Emerging Concepts in Bariatric Surgery

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1 Emerging Concepts in Bariatric Surgery C Y N T H I A L. L O N G, M D, F A C S S I N A I H O S P I T A L O F B A L T I M O R E D E P A R T M E N T O F S U R G E R Y D I V I S I O N O F M I N I M A L L Y I N V A S I V E S U R G E R Y A N D B A R I A T R I C SURGERY J U L Y 2 5,

2 Historical Perspectives Intestinal bypass in dogs First Gastric Bypass (Wangensteen) Gastroplasty Biliopancreatic Diversion (Scopinaro) First Laparoscopic Gastric Bypass (Wittgrove and Clark) FDA approval of Gastric Band Sleeve Gastrectomy

Gastroplasty Biliopancreatic Diversion (Scopinaro) First Laparoscopic

3 Emerging Concepts Laparoscopic Gastric Plication Greater Curve Plication Anterior-Posterior Plication Primary Endoluminal Plication

4 Laparoscopic Vertical Sleeve Gastrectomy

5 Sleeve Gastrectomy: Data 540 patients, Mean BMI 48 3,6, and 12 mos: 38.8%, 68%, 72% 216 patients, Mean BMI 49 Leaks : 1.4 % Mean OR times: 66 min (45-180_ LOS : 1.9 +/- 1.2 days Lee, C, Cirangle, P, Jossart, G. Vertical gastrectomy for morbid obesity in 216 patients: report of two-year results, Surg Endosc (2007) 21: Sanchez-Santos, R. et al. Short- and Mid-term Outcomes of Sleeve Gastrectomy for Morbid Obesity: The Experience of the Spanish National Registry. Obesity Surg (2009)19:

Vertical gastrectomy for morbid obesity in 216 patients: report of two-year results, Surg Endosc (2007) 21: 1810-1816.

6 Laparoscopic Greater Curvature Plication: Concept Invagination of stomach creating restriction No Staple Line Lower cost- No device, staplers nor costly adjustments Safety- no gastric resection Serosal-to-serosal apposition Reversible

Line Lower cost- No device, staplers nor costly

7 Total Gastric Vertical Plication One surgeon, Mohammad Talebpour, cases, mean BMI- 47 Mean OR time: 98 min Hospital LOS: 1.3 days %EBWL: 61 1 year, 57 3 years Main postoperative complications: vomiting, intracapsular liver hematoma, hypocalcemia, hepatitis, suture line leak, acute gastric perforation Talebpour M, Amoli BS. Laparoscopic total gastric vertical plication in morbid obesity. J Laparoendosc Adv Surg Tech 2007; 17:

3 days %EBWL: 61 % @ 1 year, 57 % @ 3 years Main postoperative complications: vomiting, intracapsular liver

8 Study OR Time (min) % 6 months % 12 months % 24 months % >36 mos Talebpour (100 pts) 98 54% 61% 60% 57% Ramos (42 pts) % Sales (100 pts) 69.6% Reoperation rate: 2.6% Complications: Suture line leak, prepyloric perf, kinking of stomach, abscess

(42 pts) 50 62 % Sales (100 pts) 69.6% Reoperation rate: 2.

9 Gastric Plication: preclinical study of durability of serosa-to-serosa apposition Menchaca et al. Surg Obes Relat Dis. 2011; 7:8-14

10 Fig. 4 Cross-section of plication at 8 weeks Significant inflammatory response All techniques intact plication at 8 wks except staple-suture combo and one row Ideal spacing 2.5 cm Multiple rows Source: Surgery for Obesity and Related Diseases 2011; 7:8-14 (DOI: /j.soard ) Copyright 2011 American Society for Metabolic and Bariatric Surgery Terms and Conditions

5 cm Multiple rows Source: Surgery for Obesity and Related Diseases 2011; 7:8-14 (DOI:10.

11 Laparoscopic Gastric Plication for Treatment of severe obesity Brethauer S et al. Surg Obes Rel Dis 2011; 7:15-22 Prospective, nonrandomized study of two techniques in 15 patients Anterior plication (AP) Greater Curve plication (GCP) Transmural Stitch placement Inclusion criterion: NIH criteria EndPoints: wt loss, %EBWL, 1 wk, 1,3,6 & 12 months Adverse events Quality of Life Assessment

Anterior plication (AP) Greater Curve plication (GCP) Transmural Stitch placement Inclusion

12 Greater Curve plication (GCP) Division of gastric vessels 2 rows of 2-0 Prolene Anterior plication (AP) 2 rows of 2-0 Prolene

13 Gastric Plications: Endoscopic Views A: Anterior plication (9) 1 patient- partially disrupted 3 mos Add l 12 mos B: Greater Curvature Plication (6) 5 pts. Durable folds 1 pt partial disruption

@ 3 mos Add l disruption @ 12 mos B: Greater Curvature

14 Procedure Visit (mo) Patients (n) Mean % EWL Anterior Plication Greater Curvature Plication Brethauer S et al. Laparoscopic Gastric Plication for Treatment of severe obesity. Surg Obes Rel Dis 2011; 7:15-22

3 3 6 38.5 6 6 49.9 12 6 53.4 Brethauer S et al.

