Slide 1

Erik B. Wilson, MD, FACS Associate Professor of Surgery Bariatric Surgery Medical Director Memorial Hermann Hospital Division Chief, Minimally Invasive and Elective General Surgery University of Texas Medical School at Houston Robotic Bariatric Surgery: Ok, When Do I Have to Deal with This

Slide 2

1999 2000 2001 2002 2003 da Vinci Surgical System U.S. Installed Base 1999 2010 2004 Alaska 2005 Hawaii Puerto Rico

Slide 3

Annual Worldwide Procedures ~300,000

Slide 4

Where is Robotics for General Surgery? Market Penetration EmergenceAdoptionStandard of Care Time Low High Prostate #1 Treatment Option for Prostate Cancer GS & ENT New, developing area for Robotic Surgery Thought leaders are gravitating to the system Opportunity to be a first mover in this area Benign GYN Rapid Adoption for Complex anatomy Rapid adoption by GYOs across the US Highly attractive to recent fellows GYN - ONC

Slide 5

General Surgery Procedures (WW) 2010 dV Gen Surg Growth = 67%

Slide 6

da Vinci General Surgery Procedures (WW) LAR, APR Colectomy Rectopexy Gastric Bypass Sleeve Gastrectomy Bands Hernia Pancreas, Liver Gastrectomy Transplant Cholecystectomy Nissen Fund. Heller Myotomy

Slide 7

Erik Wilson: Robotic Experience Robotic Cases 2002-2010 583 Roux en Y Gastric Bypasses (136 Revisions) 8 Biliopancreatic Diversions with Duodenal Switch 26 Sleeve Gastrectomies 4 Band Revisions 42 Hiatal Hernias (Nissen) 2 Heller Myotomies 25 Incisional Hernias 13 Inguinal Hernias 10 Cholecystectomies 1 Adrenalectomy 3 Subtotal Gastrectomies 1 Hepaticoduodenostomy 18 Colectomies 18 Bladder Augmentations

Slide 8

My Biases Digital platforms are the future of elective surgery They make good surgeons better and more comfortable Complications and conversions to open surgery will become less acceptable Bariatric surgery has become comprehensive in its procedures and services Failures and revisions of bariatric surgery will continue to grow

Slide 9

My Bias The Day of Open Elective Surgery and Open Conversions is Coming to a Close

Slide 10

Eliminates Counter-intuitive motion Instrument tremor Provides Improved ergonomics Hand / eye alignment 3 hands in 2 Transforms 2-D vision to true 3-D 5 DOF instruments to 7 DOF (greater endoscopic dexterity) What Can Robotic Surgery Do?

Slide 11

Challenges to RoboticsWhat Cant It Do? Increased costs Only one company in the market Large footprint No haptic feedback Limited in multi-quadrant procedures Longer set-up times Longer operative times

Slide 12

Challenges to RoboticsWhat Cant It Do? Increased costs Only one company in the market Large footprint No haptic feedback Limited in multi-quadrant procedures Longer set-up times Longer operative times

Slide 13

General Surgeons in Robotics Its a been hard sell because of the general surgery laparoscopic skill set Possible candidates Surgeon looking for a marketing advantage Open Surgeon trying to get into MIS Skeptical Laparoscopic Surgeon Early Adopter Technology Junkie Laparoscopic Surgeon

Slide 14

Robotic Gastric Bypass Outcomes 2002-2007 Curet et al. California, USA. 75 patients. Totally Robotic. 140 minute operative time, 0 leaks, 3 GI bleeds, 0 deaths. Morel et al. Switzerland. 54 patients. Totally Robotic 310 minute operative time, 0 leaks, 1 GI bleeds, 0 deaths. Parini et al. Italy. 70 patients. Hybrid Robotic 132 minute operative time, 2 fistula/leaks, 10 GI bleeds, 0 deaths. Hubens et al. Netherlands. 45 patients. Hybrid Robotic 212 minute operative time, 0 leaks (5 sb injuries), 0 deaths. Berger, Horgan et al. Illinois. 110 patients. Hybrid Robotic 190 minute operative time, 0 leaks, 3 GI bleeds, 0 deaths. Wilson, Yu et al. Texas. 249 patients. Hybrid Robotic 217 minute operative time, 0 leaks, 2 GI bleeds, 0 deaths.

Slide 15

Robotic Gastric Bypass Early Outcomes 603 Total patients 201 minute average operative time 2 fistula or leaks (0.3%) 19 GI bleeds (3%) No Mortality Standard LRYGB 5 % leak rate 0.3 to 2% mortality

Slide 16

Prospective Comparison of Robotic versus Standard Laparoscopic Roux-en-Y Gastric Bypass Erik Wilson, MD, FACS Sherman Yu, MD, FACS Terry Scarborough, MD, FACS Brad Snyder, MD Journal of Robotic Surgery 2008

Slide 17

Demographics 605 total patients Mean Age % Male Mean BMI Revisions 356 lap patients 42 years (18-68) 20% male 50.4 (34-88) 65 (18%) 249 robot patients 43 years (19-72) 21% male 50.2 (34-92) 38 (15%) No significant differences

Slide 18

Complications 356 lap patients 4 (1.1%) 8 (2.2%) 19 (5.3%) 6 (1.7%) 37 (10.4%) 4 (1.1%) 0 2 (0.6%) 1 (0.3%) 0 6 (1.7%)* 14 (3.9%) 249 robot patients 1 (0.4%) 8 (3.2%) 13 (5.2%) 4 (1.6%) 26 (10.4%) 2 (0.8%) 1 (0.4%) 2 (0.8%) 0 2 (0.8%) 0* 9 (3.6%) 605 total patients Wound Infection Stricture Vomiting/Dehydration Abdominal Pain Total Minor Intraluminal Bleed Abdominal Wall Bleeding Trocar Hernia Rhabdomyolysis Stroke Pulmonary Embolism Leak Total Major No significant differences except *p=0.040 All complications are reported over 90 days postop No mortalities in either group

