv Surg Tech A 1999;9:23–30. [10] O’Brien P, Dixon J, 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 in press. [11] Cadiere GB, Himpens J, Vertruyen M, et al. Laparoscopic gastroplasty (adjustable silicone gastric banding). Semin Laparosc Surg 2000;7:55– 65. [12] Dargent J. Laparoscopic adjustable gastric banding: lessons from the first 500 patients in a single institution. Obes Surg 1999;9:446 – 452. [13] Toppino M, Morino M, Bonnet G, Nigra I, Siliquini R. Laparoscopic surgery for morbid obesity: preliminary results from SICE registry (Italian Society of Endoscopic and Minimally Invasive Surgery). Obes Surg 1999;9:62– 65. [14] Fielding GA, Rhodes M, Nathanson LK. Laparoscopic gastric banding for morbid obesity. Surgical outcome in 335 cases. Surg Endosc 1999;13:550 –554. [15] Paganelli M, Giacomelli M, Librenti MC, et al. Thirty months experience with laparoscopic adjustable gastric banding. Obes Surg 2000; 10:269 –271. [16] Niville E, Dams A. Late pouch dilation after laparoscopic adjustable gastric and esophagogastric banding: incidence, treatment, and outcome. Obes Surg 1999;9:381–384. [17] Berrevoet F, Pattyn P, Cardon A, et al. Retrospective analysis of laparoscopic gastric banding technique: short- term and mid-term follow-up. Obes Surg 1999;9:272–275. [18] Abu-Abeid S, Szold A. Results and complications of laparoscopic adjustable gastric banding: an early and intermediate experience. Obes Surg 1999;9:188 –190. [19] Belachew M, Legrand M, Vincent V, et al. Laparoscopic adjustable gastric banding. World J Surg 1998;22:955–963. [20] Hauri P, Steffen R, Ricklin T, et al. Treatment of morbid obesity with the Swedish adjustable gastric band (SAGB): complication rate during a 12-month follow-up period. Surgery 2000;127:484 – 488. [21] Furbetta F, Gambinotti G, Robortella EM. 28-Month experience with the lap-band technique: results and critical points of the method. Obes Surg 1999;9:56 –58. [22] Gambinotti G, Robortella ME, Furbetta F. Personal experience with laparoscopic adjustable silicone gastric banding in the treatment of morbid obesity. Eat Weight Disord 1998;3:43– 45. [23] Nowara HA. Egyptian experience in laparoscopic adjustable gastric banding (technique, complications and intermediate results). Obes Surg 2001;11:70 –75. [24] O’Brien PE, Hall JC, Watts JM, et al. Gastric surgery for morbid obesity. The Adelaide Study. Ann Surg 1990;211:419 – 427. [25] Pories WJ, Swanson MS, MacDonald KG, et al. Who would have thought it? An operation proves to be the most effective therapy for adult-onset diabetes mellitus. Ann Surg 1995;222:339 –350.
Weight loss and early and late complications—the international experience Paul E. O’Brien, M.D.*, John B. Dixon, M.B.B.S. Monash University Department of Surgery and the Alfred Hospital, Commercial Road, Melbourne, Victoria 3181, Australia
Abstract Following its introduction in 1993, the LAP-BAND (INAMED Health, Santa Barbara, CA) has been used extensively across the world for the treatment of obesity, and data on safety and effectiveness are now available. This review draws on the literature and our own clinical patient base to provide an overview of the early and late problems associated with LAP-BAND placement and its effects on weight loss. It has proved to be a remarkably safe procedure. A report analyzing international data on laparoscopic adjustable gastric bands identified 3 deaths in 5,827 patients (approximately 1 in 2,000). In our series of 1,120 patients, there have been no deaths and no life-threatening perioperative complications. Significant early complications occurred in 17 (1.5%) of our patients; late problems have been more common, particularly during our early experience. Prolapse of the stomach through the band occurred in 125 (25%) of our first 500 patients but has occurred in only 28 (4.7%) of our last 600 patients. Erosion of the band into the stomach occurred in 34 patients (3%); all occurred in the first 500 patients. No erosions have occurred in the last 600 patients. Both problems are treated laparoscopically by removal and replacement. Combined international data show that weight loss after LAP-BAND placement is characterized by steady progressive weight loss over a 2- to 3-year period, followed by stable weight out to 6 years. This pattern reflects the benefit of adjustability. For the international series, the percent excess weight loss (%EWL) at 2 years has been between 52% and 65%. In our series, %EWL at 5 years and 6 years was 54% and 57%, respectively. The LAP-BAND is proving to be extremely safe, able to facilitate good weight loss, and able to maintain weight loss over time. © 2002 Excerpta Medica Inc. All rights reserved.
