Fibroids: Myomectomy and New Approaches (Didactic) › 2012syllabus › PG113.pdf · 2020-01-30 ·...

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Fibroids: Myomectomy and New

Approaches (Didactic)

PROGRAM CHAIR

Tommaso Falcone, MD

Ted L. Anderson, MD Jon I. Einarsson, MD

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 Which Myomas Require Intervention? T. Falcone ..................................................................................................................................................... 5 Hysteroscopic Approach to Myomas T.L. Anderson ............................................................................................................................................. 11 What Limits a Conventional Laparoscopic Approach? J.I. Einarsson ............................................................................................................................................... 21 Robotic Myomectomy ‐‐ Surgical Tips T. Falcone ................................................................................................................................................... 27 Myoma Ablation and Uterine Artery Occlusion Techniques for the Management of Leiomyomas J.I. Einarsson ............................................................................................................................................... 36 Single Port Myomectomy – Surgical Tips J.I. Einarsson ............................................................................................................................................... 43 Tips to Prevent Excessive Blood Loss at Myomectomy T. Falcone ................................................................................................................................................... 47 Abdominal Myomectomy as a Minimally Invasive Alternative to Hysterectomy for Large Fibroids T.L. Anderson ............................................................................................................................................. 51 Cultural and Linguistics Competency ......................................................................................................... 55

PG 113 Fibroids: Myomectomy and New Approaches (Didactic)

Tommaso Falcone, Chair

Faculty: Ted L. Anderson, Jon I. Einarsson

Course Description This course is designed for all gynecologists who wish to expand their experience in the management of myomas. The course is designed to be case-based and each presentation will include several illustrative cases. The program will emphasize practical information with multiple video demonstrations of surgical techniques. The program will begin with a fundamental review of preoperative evaluation of patients with leiomyomas and appropriate selection of patients for intervention. Minimally invasive surgical and non-surgical approaches will be presented. Case presentations will show when medical or radiologic-based approaches may be acceptable. Conventional, robotic and single port laparoscopic approaches as well as laparotomy will be discussed within the context of specific cases.

Course Objectives At the conclusion of this course, the participant will be able to: 1) Identify the concepts of selecting patients appropriately for surgery or other intervention; 2) analyze the role of different surgical and non-surgical minimally invasive techniques for the treatment of uterine fibroids; 3) assess techniques to safely perform laparoscopic myomectomy; 4) appraise the surgical approach to single port myomectomy; and 5) identify when myomectomy by laparotomy is indicated.

Course Outline 8:00 Welcome, Introductions and Course Overview T. Falcone 8:05 Which Myomas Require Intervention? T. Falcone 8:30 Hysteroscopic Approach to Myomas T.L. Anderson 8:55 What Limits a Conventional Laparoscopic Approach? J.I. Einarsson 9:20 Robotic Myomectomy -- Surgical Tips T. Falcone 9:45 Questions & Answers All Faculty 9:55 Break 10:10 Myoma Ablation and Uterine Artery Occlusion Techniques for the Management

of Leiomyomas J.I. Einarsson 10:35 Single Port Myomectomy – Surgical Tips J.I. Einarsson 11:00 Tips to Prevent Excessive Blood Loss at Myomectomy T. Falcone

1

11:25 Abdominal Myomectomy as a Minimally Invasive Alternative to Hysterectomy

for Large Fibroids T.L. Anderson 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). Tommaso Falcone* Jon I. Einarsson Consultant: Ethicon Endo-Surgery Ted L. Anderson* Georgine Marie Lamvu*

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Asterisk (*) denotes no financial relationships to disclose.

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Indications for Indications for MyomectomyMyomectomy

Tommaso Falcone, M.DTommaso Falcone, M.DProfessor & ChairProfessor & Chair

Department of Obstetrics & GynecologyDepartment of Obstetrics & GynecologyCleveland ClinicCleveland Clinic

Financial DisclosureFinancial Disclosure

I have no financial relationships to I have no financial relationships to di ldi ldisclose disclose

Learning ObjectivesLearning Objectives

Analyze the data on the impact of fibroids Analyze the data on the impact of fibroids on obstetric outcomeson obstetric outcomes

Li t th b fit f t f tilitLi t th b fit f t f tilit List the benefits of myomectomy on fertility List the benefits of myomectomy on fertility outcomesoutcomes

Discuss the impact of pregnancy on fibroid Discuss the impact of pregnancy on fibroid growth growth

Leiomyoma related hospitalizationLeiomyoma related hospitalization

Wechter et al AJOGWechter et al AJOG-- 20112011

2007 data from Nationwide inpatient 2007 data from Nationwide inpatient sample (NIS)sample (NIS)

355 135 h it li d355 135 h it li d 355, 135 women were hospitalized355, 135 women were hospitalized

Excludes all minimally invasive interventionsExcludes all minimally invasive interventions

Rates of myomectomyRates of myomectomy•• BlackBlack-- 9.2/10,000 women years9.2/10,000 women years

•• WhiteWhite-- 1.3/ 10,00 women years1.3/ 10,00 women years

•• By 2050By 2050--31 % increase in myomectomies31 % increase in myomectomies

Impact of RaceImpact of Race

Huyck et al AJOG 2008Huyck et al AJOG 2008 Black women present earlier ( 5.3 years) and Black women present earlier ( 5.3 years) and p ( y )p ( y )

more severe diseasemore severe disease

Natural History of FibroidsNatural History of Fibroids

MaverlosMaverlos et al. Ultrasound et al. Ultrasound ObstetObstet GynecolGynecol20102010 Women examined at least twice by a single Women examined at least twice by a single

sonographersonographer at least 8 months apart (medianat least 8 months apart (mediansonographersonographer at least 8 months apart (median at least 8 months apart (median 21 months)21 months)

Median age was 40 years; majority were Median age was 40 years; majority were under 5 cmunder 5 cm

21 % of fibroids showed evidence of 21 % of fibroids showed evidence of spontaneous regression. spontaneous regression.

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Indication for SurgeryIndication for Surgery

Abnormal Uterine BleedingAbnormal Uterine Bleeding

Pelvic pressure and painPelvic pressure and pain

Urinary or rectal symptomsUrinary or rectal symptomsUrinary or rectal symptomsUrinary or rectal symptoms

InfertilityInfertility-- exclude other causesexclude other causes

Recurrent Pregnancy LossRecurrent Pregnancy Loss--exclude other exclude other causescauses

Adverse pregnancy outcomeAdverse pregnancy outcome

Myomectomy: Refuted reasonsMyomectomy: Refuted reasonsASRM practice committee 2008ASRM practice committee 2008

Size (>12 weeks)Size (>12 weeks)Cannot palpate the adnexaeCannot palpate the adnexae Symptoms will developSymptoms will develop Symptoms will developSymptoms will develop Surgery could be more difficult if surgery Surgery could be more difficult if surgery

delayeddelayed Possible leiomyosarcomaPossible leiomyosarcoma

Sarcoma does not relate to size or rate of Sarcoma does not relate to size or rate of growth and more related to age ( over 60)growth and more related to age ( over 60)

Fibroids and Pregnancy lossFibroids and Pregnancy loss

Klatsky et al AJOG 2008Klatsky et al AJOG 2008-- Systematic Systematic reviewreview

Submucosal fibroidsSubmucosal fibroids-- associated with associated with increased Spontaneous abortion rateincreased Spontaneous abortion rateincreased Spontaneous abortion rateincreased Spontaneous abortion rate OR 3.85 ( 1:12OR 3.85 ( 1:12--13.27)13.27)

Intramural fibroidsIntramural fibroids-- OR 1.34 ( 1.04OR 1.34 ( 1.04--1.65)1.65)

Early first trimester u/s OR 1.82 (1.43Early first trimester u/s OR 1.82 (1.43--2.3)2.3)

Number was more important than sizeNumber was more important than size

Fibroids and Pregnancy lossFibroids and Pregnancy loss

Saravelos et al Hum Reprod 2011Saravelos et al Hum Reprod 2011 8 % prevalence in patients with RPL (n=966)8 % prevalence in patients with RPL (n=966)

Cavity distorting fibroidCavity distorting fibroid--•• Early lossEarly loss no changeno change•• Early lossEarly loss-- no changeno change

•• MidMid--trimester lossestrimester losses-- reduced significantlyreduced significantly--Live Live birth 52 %birth 52 %

NonNon--cavity distorting fibroidscavity distorting fibroids--no surgery & no surgery & unexplained RPLunexplained RPL

•• Live birth rate was 70 %Live birth rate was 70 %

Leiomyomas and InfertilityLeiomyomas and Infertility Casini et al Gynecological Endocrinology 2006Casini et al Gynecological Endocrinology 2006--

Infertile patientsInfertile patients Only RCT of surgery vs. no surgery & fertility outcomeOnly RCT of surgery vs. no surgery & fertility outcome

SubMucous (SM) fibroidsSubMucous (SM) fibroids-- P<.05P<.05•• with surgerywith surgery--PRPR--43%43%•• Without surgeryWithout surgery PRPR 27 %27 %•• Without surgeryWithout surgery-- PRPR--27 %27 %

Intramural (IM) fibroidsIntramural (IM) fibroids-- NSNS•• with surgerywith surgery--PRPR--56%56%•• Without surgeryWithout surgery-- PRPR--41 %41 %

SMSM--IMIM-- P<.05P<.05•• with surgerywith surgery--PRPR--36%36%•• Without surgeryWithout surgery-- PRPR--15%15%

PR = pregnancy rate

Leiomyomas and InfertilityLeiomyomas and Infertility

Submucosal fibroidsSubmucosal fibroids PR after hysteroscopic resection up to 43%PR after hysteroscopic resection up to 43%y p py p p

•• Goldberg F&S 1995Goldberg F&S 1995

•• Hart Br J Obstet & Gynecol 1999Hart Br J Obstet & Gynecol 1999

•• Bernard Eur J Obstet Gynecol Reprod Biol 2000Bernard Eur J Obstet Gynecol Reprod Biol 2000

PR = pregnancy rate

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Hysteroscopic myomectomy:Hysteroscopic myomectomy: ShokeirShokeir et al. 2010 Fertil Steril 2010 et al. 2010 Fertil Steril 2010

Randomized matched trialRandomized matched trial

Unexplained infertilityUnexplained infertility

Type 0 and Type 1Type 0 and Type 1 myomasmyomas Type 0 and Type 1 Type 0 and Type 1 myomasmyomas

HysteroscopicHysteroscopic surgery was performedsurgery was performed

PR significantly improved (63% vs. 28%)PR significantly improved (63% vs. 28%)

Cavity Distorting Intramural Cavity Distorting Intramural MyomasMyomas

Systematic Review Systematic Review –– Pritts, Parker and Pritts, Parker and Olive F&S 2009Olive F&S 2009 Clinical Pregnancy rate/ Implantation Clinical Pregnancy rate/ Implantation

rate/ongoing pregnancy rate/live birth raterate/ongoing pregnancy rate/live birth rate--rate/ongoing pregnancy rate/live birth raterate/ongoing pregnancy rate/live birth ratedecreaseddecreased

Spontaneous abortion rate is increasedSpontaneous abortion rate is increased

Myomectomy vs. women with no fibroidsMyomectomy vs. women with no fibroids•• Clinical pregnancy rate is similarClinical pregnancy rate is similar

Impact of Subserosal Fibroids on Impact of Subserosal Fibroids on Fertility outcomeFertility outcome

Systematic Review Systematic Review –– Pritts, Parker and Pritts, Parker and Olive F&S 2009Olive F&S 2009

Uniquely Subserosal fibroids have no Uniquely Subserosal fibroids have no impact on fertility or spontaneous abortion impact on fertility or spontaneous abortion ratesrates

Systematic Review Systematic Review –– Fibroids and Fibroids and FertilityFertility

Pritts, Parker and Olive 2009Pritts, Parker and Olive 2009 Effect on fertility Effect on fertility –– no intracavitary involvementno intracavitary involvement

•• Pregnancy rate ( 24 studies): RR .89 (.8Pregnancy rate ( 24 studies): RR .89 (.8--1.0)1.0)•• Implantation rate ( 14 studies): RR .79 (.69Implantation rate ( 14 studies): RR .79 (.69--.9).9)Implantation rate ( 14 studies): RR .79 (.69Implantation rate ( 14 studies): RR .79 (.69 .9).9)•• LiveLive--birth rate ( 16 studies): RR .78 ( .69birth rate ( 16 studies): RR .78 ( .69--.88).88)•• Spontaneous abortion (16 studies): RR 1.8 (1.47Spontaneous abortion (16 studies): RR 1.8 (1.47--2.4)2.4)

Myomectomy for intramural fibroids (controlsMyomectomy for intramural fibroids (controls--fibroids in situ) ( nonfibroids in situ) ( non--cavity distorting)cavity distorting)

•• Pregnancy rate ( 2 studies ): RR 3.7 ( .47Pregnancy rate ( 2 studies ): RR 3.7 ( .47--30)30)•• LiveLive--birth rate (1 study): RR .75 ( .29birth rate (1 study): RR .75 ( .29--1.9)1.9)

RR = relative risk

Impact of Fibroids on IVFImpact of Fibroids on IVF

Variables that explain differences in results:Variables that explain differences in results: Location of the fibroidsLocation of the fibroids

Size of leiomyoma: large (>5Size of leiomyoma: large (>5--7cm) often excluded7cm) often excluded

CaseCase--control studies: retrospective biascontrol studies: retrospective biaspp

Assessment of fibroids HSG vs. US vs. hysteroscopy Assessment of fibroids HSG vs. US vs. hysteroscopy (SIS was not used in the studies)(SIS was not used in the studies)

Contribution of the fibroid that does not distort Contribution of the fibroid that does not distort the cavity may not be appreciated if there is a the cavity may not be appreciated if there is a low PR or implantation ratelow PR or implantation rate

HSG = hysterosalpingogram; US = ultrasound; SIS = saline-infusion sonogram

Effect of Intramural Fibroids on IVF Effect of Intramural Fibroids on IVF OutcomeOutcome

Sunkara et al. HR 2010Sunkara et al. HR 2010 MetaMeta--analysisanalysis Intramural fibroids Intramural fibroids without cavity distortionwithout cavity distortion 19 studies: 6087 cycles19 studies: 6087 cyclesyy Significant decrease in liveSignificant decrease in live--birth (RR 0.79, birth (RR 0.79,

95% CI 95% CI --.70.70--.88) and clinical pregnancy rates .88) and clinical pregnancy rates (RR 0.85, 95% CI .77(RR 0.85, 95% CI .77--.94).94)

This does not mean that removal will restore This does not mean that removal will restore PR to the levels expected in women without PR to the levels expected in women without fibroidsfibroids

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Impact of Fibroids on IVF: Impact of Fibroids on IVF: ConclusionsConclusions

Because of the lack of consistent or wellBecause of the lack of consistent or well--designed studies and high reported PR, designed studies and high reported PR, prophylactic prophylactic myomectomymyomectomy prepre--IVF if the IVF if the p p yp p y y yy y ppcavity is normal should be individualized cavity is normal should be individualized and not routine. No data for fibroids >5and not routine. No data for fibroids >5--7 7 cm.cm.

