Sleeve Gastrectomy as the Primary Procedure James Ellsmere

Sleeve Gastrectomy as the Primary Procedure James Ellsmere, MD MSc FRCSC Surgical Director, Weight Loss Program QE II Health Sciences Centre Dalhousie University, Halifax NS

Disclosure • Ethicon Endosurg – speaking

Sleeve Gastrectomy • First used in staged approach for the super obese • Increasingly being used as primary procedure with good weight loss and resolution of obesity related comorbidities • Involves resecting the greater curvature of the stomach • Reduces ghrelin levels for up to a year Gagner et al. Surg Obes Relat Dis 2009

Advantages • • • Low mortality rate (0. 39 percent) Low complication rate (3 to 8 percent) Low reintervention rate Preservation of the pylorus Maintenance of physiological food passage Avoidance of foreign material

Disadvantages • Long term follow-up is limited • Can exacerbate GERD • Leaks though manageable can be challenging

International SG Expert Panel Consensus Statement • Expert panelists were invited to participate according to their publications, knowledge and experience, and identification as surgeons who had performed 500 cases (>12000 cases) • Topics for consensus – patient selection – contraindications – surgical technique – prevention of complications – management of complications Rosenthal et al. Surg Obes Relat Dis 2012

Objectives • Review the ASMBS position on SG • Discuss the common criticisms of SG • Nova Scotia experience

ASMBS 2011 Position Statement • SG is acceptable option as a primary bariatric procedure • SG has a risk/benefit profile that lies between LAGB and RYGB • Long-term weight regain can occur and, in the case of SG, this could be managed effectively with reintervention • Informed consent for SG used as a primary procedure should be consistent with consent provided for other bariatric procedures and should include the risk of long-term weight gain

Criticisms • Earlier data suggest SG only half as good as DS • Lack of long term data does not justify this approach • Why base program on operation where we expect failure to be 30% • Poor outcomes have the potential to tarnish image of bariatric surgery • SG complications though rare can be very challenging to manage

Expected Excess Weight Loss Brethauer et al. Surg Obes Relat Dis 2009

Bougie • The bougie is positioned on the lesser curve distal to the point of transection • Too large will decrease expected weight loss • Too small will increase risk of post-op nausea, stenosis and leak • Most surgeons use 32 -40 F (range 30 -60 F)

Michigan Bariatric Surgery Collaborative • Comparative effectiveness analysis of the safety and effectiveness of SG, RYGB, and LAGB • ~ 9, 000 patients matched on preoperative risk factors and predictors of weight loss outcomes to deal with the issue of selection bias • Outcomes included complications occurring within 30 days, weight loss, comorbidity resolution, quality of life, and patient satisfaction at 1, 2, and 3 years follow -up

Michigan Bariatric Surgery Collaborative • Overall complication rates among patients undergoing SG (6. 3%) were significantly lower than for RYGB (10. 0%, p<0. 0001) but higher than for LAGB (2. 4%, p<0. 0001) • Serious complication rates were similar for SG (2. 4%) and RYGB (2. 5%, p=0. 736) but higher than for LAGB (1. 0%, p<0. 0001) • Excess body weight loss at 1 -year was 69% RYGB, 60% SG, and 34% LAGB • SG was similarly closer to RYGB than LAGB with regard to resolution of obesity-related comorbidities, quality of life, and patient satisfaction

Co-morbidity Remission and Improvement Brethauer et al. Surg Obes Relat Dis 2009

Long-term follow-up after SG

NEJM, Vol 351, No. 26, December 23, 2004

Weight Change (%)

Unacceptable Failure Rate • What definition of failure? – EWL < 50 % – Persistent co morbidities – Lack of lifestyle modification (diet & exercise) • How does the failure rate compare? – SG 25 -30% – RYGB 20% – LAGB 35 -40% • Causes of failure are multifactorial – Addressing anatomical issues without addressing lifestyle issues likely result in poor long term outcomes

Poor Outcomes Tarnish Bariatric Surgery • Weight regain though frustrating is accepted complication of bariatric procedures • Debilitating complications like anemia secondary recalcitrant ulcers and internal hernias resulting in short gut syndrome can have a negative lasting effect • Nutritional and Vitamin deficiency requiring hospital admission for management also tarnish image

Managing Leaks is Challenging • Early < 48 h – repair, drain +/- j tube for feeding • Late > 4 days – drain + j tube for feeding

Options if Drainage Persists • Refer to center with experience in endoscopic stenting, clips, glue • If persists, consider RYGB • Stoma appliance

Nova Scotia SG Program • The best option for morbidly obese patients is to have access to bariatric surgery program in their home province • Patients who do not develop healthier lifestyle (diet and exercise) will fail any operation over the long term • Patients undergoing malabsorptive procedures should have access to long term follow-up • Deaths or significant number of complications would could potentially shut down program

