PROGRAM CHAIR PROGRAM CO-CHAIR Isabel C. Green, MD · final safeguards in assuring that a CME...

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AAGLAdvancing Minimally Invasive Gynecology Worldwide

A Practical Guide for Hysteroscopy

in the Offi ce (Didactic)

PROGRAM CHAIR

Amy L. Garcia, MD

PROGRAM CO-CHAIR

Isabel C. Green, MD

Andrew I. Brill, MD Micah Harris, MD Eileen C. Young, RN

Professional Education Information Target Audience Educational activities are developed to meet the needs of surgical gynecologists in practice and in training, as well as, other allied healthcare professionals in the field of gynecology. Accreditation AAGL is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. The AAGL designates this live activity for a maximum of 3.75 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity. DISCLOSURE OF RELEVANT FINANCIAL RELATIONSHIPS As a provider accredited by the Accreditation Council for Continuing Medical Education, AAGL must ensure balance, independence, and objectivity in all CME activities to promote improvements in health care and not proprietary interests of a commercial interest. The provider controls all decisions related to identification of CME needs, determination of educational objectives, selection and presentation of content, selection of all persons and organizations that will be in a position to control the content, selection of educational methods, and evaluation of the activity. Course chairs, planning committee members, presenters, authors, moderators, panel members, and others in a position to control the content of this activity are required to disclose relevant financial relationships with commercial interests related to the subject matter of this educational activity. Learners are able to assess the potential for commercial bias in information when complete disclosure, resolution of conflicts of interest, and acknowledgment of commercial support are provided prior to the activity. Informed learners are the final safeguards in assuring that a CME activity is independent from commercial support. We believe this mechanism contributes to the transparency and accountability of CME.

Table of Contents

Course Description ........................................................................................................................................ 1 Disclosure ...................................................................................................................................................... 3 Getting Started with Hysteroscopic Procedures in Your Office: Patient Safety, Regulation and Financial Considerations M. Harris ....................................................................................................................................................... 5 Local Anesthesia, Oral and Injectable Medication for Office Procedures I.C. Green .................................................................................................................................................... 15 Diagnostic Hysteroscopy: Evaluation of the Uterine Cavity and Preoperative Decision Making A.L. Garcia .................................................................................................................................................. 20 Office Operative Hysteroscopic Procedures: Directed Biopsy, Polypectomy, Metroplasty and IUD Retrieval A.L. Garcia .................................................................................................................................................. 27 Hysteroscopic Sterilization: The Essure Procedure in the Office I.C. Green .................................................................................................................................................... 31 Hysteroscopic Morcellators: What’s on the Horizon for Hysteroscopic Polypectomy and Myomectomy in the Office? A.I. Brill ....................................................................................................................................................... 37 Identifying and Managing Hysteroscopic Complications in the Office M. Harris ..................................................................................................................................................... 46 Equipment Maintenance: The Rigid and Flexible Hysteroscope E.C. Young .................................................................................................................................................. 52 Cultural and Linguistics Competency ......................................................................................................... 55

PG 208 A Practical Guide for Hysteroscopy in the Office (Didactic)

Amy L. Garcia, Chair

Isabel C. Green, Co-Chair

Faculty: Andrew I. Brill, Micah Harris, Eileen C. Young

Course Description This course provides the practical guidance necessary to perform hysteroscopic procedures safely and efficiently in the office setting. Designed for the gynecologist who wants to overcome common barriers, this course offers essential instruction, tools and information needed to begin or enhance a comprehensive in-office hysteroscopy practice. The course addresses billing and coding issues including RVU with CPT codes for hysteroscopic procedures and use of modifiers for reimbursement. Patient counseling, informed consent and documentation of procedures. Patient safety and regulatory guidelines, procedure checklists and personnel requirements guide the participant. Equipment acquisition, set-up and maintenance for both rigid and flexible hysteroscopes are presented. Office use of local anesthesia and oral medication for hysteroscopic procedures is examined in detail. Video based didactics address specific office operative hysteroscopic procedures in depth including tips, tricks and troubleshooting techniques as well as identification and management of office hysteroscopic complications.

Course Objectives At the conclusion of this course, the participant will be able to: 1) Implement patient safety regulations and safety protocols for in-office procedures; 2) use correct coding and billing to maximize reimbursement for office hysteroscopic procedures; 3) appropriately counsel patients regarding in-office hysteroscopic procedures, obtain informed consent and document procedures correctly; 4) acquire, set-up and maintain equipment and supplies needed for office hysteroscopic procedures; 5) use cervical anesthesia, oral and injectable medication effectively for patient comfort with office hysteroscopic procedures; 6) utilize hysteroscopy for in office procedures such as biopsy, polypectomy, myomectomy, metroplasty, sterilization and IUD removal; 7) discern new technologies for hysteroscopic morcellation of polyps and myomas in the office; and 8) identify and address common complications encountered with office hysteroscopic procedures.

Course Outline

8:00 Welcome, Introductions and Course Overview A.L. Garcia 8:05 Getting Started with Hysteroscopic Procedures in Your Office: Patient Safety,

Regulation and Financial Considerations M. Harris

8:30 Local Anesthesia, Oral and Injectable Medication for Office Procedures I.C. Green

8:55 Diagnostic Hysteroscopy: Evaluation of the Uterine Cavity and

Preoperative Decision Making A.L. Garcia

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9:20 Office Operative Hysteroscopic Procedures: Directed Biopsy, Polypectomy,

Metroplasty and IUD Retrieval A.L. Garcia

9:45 Questions & Answers All Faculty 9:55 Break 10:10 Hysteroscopic Sterilization: The Essure Procedure in the Office I.C. Green

10:35 Hysteroscopic Morcellators: What’s on the Horizon for Hysteroscopic Polypectomy

and Myomectomy in the Office? A.I. Brill

11:00 Identifying and Managing Hysteroscopic Complications in the Office M. Harris

11:25 Equipment Maintenance: The Rigid and Flexible Hysteroscope E.C. Young

11:50 Questions & Answers All Faculty 12:00 Course Evaluation

2

PLANNER DISCLOSURE The following members of AAGL have been involved in the educational planning of this workshop and have no conflict of interest to disclose (in alphabetical order by last name). Art Arellano, Professional Education Manager, AAGL* Viviane F. Connor Consultant: Conceptus Incorporated Frank D. Loffer, Executive Vice President/Medical Director, AAGL* Linda Michels, Executive Director, AAGL* Jonathan Solnik Other: Lecturer - Olympus, Lecturer - Karl Storz Endoscopy-America SCIENTIFIC PROGRAM COMMITTEE Arnold P. Advincula Consultant: CooperSurgical, Ethicon Women's Health & Urology, Intuitve Surgical Other: Royalties - CooperSurgical Linda Bradley Grants/Research Support: Elsevier Consultant: Bayer Healthcare Corp., Conceptus Incorporated, Ferring Pharmaceuticals Speaker's Bureau: Bayer Healthcare Corp., Conceptus Incorporated, Ferring Pharm Keith Isaacson Consultant: Karl Storz Endoscopy Rosanne M. Kho Other: Honorarium - Ethicon Endo-Surgery C.Y. Liu* Javier Magrina* Ceana H. Nezhat Consultant: Intuitve Surgical, Lumenis, Karl Storz Endoscopy-America Speaker's Bureau: Conceptus Incorporated, Ethicon Women's Health & Urology William H. Parker Grants/Research Support: Ethicon Women's Health & Urology Consultant: Ethicon Women's Health & Urology Craig J. Sobolewski Consultant: Covidien, CareFusion, TransEnterix Stock Shareholder: TransEnterix Speaker's Bureau: Covidien, Abbott Laboratories Other: Proctor - Intuitve Surgical FACULTY DISCLOSURE The following have agreed to provide verbal disclosure of their relationships prior to their presentations. They have also agreed to support their presentations and clinical recommendations with the “best available evidence” from medical literature (in alphabetical order by last name). Amy L. Garcia Grants/Research Support: Hologic Consultant: Conceptus Incorporated, Ethicon Endo-Surgery, Ethicon Women's Health & Urology, IOGYN, Minerva Surgical Speaker's Bureau: Conceptus Inc. Isabel C. Green*

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Andrew I. Brill Consultant: Karl Storz Endoscopy-America, Ethicon Endo-Surgery, Conceptus Incorporated, CooperSurgical Speaker's Bureau: Karl Storz Endoscopy-America, Ethicon Endo-Surgery, Conceptus Incorporated, CooperSurgical Micah Harris Grants/Research Support: Halt Medical Eileen C. Young Other: Employee - Olympus Gary N. Frishman* Asterisk (*) denotes no financial relationships to disclose.

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Principles of Office Based Gynecologic Surgery

Office Based Hysteroscopy:Office Based Hysteroscopy:

MICAH HARRIS M.D.

OB/GYN CONSULTANTS ANDWOMEN’S HEALTH RESEARCH

PHOENIX, AZ

Safety and RegulationSafety and Regulation


Office Based Hysteroscopy

Grants/Research Support: Halt Grants/Research Support: Halt MedicalMedicalpppp


Office Based Hysteroscopy

At the conclusion of this activity, the participant will be able to:

List patient co-morbidities that are contraindications to office surgery.

List qualities of surgical procedures that make them f ffappropriate for the office setting.

List the Levels of Office-Based Surgery

List important features of an office-based surgical practice to promote patient safety.

Describe the types of documentation necessary to maintain an office-based surgical practice

List the various agencies and associations that have published guidelines concerning office-based surgery


So Many New Procedures..


Gynecologic Surgery in the Office:Overview

Gynecology is a procedureGynecology is a procedure--based specialtybased specialty Range from very minor (Range from very minor (egeg, Pap smear) to very , Pap smear) to very

major (major (egeg, hysterectomy and pelvic support), hysterectomy and pelvic support)

Majority of income is from proceduresMajority of income is from proceduresj y pj y p Better income per hour spent of actual effortBetter income per hour spent of actual effort

Income potential diluted by associated activitiesIncome potential diluted by associated activities PaperworkPaperwork

Travel between office and surgery centers or hospitalsTravel between office and surgery centers or hospitals

PeriPeri--operative care operative care –– nonnon--operative time with patientoperative time with patient


Gynecologic Surgery in the Office:Overview

Traditional procedure model keeps us out of Traditional procedure model keeps us out of the officethe office Hospitals or surgery centersHospitals or surgery centers

Time out of office is not reimbursedTime out of office is not reimbursed

Must become more efficientMust become more efficient Integrate procedures into office when possibleIntegrate procedures into office when possible

Allows greater productivityAllows greater productivity

Work smarter, not longer!Work smarter, not longer!

5


Gynecologic Surgery in the Office:General Considerations

Must be the correct surgeonMust be the correct surgeon Must be the correct patientMust be the correct patient Must be the correct procedureMust be the correct procedure Patient safety a priority!Patient safety a priority! Patient safety a priority!Patient safety a priority!


Gynecologic Surgery in the Office:Patient Selection

Patient Selection (ASA class I or II)Patient Selection (ASA class I or II)

Avoid CoAvoid Co--morbid conditionsmorbid conditions AnxietyAnxiety

AsthmaAsthma

ObesityObesity

Heart diseaseHeart disease

Psychosocial issuesPsychosocial issues Prior experience with office proceduresPrior experience with office procedures

Realistic patient expectationsRealistic patient expectations


Gynecologic Surgery in the Office:Procedure Choice

Appropriate for performing in officeAppropriate for performing in office Brief and focusedBrief and focused Not overly complicatedNot overly complicated Basic technological requirementsBasic technological requirementsg qg q

Anticipation of patient comfortAnticipation of patient comfort How long will patient be immobilized?How long will patient be immobilized? Comfortable table / bed for patientComfortable table / bed for patient Adequate room / time for recoveryAdequate room / time for recovery Anticipation of analgesiaAnticipation of analgesia

Reasonable anticipation of patient safetyReasonable anticipation of patient safety


Gynecologic Surgery in the Office:Procedure Choice

Safe and effective proceduresSafe and effective procedures Minimal analgesia / anesthesia requirementsMinimal analgesia / anesthesia requirements

No increase in liabilityNo increase in liability

Easy to learn and performEasy to learn and perform

I d i b tI d i b t Improved reimbursementImproved reimbursement Global fee for inGlobal fee for in--office proceduresoffice procedures

Efficient use of timeEfficient use of time

Reasonable capital investmentReasonable capital investment Leasing incentivesLeasing incentives

Cost per procedure based on volumeCost per procedure based on volume


Office Surgery Patient Safety Issues

Increasing number of office Increasing number of office proceduresprocedures

Less oversight and scrutinyLess oversight and scrutiny

ACOG Presidential Task Force on ACOG Presidential Task Force on Office SurgeryOffice Surgery “Patients have a right to expect the “Patients have a right to expect the

same level of safety regardless of where same level of safety regardless of where they seek treatment.”they seek treatment.”


Gynecologic Surgery in the Office:Safety and Regulatory Considerations

Patient safety must remain primaryPatient safety must remain primary Desire for convenience should NOT increase riskDesire for convenience should NOT increase risk

Desire for convenience should NOT trump safetyDesire for convenience should NOT trump safety

Accreditation requirements by certain statesAccreditation requirements by certain states Accreditation requirements by certain statesAccreditation requirements by certain states

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Consider outpatient surgery guidelines ofConsider outpatient surgery guidelines of ACOG monograph on ambulatory proceduresACOG monograph on ambulatory procedures

American College of Surgeons (ACS)American College of Surgeons (ACS) www facs orgwww facs orgwww.facs.orgwww.facs.org

American Association of Anesthesiologists (ASA)American Association of Anesthesiologists (ASA) www.asahq.orgwww.asahq.org

Professional liability insurersProfessional liability insurers

State (governmental) regulatory agencies State (governmental) regulatory agencies


Office Surgery Patient Safety Issues

Florida Board of Medicine 4/2000 to 4/2002Florida Board of Medicine 4/2000 to 4/2002 Adverse incidents Adverse incidents

Office 66 per 100,000 proceduresOffice 66 per 100,000 procedures ASC 5.3 per 100,000 proceduresASC 5.3 per 100,000 procedures Relative risk: Office vs ASCRelative risk: Office vs ASC 12.4 12.4 (95% (95%

confidence interval, 9.5confidence interval, 9.5--16.2) 16.2) Death rate Death rate

Office 9.2 per 100,000 procedures Office 9.2 per 100,000 procedures ASC 0.78 per 100,000 proceduresASC 0.78 per 100,000 procedures Relative risk: Office vs ASC Relative risk: Office vs ASC 11.811.8 (95% (95%

confidence interval, 5.8confidence interval, 5.8--24.1), respectively24.1), respectively


ACOG: Quality and Safety in Women’s Health Care


www.facs.org/patientsafety/patientsafety.html


www.asahq.org/publicationsAndServices/standards/12.pdf

7


Levels of Anesthesia

I 32 4


Levels of Office Based Surgery

Level I Level I -- local anesthetic with minimal local anesthetic with minimal preoperative oral anxiolyticpreoperative oral anxiolytic

Level II Level II –– Moderate sedationModerate sedation

Level III Level III –– Deep sedation or General Deep sedation or General anesthesiaanesthesia


Getting Started

Identify a Medical DirectorIdentify a Medical Director

Create ChecklistsCreate Checklists

Initiate DrillsInitiate Drills

Maintain a LogMaintain a Log


Getting Started

Identify a Medical DirectorIdentify a Medical Director A designated partner in the practice, or A designated partner in the practice, or

yourself if a solo practitioner.yourself if a solo practitioner.