Myomas & PregnancyMyomas & Pregnancy

Growth of Myomas during pregnancyGrowth of Myomas during pregnancy•• 4949--60 % no change60 % no change

•• 2222--32% increase in size32% increase in size

•• 88--27 % decrease in size27 % decrease in size

Most of the growth is in the first trimesterMost of the growth is in the first trimester

Mean increase is 12 %Mean increase is 12 %

90 % of women with fibroids detected in the 90 % of women with fibroids detected in the first trimester will have regression of volume first trimester will have regression of volume postpartumpostpartum

Adapted from Stout et alAdapted from Stout et al Leiomyomas at second trimester Leiomyomas at second trimester u/s Obstet Gynecol 2010u/s Obstet Gynecol 2010

Adapted from Stout et alAdapted from Stout et al Leiomyomas at second trimester Leiomyomas at second trimester u/s Obstet Gynecol 2010u/s Obstet Gynecol 2010

Klatsky et al AJOG 2007Klatsky et al AJOG 2007Nomenclature of Professional Communication

International Consensus Meeting 2005…

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Acute versus Chronic AUBAcute versus Chronic AUBFor nonpregnant women of reproductive ageFor nonpregnant women of reproductive age

Chronic Abnormal Uterine BleedingChronic Abnormal Uterine Bleeding Bleeding from the uterine corpus, that is abnormal in Bleeding from the uterine corpus, that is abnormal in

duration, volume, regularity, and/or frequency and duration, volume, regularity, and/or frequency and has been present for the majority of the last six (6) has been present for the majority of the last six (6) monthsmonthsmonths.months.

Acute Abnormal Uterine Bleeding Acute Abnormal Uterine Bleeding is an episode of bleeding that is of sufficient quantity is an episode of bleeding that is of sufficient quantity

to require immediate intervention to prevent further to require immediate intervention to prevent further blood loss. blood loss.

Nomenclature of Professional Communication Nomenclature of Professional Communication

AUBAUB-- Recommended Descriptive Recommended Descriptive Nomenclature for SymptomsNomenclature for Symptoms

Fraser IS, Critchley HOD, Munro MG, Fraser IS, Critchley HOD, Munro MG, et al et al Hum ReprodHum Reprod 2007;222007;22::635635--43 and 43 and Fertil SterilFertil Steril 2007;87:4662007;87:466--7676



Fraser IS, Critchley HOD, Munro MG, Fraser IS, Critchley HOD, Munro MG, et al et al Hum ReprodHum Reprod 2007;22:6352007;22:635--43 and 43 and Fertil Steril Fertil Steril 2007;87:4662007;87:466--7676



Fraser IS, Critchley HOD, Munro MG, Fraser IS, Critchley HOD, Munro MG, et al et al Hum ReprodHum Reprod 2007;22:6352007;22:635--43 and 43 and Fertil Steril Fertil Steril 2007;87:4662007;87:466--7676

Unresolved IssuesUnresolved Issues VolumeVolume

•• Since the volumetric measurement of 5Since the volumetric measurement of 5--80 mL is 80 mL is NOT practical in the clinical environment, what are NOT practical in the clinical environment, what are practicable measures of menstrual volume?practicable measures of menstrual volume?

RegularityRegularity•• Is Is ±± 22--20 days a practical definition of a group who 20 days a practical definition of a group who

is primarily ovulatoryis primarily ovulatory??

Polyp

Adenomyosis

Leiomyoma

Malignancy & Hyperplasia

Structural Abnormality

Coagulopathy

Ovulatory Dysfunction

Endometrial

Iatrogenic

Not Yet Classified

Dysfunctional Uterine Bleeding

No Structural Abnormality

Leiomyoma Subclassification System

S M‐ Submucous 0 Pedunculated Intracavitary

1 <50% Intramural

2 ≥ 50% Intramural

O ‐ Other 3 Contacts endometrium; 100% Intramural

Polyp

Adenomyosis

Leiomyoma


Coagulopathy


Endometrial

Iatrogenic

Not Yet Classified

O Other 3 Contacts endometrium; 100% Intramural

4 Intramural

5 Subserous ≥50% Intramural

6 Subserous < 50% Intramural

7 Subserous Pedunculated

8 Other (specify eg. cervical, parasitic)

Hybrid

Leiomyomas (impact both

endometrium and

serosa)

Two numbers are listed separated by a dash. By convention, the first

refers to the relationship with the endometrium while the second refers to

the relationship to the serosa. One example is below

2‐5 Submucosal and subserosal, each with less

than half the diameter in the endometrial

and peritoneal cavities respectively.

9

Polyp

Adenomyosis

Leiomyoma


Coagulopathy


Endometrial

Iatrogenic

Not Yet ClassifiedHow could / should FIGO’sHow could / should FIGO’sHow could / should FIGO’sHow could / should FIGO’sPALMPALM--COEIN system be used?COEIN system be used?PALMPALM--COEIN system be used?COEIN system be used?

Classification CategorizationClassification CategorizationSingle Entity ExamplesSingle Entity Examples

P0 A0 L1(SM) M0 - C0 O0 E 0 I0 N0

P0 A1 L0 M0 - C0 O0 E 0 I0 N0

P1 A0 L0 M0 - C0 O0 E 0 I0 N0

P0 A0 L0 M0 - C0 O0 E 0 I0 N0

Classification CategorizationClassification CategorizationMultiple Entity ExamplesMultiple Entity Examples

P0 A0 L1 (SM) M1 - C0 O0 E 0 I0 N0

P1 A1 L0 M0 - C0 O0 E 0 I0 N0

AUB-M

P1 A0 L1(O) M0 - C0 O0 E 0 I0 N0

P0 A1 L1(O) M0 - C1 O0 E 0 I0 N0

AUB-P, -A

AUB-P, -Lo

AUB-A, -Lo, -C

ReferencesReferences Sunkara SK, Khairy M, ElSunkara SK, Khairy M, El--Toukhy T, Khalaf Y, Coomarasamy A. The effect Toukhy T, Khalaf Y, Coomarasamy A. The effect

of intramural fibroids without uterine cavity involvement on the outcome of of intramural fibroids without uterine cavity involvement on the outcome of IVF treatment: a systematic review and metaIVF treatment: a systematic review and meta--analysis. Hum Reprod analysis. Hum Reprod 2010;25:4182010;25:418--429.429.

Pritts E, Parker W, Olive D. Fibroids and infertility: an updated systematic Pritts E, Parker W, Olive D. Fibroids and infertility: an updated systematic review of the evidence. Fertil Steril 2009;91:1215review of the evidence. Fertil Steril 2009;91:1215--1223.1223.

Saravelos S, Yan J, Rehmani H, Li TC. The prevalence and impact of Saravelos S, Yan J, Rehmani H, Li TC. The prevalence and impact of fibroids and their treatment on the outcome of pregnancy in women withfibroids and their treatment on the outcome of pregnancy in women withfibroids and their treatment on the outcome of pregnancy in women with fibroids and their treatment on the outcome of pregnancy in women with recurrent miscarriage. Hum Reprod 2011;26:3274recurrent miscarriage. Hum Reprod 2011;26:3274--3279.3279.

Shokeir T, ElShokeir T, El--Shafei M, Yousef H, Allam AF, Sadek E. Submucous myomas Shafei M, Yousef H, Allam AF, Sadek E. Submucous myomas and their implications in the pregnancy rates of patients with otherwise and their implications in the pregnancy rates of patients with otherwise unexplained primary infertility undergoing hysteroscopic myomectomy: a unexplained primary infertility undergoing hysteroscopic myomectomy: a randomized match control study. Fertil Steril 2010;94:724randomized match control study. Fertil Steril 2010;94:724--729.729.

Stout M, Odibo A, Graseck A, Macones G, Crane J, Cahill A. Leiomyomas Stout M, Odibo A, Graseck A, Macones G, Crane J, Cahill A. Leiomyomas at routine secondat routine second--trimester ultrasound examination and adverse obstetric trimester ultrasound examination and adverse obstetric outcomes. Obstet Gynecol 2010;116:1056outcomes. Obstet Gynecol 2010;116:1056--1063.1063.

ReferencesReferences Klatsky P, Tran N, Caughey A, Fujimoto V. Fibroids and Klatsky P, Tran N, Caughey A, Fujimoto V. Fibroids and

reproductive outcomes: a systematic literature review from reproductive outcomes: a systematic literature review from conception to delivery. Am J Obstet Gynecol 2008;198:357conception to delivery. Am J Obstet Gynecol 2008;198:357--366.366.

Mavrelos D, BenMavrelos D, Ben--Nagi J, Holland T, Hoo W, Naftalin J, Jurkovic D. Nagi J, Holland T, Hoo W, Naftalin J, Jurkovic D. The natural history of fibroids. Ultrasound Obstet Gynecol The natural history of fibroids. Ultrasound Obstet Gynecol 2010;35:2382010;35:238--242.242.

Huyck K, Panjuysen C, Cuenco K, Zhang J, Goldhammer H, Jones Huyck K, Panjuysen C, Cuenco K, Zhang J, Goldhammer H, Jones y , j y , , g , ,y , j y , , g , ,E, et al. The impact of race as a risk factor for symptom severity and E, et al. The impact of race as a risk factor for symptom severity and age at diagnosis of uterine leiomyomata among affected sisters. Am age at diagnosis of uterine leiomyomata among affected sisters. Am J Obstet Gynecol 2008; 198:168.e1J Obstet Gynecol 2008; 198:168.e1--168.e9.168.e9.

Practice Committee of American Society for Reproductive Medicine Practice Committee of American Society for Reproductive Medicine in collaboration with Society of Reproductive Surgeonsin collaboration with Society of Reproductive Surgeons. Fertil Steril . Fertil Steril 2008;90:S1252008;90:S125--S130.S130.

Wechter ME, Stewart E, Myers E, Kho R, Wu J. LeiomyomaWechter ME, Stewart E, Myers E, Kho R, Wu J. Leiomyoma--related related hospitalization and surgery: prevalence and predicted growth based hospitalization and surgery: prevalence and predicted growth based on population trends. Am J Obstet Gynecol 2011; 205:492.e1on population trends. Am J Obstet Gynecol 2011; 205:492.e1--492.e5.492.e5.

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Hysteroscopic Approach to Leiomyomata

11Minimally Invasive Gynecologic

Surgery

Ted L. Anderson, MD, PhD, FACOG, FACSAssociate Professor of Obstetrics & Gynecology

Director, Division of GynecologyVanderbilt University Medical Center, Nashville, TN

[email protected]

Disclosure

• I have no financial relationships to disclose.


Surgery

Objectives

• Participants will be able to:

– Assess submucosal leiomyomata appropriately

– Compare approaches to hysteroscopic resection

– Predict and manage common complications


Surgery

– Surgically manage submucosal leiomyoma patients

Background

• Affects approximatly 33% of women• Age and race variables up to 75%

• Varied symptoms, may be asymptomatic• Menorrhagia (30%), Pain (34%), Infertility (27%)


Surgery

• Approximately 5% submucosal• Definitions

• Identification

Stewart EA (2001) Uterine Fibroids. Lancet 357:293‐98.Fedele L et al (1991) Transvaginal ultrasonography versus hysteroscopy in the diagnosis of uterine submucous myomas. Obstet Gynecol 77(5):745‐48.

Interventions

• Indications for treatment• Abnormal uterine bleeding

• Pelvic pain / dysmenorrhea

• Infertility

G l id ti


Surgery

• General considerations• Desire for future fertility

• Desire for uterine preservation

• Aggressiveness vs expectations

• Co‐morbidities

Treatment Decisions

Fibroid Fibroid Patient Patient

MonopolarMonopolar

BipolarBipolar cations


Surgery

EvaluationEvaluation ManagementManagementBipolarBipolar

MechanicalMechanical

Compli

11

Treatment Decisions


MonopolarMonopolar



Surgery


MechanicalMechanicalCompli

Submucosal Fibroid Types

• ESGE classification

• Intramural extension• Type 0 None

• Type I < 50%


Surgery

• Type II > 50%

Wamsteker K et al (1993) Transcervical hysteroscopic resection of submucous fibroids for abnormal bleeding: results regarding the degree of intramural extension. Obstet Gynecol 82:736‐40.

The extension of the basewith respect to the wall of

the uterus


the uterus


the uterus

The penetration level ofthe myoma into the

myometrium


myometrium


myometrium

Preoperative Assessment (NC)


Surgery

The location at fundus,body or lower segmentThe location at fundus,body or lower segmentThe location at fundus,body or lower segment

< 2 cm = score 0< 2 cm = score 0

2 cm – 5 cm = score 12 cm – 5 cm = score 1

> 5 cm = score 2> 5 cm = score 2

< 2 cm = score 0

2 cm – 5 cm = score 1

> 5 cm = score 2

Lasmar RB et al (2005) Submucous myomas: A new presurgical classification to evaluate the viability of hysteroscopic surgical treatment – preliminary report. JMIG 12:308‐311.

