Gregory Eads MD Women s Centre for Well Being

Gregory Eads MD Women s Centre for Well Being 1 Program Gynecologic Conditions Surgical Options da Vinci Gynecologic Surgery da Vinci Hysterectomy da Vinci Hysterectomy for Cancer da Vinci Myomectomy (fibroids) da Vinci Sacrocolpopexy (vaginal prolapse) Summary Fibroids Pelvic masses Abnormal bleeding Endometriosis Pelvic floor disorders Pre-cancer Cancer Fallopian Tube Uterus Ovary Bladder Pubic Bone Urethra Rectum Vagina 1

Usually benign (0.01% are sarcomas) muscle growths of the uterus Most common gyn tumor present in 30% of women in reproductive age Majority are asymptomatic However, 75% of hysterectomies are performed for menorrhagia with fibroids Can occur on a stalk on the outside of the uterus. In the uterine wall, or on the inside of the uterus Exam Ultrasound MRI CT Laparoscopy Pressure to pain Menorrhagia Dyspareunia Infertility 2

Endometrial ablation Myomectomy open, laparoscopic, da Vinci, or hysteroscopic Uterine artery occlusion da Vinci or embolization Myolysis Medical GnRH agonist (Lupron) Hysterectomy open, vaginal, straight stick laparoscopic or da Vinci Presence of endometrial tissue outside the lining of the uterine cavity or Proliferation of endometrium in any site other than the uterine mucosa Age: common in reproductive period True Incidence Unknown:? 1-5% & 30 50 % infertility. Does NOT Discriminate by Race. Histology: Endometrial Glands with Stroma +/- Inflammatory Reaction. Hereditary ( among sisters). 3

- Pelvic - Extra pelvic Umbilicus. Scars (Lap.). Lungs & plura. Others. Eads 4

Abnormal cells Cervix (dysplasia) Endometrial lining (hyperplasia) Symptoms Cervix (dysplasia) is asymptomatic Diagnosed by PAP smear Endometrial lining (hyperplasia) often cause abnormal bleeding Diagnosed by office biopsy or D&C 5

Treatment options Cervix dysplasia often treated by removing part of the cervix Endometrial hyperplasia treated by hysterectomy Hormonal treatment is an experimental, short-term option Malignant growth or tumor Uterus or endometrium Cervix Ovary Ovarian Cancer Endometrial Cancer Cervical Cancer The most common gynecologic cancer Usually detected in an early stage Commonly causes post-menopausal bleeding Almost always treated with surgery 6

Can be detected by an abnormal PAP smear Symptoms include abnormal bleeding, discharge, or bleeding after intercourse Early stages usually treated with surgery Advanced stages treated with radiation/ chemotherapy Sometimes known as the silent killer Early cases are often curable Most women are diagnosed with advanced disease There is no screening test for ovarian cancer Hysterectomy* Supracervical hysterectomy Total hysterectomy Radical hysterectomy *Removal of ovaries & fallopian tubes depends upon pathology Lymph node removal for cancer staging Myomectomy Vaginal suspension 7

Most common female surgery Definitive solution for many uterine conditions 650,000 procedures annually Most performed through abdominal (open) incision Advances in minimally invasive surgery (MIS) for hysterectomy More GYN surgeons performing MIS for hysterectomy Open (abdominal) surgery Minimally invasive surgery (MIS) Vaginal surgery Conventional laparoscopic surgery da Vinci Hysterectomy (robot-assisted surgery) Reduced blood loss Fewer complications Shorter LOS Faster recovery Less scarring Circa. 1991 8

Pros Minimally invasive Less pain compared to abdominal hysterectomy Short length of stay (LOS) Cons Difficult to perform Reduced visualization Not indicated for many patients Nulliparious Multiple fibroids (or large masses) Cancer Adhesions, e.g., endometriosis, prior pelvic surgery Obesity Laparoscopic Surgery Minimally invasive surgery (MIS) Ability to operate through small keyhole incisions Camera and instruments fit through the keyhole incisions Better visualization than open surgery Evolution of Surgical Access Minimally invasive Ability to operate through small, keyhole incisions Better visualization than open surgery Open Vertical Incision Open Transverse Incision Laparoscopic Incision or da Vinci Surgical Incision 9

Surgeon operates from a 2D image Straight, rigid instruments (limited range of motion) Instrument tips controlled at a distance Reduced dexterity, precision & control Unsteady camera controlled by assistant Dependent on assistant for surgical support through accessory port Greater surgeon fatigue Makes complex operations more difficult How do we overcome these drawbacks? Better visualization Better instrument control Better dexterity for technically challenging aspects of the procedure Better ergonomics State-of-the-art robotic technology Surgeon in control Assistant has direct access 10

