Surgery for Obesity and Related Diseases ] (2014) 00–00

Review article

Long-term complications requiring reoperations after laparoscopic adjustable gastric banding: a systematic review Xiaojun Shen, M.D., Ph.D., Xin Zhang, M.D., Ph.D., Jianwei Bi, M.D., Ph.D., Kai Yin, M.D., Ph.D.* Department of General Surgery, Changhai Hospital, Second Military Medical University, Shanghai, China Received September 11, 2014; accepted November 10, 2014

Abstract

At present, bariatric surgery is the most effective option for morbidly obese patients. Among all of the surgical procedures, laparoscopic adjustable gastric banding (LAGB) is characterized by superior safety, a stable weight loss effect, and unique reversibility. However, the worldwide popularity of LAGB is challenged and overshadowed by a number of adverse events. This systematic review examined the incidence and outcomes of the long-term complications that require reoperations after LAGB. A PubMed search was conducted through October 31, 2014, for relevant studies that included minimal 10-year follow-up data for LAGB patients. The defined outcomes of interest were weight loss outcomes, long-term complications, and reoperations. Seventeen studies, including 2 randomized controlled trials and 15 observational studies, were identified involving a total of 9706 LAGB patients, of which 8215 patients (84.6%) were followed up and 1974 patients (20.3%) were available 10 years after LAGB. The follow-up data indicated that the mean percentage of excess weight loss at 10 years after LAGB was 49.1% ⫾ 13.1% and the median long-term complication rate and reoperation rate for the LAGB patients were 42.7% (5.9%–52.9%) and 36.5% (7.2%– 66.1%), respectively. At the end of long-term follow-up, approximately 22.9% (5.4%–54.0%) of the LAGB patients had their bands removed and the commonest reason was complications. In conclusion, long-term adverse events are important and remarkable for LAGB patients. The role of LAGB in bariatric surgery is worthy of further appraisal, by comparing with other types of bariatric procedures, because of the limited high-quality evidence. (Surg Obes Relat Dis 2014;]:00–00.) r 2014 American Society for Metabolic and Bariatric Surgery. All rights reserved.

Keywords:

Laparoscopic adjustable gastric banding; Bariatric surgery; Outcomes

Morbid obesity is a chronic disease, which has continued to increase and become one of the major epidemics of the present generation. As the most efficacious and durable therapy, bariatric surgery has evolved into a variety of surgical procedures that are predominantly based on pure gastric restrictions, as well as gastric restriction with some or * Correspondence: Kai Yin, M.D., Ph.D., Department of General Surgery, Changhai Hospital, Second Military Medical University, 168 Changhai Road, Yangpu, Shanghai, 200433, China. E-mail: [email protected]

significant intestinal malabsorption, since the jejunoileal bypass was introduced in 1954 [1]. With the goal of uncompromising safety, efficiency, and durability, bariatric surgeons currently perform these 3 options most often: laparoscopic Roux-en-Y gastric bypass (LRYGB), laparoscopic sleeve gastrectomy (LSG), and laparoscopic adjustable gastric banding (LAGB) [2–5]. Since its introduction in 1993, LAGB has gained popularity due to durable weight loss results, very low operative morbidity, and almost no mortality [6–9]. In a previous systematic review regarding midterm bariatric operations, although LAGB showed poor weight loss

http://dx.doi.org/10.1016/j.soard.2014.11.011 1550-7289/r 2014 American Society for Metabolic and Bariatric Surgery. All rights reserved.