Uterine Evaluation

Sensitivity 100%

Specificity 94%

Predictive Value• Abnormal scan 81%

N l 100%

1100

Minimally Invasive Gynecologic

Surgery

• Normal scan 100%

Precise mapping

Polyp vs fibroid

Fedele L et al (1991) Transvaginal ultrasonography versus hysteroscopy in the diagnosis of uterine submucous myomas. Obstet Gynecol 77(5):745‐48.

Ultrasound Mapping

1111


Surgery

Saline Infusion Sonography

1122


Surgery

Kelekci S et al (2005) Comparison of transvaginal sonography, saline infusion sonography, and office hysteroscopy in reproductive‐aged women with or without abnormal uterine bleeding. Fertil Steril 84(3):682‐86.Widrich T et al (1996) Comparison of saline infusion sonography with office hysteroscopy for the evaluation of the endometrium. Am J Obstet Gynecol. 174(4):1327‐34.

• As sensitive as hysteroscopy for intracavitary pathology

• Less uncomfortable than hysteroscopy when both performed in the office

• Added benefit of myometrial evaluation

12

3‐D Reconstruction

1133


Surgery

Benacerraf BR et al (2006) Improving the Efficiency of Gynecologic Sonography With 3‐Dimensional Volumes: A Pilot Study. JUM 25(2):165‐71.Lee C et al (2006) Reproducibility of the measurement of submucous fibroid protrusion into the uterine cavity using three‐dimensional saline contrast sonohysterography. Ultrasound in Obstet Gynecol 28(6):837–841.Haemila et al (2005) A prospective comparative study of 3‐D ultrasonography and hysteroscopy in detecting uterine lesions in premenopausal bleeding. Middle East Fertil Soc 10(3):239‐243.

• As accurate as 2D saline infusion sonography

• Faster, more accurate interpertation, especially of submucosal component

• Comparable to hysteroscopy for intracavitary lesions

Magnetic Resonance (MRI)

1144


Surgery

Stewart EA (2001) Uterine Fibroids. Lancet 357:293‐98.Spielmann AL et al (2006) Comparison of MRI and Sonography in the Preliminary Evaluation for Fibroid Embolization. AJR December 2006 vol. 187 no. 6 1499‐1504

• Better visualization and mapping of individual fibroids

• More accurate characterization of number, location, and volume of fibroids

• Additional information gained may not justify additional cost

Hysteroscopy

1155


Surgery

High vs Low Pressure

1166


Surgery

Treatment Decisions


MonopolarMonopolar


1177


Surgery



Compli

ACTIVE

ELECTRODE

Monopolar Current

• Cuts and Desiccates Tissue

• High Current Density at Active Electrode

• Deep Necrosis

1188


Surgery

CURRENT FLOW

DEEP THERMAL EFFECT

• Broad thermal margins

• Current flows through patient

• Electrolyte‐free fluid

• Current dispersed in saline

13

Monopolar Current

1199


Surgery

Loop electrodes at 45° and 90° angulations

2200


Surgery

Roy KK et al (2010) Reproductive outcome following hysteroscopic myomectomy in patients with infertility and recurrent abortions. Arch Gynecol Obstet 282(5):553‐560. Bradley L (2012) Hysteroscopic myomectomy. http://www.uptodate.com/contents/hysteroscopic‐myomectomy

• Most commonly used method

• Loop resection or bulk vaporization

• Risk for hyponatremia

Treatment Decisions


MonopolarMonopolar


2211


Surgery



Compli

• Energy Flow

• Generator to active electrode

• Sodium Vapor Pocket

• Contacts tissue

• Instantaneous cellular rupture

Bipolar Current

2222


Surgery

• Cutting is non‐mechanical

• Energy Flow

• Return electrode

• Controlled Thermal Effect

• Vapor pocket proportional to voltage

NaNa++NaNa++

4 x 2.5 mmActive Electrode

Return Electrode

Bipolar Resection

2233


Surgery

Insulator

• 1.6 mm (5 Fr) in diameter• Focused Tissue Effects• Ball Tip

• Vaporization• Desiccation

Bipolar Resection

2244


Surgery

• Spring Tip• Vaporization • Desiccation

• Twizzle Tip• Vaporization• Pin‐point cutting

14

• Just as effective as monopolar

2255


Surgery

Varma R et al (2009) Hysteroscopic myomectomy for menorrhagia using Versascope bipolar system: Efficacy and prognostic factors at a minimum of one year follow up. Eur J Obstet Gynecol Reprod Biol 142:154–159Bradley L (2012) Hysteroscopic myomectomy. UpToDate. http://www.uptodate.com/contents/hysteroscopic‐myomectomy

• Just as effective as monopolar

• Pencil‐type electrode, loop, or bulk vaporization

• Decreased (not absent) risk of fluid absorption

Treatment Decisions


MonopolarMonopolar


2266


Surgery



Compli

Hysteroscopic Morcellator

• Operate in Saline

• Mechanical• No thermal injury

• Remove Tissue Pieces• Clear visual field

2277


Surgery

Clear visual field

• Are Easy to Use ‐ Office use?

• Facilitate Removal Type 0 and I MyomasEmanuel MH et al (2005) The Intra Uterine Morcellator: A new hysteroscopic operating technique to remove intrauterine polyps and myomas. J Minim Invasive Gynecol 12:62‐66. Cohen S, Greenberg JA (2011) Hysteroscopic morcellation for treating intrauterine pathology. Rev Obstet Gynecol 4(2):73‐80. Miller C et al (2009) Clinical evaluation of a new hysteroscopic morcellator – retrospective case review. J Clin Med 2(3):163‐166

Hysteroscopic Morcellator ‐ TruClear

• FDA Approved 2005

Decreased Operative TimePolyps 2/3Type 0 or 1 1/2

2288


Surgery

FDA Approved 2005• Dedicated Fluid Pump• Tissue Removed with Suction• Offset Lens Hysteroscope• Inner/Outer Rotating‐Oscillating Blades• Different Serrated Cutter for Polyps• Hysteroscopic Sheath 9 mm OD

Emanuel MH et al (2005) The Intra Uterine Morcellator: A new hysteroscopic operating technique to remove intrauterine polyps and myomas. J Minim Invasive Gynecol 12:62‐66.

Hysteroscopic Morcellator ‐MyoSure

2299


Surgery

• FDA Approved 2009• Standard Set‐up Fluid/Suction• Tissue Removed with Suction• Offset Lens Hysteroscope• Inner/Outer Rotating‐Oscillating Blades• Hysteroscopic Sheath Outer Diameter 6.25 mm

Cohen S, Greenberg JA (2011) Hysteroscopic morcellation for treating intrauterine pathology. Rev Obstet Gynecol 4(2):73‐80.

Treatment Decisions


MonopolarMonopolar


3300


Surgery



Compli

15

Complications

• Fluid absorption

• Gas embolism

• Perforation

• Hemorrhage

3311


Surgery

Hemorrhage

• Incomplete resection

• Objectives of fluid distension• Overcoming myometrial resistance, maximize visualization

• Create and maintain elctrosurgical environment

• Challenges of fluid absorption• Minimize fluid medium absorption and consequences

Fluid Absorption

3322


Surgery

Minimize fluid medium absorption and consequences

• Drivers of fluid absorption• Pressure, time, procedure invasiveness, comorbidities

• Pathways of fluid absorption• Direct vascular channels

• Peritoneal absorption

Nonionic (Hypotonic) Media

• 1.5% Glycine (200 mOsm/L)• Metabolized to ammonia/urea + water

• Hyperammonemia + hypo‐osmolal hyponatremia

• 3% Sorbitol (178 mOsm/L)

3333


Surgery

• Metabolized to fructose + glucose

• Hyperglycemia + hypo‐osmolal hyponatremia

• 5% Mannitol (274 mOsm/L)• Essentially inert (only ~10% metabolized)

• Metabolized to glucose

• Half‐life ~15 min; acts as osmotic diuretic

Nonionic (Hypotonic) Media

• Significant Morbidity• Headache

• Nausea, vomiting

• Lethargy, confusion, stupor

• Muscle aches and twitches

• Seizure

MediumMedium

NaNa++

3344


Surgery

• Significant Mortality• Cerebral edema

– herniation

• Pulmonary edema

• Cardiac arrhythmias

• Coma

• Death

HH22OO

Osmotic Osmotic PressurePressure

Ionic (Isotonic) Medium

• Normal Saline

• Lactated Ringers

• Pure fluid overload• Tissue edema

• Pulmonary edema

Normal Normal SalineSaline

3355


Surgery

• Treat with lasixNaNa++

NaNa++ NaNa++

Factors Affecting Intravasation

• Surgery that opens larger vascular channels• Resection of myoma > endometrial ablation

• Lysis of intrauterine adhesions

• Division of uterine septum

• Partial perforation

3366


Surgery

• Cervical/lower segment tear

• False passageway

• Excessive operating time

• Excessive intrauterine pressure• MAP aproximately 75 mm Hg

• 40‐110 mm Hg required to distend uterus

16

Mitigating Risk

• Iso‐osmolar fluids preferentially• Chilled fluid decreases absorption

• Appropriate distension pressure

• Cervical vasopressin or GnRH analogs

• Timely purposeful procedure

3377


Surgery

• Timely purposeful procedure

• Fluid management system

• Pre‐designate STOP• 1000 cc for hypotonics

• 2500 cc for isotonics

• Communication between team members

Treatment of Hyponatremia

• Early detection, rapid initiation of treatment• Loop diuretic such as furosemide for rapid diuresis

• Regular monitoring of electrolytes, intake, and output

• Restrict fluid intake, provide supplemental oxygen

d l

3388


Surgery

• Sodium <120 requires critical care setting• Engage a specialist in critical care medicine

• 3% saline with abnormal cardiac or neuromuscular function, or sodium <120 mmol/L

• Correct sodium gradually (1 ‐ 2 meq/l/hr) to 130

Gas Embolism

3399


Surgery

Heart

LungsBlood Alveoli

CO2

O2

PulmonaryDead Space

• Pulmonary vasoconstriction

4400


Surgery

y• Pulmonary vascular resistance• PAP

• RV ejection• RV end systolic/diastolic vol.

• Acute right heart failure• CVP• Cardiac Output

Gas Embolism with Electrosurgery

• No clinically significant difference in gas produced by monopolar or bipolar

• Composition – soluble: H+, CO, CO2, & O2

• Enters venous circulation

4411


Surgery

– equilibrate with pulmonary clearance

– exceed pulmonary clearance

Munro MG et al (2001) Gas and air embolization during hysteroscopic electrosurgical vaporization: comparison of gas generation using bipolar and monopolar electrodes in an experimental model. JAAGL 8(4), 488-94

Factors Predisposing Gas Embolism

• Unpurged gas bubbles in the inflow line

• Inadequate uterine flushing of bubbles

• Piston‐like action of repetitive insertions

• Excessive intrauterine pressure

• Proportionate to size of instruments

4422


Surgery

p

• Trendelenburg patient positioning

• Presence of large intramural venous channels• (e.g. vascular myoma)

• Surgical penetration into the myometrium

• Disruption and exposure of vasculature

• Excessive operating times

17

Treatment of Gas Embolism

• Stop case• stops further air entry

• Stop nitrous oxide if using• prevent bubble expansion

• Left lateral decubitus

4433


Surgery

• prevents air lock in the right heart

• Evacuate embolized air in through CVP or PA line

• Maintenance of cardiac output• raise BP and push air out

• Closed chest cardiac message / respiratory care

Uterine Perforation

• Rare overall

• 0.1 – 0.5% in simple hysteroscopy

• Up to 5% in operative hysteroscopy cases

4444


Surgery

• Consequences• Inconsequential

• Vessel injury

• Visceral injury

Perforation Risk

• Cervical dilation (most often)

• Rigid instrument placement

• Challenging access

C i l i

4455


Surgery

• Cervical stenosis

• Asherman’s syndrome

• Altered myometrium

• Uterine anomaly

• Menopause (up to 10x)

• EUA with empty bladder

• Cervical preparation, adequate dilation

• Avoid using dilators like a sound

• Gentle insertion of instruments

Perforation Prevention

4466


Surgery

• Advance electrode only if unobstructed view

• Do not advance scope with electrode extended

• Do not advance activated electrode

• Ultrasound or laparoscopy assistance

• Fundal without RF Energy• Discontinue and observe

• Fundal with RF Energy• Laparoscopy / laparotomy to inspect for visceral injury

• Lateral

Management of Uterine Perforation

4477


Surgery

• Lateral • Laparoscopy to inspect for broad ligament hematoma

• Anterior• Cystoscopy

• Remove excessive distention media• Delayed fluid absorption issues

Hemorrhage

• Greatest risk with myomectomy (2.5%)

• Look for cervical tear / partial perforations

Miti ti i k

4488


Surgery

• Mitigating risk• vasopressin

• preop GnRH agonist

Mencaglia L, Tantini C (1993) GnRH agonist analogs and hysteroscopic recection of myomas. Int J Gynaecol Obstet. 43:285Phillips DR et al (1997) The effect of dilute vasopressin solution on the force needed for cervical dilation: a randomized controlled trial. Obstet Gynecol 89:507.Phillips DR et al (1996) The effect of dilute vasopressin solution on blood loss during operative hysteroscopy: a randomized controlled trial. Obstet Gynecol 88:761.

