Surgery for Obesity and Related Diseases ] (2013) 00–00

Original article

Adjustable gastric banding: a comparison of models Subhashini M. Ayloo, M.D., F.A.C.S.*, Eduardo Fernandes, M.D., Mario A. Masrur, M.D., Pier C. Giulianotti, M.D., F.A.C.S. Division of General, Minimally Invasive and Robotic Surgery, Department of Surgery, University of Illinois at Chicago, Chicago, Illinois Received December 20, 2012; accepted May 6, 2013

Abstract

Background: There are several models of adjustable gastric banding in use with little evidence for choosing a particular model. The objective of this study was to evaluate factors for selecting a particular type of band in terms of weight loss, complications, and co-morbidities. Methods: From July 2006 to May 2012, 222 patients underwent laparoscopic adjustable gastric banding (LAGB) by a single surgeon. Patient demographic characteristics, weight loss, body mass index (BMI), percentage of weight loss (%EWL), complications, and co-morbidities were retrospectively reviewed. Patients were grouped according to the band model into 6 categories: 27 LAPBAND Adjustable Gastric Banding System VG, 25 Allergan-LAGB, 20 LAP-BAND APM Standard, 18 LAP-BAND APM Large, 34 Realize Band, and 98 Realize-C band. Results: At 60 months follow up, in the LAP-BAND VG Group, the mean %EWL was 41%, percentage of co-morbidity improvement was 66%, and percentage of complications was 14.3%; the same percentages in the Allergan-LAGB Group were 41%, 0%, and 52%, respectively; in the LAPBAND AP Standard Group were 42%, 20%, and 40%, respectively; in the LAP-BAND AP Large group were 38% , 12.5%, and 27.8%, respectively (at 48 months); in the Realize Band Group were 37%, 60%, and 0%, respectively (at 48 months); and in the Realize-C Band Group were 48%,12.5%, and 12.2%, respectively (at 36 months). Conclusions: In terms of weight loss and co-morbidities, no differences were found supporting the choice of one model over the others. Short-term and long-term band-related complications occurred without any clear predilection. The port-related complications were significantly lower in the Realize bands. (Surg Obes Relat Dis 2013;]:00-00.) r 2013 American Society for Metabolic and Bariatric Surgery. All rights reserved.

Keywords:

Bariatric surgery; Gastric bands models; Adjustable gastric banding

More than 200,000 bariatric procedures are performed each year in the United States, according to the American Society for Metabolic and Bariatric Surgery. One of the most popular bariatric procedures is laparoscopic adjustable gastric banding (LAGB), due in large part to its technical simplicity, reversibility, and safety profile. It also lends itself well for placement in an outpatient setting, resulting in successful weight loss and improvement in co-morbidities [1–6]. *

Correspondence: Subhashini Ayloo, M.D., Division of General, Minimally Invasive and Robotic Surgery, University of Illinois at Chicago, 840 S. Wood Street, M/C 958, Suite 435 E, Chicago, 60612 IL. E-mail: [email protected]

Since Food and Drug Administration approval in 2001, several band models have been manufactured. Some have evolved as an improvement from previous prototypes, while others have been developed to accommodate a variety of sizes. There is little data available, however, for guiding the surgeon in the selection of a particular band model. In fact, few studies have been published comparing the different bands available [7–11]. In this study, the longterm experience of a single surgeon at a single institution in the use of various band models is presented. The results in terms of weight loss (WL), percentage of excess weight loss (%EWL), co-morbidities, and complications were compared.

