BARIATRIC SURGERY: WHY SOONER THAN LATER? Bruce Schirmer, M.D. DISCLOSURES • Consulting Board for Allurion Inc., which has no conflict regarding the content of this talk •
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BARIATRIC SURGERY: WHY SOONER THAN LATER? Bruce Schirmer, M.D. DISCLOSURES • Consulting Board for Allurion Inc., which has no conflict regarding the content of this talk • I have been doing bariatric and metabolic surgery for 27 years TALK OUTLINE • Progress in bariatric surgery in the U.S. in past two decades • Available operations and outcomes • Ten reasons why sooner is better than later (with apologies to David Letterman) NIH Consensus Conference 1991 • Diet/non-surg rx tried first • Gastric restrictive or bypass procedures for informed patients with BMI >40 or >35 with comorbid medical problem • Multidiscipline evaluation • Done by experienced surgeon • Lifelong medical follow-up BARIATRIC SURGERY ‘93 • National volume 15,000/yr • Few academic centers • History of multiple failed operations (VBG data going sour) • Laparoscopy will be hard to do LAPAROSCOPIC REVOLUTION • Lap cholecystectomy widespread by 1991, dramatic acceptance • By 1994 most major types of abdominal surgery being done with a laparoscopic approach EXCEPT bariatric surgery and liver/pancreas surgery GASTRIC BYPASS 140000 120000 100000 80000 60000 40000 20000 0 1994 1996 1998 2000 2002 2004 THE BARIATRIC REVOLUTION • Began around 1998 • Combination of factors: –Laparoscopic alternative –Mass communication/internet –Industry and mass media –Public/medical opinion UVA BARIATRIC SURGERY # OPERATIONS BY YEAR 80 70 60 50 Total 40 Open GBP 30 Lap GBP 20 10 0 1996 1997 1998 1999 2000 UVA BARIATRIC SURGERY # OPERATIONS BY YEAR 350 300 250 200 Total Open GBP 150 Lap GBP 100 50 0 2000 2001 2002 2003 2004 Membership • Growth 7% last year EFFICACY OF BARIATRIC SURGERY • Large meta-analyses: Maggard et al Ann Int Med April 2005; 142:547-59 Buchwald et al JACS April 2005; 200:593-604 LAP BARIATRIC SURGERY: IT IS BETTER THAN OPEN ? • Evidence-based medicine: PRCT by Nguyen*, others • Multiple reports of improvements in wound and hernia complication rates * Nguyen NT, et al. Ann Surg 2000; 232:515-29 UVA GASTRIC BYPASS: PATIENT CHARACTERISTICS OPEN LAP. p value Patients 363 41.8 Age 765 % male 19.6% Wt lbs 357.4 57.5 BMI 17.8% ns ns 315.6 <0.001 50.9 <0.001 Comorb 3.6 2.7 <0.001 42.1 UVA GASTRIC BYPASS: PATIENT CHARACTERISTICS LOS days Intraop c Tot comp Reoperat 30 d mort Tot mort OPEN 5.13 2.2% 57.3% 41.3% 1.7% 5.0% LAP 3.18 0.7% 14.5% 8.8% 0.3% 0.7% p value <.001 <0.03 <.001 <.001 <0.02 <0.05 UVA GASTRIC BYPASS: PATIENT CHARACTERISTICS OPEN LAP p value Wnd infx 7.4% 1.8% <.001 In. hernia 33.9% 1.7% <.001 Pulmon. 4.4% 2.1% <0.03 DVT/PE 3.6% 0.6% <0.01 %EWL 1yr 62.6% 65.2% <0.03 %EWL 3yr 63.1% 61.4% ns UVA: LRYGB RESOLUTION OF COMORBIDITIES • • • • • • Diabetes in 80% of cases Reflux in 90% of cases Hypertension in over 50% Sleep apnea in over 70% Venous stasis: better in all Asthma: over 90% improved LAP BAND RESULTS • Improve with increased frequency of followup, coverage • Best results from Australia • EWL approaches bypass at 5 yrs (45-50% EWL overall best series) • Other countries much less good LAP BAND RESULTS • Up to 40% of lap bands reoperated or removed in France • UVA data: 35-40% EWL • Tend to be dramatic positives and negatives • Effort dependent (exercise) OPTIMAL LAP BAND CANDIDATE • • • • • • BMI < 50 (certainly no 400 lbs) Physically can and will exercise Good support system Very motivated Have successfully dieted Adjustments easy (distance, money) BSCN: RISK ADJUSTED