Responsible for overseeing regulatoryResponsible for overseeing regulatory Responsible for overseeing regulatory Responsible for overseeing regulatory and safety concerns, including and safety concerns, including credentialing and protocols.credentialing and protocols.


Getting Started:Checklists

Create and use checklists for each Create and use checklists for each casecase

Promotes consistent Promotes consistent behaviourbehaviour

Provides documentation for ongoing Provides documentation for ongoing quality monitoring or external quality monitoring or external reviewersreviewers


Checklists for Office Based Surgery

PreoperativePreoperative Informed consent, Patient RightsInformed consent, Patient Rights

History/Physical, workHistory/Physical, work--up and resultsup and results

Current medications, past reactionsCurrent medications, past reactions

Confirmation NPO statusConfirmation NPO status

Airway assessment Airway assessment

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IntraoperativeIntraoperative Surgical Time OutSurgical Time Out

Record of medications administeredRecord of medications administered

Vital signs at 5 minute intervalsVital signs at 5 minute intervals Blood pressureBlood pressure

PulsePulse

Oxygen saturationOxygen saturation

End Tidal CO2 (optional)End Tidal CO2 (optional)



PostoperativePostoperative Return of vital signs to within 20% of Return of vital signs to within 20% of

baselinebaseline

Other signs: Bleeding swellingOther signs: Bleeding swelling Other signs: Bleeding, swellingOther signs: Bleeding, swelling

Discharge instructionsDischarge instructions

Driver for procedures having required Driver for procedures having required any sedationany sedation

Follow up phone call within 48 hoursFollow up phone call within 48 hours


Mock Drills

Performed quarterlyPerformed quarterly

Involve specifically identified Involve specifically identified individuals in the office (e.g. in the individuals in the office (e.g. in the

t f Ti ill llt f Ti ill llevent of an emergency Tim will call event of an emergency Tim will call 911.)911.)

Physically rehearsed for particular Physically rehearsed for particular scenariosscenarios


Mock Drills

Recommended Scenarios Recommended Scenarios Vasovagal ReactionVasovagal Reaction

Local anesthetic toxicityLocal anesthetic toxicity

Allergic reactionAllergic reaction

HemorrhageHemorrhage

Respiratory arrest/excessive sedationRespiratory arrest/excessive sedation


Create a Procedure Log

Documentation in addition to that in Documentation in addition to that in patient chartpatient chart

Essential for ongoing review, quality Essential for ongoing review, quality ttassessmentassessment

Documentation of compliance and Documentation of compliance and safety in one separate locationsafety in one separate location

Necessary should accreditation be Necessary should accreditation be soughtsought


Accreditation

Worthwhile if all recommendations Worthwhile if all recommendations followed and documentedfollowed and documented

Process may assist in setting up Process may assist in setting up t lt lprotocolsprotocols

Many agencies availableMany agencies available

Not required in all instancesNot required in all instances State Board of MedicineState Board of Medicine

Malpractice InsurerMalpractice Insurer

Third Party Third Party PayorsPayors

9


Gynecologic Surgery in the Office: www.jointcommission.org


Gynecologic Surgery in the Office:Patient Safety

General ConsiderationsGeneral Considerations Strict adherence to indications / contraindicationsStrict adherence to indications / contraindications

Thorough evaluation in advanceThorough evaluation in advancegg Imaging and other testingImaging and other testing

No surprises in procedure roomNo surprises in procedure room

Not the time or place for “atypical patient”Not the time or place for “atypical patient”


Gynecologic Surgery in the Office:Transition to Office

More than just a change in locationMore than just a change in location Start with full sedation in operating roomStart with full sedation in operating room

Become totally comfortable with techniqueBecome totally comfortable with technique

Slowly lessen level of anesthesiaSlowly lessen level of anesthesia

Achieve minimum needed anesthesia levelAchieve minimum needed anesthesia level Balance between comfort and alertnessBalance between comfort and alertness

Mimic office conditions in OR before moveMimic office conditions in OR before move Use only instruments you have in officeUse only instruments you have in office


Gynecologic Surgery in the Office:Transition to Office

Know indications / contraindicationsKnow indications / contraindications

Complete comfort with procedureComplete comfort with procedure

Review IFU completelyReview IFU completely

Have written protocols in placeHave written protocols in place

Have emergency contingency planHave emergency contingency plan

Not the time or place for “atypical” procedureNot the time or place for “atypical” procedure


Gynecologic Surgery in the Office:Patient Analgesia

Learn from our oral surgeon colleaguesLearn from our oral surgeon colleagues

Comfort, convenience and safety NOT mutually exclusiveComfort, convenience and safety NOT mutually exclusive


ASA Physical Status Classification System

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ASA Status and Mortality


Recommendation

Only ASA Status 1 or 2 in officeOnly ASA Status 1 or 2 in office

PrescreeningPrescreening Adverse rxn to local anesthesia (personal or FH)Adverse rxn to local anesthesia (personal or FH)

Previous failure with local anesthesia or low painPrevious failure with local anesthesia or low pain Previous failure with local anesthesia or low pain Previous failure with local anesthesia or low pain thresholdthreshold

An acute respiratory processAn acute respiratory process

Failure to comply with preoperative dietary restrictionsFailure to comply with preoperative dietary restrictions

Substance abuseSubstance abuse

HighHigh--risk airway assessmentrisk airway assessment

Abnormal blood sugarsAbnormal blood sugars

Pregnancy (unless procedure is pregnancy related)Pregnancy (unless procedure is pregnancy related)


Mallampati Airway ClassificationPrinciples of Office Based Gynecologic Surgery

Recommendation

Ability to Rescue PatientsAbility to Rescue Patients Level ILevel I

BLS trainingBLS training

Emergency equipment for cardiorespiratory support and Emergency equipment for cardiorespiratory support and t t t f h l it t t f h l itreatment of anaphylaxistreatment of anaphylaxis

Level IILevel II Min of 2 staff Min of 2 staff ––

Physician/ surgeonPhysician/ surgeon

Health care professional with ACLS trainingHealth care professional with ACLS training

TimeTime--OutsOuts


Office Procedure Examples

Hysteroscopic sterilizationHysteroscopic sterilization

Endometrial ablationEndometrial ablation


Local Anesthetic Toxicity

Agent Duration Maximum Dose

1% Lidocaine 30-60 min 4.5 mg/kg

1% Lidocaine with Epinephrine

120-360 min 7 mg/kg

0.25% Marcaine 120-240 min 2.5 mg/kg

0.25% Marcainewith Epinephrine

180-420 minDo not exceed 225 mg

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Gynecologic Surgery in the Office:Patient Analgesia

Dedicated patient monitoringDedicated patient monitoring Surgeon should focus on procedure, not patientSurgeon should focus on procedure, not patient

Must have dedicated person to monitor patientMust have dedicated person to monitor patientMust have dedicated person to monitor patientMust have dedicated person to monitor patient

Emergency measuresEmergency measures ACLS certificationACLS certification

Resuscitation / stabilization equipmentResuscitation / stabilization equipment


Endometrial Ablation in the Office:Medicare Fee Schedule


Procedure Billing

Procedure Code Place of Service Code

Professional Fee(facility)21, 22, 24

Professional Fee(non-facility)11

Tells insurance company what you did

Tells insurance company where you did it

11: in office21: inpt hospital22: outpt hospital24: ASC

Fee for service goes to you

Fee for providing equipment, room, staff, etc goes to facility

Fee for service goes to you

Fee for providing equipment, room, staff, etc ALSO goes to you


CPT Codes

ProcedureProcedure RVU’sRVU’s

Office HSC Sterilization Office HSC Sterilization 53.9353.93

Hospital HSC SterilizationHospital HSC Sterilization 11.6111.61

Office HSC AblationOffice HSC Ablation 58.2858.28

Office Her OptionOffice Her Option 6464Office Her OptionOffice Her Option 6464

Hospital HSC AblationHospital HSC Ablation 9.489.48

Office HSC with biopsyOffice HSC with biopsy 7.837.83

Endometrial biopsyEndometrial biopsy 2.982.98

Office CystoscopyOffice Cystoscopy 5.775.77

Saline infusion sonogramSaline infusion sonogram 44

Laparoscopic TubalLaparoscopic Tubal 9.79.7

Vaginal HysterectomyVaginal Hysterectomy 2222

Global Obstetrical feeGlobal Obstetrical fee 47.447.4


ConsultationConsultation

Endometrial BiopsyEndometrial Biopsy

UltrasoundUltrasound

SIS + guidance + SIS + guidance + infusioninfusion

HysteroscopyHysteroscopy

ProcedureProcedure FollowFollow--upup

Procedures in the Office:Evaluation and Management

Consult?Consult?New patient?New patient?Established Established

patient?patient?

At time of consult?At time of consult?Unique visit?Unique visit?

Modifiers?Modifiers?

Type?Type?Where?Where?

Global?Global?


Procedures in the Office:Reimbursement for Evaluation

CodeCode ProcedureProcedure Work Work RVURVU

NonNon--FacilityFacility

PE RVUPE RVUMP MP

RVURVU

NonNon--Facility Facility

TotalTotalConversionConversion ReimbursementReimbursement

9924399243 Office Office ConsultConsult 1.721.72 1.391.39 0.130.13 3.243.24 37.89737.897 $ 122.79$ 122.79

7683076830

5834058340

7683176831

TVUSTVUS

Cath for SISCath for SIS

SISSIS

0.690.69

0.880.88

0.720.72

1.751.75

3.163.16

1.771.77

0.130.13

0.090.09

0.130.13

2.572.57

4.134.13

2.622.62

37.89737.897

37.89737.897

37.89737.897

$ 97.40$ 97.40

$ 156.52$ 156.52

$ 99.29$ 99.29

5855858558HysteroscopHysteroscop

y with y with BiopsyBiopsy

4.474.47 2.172.17 0.570.57 7.487.48 37.89737.897 $ 283.47$ 283.47

Total reimbursement: up to $ 759.47Total reimbursement: up to $ 759.47

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Procedures in the Office:Reimbursement for Procedure

CodeCode ProcedureProcedure Work Work RVURVU

FacilityFacility

PE RVUPE RVUMP MP

RVURVUFacility Facility TotalTotal ConversionConversion ReimbursementReimbursement

5856358563HysteroscopyHysteroscopy, endometrial , endometrial

ablationablation6.166.16 2.752.75 0.740.74 9.659.65 37.89737.897 $ 365.71$ 365.71

5856358563HysteroscopyHysteroscopy, endometrial , endometrial

ablationablation6.166.16

56.1956.19

NonNon--facilityfacility

0.740.7463.0963.09

NonNon--facilityfacility

37.89737.897 $ 2390.05$ 2390.05

Place of Service: inpatient hospital (21); outpatient hospital (22); ambulatory surgery center (24)Place of Service: inpatient hospital (21); outpatient hospital (22); ambulatory surgery center (24)

Place of Service: in office (11)Place of Service: in office (11)


Procedures in the Office:Effective Reimbursement in Office

Procedure ReimbursementProcedure Reimbursement $ 3000.00$ 3000.00

Device (approximate cost)Device (approximate cost) -- $ 1300 00$ 1300 00Device (approximate cost) Device (approximate cost) -- $ 1300.00$ 1300.00

Disposables (drapes / drugs)Disposables (drapes / drugs) -- $ 100.00$ 100.00

CRNA*CRNA* -- $ 250.00$ 250.00

Effective ReimbursementEffective Reimbursement $ 1350.00$ 1350.00

* * CRNA may be able to bill independentlyCRNA may be able to bill independently


Procedures in the Office:Follow-up Visits

Global IntervalGlobal Interval Hysterectomy Hysterectomy –– 90 days90 days

Ablation Ablation –– 0 days0 days


Procedures in the Office:Summary

Can be performed easily in officeCan be performed easily in office Adequate preparation / trainingAdequate preparation / training Logical progression from OR to officeLogical progression from OR to office

Can be performed safely in officeCan be performed safely in office Can be performed safely in officeCan be performed safely in office Adherence to indications / contraindicationsAdherence to indications / contraindications Adherence to published guidelinesAdherence to published guidelines

Is well accepted by (selected) patientsIs well accepted by (selected) patients does not need to be uncomfortabledoes not need to be uncomfortable More comfortable for someMore comfortable for some Perceived as more “confidential”Perceived as more “confidential”


Procedures in the Office:Summary

Increases practice diversityIncreases practice diversity Can offer procedures in hospital or in officeCan offer procedures in hospital or in office

Ease of schedulingEase of schedulingEase of schedulingEase of scheduling

Reduces time spent out of officeReduces time spent out of office

Optimize office space and personnelOptimize office space and personnel


Office Hysteroscopy

13

Office-Based Surgery

Office Based Surgery Resident Didactic October 2011

Thank youThank you


References

1.1. WortmanWortman M . Instituting an Office Based Surgery Program in M . Instituting an Office Based Surgery Program in the Gynecology Office. JIMG 2010; 17, 673the Gynecology Office. JIMG 2010; 17, 673--683.683.