NS Experience § § § § 166 patients 136 female (82%) Mean age 44 years (range 16 -68, SD 10) Mean pre-operative BMI 49. 6 (range 23. 9 -73. 5, SD 7) Mean operative time 93 min (range 56 -232, SD 33) Mean hospital stay 2. 6 (2 -8, SD 0. 8) days Reoperation rate 1. 8%

Complications Complication Staple line leak Bleeding Sleeve stenosis Death Minor Total Number (%) 1 (0. 6) 2 (1. 2) 0 0 7 (4. 2) 10 (6)

Postoperative follow-up Time (months postop) %EWL (Range, SD) Number of patients/ Total eligible (%) 6 49. 3 (18. 9 -92. 4, 13) 99/140 (71) 12 54. 24 (0. 7 -95. 9, 19) 59/109 (53) 24 64. 4 (38. 3 -101, 31) 12/44 (27)

Summary • SG is acceptable option as a primary bariatric procedure • SG has a risk/benefit profile that lies between LAGB and LRYGB • Long-term weight regain can occur and, in the case of SG, this could be managed effectively with re-intervention

Thank you James Ellsmere, MD MSc FRCSC James. Ellsmere@dal. ca

Selection Criteria Factor Criteria Weight (adults) BMI > 40 kg/m 2 with no comorbidities BMI > 35 kg/m 2 with obesity-related comorbidity Weight Loss History Failure of previous nonsurgical attempts at weight reduction, including nonprofessional programs (i. e. Weight Watchers) Commitment • Expectation that patient will adhere to post-op care • Follow-up visits with physician's and team members • Recommended medical management, including the use of dietary supplements • Instructions regarding any recommended procedures or tests • Reversible endocrine or other disorders that can cause obesity • Current drug or alcohol abuse • Uncontrolled, severe psychiatric illness • Lack of comprehension of risks, benefits, expected outcomes, alternatives, and lifestyle changes required with bariatric surgery Exclusion

Nova Scotia WLS Program • BMI > 60 – Challenging to perform high quality sleeve with low complication rate – Patients counseled and offered medically supervised diet/exercise plan – Graduate 50% from program with excellent outcomes • BMI 35 – 60 – Goal 10 lb weight loss prior to sleeve

Outcomes Brethauer et al. Surg Obes Relat Dis 2009

Access and Port Placement Karmali et al. Can J Surg 2010

Mobilization of the Greater Curvature

Distal Transection Point • The distal transection point is measured relative to the pylorus • Too long will decrease expected weight loss • Too short may effect gastric emptying • Most surgeons start 5 cm (range 1 -10 cm) proximal to the pylorus

Bougie • The bougie is positioned on the lesser curve distal to the point of transection • Too large will decrease expected weight loss • Too small will increase risk of post-op nausea, stenosis and leak • Most surgeons use 32 -40 F (range 30 -60 F)

Stapling • The goal is the creation of a uniform gastric tube • Requires optimal visualization and lateral traction on the stomach • Avoid the esophagus leave 1 cm of fundus as precaution

Staple Line Reinforcement • Staple-line was reinforced by 65. 1% of the surgeons; of these, 50. 9% over-sew, 42. 1% buttress, and 7% do both • Several series without buttress material with 1% bleeding rate, 1% leak rate • Consider optimal staple height, need for tissue compression, clipping bleeders and selectively oversewing Gagner et al. Surg Obes Relat Dis 2009

Staple Line Testing • Intraoperative leak testing with air (gastroscope) and/or methylene blue dye • Consider leaving drain

Removing Specimen

Sleeve Gastrectomy and Hiatal Hernia Repair • Small cases series • Morbid obesity is risk factor failed hiatal hernia repair • If large or symptomatic hernia and BMI > 35, hernia repair + sleeve is an option • Post op course similar to sleeve alone

Band to Sleeve • Small case series • Risk of complications higher than primary operation • If treating band complications, consider two stage approach • Avoid stapling through compromised tissue

Low Rate of Complications • • High leak occurred in 1. 5% Lower leak in 0. 5% Hemorrhage in 1. 1% Splenic injury in 0. 1% Stenosis in 0. 9% GERD @ 3 mo 6. 5% (range 0 -83%) Mortality was 0. 2 +/-0. 9% Gagner et al. Surg Obes Relat Dis 2009

Patient Decision • Boils down to tolerance for risk and perceived risk reward • Bariatric vs non-operative management question is clear • What’s the best bariatric surgery for the patient is difficult to know

