Safety, efficacy and durability of laparoscopic adjustable gastric banding in a single surgeon, medium volume community practice

Title: Safety, efficacy and durability of laparoscopic adjustable gastric banding in a single surgeon, medium volume community practice
BODY:
Background: Volume requirements and standardization programs have greatly improved the safety and efficacy of Roux-en-y gastric bypass (RYGBP). Laparoscopic adjustable gastric banding (LAGB) is a less technically demanding operation. Results, however, remain variable with some large centers reporting high failure rates. LAGB has become increasingly popular in community practice which has raised concern in some circles. We report a single surgeon’s experience in a medium volume community practice.
Methods: From March 30, 2004 to August 31, 2008, a total of 321 patients underwent LAGB. (82% female; mean age 47, range 18-71; mean BMI 48 kg/m2, range 35-78). The maximum number of procedures performed in a 12 month period was 104. LAGB was the only bariatric procedure offered. Patients were seen every six weeks for the first year, every three months for the second year and twice yearly thereafter. Follow up information was available in 96% of patients (95%, 92% and 100% at >36 months, 24 months and 12 months post surgery respectively).
Results: The peri-operative mortality was 0%. Average excess weight loss was 32% at 6 months (SD=17), 42% at 12 months (SD=23), 47% at 18 months (SD=24), 54% at 24 months (SD=26), 55% at 36 months (SD 24) and 71% at 48 months. At > 36 months, 2 patients (4%) failed to lose at least 25% of their excess body weight. The explantation rate was 2.1%. Gastric prolapse occurred in 1.8% of patients and erosions occurred in 0.6 % of patients.
Conclusion: LAGB can be done safely in a community setting with acceptable weight loss and very low failure rates. Our results compare favorably with larger academic practices. LAGB is less technical than RYGBP but results depend heavily on meticulous long term follow up. Low attrition rates and close follow up may be more readily obtainable in a community practice which may partially explain this finding.

A retrospective analysis of a prospective data base was performed. Between March 30, 2004 and August 31, 2008, 321 adjustable laparoscopic gastric bands were placed. All bands were placed by a single surgeon in a community based practice using a standardized technique. Gastric banding was the only procedure offered. We did not employ an upper BMI limit.
 
Operative Technique.
All bands were placed via a laparoscope. Five ports were used: two for the assistant, two for the surgeon and one for the liver retractor. The upper abdomen was routinely assessed. Fat pads were resected if they were felt to lead to band tension. Hiatal hernias were repaired when encountered.
The left upper quadrant dissection was minimal. A pars flaccida technique was used routinely for the lesser curvature dissection. Inferior vena cava and caudate lobe were routinely identified and protected. Band size was chosen based on the appearance of the upper abdomen and the amount of perigastric fat.
The retro gastric dissection was done under direct vision using an angled laparoscope. Band fixation was routinely performed using permanent gastro-gastric sutures.
Ports were placed anterior to the rectus sheath as high as possible on the abdominal wall. The ports were routinely fixed to the rectus sheath using permanent sutures.
Post Operative Care
The patients were placed on clear liquids following surgery and then advanced to full liquids the day following surgery. Routine fluoroscopy was not used after the first 50 patients. Patients were released when they were able to tolerate liquids, able to ambulate and their pain was adequately controlled.
Follow up Care
Follow up was performed in the office. Adjustments were made based on weight loss, level of satiety and hunger. Fluoroscopy was only used for ports that were not palpable. Patients were seen two weeks post op and then every six weeks for the first year, every three months for the second year and twice yearly thereafter. Follow up was, however, tailored to patient needs. Results were reported from weights measured in the office on all patients who were actively being followed. Follow up by mail or telephone was obtained in patients not actively participating in follow up.
  
In response to the obesity epidemic, there has been a corresponding increase in the numbers of bariatric procedures performed. The two most commonly performed procedures are Roux-en-y gastric bypass (RYGBP) and laparoscopic adjustable gastric banding (LAGB). Banding has become increasingly popular and has experienced a rapid increase in use. (1) Results from banding have been wildly disparate. Results from Australia and several select US centers have been excellent. (2,3,4). This has not been universally reproducible. The results from the FDA “A Trial” were disappointing (5). More recently, reports from Europe have called into question the viability of banding as an option, citing high failure rates (6). We report a single surgeon’s experience with gastric banding in the United States with greater than three year follow up.