2.2. ACOG Guidelines for Initiating an Office Based Surgical ACOG Guidelines for Initiating an Office Based Surgical Practice. http:// Practice. http:// www.acog.org/www.acog.org/

3.3. AMA Core Principles of Office Based Surgery . AMA Core Principles of Office Based Surgery . http://www.asahq.org/washington/coreprinciples.htmhttp://www.asahq.org/washington/coreprinciples.htm

4.4. American Society of Anesthesiologists Guidelines for Office American Society of Anesthesiologists Guidelines for Office Based Anesthesia. http://www.asahg.org/Publicationsand Based Anesthesia. http://www.asahg.org/Publicationsand services/sgstoc.htmservices/sgstoc.htm


References

4. ASA Physical Status Classification System 4. ASA Physical Status Classification System http://www.asahq.org/clinical/physicalstatus.htmhttp://www.asahq.org/clinical/physicalstatus.htm

5. 5. Accreditation Handbook for Office Based Surgery Accreditation Handbook for Office Based Surgery http://www.jointcommission.org/NR/rdonlyres/http://www.jointcommission.org/NR/rdonlyres/

14

Patient Comfort for Office Procedures

Isabel Green, MD

Johns Hopkins University

AAGL 2012

Disclosures

• I have no financial relationships to disclose.

Objectives

• Describe the innervations of the uterus and cervix, and apply knowledge of anatomy to consider sources of discomfort during hysteroscopy y py

• Describe the analgesic options for office hysteroscopy, including mechanism of action, risks and dosages of each class of medication.

• Apply current data on analgesic options to establish a safe analgesia protocol for the office

CHALLENGE

Pain is the most frequently cited reason for failed office hysteroscopy, it is the most important determinant of procedure acceptability

“Once a patient is invited into the office setting, they have the right to expect the same level of patient safety that occurs in a more regulated hospital setting”

Kaneshiro Cochrane 2012ACOG Presidential Task Force, 2010

Innervation of the Uterus

Superior hypogastric plexus – uterovaginalplexus

Plexus courses lateral to attachment of uterosacral ligaments

Fibers travel in the parametrial tissue

Nerves course with uterine branches and IP ligamentsMyometriumBasal layer of endometriumSubmucosal layer of the cervix

15

Sources of DiscomfortConsider anatomy

Speculum

Cervix

Dilation

Whittemore Enterprises

Manipulation

Uterine distension

Endometrium

Fallopian tube

PROCEDURE SPECIFICPATIENT FACTORS

MenopauseCervical StenosisObesityAnxiety

Analgesia Options

NSAIDS

NARCOTICS

ANXIOLYTIC

LOCAL

Mechanism of ActionDosagesRisks

Data supporting use

NSAIDSExamples Mechanism of Action Onset/Duration

IbuprofenKetorolacMeloxicamNabumetoneNaproxenCelecoxib

Cyclooxygenase inhibition

Inhibits PG synthesis

Anti‐inflammatory

30 – 60 minDuration 4‐6 hrs

Long acting: Duration 12 hrs

Clinical efficacy is similar, patient response is highly variable

RISKS:GI toxicityAcute renal failureDrug interactionsAllergies

Short treatment durationCheck med listCheck allergies

NSAIDS ‐ Data

Double‐blind placebo trial demonstrates significant reduction in POST procedure pain, NO significant benefit in discomfort during procedure

Nagele et al. BJOG. 1997Marsh et al. Fertility & Sterility, 2005Fothergill. Obstet Gynecol Clinics, 2008

May reduce pain post procedureMay reduce need for rescue analgesia

NarcoticsExamples Mechanism of Action Onset/Duration

OxycodoneTramadolFentanylBuprenorphine

CNS: opioid receptorsSerotonin Norepinephrine

ORAL15‐60 min/4 hour

IV<10 min/30‐6o min

RISKS:SomnolenceRespiratory DepressionHypotensionNausea/vomitingPruritusAllergic reaction

Poyhia et al 1992

Consider cumulative effects & drug interactions

Narcotics ‐ Data

IV Tramadol 30 min prior resulted in significant decrease in VAS during and immediately following procedure when compared to placebo.

Ahmad. Cochrane 2010Kaneshiro. Cochrane 2012Floris et al. Fertility & Sterility. 2007

May result in decreased pain score at placement of 2nd Essure device

Limited isolated RCT

16

AnxiolyticExamples Mechanism of action Onset/Duration

Lorazepam (2mg)

Alprazolam(0.5mg)

Diazepam (10mg)

Bind to GABA receptor•Anxiolysis•No analgesic properties

IV2‐5 min/30‐60 min

PO30 min/60‐120min

Diazepam (10mg)

RISKSCNS depressionRespiratory depressionUnclear dose dependance

Coadministration with opioid may potentiate sedation

Counsel patient for recovery

Anxiolytics ‐ Data

• Clinical case studies support use for procedure anxiety

• Hysteroscopy: Isolated studies are missing

i l ti t l i– anxiolytic, not analgesic

• In combination, may improve pain VAS

• Weigh benefit and risk of sedation

Sharma et al. Indian J Med Sci 2009Bluemke et al. Radiology 2000

LOCALBeyond paracervical

LIDOCAINEBUPIVICAINEMARCAINE

Cooper et al BMJ 2010;340:c1130 Local Dosing

Agent Duration (min) Maximum Dose

1% Lidocaine 30‐60 4.5 mg/kg

1% Lidocaine w/ Epi 120‐360 7 mg/kg

0.25% Marcaine 120‐240 2.5 mg/kg

0.25% Marcaine w/ Epi 180‐420Do not exceed 225 mg

EPINEPHRINEVasoconstrictor – slows absorption, increase durationAdditional risks – BP variations, dysrythmias, orcatecholamine sensitivity

Local ‐ Data

Topical:

– Spray, gel, instillation

• Not demonstrated to be effective in limited, poor quality studies

Blocks:Blocks:

–Paracervical

• Reduced pain during parts of office procedures

– Intracervical

• Reduced pain, less pronounced than paracervical

Munro et al. JMIG 2010Ahmad et al. Cochrane. 2010Kaneshiro et al. Cochrane, 2012

Risks

• Medication absorption – toxicity– Intravascular injection, dose is exceeded, or idiosyncratic response

• Vasovagal episodesg p– Data to support use in high risk patients

– Data to support possible increase risk of episodes

• Bleeding at injection site

• Pain from administration

17

ComplicationsLocal anesthetic toxicity

NEURO

– Ringing in ears, tingling, metallic taste, agitation, seizures

– Stop infiltration, airway support, serial vitals,

– Consider/prepare benzodiazepine for seizuresConsider/prepare benzodiazepine for seizures

CARDIO

– Bradycardia, vasodilation, AV block, ventricular arrythmias

– Stop infiltration, airway, cardiac monitor, call for help

– ACLS

– Consider fat emulsion

ComplicationsAllergic Reaction/Anaphylaxis

– Urticaria, flushing, pruritus, respiratory distress

– Stop, position, airway, oxygen, call for help

– 1st step: epinephrine (1mg/mL): 0.3‐ 0.5 mg IM, repeat q 5‐15 min

– IV fluid boluses

Over sedation/Respiratory Depression

– Decrease responsiveness to stimuli, desaturation

– Stop meds, engage the patient, position, airway, oxygen, call for help

– Reverse w/ meds: naloxone or flumazenil

Minimize Need for Analgesia

Flexible hysteroscope

Smallest diameter

Vaginoscopy technique

Balance patient comfort and no analgesia

Yang et al. Obstet & Gynecol Survey 2002

Put it all together: example protocols

Diagnostic Hysteroscopy & Endometrial biopsy

Ibuprofen 800 mg at 10pm prior

Ibuprofen 800mg 1 hour prior

HysteroscopicSterilizationIbuprofen 800 mg q 8hr day

prior

Toradol 30 mg IM 30 min‐60 min prior

Paracervical block

1% lidocaine, 10cc total

10 min prior

min prior

Paracervical block 1% lidocaine, 10cc total, 10 min prior

Optional:

Oxycodone 5mg PO 30 min prior

Xanax 0.5mg PO 30 min prior

Analgesia Levels

Level I: Local anesthesia with limited preoperative oral anxiolyticanxiolytic

Level II: Moderate sedation

Level III: Deep sedation

ACOG, Presidential Task Force, 2010

Definitions

Analgesia: relief of pain without intentionally producing a sedated state. Altered mental status may occur as a secondary effect of medications administered for analgesiamedications administered for analgesia

18

Definitions

• Minimal sedation: patient responds normally to verbal commands. Cognitive function and coordination may be impaired, but ventilatoryand cardiovascular functions are unaffected.

• Moderate sedation: patient responds to verbal commands alone or when accompanied by light No mention of types of medications, p y gtouch. Protective airway reflexes and adequate ventilation are maintained. Cardiovascular function remains stable.

• Deep sedation: Patient cannot be easily aroused, but responds purposefully to noxious stimulation. Assistance may be needed to ensure airway is protected and ventilation maintained. Cardiovascular function is stable.

dosages, or route of administration

What to do in your office?

Beyond ACOG guidelines:

State regulation and accreditation requirements

Hospital regulations and protocols

“The decision regarding type of anesthesia shouldThe decision regarding type of anesthesia should NOT be altered based on limitations of equipment or personnel ... Such limitations might necessitate performing the procedure in a more acute care facility.”

What level of sedation are you afforded?Are you also regulated in meds and routes?

ACOG Presidential Task Force 2010

Right patient, Right procedure, Right Surgeon, Right Place

References

• Fertil Steril. 2010 Sep;94(4):1189‐94. Epub 2009 Aug 14.Analysis of pain and satisfaction with office‐based hysteroscopic sterilization.Levie M, Weiss G, Kaiser B, Daif J, Chudnoff SG.

• Fertil Steril. 2008 Oct;90(4):1182‐6. Epub 2008 Jan 16.Satisfaction and tolerance with office hysteroscopic tubal sterilization.Arjona JE, Miño M, Cordón J, Povedano B, Pelegrin B, Castelo‐Branco C.SourceDepartment of Gynecology and Obstetrics, Hysteroscopy Unit, Reina Sofía University Hospital, Cordoba, Spain.

• Cochrane Database Syst Rev. 2010 Nov 10;(11):CD007710.Pain relief for outpatient hysteroscopy.Ahmad G, O'Flynn H, Attarbashi S, Duffy JM, Watson A.SourceObstetrics & Gynaecology, Pennine Acute NHS Trust, Manchester, UK.

• Nagele F. Lockwood G. Magos AL. Randomised placebo controlled trial of mefenamic acid for premedication at outpatient hysteroscopy: a pilot study. Br J Obstet Gynaecol. 1997; 104 (4): 842‐4.

• Marsh F, Thewlis J, Duffy S. Thermachoice endometrial ablation in the outpatient setting, without local h i i d i i h d il & ili ( )anesthesia or intravenous sedation: A prospective cohort study. Fertilty & Sterility. 2005; 83 (3); 715‐720.

• Floris et al. Efficacy of intravenous tramadol treatment for reducing pain during office diagnostic hysteroscopy. Fertility & Sterility. 2007; 87 (1): 147‐151

• ACOG Presidential Task Force on Patient Safety in the Office Setting. April 2010.• Kaneshiro B, Grimes DA, Lopez LM. Pain management for tubal sterilization by hysteroscopy. The Cochrane

Collaboration. 2012.• Munro MG, Brooks PG. Use of local anesthesia for office diagnostic and operative hysteroscopy. JMIG.2010;

17 (6): 709‐18• Williams Gynecology 2008.• Bluemke DA, Breiter SN. Sedation procedures in MR imaging: safety, effectiveness and nursing effect on

examinations. Radiology. 2000; 216 (3): 645• Sharma et al. Comparison of efficacy of oral drotaverine plus mefenamic acid with parcervical block and

with intravenous sedation for pain relief during hysteroscopy and endometrial biopsy. Indian J Med Sci. 2009; 63 (6): 244‐52.

19

Diagnostic Hysteroscopy Diagnostic Hysteroscopy Evaluation of the Uterine Evaluation of the Uterine CCavity andavity and

PrePre--Operative Operative DDecision ecision MMakingaking

Amy Amy Garcia, Garcia, MDMD

AAGL/SRS FellowshipAAGL/SRS Fellowship--Trained in MIGTrained in MIG

DirectorDirector, Center for Women, Center for Women’’s Surgerys Surgery

Clinical Assistant Clinical Assistant Professor, University of New MexicoProfessor, University of New MexicoDepartment of Obstetrics and GynecologyDepartment of Obstetrics and Gynecology

Division of UrogynecologyDivision of Urogynecology

Albuquerque, New MexicoAlbuquerque, New Mexico

DisclosureDisclosure Grants/Research Support: HologicGrants/Research Support: Hologic

Consultant: Conceptus Incorporated, Ethicon EndoConsultant: Conceptus Incorporated, Ethicon Endo--Surgery, Ethicon Women's Health & Urology, IOGYN, Surgery, Ethicon Women's Health & Urology, IOGYN, Minerva SurgicalMinerva Surgical

Speaker's Bureau: Conceptus Speaker's Bureau: Conceptus IncInc

ObjectivesObjectives

Acquire, setAcquire, set--up and utilize supplies and up and utilize supplies and equipment necessary for diagnostic equipment necessary for diagnostic hysteroscopy in the officehysteroscopy in the officehysteroscopy in the office hysteroscopy in the office

Utilize a Utilize a hysteroscope (rigid and/or flexible) hysteroscope (rigid and/or flexible) for diagnostic procedures in the officefor diagnostic procedures in the office

Discern diagnostic hysteroscopy techniques Discern diagnostic hysteroscopy techniques for infor in--office proceduresoffice procedures

Indications for HysteroscopyIndications for Hysteroscopy

Evaluation of AUBEvaluation of AUB Heavy menstrual bleedingHeavy menstrual bleeding Menopausal bleedingMenopausal bleeding

Abnormal Ultrasound FindingsAbnormal Ultrasound Findings Enlarged endometrial stripeEnlarged endometrial stripe Suspected intraSuspected intra--cavitarycavitary pathologypathology

InfertilityInfertility

IUDIUD

Hysteroscopy vs. TV USHysteroscopy vs. TV USMenopausal WomenMenopausal Women

MarelloMarello, , etaletal Menopausal women with EMS </ 5 mm Menopausal women with EMS </ 5 mm