15 Laparoscopic Gastric Plication: Clinical Outcomes

16 Laparoscopic Gastric Plication: Summary Greater Curve Plication- superior weight loss to AP Technically feasible and reproducible Good short-term weight loss Low major complication rate Remains investigational

17 Incisionless Surgery

18 Transoral Gastric Volume Reduction Transoral Gastroplasty device (TOGA) EndoCinch device RESTORe Suturing System TRIM Procedure Stomaphyx G- Prox /Endosurgical Operating System POSE ( Primary Obesity Surgery, Endoluminal) ROSE (Restorative Obesity Surgery, Endoluminal)

Stomaphyx G- Prox /Endosurgical Operating System POSE ( Primary

19 Endoluminal Vertical Gastroplasty: EndoCinch 64 patients in , Venezuela Mean BMI: 39.9 ± 5.1 ( ) Mean OR time: 45 min. LOS: < 24 hours 1,3, and 12 mos: 21.1± 6.2%, 39.6 ± 11.3 %, 58.1 ± 19.9% Follow-up EGD: 3/14 disrupted Fogel, R. et al. Clinical Experience of transoral suturing for an endoluminal vertical gastroplasty: 1-year follow-up in 64 patient. Gastro Endosc (2008) 68:

3 %, 58.1 ± 19.9% Follow-up EGD: 3/14 disrupted Fogel, R. et al.

20 EVG: EndoCinch

21 Phase 1 Trial: TOGA system Prospective, single-arm trial ; 21 patients General anesthesia, first cases done with laparoscopy Vacuum-assisted transmural apposition of anterior and posterior wall 8-9 cm length sleeve, outlet size: 1.56 cm 3 rows of staples mucosa-to-mucosa staple line and serosa-to-serosa staple line Deviere,J et al. Safety, feasibility, and weight loss after transoral gastroplasty: First human multicenter study. Surg Endosc 2008; 22:

23 Endoluminal Gastroplasty: TIOGA Avg. procedure time: 2 hr 11 min Minor complications: vomiting, dysphagia 1,3,6 mos: 16.2%, 22.6%, and 24.4% Phase 2: 11 patients 1,3,6 mos: 19.2%, 33.7%, and 46.0% Deviere,J et al. Safety, feasibility, and weight loss after transoral gastroplasty: First human multicenter study. Surg Endosc 2008; 22: Moreno C, Deviere, J et al. Transoral gstroplasty is safe, feasible, and induces signficant weight loss in morbidly obese patients: results of the second human pilot study. Endoscopy 2008:40:

24 Brethauer, S. et al. Transoral gastric reduction for weight management: technique and feasibility in 18 patients. Surg Obes Rel Dis (2010)6: Non-randomized feasibility study 18 pts Anterior & posterior wall plication w/ suture tag Procedure time- 125 min +/- 23 minutes Complications: minor Qualitative assessment of volume reduction Abstract: 1 yr 27.7% 1 yr 13/18 with partial disruption of plication

25 Endoluminal Gastric Plication: Summary Study Device 1 mo 3 mos 6 mos 12 mos Fogel et al. EndoCinch 21.1 ± 6 % 39.6 ± 11% 58.1 ± 19 % Deviere, J et al. Tioga System 16.2 % 22.6% 24.4 % Moreno, C, Deviere, J et al. Tioga System 19.2% 33.7% 46.0% Brethauer et al Restore Device 27.7%

26 Endoluminal Plication: Endoscopic View

27 Brethauer, S. et al. Endoluminal procedures for bariatric patients: expectations among bariatric surgeons. Surg Obes Rel Dis (2009 ) 5: Primary Bariatric Surgery Revisional Bariatric Surgery

28 The Future of Primary Endoluminal Bariatric Procedures Efficacy Durability Need for endoscopic revisions or touch up procedures Procedural Risk & Ideal patient population for these less invasive procedures Lower BMI patients? Higher risk patients as a bridge procedure? Guidelines for training and competence

29 Thank You

34 Laparoscopic Greater Curvature Plication

35 EndoFLIP Crospon- imaging catheter- measuring dimension and function intraluminally Measure and set consistent Lap Band stoma size FDA approved December 2009 Measurement of gastric sleeve and plication size FDA approved in 2011

36 EndoFLIP Data recorder / Screen Baloon Catheter Probe EF-325 probe- 8 cm long image field Deployed via endoscope to stoma Ascertains crosssectional areas at different points Goal diameter of mm

38 Sales Puccini CE. Surset Gastrico de Sales: una alternativa para cirugia bariatrica restrictiva. Rev Colomb Cir 2008; 23: Ramos AC et al. Tubular sleeve gastroplasty as a new approach to bariatric treatment. 14 th World Congress of IFSO Aug 26-29, 2009

41 Bariatric Surgery: Successes and Failures Roux-en-y Gastric Bypass Late failure 10 years 20.4 % Late failure 10 years % superobese (BMI>50) Biliopancreatic Diversion Late failure rate ~ 20%

43 Endoluminal Bariatric Procedures Revisional Bariatric Surgery Weight regain %EBWL:

Richard M Peterson, MD MPH FACS Chief UT Medicine Center for Bariatric and Metabolic Surgery Director Christus Weight Loss Institute Assistant

Richard M Peterson, MD MPH FACS Chief UT Medicine Center for Bariatric and Metabolic Surgery Director Christus Weight Loss Institute Assistant Professor of Surgery UTHSCSA None Laparoscopic adjustable