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X. Shen et al. / Surgery for Obesity and Related Diseases ] (2014) 00–00

results compared with LRYGB at years 1 and 2, the differences subsided after 3 years [6]. A recent study also found durable weight loss with 47% of excess weight loss (EWL) that was maintained 15 years after LAGB [7]. The appeal of LAGB also stems from device adjustability, less invasiveness with anatomy preservation and reversibility, relative simplicity, and low costs [8–9]. Obviously, LAGB contributed significantly to the boom of minimally invasive procedures for morbid obesity and was ever considered the first-choice procedure in treating morbidly obese patients [10]. However, the global trends in LAGB prevalence steeply declined from 2008 (42.3 %) to 2011 (17.8%) [11]. This phenomenon paralleled the substantial evidence that confirmed the superiority of LRYGB, and even the newer LSG, to LAGB and the higher weight loss failure rate of LAGB compared with other procedures [2–5]. Furthermore, after the enthusiasm regarding the apparent simplicity and good early results of the simple restrictive procedure, bariatric surgeons have to be concerned about high device-related complications and reoperations for insufficient weight loss, because the complication rates for LAGB have been reported to be as high as 40%–50% and reoperation rates up to 30% [6–9]. Importantly, there is no doubt that the actual incidence of these adverse events may be underestimated in consideration of nonreporting of negative results and a statistical dilution effect due to shorter follow-ups. Because the duration and completeness of follow-ups are very important to lower the bias in the literature, the longterm complication and reoperation results after LAGB are keys to understand and reevaluate the role of LAGB in the modern management of morbid obesity. The aim of the present systematic review was to examine the incidence and outcomes of long-term complications requiring reoperations using up-to-date and long-term LAGB data. Methods

included nonhuman studies, nonsurgical interventions, open bariatric surgery procedure studies, duplicate studies, publication of abstracts only, discussion papers, reviews, meta-analyses, comments, case reports, and lack of outcomes of interest (e.g., weight change, late complications, and reoperations). Only full-text articles published in English were included. Furthermore, eligible studies had to include (1) adult populations only (aged 418 years), body mass index (BMI) Z35, and consecutive patient series; (2) randomized controlled trials (RCTs) and observational studies (OBSs); and (3) data on long-term weight loss outcomes, late complications, and reoperations at 10 years or more after the primary LAGB. For multiple publications with the same data, only the most recent report was included. Quality assessment of the included studies The methodological quality of all of the studies included was systematically assessed according to the established guidelines [12–13]. The key points of the current checklist include the following: (1) a clear definition of the study population, design, and origin of country; (2) a sufficient period of a minimum of 10 years of follow-up; (3) a clear definition of weight loss outcomes; (4) a clear definition of late complications with LAGB; and (5) a clear definition of revisional surgery after LAGB. If a study did not mention all 5 points, it was excluded so as not to compromise the quality of the systematic review. A flow diagram of the study selection process is presented in Fig. 1. Data collection and analysis of the outcomes of interest The characteristics of each study were recorded, including age, sex, BMI, the design of each study (RCTs and OBSs), the LAGB performance period, the initial population size, the follow-up duration, and the number of patients

Search strategy A PubMed search was performed independently by 2 reviewers from inception to October 31, 2014, using the search terms “gastroplasty,” “gastric band,” “gastric banding,” “Swedish band,” “laparoscopic adjustable gastric banding,” “AGB,” “LAGB,” and “SAGB.” Furthermore, the terms “long term,” “long-term follow-up,” “long-term outcomes,” “long-term results,” and “10 years” were combined with each of the main search terms to ascertain the most relevant articles for the purposes of this study. Additionally, the journals Obesity Surgery and Surgery for Obesity and Related Disorders were hand searched directly. Study inclusion and exclusion criteria A review protocol was followed throughout, and the studies were evaluated for quality. Criteria for exclusion

Fig. 1. Flow chart of study selection.

Long-Term Adverse Events of LAGB / Surgery for Obesity and Related Diseases ] (2014) 00–00