18

• Type II (ESGE) Hysteroscopic Myomectomy• Increased risk of:

– Excessive fluid absorption

– Electrolyte abnormalities with non‐electrolyte media

– Excessive bleeding

Need for Staged Procedures

4499


Surgery

– Incomplete resection

– Need for additional procedure

– Increased operative time

• Applies even to experienced hysteroscopic surgeons



Type 0 Type I Type II Total

No. Patients73 97 108 278

No. Procedures

73 102 158 333

Complete N = 103 N = 271

5500


Surgery

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



5511


Surgery


Need for Stages Procedures

• 57 myomectomies compared with ESGE system

• NC more accurately predicted differences between groups I and II with respect to:

• completed procedures, fluid deficit, and operative time

5522


Surgery


Treatment Decisions


MonopolarMonopolar


5533


Surgery



Compli

• Adequate pre‐opertive assessment• Measure twice, cut once

• Consider appropriateness of hysteroscopy

• Consider specific surgical tools available

C l i di fl id

Patient Management

5544


Surgery

• Counsel patients regarding fluid management• Excessive absorption and consequences

• Procedure termination, need for additional procedure(s)

• Be aware of risks and vigilant for complications

• Know your surgical limits

19

References1. Benacerraf BR et al (2006) Improving the Efficiency of Gynecologic Sonography With 3‐Dimensional Volumes: A

Pilot Study. JUM 25(2):165‐71.

2. Bradley L (2012) Hysteroscopic myomectomy. http://www.uptodate.com/contents/hysteroscopic‐myomectomy

3. Cohen S, Greenberg JA (2011) Hysteroscopic morcellation for treating intrauterine pathology. Rev Obstet Gynecol 4(2):73‐80.

4. Emanuel MH et al (2005) The Intra Uterine Morcellator: A new hysteroscopic operating technique to remove intrauterine polyps and myomas. J Minim Invasive Gynecol 12:62‐66.

5. Fedele L et al (1991) Transvaginal ultrasonography versus hysteroscopy in the diagnosis of uterine submucous myomas. Obstet Gynecol 77(5):745‐48.

6. Haemila et al (2005) A prospective comparative study of 3‐D ultrasonography and hysteroscopy in detecting uterine lesions in premenopausal bleeding Middle East Fertil Soc 10(3):239 243

5555


Surgery

uterine lesions in premenopausal bleeding. Middle East Fertil Soc 10(3):239‐243.

7. Kelekci S et al (2005) Comparison of transvaginal sonography, saline infusion sonography, and office hysteroscopy in reproductive‐aged women with or without abnormal uterine bleeding. Fertil Steril 84(3):682‐86.

8. Lasmar RB et al (2005) Submucous myomas: A new presurgical classification to evaluate the viability of hysteroscopic surgical treatment – preliminary report. JMIG 12:308‐311.

9. Lee C et al (2006) Reproducibility of the measurement of submucous fibroid protrusion into the uterine cavity using three‐dimensional saline contrast sonohysterography. Ultrasound in Obstet Gynecol 28(6):837–841.

10. Mencaglia L, Tantini C (1993) GnRH agonist analogs and hysteroscopic recection of myomas. Int J Gynaecol Obstet. 43:285

11. Miller C et al (2009) Clinical evaluation of a new hysteroscopic morcellator – retrospective case review. J Clin Med 2(3):163‐166

References10. Phillips DR et al (1996) The effect of dilute vasopressin solution on blood loss during operative

hysteroscopy: a randomized controlled trial. Obstet Gynecol 88:761.

11. Phillips DR et al (1997) The effect of dilute vasopressin solution on the force needed for cervical dilation: a randomized controlled trial. Obstet Gynecol 89:507.

12. Roy KK et al (2010) Reproductive outcome following hysteroscopic myomectomy in patients with infertility and recurrent abortions. Arch Gynecol Obstet 282(5):553‐560.

13. Spielmann AL et al (2006) Comparison of MRI and Sonography in the Preliminary Evaluation for Fibroid Embolization. AJR December 2006 vol. 187 no. 6 1499‐1504

14. Stewart EA (2001) Uterine Fibroids. Lancet 357:293‐98.

5566


Surgery

15. Varma R et al (2009) Hysteroscopic myomectomy for menorrhagia using Versascope bipolar system: Efficacy and prognostic factors at a minimum of one year follow up. Eur J Obstet Gynecol Reprod Biol 142:154–159

16. Wamsteker K et al (1993) Transcervical hysteroscopic resection of submucous fibroids for abnormal bleeding: results regarding the degree of intramural extension. Obstet Gynecol 82:736‐40.

17. Widrich T et al (1996) Comparison of saline infusion sonography with office hysteroscopy for the evaluation of the endometrium. Am J Obstet Gynecol. 174(4):1327‐34.

Questions?

5577


Surgery



[email protected]

20

What limits a conventional laparoscopic approach?

Jon I Einarsson MD MPHDirector of MIGS

Brigham and Women’s HospitalAssociate Professor of Obstetrics and Gynecology

Harvard Medical School

DISCLOSUREI have the following financial relationship with a commercial entity producing health-care related

products and/or services

Consultant Ethicon Endo-Surgery

Objectives

O Discuss steps of conventional laparoscopic myomectomy

O Describe the limitations of the conventional laparoscopic approach

O Describe tips and tricks to overcome some of those limitations

Our data – LM vs. RALM

289 women – 02/07-09/09 LM (n=115) RALM (n=174) p

Operative time (min) 118.3 195.1 <.0001

EBL (ml) 85.9 110.0 0.04

Conversions to laparotomy 0 0 NS

Weight of fibroids (g) 201 (1-1473) 159 (8-780) NS

Median n of fibroids 2 (1-21) 3 (1-16) NS

Largest fibroid (cm) 7.5 (2.2-16.5) 7.3(3.1-13.8) NS

Blood transfusions n(%) 1(0.9) 10(5.7) NS

Hospital stay >1 day n(%) 4(3.5) 29(16.9) OR 5.73

Brief description of our technique

O Two parallel trocars on surgeon sideO Faciliates suturing – especially in the setting of a

horizontal hysterotomyO Inject dilute vasopressin subserosally – avoid

using more than 10 units every 30 minutesO Consider diluting the vasopressin in a Marcaine

cocktail – possible pain relief at the hysterotomy site

O We like to use large volumes, 20 units of vasopressin in 400 ml of saline – we inject 200 ml (10 units) at a time

O RCT ongoing comparing blood loss in using 200 vs 60 ml of diluted vasopressin solution

Step 1‐ Vasopressin injection

21

Step 2 – HysterotomyO Carry the incisioninto the fibroid– find the right planeO We prefer the Harmonic due tominimal lateralthermal spreadO A horizontal incision is preferredfor suturing with twoipsilateral trocars

Step 3 – Fibroid extractionO Rock and Roll O Needs quite a bit of forceO Avoid entering the cavity if

possible –will do this deliberatelyin women who havecompleted theirchildbearing – easy topluck out thesubmucosal fibroidsthis way

Step 4 – Closure of endometrial cavity

O Close cavity separately (if entered) with small (3/0) monofilament (Monocryl)

O Take care not to place sutures inside the uterine cavityinside the uterine cavity

O Intracorporeal knot tyingO We will not close the cavity

separately in patients who are not of reproductive potential

Step 5 – Hysterotomy closure

O Close hysterotomy in layers making sure to approximate all dead-space

O We use bidirectional barbed suture routinelyy

O 0 PDO (equivalent to 2/0 PDS)O This suture has a needle on each end and

barbs that are directed in an opposite direction to the needles

O Use as many layers as needed to securely approximate the edges

Bidirectional barbed suture Step 5 – Hysterotomy closure

O We tack the first needle into the anterior abdominal wall on the right side to avoid tangling

O First bite taken and suture pulled through until resistance is met (middle of suture)( )

O First layer completed, needle cut awayO Second layer taken with other needleO The hysterotomy closure is “time sensitive” –

as long as the hysterotomy is open there is going to be active bleeding

O Cover hysterotomy with adhesion barrier (interceed)

22

Step 5 – Hysterotomy closure

O We close the serosa in a baseball configuration

O No evidence that a baseball closure reduces adhesion risk

O A recent RCT in a sheep model showed no difference in adhesion formation between vicryl and barbed suture

Hysterotomy closure ‐ video

Hysterotomy closure – baseball Step 6 ‐MorcellationO We need better tissue

morcellatorsO Try to stay on the surface (peel

an orange)O Make sure to get all the pieces

outO Time consuming in the setting of

large or calcified fibroids O 12-40 grams per minuteO 1000 grams takes 25-83

minutes to morcellate

Limits

O Surgeon experienceO SizeO NumberO LocationO What is the ultimate goal of surgery? Fertility

preservation? Volume reductionO Blood loss – will the pt accept a

transfusion?

Surgeon experience

O Most important factorO Move strategically and control the situation

at all timesO Gradually build upO Need high volumes (>50/year) to become

really goodO Rapid suturing is important

23

Size

O The largest specimen weight for a myomectomy in our group is 3080 g

O Does not tell the whole storyMUCH i t l g fib id th O MUCH easier to remove one large fibroid rather than multiple small ones (raisin bread)

O Time for extraction can be excessive – a minilaparotomy may be advisable with manual morcellation with a 10 blade

O Also consider hand assisted surgery

Laparoscopically assisted myomectomy

O Hybrid procedureO Fibroids usually removed laparoscopically

and suturing and fibroid extraction performed through a minilaparotomy incision (4 5 cm)incision (4-5 cm)

O Challenging for posterior fibroidsO Longer recovery time than LMO Also can be done hand assisted, but then

the incision is larger – around 7 cm

Taniguchi et al Fertil Steril. 2004;81(4):1120-4

Hand assisted video

Number

O Have removed over over 60 fibroids in one patient, but our median number is 2 per case.

O Important to have a discussion with the patient about limitations. It is not always possible to remove all fibroids. Small ones may be left behind

O Preoperative evaluation is very important for mapping

Location

O Intramural vs submucosal vs intracavitary vs subserosal

O Cervical – watch out for uterines – clip at forigin if necessary

O Broad ligament – usually pretty easy – open peritoneum and peel out – again stay away from major vessels

24

Preoperative evaluation

O MRI is obtained on most patients

O Delineates location, characteristics and size of fibroids

O Detects adenomyosisO Helps with

preoperative counseling and planning

Goal of surgery?

O Fertility preservationO prefer not to embolize or use permanent clips, but

OK to use clips and remove at end of caseO Important to take care of any fibroids in vicinity of

cavityO Close endometrium separately

O No Fertility preservationO OK to remove the whole top of uterus and close

en mass – shortens and simplifies procedureO No need to close endometrium separatelyO Remove submucosal fibroids laparoscopically

Tips for limiting blood loss

O Use high volume vasopressin – 20 units in 400 ml of saline – inject 200 ml

O Use lupron preoperatively to build blood counts – may make dissection of fibroids more difficult IF the fibroids are already necroticIF the fibroids are already necrotic

O Be quickO Avoid making an incision close to ascending

uterinesO Use clips on the uterine arteriesO Consider preop embolizationO Consider using cell saver

Laparoscopic uterine artery occlusion

Case in point

O 39 y/o G0 – Jehovah's witnessO Heavy bleeding despite Lupron for 6 monthsO H/H 9/29 despite repeated iv iron infusions

fO Wants pregnancy in near futureO Multiple fibroids on imaging, overall uterine

size 19.5x17.2x8.6cm – 10 cm intracavitaryfibroid – total uterine weight approx 1500 grams

O EMB benign

Video

25

Thank youReferences

O Einarsson JI, Grazul-Bilska AT, Vonnahme KA. Barbed vs. standard suture; a randomized single-blinded comparison of adhesion formation and ease of use in an animal model. J Minim Invasive Gynecol. 2011 Nov;18(6):716-9.

O Einarsson JI, Vonnahme KA, Sandberg EM, Grazul-Bilska AT. Barbed compared to standard suture: effects on cellular composition and proliferation of the healing wound in

the ovine uterus. Acta Obstet Gynecol Scand. 2012 May;91(5):613-9.y y; ( )

O Gargiulo AR, Srouji SS, Missmer SA, Correia KF, Vellinga T, Einarsson JI. Robot-assisted laparoscopic myomectomy compared with standard laparoscopic myomectomy. Obstet Gynecol. 2012 Aug;120(2 Pt 1):284-91.

O Einarsson JI, Chavan NR, Suzuki Y, Jonsdottir G, Vellinga TT, Greenberg JA. Use of bidirectional barbed suture in laparoscopic myomectomy: Evaluation of perioperative

outcomes, safety, and efficacy. J Minim Invasive Gynecol. 2011; 18(1):92-5.

O Taniguchi et al Fertil Steril. 2004;81(4):1120-4

26

Robot –Assisted Laparoscopic Myomectomy

Tommaso Falcone,M.D.Professor and ChairDepartment of Obstetrics & Gynecology


•• I have no financial relationships to I have no financial relationships to ppdisclose.disclose.

