Adjustable Gastric Band Surgery: Review of Current Practice Dr. Chris Cobourn The Surgical Weight Loss Centre Mississauga, Ontario Canada March 31, 2012
Disclosures Allergan Canada Unrestricted Research Grant Speaker Support Life Cell Consultant 2
Our Experience 3500 primary gastric band procedures since 2005 patients from across Canada 45 revisions of prev VBG, RNY 98% procedures in free standing ambulatory centre Dedicated team of surgeons, anaesthetists, nurses, dietitian, wellness coach Network of physicians and nurses across Canada to assist with band adjustments 3
LAPAROSCOPIC ADJUSTABLE GASTRIC BAND (LAP-BAND) Band is placed around upper part of stomach - laparoscopic No division or diversion of GI tract Adjustable Reversible Mortality 1:5000 Purely satiety inducing (restrictive), no malabsorption
Correct Position around Cardia CORE under licence
Normal bite of food being squeezed across the band
Vagus Nerve in the Upper Stomach CORE under licence
Optimal Surgical Technique All these steps are critical to achieve optimal results Cutting corners leads more revision surgery later Enhanced visualization by using Nathanson retractor Minimal pouch size, removal of greater curve fat pad Pars flaccida placement (not peri-gastric) Gastric plication to prevent acute band slippage Crural repair to reduce heartburn and possibly to reduce pouch dilatation Port fixation to minimize port flips Minimal narcotics and sedatives to promote minimize the risk of respiratory problems and allow safe and early discharge and recovery 10
11
Crural Repair Year Crural Repair Revision Rate 2005 4.3% 17.2% 2006 14.4% 12.3% 2007 36.4% 5.9% 2008 59.9% 1.9% 2009 87.0% 1.9% 2010 93.2% 0.0% 12
Follow up The adjustable nature of the band means that comprehensive follow up by an experienced and dedicated team is critical to success with gastric band surgery Poor results have been reported by low volume centres providing inadequate follow up Patients need to be motivated and capable of follow up to enhance success F/U more important than with other procedures such as RNYGB and gastric sleeve 13
Factors Determining Success Band Follow Up Patient
Outcomes of Bariatric Surgery We tend to focus and compare the magnitude of weight loss, but that is not the most important factor in improving health and is not the most important factor for patients Other speakers will shows that it does not take much weight loss, but it needs to be sustained to improve health and resolve comorbidities More weight loss is not better, especially if it comes at the price of more surgical and nutritional complications Patients are interested in improved QOL and safety
Comparison of RYGB and LAGB Published series of at least 3 years follow up and n >100 80 RYGB Lap-Band 70 60 50 % Excess Weight Loss 40 30 20 10 0 6 12 18 24 36 48 60 Months O'Brien PE, Dixon JB. Arch Surg 2003;138:376-82.
18 Meta-Analysis: Medium-Term Weight Loss Mean %EWL 90 80 70 60 50 40 30 20 10 0 * * BPD RYGB LAGB * 0 2 4 6 8 10 Time Postprocedure (y) O'Brien PE et al. Obes Surg. 2006;16(8):1032-1040.
Swedish Obese Subjects (SOS) Study Sjöström, L. NEJM 2004;351:2683-2693.