The LAP-BAND (INAMED Health, Santa Barbara, CA) has now been placed in more than 80,000 people. Data on its safety and effectiveness are accumulating to the point where its potential impact on health can be measured and comparative analyses with alternative treatments are possible. To date, there have been no randomized controlled trials of its effectiveness in comparison with optimal medical therapy or with traditional surgical approaches. The quality of comparative published data is marred by inconsistent measures of outcome, incompleteness of data, and frequent lack of measures of dispersion of the data about the mean. The Australian Safety and Efficacy Register of New Interventional Procedures–Surgical (ASERNIP-S) recently analyzed existing international data regarding laparoscopic adjustable gastric banding and 55 selected papers covering vertical banded gastroplasty (VBG) and Rouxen-Y gastric bypass (RYGBP) [1]. The literature search included all randomized controlled studies, controlled clinical trials, and prospective case series of laparoscopic ad-
* Corresponding author: Tel.: ⫹61-3-9903-0608; fax: ⫹61-3-9510-3365 E-mail address: [email protected]
justable gastric banding worldwide contained in the databases of Current Contents, Medline, Embase, Healthstar, and the Cochrane Library up to September 2001. This article draws on details from our research group’s published reports combined with data from the systematic ASERNIP-S review. The outcomes covered include perioperative mortality and morbidity, weight loss over time after surgery, and late events that have required additional procedures. The changes in the health of the patients in association with weight loss are covered in a separate article (see Dixon and O’Brien [2]). Perioperative mortality There have been no deaths in our series, which now includes more than 1,100 patients. In the overall international experience, LAP-BAND surgery has shown similar low mortality rates. The ASERNIP-S review of the world literature to September 2001 reported 3 deaths in 5,827 cases (approximately 1 in 2,000 or 0.05%). This is significantly fewer than occurred after RYGBP, where the ASERNIP-S review noted 25 deaths in 7,232 cases (0.3%). In a
0002-9610/02/$ – see front matter © 2002 Excerpta Medica Inc. All rights reserved. doi:10.1016/S0002-9610(02)01179-0
P.E. O’Brien and J.B. Dixon / The American Journal of Surgery 184 (2002) 42S– 45S Table 1 Early complications after laparoscopic placement of LAP-BAND (N ⫽ 1,120) Infection at access port Delayed emptying through band Deep venous thrombosis Hepatotoxicity (causes questionable) Bile leak from liver Total
10 4 1 1 1 17 (1.5%)
large RYGBP series [3] not included in the ASERNIP-S review, 21 of 1,976 patients (⬎1%) died.
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become infrequent (15 [2.5%] in the last 600 patients) in association with improvement in design of the tubing and in the technique of its placement. The breaks are generally easily repaired because the port is in a subcutaneous position. Other problems have been uncommon. Symptomatic gallstone disease led to cholecystectomy in 55 patients (5%). Eleven patients (1%) had the band removed because they could not cope with the effect. Esophageal dilatation was common when a prolapse occurred or the band was adjusted excessively. There has been no instance of persistence of the esophageal dilatation after removal of fluid from the band or treatment of the prolapse. There has been no symptomatic esophageal dysmotility noted in our series.