OUTCOMES LAGB LSG LRYGB ORYGB n 12,193 944 14,491 988 30d mortal 0.05% 0.11% 0.14% 0.71% 1yr mortal 0.08% 0.21% 0.34% 1.11% 30d morbid 1.44% 5.61% 5.91% 14.98% 30d 1.71% readmit 30d 0.92% reop 5.40% 6.47% 9.41% 2.97% 5.02% 5.06% BMI LOSS AT 1 YEAR Hutter MM et al Ann Surg 2011; 254:410-22 OPERATION BMI loss LAGB 7.05 LSG 11.87 LRYGB 15.34 % IMPROVED OR RESOLVED LAGB LSG LRYGB DIABETES 44 55 83 HTN 44 68 79 OSA 38 62 66 HYPERLIP 33 35 66 GERD 50 70 64 BOLD DATABASE (30 DAY)(11/11) BYPASS BAND SLEEVE n 149,847 120,269 16,885 % / %lap 50.7 91.5 40.7 99.4 5.7 97.9 mortality 0.15% 0.03% 0.08% morbidity 11.79% 3.42% 8.52% LOS 2.4 0.7 1.9 Readmit 4.8% 1.4% 3.7% Reoperate 2.8% 0.65% 1.7% Recent Improvements in Bariatric Surgery Outcomes William E. Encinosa, PhD,* Didem M. Bernard, PhD,† Dongyi Du, MS,‡ and Claudia A. Steiner, MD, MPH* N Engl J Med 2009;361:445-54. 11/7/2015 Ann of Surg, 248, 5, Nov 08 29 LABS RESULTS • 4776 patients • Age 44.5 yrs, 21% male, BMI 46.5 • RYGB in 3412 (87.2% lap.) • LAGB in 1198 • Mortality: band=0 • 4.3% patients had one major adverse outcome RYGB: LABS OUTCOMES OPEN LAP RYGB RYGB (#/%) (#/%) # PATIENTS 437 2975 DEATHS 9 (2.1) 6 (0.2) REINTUB. 6 (1.4) 12 (0.4) ENDOSC. 5 (1.1) 45 (1.5) ABD. OP. 15 (3.4) 94 (3.2) LOS > 30 D. 4 (0.9) 13 (0.4) CANDIDATE FOR SLEEVE VS BYPASS • Insurance now covering both • Diabetes and GERD better with bypass • Very high risk: sleeve? • Sleeve long-term data still not in • Patient preference big factor Recent Improvements in Bariatric Surgery Outcomes William E. Encinosa, PhD,* Didem M. Bernard, PhD,† Dongyi Du, MS,‡ and Claudia A. Steiner, MD, MPH* • Funded by the Agency for Healthcare Research and Quality Medical Care • Volume 47, Number 5, May 2009 MAJOR CHANGES OF st BARIATRIC SURGERY IN 21 CENTURY • Conversion to laparoscopy • U.S.: lap band in 2003 • Centers of Excellence (2004-5) • ASBS to ASMBS (2009) and emphasis on rx medical problems Of Aesculapius and the Medicine Man: Some Comments on the College Seal by George W. Stephenson, MD, FACS Descriptions of the Seal of the College and explanations of its symbolism have appeared in the Bulletin several times since 1915, lows may now be interested in such information. TOP TEN REASONS WHY BARIATRIC SURGERY SHOULD BE SOONER RATHER THAN LATER # 10 Improves cardiovascular function IMPROVED CARDIAC FUNCTION AFTER BARIATRIC SURGERY • Matched control study showing 1yr after bariatric surgery LVEF 22% to 35% vs. no change in controls Ramani GV et al Clin Cardiol 2008; 31:516-20. • Improved LVEF from 25% to 45% in young Class IV heart failure males after bariatric surgery, taken off transplant list Ristow B et al. J Cardiac Failure 2008; 14:198-202. #9 Decreases the risk of cancer BARIATRIC SURGERY EFFECT ON MORBIDITY AND MORTALITY • Search of databases including Medline, Cochran library, and Science Direct • Six studies clearly showed that bariatric surgery prolongs life, and the effect is most marked in diabetics and predominantly attributable to due to reductions in death due to cardiovascular causes and cancer. Chang J, Wittert G Int J Evidence-Based Healthcare 2009; 7:43-8 #8 Improves or resolves components of the metabolic syndrome –Hypertension –Hyperlipidemia –Glucose intolerance (type 2 diabetes) –Fatty liver HEPATIC • • • • NAFLD: present in over 90% NASH: evolves or present in 30% Only known treatment is weight loss One study showed paired liver bx pre- and postop with 70% resolution of NASH Mummadi RR et al Clin Gastroenterol Hepatol 2008; 6:1396-1402 RYGB VS. DIABETES AND HYPERTENSION • • • • • 1025 pts at MCV treated with RYGB Preop 15% with DM2, 51% with