Follow- up
Follow up information was available for 96% of our patients. (>36 months post op 95%; 2 years 92%). 290 (91%) patients were actively participating in follow up. (Active participation was defined as being seen in the office within the past twelve months.)

Complications
The peri-operative mortality was 0%. Gastric prolapsed/ pouch dilation occurred in 6 (2.1%) patients, erosions occurred in 2 (0.6 %) patients. Port and tubing complications occurred in 8 (2.4%) patients. Five patients (1.5%) had subsequent hiatal hernia repairs.

Weight lost
Weight loss was reported in percentage of excess body weight loss (EWL).  At three months 243 patients had an average of 21% EWL (SD 12). At six months 199 patients had an average of 32% EWL (SD 3). At nine months 165 patients had an average of 37% EWL (SD 20). At twelve months 136 patients had an average of 42% EWL (SD 23). At eighteen months 110 patients had an average of 47% EWL (SD24). At twenty four months, 74 patients had an average of 54% EWL (SD 26). At thirty six months 49 patients had an average of 55% EWL (SD 24) and by forty eight months 6 patients had an average of 71% EWL (SD 28).

Weight loss compares favorably with “Vanguard” studies
Complication rates low
Failure rates low
Case volumes remained below SRC standards while follow up rates exceeded SRC standards, suggesting that close follow up may be more important than high volumes
Small community practices may be ideal for gastric banding
The best operation is the operation you do best.

1.Hinojosa MW et al. National trends in use and outcome of laparoscopic adjustable gastric banding. SOARD Vol. 5, (2) 150-155 Mar 2009

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.Ren CJ, Weiner M, Allen JW. Favorable early results of gastric banding for morbid obesity: The American experience. Surg Endosc 2004;18:543– 6.

4.Ponce J, Dixon J. Laparoscopic adjustable gastric banding. Surgery for Obesity and Related Diseases 1 2005: 310-316

5. DeMaria EJ, Sugerman HJ, et al . High failure rate after laparoscopic adjustable silicone gastric banding for treatment of morbid obesity. Ann Surg. 2001 Jun;233(6):809-18.

6.Suter, M. Calmes, J M. Paroz, A. Giusti, V. A 10-year experience with laparoscopic gastric banding for morbid obesity: high long-term
complication and failure rates. Obesity Surgery. 16(7):829-35, 2006 Jul.

7.Parikh MS, Fielding GA, Ren CJ . US experience with 749 laparoscopic adjustable gastic bands: intermediate outcomes. Surg Endosc 19: 1631-1635, 2005.

PRELIMINARY RESULTS FROM A BSCOE FREESTANDING SURGERY CENTER

TITLE: PRELIMINARY RESULTS FROM A BSCOE FREESTANDING SURGERY CENTER
ABSTRACT BODY:
Background: The Surgical Review Corporation (SRC) recently began to accreditate outpatient surgery centers as Centers of Excellence. Of the 382 BSCOE’s , currently only two have been accreditated as Freestanding Out Patient Surgery Centers. We report our preliminary data of procedures performed at one of these centers.

Methods: 89 primary bariatric procedures were performed between February 1, 2008 and October 23, 2009. All patients met SRC outpatient guidelines. Only the procedures performed at the outpatient center are reported.

Results: Demographics of our patients were as follows: 79% female; average age 44 years; average starting weight 264 pounds; average starting BMI 44 kg/m2. There were 22 self- paying patients (25%) and 67 privately insured patients (75%). (Neither Medicare nor Medicaid currently approve outpatient bariatric procedures.) Average operative time was 47 minutes and average length of stay was 3 hours. There were no mortalities. There were no DVT’s nor PE’s. There were 3 readmissions. (There was one intra-operative complication of a suture laceration on the proximal stomach which was recognized and repaired and two admissions for nausea and vomiting. All three resolved without further intervention). Weight loss was as follows: 3 months 19% EWL, (n=85 SD=10); 6 months 24% EWL, (n=68 SD=13); 9 months 29% EWL, (n=48 SD=17); 12 months 50% EWL, (n=39 SD=21); 18 months 53% EWL, (n=14 SD=28).