1550-7289/13/$ – see front matter r 2013 American Society for Metabolic and Bariatric Surgery. All rights reserved. http://dx.doi.org/10.1016/j.soard.2013.09.003

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S. M. Ayloo et al. / Surgery for Obesity and Related Diseases ] (2013) 00–00

Methods

Statistical analysis

From July 2006 to May 2012, a total of 222 patients were retrospectively followed up after undergoing a LAGB procedure. All procedures were performed by a single surgeon at an academic institution. The patients selected for this approach met the National Institute of Health Consensus criteria and the institutional policies for bariatric procedures. The study included all patients who underwent a LAGB procedure. No patients were excluded from the study. Data on patient demographic characteristics, operative variables, and postoperative complications and outcomes were collected prospectively in a bariatric database and reviewed retrospectively. Co-morbidity improvement (in type II diabetes, hypertension, hypercholesterolemia, and asthma) was defined as resolution or any improvement in symptoms and/or reduction in dosages of medications and reported as a percentage of patients. Patients were divided for analysis into 6 different groups, according to band model and size used in the procedure. Of the 222 patients in this series, 90 received bands that were manufactured by Allergan Inc. (Irvine, CA). Of these, 27 (12.2%) received the LAP-BAND Adjustable Gastric Banding System VG (Allergan VG), 25 (11.3%) received the LAP-BAND Adjustable Gastric Banding System LAGB (Allergan-LAGB), 20 patients (9%) received the LAP-BAND AP Standard, and 18 (8.1%) received the LAP-BAND AP Large. The remaining 132 patients received bands from Ethicon Endo-Surgery Inc. (Cincinnati, OH). Of these, 34 (15.3%) patients received the Realize Band, and 98 (44.1%) patients received the Realize-C band. The determination as to which gastric band to use was made as the bands became available in the market.

Statistical analysis using the χ2 test was performed using IBM SPSS Statistics software (Chicago, IL), and results are shown in Table 1. Statistical analysis performed as one-way ANOVA is shown in Tables 2B, 3, and 4. Surgical technique The surgical technique was the same for all patients, independent of the band model selected. Patients were placed in the semi-lithotomy position under general anesthesia. Pneumoperitoneum was induced using a Veress needle placed subcostal in the left upper quadrant. A 5mm trocar (camera port) was placed to the left side of the midline supraumbilical position under direct vision, with an Endopath Xcel with Optiview Technology (Ethicon EndoSurgery Inc, Cincinnati, OH). A 15-mm trocar and 5-mm trocar were placed on either side of the camera port for the surgeon’s right and left hand. The 15-mm trocar was used to bring in the sutures, the band, and later, to exteriorize the tubing. A 5-mm trocar was placed on the left lateral abdomen for the first assistant. A 5-mm incision was made in the subxiphoid area for the Nathanson retractor (Mediflex, Islandia, NY) to retract the left lobe of the liver anteriorly. All gastric bands were placed via the pars flaccida technique. When reviewing the technical steps of the Allergan band procedure versus the Realize band procedure, the primary differences involved the number of gastrogastric plication sutures that were placed and the port fixation. In procedures involving the Realize bands, 2 sutures of 2/0 Ethibond (Ethicon, Somerville, NJ) were used. Procedures involving the Allergan bands required 3 sutures, along with an additional gastrogastric suture placed below the band to keep it in position. Additionally, in procedures involving the Realize band, the port was fixated using a port applicator, while the

Table 1 Early and late, major and minor complications with different band models Complications Major Complications Slippage Erosion Early PO obstruction Band Leak Replacement or Explantation secondary to intractable stoma tightness Band Removal Minor Complications Port Flipped Port Infection Port/tube disconnection or break

Allergan-VG (27 patients)

Allergan-LAGB (25 patients)

AP-APS (20 patients)

AP-APL (18 patients)

Realize (34 patients)

Realize C (98 patients)

P value 4.05

2

1 1 1

1

1 1

1

5

1

4

1

1 3

2 2

2

4

1

1 1 1

4.05 o.05

Allergan-LAGB ¼ LAP-BAND Adjustable Gastric Banding System LAGB; Allergan-VG ¼ LAP-BAND Adjustable Gastric Banding System VG; AP-APL ¼ LAP-BAND AP large; AP-APS ¼ LAP-BAND AP standard; LAGB ¼ laparoscopic adjustable gastric banding; PO ¼ postoperative; Realize ¼ Realize Band; Realize-C ¼ Realize-C band.