HTN One year postop DM2 resolved 83% One year postop HTN resolved 69% Five years postop resolution of DM2 and HTN were 86% and 66% From: Sugerman HJ et al Ann Surg 2003; 237:751-6 RYGB REDUCES PROGRESSION AND MORTALITY OF NON-INSULIN DEPENDENT DIABETES • • • • ECU patients 1979-94 154 RYGB vs. 78 who had no surgery Mean follow-up: 9 (S), 6.2 (NS) yrs % oral hyoglycemics: Surg: 8.6%, nonSurg 87.5% • Mortality rate: Surg 9%, nonSurg 28% From MacDonald KG et al J Gast. Surg 1997; 1:213-30. CHANGE IN COMORBIDITIES AFTER GASTRIC BYPASS % RESOLVED / %IMPROVED DIABETES 76.8 / 85.4 HTN 61.7 / 78.5 OSA 85.7 / 83.6 HYPERLIPID 70.0 / 96.9 Buchwald H et al JACS 2005; 200:593-604 IMPROVEMENTS IN DIABETES (% improved or resolved) Brolin et al (1992) 100% Hall et al (1990) 75% Pories et al (1982) 100% Karason et al (2000) 48% Van Rij (1984) 83% Brolin et al (1994) 90% Kothari et al (2002) 75% Mittermair et al (2003) 86% O’Brien et al (2002) 96% (LAP BAND) Scopinaro (1996) 100% (BPD) LAP BAND AND DIABETES • RCT from 2002-6, lap band vs. conventional diet rx. • Remission of diabetes 73% in surgical group vs. 13% in medical group Dixon JB, et al. JAMA 2008; 299:316-23 SURGERY VS. MEDICAL RX FOR DIABETES • PRCT medical vs surgical rx for uncontrolled diabetes (1 yr rx) • Endpoint: HgbA1C < 6.0% – 4/41 medical rx =12% – 21/50 RYGB = 42% (p = .002) – 18/49 Sleeve = 37% (p = .008) • More DM, HTN, Statin drugs in medical and less in surgical pts Schauer PR, et al NEJM 2012; 366:1567-76 #7 Benefits last for decades SWEDISH OBESITY STUDY • 4047 patients: 2010 surgery vs. 2037 conventional rx. • Mortality at 10.9 yr follow: • 129 vs. 101 deaths, p=.04 • Wt loss 25, 16, and 14% based on operation Sjostrom L, et al NEJM 2007; 357; 741-52 #6 Disease regression is best and more durable if it occurs earlier in the course of the disease REMISSION AND RELAPSE OF TYPE 2 DIABETES AFTER GASTRIC BYPASS • 4434 adults with type 2 diabetes and bypass • 68% achieved remission within 5 yrs postop • Of these, 35% re-developed diabetes within five years • Avg duration of remission 8.3 years • Predictors of relapse were poor preop control, insulin use, longer diabetes duration Aterburn DE et al Obes Surg 2013; 23:93-102 #5 Surgical mortality is higher in older patients MORTALITY AFTER GASTRIC BYPASS • Strong correlation with age in patients over age 70, significant for patients over age 60 • For patients over age 50, survival of a complication is less than for a younger patient Flum DR, Dellinger EP JACS 2004; 199:543-51 #4 Bariatric surgery prolongs life BARIATRIC SURGERY PROLONGS LIFE • 1035 patients treated at McGill from 1986-2002 • Control group from Quebec health database • Those with comorbids excluded McGILL STUDY • 67.1% excess weight loss • Mortality: 0.68% vs. 6.17% • Relative risk of death reduced by 89% Christou et al Ann Surg 2004;240:416-24 U.S. POPULATION STUDY • Compared 9949 patients undergoing RYGB to 9628 obese applied drivers license • National Death Index; 7.1 yr. • 36.7 vs. 57.1 deaths/10,000 person yrs, p<.001 Adams et al. NEJM 2007; 357:753-61 #3 Less office visits Less medications Lower cost of health care McGILL STUDY: COSTS YEAR SURGERY MEDICAL 1 $12,461,938* $3,609,680 5 $19,516,667 $25,264,608* Costs of surgery amortized over 3.5 years Sampalis et al Obes Surg 2004;14:939 #2 Why wouldn’t you want to give a patient an effective treatment against so many diseases? #1 Because they may not be around long enough if you don’t (especially the men) OBESITY BY AGE/SEX % population BMI > 40 Age Males Females >20 3.3 6.4 40-59 59>60 3.9 1.7 7.8 5.6 From: Hedley et al JAMA 06/16/04 THANK YOU