Conclusion: Results of patients undergoing surgery at a BSCOE Freestanding Outpatient Surgery Center demonstrate acceptable weight loss and a low risk of complications and re-admissions.

AUTHORS (FIRST NAME INITIAL LAST NAME): J. B. Ray1, S. Ray2
INSTITUTIONS (ALL): 1. Center for Advanced Laparopscopic and Bariatric Surgery, Bloomington, IN, USA.
2. Applied Health Science, Indiana University, Bloomington, IN, USA.

FOUR YEAR RESULTS OF PUBLIC FUNDED BARIATRIC SURGERY PATIENTS IN THE US

TITLE: FOUR YEAR RESULTS OF PUBLIC FUNDED BARIATRIC SURGERY PATIENTS IN THE US
ABSTRACT BODY:
Background: Despite the fact that public patients have coverage for bariatric surgery, access remains limited. There are reports that public patients have poorer outcomes. We report our findings of both public and private patients.

Methods: A total of 393 patients underwent LAGB between Mar 30, 2004 and October 23, 2009. Patients were divided into three groups: Public (Pub), Cash (C) and Private Insurance (Pvt). Demographics, follow up, and results are reported.

Results: There were 60 Public patients (16 Medicare, 46 Medicaid, 2 other public funding), 41 Cash patients and 282 Private Insurance patients. All groups were similar in regards to age (Pub:47y; C 48 y; Pvt 46 y p=.409) ) and gender (Pub 79% F; C 75% F; Pvt:77% F. ( p=.949)). Public Patients had a higher initial BMI compared to both other groups. (Pub: 54 kg/m2 vs. C 47 kg/m2 vs. Pvt 46 kg/m2; p<.001). Overall follow up was lower in the Public Group. (Pub. 78% vs. C 100% vs. Pvt 91%; p=.001). Excess weight loss was statistically similar in all groups ( 12 mo.: Pub 33% vs. C 42% vs. Pvt. 38%; 24 mo.: Pub 41% vs. C 50% vs. Pvt. 51%; 36 mo:Pub. 45% vs. C 61% vs. Pvt. 54%; 48 mo.: Pub. 51% vs. C N/A vs. Pvt . 64%) Weight loss failure (<25% EWL) at 24, 36 and 48 months were higher among Public patients, but not significantly different (24 mo.: Pub 26% vs. C 8% vs. Pvt. 15%, p=.210; 36 mo: Pub. 20% vs. C 11% vs Pvt 15%, p=.740: 48 mo. Pub. 12% vs. C N/A vs. Pvt 3%, p=.390). Explantation rates were also higher in Public patients (Pub. 9%; Cash 0%; Pvt Ins 0.6% (p<.001)). Mortality in all groups was 0%.

Conclusion: Publically funded patients lost a similar amount of weight compared to private and cash patients, despite a higher starting BMI. However, they had a lower rate of follow up and a higher explantation rate.

AUTHORS (FIRST NAME INITIAL LAST NAME): J. B. Ray1, S. Ray2
INSTITUTIONS (ALL): 1. Center for Advanced Laparopscopic and Bariatric Surgery, Bloomington, IN, USA.
2. Applied Health Science, Indiana University, Bloomington, IN, USA.
PRESENTATION TYPE: Plenary
CATEGORY: GASTRIC BANDING (all work that primarily involves gastric banding or comparison studies that involve gastric banding)
AWARDS:
(No Table Selected)
TABLE FOOTER: (No Tables)

Safety, efficacy and durability of laparoscopic adjustable gastric banding in a single surgeon, medium volume community practice