available at the 10-year follow-up point in each study. Further weight loss outcome data were also extracted, in terms of the excess weight loss percentage (%EWL; calculated as [(initial weight – current weight)/(initial weight – ideal weight)]), overall complication and reoperation rates, and the time to complication and revision occurrence. Long-term complications after LAGB were classified as related to either band or port/tubing, as well as psychological intolerance. The target band-related complications included slippage/pouch dilation, esophageal dilation, reflux esophagitis, band erosion, band leakage, and band infection. The data related to reoperations after LAGB, defined as band reposition, band replacement, band removal, and port/tubing-related procedures, were obtained from the original publication. Additionally, the band was assumed to be at its initial position if no clear statement was provided regarding the band status. Pooled, sample size-weighted estimates and 95% CI were calculated for the defined outcomes of interest (SPSS statistical software version 18.0; SPSS Inc., Chicago, IL). A meta-analysis was not used to combine results across studies because of the significant heterogeneity in the study designs, different outcome definitions, and the different methods for assessing the outcomes. Results Study and patient characteristics Seventeen long-term LAGB outcome studies were extracted and are reported in Table 1 [7,14–29]. The study designs included 2 RCTs and 15 OBSs. Of the 17 studies,

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13 were from Europe, 2 were from Australia, 1 was from Lebanon, and 1 was from the United States. A total of 9706 patients were enrolled in this systematic review. The range of follow-up rate and period was from 50.9% to 100% and from 10 years to 18 years, respectively. Of the 9706 patients, 8215 patients (84.6%) were followed up and 1974 patients (20.3%) were available at 10 years after LAGB. The weighted mean patient age was 40.6 ⫾ 5.4 years, and the weighted mean BMI of the primary LAGB patients was 44.4 ⫾ 4.1 kg/m2. Long-term weight loss outcomes The pooled mean %EWL over the 10-year follow-up period is shown in Fig. 2. Sixteen studies reported %EWL at 10 years after LAGB, and the overall mean %EWL was 49.1 ⫾ 13.1% (range from 30.8% to 82.7%) . Of them, O’Brien et al. reported a 60% EWL at the maximum 17 years of follow-ups [7]. Impressively, 5 papers included in the literature review reported a mean %EWL at the 10-year follow-up that exceeded 50% [7,15,16,19,27]. Long-term complications As shown in Fig. 3, the median complication rate was 42.7% (range 5.9%–52.9%). As listed in Table 2, LAGB has the most common slippage and pouch dilation incidence (median rate, 15.3%; range 1.1%–39.9%). The subsequent common complications were as follows: port/tubing problems (median rate, 11.1%; range .9%–24.2%), band leakage (median rate, 6.5%; range 1.6%–20.5%), reflux esophagitis (median rate, 5.0%; range .9%–28.8%), band erosion

Table 1 Long-term LAGB studies (follow-up Z10 years) Author, Year

Favretti et al. [14], 2007 Miller et al. [15], 2007 Biagini et al. [16], 2008 Mittermair et al. [17], 2009 Naef et al. [18], 2010 Lanthaler et al. [19], 2010 Stroh et al. [20], 2011 Himpens et al. [21], 2011 Van Nieuwenhove et al. [22], 2011 Spivak et al. [23], 2012 Arapis et al. [24], 2012 O’Brien et al. [25], 2013 Angrisani et al. [26], 2013 O’Brien et al. [7], 2013 Victorzon et al. [27], 2013 Busetto et al. [28], 2014 Aarts et al. [29], 2014

Design

OBS OBS OBS OBS OBS OBS OBS OBS OBS OBS OBS OBS RCT RCT OBS OBS OBS

Country

UK Germany Lebanon Austria Switzerland Austria Germany Belgium Belgium USA France Australia Italy Australia Finland Italy Netherlands

Period of LAGB

1993–2005 1994–2001 1996–2006 1996–2006 1998–2009 1996–2000 1995–2009 1994–1997 1998–2004 2000–2002 1995–2007 1994–2011 2000 2002 1996–1999 1993–2000 1995–2003

Number

1791 554 591 785 167 276 200 151 656 127 186 3227 27 57 60 650 201

Follow-up %

Maximal yr

Available patients at 10 yr

91.0 92.0 95.8 98.3 94.0 80.0 83.5 54.3 88.0 86.0 89.0 81.0 81.4 78.0 100 50.9 99.0

12 10 10 10 10 10 12 12 12 10 14 15 10 10 16 14 18

74 278 2 1 18 NA 53 69 NA 39 90 714 22 46 51 318 199

Abbreviations: LAGB ¼ laparoscopic adjustable gastric banding; OBS ¼ observational study; RCT ¼ randomized controlled trial; NA ¼ not available.