Surgeon immersed in 3D image of the surgical field Surgeon directs precise movements of the instruments using Console controls Conventional laparoscopic instruments are rigid with no wrists EndoWrist Instrument tips move like a human wrist Allows surgeon to operate with increased dexterity & precision 11

Small Wristed Instruments Through Keyhole Incisions da Vinci System patented EndoWrist instruments are small and fit through keyhole incisions EndoWrist Instruments fit through dime-sized incisions A wide range of instruments are available Double-click to view video Surgeon has Improved visualization Better instrumentation, surgical control & precision Better surgical dexterity for complex aspects of procedure Easier & faster suturing Better ergonomics 12

General laparoscopic surgery (2000) Radical prostatectomy (2001) Thoracoscopically assisted cardiotomy procedures (2002) Intracardiac procedures (2002) Coronary revascularization (2004) Urologic surgery (2005) Gynecologic laparoscopic surgery (2005) Total abdominal hysterectomy (TAH) Laparoscopically-assisted vaginal hysterectomy (LAVH) Total laparoscopic hysterectomy (TLH) Total supracervical hysterectomy (TSH) Now there is davinci Hysterectomy da Vinci Surgery appropriate for a broader range of gynecologic conditions & patient situations compared to conventional laparoscopy Cervical cancer Conventional laparoscopy not widely accepted Endometrial cancer Conventional laparoscopy accepted, but technically difficult to perform Vaginal or uterine prolapse Conventional laparoscopic suturing not reliable Endometriosis Uterine fibroids Obese patients 13

Goals of da Vinci Hysterectomy Enable more precise, meticulous dissection Around ureters & bladder Colpotomy Increase ability to visualize & dissect compromised anatomy & tissue planes Endometriosis, prior pelvic surgery (e.g., C-sections) Suture more easily & quickly Better vaginal cuff closure Provide benefits of minimally invasive surgery to vast majority of hysterectomy candidates 1 day LOS, minimal pain, quick recovery, cosmesis Enables GYNs to treat complex pathology endoscopically Unsurpassed precision, dexterity & control offer potential for: More precise & efficient dissections Ureters, vesico-uterine reflection, colpotomy Quicker, easier vaginal cuff closure Greater ability to perform MIS on more patient types Compromised anatomy & tissue planes, e.g., due to endometriosis & adhesive disease from prior pelvic surgeries Larger pathology Obese patients Enables GYNs to offer the potential benefits of MIS to more of their hysterectomy patients Short hospital stay Minimal blood loss Fewer complications Less risk of infection Significantly less pain Faster recovery Improved cosmesis Equivalent or better outcomes 14

40,000 procedures performed annually Most performed through abdominal (open) incision Size, number & location of fibroids may require complete removal of uterus Advances in minimally invasive surgery (MIS) for myomectomy More GYN surgeons performing MIS for myomectomy Goals of da Vinci Myomectomy Enable minimally invasive surgery (MIS) approach Conventional laparoscopy for myomectomy is very difficult to learn & perform Most myomectomies performed through open incision Enable women to retain their uterus* Provide means for women to preserve their fertility Provide benefits of MIS to myomectomy patients Short hospital stay Minimal pain & scarring Quick recovery & return to normal activities *Assumes women is a surgical candidate for myomectomy. da Vinci Myomectomy Enables MIS approach for myomectomy Open is standard; laparoscopy very difficult to learn/perform Effective 3-layer suture reconstruction difficult Concern over conversions & uterine rupture Most GYNs perform open or opt for hysterectomy instead Advantages over laparoscopy Better suture reconstruction & faster than laparoscopy Advantages over laparotomy Potential patient benefits associated with MIS Longer procedure times outweighed by improved outcomes Short LOS, min EBL, min comps or conversions, quick recovery, better cosmesis 15

High-mag 3D visualization of tissue planes for more precise dissection & enucleation Enhanced dexterity facilitates enucleation of larger myomas Double-click to view video Video courtesy of Arnold Advincula, M.D. Precise, 3-layer suture reconstruction of uterus Sacral colpopexy considered gold standard for vaginal vault prolapse <5% performed with laparoscopy Difficult dissections & extensive suturing da Vinci enables endoscopic approach for sacral colpopexy The unsurpassed visualization & dexterity of da Vinci System provide: Greater ability to visualize & dissect vaginal vault & sacral promontory for accurate graft attachment More precise, faster & easier suturing o Attach graft to anterior-posterior vaginal wall & sacrum o Retroperitonealize graft Enables Urogyns to offer the benefits of MIS to their patients Enables GYN Oncologists to offer the potential benefits of MIS to their early stage GYN cancer patients Short hospital stay Minimal blood loss Fewer complications Less risk of infection Significantly less pain Faster recovery Improved cosmesis Equivalent or better outcomes 16