3% of symptomatic women3% of symptomatic women polypspolyps

10 % of asymptomatic women10 % of asymptomatic women 16 polyps16 polyps

3 3 myomasmyomas

Hysteroscopy (HS) & Saline Infusion Hysteroscopy (HS) & Saline Infusion Sonography (SIS) vs. TV USSonography (SIS) vs. TV US

Di i fDi i f I t itI t it P th lP th l Diagnosis of Diagnosis of IntracavitaryIntracavitary PathologyPathology TV US vs. HS TV US vs. HS BreitkopfBreitkopf et al.et al. 1 of 6 women had 1 of 6 women had intracavitaryintracavitary lesions missed by TV USlesions missed by TV US 74% sensitivity 74% sensitivity

HS and SIS vs. TV US Jansen et al.HS and SIS vs. TV US Jansen et al. HS and SIS equal in diagnosis of HS and SIS equal in diagnosis of intracavitaryintracavitary pathologypathology Significantly greater sensitivity/specificity vs. TV USSignificantly greater sensitivity/specificity vs. TV US

20

19 studies from 1980 through July 200119 studies from 1980 through July 2001 19 studies from 1980 through July 200119 studies from 1980 through July 2001

TVUS higher false negative vs. SH and HS for diagnosis of TVUS higher false negative vs. SH and HS for diagnosis of intrauterine pathologyintrauterine pathology

SH and HS excellent diagnostic accuracy for hyperplasia and SH and HS excellent diagnostic accuracy for hyperplasia and submucosalsubmucosal myomasmyomas

Hysteroscopy was the best for diagnosis of Hysteroscopy was the best for diagnosis of submucosalsubmucosalmyomasmyomas

89 patients 89 patients –– premenopausal TVUS, SIS, HSpremenopausal TVUS, SIS, HS

HS and SIS superior diagnostic accuracy to TVUSHS and SIS superior diagnostic accuracy to TVUS

HS HS best diagnostic accuracybest diagnostic accuracy Especially for endometrial polypsEspecially for endometrial polyps

2004 to 2006

38 patients TVUS, SIS and DH

DH the most accurate diagnostic technique for: Diagnosis of any endometrial pathology

Diagnosis of endometrial diseases – hyperplasia or cancer

Intracavitary mass – polyp or myoma

Structural abnormalities

Hysteroscopy and SIS Hysteroscopy and SIS are BETTER than TV US are BETTER than TV US

at evaluating the uterine cavity.at evaluating the uterine cavity.

HS vs. SISHS vs. SIS

Advantages of HysteroscopyAdvantages of Hysteroscopy Direct visualizationDirect visualization Opportunity for directed biopsyOpportunity for directed biopsy Opportunity for directed biopsyOpportunity for directed biopsy HistopathologyHistopathology

Blind BiopsyBlind Biopsy PolypsPolyps MyomasMyomas HyperplasiaHyperplasia

Sensitivity % 11 13 25

Specificity % 93 100 92

Accuracy % 59 98 80

HysteroscopyHysteroscopy PolypsPolyps MyomasMyomas HyperplasiaHyperplasia

Sensitivity % 89 100 74

Specificity % 93 99 93

Accuracy % 91 99 90

21

HS with Directed Biopsy vs. D & CHS with Directed Biopsy vs. D & CEvaluation of AUBEvaluation of AUB

LofferLoffer 19891989

Evaluation of AUBEvaluation of AUB

HS with Directed Biopsy vs. D & CHS with Directed Biopsy vs. D & C 100% specificity for both100% specificity for both

98% sensitivity for HS vs. 65% for D & C98% sensitivity for HS vs. 65% for D & C

HS with directed biopsy missed 1 HS with directed biopsy missed 1 endometritisendometritis

CLINICAL PRACTICE CLINICAL PRACTICE EVALUATION OF AUB: EVALUATION OF AUB:

Hysteroscopy with possible directedHysteroscopy with possible directedHysteroscopy with possible directed Hysteroscopy with possible directed biopsy or EMBbiopsy or EMB

Overcoming Barriers toOvercoming Barriers toInIn--Office HysteroscopyOffice Hysteroscopy

Surgeon SkillSurgeon Skill StaffStaff

Procedure awarenessProcedure awareness Procedure assistanceProcedure assistance Equipment maintenanceEquipment maintenance Equipment maintenanceEquipment maintenance

Patient ExpectationsPatient Expectations Patient comfortPatient comfort Ease of evaluationEase of evaluation Less overall riskLess overall risk Immediate visual feedbackImmediate visual feedback

Capitol ExpenditureCapitol Expenditure

2.8 procedures / office day2.8 procedures / office day

Evaluation TechniqueEvaluation Technique

Cervical Cervical evaluationevaluation

Identify Identify ccornuornu

E l ti fE l ti f itit Evaluation of Evaluation of cavitycavity Size, contour, septum, polyps, Size, contour, septum, polyps,

myomatamyomata, scaring, scaring

Evaluation of Evaluation of endometriumendometrium

Better cBetter cervical evaluationervical evaluation

Endometrial Endometrial AdenocarcinomaAdenocarcinoma

3401 3401 resectoscopicresectoscopic proceduresprocedures 16 occult, 3 known cancers16 occult, 3 known cancers Standard treatment with hysterectomyStandard treatment with hysterectomy 55--14 year follow14 year follow--upup No change in 5 year survival or longNo change in 5 year survival or long--term followterm follow--upup

22

Submucosal FibroidsSubmucosal FibroidsPreoperative Evaluation ESGEPreoperative Evaluation ESGE

Percent Intramural ExtensionPercent Intramural Extension Type 0 NoneType 0 None Type I < 50%Type I < 50% Type II > 50%Type II > 50% Type II > 50%Type II > 50%

Wamsteker K,Wamsteker K, et al. et al. Transcervical hysteroscopic resection Transcervical hysteroscopic resection

of submucous fibroids for abnormal of submucous fibroids for abnormal uterine bleeding: results regarding uterine bleeding: results regarding the degree of intramural extension. the degree of intramural extension. Obstet GynecolObstet Gynecol 1993;82:7361993;82:736--740. 740.

AnesthesiaAnesthesia

3 mm 3 mm Flexible/RigidFlexible/Rigid Usually not neededUsually not needed

5.5 mm Rigid w/o Dilation5.5 mm Rigid w/o DilationParousParous usually not neededusually not needed ParousParous usually not neededusually not needed

TenaculumTenaculum site localsite local 1% 1% LidocaineLidocaine

5.5 mm Rigid with Dilation5.5 mm Rigid with Dilation TenaculumTenaculum site localsite local ParacervicalParacervical blockblock 1% 1% LidocaineLidocaine

No Cervical PreparationNo Cervical Preparation

See and TreatSee and Treat Cervical dilation usually not neededCervical dilation usually not needed 3 mm flexible hysteroscope3 mm flexible hysteroscope

MisoprostilMisoprostil Cramping and bleedingCramping and bleeding Give narcotic pain medicationGive narcotic pain medication Not useful for menopausal womenNot useful for menopausal women

MisoprostolMisoprostol

Oral/Vaginal 400 Oral/Vaginal 400 μgmμgm 66--8 8 hrhr priorprior

Sublingual 400 Sublingual 400 μgmμgm 22--4 4 hrhr priorprior

InIn--Office EssentialsOffice Essentials Patient is Patient is awakeawake

Keep fluid pressure lowKeep fluid pressure low Remove speculumRemove speculum Minimize movementMinimize movement

ScopeScope--llight ight ccord relationshipord relationship 3030oo lenslens

Communicate with Communicate with patientpatient Position MonitorPosition Monitor

Hysteroscopy EssentialsHysteroscopy EssentialsProcedure StepsProcedure Steps

Lithotomy with boot stirrupsLithotomy with boot stirrups

Manual exam of uterusManual exam of uterus

SpeculumSpeculum PedersonPederson OpenOpen--sidedsided

Clean cervixClean cervix

Place hysteroscopePlace hysteroscope

23

Vaginoscopic HysteroscopyVaginoscopic HysteroscopyProcedureProcedure

Consideration for Consideration for misoprostolmisoprostol

No sNo speculum neededpeculum needed

B diB di ii BetadineBetadine vaginavagina

No No anesthesiaanesthesia

Fill pFill posterior fornix osterior fornix with with salinesaline

3 mm Flexible 3 mm Flexible HysteroscopeHysteroscope

R

Vaginoscopic ViewVaginoscopic View

Retroverted Uterus Anteverted Uterus

Posterior Fornix Posterior Fornix

Mucous/Blood

Recreated from the work of Dr. Martin Farrugia

EquipmentEquipment MonitorMonitor

CameraCamera Camera headCamera head Camera headCamera head ProcessorProcessor Light sourceLight source

TowerTower

Recording DeviceRecording Device

Flexible HysteroscopeFlexible Hysteroscope

EMB ftEMB ft FiberFiber--optic or digitaloptic or digital

Single channel Single channel

3 3 –– 4 mm diameter4 mm diameter

OOoo lens with 240lens with 240oo range of visual fieldrange of visual field

Saline as distention mediumSaline as distention medium

IV tubing/cystoscopy tubing or 60 cc syringeIV tubing/cystoscopy tubing or 60 cc syringe

EMB after EMB after evacuation of evacuation of

saline with saline with syringesyringe

Flexible HysteroscopeFlexible Hysteroscope1.9 to 3 1.9 to 3 mm mm

Diagnostic Rigid Diagnostic Rigid HysteroscopeHysteroscope

EMB after EMB after evacuation of evacuation of

saline with saline with syringesyringe

Office SetOffice Set--UpUpProcedure RoomProcedure Room

24

Office SetOffice Set--UpUpProcedure RoomProcedure Room Supplies and InstrumentsSupplies and Instruments

Supplies and InstrumentsSupplies and Instruments Supplies and InstrumentsSupplies and Instruments

DocumentationDocumentation ReimbursementReimbursement

InIn--Patient (21), OutPatient (21), Out--Patient (22), ASC (24)Patient (22), ASC (24)

58555 Diagnostic Hysteroscopy58555 Diagnostic Hysteroscopy

2012 RVU2012 RVUMedicareMedicareCFCF 34 03734 037

125%125%CF 42 55CF 42 55

No GlobalNo Global20122012

2012 RVU2012 RVU CFCF 34.03734.037 CF 42.55CF 42.55

5.67 $ 192.99 $ 241.24

NonNon--Facility/OfficeFacility/Office (11)(11)

8.56 $ 291.36 $ 364.20

With E/M VisitWith E/M VisitModifier 25Modifier 25

Document HS SeparatelyDocument HS Separately

25

ReimbursementReimbursement


58558 Hysteroscopy with58558 Hysteroscopy withPolypectomy,Polypectomy, Biopsy, D & CBiopsy, D & C


125%125%CF42 55CF42 55


2012 RVU2012 RVU CFCF 34.037 34.037 CF42.55CF42.55

7.97 $ 271.28 $ 339.10


11.27 $ 383.60 $ 479.50



HS 185

Flexible HS $ 6,000/192.00 = Flexible HS $ 6,000/192.00 = 31.2 procedures31.2 procedures

InIn--Office HysteroscopyOffice Hysteroscopy----WhyWhy

Patient ComfortPatient Comfort Patient Financial Burden LessenedPatient Financial Burden Lessened

Office coOffice co--pay vs. outpatient copay vs. outpatient co--paypay CoCo--insurance, selfinsurance, self--paypay

Reduced RiskReduced Risk No general anesthesiaNo general anesthesia EMB vs. D & CEMB vs. D & C See and treatSee and treat

Immediate Visual AffirmationImmediate Visual Affirmation Patient ConveniencePatient Convenience Physician ConveniencePhysician Convenience

26

Operative Hysteroscopy Operative Hysteroscopy

Amy Amy Garcia, Garcia, MDMD

AAGL/SRS FellowshipAAGL/SRS Fellowship--Trained in MIGTrained in MIG

DirectorDirector, Center for Women, Center for Women’’s Surgerys Surgery

Clinical Assistant Clinical Assistant Professor, University of New MexicoProfessor, University of New MexicoDepartment of Obstetrics and GynecologyDepartment of Obstetrics and Gynecology

Division of Division of UrogynecologyUrogynecology

Albuquerque, New MexicoAlbuquerque, New Mexico

DisclosureDisclosure

Grants/Research Grants/Research Support: HologicSupport: Hologic

Consultant: Conceptus Incorporated, Consultant: Conceptus Incorporated, Ethicon EndoEthicon Endo--Surgery Ethicon Women'sSurgery Ethicon Women'sEthicon EndoEthicon Endo--Surgery, Ethicon Women s Surgery, Ethicon Women s Health & Urology, IOGYN, Minerva Health & Urology, IOGYN, Minerva SurgicalSurgical

Speaker's Bureau: Conceptus Speaker's Bureau: Conceptus IncInc

ObjectivesObjectives

Acquire, setAcquire, set--up and utilize supplies and up and utilize supplies and equipment necessary for procedures in the equipment necessary for procedures in the officeofficeoffice office

Utilize an operative hysteroscope and Utilize an operative hysteroscope and operative instruments in the officeoperative instruments in the office

Discern operative hysteroscopy techniques Discern operative hysteroscopy techniques for infor in--office proceduresoffice procedures

Operative Office HysteroscopyOperative Office Hysteroscopy

MyomectomyMyomectomyUterine SeptumUterine SeptumPolypectomyPolypectomyPolypectomyPolypectomy MechanicalMechanicalScissorsScissorsMorcellatorMorcellator

Bipolar energyBipolar energy

Operative HysteroscopeOperative Hysteroscope

Rigid LensRigid Lens 2.8 2.8 –– 3.2 mm diameter3.2 mm diameter

Continuous Flow SheathContinuous Flow Sheath Continuous Flow SheathContinuous Flow Sheath 5.5 mm diameter5.5 mm diameter

Operative ChannelOperative Channel 3 3 FrFr or 5 or 5 FrFr

00oo , 12, 12oo , 25, 25oo , 30, 30oo

Operative HysteroscopeOperative Hysteroscope

ININ

OUOUTTOUOUTT

27

Continuous Flow Sheath Continuous Flow Sheath

Operative Operative hysteroscopeshysteroscopes and and rresectoscopesesectoscopes

Inflow through inner channelInflow through inner channel——low resistancelow resistance