Perioperative Outcomes of Laparoscopic Sleeve Gastrectomy, Effectiveness in Short to Medium Term Weight Loss and Improvement in Diabetes Mellitus C. Hoogerboord MB Ch. B, MMed, S. Wiebe MD, D. Lawlor NP, R. Stewart BSc, T. Ransom MD, D. Klassen MD, J. Ellsmere MD, MSc (jellsmer@dal. ca) Department of Surgery, Division of General Surgery, Dalhousie University, Halifax NS

Introduction Laparoscopic Sleeve Gastrectomy (LSG) is increasingly being performed as a stand-alone bariatric procedure with short and medium term weight loss and improvement in obesity associated comorbidities comparable to Laparoscopic Roux-en-Y Gastric Bypass, (LRYGBP) the current gold standard in bariatric surgery.

Discussion § LSG is gaining popularity as a final surgical treatment for morbid obesity § Complications are infrequent but most significant for staple line leak (2%), bleeding (1. 2%), sleeve stenosis (0. 8%) and death (0. 19%)1. Gagner et al. Surg Obes Relat Dis 2009

§Effectiveness as weight loss procedure confirmed by several studies, 12 and 24 month %EWL 55. 8 and 52. 4 respectively in a systematic review of Brethauer et al 2. More than weight loss seen with LAGB but somewhat less than with LRYGBP 3. § Concept of metabolic surgery now recognized by endocrine specialists. LSG led to 2 year remission rate of Type 2 DM of 75% vs 0% with optimal medical therapy in patients with BMI>354.

Aim To review our experience with Laparoscopic Sleeve Gastrectomy (LSG) in terms of perioperative outcomes, effectiveness in inducing weight loss and improvement or resolution of Diabetes Mellitus (DM) over a two year period

Methods § A retrospective review of prospectively recorded data was performed for all patients who underwent LSG from September 01, 2007 to June 30, 2011 § Patient demographics and perioperative data were collected. § Postoperative follow-up data was obtained at 6, 12 and 24 months and included Percentage Excess Weight Loss (%EWL) for all patients § In the subgroup of 85 patients with a preoperative diagnosis of DM, additional data included Hb. A 1 c, AC Glucose and improvement or resolution of Diabetes § Improvement of DM was defined as a decrease in dose or number of anti-diabetic drugs required to control serum glucose whereas resolution was defined as normalization of AC glucose (<5. 6 mmol/l) and Hb. A 1 c (<6. 5%) with discontinuation of all anti-diabetic drugs

Perioperative Results § § § § 166 patients 136 (82%) female Mean age 44 (range 16 -68, SD 10) years Mean pre-operative BMI 49. 6 (range 23. 9 -73. 5, SD 7) Mean operative time 93 (Range 56 -232, SD 33) minutes. One (0. 6%) conversion to laparotomy Mean hospital stay 2. 6 (2 -8, SD 0. 8) days. Reoperation rate 1. 8%.

Complications Complication Staple line leak Bleeding Sleeve stenosis Death Minor Total Number (%) 1 (0. 6) 2 (1. 2) 0 0 7 (4. 2) 10 (6)

Postoperative follow-up Time (months postop) %EWL (Range, SD) Number of patients/ Total eligible (%) 6 49. 3 (18. 9 -92. 4, 13) 99/140 (71) 12 54. 24 (0. 7 -95. 9, 19) 59/109 (53) 24 64. 4 (38. 3 -101, 31) 12/44 (27)

Time (months postop) Hb. A 1 c (Range, SD) Number of patients/Total eligible (%) 0 7. 6 (4. 5 -14. 0, 1. 7) 6 6. 3 (4. 5 -10. 4, 1) 50/66 (77) 12 6. 5 (4. 4 -9. 5, 1. 2) 27/52 (52) 24 6. 2 (5. 2 -6. 6, 0. 5) 2/19 (11)

Time (months postop) AC Glucose (mmol/l) (Range, SD) 0 8. 3 (3. 3 -21. 5, 2. 9) 6 6. 4 (2. 2 -22. 0, 2. 2) 12 6. 9 (3. 7 -14. 3, 2. 3) 24 5. 6 (4. 2 -6. 3, 0. 7)

Diabetic outcomes at 12 months postop § Resolution: 21/27 (78%) § Improvement: 2/27 (7%)

Conclusion § LSG can be performed safely with acceptable complication rates at our institution § It is an effective bariatric procedure and can play an important role as metabolic therapy for DM §Longer term studies are needed

Healthcare Economics • Surgery is one arm of an expensive multidisciplinary intervention • Reoperative outcomes are not as good as primary interventions in part because patient group already failed multidisciplinary intervention • It may be more cost effective to offer the multidisciplinary intervention to a new person on the wait list vs revise someone who failed