Learning ObjectivesLearning Objectives•• Analyze if a laparoscopic approach to the Analyze if a laparoscopic approach to the

management of a fibroid uterus gives management of a fibroid uterus gives similar results to a laparotomysimilar results to a laparotomy

•• List the benefits of Laparoscopic List the benefits of Laparoscopic myomectomymyomectomy

•• Discuss the possible technical limitations Discuss the possible technical limitations of laparoscopic myomectomyof laparoscopic myomectomy

•• Discuss the role of robotics Discuss the role of robotics

27

Summary of Literature on Robotic Myomectomy SurgerySummary of Literature on Robotic Myomectomy Surgery

NumberNumber RemovedRemovedof Roboticof Robotic Type of Type of MyomasMyomas

Author Author Year Year Cases Cases Study Study WeightWeight ResultsResults

Advincula 2004 35 Preliminary Mean = Robotic myomectomyAP et al experience 223.2 + 244.1g is new promising

approach

Mao SP 2007 1 Case report Not Successfulet al available robotically-assistedet al available robotically-assisted

excision of large uterine myoma measuring 9x8x7cm

Bocca S 2007 1 Case report Not Achievement of et al available uncomplicated full

term pregnancy after robotic myomectomy

Summary of Literature on Robotic Myomectomy Summary of Literature on Robotic Myomectomy SurgerySurgery

NumberNumber RemovedRemovedof Roboticof Robotic Type ofType of MyomasMyomas

Author Author Year Year Cases Cases StudyStudy WeightWeight ResultsResults

Advincula 2007 29 Retrospective Mean = Robotic myomectomyAP, et al case matched 227.86 + 247.54g approach is

between comparable to openrobotic and approach regardingopen short term surgicalmyomectomy outcome and costs

Nezhat C 2009 15 Retrospective Mean = 116g Robotic myomectomy et al case matched (min 25-max 350)g had significant longer

between surgical time withoutrobotic and offering any majorlaparoscopic advantages

myomectomy

Summary of Literature on Robotic Myomectomy Summary of Literature on Robotic Myomectomy SurgerySurgery

NumberNumber RemovedRemovedof Roboticof Robotic Type ofType of MyomasMyomas

Author Author Year Year CasesCases StudyStudy WeightWeight ResultsResults

George A 2009 77 Effect of the Median = 235g Obesity is not aet al BMI on the (range 21.2 - 980)g risk factor for poor

surgical surgical outcome outcome in roboticoutcome in robotic

myomectomy

Bedient CE 2009 40 Comparing Mean = 210g No difference in et al robotic to (range 7 - 1076)g relation to short

laparoscopic term surgical myomectomy outcome measures

Robotic trialRobotic trial

•• Robotic myomectomy versus laparotomyRobotic myomectomy versus laparotomy–– AscherAscher-- Walsh & Capes JMIG 2010Walsh & Capes JMIG 2010–– Robot N= 75; 4 portsRobot N= 75; 4 ports-- 3 robotic and 1 assistant; 3 robotic and 1 assistant;

ControlControl N=50;N=50;ControlControl-- N=50;N=50;–– Inclusion criteria were 3 myomas or fewer Inclusion criteria were 3 myomas or fewer –– Mean BMI was 20Mean BMI was 20--2121–– Duration of surgery 192 minutes versus 138 minutesDuration of surgery 192 minutes versus 138 minutes–– Uterine Weight 320 g; LOS 0.5 days versus 3 daysUterine Weight 320 g; LOS 0.5 days versus 3 days–– Less blood loss; less febrile morbidityLess blood loss; less febrile morbidity

28

Robot vs. laparoscopic Robot vs. laparoscopic MyomectomyMyomectomy

•• 2 separate teams with 2 separate 2 separate teams with 2 separate expertise ( Gargiulo et al Obstet Gynecol expertise ( Gargiulo et al Obstet Gynecol 2012)2012)

•• N= 115 scope myomectomyN= 115 scope myomectomy•• N= 174 robot myomectomyN= 174 robot myomectomy•• Median # of myomasMedian # of myomas-- 2 vs 32 vs 3•• WeightWeight-- 201 ( 1201 ( 1--1.5 kg) vs 159 g (81.5 kg) vs 159 g (8--780 780

g)g)•• Median dimension 7.5 cm Median dimension 7.5 cm

Gargiulo et al 2012Gargiulo et al 2012

•• OR time: 118 minutes ( laparosocpy) vs. OR time: 118 minutes ( laparosocpy) vs. 195 minutes (robot)195 minutes (robot)

•• Robot case had a higher odds of Robot case had a higher odds of d i i h i l d h i ld i i h i l d h i ladmission to hospital and having a longer admission to hospital and having a longer

than 1 day hospital staythan 1 day hospital stay•• Risk of complications were the sameRisk of complications were the same--but but

note that transfusion rate was 0.9 % in note that transfusion rate was 0.9 % in the scope myomectomy group vs. 5.7 % the scope myomectomy group vs. 5.7 % in the robot groupin the robot group

Cleveland ClinicCleveland Clinic--Obstet Gynecol 2011Obstet Gynecol 2011

AbdominalAbdominal(n=393)(n=393)

Laparoscopic Laparoscopic (n=93) (n=93)

Robotic Robotic (n=89)(n=89)

p value p value

Age yearsAge years36.9336.93( 5 61)( 5 61)

39.5739.57( 9 17)( 9 17)

36.6236.62( 5 18)( 5 18)

< < 0 0010 001Age years Age years ( 5.61) ( 5.61) ( 9.17) ( 9.17) ( 5.18) ( 5.18) 0.001 0.001

Weight KgWeight Kg75.575.5(62.8,90.7) (62.8,90.7)

64.8 (59.1, 64.8 (59.1, 76.66) 76.66)

68.0468.04( 57.6, 82.5) ( 57.6, 82.5)

< < 0.001 0.001

Height cm Height cm 163.92163.92( 13.17) ( 13.17)

164.02164.02( 6.19) ( 6.19)

163.63163.63(6.62) (6.62) 0.97 0.97

BMI kg/m2BMI kg/m2 27(23,32) 27(23,32) 24.1 ( 22, 28.1) 24.1 ( 22, 28.1) 25.1 ( 22.1, 25.1 ( 22.1, 29.4) 29.4)

< < 0.001 0.001

Maximum Diameter of the Resected Maximum Diameter of the Resected Myoma (in cm) by Surgical ApproachMyoma (in cm) by Surgical Approach

20

30

0

10

Abdominal Laparascopic Robotic

(P=0.036)

Weight of the Resected Myomas Weight of the Resected Myomas (in grams) by Surgical Approach(in grams) by Surgical Approach

2,500

2,000 OverallP < 0.001

0


1,500

1,000

500

RM vs LM < 0.001

The Actual Operative Time (in minutes)The Actual Operative Time (in minutes)by Surgical Approachby Surgical Approach

300

250

350

Overall P < 0.001

150

50


100

200 RM vs LM NS

29

The Intra−operative Blood Loss (mL) The Intra−operative Blood Loss (mL) by Surgical Approachby Surgical Approach

2,500

2,000 Overall P < 0.001

0


1,500

1,000

500

RM vs. LM NS

The Postoperative Hemoglobin Drop The Postoperative Hemoglobin Drop (gm/dL) by Surgical Approach(gm/dL) by Surgical Approach

5

6

7

Overall P < 0.001

0

1

2

3


4RM vs LM NS

Technical LimitationsTechnical Limitations-- robot robot approachapproach-- What are the solutions?What are the solutions?

•• Procedures are longer Procedures are longer –– Requires trainingRequires training

•• Most important learning step is portMost important learning step is portMost important learning step is port Most important learning step is port placementplacement

•• Matthews et al JMIG 2010Matthews et al JMIG 2010•• Mean distance from symphysis pubis to Mean distance from symphysis pubis to

the umbilicus less than 16 cm, 100 % the umbilicus less than 16 cm, 100 % required port placement above the required port placement above the umbilicus.umbilicus.

Port placementPort placement

•• Should we use the fourth armShould we use the fourth armS ou d e use e ou aS ou d e use e ou a•• Accessory port/portsAccessory port/ports

Technical considerationsTechnical considerations

•• Uterine manipulatorUterine manipulator•• 88--10 cm between the endoscope and the10 cm between the endoscope and the•• 88 10 cm between the endoscope and the 10 cm between the endoscope and the

top of the elevated uterustop of the elevated uterus•• Accurate myoma “mapping”Accurate myoma “mapping”

–– No tactile feedbackNo tactile feedback

30

15°

10 cm

45°

8-10 cm

31

Side Docking Side Docking –– 4 arm4 arm

32

Cost analysisCost analysis

•• Advincula et al JMIGAdvincula et al JMIG--20072007•• hospital charges Robothospital charges Robot--$30,000 versus $ $30,000 versus $

13 000 f l t13 000 f l t13,000 for laparotomy13,000 for laparotomy•• Behera et al JMIF 2012Behera et al JMIF 2012--

–– CostCost-- AM $4937/ LM $6219 and RM $7299AM $4937/ LM $6219 and RM $7299•• ReimbursementReimbursement

–– What will we get in the future?What will we get in the future?

ConclusionConclusion

•• Robotic Surgery may have some Robotic Surgery may have some advantage over conventional surgery.advantage over conventional surgery.

•• Robotics may help the suturing taskRobotics may help the suturing task•• There is a learning curveThere is a learning curve•• Robotic times are longerRobotic times are longer•• Costs ?Costs ?

Case 1Case 1

•• 35 year old G1P0010 35 year old G1P0010 •• uterine fibroids and desires future fertility uterine fibroids and desires future fertility •• Patient has a history of menorrhagia in 2006.Patient has a history of menorrhagia in 2006.y gy g•• Missed AB at approx 8 weeks. Missed AB at approx 8 weeks. •• Severe vaginal bleeding and a drop in H&H that Severe vaginal bleeding and a drop in H&H that

necessitated a 2 unit transfusion of blood. necessitated a 2 unit transfusion of blood. •• Show MRIShow MRI--would you do this case robotically?would you do this case robotically?

33

Case 3Case 3

•• 29 year old G0 presents with a history of 29 year old G0 presents with a history of l i bd i l i th d h tl i bd i l i th d h tenlarging abdominal girth mass and what enlarging abdominal girth mass and what

was thought to be an umbilical hernia. was thought to be an umbilical hernia. •• Patient strongly desires future fertilityPatient strongly desires future fertility

34

referencesreferences

•• Mao SP, Lai HC, Chang FW, Yu MH, Chang CC. LaparoscopyMao SP, Lai HC, Chang FW, Yu MH, Chang CC. Laparoscopy--assisted robotic assisted robotic myomectomy using the da Vinci system. Taiwan J Obstet Gynecol 2007 myomectomy using the da Vinci system. Taiwan J Obstet Gynecol 2007 Jun;46(2):174Jun;46(2):174--6.6.

•• Bedient CE, Magrina JF, Noble BN, Kho RM. Comparison of robotic and Bedient CE, Magrina JF, Noble BN, Kho RM. Comparison of robotic and laparoscopic myomectomy. Am J Obstet Gynecol 2009 Dec;201(6):566 e1laparoscopic myomectomy. Am J Obstet Gynecol 2009 Dec;201(6):566 e1--5.5.

•• Ne hat C La ie O Hs S Watson J Ba nett O Lem e M RoboticNe hat C La ie O Hs S Watson J Ba nett O Lem e M Robotic assistedassisted•• Nezhat C, Lavie O, Hsu S, Watson J, Barnett O, Lemyre M. RoboticNezhat C, Lavie O, Hsu S, Watson J, Barnett O, Lemyre M. Robotic--assisted assisted laparoscopic myomectomy compared with standard laparoscopic laparoscopic myomectomy compared with standard laparoscopic myomectomymyomectomy----a retrospective matched control study. Fertil Steril 2009 a retrospective matched control study. Fertil Steril 2009 Feb;91(2):556Feb;91(2):556--9.9.

•• Advincula AP, Xu X, Goudeau St, Ransom SB. RobotAdvincula AP, Xu X, Goudeau St, Ransom SB. Robot--assisted laparoscopic assisted laparoscopic myomectomy versus abdominal myomectomy: a comparison of shortmyomectomy versus abdominal myomectomy: a comparison of short--term term surgical outcomes and immediate costs. J Minim Invasive Gynecol 2007 surgical outcomes and immediate costs. J Minim Invasive Gynecol 2007 NovNov--Dec;14(6):698Dec;14(6):698--705.705.

•• George A, Eisenstein D, Wegienka G. Analysis of the impact of body mass George A, Eisenstein D, Wegienka G. Analysis of the impact of body mass index on the surgical outcomes after robotindex on the surgical outcomes after robot--assisted laparoscopic assisted laparoscopic myomectomy. J Minim Invasive Gynecol 2009 Novmyomectomy. J Minim Invasive Gynecol 2009 Nov--Dec;16(6):730Dec;16(6):730--3.3.

•• Barakat EE, Bedaiwy MA, Zimberg S, Nutter B, Nosseir M, Falcone T. Barakat EE, Bedaiwy MA, Zimberg S, Nutter B, Nosseir M, Falcone T. RoboticRobotic--assisted, laparoscopic, and abdominal myomectomy: a comparison assisted, laparoscopic, and abdominal myomectomy: a comparison of surgical outcomes. Obstet Gynecol 2011 Feb;117(2 Pt 1):256of surgical outcomes. Obstet Gynecol 2011 Feb;117(2 Pt 1):256--265.265.

ReferencesReferences

•• Gargiulo A, Srouji S, Missmer S, Correia K, Vellinga T, Einarsson J. RobotGargiulo A, Srouji S, Missmer S, Correia K, Vellinga T, Einarsson J. Robot--Assisted laparoscopic myomectomy compared with standard laparoscopic Assisted laparoscopic myomectomy compared with standard laparoscopic myomectomy. Obstet Gynecol 2012;120:284myomectomy. Obstet Gynecol 2012;120:284--291291

•• AscherAscher--Walsh C, Capes T. RobotWalsh C, Capes T. Robot--assisted laparoscopic myomectomy is an assisted laparoscopic myomectomy is an improvement over laparotomy in women with a limited number of myomas. improvement over laparotomy in women with a limited number of myomas. J Minim Invasive Gynecol 2010;17:306J Minim Invasive Gynecol 2010;17:306--310.310.

•• Behera M Likes C Judd J Barnett J Havrilesky L Wu J Cost analysis ofBehera M Likes C Judd J Barnett J Havrilesky L Wu J Cost analysis of•• Behera M, Likes C, Judd J, Barnett J, Havrilesky L, Wu J. Cost analysis of Behera M, Likes C, Judd J, Barnett J, Havrilesky L, Wu J. Cost analysis of abdominal, laparoscopic, and roboticabdominal, laparoscopic, and robotic--assisted myomectomies. J Minim assisted myomectomies. J Minim Invasive Gynecol 2012;19:52Invasive Gynecol 2012;19:52--57.57.

•• Matthews C, Schubert C, Woodward A, Gill E. Variance in abdominal wall Matthews C, Schubert C, Woodward A, Gill E. Variance in abdominal wall anatomy and port placement in women undergoing robotic gynecologic anatomy and port placement in women undergoing robotic gynecologic surgery. J Minim Invasive Gynecol 2010;17:583surgery. J Minim Invasive Gynecol 2010;17:583--586.586.