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Fig. 2. The overall %EWL of laparoscopic adjustable gastric banding patients over the long-term follow-up period. Error bars represent the 95% CI for the means. Abbreviation: EWL ¼ excess weight loss.

(median rate, 3.9%; range .8%–28.0%), esophageal dilation (median rate, 3.6%; range .5%–24.0%), psychological intolerance (median rate, 2.7%; range .3%–7.1%), and band infection (median rate, 1.2%; range .3%–3.2%).

Reoperations and band explantations The median reoperation rate of the overall LAGB patients was 36.5% (range 7.2%–66.1%), which included band

Fig. 3. The overall outcomes of long-term adverse events for laparoscopic adjustable gastric banding patients. Box and whisker plots were used to show the frequency distribution features: the bottom and top of the boxes represent the 25th and 75th percentiles; the band near the middle of the box represents the 50th percentile (the median); and the ends of the whiskers represent the minimum and maximum of all of the data.

Long-Term Adverse Events of LAGB / Surgery for Obesity and Related Diseases ] (2014) 00–00

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Table 2 Long-term complications and reoperations of LAGB patients with follow-ups Z10 years

Complications Slippage/pouch dilation Port-/tubing-related complications Band leakage Reflux esophagitis Band erosions Esophageal dilation Psychological intolerance Band infection Procedures of reoperations Band repositioning Band replacement Band removal only Conversional procedures Port-related reoperations

N

n

Median (%)

95% CI (%)

References

9275 8369 2043 2531 9218 2952 3969 4372

1511 1211 126 358 346 172 58 43

15.3 11.1 6.5 5.0 3.9 3.6 2.7 1.2

8.7–24.1 5.3–17.5 1.1–16.7 0–19.7 0.9–11.2 0–14.4 0.6–5.0 0.4–2.6

7,14–29 7,14–15,17–27,29 15,17–19,27,29 14,17,22–24,26,29 14–26–29 14,17–19,22–24,29 7,14,16–20,23 14,16–19,21,24,28,29

3531 1489 8751 8751 3725

178 127 529 440 482

5.4 6.2 10.0 10.2 13.9

1.6–11.3 2.8–16.0 5.4–16.8 3.8–23.9 4.1–23.4

14,17–18,21,23,27–29 17–19,27,29 7,14,16–29 7,14,16–29 14,17–19,23,27–29

Abbreviations: LAGB ¼ laparoscopic adjustable gastric banding; BMI ¼ body mass index; N ¼ number of total patients in the relevant studies; n ¼ number of target patients.

repositioning in 5.4% (range 1.2%–14.6%), band replacements in 6.2% (range 5.4%–17.8%), port-related procedures in 13.9% (range 1.7%–30.8%), only band removal in 10.0% (range 2.5%–32.9%), and conversions to other bariatric procedures in 10.2% (range 0%–48%) of the patients (Table 2). At the end of long-term follow-up, approximately 22.9% of the LAGB patients removed their bands (range 5.4%–54.0%). The reasons for band explantations were specifically listed in 12 studies [7,14,16,17,19–23,25–27]. In these studies, a total of 866 patients underwent band removals: 571 (65.9%) with complications, 144 (16.6%) with unsatisfactory weight loss, 73 (8.4%) with patient request or psychological intolerance but without evidence of complication, 23 (2.7%) with excellent excessive weight loss, and 56 (6.5%) with unclear reason.

LRYGB patients and randomly assigned 27 patients into an LAGB group and 24 patients into an LRYGB group [25]. At the end of their 10-year follow-ups, band removal was performed in 9 (40.9%) LAGB patients and port replacement was required in 1 (4.3%) patient. In contrast, 28.6% of the LRYGB patients received reoperations for major complications. Importantly, compared with the non–life-threatening complications of LAGB, 4.7% of their LRYGB patients underwent potentially lethal complications, such as internal hernias and bowel obstructions. The other RCT was conducted by O’Brien et al., in which 80 patients were randomly assigned into an LAGB arm or an intensive-medical-therapy arm [26]. Of the 40 nonsurgical patients, 17 patients had crossed over to LAGB and 10 patients completed their 10-year followup. At the end of the follow-ups, 28 (49.1%) of the patients developed late complications, and 24 (42.1%) patients received reoperations, which included 7 (12.0%) band explantations.