Outflow through outer sheathOutflow through outer sheath——high resistancehigh resistance

Creates a clear visual fieldCreates a clear visual field

Helps to maintains uterine distentionHelps to maintains uterine distention

Rigid LensRigid Lens

Supplies and InstrumentsSupplies and Instruments Supplies and InstrumentsSupplies and Instruments

Operative Office Operative Office HysteroscopyHysteroscopy

SemiSemi--rigid Instrumentsrigid Instruments

5 5 FrFr DiameterDiameter

34 d 40 L th34 d 40 L th 34 and 40 cm Length34 and 40 cm Length ScissorsScissors Alligator forcepsAlligator forceps Biopsy Biopsy forcepsforceps TenaculumTenaculum

Supplies and InstrumentsSupplies and Instruments

28

Supplies and InstrumentsSupplies and Instruments Risk Factors for PolypsRisk Factors for Polyps

Significance Significance associationassociation AgeAge MenopauseMenopause HTNHTN ObesityObesity

Only AGE keeps statistical significance Only AGE keeps statistical significance in in univariableunivariable analysisanalysis

Endometrial Polyps and HyperplasiaEndometrial Polyps and Hyperplasia

International Journal of Gynecological

Increased Increased risk risk of of atypical atypical hhyperplasia yperplasia in in random random ddirected biopsiesirected biopsies

International Journal of Gynecological Pathology 28;522-528. 2010

DocumentationDocumentation





125%125%CF42 55CF42 55


2012 RVU2012 RVU CFCF 34.037 34.037 CF42.55CF42.55

7.97 $ 271.28 $ 339.10


11.27 $ 383.60 $ 479.50





58562 Hysteroscopy with58562 Hysteroscopy withRemoval Foreign BodyRemoval Foreign Body


125%125%CF 42 55CF 42 55


2012 RVU2012 RVU CFCF 34.03734.037 CF 42.55CF 42.55

8.62 $ 294.77 $ 368.46


11.72 $ 398.92 $ 498.65



29

InIn--Office HysteroscopyOffice Hysteroscopy----WhyWhy

Patient ComfortPatient Comfort Patient Financial Burden LessenedPatient Financial Burden Lessened

Office coOffice co--pay vs. outpatient copay vs. outpatient co--paypay CoCo--insurance, selfinsurance, self--paypay

Reduced RiskReduced Risk Reduced RiskReduced Risk No general anesthesiaNo general anesthesia EMB vs. D & CEMB vs. D & C See and treatSee and treat

Immediate Visual AffirmationImmediate Visual Affirmation Patient ConveniencePatient Convenience Physician ConveniencePhysician Convenience

30

Hysteroscopic Sterilization: Changing the Paradigm of Permanent Contraception

Isabel Green, MD

Johns Hopkins University

Disclosures

• I have no financial relationships to disclose.

Objectives

• Anticipate needed equipment and supplies for successful implementation of office sterilization

• Demonstrate proper patient selection &• Demonstrate proper patient selection & counseling for office hysteroscopic sterilization

• Demonstrate proper technique of the Essureprocedure and confirmation test

• Establish protocols for office sterilization

Hysteroscopic Sterilization: Essure• Hysteroscopic

placement of

radiopaque inserts in

the proximal portion of

h f ll bthe fallopian tube

• Tissue ingrowth occurs

through the insert

creating natural barrier

4

Outer Coilmaintains placement

during ingrowth

Inner CoilPET fibers create

3cm occlusion

Special thanks: Conceptus Inc

The Essure insert Design

• Device Length: ~3.85 cm

• PET Fiber Length: ~1.75 cm

• Expanded Outer Diameter: 1.5 – 2.0 mm

• Inserts are visible by X-Ray, Ultrasound, MRI and CT Scan

PET Fiber Dynamic Expanding Super elastic Nitinol Outer CoilStainless Steel

Innercoil

Permanent Contraception

re∙li∙able adj \ri‐ˈlī‐ə‐bəl\1: suitable or fit to be relied on: dependable

SAFE

&

CONVENIENT

31

Essure Tubal Occlusion Results*

% occluded at three months

96.5%

% occluded at six% occluded at six months

100%**

7

*Essure Instructions for Use, CONCEPTUS**Tubal patency was demonstrated in 16 women at the 3-month HSG, but all 16 women were shown to have tubal occlusion at a repeat HSG performed 6-7 months after Essure placement7

Adverse EventsPhase II Trial

ESS-005Pivotal Trial

ESS-005

2009 Commercial Setting

Reported Rate1

Perforations 3.4%2 1.1% 0.177%

Expulsions 0.5% 2.9%3 0.043%

Initial tubal patency4 3.5% 3.5% 0.097%

Other unsatisfactory location

0.5% 0.6% NA

1 Based on Conceptus’ reporting system , MAUDE database and number of devices sold in 2009.2 A support catheter was utilized in this trial and resulted in a higher incidence of perforation. This catheter is not on the current design.3 3/14 devices were placed proximally. Current labeling recommends devices with ≥18 coils visible be removed and replaced. 9/14 patients opted to

have another device placed and all were successful.4 In both clinical trials, all patients were occluded at HSG 6-7 months post-procedure5 Povedano et al. BJOG 20128

COMPLICATIONSVasovagal episodes 2‐5%

Why transition to the office?

The case of Mrs. Jones….

39 ld l i h l d39 year old, multiparous, has completed her family, and after counseling desires hysteroscopic tubal occlusion.

Mrs. Jones in the office….

• Patients:– Familiar setting for patients

– Avoids hospital hassle

– Can watch procedure if desired

– “have a procedure,” not a surgery

• Surgeon:– Time‐saving

– Consistent staffing

– Higher reimbursement

Essure in the Office Of 209 women…70% experienced pain less than or equal to menses

2.53.5

2

4

6

8

10

Levie M et al. Fertil Steril 2010Arjona et al. Fertil Steril 2008Sinha et al. BJOG 2007.

0

Essure Procedure Menses

Of 1603 women…..97% would recommend the procedure to others52% state the most valuable aspect was avoidance of the operating room

Equipment

HIGH COST

• Hysteroscope– Operative

• Camera

Li ht• Light source

• Monitor

• Mobile cart

• Printer

• Recorder

• Disinfection station

32

Equipment

Low cost:• Speculum• Stirrups• Tenaculum• Paracervical block• Paracervical block• Dilators• Distending medium• Tubing• Pressure bag• Outflow pouch• Channel seal

Priceless: reliable well‐trained staff

Equipment Cost as a Barrier

• Multiple indications

• Shared equipment

• Equipment programs & trials

• Reimbursement

ICDICD‐‐9 9 V25.2V25.2Interruption of fallopian tubes or vas deferensInterruption of fallopian tubes or vas deferens

CPTCPT5856558565Bilateral fallopian tube Bilateral fallopian tube cannulationcannulation to induce to induce occlusion by placement of permanent implantsocclusion by placement of permanent implants



Hysteroscopic SterilizationHysteroscopic Sterilization5856558565

MedicareMedicare 125%125%

90 Day Global90 Day Global20122012

2012 RVU2012 RVUMedicareMedicareCFCF 34.03734.037

125%125%CF 42.55CF 42.55

12.96 $ 441.13 $ 551.41


56.82 $ 1,934.02 $ 2,417.53

Essure Device Cost $1,350.00Essure Device Cost $1,350.00Courtesy of Amy Garcia MD

Essure Candidates for the Office

Woman who….

• Qualifies for permanent sterilization

• Has no contraindications to hysteroscopicili isterilization

• Good candidate for an office procedure

• Understands follow up after Essure procedure

Contraindications*

• Uncertain about her desire to end her fertility

• Can have only 1 insert placed

• Has previously undergone a tubal ligation

• Pregnant or suspected pregnancy

• Delivery or termination less than 6 weeks prior

• Active or recent upper or lower pelvic infection

• Known allergy to contrast media**

• Should not be used concomitantly with ablation procedures

• Discouraged in women undergoing immunosuppressive therapy

* See complete Instructions for Use in Essure packaging** Non-iodine containing contrast medias are available

AnalgesiaExample Agents

• LOCAL

– Paracervical Block

– Intrauterine lidocaine

NSAIDS• NSAIDS

– Motrin, Toradol, Mefenamic Acid

• Narcotic

– IV tramadol, Oxycodone

• Anxiolytic

Kaneshiro et al. Cochrane Database Syst Rev 2012Chudnoff et al. Obstet Gynecol 2010

33

Reducing pain in the office

RCT 1% RCT 1% LidocaineLidocaine vsvs Saline for PCBSaline for PCBSignificant Lower Pain ScoresSignificant Lower Pain Scores•• TenaculumTenaculum placementplacement•• Traversing external cervical Traversing external cervical osos•• Traversing internal cervical Traversing internal cervical osos

No Difference for Device PlacementNo Difference for Device Placement

Chudnoff et al Obstet Gynecol 2010Courtesy Amy Garcia MD

Example Protocol

Preprocedure:

NSAIDS

Motrin 600 mg day prior

Toradol 30 mg IM 30 min prior

Anxiolytic

IDEAL PROTOCOL HAS YET TO BE DETERMINEDLiterature doesn’t support single protocolAnxiolytic

Xanax 0.5 mg po 30 min prior as needed

Paracervical block

1% lidocaine, 10cc total, wait time 10 min

Postprocedure: NSAIDS

Literature doesn t support single protocol

Ess305 System

Ess305 System consists of

(1) Delivery System; (2) Insert; and (3) DryFlow Introducer

1.

2.

3.


Procedure Steps

2. Confirm position = gold band at ostium + green catheter in view!

3. Deploy device = push button, wheel back button toward you to hard stop again while maintaining stabilization

4. Confirm placement and record in notes

1. Insert catheter to black marker – stabilize Essure handle to hysteroscope –

wheel button toward you to hard stop


Essure Procedure

Preprocedure checklist & HCGPremedicationsModerate lithotomyBimanual examSpeculumClean cervixSingle tooth tenaculumParacervical block – pause!Place Hysteroscope ‐hydrodilateDilate if neededDiagnostic hysteroscopy – identify both ostia!Place devicesPhotographAssess hemostasis at cervixDocument:

FluidsAnatomy# of coilsPain scale

Tips for Success in the Office

• Contraception before and after

• Scheduling in early proliferative phase

– Improve visualization

– Decrease risk of pregnancy

– Hormonal meds favorable

• Avoid unnecessary instrumentation

– Decrease cost and clutter

– Remove speculum for comfort

– Vaginoscopy

• Maintain back up equipment/kits

• Know your learner and use visual imagery

34

Tips for Success in the Office30 degree scope


Performing the Essure Confirmation Test

• Perform at 3 months

• Confirm satisfactoryinsert location

• Document bilateral tubal occlusion

If satisfactory position, but contrast seen past the outer coil – repeat in 3 months

Suspected Expulsion & Perforation

If unsatisfactory position, patient cannot rely on Essure for contraception and alternative should be sought and coils removed is possible

Example Follow‐up Protocol

• Essure list with due date for HSG

• Phone call at due date

• Follow up phone call at 2 weeks

• Follow up phone call at 4 weeks with certified letterRATES OF COMPLIANCEVary based on clinical setting12‐80%Area of improvement for successful permanentcontraception

EssureEssure Typical UseTypical Use

No Info.No Info.PendingPending

26%26%

Prior to Prior to ECTECT8%8%

Luteal Phase Luteal Phase 7%7%

PhysicianPhysicianOff Label 7%Off Label 7%Pregnancy Rate = .12%Pregnancy Rate = .12%

No ECTNo ECT44%44%

26%26%

As reported to the FDA in the 2008 PMA annual report (1998 As reported to the FDA in the 2008 PMA annual report (1998 through Dec 2008) there have been 305 reported pregnancies through Dec 2008) there have been 305 reported pregnancies out of 259,746 procedures. out of 259,746 procedures. Courtesy Amy Garcia MD

Comparing Effectiveness to CREST: Five‐Year Failure Rates per 1000 Women

2.6

6.3

7

0 2 4 6 8 10 12 14 16 18

Essure

Postpartum Salpingectomy

Mirena

1

2

3

11.3

13.1

15.1

16.5

Vasectomy

All "CREST" Data

Interval Salpingectomy

Bipolar LTL

1 Data on file, Conceptus INC2 Peterson HB et al. The risk of pregnancy after tubal sterilization: findings from the U.S. Collaborative Review of Sterilization. Am J Obstet Gynecol.1996;174(4):1161-8.3 Mirena Prescribing Information. Bayer Health Care Pharmaceuticals. July 20084 Jamieson DJ et al. The risk of pregnancy after vasectomy. Obstet Gynecol. 2004; 103 (5 Pt 1): 848-50.30

4

2

2

2

35

Tips for Success in the Office

• Invest in your team– Vocal anesthesia

– Set the atmosphere

– Practice safety drills

• Involve the patient– Use the monitor

• Write a protocol, circulate and post it in the office

Thank you

References

• Sinha D, Kalathy V, Gupta JK, Clark TJ. The feasibility, success and patient satisfaction associated with outpatient hysteroscopic sterilisation. BJOG. 2007 Jun;114(6):676‐83.

• Miño M, Cordón J, Povedano B, Pelegrin B, Castelo‐Branco C.Satisfaction and tolerance with office hysteroscopic tubal sterilization.Arjona JE, Fertil Steril. 2008 Oct;90(4):1182‐6. Epub 2008 Jan 16.

• Shavell VI, Abdallah ME, Diamond MP, Kmak DC, Berman JM. Post‐Essure hysterosalpingography compliance in a clinic population.J Minim Invasive Gynecol. 2008 Jul‐Aug;15(4):431‐4. Epub 2008 Apr 28.

• Connor VF. Essure: a review six years later.J Minim Invasive Gynecol. 2009 May‐Jun;16(3):282‐90. Review.

• .Povedano B, Arjona JE, Velasco E, Monserrat JA, Lorente J, Castelo‐Branco C. Complications of hysteroscopic Essure(®) sterilisation: report on 4306 procedures performed in a single centreBJOG. 2012 Jun;119(7):795‐9. doi: 10.1111/j.1471‐0528.2012.03292.x. Epub 2012 Feb 23.

• .Chudnoff S, Einstein M, Levie M. Paracervical block efficacy in office hysteroscopic sterilization: a randomized controlled trialObstet Gynecol. 2010 Jan;115(1):26‐34Jan;115(1):26 34.