•• Advincula AP, Song A, Burke W, Reynolds RK. Preliminary experience with Advincula AP, Song A, Burke W, Reynolds RK. Preliminary experience with robotrobot--assisted laparoscopic myomectomy. J Am Assoc Gynecol Laparosc assisted laparoscopic myomectomy. J Am Assoc Gynecol Laparosc 2004 Nov;11(4):5112004 Nov;11(4):511--8.8.

•• Bocca S, Stadtmauer L, Oehninger S. Uncomplicated full term pregnancy Bocca S, Stadtmauer L, Oehninger S. Uncomplicated full term pregnancy after da Vinciafter da Vinci--assisted laparoscopic myomectomy. Reprod Biomed Online assisted laparoscopic myomectomy. Reprod Biomed Online 2007 Feb;14(2):2462007 Feb;14(2):246--9.9.

35

Jon Ivar Einarsson MD MPHDirector of Minimally Invasive Gynecologic SurgeryBrigham and Women’s HospitalAssociate ProfessorHarvard Medical School

I have the following financial relationships witha commercial entity producing health‐carey p grelated products and/or services.

Consultant for Ethicon‐Endosurgery

Describe various available myoma ablation methods

Describe various availble UAO methodsDiscuss other treatment options on the Discuss other treatment options on the horizon

1813Modern vaginal h t t

1995Uterine artery embolization

1984GnRH agonists 2001

Laparoscopic

1989Myolysis

hysterectomy 1825

Total abdominal hysterectomy

1844Myomectomy

1956Hormonal treatment

1981Endometrial ablation

Laparoscopicuterine arteryocclusion

2004MRgFUS

1800 1850 1900 1950 2000

Uterine artery embolization (UAE) Magnetic resonance‐guided focused ultrasound (MRgFUS)

Laparoscopic uterine artery occlusion (L‐UAO) Doppler‐guided uterine artery occlusion (D‐UAO)pp g y ( ) Radiofrequency ablation (RFA) Halt VizAblate

Cryomyolysis

Involves an injection of trisacryl gelatin microspheres, polyvinyl alcohol particles, or gelatin sponge into the uterine arteries for occlusion

Effective in appropriately selected patients Patients with multiple fibroids or large

fibroids have less favorable outcomesfibroids have less favorable outcomes Patients with submucosal fibroids or

pedunculated fibroids on a stalk smaller than 2 cm are not ideal candidates

Goodwin et al. Obstet Gynecol. 2008;111(1):22-33

36

Clinical Efficacy From Fibroid Registry Data Significant and durable improvement in symptoms and quality of life, measured at 6 and 12 months

Mean symptom score (UFS‐QOL) reduced from 58.61 to 19 23 (P <0 001)19.23 (P <0.001)

Mean quality of life score rose to 86.68 from 46.95 (P <0.001)

>85% of patients had at least a 10‐point improvement in symptoms

82% of patients were pleased with their outcome

Spies JB, et al. Obstet Gynecol. 2005;106:1309‐1318.

Embolization to nontarget organs and tissues (eg, ovaries) Ovarian failure as high as 13.6% (increased risk for women older than 45 years)1women older than 45 years)

Uterine necrosis and sepsisPassage of submucous myomata Postembolization syndromeLocal (hematoma, ecchymoses)Mortality

1Chrisman HB, et al. J Vasc Interv Radiol. 2000;11:699‐703.

Current status (ACOG):Based on current evidence, it appears that uterine artery embolization, when performed by experienced physiciansperformed by experienced physicians, provides good short‐term relief of bulk‐related symptoms and a reduction in menstrual flow. Remains investigational withregard to preservation of fertility

ACOG. Obstet Gynecol. 2004;103:403‐404.

UFE is associated with shorter hospital stay (1 vs 2.5 days) and quicker return to normal activities (15 vs 44 days) when compared with abdominalmyomectomy myomectomy

Goodwin et al Fertil Steril. 2006;85(1):14‐21

One study found that UFE and laparoscopicmyomectomy have similar recovery rates –complications were more common in the UFE group

Ohgi et al J Obstet Gynaecol Res. 2007;33(4):506‐11

106 pts UFE vs 51 surgery (43 hyst, 8 myomect) via laparotomy No significant differences in SF‐36 scores at one year (POM) UFE with shorter hospital stay (1 vs 5 days) and quicker return to work At one year symptom scores were better in surgery group Complication rates similar – however most complications in surgery p p g y

group were during initial hospitalization while most of the UFE complications occurred after hospital discharge

Nine percent of the UFE group required re‐embolization or hysterectomy at one year of follow‐up

Edwards et al. N Engl J Med. 2007;356(4):360-70

RCT comparing 88 UAE vs 89 abdominal hyst pts Rate of minor complications higher for UAE Shorter hospital stay in UAE group Similar symptom relief in both groups 23.5% of the women in the UFE group had undergone a g p g

hysterectomy at 24 months and 28.4% at 5 years. This trial has been faulted for high rates of technical failure

during UAE – perhaps indicating lack of expertize by the radiologists in this trial

Volkers et al. Am J Obstet Gynecol. 2007;196:519.e1–519.e11

Van Der Kooii SM et al. Am J Obstet Gynecol 2010;230(2):105.e1-13

37

RCT between UFE and myomectomy among 121 women with reproductive plans with an intramural fibroid larger than 4 cm

Mean follow up at interval report was 2 years Embolization was less invasive (shorter hospital stay, shorter recovery)

Statistically significantly more pregnancies (78% vs 50%), live births (48% vs 19%) and fewer miscarriages (23% vs 64%) in the myomectomy group

Mara et al. Cardiovasc Intervent Radiol. 2008 Jan-Feb;31(1):73-85

Fibroids located and mapped with MRI Ultrasound beams are focused on fibroids and cause

intense heat and destruction Patient prone on MRI table for 2‐4 hours Not recommended for women of childbearing Not recommended for women of childbearing

potential, or for submucosal fibroids, multiple fibroids, fibroids near bowel or bladder or where abdominal scars are in the way of the ultrasound beams

Fennessy et al. Radiology 2007;243(3):885-93

A study of 109 women found a 13.5% and 9.4% myoma volume reduction at 6 and 12 months

80% reported symptom improvement at 6 months 28% required alternative treatment within 12 months This treatment is not covered by most insurance plans –

costs $18 000 to $26 000 out of pocketcosts $18,000 to $26,000 out of pocket Treatment times were conservative (on average 10% NPV)

in the early trials and further refinements are underway

Stewart et al. Fertil Steril. 2006;85:22–29

NPV (%) Count Any symptom improvement (%)

Alternative treatment

0-10 69 38 4810-20 55 47 4420-30 37 57 3530-40 26 73 23Over 40

29 79 17

Stewart et al. Obstet Gynecol 2007 Dec;110(6):1428-9NPV – non perfused volume

Based on 4 published case series

71%‐88% and 51%‐91% achieved a 10‐point reduction in UFS symptom severity scale at 6 and 12 months, respectively

R i t ti t 12% 34% (f ll 6 12 th ) Reintervention rate – 12%‐34% (follow‐up 6‐12 months) “Current evidence on the safety and efficacy of magnetic resonance image (MRI)‐guided transcutaneous focused ultrasound for uterine fibroids is such that this procedure should only be used with special arrangements for consent and for audit or research.”

National Institute for Health and Clinical Excellence. Magnetic resonance image‐guided transcutaneous focused ultrasound ablation for uterine fibroids. September 2007.

Study n Duration NPV SSSReduction

Volume Reduction

Stewart et al, 2007 416 24 months 38.0% ~ 50% 20% (6 months)

Funaki et al, 2009 91 24 months ~ 54% 57% 39.5%

Lénárd et al, 2008 135 12 months 16.3% 39% 17.0%

Fennessey et al, 2007 160 12 months 16.7%‐25.8%

47% N/A

Kim et al, 2011* 40 36 months 32% 48% 32%

*9 (22.5%) patients had needed reintervention at 3 years, 2 hysts, 2 myomectomies, 5 UFEs

38

The uterine arteries are located and permanently occluded laparoscopically

Requires dissection of the origin of the uterine artery from the internal iliac vessels

Currently being performed at BWH in women with multiple fib id h d i t i ti d h l t d fibroids who desire uterine conservation and have completed their childbearing

The largest fibroids are removed concurrently – this may reduce the necrosis and pain following the occlusion of the uterine arteries

Allows for diagnosis and treatment of other potential pathology

Good for “bag of marbles” Requires advanced laparoscopic skills

Hald and Istre 2007: 58 women randomized to UAE or L‐UAO (29 in each group) followed for six months

No significant difference in mean reduction in PBAC scores

Fewer women in the UAE group complained of menorrhagia at six months, however (4% vs 21%, P = 0.044)

P i d i t i ifi tl hi h ft UAE Pain med requirements significantly higher after UAE Hald and Istre 2009: same patients followed up to 73 months (median

48 months)

Higher hysterectomy rate in L‐UAO group (28% vs 7%; P = 0.041)

Clinical failure/symptom recurrence rate higher in L‐UAO group (48% vs 17%; P = 0.02)

All UAE patients had complete infarction vs 23% of L‐UAO pts

Proximal laparoscopic UA occlusion might not block distal cervicovaginal anastomoses

Greater propensity towards technical failure of the laparoscopic approach?

Visualization of retroperitoneal vessels is more tenuous with laparoscopy, especially with large uteri

Unlike angiography, cannot rule out vascular anomalies (aberrant UA, duplicate UA)

The uterine vessels are located and clamped transvaginally without an incision

A doppler sensor at the end of the clamp recognizes the pulsation of the uterine artery

The patient has an epidural and the clamp is left in p p pplace for 6 hours

Cystoscopy is performed prior to and after clamp placement

Lichtinger et al. J Minim Invasive Gynecol. 2005;12(1):40-2

Uterine Sound

Transvaginal Doppler

Clam

Tenaculum Guide Rod

Tenaculum

Coupler

39

Volumetric, image‐guided ablation

Optimizes ablated volume of targeted fibroid

Avoids multiple passes of energized needles through the serosa

Not a global therapy‐treats the fibroids that are likely to be symptomatic

Incites thermal fixation and coagulative necrosis

▪ Avoids infarction‐related postembolization syndrome seen with UAE

RF volumetric ablation has been used in many organs in the body, including uterine fibroids, liver, lung, kidney, spine, and pancreas

Studies in uterine fibroids have used off‐the‐shelf RF ablation devices with laparoscopic percutaneous and transvaginal

Study n Duration Reintervention SSSReduction

QOLImprovement

Volume Reduction

Carrafiello 2009 11 3‐12 months 9% (1/11) 73% 46% 82%

Ghezzi 2007 25 12‐36 months 4% (1/25) 100% 59% 84%

Cho 2008 153 18 months 4% (6/153) 66% 43% 73%

devices with laparoscopic, percutaneous, and transvaginal approaches

Ultrasound guided laparoscopic RF fibroid ablation

FDA approved 2010 FDA approved 2010 Currently completing a clinical trial in the US

Preliminary data from Garza et al on 31 pts showed promising results at 12 months follow up

VizAblate® is an intrauterine ultrasound (IUUS)-guided radiofrequency ablation system designed to treat submucosal andsubmucosal and intramural fibroids

• Combines RF ablation with intrauterine ultrasound

• Inserted transcervically

• Performed by gynecologists

• Short procedure time

40

VizAblate CV Handpiece

Scalable ablation from

Treatment Planning Control Knob

Scalable ablation from 1cm to 4cm in diameter

8mm diameter shaft

• The graphical overlay enables the gynecologist to plan a safe and predictable ablation

Th d l• The red oval indicates the ablation zone

• The green oval indicates the thermal safety boundary. Outside this area, there is no significant risk of thermal injury.

The VizAblate System was granted the CE Mark in December, 2010

Safety has been demonstrated

> 120 peri- and prehysterectomy procedures

Treatment of > 55 women for symptomatic relief without any issues relating to ablation safety

Involves localizing fibroids laparoscopically, with ultrasound or MRI and destroying them with extreme cold

Preliminary studies have shown significant reduction in fibroid volume and symptom improvementin fibroid volume and symptom improvement

No suturing required Can result in severe adhesion formation Not recommended for women planning childbearing Experimental and limited experience

Zupi et al. Clin Obstet Gynecol. 2006;49(4):821-33

Several non‐surgical methods available UFE has the longest track‐record MRgFUS is promising, but needs refinement

d band recognition by payers Other non‐invasive options on the horizon, time will tell where they will fit into current landscape of treatment options

41

Goodwin et al. Obstet Gynecol. 2008;111(1):22‐33 Spies JB, et al. Obstet Gynecol. 2005;106:1309‐1318 Chrisman HB, et al. J Vasc Interv Radiol. 2000;11:699‐703 ACOG. Obstet Gynecol. 2004;103:403‐404 Goodwin et al Fertil Steril. 2006;85(1):14‐21 Ohgi et al J Obstet Gynaecol Res. 2007;33(4):506‐11 Edwards et al. N Engl J Med. 2007;356(4):360‐70

V lk t l A J Ob t t G l 6 Volkers et al. Am J Obstet Gynecol. 2007;196:519.e1–519.e11 Van Der Kooii SM et al. Am J Obstet Gynecol 2010;230(2):105.e1‐13 Mara et al. Cardiovasc Intervent Radiol. 2008 Jan‐Feb;31(1):73‐85 Fennessy et al. Radiology 2007;243(3):885‐93 Stewart et al. Fertil Steril. 2006;85:22–29 Stewart et al. Obstet Gynecol 2007 Dec;110(6):1428‐9 Lichtinger et al. J Minim Invasive Gynecol. 2005;12(1):40‐2

42

Jon Ivar Einarsson MD MPHDirector of Minimally Invasive Gynecologic SurgeryBrigham and Women’s HospitalAssociate ProfessorHarvard Medical School

I have the following financial relationships witha commercial entity producing health‐carey p grelated products and/or services.