Comparison of Gastric Bands Models / Surgery for Obesity and Related Diseases ] (2013) 00–00

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Table 2A Gastric band models and BMI-weight in pounds over time*

Basal Wt Basal BMI 3 mo Wt 3 mo BMI 6 mo Wt 6 mo BMI 1 yr Wt 1 yr BMI 2 yr wt 2 yr BMI 3 yr wt 3 yr BMI 4 yr wt 4 yr BMI 5 yr wt 5 yr BMI

Allergan VG (N ¼ 27)

Allergan LAGB (N ¼ 25)

APS (N ¼ 20)

APL (N ¼ 18)

Realize (N ¼ 34)

Realize-C (N ¼ 98)

293 ⫾ 51 (27) 47 ⫾ 7 (27) 259 ⫾ 43 (24) 41 ⫾ 6 (24) 252 ⫾ 49 (21) 40 ⫾ 6 (21) 239 ⫾ 55 (18) 37 ⫾ 6 (18) 239 ⫾ 55 (20) 39 ⫾ 8 (20) 220 ⫾ 64 (15) 36 ⫾ 8 (15) 218 ⫾ 29 (11) 35 ⫾ 5 (11) 219 ⫾ 30 (7) 35 ⫾ 4 (7)

258 ⫾ 83 (25) 46 ⫾ 6 (25) 253 ⫾ 44 (21) 41 ⫾ 7 (21) 234 ⫾ 35 (20) 39 ⫾ 5 (20) 242 ⫾ 50 (15) 39 ⫾ 6 (15) 227 ⫾ 48 (14) 36 ⫾ 6 (14) 226 ⫾ 47 (10) 36 ⫾ 5 (10) 241 ⫾ 44 (8) 39 ⫾ 6 (8) 200 ⫾ 42 (2) 38 ⫾ 6 (2)

255 ⫾ 40 (20) 45 ⫾ 5 (20) 240 ⫾ 44 (16) 41 ⫾ 6 (16) 224 ⫾ 39 (11) 39 ⫾ 5 (11) 207 ⫾ 40 (13) 35 ⫾ 6 (13) 207 ⫾ 32 (13) 35 ⫾ 6 (13) 209 ⫾ 30 (14) 37 ⫾ 4 (14) 218 ⫾ 28 (5) 36 ⫾ 4 (5) 202 (1) 32 (1)

323 ⫾ 66 (18) 52 ⫾ 7 (18) 317 ⫾ 65 (13) 51 ⫾ 8 (13) 298 ⫾ 64 (11) 49 ⫾ 9 (11) 268 ⫾ 55 (10) 44 ⫾ 6 (10) 273 ⫾ 67 (12) 45 ⫾ 10 (12) 236 ⫾ 82 (11) 44 ⫾ 10 (11) 232 ⫾ 47 (8) 39 ⫾ 8 (8) – –

288 ⫾ 42 (34) 48 ⫾ 6 (34) 264 ⫾ 43 (26) 43 ⫾ 6 (26) 254 ⫾ 34 (24) 43 ⫾ 6 (24) 245 ⫾ 37 (26) 40 ⫾ 6 (26) 240 ⫾ 35 (18) 40 ⫾ 5 (18) 239 ⫾ 37 (15) 39 ⫾ 6 (15) 237 ⫾ 29 (5) 41 ⫾ 4 (5) – –

285 ⫾ 59 (98) 47 ⫾ 9 (98) 233 ⫾ 99 (71) 44 ⫾ 8 (71) 238 ⫾ 87 (48) 44 ⫾ 7 (48) 247 ⫾ 58 (37) 41 ⫾ 8 (37) 247 ⫾ 67 (40) 41 ⫾ 10 (40) 230 ⫾ 76 (8) 37 ⫾ 12 (8) – – – –

Allergan-LAGB ¼ LAP-BAND Adjustable Gastric Banding System LAGB; Allergan-VG ¼ LAP-BAND Adjustable Gastric Banding System VG; AP-APL ¼ LAP-BAND AP large; AP-APS ¼ LAP-BAND AP standard; BMI ¼ body mass index; LAGB ¼ laparoscopic adjustable gastric banding; Realize ¼ Realize Band; Realize-C ¼ Realize-C band; Wt ¼ weight. * Values expressed in pounds or kg/m2 ⫾ standard deviation (number of patients seen at different time-point follow-up).