• .Levie M, Chudnoff SG. A comparison of novice and experienced physicians performing hysteroscopic sterilization: an analysis of an FDA‐mandated trialFertil Steril. 2011 Sep;96(3):643‐648.e1. Epub 2011 Jul 23.

• Levie M, Weiss G, Kaiser B, Daif J, Chudnoff SG. Analysis of pain and satisfaction with office‐based hysteroscopic sterilization.Fertil Steril. 2010 Sep;94(4):1189‐94. Epub 2009 Aug 14.

• Finer LB and Zolna MR, Unintended pregnancy in the United States: incidence and disparities, 2006, Contraception, 2011, 84(5):478–485.

• ACOG 2011 Women’s Health Stats & Facts Derived from 2010 CDC report

• Peterson HB et al. The risk of pregnancy after tubal sterilization: findings from the U.S. Collaborative Review of Sterilization. Am J ObstetGynecol.1996;174(4):1161-8.

• Mirena Prescribing Information. Bayer Health Care Pharmaceuticals. July 2008

• Jamieson DJ et al. The risk of pregnancy after vasectomy. Obstet Gynecol. 2004; 103 (5 Pt 1): 848-50.

• Data on file Conceptus Inc

• IFU insert Essure

36

Hysteroscopic Hysteroscopic MorcellatorsMorcellators::What’s on the horizon?What’s on the horizon?

Andrew I. Brill MDAndrew I. Brill MDAndrew I. Brill MDAndrew I. Brill MD

Director, Minimally Invasive GynecologyDirector, Minimally Invasive Gynecology

California Pacific Medical CenterCalifornia Pacific Medical Center

San Francisco, CASan Francisco, CA

DisclosureDisclosure

Consultant: Karl Storz EndoscopyConsultant: Karl Storz Endoscopy--America, Ethicon EndoAmerica, Ethicon Endo--Surgery, Surgery, Conceptus Inc., CooperSurgicalConceptus Inc., CooperSurgical

Speaker's Bureau: Karl Storz Speaker's Bureau: Karl Storz EndoscopyEndoscopy--America, Ethicon EndoAmerica, Ethicon Endo--Surgery, Conceptus Inc., Surgery, Conceptus Inc., CooperSurgicalCooperSurgical

Submucosal FibroidsSubmucosal Fibroids Clinical Indications for Clinical Indications for Hysteroscopic MyomectomyHysteroscopic Myomectomy

Molecular Causal RelationshipMolecular Causal Relationship Rackow BW, Taylor HSRackow BW, Taylor HS

Submucosal uterine leiomyomas have a global effect Submucosal uterine leiomyomas have a global effect


Submucosal uterine leiomyomas have a global effect Submucosal uterine leiomyomas have a global effect on molecular determinants of endometrial receptivity. on molecular determinants of endometrial receptivity. Fertil SterilFertil Steril. 2010;93(6):2027. 2010;93(6):2027--20342034

Improved Fertility After MyomectomyImproved Fertility After Myomectomy Pritts EA, Parker WH, Olive DL Pritts EA, Parker WH, Olive DL

Fibroids and Infertility: An updated systematic review of Fibroids and Infertility: An updated systematic review of the evidence. the evidence. Fertil SterilFertil Steril. 2009;91(4):1215. 2009;91(4):1215--12231223

Clinical Indications for Clinical Indications for Hysteroscopic MyomectomyHysteroscopic Myomectomy

Improved Pregnancy RatesImproved Pregnancy Rates Shokeir T, etal.Shokeir T, etal.

Submucosal myomas and their implications in the pregnancy rates of patients Submucosal myomas and their implications in the pregnancy rates of patients with otherwise unexplained primary infertility undergoing hysteroscopic with otherwise unexplained primary infertility undergoing hysteroscopic


myomectomy: a randomized matched control study. myomectomy: a randomized matched control study. Fertil SterilFertil Steril. . 2010;94(2):7242010;94(2):724--729729

215 women infertility longer than 12 months215 women infertility longer than 12 months Fibroids classified by US with ESGE classificationFibroids classified by US with ESGE classification

ResultsResults Myomectomy patients twice as likely as control to become Myomectomy patients twice as likely as control to become

pregnant (RR = 2.1; 95% CI = 1.59pregnant (RR = 2.1; 95% CI = 1.59--2.9)2.9) Women with type 0 and type 1 myomas removed had Women with type 0 and type 1 myomas removed had

significantly higher pregnancy rates than control (p < .001)significantly higher pregnancy rates than control (p < .001) No statistically significant difference in the type ll groupsNo statistically significant difference in the type ll groups

Clinical Indications for Clinical Indications for Hysteroscopic MyomectomyHysteroscopic Myomectomy

Genetic Genetic –– Molecular LevelMolecular Level Stewart EA, Nowak RAStewart EA, Nowak RA

MyomaMyoma--related bleeding: a classic hypothesis updated for the molecular related bleeding: a classic hypothesis updated for the molecular era. era. Human Repro UpdateHuman Repro Update 1996;2:2951996;2:295--306306

Laughlin SK Stewart EALaughlin SK Stewart EA

Abnormal Uterine BleedingAbnormal Uterine Bleeding

Laughlin SK, Stewart EALaughlin SK, Stewart EA Uterine Leiomyomas. Individualizing the Approach to a Heterogeneous Uterine Leiomyomas. Individualizing the Approach to a Heterogeneous

Condition. Condition. Obstet GynecolObstet Gynecol 2011;117:3962011;117:396--403403

Improved Bleeding after MyomectomyImproved Bleeding after Myomectomy Loffer FDLoffer FD

Improving results of hysteroscopic submucosal myomecomy for Improving results of hysteroscopic submucosal myomecomy for menorrhagia by concomitant endometrial ablation. menorrhagia by concomitant endometrial ablation. J Minim Invasive J Minim Invasive GynecolGynecol 2005;12:2542005;12:254--260260

Emanuel MHEmanuel MH LongLong--term results of hysteroscopic myomectomy for abnormal uterine term results of hysteroscopic myomectomy for abnormal uterine

bleeding. bleeding. Obstet Gynecol Obstet Gynecol 1999;93:7431999;93:743--748748

37

SubmucosalSubmucosal FibroidsFibroidsPrePre--Operative Decision MakingOperative Decision Making

PrePre--operative Assessment operative Assessment of Submucosal Myomas is of Submucosal Myomas is of Submucosal Myomas is of Submucosal Myomas is

Essential!Essential!

Submucosal FibroidsSubmucosal FibroidsPreoperative Evaluation Preoperative Evaluation

European Society for Gynaecological Endoscopy European Society for Gynaecological Endoscopy (ESGE)(ESGE)

Percent Intramural ExtensionPercent Intramural Extension Type 0 NoneType 0 None Type I < 50%Type I < 50% Type II > 50%Type II > 50%

Wamsteker K,Wamsteker K, et al. et al. Transcervical hysteroscopic resection Transcervical hysteroscopic resection

of submucous fibroids for abnormal of submucous fibroids for abnormal uterine bleeding: results regarding uterine bleeding: results regarding the degree of intramural extension. the degree of intramural extension. Obstet GynecolObstet Gynecol 1993;82:7361993;82:736--740. 740.

Hysteroscopic MyomectomyHysteroscopic Myomectomy

Type 0 Type I Type II Total

No. Patients 73 97 108 278

No. 73 102 158 333

Wamsteker K, 1993Wamsteker K, 1993

No. Procedures 73 102 158 333

Complete Resection

N = 73 100%

N = 95 98%

N = 103 95%

N = 27197%

Repeat Procedures - 5% 40% 17%

Mean Fluid Intravasation cc

437 971 1642 1110

SubmucosalSubmucosal FibroidsFibroidsPreoperative EvaluationPreoperative Evaluation

Type II Hysteroscopic MyomectomyType II Hysteroscopic Myomectomy Increased risk of:Increased risk of: Excessive fluid absorptionExcessive fluid absorption

El t l t b liti ith El t l t b liti ith l t l t dil t l t di

Wamsteker K, 1993Wamsteker K, 1993

Electrolyte abnormalities with nonElectrolyte abnormalities with non--electrolyte mediaelectrolyte media Excessive bleedingExcessive bleeding Incomplete resection Incomplete resection Need for additional procedureNeed for additional procedure Increased operative timeIncreased operative time

Even with expert Even with expert hysteroscopichysteroscopic surgeonssurgeons

SubmucosalSubmucosal FibroidsFibroidsPreoperative Evaluation New ClassificationPreoperative Evaluation New Classification

LasmarLasmar RB,RB, et al. et al.

SubmucousSubmucous myomasmyomas: A new: A newi li l l ifi ti t l t th l ifi ti t l t th presurgicalpresurgical classification to evaluate the classification to evaluate the

viability of viability of hysteroscopichysteroscopic surgical surgical treatmenttreatment——Preliminary report. Preliminary report.

J Minim Invasive J Minim Invasive GynecolGynecol 2005;12:3082005;12:308--311. 311.

38

SSize, ize, TTopography, opography, EExtension of Base,xtension of Base,PPenetration, Lateral enetration, Lateral WWall all (STEPW)(STEPW)L L Lasmar, Lasmar,

2005, 20112005, 2011SubmucosalSubmucosal FibroidsFibroids

Preoperative Evaluation New ClassificationPreoperative Evaluation New Classification

STEPWSTEPW 57 myomectomies compared to ESGE57 myomectomies compared to ESGE STEPW more accurately predicted differences STEPW more accurately predicted differences

Lasmar, 2005Lasmar, 2005

STEPW more accurately predicted differences STEPW more accurately predicted differences between groups I and II with respect to:between groups I and II with respect to: completed procedurescompleted procedures fluid deficit fluid deficit operative time operative time

465 465 myomasmyomas comparing STEPW and ESGEcomparing STEPW and ESGE Complete removal in 432 (92.9%) incomplete in 33 (7.1%)Complete removal in 432 (92.9%) incomplete in 33 (7.1%) ALL 320 ALL 320 myomasmyomas with score </4 removed (100%)with score </4 removed (100%)

Fertil Steril. 2011;95:2073-2077

Lasmar RB, Xinmei Z, Indman PD, et al.

3 0 3 0 yo asyo as sco e / e o ed ( 00%) sco e / e o ed ( 00%) 112/145 112/145 myomasmyomas with score with score > 4 > 4 removed (77.2%)removed (77.2%) ALL 33 cases of incomplete removal had score ALL 33 cases of incomplete removal had score > 4 > 4 (100%)(100%)

85/86 Type 0 removed (98.9%)85/86 Type 0 removed (98.9%) 278/298 Type 1 removed (93.3%)278/298 Type 1 removed (93.3%) 69/81 Type 2 removed (85.2%)69/81 Type 2 removed (85.2%)

STEPW Better predicted STEPW Better predicted incomplete resection ofincomplete resection ofFibroids (p < .001)Fibroids (p < .001)

Receiver Operating CharacteristicReceiver Operating Characteristic

STEPWSTEPW ESGEESGESensitivity 100% (95% CI 89.4%-100%) 36.4% (95% CI 20.4%-54.9%)

Specificity 74.1% (95% CI 69.7%-78.1%) 84.0% (95% CI 80.2%-87.3%)

ESGE Classification of FibroidsESGE Classification of Fibroids

0.4 cm Type 10.4 cm Type 1






0 0

00

+ 1 + 1

+ 1+ 1

+ 0 + 0

+ 0+ 0

+ 1 + 1

+ 0+ 0

SSize, ize, TTopography, opography, EExtension of Base, xtension of Base, PPenetration, Lateral enetration, Lateral WWall all (STEPW)(STEPW)

+ 0 = 2 + 0 = 2

+ 1 = 2+ 1 = 2



0 0

1 1

0 0

+ 1+ 1

+ 0 + 0

+ 0 + 0

+ 0 + 0

+ 1 + 1

+ 0 + 0

+ 0 + 0

+ 1 + 1

+ 2 + 2 LasmarLasmar, , 20052005, 2011, 2011

+ 1 = 2 + 1 = 2

+ 1 = 4+ 1 = 4

+ 1 = 3 + 1 = 3

39

STEPWSTEPWLasmarLasmar, ,

20052005, 2011, 2011

Prediction of complete removal 100% Prediction of complete removal 100%

Submucosal FibroidsSubmucosal FibroidsVaporizing ElectrodeVaporizing Electrode

BIPOLARBIPOLARBIPOLARBIPOLARSalineSaline

ResectoscopyResectoscopy

Requires Skilled SurgeonRequires Skilled Surgeon

Risk of:Risk of: Fluid overload (nonFluid overload (non electrolyte fluid)electrolyte fluid) Fluid overload (nonFluid overload (non--electrolyte fluid)electrolyte fluid) Multiple instrumentations of the uterusMultiple instrumentations of the uterus Uterine perforation, air embolus, false passagewayUterine perforation, air embolus, false passageway

Injury related to electrical energy sourceInjury related to electrical energy source

Generates Visually Obscuring Tissue Generates Visually Obscuring Tissue PiecesPieces NonNon--vaporizing or automatic tissue removingvaporizing or automatic tissue removing

Hysteroscopic ResectionHysteroscopic ResectionSurgical TrainingSurgical Training

Miller CEMiller CE Training in minimally Invasive surgeryTraining in minimally Invasive surgery——you say you want a you say you want a

revolution. revolution. J Minim Invasive GynecolJ Minim Invasive Gynecol. 2009;16(2):113. 2009;16(2):113––120.120.

The Typical ObGyn resident graduating The Typical ObGyn resident graduating b t 2002 d 2007 h d f d b t 2002 d 2007 h d f d between 2002 and 2007 had performed between 2002 and 2007 had performed a median of only 40 operative a median of only 40 operative hysteroscopic procedures hysteroscopic procedures

10 Operative 10 Operative HysteroscopicHysteroscopicProcedures Procedures Per Per YYearear!!

Clinical Indications for Clinical Indications for Hysteroscopic PolypectomyHysteroscopic Polypectomy

AUBAUB Nathani F, Clark TJ. Nathani F, Clark TJ.

Uterine polypectomy in the management of abnormal uterine bleeding: A Uterine polypectomy in the management of abnormal uterine bleeding: A systematic review. systematic review. J Minim Invasive Gynecol J Minim Invasive Gynecol 2006;13:2602006;13:260--268.268.