Randomized controlled trials As summarized in Table 3, 2 RCTs were included in the present review. Angrisani et al. compared LAGB with Table 3 Two long-term RCTs for comparing LAGB with medical treatment and LRYGB

O’Brien et al. [27]

Angrisani et al. [26] LRYGB

LAGB

Crossover

Medical

27/22 33.3 43.4 46.0 (27.0)

24/21 34.7 43.8 69.0 (29.0)

31 53.6 (6.2) 33.6 (1.9) 63.0 (41.0)

10 52.0 (7.4) 33.8 (1.7) 48.2 (51.6)

10 53.3 (8.3) 33.2 (1.3) 2.63 (1.3)

0 9 (40.9) 9 (40.9) 9 (40.9)

2 (8.4) 6 (28.6) 6 (28.6) –

0 28 (49.1) 24 (42.1) 7 (12.0)

LAGB Total /patients present at 10 follow-up yr Initial mean age (SD) Initial mean BMI (SD), kg/m2 %EWL Number of complication (% ) Early Late Number of reoperations (% ) Number of band explantations (% )

– – – –

Abbreviations: RCTs ¼ randomized controlled trials; LRYGB ¼ laparoscopic Roux-en-Y gastric bypass;.LAGB ¼ laparoscopic adjustable gastric banding; BMI ¼ body mass index; EWL ¼ excess weight loss.

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Discussion As one of leading causes of preventable death worldwide, obesity needs therapeutic options that can remain effective for decades rather than years. It is well known that there is a tendency for bariatric patients to regain weight after initial weight loss, leading to nonresolution or recurrence of comorbid conditions. Hence, the success of any bariatric procedure depends on excellent weight loss efficiency and durability. As far as the clinical effectiveness of LAGB is concerned, the pooled data in this study indicated that the overall mean %EWL 10 years after LAGB was nearly 50%, which is generally defined as successful in the bariatric literature. Whereas LAGB had a moderate weight loss effect in the 2 RCTs, the use of LAGB was sufficient in the cost effectiveness, especially with class I obesity (BMI 30–35 kg/m2), and in at least 1 obesity-related health condition [30]. Improved surgical technique, innovation of gastric bands, and intense postoperative management are believed to attenuate the disturbing, but usually not life-threatening, complications of LAGB. However, the 440% complication incidence within the 10-year or more follow-up periods suggested that it was unlikely to eradicate the inherent shortcomings of LAGB in terms of imposed foreign bodies on a hollow viscus and eliminate the LAGB-related complications entirely. As the commonest adverse event, the incidence of band slippage and pouch dilation increased over time and ranged from 1.1%–39.9%, as quoted in the reviewed literature. The great variability in complication rates suggests that there is no universal consensus regarding what constitutes a proximal enlargement. Additionally, esophageal stages III and IV dilations were generally classified as complications according to Dargent [31]. The possible reasons for late enlargement appearances may be related to surgical technique, due to overinflation of the band, or the natural evolution of a hollow viscus proximal to an imposed stenosis. Slippage rates have fallen dramatically over the past few years after a change from the perigastric to the pars flaccida method of band insertion and the use of gastric fixation sutures [32–34]. In the cases when bands are too tight, a compromise between weight maintenance and food tolerance has to be made, usually at the expense of weight. Therefore, strict preoperative patient selection for compliance and motivation is essential. Patients who present with abnormal esophageal body motility before gastric banding are susceptible to developing a dilated esophagus, which is often combined with pouch dilation and achalasia-like symptoms [17]. According to this review, 3.9% of LAGB patients (overall median) experienced erosion, which is perhaps the most serious complication related to band insertion. As a major concern to opponents of LAGB, band erosion was thought to represent a total failure of the concept of gastric banding in terms of natural rigidity effects on the lumen of a hollow