(range: 84–225 kg). The mean blood loss was 8.9 ⫾ 7.4 mL, and the median length of stay was .4 days (range: .1–5). Of the 222 patients, 177 patients (79.7%) had procedures performed on an outpatient basis, and 25 patients (11.3%) underwent a LESS procedure. The mean operative time was 77.9 ⫾ 33.7 minutes (range: 25– 263 min). Throughout the series, 33 patients (14.9%) underwent additional associated procedures, including lysis of adhesions, hiatal hernia repairs, ventral hernia repair, and soft tissue mass excision. There were no mortalities in this study. The overall percentage of complications in the entire series was 16.7%. There were 12 (5.4%) patients who required gastric band removal, and 14 patients (6.3%) who required port revision for various reasons (Table 1). The subsequent postoperative course was uneventful for all

lap-band port was fixated using 4 2/0 Ethibond sutures secured to the abdominal fascia. In patients whose procedures were performed as a laparoendoscopic single-site surgery (LESS), the gastric band was placed using a pars flaccida technique, as described previously [12]. Results During the study period, 222 patients underwent a LAGB procedure at a single institution. There were 198 women (89.2%) and 24 men (10.8 %), with a median age of 44 years (range: 18–68). The overall mean preoperative body mass index (BMI) was 48 ⫾ 7.6 kg/m2 (range: 34–79 kg/ m2), and the mean preoperative weight was 131 ⫾ 24.9 kg Table 2B Mean weight loss and %EWL for different gastric band models over time*

1 1 2 2 3 3 4 4 5 5

yr yr yr yr yr yr yr yr yr yr

WL %EWL WL %EWL WL %EWL WL %EWL WL %EWL

Allergan VG (N ¼ 27)

Allergan LAGB (N ¼ 25)

APS (N ¼ 20)

APL (N ¼ 18)

Realize (N ¼ 34)

Realize-C (N ¼ 98)

50.5 34% 56.8 40% 64.3 44% 46 38% 53 41%

42.7 37% 52.9 41% 53.5 41% 50.1 42% 51.1 41%

48.4 39% 53 44% 50.5 40% 46 38% 50.5 42%

34.9 32% 46.8 37% 61.7 51% 44.3 38% – –

40.6 35% 45.4 37% 41.6 36% 49.2 37% – –

42.4 34% 41.7 36% 58.5 48%

(18) (18) (20) (20) (15) (15) (11) (11) (7) (7)

(15) (15) (14) (14) (10) (10) (8) (8) (2) (2)

(13) (13) (13) (13) (14) (14) (5) (5) (1) (1)

(10) (10) (12) (12) (11) (11) (8) (8)

(26) (26) (18) (18) (15) (15) (5) (5)

– – –

(37) (37) (40) (40) (8) (8)

P value 4.05 4.05 4.05 4.05 4.05

Allergan-LAGB ¼ LAP-BAND Adjustable Gastric Banding System LAGB; Allergan-VG ¼ LAP-BAND Adjustable Gastric Banding System VG; AP-APL ¼ LAP-BAND AP large; AP-APS ¼ LAP-BAND AP standard; LAGB ¼ laparoscopic adjustable gastric banding; Realize ¼ Realize Band; Realize-C ¼ Realize-C band; WL ¼ weight loss; %EWL ¼ percentage of excess weight loss. * Values expressed in pounds or percentage (number of patients seen at different time-point follow-up).