InfertilityInfertility Rackow etal.Rackow etal.

Endometrial polyps affect uterine receptivity. Endometrial polyps affect uterine receptivity. Fertil SterilFertil Steril 2011 (In2011 (In--Press).Press).

Afifi etal.Afifi etal. Management of endometrial polyps in subfertile women: a systematic Management of endometrial polyps in subfertile women: a systematic

review. review. Eur J Obstet Gynecol Reprod BiolEur J Obstet Gynecol Reprod Biol 2010;151:1172010;151:117--121.121.

HysteroscopicHysteroscopic MorcellatorMorcellator

40

TRUCLEAR TRUCLEAR 8.0 8.0 –– Smith & Smith & Nephew Nephew FDA FDA Approved 2005Approved 2005

Dedicated Fluid ManagementDedicated Fluid Management Tissue Removed with SuctionTissue Removed with Suction Offset Lens Offset Lens HysteroscopeHysteroscope

O l d 4 0 OO l d 4 0 O Outer Blade 4.0 mm ODOuter Blade 4.0 mm OD Scope 8 mm, 0Scope 8 mm, 0°° HysteroscopicHysteroscopic Sheath 9 mm ODSheath 9 mm OD Continuous flowContinuous flow Tissue TrapTissue Trap Reusable HandReusable Hand--piece piece

Images Courtesy of Smith and NephewImages Courtesy of Smith and Nephew

TRUCLEARTRUCLEAR 8.0 8.0 –– Smith & NephewSmith & Nephew

Reusable HandReusable Hand--PiecePiece Rotary Rotary MorcellatorMorcellator

PolypsPolyps Oscillates back and forthOscillates back and forth SerratedSerrated 7 mm cutting 7 mm cutting window at tipwindow at tip

Reciprocating Reciprocating MorcellatorMorcellator MyomasMyomas Rotates and reciprocatesRotates and reciprocates 357 357 bites per bites per minuteminute

TRUCLEAR TRUCLEAR 5.0 5.0 –– Smith & Smith & NephewNephew

Offset Offset Lens Lens HysteroscopeHysteroscope Outer Blade TRUCLEAR INCISOR PLUSOuter Blade TRUCLEAR INCISOR PLUSTMTM

2.9 mm 2.9 mm ODOD Rotary Rotary morcellatormorcellator Polyps Polyps –– especially fundalespecially fundal

Scope 5.0 mm, 0Scope 5.0 mm, 0°° HysteroscopicHysteroscopic Sheath 5.6 mm Sheath 5.6 mm ODOD Continuous FlowContinuous Flow Ideal for office useIdeal for office use

Fluid Fluid ManagementManagementSmith and NephewSmith and Nephew

Pressure Inflow ControlledPressure Inflow Controlled

Total Fluid UsedTotal Fluid Used

Total DeficitTotal Deficit Weight basedWeight based

Any Operative HS Any Operative HS ProcedureProcedure

Image Courtesy of Smith and NephewImage Courtesy of Smith and Nephew

Decreased Operative TimeDecreased Operative TimePolyps Polyps 22/3/3Type 0 and Type 1 Type 0 and Type 1 11/2/2

Operating Operating Operating Operating

Volume of intrauterine lesion cmVolume of intrauterine lesion cm33Volume of intrauterine lesion cmVolume of intrauterine lesion cm33

Operating Operating time time

(minutes)(minutes)

Operating Operating time time

(minutes)(minutes)

41

Retrospective Experience Report Retrospective Experience Report 315 women 2006 315 women 2006 -- 20092009

P l P l R t Bl d S & NR t Bl d S & N

Gynecol Surg (2011) 8:193 -196

Polyps Polyps –– Rotary Blade S & NRotary Blade S & N Total 278Total 278 Mean 7.3 minutes operative timeMean 7.3 minutes operative time Mean diameter 2.4 cm, fluid deficit 40 mL (0Mean diameter 2.4 cm, fluid deficit 40 mL (0--300)300)

MyomasMyomas Type I and II Type I and II –– Reciprocating BladeReciprocating Blade Mean 18.2 minutes operative timeMean 18.2 minutes operative time Total = 37 (Type 0 = 23, Type 1 = 11, Type 2 = 3)Total = 37 (Type 0 = 23, Type 1 = 11, Type 2 = 3) Mean diameter 2 cm, fluid deficit 440 mL (100Mean diameter 2 cm, fluid deficit 440 mL (100--890)890)

MyoSureMyoSure –– HologicHologicFDA Approved 2009FDA Approved 2009

Standard SetStandard Set--up Fluid/up Fluid/SuctionSuction Tissue Removed with SuctionTissue Removed with Suction Offset Lens Offset Lens HysteroscopeHysteroscope Outer Blade 3 mm ODOuter Blade 3 mm OD

7 mm cutting 7 mm cutting window 7 mm from tipwindow 7 mm from tip Inner RotatingInner Rotating--Oscillating Blade 2 mmOscillating Blade 2 mm

HysteroscopicHysteroscopic Sheath 6.25 mm Sheath 6.25 mm ODOD Tissue TrapTissue Trap Removes 1.5 Removes 1.5 gmgm/min of tissue/min of tissue SingleSingle--Use DeviceUse Device

Fluid Fluid ManagementManagementHologicHologic AquilexAquilex

Use with Use with MyoSureMyoSure inin--officeoffice

Pending 510(K) FDA ApprovalPending 510(K) FDA Approval

Small footprintSmall footprint Pressure Inflow ControlledPressure Inflow Controlled Total Fluid UsedTotal Fluid Used Deficit Deficit MMeter eter

Inflow roller wheel RPM basedInflow roller wheel RPM based

MyomectomyMyomectomyHologicHologic MyoSureMyoSure

11 Women11 Women

J of Medicine 2009;2:163-166.

Polyps Mean Operating TimePolyps Mean Operating Time 37 seconds (100%)37 seconds (100%)

Myomas Mean Operating TimeMyomas Mean Operating Time Type 0 2 minutes 19 seconds (100%)Type 0 2 minutes 19 seconds (100%) Type1 9 minutes 10 seconds (100%)Type1 9 minutes 10 seconds (100%) Type 2 11 minutes 49 seconds (50%)Type 2 11 minutes 49 seconds (50%)

42

InIn--Office Office PolypectomyPolypectomyHologicHologic MyoSureMyoSure

IOGYN MistralIOGYN Mistral

Integrated Office Integrated Office SSystemystem Rapid Rapid TTissue Removalissue Removal

Bipolar RF initiated plasma energyBipolar RF initiated plasma energy Hemostatic capabilitiesHemostatic capabilities

INVESTIGATIONALINVESTIGATIONAL

Offset Lens Offset Lens HysteroscopeHysteroscope HysteroscopicHysteroscopic Sheath OD 5.2 mmSheath OD 5.2 mm

Continuous FlowContinuous Flow ClosedClosed--Loop Loop FFluid luid MManagementanagement

Can eliminate fluid overloadCan eliminate fluid overload Max deficit set at 2,500 ccMax deficit set at 2,500 cc

Compatible with other RF GeneratorsCompatible with other RF Generators

Fluid ManagementFluid ManagementIOGYN MistralIOGYN Mistral

Courtesy of IOGYNCourtesy of IOGYN

PolypectomPolypectomyyIOGYN MistralIOGYN Mistral

10 grams in 50 seconds

Courtesy of IOGYNCourtesy of IOGYN

MorcellatedMorcellated MyomaMyomaIOGYN MistralIOGYN Mistral

Narrow Coagulation Narrow Coagulation ZoneZone

Adequate Tissue Adequate Tissue PreservationPreservation

HistopathologicHistopathologicEvaluation`Evaluation`

Images Courtesy of IOGYNImages Courtesy of IOGYN

Instrument TrainingInstrument TrainingTruclearTruclear

Courtesy of Smith and NephewCourtesy of Smith and Nephew

43

HysteroscopicHysteroscopic MorcellatorsMorcellatorsAdvantagesAdvantages

Operate in SalineOperate in Saline Decreased risk of fluid overloadDecreased risk of fluid overload

MechanicalMechanical No thermal injuryNo thermal injury No thermal injuryNo thermal injury

Remove Tissue PiecesRemove Tissue Pieces Clear visual fieldClear visual field Decreases risks of multiple instrument Decreases risks of multiple instrument

placementplacement Uterine perforation, false passageway and air Uterine perforation, false passageway and air

embolusembolus

HysteroscopicHysteroscopic MorcellatorsMorcellatorsAdvantagesAdvantages

Are Easy to UseAre Easy to Use Facilitate Removal Type 0 and I Facilitate Removal Type 0 and I MyomasMyomas

Decreased operative time and Decreased operative time and fluid fluid deficitdeficit Small Diameter Can Be Used in the Office Small Diameter Can Be Used in the Office

Fluid UseFluid Use Emanuel Emanuel ---- TRUCLEARTRUCLEAR

Total not recordedTotal not recorded Deficit ALL Deficit ALL MyomasMyomas

714 (0714 (0--3,000)3,000)

Van Van DongenDongen TRUCLEARTRUCLEAR

Miller Miller ---- MyoSureMyoSure Type 0 Type 0

3,400 (1,500 3,400 (1,500 –– 5,300) 5,300) Deficit 205 (200Deficit 205 (200--210)210)

Type 1 Type 1 MyomaMyoma 11,153 (4,670 11,153 (4,670 –– 24,000)24,000)

Van Van DongenDongen ----TRUCLEARTRUCLEAR All ProceduresAll Procedures

3,413 (2,2093,413 (2,209--4,617)4,617) Deficit All ProceduresDeficit All Procedures

409 (229409 (229--589)589)

WibekeWibeke ---- TRUCLEARTRUCLEAR Total not recordedTotal not recorded Deficit ALL Deficit ALL MyomasMyomas

400 (100 400 (100 –– 890) 890)

, ( ,, ( , , ), ) Deficit 1,300 (500Deficit 1,300 (500--1,900)1,900)

Operative Hysteroscopy of Operative Hysteroscopy of MyomasMyomas

(resectoscopy or morcellator)(resectoscopy or morcellator)==

Fluid Management SystemFluid Management System

Hysteroscopic MorcellatorsHysteroscopic MorcellatorsDisadvantagesDisadvantages

No No electrosurgeryelectrosurgery for for hemostasishemostasis IOGYN Mistral has IOGYN Mistral has electrosurgeryelectrosurgery

Type 2 Type 2 myomasmyomas are difficultare difficult Fundal pathology is difficultFundal pathology is difficultgg

Easier with TRUCLEAR Easier with TRUCLEAR blades and with Mistralblades and with Mistral Potential for significant fluid Potential for significant fluid useuse

MyosureMyosure Cost of fluid management Cost of fluid management systemsystem

Mistral is incorporated into deviceMistral is incorporated into device Currently no reimbursement for office useCurrently no reimbursement for office use





125%125%CF 42 5125CF 42 5125


Myosure Myosure Device CostDevice Cost

$1,300$1,3002011 RVU2011 RVU CFCF 34.0134.01 CF 42.5125CF 42.5125

7.95 $ 270.38 $ 337.97


10.6 $ 360.50 $ 450.63





Hysteroscopy with MyomectomyHysteroscopy with Myomectomy5856158561

MedicareMedicare 125%125%


2011 RVU2011 RVUMedicareMedicareCFCF 34.0134.01

125%125%CF 42.5125CF 42.5125

16.33 $ 555.38 $ 694.23


0 $ 0 $ 0

44

HysteroscopicHysteroscopic MorcellatorsMorcellatorsSummarySummary

More women will have the More women will have the opportunity for uterine preserving opportunity for uterine preserving surgery with the removal of Type surgery with the removal of Type surgery with the removal of Type surgery with the removal of Type 0 and 1 0 and 1 myomasmyomas with safer with safer instruments, that require less instruments, that require less surgical skill. surgical skill. Removal Removal of polyps is of polyps is easier and easier and faster.faster.

Learning ObjectivesLearning Objectives

Describe intracavitary Describe intracavitary myomasmyomas using a classification systemusing a classification system

Explain the different types of hysteroscopic Explain the different types of hysteroscopic morcellatorsmorcellators

Employ techniques to reduced risk during removal of intracavitary Employ techniques to reduced risk during removal of intracavitary myomasmyomas

Enumerate the fundamental differences between traditional Enumerate the fundamental differences between traditional resectoscopyyresectoscopyy and and h i l ll ti f l f i t it l ih i l ll ti f l f i t it l imechanical morcellation for removal of intracavitary lesionsmechanical morcellation for removal of intracavitary lesions

List the potential challenges and advantages of performing hysteroscopic List the potential challenges and advantages of performing hysteroscopic removal of intracavitary lesions in the office settingremoval of intracavitary lesions in the office setting

..

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Micah Harris M.D. Women’s Health Research

Phoenix, AZ

Grants/Research Support: Halt Medical

At the conclusion of this presentation the participant will be able to:1. List the common potential complications

encountered during or after office hysteroscopy.2. Identify the correct management of uterine

perforation dependant upon location.3. List the risk factors for uterine perforation.4. State AAGL Guidelines for hysteroscopic fluid

management.5. Identify office hysteroscopic procedures that have a

higher risk of complication.

Related to Entry/ Dilation of the cervix: 50%- Creation of a False Passage- Cervical Laceration/Hemorrhage - Uterine Perforation- Uterine Perforation

Related to Distention Medium-Fluid Overload, Hyponatremia- Air/Gas Embolism

Related to Procedure- Adhesiolysis

Vaso-vagal Reaction

Local Anesthetic Toxicity

Inadequate Analgesia/Anesthesia

Airway Management Excessive Sedation Allergic Reaction

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Happens

Loss of cavitary distention Change in the patient’s level of pain

Shoulder pain

Sudden fluid deficit Sudden fluid deficit Abdomenal distention Ultrasound may show accumulation of pelvic

ascites/hemoperitoneum

Incidence less than 1%, yet 50% of all hysteroscopic complications

May result in: Local bleedingg Visceral injury Inability to complete the procedure Laparoscopy/laparotomy

Actual incidence may be higher than expected

6,408 women underwent first trimester abortions, 706 with concurrent laparoscopic tubal 1.3/1000 rate of perforation Although 2 perforations were suspected and confirmed

with laparoscopy twelve (15 6/1000) were unsuspected with laparoscopy, twelve (15.6/1000) were unsuspected and only detected at laparoscopic sterilization following the termination.