Perioperative and late morbidity International experience Authors’ experience For our 1,120 patients, we have kept a prospective database of all perioperative and late complications that either delayed discharge or required readmission or reoperation. For patients treated laparoscopically, the overall perioperative complication rate was 1.5% (Table 1). No serious complication has occurred. No patient in our series has required admission to intensive care. Late complications requiring reoperation were a major issue, particularly in our early experience, with the problems of prolapse and, less commonly, erosions and tubing breaks. Each of these problems has become much less frequent with time and evolution of our technique. Gastric prolapse/slippage has been the most common problem. There were 125 episodes in our first 500 patients (25%) and, thus far, 28 episodes in the last 600 patients (4.7%). Almost all have been posterior prolapse and reflect the placement of the band across the apex of the lesser sac, a feature of the perigastric approach. We have had no episodes of posterior prolapse since adopting the pars flaccida approach (see Fielding and Allen, [4]). Posterior prolapse is treated by laparoscopic removal of the band and placement of a new band along the pars flaccida pathway. Anterior prolapse has generally been treated by laparoscopic reduction and refixation. Erosion of the band into the lumen of the stomach occurred in 34 (3%) of 1,120 patients; all occurred in the first 500 patients treated. To date, we have had no erosions in our last 600 patients. Aspects of the particular technique of anterior fixation we used initially probably were a significant factor in most erosions. Various treatment strategies have been used. The current preferred approach is for laparoscopic removal of the band, repair of the gastric wall, and placement of a new LAP-BAND in a single operation. We have used this approach in 12 patients thus far; no complications have occurred, and the patients remain on track with weight loss or weight maintenance. Tubing breaks or other problems with the access port occurred in 61 (5.4%) of 1,120 patients. These have now
The literature is patchy and anecdotal in covering the perioperative complications of laparoscopic adjustable gastric banding. Most reviews address the incidence of complications as a secondary outcome measure, and the validity of the counting cannot be easily established. The morbidity rates reported in the literature vary widely, reflecting differing views as to what is regarded as reportable, variations in technique, and level of skill and the “learning curve” in LAP-BAND placement. The ASERNIP-S review struggled to find an appropriate method for bringing together the data relating to postoperative events because of the data and reporting quality issues noted. The group pooled perioperative complications and late events that required reoperation or further procedures, such as prolapse, erosion, or tubing breaks related to laparoscopic adjustable gastric banding, and stenoses, obstructions, hernia, and so on related to stapling procedures. The report noted an overall morbidity rate of 11.3% for laparoscopic adjustable gastric banding, 23.6% for VBG, and 25.7% for RYGBP. Consistent with these results, the Italian Collaborative Study Group documented an 11.3% rate of LAP-BAND– related complications [5], including gastric pouch dilatation (5.2%), port-tube complications (4.2%), and band erosion (1.9%). Of 830 LAP-BAND patients with up to 7 years of follow-up, Favretti and colleagues reported major complications requiring reoperation in 3.9% [6]. Early complications included 1 gastric perforation requiring band removal and 1 gastric prolapse treated by band repositioning. Late complications included gastric prolapse in 17 patients (12 repositioned and 5 removed), malpositioned band in 9 (all repositioned), erosions in 4 (all removed), psychological intolerance in 3 (all removed), and human immunodeficiency virus in 1 (removed). Reservoir leakage, which the authors regarded as a minor complication requiring reoperation, occurred in 91 patients (11%). Belachew and colleagues in Belgium reported a need to convert to laparotomy in 10 of their 763 LAP-BAND patients (1.3%) [7]. Reoperations were necessary in 80 patients (10.5%). Of these 80, 71 (88.8%) were readily cor-
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P.E. O’Brien and J.B. Dixon / The American Journal of Surgery 184 (2002) 42S– 45S
Table 2 Weight loss after LAP-BAND expressed as percent excess weight loss Months after surgery Study
N
12
Belachew et al, 2002 [7] O’Brien et al, 2002 [10] Cadiere et al, 2000 [11] Vertruyen, 2002 [8] Dargent, 1999 [12] Toppino et al, 1999 [13] Fielding et al, 1999 [14] Paganelli et al, 2000 [15] Niville and Dams, 1999 [16] Berrevoet et al, 1999 [17]
763 706 652 543 500 361 335 156 126 120
40 47 38 38 56 42 52 43 48 46
18 51
24 50 52 62 61 65
36
48
60
72
53
52
50–60* 54
57
62 64
58
53
84
52†
62 58 53
* Percentage reduction of excess weight for patients with greater than 5-year follow-up. † Percentage shown was at 86 months.
rected by laparoscopy. Early complications included 4 cases of gastric perforation (0.5%), 1 case of large-bowel perforation (0.1%), 1 case of severe bleeding (0.1%), and 1 port infection (0.1%). Late complications included 7 cases of band erosion (0.9%), 59 cases of total and irreversible food intolerance related to pouch dilatation or gastric slippage (8%), and 20 port-related complications (2.5%). Vertruyen in Belgium reported a conversion to laparotomy in 6 of 543 patients (1.1%) [8]. Perioperative and early complications occurred in 8 patients.The most common late complication was total and irreversible food intolerance caused by distal pouch dilatation, which occurred in 24 patients (4.6%). Laparoscopic reoperation was performed in 6 patients (1.1%) who required band removal and 17 patients (3.1%) who required band repositioning. Port or tube problems were seen in 16 patients (2.9%). Weiner and colleagues in Germany reported a postoperative complication rate of approximately 9% [9], which included port-related complications (3.2%), prolapse (2.2%), and erosions (1.1%). In their series of 184 LAPBAND patients, 6.4% required reoperation.