TITLE: Safety, efficacy and durability of laparoscopic adjustable gastric banding in a single surgeon, medium volume community practice
BODY:
Background: Volume requirements and standardization programs have greatly improved the safety and efficacy of Roux-en-y gastric bypass (RYGBP). Laparoscopic adjustable gastric banding (LAGB) is a less technically demanding operation. Results, however, remain variable with some large centers reporting high failure rates. LAGB has become increasingly popular in community practice which has raised concern in some circles. We report a single surgeon’s experience in a medium volume community practice.
Methods: From March 30, 2004 to August 31, 2008, a total of 321 patients underwent LAGB. (82% female; mean age 47, range 18-71; mean BMI 48 kg/m2, range 35-78). The maximum number of procedures performed in a 12 month period was 104. LAGB was the only bariatric procedure offered. Patients were seen every six weeks for the first year, every three months for the second year and twice yearly thereafter. Follow up information was available in 96% of patients (95%, 92% and 100% at >36 months, 24 months and 12 months post surgery respectively).
Results: The peril-operative mortality was 0%. Average excess weight loss was 32% at 6 months (SD=17), 42% at 12 months (SD=23), 47% at 18 months (SD=24), 54% at 24 months (SD=26), 55% at 36 months (SD 24) and 71% at 48 months. At > 36 months, 2 patients (4%) failed to lose at least 25% of their excess body weight. The explanation rate was 2.1%. Gastric prolapsed occurred in 1.8% of patients and erosions occurred in 0.6 % of patients.
Conclusion: LAGB can be done safely in a community setting with acceptable weight loss and very low failure rates. Our results compare favorably with larger academic practices. LAGB is less technical than RYGBP but results depend heavily on meticulous long term follow up. Low attrition rates and close follow up may be more readily obtainable in a community practice which may partially explain this finding.

FIVE YEAR FOLLOW UP AFTER LAGB IN PATIENTS IN THE SUPER OBESE POPULATION

TITLE: FIVE YEAR FOLLOW UP AFTER LAGB IN PATIENTS IN THE SUPER OBESE POPULATION
ABSTRACT BODY:
Background: While LAGB has been gaining in popularity, controversy remains over it’s efficacy. This is particularly true in the super obese. Some authors have advocated that LAGB should not be offered to patients with higher BMI’s. We offer lap banding to all patients regardless of their starting BMI and report our findings.

Methods: Between March 30, 2004 and October 23, 2009 information was gathered on 383 consecutive lap bands. The groups were divided into a Super Obese Group (SO) (BMI >50) and a Standard Group (SG) (BMI of 35-49). Five year data is reported.

Results: The Super Obese group had 126 patients (ave. weight 343; ave. BMI 56 kg/m2; BMI range 50-78.5) The Standard Group had 257 patients (Ave wt. 264; ave. BMI 43 kg/m2 ; BMI range 35-49 kg/m2). There was no difference in age (SO:47 y vs. SG 46 y ; p=.6370) The Super Obese group had a higher percentage of male patients ( SO 33% vs. SG 18% p<.001) Follow up was 89% in the SO and 93% % in the SG. In terms of weight loss, both groups reached a goal of 50% excess weight loss (EWL) but the Super Obese group took longer to attain this. (12 months: SO: 29% (n=97) , SG 42% (n=182) p<.005; 18 months: SO 33% (n=82); SG 48% (n=147) p<.005; 24 months: SO 37% (n=62) SG 55% (n=104); 36 months, SO 44% (n=48), SG 56% (n=75) p =.008; 48 months SO 49% (n=25) SG 64% (n=34) p=.394; 60 months, 51% (n=14) SG 68% (n=12) p= .024. Explantation rate was lower in the Super Obese (SO 0.8% vs. SG 3.4%; p=.176). There were no mortalities in either group.

Conclusion: LAGB demonstrated acceptable and durable weight loss in both the Super Obese as well as well as the Standard group, although it took longer for the Super Obese to achieve the goal weight loss.There was no increase in complications. LAGB should be offered as an alternative the Super Obese but long term commitment must be emphasized.

AUTHORS (FIRST NAME INITIAL LAST NAME): J. B. Ray1, S. Ray2
INSTITUTIONS (ALL): 1. Center for Advanced Laparopscopic and Bariatric Surgery, Bloomington, IN, USA.
2. Appled Health Science, Indiana University, Bloomington, IN, USA.
PRESENTATION TYPE: Plenary
CATEGORY: GASTRIC BANDING (all work that primarily involves gastric banding or comparison studies that involve gastric banding)
AWARDS:
(No Table Selected)
TABLE FOOTER: (No Tables)