Seven-fold difference between suspected vs. incidentally noted.

Kaali SG, et al. Frequency and Management of Uterine Perforations During First Trimester Abortion. Am J Obstet Gynecol 1989;16: 406-8.

Fundal Without RF energy- Discontinue and observe Laparoscopy to inspect for visceral injury

Lateral Ultrasound or laparoscopy to inspect for broad

ligament hematoma

Anterior Assess for hematuria, consider cystoscopy

Posterior As with Fundal, depending on whether RF used.

Nulliparity

Menopause

Use of GnRH agonists

Cervical stenosis (Prior conization)

Marked Retroversion

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Most office procedures involve small diameter scopes, and therefore little dilation is necessary.

Over-dilation results in inadequate distention Over dilation results in inadequate distention of the uterine cavity.

The use of cervical dilators can result in potentially undetected uterine perforation.

Consider using the hysteroscope as the dilator.

Directly visualize the passage

Avoid creating a False Passage

Recognize perforation

Dilate only as much as necessary

Misoprostil 400 mcg vaginally 6-12 hours pre-procedure

Reduces the force necessary for dilation Reduces pain scores associated with dilation Reduces pain scores associated with dilation Concern for over-dilation

Waddell G, et al. Cervical Ripening Using Vaginal Misoprostil Before Hysteroscopy. JMIG 2008; 15: 739-744

In dilute solutions ( 0.05-0.2 U/cc NS) promotes cervical dilation and myometrial hemostasis, as well as decreases fluid medium absorption.

Toxicity is cardiac/vascular (Hypertensive Crisis, A h th i )Arrhythmia)

Cardiac effects may be treated with Nitroglycerin

Chudnoff, S et al. Review of Vasopressin Use in Gynecologic Surgery, JMIG 2012; 19: 422-433

Prospective study of 13,600 subjects Adhesiolysis 4.48%

Endometrial Resection 0.81%

Myomectomy 0.75%

Polypectomy 0.38%

Jansen FW, et al. Complications of Hysteroscopy..Obstst Gynecol2000; 96 266-270

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Rarely suspected at the time Associated with a sudden “give” in pressure

during placement Associated with an abnormal deployment of

th i i t ilthe microinsert coil No reported acute complication such as

hemorrhage Chronic problems include pain, lack of efficacy

Connor VF Essure: A Review Six Years Later. JIMG 2009; 16 282-90

Cervical/Vaginal Inspect, suture as necessary. Prevent cervical laceration with “solid” first

tenaculum application

Myometrial Intrauterine balloon- carries some risk of uterine

rupture if overinflated. Remember Bimanual Compression- it works!!

Carbon Dioxide- Primarily used for Diagnostic Procedures. Visualization obscured by bleeding Actually more water-soluable than Nitrogen-

containing room air The “Lethal Dose” of Room Air is 5X less than that of

CO2

Groenman FA et al, Embolism of Air and Gas in HysteroscopicProcedures, JMIG 2008; 15 241-247

Signs and Symptoms: Related to bubbles creating disturbances in gas exchange or most severly, an Air-Lock in the Right Heart.

Decreasing Oxygen Saturation

Hypotension due to decreased venous return

Decreased End-Tidal CO2

Gaseous Distention Pressures > 100mmHg

Trendelenburg Position

More frequent insertions of the hysteroscope

Procedures injuring myometrial vessels Adhesiolysis Myometrial Resection

Up to 50% Mortality

Recognize Pulmonary symptoms early

Administer 100% Oxygen

Reverse Trendelenberg, Left Decubitus (Durant Manuever)

Cardiovascular Rescuscitation/ Support

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Non-ionic media Glycine 1.5% Sorbitol/Mannitol 3%/0.54% Mannitol 5%

Ionic Media Normal Saline

Complications arise from absorption and fluid overload. Maintain I/O’s, especially when a pressure bag is

used

Hyponatremia and Cereberal Edema Pulmonary Edema Primary treatment is Diuresis Less common in the office setting

Deficit >750cc, electrolyte poor solution Plan to terminate the procedure

Deficit >1000cc electrolyte poor, >2500cc ionic Terminate the procedure Assess serum sodium Lasix 10 mg IV

Ad Hoc Committee on Hysteroscopic Fluid Management. JAAGL 2000 7(2) 167-168.

Anesthetic Toxicity- Be aware of toxic doses of injectable anesthetics- Lidocaine, Marcaine

Vasovagal reactions- Identify, support, Vasovagal reactions Identify, support, administer Atropine 0.4-0.6mg SC/IM/IV

HAVE A FULLY STOCKED CRASH-CART, AND STAFF WHO UNDERSTANDS HOW TO USE IT.

Infectious- 0.01-1.4% ACOG guidelines do not support prophylactic

antibiotics for hysteroscopic surgery in the absence of a history of PIDT t t f l i i l d Treat symptoms of pelvic pain, malodorous discharge, fever with extended spectrum penicillinor cephalosporin

Ultrasound if on pelvic exam an mass is felt

Hematometrium 1-2% Chronic or cyclic pain Drainage with or without ultrasound guidance

Complications are fortunately rare (0.3%) Half are entry related, e.g. perforation

Avoid with entry under visualisation Cervical ripening can be helpful

b l h Air embolism is more common than CO2 embolism

Overabsorption of fluid media is preventable and easily treated.

Know the contents of your crash cart and have knowledgable support staff.

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1. Jansen FW, Vredevoogd CB, Ulzen K et al. Complications of Hysteroscopy: A Prospective Multicenter Study. Obstet Gynecol2000; 96 266-270.

2. Propst AM, Liberman RF, Harlow BL Ginsberg ES Complications of Hysteroscopic Surgery: Predicting Patients at Risk Obstetof Hysteroscopic Surgery: Predicting Patients at Risk. ObstetGynecol 2000; 96 517-520.

3. Uckuyu A, Ozcimen EE, Sevinc FC, Zeyneloglu HB Efficacy of Vaginal Misoprostil Before Hystersocopy for Cervical Priming in Patients Who Have Undergone Cesarean Delivery and No Vaginal Deliveries. JMIG 2008; 15 739-744.

4. Wadell G, Desindes S, Takser L,Beauchermin MC, Besette P Cervical Ripening Using Misoprostil Before Hysteroscopy: A Randomized Double Blind Trial. JMIG 2008; 15 739-744.

5. Chudnoff S. Glazer S, Levie M Review of Vasopressin Use in Gynecologic Surgery JMIG 2012; 19 422 433Gynecologic Surgery. JMIG 2012; 19 422-433.

6. Groenman FA, Peters LW, Rademaker BM, Bakkum EA Embolism of Air and Gas in Hysteroscopic Procedures: Pathophysiology and Implications for Daily Practice. JMIG 2008; 15 241-247.

7. Kaali SG, Szigetvari IA, Bartfai GS. The Frequency and Management of Uterine Perforations During First Trimester Abortions Am J Obstet Gynecol. 1989; 16: 406-8

8. Ad Hoc Committee on Hysteroscopic Fluid Management. Guidelines of the AAGL JAAGL 2000 7(2) 167 168 Guidelines of the AAGL. JAAGL 2000 7(2) 167-168.

9. Antibiotic Prophylaxis for Gynecologic Procedures ACOG Practice Bulletin Number 104 May 2009- Reaffirmed 2011

10. Connor VF Essure: A Review Six Years Later. JIMG 2009; 16 282-90.

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Equipment Maintenance: The Rigid and Flexible

Hysteroscope

Eileen Young RN BSN CNOREileen Young, RN, BSN, CNOR

• Other: Employee ‐ Olympus

Identify safe handling techniques for hysteroscopes.

Describe proper reprocessing steps for hysteroscopeshysteroscopes.

Advantages of Hysteroscope Types

Rigid with rod lens opticsClearest visualization

Easiest to insert

Semi‐rigid with fiberoptic/digital imageSemi rigid with fiberoptic/digital image

Large working channel and no additional telescopes

FlexiblePatient comfort and no additional components

Rigid Hysteroscopes

Telescope 12 and/or 30°

Sheath Standard, intermittent flow (usually smaller diameter) Continuous flow (may have inner and outer sheaths)Continuous flow (may have inner and outer sheaths)

Obturator Visual, used for atraumatic insertion

Bridge / AdaptorUsed with a seal to insert accessory devices

Biopsy forceps Tubal sterilization

Sheaths

Size dependent on patient anatomy and desired channel

Continuous flow sheaths will likely provide better visualizationbetter visualization

Small cavity size

Bleeding can obscure vision

Inflow and outflow pathways NOT interchangeable

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Telescopes

Angle of view 30° wide angle provides best visualization of cavity and cornua

12° is more direct, better for use with resection devices

Lens is always opposite light posty pp g p

Field of view – amount of area seen through lens

Characteristics Most fragile and expensive component

Damaged telescope = no hysteroscope

Handle with eyepiece, protect lens

Semi‐Rigid Hysteroscopes

Hybrid device Fiberoptic or digital image

May have a deflecting tip

Housed in a metal shaftHoused in a metal shaft

May be easier to insert / handle than flexible

Flexible Hysteroscopes

Diagnostic

Intermittent flow only

Accessory channel is same as irrigation channelAccessory channel is same as irrigation channel

Less discomfort for patient

Require practice inserting and manipulating

Repairs can be expensive

Buying Guide

Determine patient population

Infertility and/or post‐menopausal women – small diameter

Abnormal uterine bleeding – continuous flowAbnormal uterine bleeding continuous flow

Patient comfort – flexible

Transcervical sterilization – channel size

Decontamination Supplies

Enzymatic detergent

Soft cloth, gauze and applicators

Protective attire

Syringes

Leak tester for flexible and semi‐rigid scopes

Alcohol to clean glass surfaces

Decontamination ProcessWipe and flush immediately after procedure

Clean as soon as possible with properly mixed enzymatic detergent

Flush and/or brush all lumens

Dry exterior surface and push air through channelDry exterior surface and push air through channel

High‐level disinfect or sterilize If using a steam sterilizer, may wrap devices to maintain sterility

High‐level disinfectants must be thoroughly rinsed and dried prior to storage or use

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High‐level Disinfection Considered semi‐critical devices (not entering sterile cavity or bloodstream, moderate risk of infection) Minimum preparation is HLD, but can sterilize

Glutaraldehyde‐based HLD are most common OPA may be alternative

Exposure time and temperature, rinsing

Safety considerations Venting

Gloves

Monitoring concentration

Sterilization

Steam

High temperature and vacuum may not be compatible with device

Follow OEM recommendations for cycle type time Follow OEM recommendations for cycle type, time and temperature

Conclusion

Hysteroscopes are an investment in your practice

Require careful handling

i ifi iRequire specific reprocessing

Office procedures can enhance your practice

Repairs can be minimized with proper care and handling

Clemens, J., Dowling, R., Foley, F., Goldman, H., Gonzalez, C., Tessier, C., Wasner, M., & Young, E. (2009). Joint AUA/SUNA White Paper on Reprocessing of Flexible Cystoscopes. Retrieved from: http://www.suna.org/cgi‐bin/WebObjects/SUNAMain.woa/1/wa/viewSection?wosid=yQgi599ceBCE3lm6dhp1282yNf2&tName=whitePaper&s_id=1073743840& id 173743840&ss_id=1

Rutala, W., Weber, D., HICPAC. (2008). Guidelines for Disinfection and Sterilization in Healthcare Facilities. Retrieved from: http://www.cdc.gov/hicpac/Disinfection_Sterilization/acknowledg.html

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CULTURAL AND LINGUISTIC COMPETENCY Governor Arnold Schwarzenegger signed into law AB 1195 (eff. 7/1/06) requiring local CME providers, such as

the AAGL, to assist in enhancing the cultural and linguistic competency of California’s physicians

(researchers and doctors without patient contact are exempt). This mandate follows the federal Civil Rights Act of 1964, Executive Order 13166 (2000) and the Dymally-Alatorre Bilingual Services Act (1973), all of which

recognize, as confirmed by the US Census Bureau, that substantial numbers of patients possess limited English proficiency (LEP).

California Business & Professions Code §2190.1(c)(3) requires a review and explanation of the laws

identified above so as to fulfill AAGL’s obligations pursuant to California law. Additional guidance is provided by the Institute for Medical Quality at http://www.imq.org

Title VI of the Civil Rights Act of 1964 prohibits recipients of federal financial assistance from

discriminating against or otherwise excluding individuals on the basis of race, color, or national origin in any of their activities. In 1974, the US Supreme Court recognized LEP individuals as potential victims of national

origin discrimination. In all situations, federal agencies are required to assess the number or proportion of LEP individuals in the eligible service population, the frequency with which they come into contact with the

program, the importance of the services, and the resources available to the recipient, including the mix of oral

and written language services. Additional details may be found in the Department of Justice Policy Guidance Document: Enforcement of Title VI of the Civil Rights Act of 1964 http://www.usdoj.gov/crt/cor/pubs.htm.

Executive Order 13166,”Improving Access to Services for Persons with Limited English

Proficiency”, signed by the President on August 11, 2000 http://www.usdoj.gov/crt/cor/13166.htm was the genesis of the Guidance Document mentioned above. The Executive Order requires all federal agencies,

including those which provide federal financial assistance, to examine the services they provide, identify any

need for services to LEP individuals, and develop and implement a system to provide those services so LEP persons can have meaningful access.

Dymally-Alatorre Bilingual Services Act (California Government Code §7290 et seq.) requires every

California state agency which either provides information to, or has contact with, the public to provide bilingual

interpreters as well as translated materials explaining those services whenever the local agency serves LEP members of a group whose numbers exceed 5% of the general population.

~

If you add staff to assist with LEP patients, confirm their translation skills, not just their language skills.

A 2007 Northern California study from Sutter Health confirmed that being bilingual does not guarantee competence as a medical interpreter. http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=2078538.

US Population

Language Spoken at Home

English

Spanish

AsianOther

Indo-Euro

California

Language Spoken at Home

Spanish

English

OtherAsianIndo-Euro

19.7% of the US Population speaks a language other than English at home In California, this number is 42.5%

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http://www.imq.org/

http://www.usdoj.gov/crt/cor/pubs.htm

http://www.usdoj.gov/crt/cor/13166.htm

http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=2078538

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