S. M. Ayloo et al. / Surgery for Obesity and Related Diseases ] (2013) 00–00

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Table 3 Percentage of patients with any co-morbidity improvement* Band Models

Time follow-up

Allergan-VG Allergan-LAGB APS APL Realize Realize-C P value

3m

6m

12 m

24 m

36 m

48 m

60 m

8.4 (24) 0 (21) 25 (16) 0 (13) 0 (26) 5.6 (71) 4 .05

9.5 (21) 0 (20) 18.2 (11) 0 (11) 0 (24) 8.3 (48) 4 .05

11.1 (18) 0 (15) 15.4 (13) 10 (10) 11.5 (26) 10.8 (37) 4 .05

15 (20) 0 (14) 30.7 (13) 8.3 (12) 44.4 (18) 7.5 (40) 4 .05

13.3 (15) 0 (10) 35.7 (14) 9.1 (11) 40 (15) 12.5 (8) 4 .05

18.1 (11) 0 (8) 40 (5) 12.5 (8) 60 (5) – 4 .05

14.3 (7) 0 (2) 0 (1) – – – 4 .05

Allergan-LAGB ¼ LAP-BAND Adjustable Gastric Banding System LAGB; Allergan-VG ¼ LAP-BAND Adjustable Gastric Banding System VG; AP-APL ¼ LAP-BAND AP large; AP-APS ¼ LAP-BAND AP standard; LAGB ¼ laparoscopic adjustable gastric banding; Realize ¼ Realize Band; Realize-C ¼ Realize-C band. * Values expressed in percentage of patient with any co-morbidity improvement of the total number of patients seen in each time-point (number of patients seen at different time-point follow-up). There was no statistical significance between the groups.

patients. One patient was readmitted for postprandial pain and observed for 24 hours with no surgical intervention required. Two patients presented with a wound infection. One was treated by oral antibiotic with cotton swab probing of the wound in an outpatient clinic, and the second patient required port removal and internalization of the tubing. Both patients were LESS cases. At 60 months follow up, the mean weight for the entire series was 104.3 kg with a mean weight loss of 24.8 kg (54.8 lbs). The mean BMI was 37 kg/m2 for the entire series. The interval weight, BMI, WL, and %EWL for each band model is shown in Table 2A and B. Also at 60 months, the mean percentage of co-morbidity improvement was 31.7% in the whole series. The trend in the percentage of co-morbidity improvements at varying follow-up times is represented in Table 3. LAP-BAND Adjustable Gastric Banding System VG group (Allergan VG) In the group of patients who received the Allergan VG bands, there were 20 women (74.1%) and 7 men (25.9%) with a median age of 41 years (range: 18–61 yr). The mean preoperative BMI was 47 ⫾ 7 kg/m2 (range: 35–64 kg/m2), and the mean preoperative weight was 129 ⫾ 23 kg (range: 92–190 kg). The mean blood loss was 8 ⫾ 7 mL, and the Table 4 OR time comparison among the 3 bands available in the market (P ¼ .3) Band Models

OR Time Average

Minimum

Maximum

Standard deviation

Median

APS APL Realize C

66.1 81.4 81

35 60 25

118 115 164

28.5 12.0 26

68 81 79

There was no statistical significance between the groups. AP-APL ¼ LAP-BAND AP large; AP-APS ¼ LAP-BAND AP standard; OR ¼ operative room; Realize-C ¼ Realize-C band.

median length of stay was .5 days (range: .2–5.8). The mean operative time was 64 ⫾ 26 minutes (range: 30–155 min). The mean WL and %EWL at different time follow-up is shown in Table 2B. At 60 months, the percentage of co-morbidity improvement was 66% and the percentage of complications was 14.3%. There were 3 complications registered in this group, including 1 patient with intractable stoma tightness requiring band removal, 1 patient with a flipped port, and 1 patient with tubing breakage at the level of the port. The latter 2 cases required port system revision. The mean number of adjustments was 3.5 during the study period. LAP-BAND Adjustable Gastric Banding System LAGB group (Allergan-LAGB) In the group of patients who received the Allergan-LAGB bands, there were 23 women (92%) and 2 men (8%), with a median age of 41 years (range: 27–58 yr). The mean preoperative BMI was 46 ⫾ 6 kg/m2 (range: 38–58 kg/m2), and the mean preoperative weight was 127 ⫾ 20 kg (range: 92– 172 kg). The mean blood loss was 9 ⫾ 10 mL, and the median length of stay was .4 days (range: .2–5.7). The mean operative time was 75 ⫾ 36 minutes (range: 40– 180 min). There were 3 patients with associated procedures, all hiatal hernia repairs. The mean WL and %EWL are presented in Table 2B. At 60 months follow up, no co-morbidity improvement was registered, and the overall percentage of complications was 52% (Table 1). Complications included 2 patients with band slippage postoperatively at 18 and 48 months, and another patient with band breakage at 5 months postoperative. All 3 patients underwent gastric band explantation with no further weight loss procedures. A fourth patient presented with band obstruction, and another presented with failure to reach good weight loss. Both patients underwent band removal and conversion to sleeve gastrectomy. Finally, 4 patients had ports that flipped and required a revisional procedure. The mean number of adjustments in this group was 5.5 during the study period.