organ [32–33]. Additionally, a higher detection rate was identified for the silent erosions in light of a lower threshold for performing endoscopy examinations [32]. In the present review data, port/tubing related complications were observed in approximately 11% of LAGB patients with follow-ups of 10 years or more, which included port tubing disconnections, discomfort or pain at port site, port site infections, device malfunctions, and port rotations/flips. Port/tubing disconnections or infections can be a serious problem; however, most of these complications can possibly be reduced with proper sterile technique and the use of newer port/tubing systems and can readily be resolved as a day case [35]. Despite the relative minority and simplicity, port/tubing related complications are more prevalent than have been reported and can be a source of significant morbidity, which necessitates invasive procedures [36]. With the unavoidable late LAGB complications, specific reoperations are thereby supposed to be applied for a portion of LAGB patients. According to this review, 36.5% of LAGB patients received a wide range of reoperative bariatric procedures, from early endoscopic or laparoscopic revisions to late laparoscopic or open reversals or conversions. While the most suitable bariatric procedure to salvage a failed LAGB has not yet been validated by prospective studies, the decision of whether to revise or reverse or to move to an alternate procedure is largely the surgeon’s choice. It has been suggested that all of the history, intraoperative findings, and patient requests should be taken into consideration regarding the reoperative procedure of choice [37]. When successful weight loss is achieved with an initial LAGB, band-saving revisions alone are optional for the subsequent complications. In these cases, revisions to correct or repair should not be counted as failures, but a part of the care process [14]. Revisions for LAGB can be classified into gastric band-related procedures and port/tubing-related procedures. Anterior slippage and symmetric pouch dilations were the main indications for band-related revisions by band repositioning, refixating, and replacement [38]. Notably, patients requiring surgical revision for gastric band symptoms, such as dysphagia or reflux esophagitis, should be investigated for the presence of a hiatal hernia, especially in the absence of band slippage as the cause of these symptoms [39]. The revisional portrelated procedure types include reconnection, replacement/ removals, and relocation, depending on the source of the problem. A local procedure was previously performed to simply exchange the port for the port site infections, port diaphragm rupture, or a cracked port, and a more invasive procedure involving laparoscopy was necessary for the tubing dislodgement or disconnection [35]. According to a study by O’Brien et al., which had the highest revision rate (37.4%) that was observed in the present review data, the need for revisions decreased as the technique evolved, with no revision required to date for any of the patients treated in the past 3 years [7].

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According to the present review, approximately 23% of the LAGB patients required removal of their bands with or without conversions 10 years or more after their LAGB procedures in 16 series [7,14,16–29]. Among them, it was most disappointing that Aarts et al. reported that 54% of patients no longer had any bands 14 years after their LAGB placements [29]. One possible explanation for this is that 99% of the patients in this study had 14-year follow-up, whereas most of the patients included in this review had not completed the minimal 10-year follow-up and only 20.3% were available at 10 years after LAGB, leading to the underestimated band removal rates. Furthermore, the main reasons for band removal after LAGB were a significant number of complications (65.9%) and insufficient weight loss (16.6%), which usually required conversions to alternative bariatric procedures. Of note, 8.4% of LAGB patients underwent psychological intolerance of the prosthesis and required removal of their bands, which was usually associated with intolerance for chronic symptoms, such as reflux and heartburn, or inferior quality of life7. In addition, reversals alone were performed in 2.7% of the LAGB patients who had excellent excessive weight loss outcomes but lacked compliance. Theoretically, one of the most appealing aspects of LAGB is its total reversibility, which makes only band removal possible for anatomy restoration. There are doubts, however, on the reversibility of LAGB, particularly whether the effects of excessive weight loss are sustainable after band explantations. Recently, the other study by Aarts et al. reported that all of 38 LAGB patients experienced weight regain after their band removals without initial conversions and 17 patients eventually received the secondary bariatric procedures [40]. As mentioned above, to achieve substantial further weight loss or correct persistent band-related symptoms, such as dysphagia, reflux, or motility disorders, some LAGB patients need to undergo removal of their bands and a subsequent conversion to another bariatric procedure, including different restrictive and malabsorptive procedures [41]. A systematic review supported a key reoperation principle for LAGB advocates, which converted restrictive procedures to include a malabsorptive component [37]. Specially, when the reasons for reoperation are severe, including gastroesophageal reflux, band intolerance/erosion, obstruction, or insufficient weight loss, LRYGB or a duodenal switch should be used [42]. Stable weight loss with salvage LRYGB evidenced that BMIs before LAGB (43.3 kg/m2) decreased significantly to 37.9 kg/m2 before LRYGB and to 28.8 kg/m2 5 years after LRYGB [41]. Another notable point is that LSG, as a newer bariatric procedure, has been found to be effective for inadequate weight loss after LAGB in a substantial number of reports [43–45]. Moreover, 75% of patients with reflux symptoms at the time of conversion experienced improvement or remission after their LSG procedure [46]. Given the less invasiveness and technical simplicity, LSG would be a