LAGB Complications Complication Band displacement(slip) Pouch dilatation Erosion Port dislocation Catheter rupture/ disconnection/leak Infection band/port LAGB (n=8,504) n % 138 338 50 74 68 31 1.62 3.97 0.59 0.87 0.80 0.36 Chapman, et al. A systematic literature review. Surgery March 2004; 135:326-51
LAGB Safety World literature review-comparison study 121 studies Procedure LAGB RYGB VBG Mortality* 0.05% 0.50% 0.31% Morbidity 11.3% 23.6% 25.7% *LAGB 10 times safer than RYGB, and 6 times safer than VBG Chapman, et al. A systematic literature review. Surgery March 2004; 135:326-51
23
Our Data Unique issues of Lap Band surgery in Ontario Private cash pay patients Motivation of patient and clinic to follow up patients and deal with problems Separation of band and bypass programs LAGB clinics must deal with problems because easy or rapid conversion to bypass or other procedures in not an option 25
Mature Lap Band Practice 6 yrs, 3046 primary Lap Bands 82% women 69% Ontario residents Age 44 (16 73) BMI 45 (30 93) Weight 278 (175 580) Lost to Follow Up (18 months) 14% 26
98% procedures in free standing ambulatory clinic 35 revisions of prev RNY or VBG 32 of the primary procedures done open Post Op Adjustments 5.6 in first year 3.1 in second year Actual contact with pts twice this rate 27
Excess Weight Loss 28
ADVERSE EVENTS Acute 3046 PATIENTS Hospital transfers from clinic 6 dysphagia, hypotension on induction, back pain Re-intubation 0 Acute obstruction 5 Conversion to Open 0 Transfusion 0 Other (sc emphysema, needle) 2 Infection (non band) 8 Wound (5), Port (2), Peritonitis (1)
ADVERSE EVENTS 3046 PATIENTS Port Leak (22), Flip (11) 33 = 1.1% Band Explanted 36 = 1.2% Intolerance 23 Infection 9 Concurrent Illness 4 PPD (Slip/Pouch Dil n) 124 = 4.1 % Erosion 12 = 0.4% Re-operation rate all cause 6.5%
Our Experience with Revision Surgery for PPD Months 2005 2006 2007 2008 2009 0 12 2.2% 1.5% 0.2% 0.1% 0.4% 12 24 6.5% 4.4% 1.4% 1.1% 0.6% 24 36 2.2% 2.3% 2.1 % 0.7% 36 48 3.2% 2.6% 1.4% 48 60 2.2% 1.5% 60 72 1.1% Total 17.2% 12.3% 5.9% 1.9% 1.0% 3.6% Revision 16 42 33 14 5 110 32
4 Quartiles of 400 pts Revision in first 36 months after Sx
Erosions (n=12) 8 7 6 5 4 3 2 1 0 Average 20.8 months 6.1 49.4 0 12 12 24 24 36 36 48 48 60 Months Post Op 35
Complications Complications (morbidity) of bypass and sleeve (leak, stenosis, hernia, etc) are often reported as comparable to LAGB complications We are not hesitant to revise or reposition a band if it is not working for the patient because we do not have the option of quick and easy conversion to gastric bypass Similar to Australian model There is no financial incentive to convert to bypass that is seen is some countries 36
Are Age and Gender factors in the incidence of PPD? 3000 consecutive LAGB between Feb 05 and May 11 Ambulatory Surgery Centre, Allergan Lap-Band Analysis of age and gender as independent factors in the incidence of PPD Binary logistic regression Further analysis of 1647 pts with at least 3 yr FU Pending publication in Annals of Surgery 39
Results PPD (n = 132) Entire Cohort (n=2868) p - value Age (years) 39.9 +/- 9.3 43.9 +/- 11.0 < 0.001 BMI (kg/m 2 ) 41.2 +/- 6.2 42.3+/- 7.7 0.1 % Male 5.3% 18.7% < 0.001 40
Revisions in 1647 patients during first 36 months post-op, by age and gender. The percentage of men and women in each age group to have had surgical revision for proximal pouch distension.
Discussion Male and increasing age were independent factors reducing the incidence of PPD Pre-menopausal women have highest incidence of PPD Consistent with papers that suggest pregnancy is a risk factor for PPD Perhaps we should be aggressive about defilling band during pregnancy This data shows that the perception that men are more likely to overeat and stretch their pouch is not supported All bariatric surgical procedures rely on a small proximal pouch Perhaps these findings may apply to all bariatric procedures band, sleeve, RNY although this has not been discussed in the published literature 42
Success with LAGB Optimal Outcomes are a result of: 1. Advanced surgical technique 2. Experienced surgical team 3. Well engineered device 4. Comprehensive long term follow up Studies show LAGB Safe and effective mortality 0 0.01% EWL 50 60% at 3 years and sustained Substantial improvement in comorbidities Re-operation rate 5 10%, rarely life threatening 43
Lap Band and RNYGB Some patients do not want to risk the nutritional issues and risks of bypass They are able and willing to make the commitment to regular follow up No study has been able to predict which operation is best for an individual patient Different procedures with different complication rates and different program requirements Few centres do both well 44
Summary Lap Band surgery is safe and effective when delivered in a high volume centre committed to long term follow up Various technical and device modifications are reducing need for revision surgery Increasing experience leads to lower short and long term complications Weight loss is more gradual than with gastric bypass but comparable at 3 years and more Complications with Lap Band are generally mild and easily managed rarely life threatening Older studies using abandoned techniques and those with short follow up are not relevant comparisons 45
Thank You Dr. Chris Cobourn MD, FRCS(C) The Surgical Weight Loss Centre Mississauga, Ontario, Canada March 31, 2012