Comparison of Gastric Bands Models / Surgery for Obesity and Related Diseases ] (2013) 00–00

LAP-BAND AP Standard group In the group of patients who received the Lap-Band AP Standard bands, all 20 were women, with a median age of 41 years (range: 25–61 yr). The mean preoperative BMI was 45 ⫾ 5 kg/m2 (range: 39–53 kg/m2), and the mean preoperative weight was 118 ⫾ 18 kg (range: 92–155 kg). The mean blood loss was 6 ⫾ 3 mL, and the median length of stay was .3 days (range: .2–0.7 d). The mean operative time was 66 ⫾ 28 minutes (range: 35–118 min). There were 4 patients with associated procedures, including 1 patient with extensive adhesiolysis from previous procedures, and 3 patients with hiatal hernia repairs. The mean WL and % EWL trend is presented in Table 2B. The percentage of complications was 20%, and there was no co-morbidity improvement registered at 60 months follow up (Table 3). The mean number of adjustments was 2 during the study period. There were 2 port flipped and 2 tube breakage at the port site requiring revision (Table 1). LAP-BAND AP Large group In the group that received the AP-Large bands, there were 14 women (77.8%) and 4 (22.2%) men with a median age of 45 years (range: 26–64 years). The mean preoperative BMI was 52 ⫾ 7 kg/m2 (range: 40–67 kg/m2), and the mean preoperative weight was 149 ⫾ 30 kg (range: 95–225 kg). The mean blood loss was 9 ⫾ 9 mL, and the median length of stay was .6 days (range: .1–5.7 d). The mean operative time was 81 ⫾ 12 minutes (range: 60– 115 min). There were 2 patients with associated procedures, both with extensive adhesiolysis. WL and %EWL trend is analyzed in Table 2B. The percentage of co-morbidity improvement was 12.5%, and the percentage of complications was 27.8%. The mean number of adjustments was 8. One patient presented with band erosion at 4 years follow-up, requiring band removal and conversion to sleeve gastrectomy at a later time; another patient presented early postoperative obstruction that also required band removal a few days after procedure. Realize Band group In the group that received the Realize Bands, there were 32 women and 2 men with a median age of 44 years (range: 25–62 yr). The mean preoperative BMI was 48 ⫾ 6 kg/m2 (range: 39–60 kg/m2), and the mean preoperative weight was 133 ⫾ 22 kg (range: 90–179 kg). The mean blood loss was 11 ⫾ 10 mL, and the median length of stay was .3 days (range: .1–5.7 d). The mean operative time was 78 ⫾ 28 minutes (range: 25– 180 min). There was 1 patient with associated hiatal hernia repair. The WL and %EWL was detailed in Table 2B. The percentage of co-morbidity improvement was 60% (Table 3). There were no complications in this group. The

