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Gregory Eads MD

Women’s Centre forWell Being

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

Uterus

Fallopian Tube

Ovary

Bladder

Urethra

Pubic Bone

Vagina

Rectum

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� 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

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� 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).

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---- PelvicPelvicPelvicPelvic---- Extra pelvicExtra pelvicExtra pelvicExtra pelvic�Umbilicus.� Scars (Lap.).� Lungs & plura.�Others.

Eads

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� 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

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• 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

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� 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 hysterectomySupracervical hysterectomySupracervical hysterectomySupracervical hysterectomy

◦ Total hysterectomyTotal hysterectomyTotal hysterectomyTotal hysterectomy

◦ Radical hysterectomyRadical hysterectomyRadical hysterectomyRadical hysterectomy*Removal of ovaries & fallopian tubes depends upon *Removal of ovaries & fallopian tubes depends upon *Removal of ovaries & fallopian tubes depends upon *Removal of ovaries & fallopian tubes depends upon pathologypathologypathologypathology

� Lymph node removal for cancer staging

� Myomectomy

� Vaginal suspension

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� 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

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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�ObesityObesityObesityObesity

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

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� 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

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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

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da Vinci® System patented EndoWrist®

instruments are small and fit through keyhole incisions

Small “Wristed” Instruments Through Keyhole Incisions

� EndoWrist®

Instruments fit through dime-sized incisions

� A wide range of instruments are available

Surgeon has…

� Improved visualization

� Better instrumentation,

surgical control & precision

� Better surgical dexterity

for complex aspects of

procedure

� Easier & faster suturing

� Better ergonomicsDouble-click to view video

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� 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 cancerCervical cancerCervical cancerCervical cancer�Conventional laparoscopy not widely accepted

• Endometrial cancerEndometrial cancerEndometrial cancerEndometrial cancer�Conventional laparoscopy accepted, but technically difficult to perform

• Vaginal or uterine prolapseVaginal or uterine prolapseVaginal or uterine prolapseVaginal or uterine prolapse�Conventional laparoscopic suturing not reliable

• EndometriosisEndometriosisEndometriosisEndometriosis• Uterine fibroidsUterine fibroidsUterine fibroidsUterine fibroids•Obese patientsObese patientsObese patientsObese patients

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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

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� 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.

� 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

da Vinci® Myomectomy

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� High-mag 3D visualization

of tissue planes for more

precise dissection & enucleation

� Enhanced dexterity facilitates enucleation of

larger myomas

� Precise, 3-layer suture

reconstruction of uterusVideo courtesy of Arnold Advincula, M.D.

Double-click to view video

• Sacral colpopexy considered gold standardfor vaginal vault prolapse�<5% performed with laparoscopy<5% performed with laparoscopy<5% performed with laparoscopy<5% performed with laparoscopy�Difficult dissections & extensive suturingDifficult dissections & extensive suturingDifficult dissections & extensive suturingDifficult dissections & extensive suturing

• da Vinci enables endoscopic approachfor sacral colpopexy

• The unsurpassed visualization & dexterity of da Vinci System provide:�Greater ability to visualize & dissect vaginal vault & sacral Greater ability to visualize & dissect vaginal vault & sacral Greater ability to visualize & dissect vaginal vault & sacral Greater ability to visualize & dissect vaginal vault & sacral promontory for accurate graft attachmentpromontory for accurate graft attachmentpromontory for accurate graft attachmentpromontory for accurate graft attachment

�More precise, faster & easier suturingMore precise, faster & easier suturingMore precise, faster & easier suturingMore precise, faster & easier suturingo Attach graft to anteriorAttach graft to anteriorAttach graft to anteriorAttach graft to anterior----posterior vaginal wall & sacrumposterior vaginal wall & sacrumposterior vaginal wall & sacrumposterior vaginal wall & sacrumo Retroperitonealize graftRetroperitonealize graftRetroperitonealize graftRetroperitonealize graft

�Enables Urogyns to offer the benefits of MIS to their patientsEnables Urogyns to offer the benefits of MIS to their patientsEnables Urogyns to offer the benefits of MIS to their patientsEnables 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

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� 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

Video courtesy of Javier F. Magrina, M.D.

Double-click to view video

� 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 & 4th 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

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da Vinci® Gynecology

Improving Quality of Life for Women

S M

odel

Updates

Si Model

Updates

• 3D HD Vision (720p) • Multi-quadrant access• Interactive video displays

• Enhanced HD Vision (1080i)• Dual Console option• Upgradable architecture

• 3D Vision• EndoWrist Instrumentation• Intuitive® MotionC

ore

Technology

Surgeon Training

Future PlatformsAdvanced Imaging

Advanced Instrumentation

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EADS

� 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

EADS

�45°articulating tip

�Control suction and irrigation from the surgeon console

�Ideal teaching tool for dual console

EADS

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◦ Designed to seal & cut Designed to seal & cut Designed to seal & cut Designed to seal & cut up to 7mm dia. vesselsup to 7mm dia. vesselsup to 7mm dia. vesselsup to 7mm dia. vessels

◦ Single use disposableSingle use disposableSingle use disposableSingle use disposable

◦ 8mm dia. Instrument8mm dia. Instrument8mm dia. Instrument8mm dia. Instrument

◦ Compact snake wristCompact snake wristCompact snake wristCompact snake wrist

Product is pending FDA Clearance

EADS

◦ 12mm diameter12mm diameter12mm diameter12mm diameter

◦ Wristed articulation in Wristed articulation in Wristed articulation in Wristed articulation in two directionstwo directionstwo directionstwo directions

◦ 45mm reload 45mm reload 45mm reload 45mm reload

◦ White, green, blue reWhite, green, blue reWhite, green, blue reWhite, green, blue re----loadsloadsloadsloads

Product has not yet been submitted for FDA Clearance

EADS

EADS

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� 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

EADS

� 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

EADS

� “Back-pack” ad on

� da Vinci Si compatible

� Works with any console

� 33 skill-based exercises

EADS

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� Integrated into the surgeon console

� Quantitatively measures proficiency

� Open source platform

EADS

MetricExpert(>100 cases)

Intermediate(50 – 100 cases)

Novice(0 cases)

P-Value (Expert-Intermediate)

P-Value (Expert-Novice)

N 14 23 17

Overall score (%) 88.4 75.6 62.8 0.0004 <0.0001

Comparison of performance metric medians between groups

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

EADS

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EADS

� 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

EADS

� Technology Summary:◦ Specialized hardware and software

◦ Indocyanine Green (ICG)

� Approved for: ◦ Vascular identification

◦ Soft tissue perfusion

◦ Solid organ perfusion (liver, kidney)

White Light

Fluorescence

EADS

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ICG binds to albumin protein

ICG injected into bloodstream

Excitation laser light from illuminator

Return signal from fluorescing ICG

EADS

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

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EADS

� Extend the patient value of da Vinci to single-access surgery

� Improve reproducibility, safety and outcomes of single-access surgery

� Provide a platform that enables more surgeons to perform more procedures via single-access

EADS

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Single-Site for da Vinci

� Stable, 3D HD visualization

� Precise, ergonomic control

� Restores triangulation

Laparoscopic Single Port

� Unstable 2D in-line optics

� Instrument crowding

� Lack of triangulation

CE Mark Approved

Product is pending Clearance by the FDA

Port Cannulas Instruments

CE Mark Approved

Product is pending Clearance by the FDA

EADS

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

EADS

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EADS

Summary

EADS