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reasonable alternative, especially in light of the high operative risks that LRYGB operations carry. Thus, although a consensus was reached on the point that the Roux-en-Y gastric bypass is the best option for converting a failed LAGB, LSG is an acceptable option for converting a successful, but complicated, LAGB [47]. In fact, the underlying etiology of LAGB failures is complex and often multifactorial. The incidence may depend on the surgical technique, gastric banding design changes, a wide range of commercially available products, and the postoperative follow-up frequency [42]. It has been known that follow-up assiduity and intensive behavioral support is critical for success in bariatric surgery. For LAGB, the most significant benefit is the ability to retain control over the degree of the gastric restriction through intermittent band adjustments. Therefore, continual and lifelong follow-ups, including regular band volume adjustments, are particularly necessary after LAGB procedures. Previous studies have documented that the effectiveness of LAGB is clearly more dependent on the quality of the follow-ups than other bariatric surgical procedures, and more visits to the outpatient department and more frequent adjustments result in increased EWL, although the optimal frequency remains unknown [48]. The outcomes of LAGB patients lost to follow-up were reportedly worse than patients who continued with their follow-ups, and far more intensive postoperative programs were helpful to achieve better weight loss effects than the typical post-LAGB care [49–50]. Thus, for the sake of successful LAGBs, a full long-term postoperative program cannot be overemphasized on enhancing weight loss, decreasing complications, and controlling failures. The present review is restrained by the following limitations. First, significant heterogeneity among the studies precluded meta-analysis. Second, only 2 RCTs hampered efforts to conclusively compare LAGB with other bariatric procedures on the risks of complications and reoperations. Third, lack of standardized definitions for some complications and inadequate reporting of less wellknown complications may have introduced reporting bias. Fourth, compared with the data of midterm follow-ups, the higher attrition rate of patients available for long-term follow-ups may have skewed the adverse events for LAGB. Finally, while 84.6% patients completed follow-up, the number of patients available at 10 years or more after LAGB was quite low [16–17] or unknown [19,22], which may have biased the results due to the statistical dilution effect. Conclusions The LAGB procedure was globally prevalent, but fell into disfavor with a dramatic decrease in recent years due to its relatively high complication rate and the frequent need for reoperations and explantations during the long-term

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follow-ups. Bariatric surgeons are divided on the place of LAGB in bariatric surgery, and the debate regarding LAGB has been ongoing. It can serve as an alternative procedure for motivated patients who want to benefit from the unique reversibility and a remarkably safe course under the circumstances of carefully informed risks for failure, which can be lessened with the support of an interdisciplinary team in a specialized high-volume bariatric surgery center.

[14]

[15]

[16] [17]

Disclosures The authors have no commercial associations that might be a conflict of interest in relation to this article.

[18]

Acknowledgments

[19]

The authors thank Professor Luoman Zhang, Ph.D., Second Military Medical University, Shanghai, China, for helpful consultations on the statistical methods.

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