Consultant for Ethicon‐Endosurgery

Discuss the advent and current status of single port surgery in gynecology

Describe further innovations such as hybrid dNOTES procedures

Discuss tips and tricks for performing single port myomectomy

The current trend began in 2007 with the successful completion of a single incision cholecystectomy by Rao and Curcillo (two separate sites)

Single incision surgery has been performed for years and was a common approach for a laparoscopic tubal ligation 20 years ago

This time around a lot of progress had been made in the field of This time around, a lot of progress had been made in the field of endoscopy and surgeons and industry were looking for the next “new thing”

Natural Orifice Trans‐Endoluminal Surgery (NOTES) was proposed as the next new thing, but progress has been very slow in this field Lack of instrumentation Lack interest from industry – focused on single port Resistance among hospital staff and administrators No reimbursement for “experimental procedures”

43

Benefits

Better cosmetic outcome – maybe for some patients

Less pain ‐ ??

Faster recovery ‐ ??Faster recovery ??

Disadvantages/limitations

Increased cost and disposable instruments

Triangulation is limited with traditional instruments

Challenging to perform suturing and fine dissection

Longer operative times for some procedures

May add value for certain procedures

Cholecystectomy Adnexectomy Hysterectomy? – Has been difficult to get gynecologists in USA

and elsewhere to adopt this via multiport Robotic surgery may enable more suture intense tasks to be performed g y y p

through a single incision IF the only benefit of single incision surgery is cosmetic who should absorb

the added cost?

The hospital? The surgeon? The patient?

Well designed prospective trials are urgently needed Enthusiasm for single port surgery seems to be less now than a couple of

years ago

44

Single incision (n=35) Multiport (n=35) p

Duration of surgery (min) 71.7 48.4 <0.001

Pain score on POD #1 2.1 2.2 0.477

Return to work (days) 5.3 5.9 0.274

Cosmetic results 1 month post op 8 7 7 7 0 001Cosmetic results 1 month post op 8.7 7.7 0.001

Cosmetic results 6 months post op 9.1 8.4 0.04

Lee et al. British Journal of Surgery 2010;97:1007-12

Single port (n=50) Multiport (n=50) p

OR time (minutes) 121 127 0.44

Estimated blood loss (ml) 146 166 .36

Pain score (24h) 3.64 5.08 0.01

Pain score (48 h) 1.94 2.84 0.04

Cumulative Post op analgesics 74.4 mg 104.8 0.001

Hospital stay (days) 3.7 3.9 0.25

Chen et al. Obstet Gynecol 2011;117(4):906-12

68 patients randomized to TLH with single port vs multiport

4 cases of single port converted to multiportll f d ff No statistically significant difference in pain

scores Significantly higher total requests for analgesics in the single port group

11.3 vs 7.7, p<0.001

Jung et al. Surg Endosc 2011 Feb 7

Einarsson JI. Single Port Laparoscopic Myomectomy. J Minim Invasive Gynecol. 2010;17(3):371-373.

45

Problems with single port surgery

Optical access and operative access are meshed together

Cramming 3‐4 tubes through a small hole

Potential improvement

Decouple the optical access from the operative access

Optical access through the posterior cul‐de‐sac

OASIS = Orifice Assisted Small Incision Surgery

Select your patients appropriately

Is this the right procedure for this patient? Consider OASIS – much easier suturing and triangulation

Consider using barbed suture for myometrial closure

Growing data demonstrating safety and increased efficacy

Use high volume vasopressin – we use 20 units in 400 ml saline and inject 200 ml

Morcellate through the umbilicus

The potential advantages and future role of single port surgery are uncertain at this time

Single port myomectomy is a challenging dprocedure

Using hybrid NOTES or OASIS may facilitate the performance of a small port myomectomy

Lee et al. British Journal of Surgery 2010;97:1007‐12 Chen et al. Obstet Gynecol 2011;117(4):906‐12 Jung et al. Surg Endosc 2011 Feb 7 Einarsson JI. Single port laparoscopic myomectomy. J Minim

I i G l ( ) Invasive Gynecol 2010; 17(3):371‐373 Einarsson JI, Cohen SL, Puntambekar S. Orifice‐Assisted

Small‐Incision Surgery: Case Series in Benign andOncologic Gynecology. J Minim Invasive Gynecol. 2012 May‐Jun;19(3):365‐8

46

Techniques to minimize Techniques to minimize blood lossblood loss

Tommaso Falcone, M.D.Tommaso Falcone, M.D.

Professor & ChairProfessor & Chair

Cleveland ClinicCleveland Clinic


I have no financial relationships to I have no financial relationships to di ldi ldisclose.disclose.

Learning ObjectivesLearning Objectives

List some general approaches to List some general approaches to minimizing blood loss at a myomectomy minimizing blood loss at a myomectomy procedure procedure pp

Discuss the role of vasopressin in Discuss the role of vasopressin in minimizing blood lossminimizing blood loss

Discuss the role of uterine artery ligation Discuss the role of uterine artery ligation prior to myomectomy prior to myomectomy

Preoperative GnRH agonistPreoperative GnRH agonist

Lethaby A, Vollenhoven B, Sowter MCLethaby A, Vollenhoven B, Sowter MC Preoperative GnRH analogue therapy before Preoperative GnRH analogue therapy before

hysterectomy or myomectomy for uterine hysterectomy or myomectomy for uterine fibroids. Cochrane database 2011 CD 000547fibroids. Cochrane database 2011 CD 000547

Preoperative Treatment with GnRH Preoperative Treatment with GnRH agonistsagonists

Agonist and iron treatment increases Agonist and iron treatment increases preoperative hemoglobinpreoperative hemoglobin

Doesn’t seem to improve blood loss at Doesn’t seem to improve blood loss at surgerysurgerysurgerysurgery Campo et al Hum Reprod 1999Campo et al Hum Reprod 1999

Fibroids 107 were intramural & 67 were Fibroids 107 were intramural & 67 were subserosal; mean diameter 4.7 cm; blood loss subserosal; mean diameter 4.7 cm; blood loss about 200mlabout 200ml

Interventions to reduce Interventions to reduce hemorrhage during myomectomyhemorrhage during myomectomy

Cochrane reviewCochrane review--Kongnyuy EJ, Kongnyuy EJ, Wiysonge CS Cochrane database Syst Wiysonge CS Cochrane database Syst Rev 2011 CD005355 2011Rev 2011 CD005355 2011Rev 2011 CD005355 2011Rev 2011 CD005355 2011

Bupivacaine plus epinephrine vs. placeboBupivacaine plus epinephrine vs. placebo--not clinically differentnot clinically different

Oxytocin no differenceOxytocin no difference

No data on normal saline aloneNo data on normal saline alone

47

Cochrane reviewCochrane review

Misoprostol versus placeboMisoprostol versus placebo Significant reduction in blood loss; no effect Significant reduction in blood loss; no effect

on blood transfusion rate. 400mcg 1 hr on blood transfusion rate. 400mcg 1 hr before the procedurebefore the procedurepp

IV bolus of tranexamic acidIV bolus of tranexamic acid

Gelatin thrombin matrix ( ex. FloSeal)Gelatin thrombin matrix ( ex. FloSeal) Significantly reduced blood loss at Significantly reduced blood loss at

myomectomy and need for transfusionmyomectomy and need for transfusion

VasopressinVasopressin

Cochrane reviewCochrane review-- Compared with placebo 2 Compared with placebo 2 trialstrials-- significant reduction in blood losssignificant reduction in blood loss

Antidiuretic Hormone Analog; Hormone, Antidiuretic Hormone Analog; Hormone, Posterior PituitaryPosterior Pituitary Approved for central diabetes insipidusApproved for central diabetes insipiduspp ppp p

Pitressin®: 20 units/mL (1 mL)Pitressin®: 20 units/mL (1 mL) HalfHalf--life elimination: Nasal: 15 minutes; life elimination: Nasal: 15 minutes;

Parenteral: 10Parenteral: 10--20 minutes 20 minutes I.V. infiltration: May lead to severe I.V. infiltration: May lead to severe

vasoconstriction and localized tissue necrosis.vasoconstriction and localized tissue necrosis. Water intoxicationWater intoxication

Use with caution in these disease Use with caution in these disease statesstates

Asthma: Asthma: Cardiovascular diseaseCardiovascular diseaseGoiter: Use with caution in patients with a Goiter: Use with caution in patients with a

goiter with cardiac complicationsgoiter with cardiac complicationsgoiter with cardiac complications.goiter with cardiac complications.MigraineMigraineRenal impairmentRenal impairment SeizuresSeizures Vascular diseaseVascular disease

Vasopressin doseVasopressin dose-- different surgeon different surgeon recommendations from the Listservrecommendations from the Listserv

Inject into the myometrium surrounding Inject into the myometrium surrounding fibroid or the pseudocapsule areafibroid or the pseudocapsule area

1 amp1 amp 20 units in 500 cc=use 3020 units in 500 cc=use 30 50mL50mL 1 amp1 amp-- 20 units in 500 cc=use 3020 units in 500 cc=use 30--50mL50mL 10 units in 100ml of saline (use 400ml)10 units in 100ml of saline (use 400ml) 20 units in 400 ml and inject 10020 units in 400 ml and inject 100--150 mL150 mL 200 units in 100ml200 units in 100ml 20 units in 50 ml20 units in 50 ml


Glasser MH Minilaparotomy myomectomy Glasser MH Minilaparotomy myomectomy JMIG 2005JMIG 2005

Ten mL of a dilute vasopressin solution Ten mL of a dilute vasopressin solution (six units in 60 mL NaCl) is then injected(six units in 60 mL NaCl) is then injected(six units in 60 mL NaCl) is then injected (six units in 60 mL NaCl) is then injected intracervically about 1 to 2 cm deep at intracervically about 1 to 2 cm deep at both the 8 o’clock and 4 o’clock positions.both the 8 o’clock and 4 o’clock positions.


1 ampule of vasopressin was diluted in 1 ampule of vasopressin was diluted in 1000 mL of normal saline (10001000 mL of normal saline (1000--fold) and fold) and 150150--250 mL of diluted vasopressin was 250 mL of diluted vasopressin was injected in the uterus below interstitialinjected in the uterus below interstitialinjected in the uterus below interstitial injected in the uterus below interstitial pregnancy pregnancy

48

Use of barbed sutureUse of barbed suture

Alessandri et al JMIG 2010Alessandri et al JMIG 2010-- reduced blood reduced blood loss ( drop of hgb of 0.6 versus 0.9; no loss ( drop of hgb of 0.6 versus 0.9; no bl d t f i )bl d t f i )blood transfusion)blood transfusion)

Einarsson et al showed no difference in Einarsson et al showed no difference in blood lossblood loss

Cochrane reviewCochrane review

Pericervical tourniquetPericervical tourniquet

2 trials showed significant reduction in2 trials showed significant reduction in 2 trials showed significant reduction in 2 trials showed significant reduction in blood loss and need for blood transfusionblood loss and need for blood transfusion

Laparoscopic bulldog clampsLaparoscopic bulldog clamps YasargilYasargil--type Temporary type Temporary Occlusion ClampsOcclusion Clamps-- AesculapAesculap

Uterine Artery LigationUterine Artery Ligation

Bae JH et al F&S 2011Bae JH et al F&S 2011-- no difference in no difference in blood loss w/without ligationblood loss w/without ligation

Lubin Liu et al F&S 2011- less blood loss with temporary occlusion of the uterine artery

Other observationsOther observations

Perioperative cell salvage Perioperative cell salvage

Improper plane of dissectionImproper plane of dissection

Multiple uterine incisionsMultiple uterine incisions

49

ReferencesReferences

Lubin L, Yuyan L, Huicheng X, Chen Y, Zhang G, Liang Lubin L, Yuyan L, Huicheng X, Chen Y, Zhang G, Liang Z. Laparoscopic transient uterine artery occlusion and Z. Laparoscopic transient uterine artery occlusion and myomectomy for symptomatic uterine myoma. Fertil myomectomy for symptomatic uterine myoma. Fertil Steril 2011;95:254Steril 2011;95:254--258.258.

Bae JH, Chong GO, Seong WJ, Hong DG, Lee YS. Bae JH, Chong GO, Seong WJ, Hong DG, Lee YS. Benefit of uterine artery ligation in laparoscopic Benefit of uterine artery ligation in laparoscopic y g p py g p pmyomectomy. Fertil Steril 2011;95:775myomectomy. Fertil Steril 2011;95:775--778.778.

Campo S, Garcea N. Laparoscopic myomectomy in Campo S, Garcea N. Laparoscopic myomectomy in premenopausal women with and without preoperative premenopausal women with and without preoperative treatment using gonadotropnintreatment using gonadotropnin--releasing hormone releasing hormone analogues. Hum Reprod 1999;14:44analogues. Hum Reprod 1999;14:44--48.48.

Glasser M. Minilaparotomy myomectomy: A minimally Glasser M. Minilaparotomy myomectomy: A minimally invasive alternative for the large fibroid uterus. J Minim invasive alternative for the large fibroid uterus. J Minim Invasive Gynecol 2005;12:275Invasive Gynecol 2005;12:275--283.283.

ReferencesReferences Lethaby A, Vollenhoven B, Sowter MC. PreLethaby A, Vollenhoven B, Sowter MC. Pre--operative GnRH operative GnRH

analogue therapy before hysterectomy or myomectomy for uterine analogue therapy before hysterectomy or myomectomy for uterine fibroids. Cochrane Database of Systematic Reviews 2001; Issue 2, fibroids. Cochrane Database of Systematic Reviews 2001; Issue 2, Art. No.:CD000547Art. No.:CD000547

Kongnyuy E, Wiysonge C. Interventions to reduce haemorrhage Kongnyuy E, Wiysonge C. Interventions to reduce haemorrhage during myomectomy for fibroids. Cochrane Database of Systematic during myomectomy for fibroids. Cochrane Database of Systematic Reviews 2011; Issue 11 Art. No.:CD005355.Reviews 2011; Issue 11 Art. No.:CD005355.