Slide 19

Retrospective review of prospective databases University of Texas Houston (538 patients) Database 2002-2010: Remedy MD Three robotic surgeons (E. Wilson, T. Wilson, B. Snyder) Eastern Maine Medical Center (562 patients) Database 2005-2010 : LapBase One robotic surgeon (Toder) Mean BMI 47.9 2010--1100 Robotic Bypasses

Slide 20

Weight Loss %EWL Months

Slide 21

Major Complications

Slide 22

Houston, Texas All cases are training cases Average time 196 minutes Bangor, Maine All cases with same personnel Average time 114 minutes First thirty : ~200 minutes Last 100 : ~90 minutes Operative Times

Slide 23

The Robotic RYGB is a safe and effective technique 1100 patients, no mortalities (Standard 0.3-2% for LRYGB) The robotic approach has a lower gastrojejunal leak rate (In this case series 1 leak) 1/1100 versus standard published rates of 2-5% Complications are few and may be less than conventional laparoscopic techniques The robot RYGB has good weight loss results The learning curve for a safe surgery is quick Conclusion

Slide 24

Revisional Bariatric Surgery Revisional Cases (136) Band to Bypass(27) Band to Sleeve (5) Band to Lap Band (6) VBG to Bypass (75) Sleeve to Bypass (2) Bypass to Bypass (14) Bypass to Biliopancreatic Diversion (7) The keys to success are meticulous dissection and careful staple line evaluation

Slide 25

Robotic Revisional Bariatric Surgery Robot approach with advantages Dissection versus Reconstruction

Slide 26

Robotic Revisional Bariatric Surgery Severe adhesions

Slide 27

Revisional Bypass Weight Loss Months 99 patients 2004-2010 42 Vertical GBs 29 Adjust GBs 28 Fixed GBs

Slide 28

Revisional Gastric Bypass Complications Gastrointestinal leak0(0%) Intraabdominal abscess1(1%) Hemorrhage0(0%) Pulmonary Embolism0(0%) Pneumonia1(1%) Rhabdomyolysis1(1%) Intestinal obstruction2(2%) Incisional hernia1(1%) Marginal Ulcer1(1%) Dehydration2(2%) Epigastric abdominal pain2(2%) Nausea Vomiting4(4%)

Slide 29

Revisional Gastric Bypass Complications Total Complication Rate 16% Minor 8% Major 8% Leaks 0% or 1% Compares favorably to literature reported leak rates of 15% (Higa) and 12% (Rosenthal)

Slide 30

Learning Curve-Definition The Case Volume necessary to normalize outcomes Complications Very few cases Operative Time Docking times Trocar positioning accuracy Interference understanding Console experience

Slide 31

Slide 32

Robotic Surgery Team BuildingLearning Curves Docking and set up is the key of the safety and efficacy learning curve Simulation and practice with the console is the key to the efficiency learning curve Adoption is dependent upon the surgeon and operating room team A negative OR team can kill adoption Find Champions at each level Administration, Surgeon, Surgical Staff Who has the passion?

Slide 33

Training in Robotic Surgery Assessment of Goals Case Observation System Training Proctoring of Cases Adoption Measurement Memorial Hermann Texas Medical Center Surgical Innovation and Robotics Institute >1000 surgical teams trained

Slide 34

Surgeon Ergonomics A New Push to Get Comfortable 4 ergonomic settings

Slide 35

Renal Arteries in white light mode Renal arteries - fluorescence mode (NIR) Fluorescence Imaging on da Vinci Laser Excites IC-Green and Fluoresces New camera head can pass fluorescence signal Fluorescing signal overlaid with green hue in surgeon console

Slide 36

Robotic Stapler 13 mm diameter EndoWrist 45 mm reload White, green, blue reloads Product has not yet been submitted for FDA Clearance

Slide 37

Slide 38

Single-Site Instruments da Vinci Si System 8.5 mm Si Scope Curved instrument cannulae 5 mm, non-wristed, semi-rigid instruments Single-Site Port CE mark approved Product cleared by the FDA

Slide 39

Slide 40

Single Port Single Port Give da Vinci like performance through a single incision True multi-quadrant access Perhaps enable flexible devices for NOTES and SILS Future Robotic Architectures

Slide 41

Flexible Single Port Flexible Single Port Give da Vinci like performance through a single transendoscopic incision True multi-quadrant access NOTES can really work Future Robotic Architectures

Slide 42

Whats the Point of Robotic Bariatric Surgery? Precise two-layer hand suturing for optimal anastomoses to reduce leakage and stricture rates Standardized and reproducible surgery for the entire spectrum of BMI: 1) Large abdominal walls 2) Large visceral fat 3) Large livers Meticulous dissection and suturing for complex revision cases Dramatically improves surgeon ergonomics to minimize fatigue compared to laparoscopy Open elective operations will soon be no longer acceptable when digital platforms are fully matured. This time is closer than many might believe Single Incision and NOTES techniques will mature on robotic platforms

Slide 43

Summary Digital Platforms are enabling technology that allow for increased precision. This allows for eventual improved outcomes in minimally invasive surgery for surgeons committed to embracing the technology.

Slide 44

Summary I may NOT win this debate today, but in 3-5 years I will have won it. Its just a matter of time; after 20 cases come and tell me it cant help your practice of bariatric surgery.

Slide 45

Thank You Erik B. Wilson, MD, FACS Associate Professor and Vice Chair of Surgery Division Chief, Minimally Invasive Surgeons of Texas University of Texas Health Science Center at Houston