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mean number of adjustments was 3.4 during the study period. Realize-C Gastric Bands group In the group that received the Realize-C bands, there were 89 women and 9 men with a median age of 44 years (range: 18–68 yr). The mean preoperative BMI was 47 ⫾ 9 kg/m2 (range: 34–79 kg/m2), and the mean preoperative weight was 131 ⫾ 29 kg (range: 84–221 kg). WL and %EWL is presented in Table 2. The mean blood loss was 10 ⫾ 5 mL, and the median length of stay was .7 days (range: .1–3 d). The mean operative time was 81 ⫾ 26 minutes (range: 25–164 min). There were 16 patients with associated procedures, including 5 patients with hiatal hernia repairs and 11 patients with extensive adhesiolysis. There were also 25 LESS procedures in this group. In the standard laparoscopic approach in this group, 2 patients required conversion to open approach as a result of extensive adhesions. WL and % EWL is presented in Table 2B. At 36 months follow up, the percentage of co-morbidity improvement was 12.5% (Table 3), and the percentage of complications was 12.2% (Table 1). The mean number of adjustments was 2 during the study period. With regard to complications registered in this group, 1 patient in the LESS group presented with early stoma obstruction, requiring immediate explantation of the Realize-C band and placement of a LAP-BAND AP Large in traditional multiport laparoscopic approach. Three patients presented at various follow-up periods with abdominal pain and an inability to tolerate per oral. All 3 patients required band removal. One patient had band slippage that was repositioned followed by a good postoperative course. Three patients presented with port site complications, including 1 flipped port, 1 tubing breakage, and the third with a wound infection requiring surgical wound drainage, removal of the port, and internalization of the tube. Regarding port complications, the Lap-Band (VG, LAGB, APS, and APL), which had suture fixation to the fascia in comparison with the Realize bands (Realize and Realize-C) with port fixator, were grouped into 2 different groups. The Lap-Band group presented 11 port related complications (11 of 90 patients) compared with 3 complications in the Realize group (3 of 132 patients), which was statistically significant (P o .05) (Table 1). Regarding band-related complications, the Lap-Band group had 7 patients (7 of 90), and the Realize group had 5 patients (5 of 132) with complications, which was not statistically significant (P 4 .05) (Table 1). Discussion In 2001, the first adjustable gastric band, called the LAP-BAND Adjustable Gastric Banding (LAGB) System

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S. M. Ayloo et al. / Surgery for Obesity and Related Diseases ] (2013) 00–00

(BioEnterics, Carpinteria, CA), was approved in the United States by the Food and Drug Administration. Since that time, the Lap-Band has evolved into its third generation system, the AP system, following the LAGB and VG systems. The primary difference is that the VG system has a larger size band. The AP system provides a precurved 360 degree Omniform technology to ensure even distribution of the intraballoon pressure. The AP system is the most updated and has 2 models, the AP-Standard and the AP-Large, with fill volumes of 10 cc and 14 cc, respectively. This system is approved for patients with a BMI Z30 kg/m2. In 2007, the Realize band was introduced in the United States as a prototype of the Swedish Adjustable Gastric Band (Obtech Medical, Switzerland). It soon evolved into the Realize band-C, a preshaped band with a larger diameter. This band is a low-pressure adjustable gastric band with a fill volume of 11 cc and has a low profile subcutaneous port system. This system is approved for patients with a BMI Z35. In 2011, Ponce et al. [7] published a comparative study among the Lap-Band AP, Realize Band, and Realize BandC, to examine weight loss, fill volume, and complications of each. They found the Lap-Band AP resulted in a much better weight loss and lower fill volumes, while the Realize BandC resulted in less weight loss with a higher fill volume, causing them to revert back to the Lap-Band AP. Also in 2011, Gravante et al. [9] published a prospective randomized study of their experience with weight loss and complications in the use of 2 different models of the Lap-Band, comparing them with the Swedish adjustable gastric band. They found no significant difference between the devices. Before these studies, in 2005, Suter et al. [13] published the results of a prospective randomized study comparing the Swedish Adjustable Gastric Band and Lap-Band. The study noted similar weight loss, although it was slightly faster in the Lap-Band group. They also found similar improvement in co-morbidities, long-term complications, and quality of life. In the present study, the operative times of the 3 main gastric bands currently available in the United States (LAPBAND AP Standard, LAP-BAND AP Large band, and Realize-C bands) were compared. The operative times were similar (P ¼ .3) (Table 4). With regard to the mean WL and %EWL among the 3 available gastric bands, in general, a plateau was reached in all the groups at 1-year follow up, as shown in Table 2B. In terms of reported complications, no major conclusions can be drawn among the different gastric band models. In fact, complications occurred without any clear predilection for any particular band model. When the 4 models of LapBand (VG, LAGB, APS, and APS), which had a different port fixation compared with the Realize bands (Realize and Realize-C), were grouped, the Lap-Band group showed a higher port-related complication (11 of 90 patients) compared with the Realize group (3 of 132 patients) with a