Double-click to view video Video courtesy of Javier F. Magrina, M.D. Better access & visualization enable more precise dissection Precise, controlled dissection around arteries, veins, nerves Access to pelvic & aortic lymph nodes allows replication of open surgical techniques Reproducible for cervical & endometrial cancer Superior access, precision, and control Superior outcomes to open & laparoscopy Simplification of techniques Restores open surgical technique to MIS! Fewer instruments/exchanges & energy sources at my feet Surgeon control of camera & 4 th arm is a huge advantage Teachable to fellows & residents; will make MIS more generalizable Improved patient outcomes Shorter LOS, significantly less morbidity & post-op pain, faster recovery Has made me a better surgeon Surgical technique of choice now in my practice Benefit Open da Vinci Incision size Long incision with visible scaring 4-6 dime-sized incisions with minimal scaring Hospital stay 3-5 days 1-2 days Recovery 4-6 weeks 1-3 weeks Pain or discomfort Weeks Days Return to normal activities Weeks Days 17

da Vinci Gynecology Improving Quality of Life for Women Si Model Updates Enhanced HD Vision (1080i) Dual Console option Upgradable architecture S Model Updates 3D HD Vision (720p) Multi-quadrant access Interactive video displays Core Technology 3D Vision EndoWrist Instrumentation Intuitive Motion Advanced Instrumentation Surgeon Training Advanced Imaging Future Platforms 18

Evolve the EndoWrist instrument portfolio to meet the clinical needs of our surgeons Develop multi-functional instruments that increase efficiency, precision and surgeon autonomy Further enable more complex procedures for multispecialty robotic programs 45 articulating tip Control suction and irrigation from the surgeon console Ideal teaching tool for dual console 19

Designed to seal & cut up to 7mm dia. vessels Single use disposable 8mm dia. Instrument Compact snake wrist Product is pending FDA Clearance 12mm diameter Wristed articulation in two directions 45mm reload White, green, blue re- loads Product has not yet been submitted for FDA Clearance 20

Fundamentally improve the training paradigm for residents, fellows and attending surgeons Offer an ever-expanding array of technically and clinically relevant simulation exercises Create an ecosystem of content providers to rapidly innovate rich clinical content AAGL National Standards are pending for initial training, maintenance of skills and decreasing the variation in surgeon s time for cases: this will rely heavily on simulation Back-pack ad on da Vinci Si compatible Works with any console 33 skill-based exercises 21

Integrated into the surgeon console Open source platform Quantitatively measures proficiency Comparison of performance metric medians between groups Metric Expert (>100 cases) Intermediate (50 100 cases) N 14 23 17 Novice (0 cases) P-Value (Expert- Intermediate) P-Value (Expert- Novice) Overall score (%) 88.4 75.6 62.8 0.0004 <0.0001 HUNG, Andrew J., Zahnder P, Patil M, Gill I, Desai M (2011) Face, Content and Construct Validity of a novel da Vinci Surgical Simulator; American Urology Association (AUA), Washington, DC, May 17, 2011 216 simulators installed in the US since Dec., 2010 Installs split evenly between teaching and community hospitals Integration of da Vinci simulator in hospital credentialing process 22

Real time anatomy identification better than the naked eye allows Enhance visual feedback to make real-time clinical decisions Create foundational technologies for true image-guided surgery Technology Summary: Specialized hardware and software Indocyanine Green (ICG) Approved for: Vascular identification Soft tissue perfusion Solid organ perfusion (liver, kidney) White Light Fluorescence 23

Excitation laser light from illuminator ICG injected into bloodstream ICG binds to albumin protein Return signal from fluorescing ICG Urology Partial Nephrectomy Nephrectomy Pyeloplasty Prostatectomy General Surgery Splenectomy Esophagectomy Whipples Hepatic Resection Living Donor Kidney Transplant Gynecology Hysterectomy Sacrocolpopexy Colorectal Colectomy Low Anterior Resection APR Thoracic Thymectomy Mediastinal Tumor Resection Head and Neck TORS Radical Tonsilectomy 24

Extend the patient value of da Vinci to singleaccess surgery Improve reproducibility, safety and outcomes of single-access surgery Provide a platform that enables more surgeons to perform more procedures via single-access 25

Laparoscopic Single Port Single-Site for da Vinci Unstable 2D in-line optics Instrument crowding Lack of triangulation Stable, 3D HD visualization Precise, ergonomic control Restores triangulation CE Mark Approved Product is pending Clearance by the FDA Port Cannulas Instruments CE Mark Approved Product is pending Clearance by the FDA da Vinci Si System 8.5 mm Si Scope Curved instrument cannulae 5 mm, non-wristed, semi-rigid instruments Single-Site Port da Vinci software restores Intuitive control CE Mark Approved Product is pending Clearance by the FDA 26

Summary 27