Weight loss after LAP-BAND surgery Studies of weight loss in bariatric surgery will generally express the outcomes in terms of percent excess weight lost (%EWL) or as change in body mass index (⌬BMI). To derive meaningful analysis reflecting “steady-state” practice, and because there are numerous reports with small numbers or short follow-up, we have included in Tables 2 [7,8,10 –17] and 3 [5–9,18 –23] only studies in which 100 or more patients were treated, with a 1-year follow-up for at least some of the patients. The pattern of weight loss shown in these tables is significant. There is progression of weight loss over several years. Adjustability permits a gentle progression rather than the severe early effect of RYGBP or other nonadjustable procedures. We generally expect that most of the weight loss will occur in the first 3 years after LAP-BAND placement. However, further small progression from there is still possible. Patient loss to follow-up can be an important factor in missing bad outcomes and has made the assessment of
Table 3 Weight loss after LAP-BAND expressed as reduction in body mass index* Months after surgery Study
N
Base
12
18
24
36
48
60
72
84
Angrisani et al, 2001 [5] Favretti et al, 2002 [6] Belachew et al, 2002 [7] Vertruyen, 2002 [8] Abu-Abeid and Szold, 1999 [18] Belachew et al, 1998 [19] Hauri et al, 2000 [20] Furbetta et al, 1999 [21] Weiner et al, 1999 [9] Gambinotti et al, 1998 [22] Nowara, 2001 [23]
1,265 830 763 543 391 350 207 201 184 162 108
44 46 42 44 43 43 43 43 48 43 49
35 37 32 33.2 32 30 35 35 32 32
33
30 36 30 31.3
32 37
32 37 30 31.4
36 ⬍30† 31.2
40
29
30
33 30
33 28 35
3
* Body mass index is calculated as weight (kg)/height (m ). † Reduction for patients with ⬎5 years follow-up. ‡ Reduction shown was at 86 months.
30.1
32.1‡
P.E. O’Brien and J.B. Dixon / The American Journal of Surgery 184 (2002) 42S– 45S
long-term outcome after RYGBP difficult. In our study shown in Table 2 [10], only 10 patients (1.4%) were lost to follow-up. Conclusion Perhaps the most attractive single feature of LAP-BAND surgery is its safety. Laparoscopic placement of the LAPBAND has proved to be one of the safest surgical procedures. This is at first glance surprising, because the patients, by being obese, are regarded as having higher anesthetic and perioperative risk, and furthermore frequently have multiple, severe comorbidities. This negative view fails to recognize the cardiac and respiratory “fitness” that is derived from the daily carriage of an extra 50 to 200 kg of excess weight. That they manage such a task could be seen as a mark of fitness that few of us could emulate. Eventually the strain takes its toll; ultimately, there is increased cardiovascular disease, reduced respiratory function, and premature wearing out of many body systems and functions. But as long as obese patients do not present late (ie, end-stage disease), we can offer a procedure that has a most impressive safety record. The pattern of weight loss that we noted after LAPBAND placement is different from that which we observed after RYGBP. The latter operation generates rapid weight loss in the first 12 months, followed by a plateau for approximately a year, and then a gradual regain of weight over time. In the Adelaide study [24], the peak weight loss of 69% EWL occurred at 12 months with a reduction in EWL to 59% at 5 years. Similarly, Pories and colleagues [25] noted a fade of effect, with 58% EWL at 5 years, 55% at 10 years, and 49% at 14 years. Systematic review of published reports of weight loss after RYGBP [1] provides data on 7 studies at 5-year follow-up, with a median of 62% EWL (range: 32% to 71%). Current data do not indicate a significant difference between LAP-BAND and RYGBP at 3 or more years after operation [1]. The weight loss that has occurred in our patients after LAP-BAND placement is gentle, progressive, and durable over an extended follow-up period of at least 6 years. This pattern of weight loss reflects the benefit of adjustability. With stapling operations, the day of the operation was the only chance to get the settings right. With the LAP-BAND, as long as the operative placement is correct, the degree of restriction can be varied according to the clinical need at any time after operation. For the surgeon looking after these patients, this is, by far, its most attractive feature. References [1] Chapman A, Kiroff G, Game P, et al. Systematic Review of Laparoscopic Adjustable Gastric Banding in the Treatment of Obesity (ASERNIP-S Report No. 31). Adelaide, South Australia: Australian Safety and Efficacy Register of New Interventional Procedures-Surgical, 2002, 18.