statistical significance (Table 1). But this difference was not found for band-related complications, for which the Lap-Band group (7 of 90) and the Realize group (5 of 132) had similar results (P o .05) (Table 1). As far as co-morbidity improvements among the various band groups, the Realize gastric band group registered the greatest cumulative percent co-morbidity improvement compared with the other groups (Table 3). The authors recognize that this study is limited with regard to correlation of weight loss and improvement in co-morbidity. The 2 outcome variables do not necessarily involve the same group of patients. Conclusions No correlation was found among the different type of band models, patient weight loss, and improvement of comorbidities. In fact, when comparing patient weight loss and co-morbidities as indicators, it was not possible to choose one band model over another to be more successful. All were found to be equal. The only proven difference that was noted was on port complications, where the Realize bands showed less predilection to port-related complications compared with the other models. Disclosures The authors have no commercial associations that might be a conflict of interest in relation to this article. References [1] Favretti F, Ashton D, Busetto L, Segato G, De Luca M. The gastric band: first-choice procedure for obesity surgery. World J Surg 2009;33:2039–48. [2] 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. [3] Tolonen P, Victorzon M, Makela J. Impact of laparoscopic adjustable gastric banding for morbid obesity on disease-specific and healthrelated quality of life. Obes Surg 2004;14:788–95. [4] Lee WJ, Wang W, Huang MT. Laparoscopic adjustable silicone gastric banding versus vertical banded gastroplasty in morbidly obese patients. Ann Surg 2004;240:391–2; author reply 393. [5] Salem L, Devlin A, Sullivan SD, Flum DR. Cost-effectiveness analysis of laparoscopic gastric bypass, adjustable gastric banding, and nonoperative weight loss interventions. Surg Obes Relat Dis 2008;4:26–32. [6] Himpens J, Cadiere GB, Bazi M, Vouche M, Cadiere B, Dapri G. Long-term outcomes of laparoscopic adjustable gastric banding. Arch Surg 2011;146:802–7. [7] Ponce J, Lindsey B, Pritchett S, Bleech M, Marlowe K. New adjustable gastric bands available in the United States: a comparative study. Surg Obes Relat Dis 2011;7:74–9. [8] Fried M, Miller K, Kormanova K. Literature review of comparative studies of complications with Swedish band and Lap-Band. Obes Surg 2004;14:256–60. [9] Gravante G, Araco A, Araco F, Delogu D, De Lorenzo A, Cervelli V. Laparoscopic adjustable gastric bandings: a prospective randomized study of 400 operations performed with 2 different devices. Arch Surg 2007;142:958–61.

Comparison of Gastric Bands Models / Surgery for Obesity and Related Diseases ] (2013) 00–00 [10] Ponson AE, Janssen IM, Klinkenbijl JH. Laparoscopic adjustable gastric banding: a prospective comparison of two commonly used bands. Obes Surg 2002;12:579–82. [11] Collet D, Rault A, Sa Cunha A, Larroude D, Masson B. Laparoscopic adjustable gastric banding results after 2 years with two different band types. Obes Surg 2005;15:853–7.

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[12] Ayloo SM, Buchs NC, Addeo P, Giulianotti PC. Laparoendoscopic single-site adjustable gastric banding: technical considerations. Surg Laparosc Endosc Percutan Tech 2011;21:e295–300. [13] Suter M, Giusti V, Worreth M, Heraief E, Calmes JM. Laparoscopic gastric banding: a prospective, randomized study comparing the Lapband and the SAGB: early results. Ann Surg 2005;241:55–62.

Adjustable gastric banding: a comparison of models.

There are several models of adjustable gastric banding in use with little evidence for choosing a particular model. The objective of this study was to...
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