45S
[2] Dixon JB, O’Brien PE. Changes in comorbidities and improvements in quality of life after LAP-BAND placement. Am J Surg 2002;184: 51S–54S. [3] Sugerman HJ, Sugerman EL, Wolfe L, et al. Risks and benefits of gastric bypass in morbidly obese patients with severe venous stasis disease. Ann Surg 2001;234:41– 46. [4] Fielding GA, Allen JW. A step-by-step guide to placement of the LAP-BAND adjustable gastric banding system. Am J Surg 2002; 184(suppl):26S–31S. [5] Angrisani L, Alkilani M, Basso N, et al. Laparoscopic Italian experience with the LAP-BAND. Obes Surg 2001;11:307–310. [6] Favretti F, Cadiere GB, Segato G, et al. Laparoscopic banding: selection and technique in 830 patients. Obes Surg 2002;12:385–390. [7] Belachew M, Belva PH, Desaive C. Long-term results of laparoscopic adjustable gastric banding for the treatment of morbid obesity. Obes Surg 2002;12:564 –568. [8] Vertruyen M. Experience with LAP-BAND system up to 7 years. Obes Surg 2002;12:569 –572. [9] Weiner R, Wagner D, Bockhorn H. Laparoscopic gastric banding for morbid obesity. J Laparoendosc Adv Surg Tech A 1999;9:23–30. [10] O’Brien P, Dixon J, 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 in press. [11] Cadiere GB, Himpens J, Vertruyen M, et al. Laparoscopic gastroplasty (adjustable silicone gastric banding). Semin Laparosc Surg 2000;7:55– 65. [12] Dargent J. Laparoscopic adjustable gastric banding: lessons from the first 500 patients in a single institution. Obes Surg 1999;9:446 – 452. [13] Toppino M, Morino M, Bonnet G, Nigra I, Siliquini R. Laparoscopic surgery for morbid obesity: preliminary results from SICE registry (Italian Society of Endoscopic and Minimally Invasive Surgery). Obes Surg 1999;9:62– 65. [14] Fielding GA, Rhodes M, Nathanson LK. Laparoscopic gastric banding for morbid obesity. Surgical outcome in 335 cases. Surg Endosc 1999;13:550 –554. [15] Paganelli M, Giacomelli M, Librenti MC, et al. Thirty months experience with laparoscopic adjustable gastric banding. Obes Surg 2000; 10:269 –271. [16] Niville E, Dams A. Late pouch dilation after laparoscopic adjustable gastric and esophagogastric banding: incidence, treatment, and outcome. Obes Surg 1999;9:381–384. [17] Berrevoet F, Pattyn P, Cardon A, et al. Retrospective analysis of laparoscopic gastric banding technique: short- term and mid-term follow-up. Obes Surg 1999;9:272–275. [18] Abu-Abeid S, Szold A. Results and complications of laparoscopic adjustable gastric banding: an early and intermediate experience. Obes Surg 1999;9:188 –190. [19] Belachew M, Legrand M, Vincent V, et al. Laparoscopic adjustable gastric banding. World J Surg 1998;22:955–963. [20] Hauri P, Steffen R, Ricklin T, et al. Treatment of morbid obesity with the Swedish adjustable gastric band (SAGB): complication rate during a 12-month follow-up period. Surgery 2000;127:484 – 488. [21] Furbetta F, Gambinotti G, Robortella EM. 28-Month experience with the lap-band technique: results and critical points of the method. Obes Surg 1999;9:56 –58. [22] Gambinotti G, Robortella ME, Furbetta F. Personal experience with laparoscopic adjustable silicone gastric banding in the treatment of morbid obesity. Eat Weight Disord 1998;3:43– 45. [23] Nowara HA. Egyptian experience in laparoscopic adjustable gastric banding (technique, complications and intermediate results). Obes Surg 2001;11:70 –75. [24] O’Brien PE, Hall JC, Watts JM, et al. Gastric surgery for morbid obesity. The Adelaide Study. Ann Surg 1990;211:419 – 427. [25] Pories WJ, Swanson MS, MacDonald KG, et al. Who would have thought it? An operation proves to be the most effective therapy for adult-onset diabetes mellitus. Ann Surg 1995;222:339 –350.