.. Einarsson JI, Chavan NR, Suzuki Y, Jonsdottir G, Vellinga TT, Einarsson JI, Chavan NR, Suzuki Y, Jonsdottir G, Vellinga TT,

Greenberg JA. Use of bidiredtional barbed suture in laparoscopic Greenberg JA. Use of bidiredtional barbed suture in laparoscopic myomectomy: evaluation of perioperative outcomes, safety, and myomectomy: evaluation of perioperative outcomes, safety, and efficacy. J Minim Invasive Gynecol 2011;18:92efficacy. J Minim Invasive Gynecol 2011;18:92--95.95.

Alessandri F, Remorgida V, Venturini PL, Ferrero S. Unidirectional Alessandri F, Remorgida V, Venturini PL, Ferrero S. Unidirectional barbed suture versus continuous suture with intracorporeal knots in barbed suture versus continuous suture with intracorporeal knots in laparoscopic myomectomy: a randomized study. J Minim Invasive laparoscopic myomectomy: a randomized study. J Minim Invasive Gynecol 2010;17:725Gynecol 2010;17:725--729.729.

50

Abdominal Myomectomy: Minimally Invasive Alternative to Hysterectomy for Large Fibroids?


Surgery



[email protected]

Disclosure

I have no financial relationships to disclose.


Surgery

Objectives

Participants will be able to:

• Assess the impact of leiomyomata on patients

• Compare advantages / disadvantages of


Surgery

• Compare advantages / disadvantages of myomectomy and hysterectomy for fibroids

• Counsel patients knowledgeably regarding surgical options for fibroids

Leiomyomata Background

• Affects approximatly 33% of women• Age and race variables up to 75%

• Accounts for appx 30% of hysterectomies

(Pre) cancer10% Chronic pelvic pain 10%


Surgery

Stewart EA (2001) Uterine Fibroids. Lancet 357:293‐98.Carlson KJ et al (1991) Indications for hysterectomy. NEJM 328(12):856‐860.

DUB 20%

Fibroids 30%

Endometriosis/Adenomyosis 20%

Chronic pelvic pain 10%Prolapse 15%

Hospital Discharges 1979‐2001

• 6,091,700 hysterectomies

• Ave age: 45.2

• Rate 1979: 2.4/1000

• Rate 2001: 2.3/1000

• African Am: 3.3/1000

• 500,000 myomectomies

• Ave age: 35.6

• Rate 1979: 0.11/1000

• Rate 2001: 0.21/1000

• African Am: 0.4/1000


Surgery

/

• Caucasian: 1.8/1000

/

• Caucasian: 0.1/1000

Burrows LJ et al (2005) Rates of Hysterectomy for Uterine Myomas and Myomectomy in the United States, 1979–2001. J Pelvic Med Surg 11(2):84.

• Hysterectomy 12x more common than myomectomy

• Hysterectomy rate stable; myomectomy rate doubled

• No differences in morbidity with respect procedure or race

Why Myomectomy?

• Pain• Dysmenorrhea, dyspareunia, abdomino‐pelvic pain

• Bleeding• Amount, duration, anemia

• Infertility


Surgery

• Infertility• Submucous vs intramural fibroids

• Mass effect• Compression of bladder, bowel, ureter, stomach, etc

• Rapidly growing leiomyoma

Stewart EA (2001) Uterine Fibroids. Lancet 357:293‐98.Carlson KJ et al (1991) Indications for hysterectomy. NEJM 328(12):856‐860.

51

Leiomyosarcoma

• Not from “malignant degeneration” of myomata• Distinct genetic origin

• Incidence between 0.13‐0.29% of leiomyomata

• Less than 0.26% of rapidly growing fibroids


Surgery

Flake GP, Andersen J, Dixon D (2003) Etiology and pathogenesis of uterine leiomyomas: a review. Environ Health Perspect. 111:1037–1054.Leibsohn S et al (1990) Leiomyosarcoma in a series of hysterectomies performed for presumed uterine leiomyomas. Am J Obstet Gynecol 162(4):968‐74.

Leiomyosarcoma

• Rapid uterine growth in premenopausal women• Almost never associated with leiomyosarcoma

• Rapid uterine growth in postmenopausal women• Often associated with pain and bleeding


Surgery

• Increased level of LDH isoenzyme 3

• Increased uptake of gadolinium on MRI (40‐60 seconds)

• Approaches 100% diagnostic accuracy

Parker WH, Fu YS, Berek JS (1994) Uterine sarcoma in patients operated on for presumed leiomyoma and rapidly growing leiomyoma. Obstet Gynecol. 83:414–418.Goto A et al (2002) Usefulness of Gd‐DTPA contrast‐enhanced dynamic MRI and serum determination of LDH and its isozymes in the differential diagnosis of leiomyosarcoma from degenerated leiomyoma of the uterus. Int J GynecolCancer. 12:354–361.

Impact on Fertility• 75 myomectomy patients

– No other cause of infertility– Uterus at least twice normal size or submucous fibroid– At least two years follow‐up

• 37 patients conceived – 49.3%


Surgery

Ingersoll FM, Malone LJ (1970) Myomectomy: An alternative to hysterectomy. Arch Surg 100:557‐561.

“…decision regarding operation on patients in their 40’s should depend upon how strongly the patient feels about childbearing.”

“…for some of those who never conceive, it is important to have been able to try.”

Impact on Fertility• Fibroids that distort cavity impact fertility

• Decrease pregnancy rate by 70% (RR 0.32; CI .13 ‐ .70)

• No evidence for intramural or subserosal impact• Assess fertility potential aside from fibroids• Possible increased risk

• myoma degeneration and pain

1100


Surgery

y g p• Spontaneous abortion, premature labor and delivery• abnormal fetal lie, dysfunctional labor patterns• placental abruption, need for operative intervention• postpartum hemorrhage.

Parker WH (2008) Uterine fibroids: childbearing, cancer, and hormone effects. OBG Management 20(5):42‐52.Pritts EA (2001) Fibroids and infertility: asystmatic rviewof the evidence. Obstet Gynecol Surv 56:483‐491.GuarnacciaMM, Rein MS (2001) Traditional surgical approaches to uterine fibroids: abdominal myomectomy and hysterectomy. Clin Obstet Gynecol 44(2):385‐400.

Laparoscopic vs Abdominal

• Guidelines for laparoscopic myomectomy• < 16 weeks uterus or, 1 or 2 fibroids, < 8 cm

• No difference with respect to fertility outcome

• LaparoscopicL i h t h it li ti h t


Surgery

• Less pain, shorter hospitalization, shorter recovery

• Longer operative time, more blood lossStewart EA (2001) Uterine Fibroids. Lancet 357:293‐98.Dubuisson JB et al (1999) Laparoscopic myomectomy and myolysis. Curr Opin Obstet Gynecol 9:233‐238.Seracchioli R et al (2000) Fertility and obstetric outcome after laparoscopic myomectomy of large myomata: a randomized comparison with abdominal myomectomy. Hum Reprod 15(12):2663–2668Campo S et al (2003) Reproductive outcome before and after laparoscopic or abdominal myomectomy for subserousor intramural myomas. Eur J Obstet Gynecol Reprod Biol 110(2):215–219.Soriano D et al (2003) Pregnancy outcome after laparoscopic and laparoconverted myomectomy. Eur J ObstetGynecol Reprod Biol 108(2):194–198.Olive DL (2011) The surgical treatment of fibroids for infertility. Seminars in Reprod Med 29(2):113‐123.

Comparative Morbidity

• Retrospective cohort study, 3 year interval• 197 hysterectomies, 197 myomectomies

• Primary outcome – perioperative morbidity• 40% in hysterectomy, 39% in myomectomy

1122


Surgery

• Secondary outcomes• Febrile morbidity, hemorrhage

• Unintended major procedures, rehospitalization

• Life threatening events

Sawin SW et al (2000) Comparability of perioperative morbidity between abdominal myomectomy and hysterectomy for women with uterine fibroids. Obstet Gynecol 183:1448‐1455.

52


1133


Surgery

Myomectomy patients younger, weighed less, smaller uterine size• Crude morbidity odds ratio for myomectomy 0.93 (0.63 – 1.40) ns• Adjusted odds ratio for myomectomy 1.46 (0.77 – 2.77) ns



1144


Surgery

• Hysterectomy group: more blood loss, 13% complications• 1 cystotomy, 1 ureteral injury, 3 bowel injuries, 8 cases of ileus, 6 pelvic abscesses

• Myomectomy Group: 5% complications• 1 cystotomy, 2 reoperations for obstruction, 6 cases of ileus



• 89 hysterectomies

• Average age: 39.2

• Uterine size: 15.2 weeks

• GnRH agonist: 23.6%

• 103 myomectomies

• Average age: 34.4

• Uterine size: 11.5 weeks

• GnRH agonist: 55.3%

• Procedures over 5 year interval

1155


Surgery

• Blood loss: 796 ml

• Complications:– 1 bladder, 2 ureteral injuries, 1 bowel

injury, 1 femoral nerve injury

• Blood loss: 464 ml

• Complications:– none

Iverson RE et al (1996) Relative morbidity of abdominal hysterectomy and myomectomy for management of uterine leiomyomas. Obstet Gynecol 88:415‐419.

• Myomectomy compares favorably to hysterectomy

Preoperative Preparation

• GnRH analogs prior to myomectomy• 3 months therapy, reversible in 3 months

• Decreased blood flow and decreased arterial size

• alterations in the extracellular matrix of the myoma

• Necrosis, especially in submucosal myomas.

• GnRH analogs prior to hysterectomy

1166


Surgery

GnRH analogs prior to hysterectomy• 3 months therapy, reversible in 3 months

• Smaller uterus, less blood loss

• Increased likelihood of transverse incision or vaginal hysterectomy

Stovall TG et al (1995) GnRH agonist and iron versus placebo and iron in the anemic patient before surgery for leiomyomas: A randomized, controlled trial. Leuprolide Acetate Study Group. Obstet Gynecol 86:65–71.Gerris J et al (1996) The place of Zoladex in deferred surgery for uterine fibroids. Zoladex Myoma Study Group. HormRes. 45:279–284.GuarnacciaMM, Rein MS (2001) Traditional surgical approaches to uterine fibroids: abdominal myomectomy and hysterectomy. Clin Obstet Gynecol 44(2):385‐400.

Intraoperative Management

• Vasopressin (20 units in 50‐100 cc saline)• Inject into serosa or pseudocapsule

• Penrose tourniquet at uterine base• Through windows in broad ligament

• Conflicting studies on superiority

1177


Surgery

• Conflicting studies on superiority• Reperfusion issues

• Trapped blood issues

GuarnacciaMM, Rein MS (2001) Traditional surgical approaches to uterine fibroids: abdominal myomectomy and hysterectomy. Clin Obstet Gynecol 44(2):385‐400.Ginsburg ES et al (1993) The effect of operative technique and uterine size on blood loss during myomectomy: A prospective randomized study. Fertil Steril. 60:956–962.Fletcher H et al (1996) A randomized comparison of vasopressin and tourniquet as hemostatic agents duringmyomectomy. Obstet Gynecol. 87:1014–1018.

Women’s Attitudes

• 18 women, age 31‐49, 14 Caucasian, 4 African Am

• All had uterine fibroids

• Hysterectomy (10) or myomectomy (8)

• All with college degree, all but 1 advanced degree

1188


Surgery

• Sample distributed across 12 states

• 17/18 proactive in researching information• Books, internet, friends

• Given pamphlets by gynecologists; invited to ask questions

• Did not know what questions to ask

Askew J (2009) A Qualitative Comparison of Women's Attitudes Toward Hysterectomy and Myomectomy, Health Care for Women International 30(8):728‐742

53

Women’s Attitudes

• 7/8 women with myomectomy “shopped around”• Did not necessarily believe doctors opinions were correct

• Willing to go out of state to get “right doctor”

• Women with hysterectomy more trusting• 6/10 had procedure with their “usual gynecologist”

D i i i fl d b i d f t

1199


Surgery

• Decisions influenced by varied factors• Attitude toward body, opinion / experience of friends or family or partner, internet research, attitude toward doctors, relationship with doctor

• No differences with respect to gender of GYN

Askew J (2009) A Qualitative Comparison of Women's Attitudes Toward Hysterectomy and Myomectomy, Health Care for Women International 30(8):728‐742

Decision Making

• First decide IF, then decide HOW

• Abdominal myomectomy vs hysterectomy

• Exactly what is “minimally invasive”?

2200


Surgery

Abdominal myomectomy vs hysterectomy

– Also consider

• vs laparoscopic myomectomy

• vs laparoscopic hysterectomy

• vs embolization

Myomectomy Surgical Counseling

• Focus on expectations of patient

• Risk of new fibroid growth (up to 30%)

• Growth of fibroid too small to detect

• Conversion to hysterectomy for complications

2211


Surgery

Conversion to hysterectomy for complications

• Discuss all alternatives• Data suggest patient hear less than we think

References• Askew J (2009) A Qualitative Comparison of Women's Attitudes Toward Hysterectomy and Myomectomy,

Health Care for Women International 30(8):728‐742

• Burrows LJ et al (2005) Rates of Hysterectomy for Uterine Myomas and Myomectomy in the United States, 1979–2001. J Pelvic Med Surg 11(2):84.

• Campo S et al (2003) Reproductive outcome before and after laparoscopic or abdominal myomectomy for subserous or intramural myomas. Eur J Obstet Gynecol Reprod Biol 110(2):215–219.

• Carlson KJ et al (1991) Indications for hysterectomy. NEJM 328(12):856‐860.

• Dubuisson JB et al (1999) Laparoscopic myomectomy and myolysis. Curr Opin Obstet Gynecol 9:233‐238.

• Flake GP, Andersen J, Dixon D (2003) Etiology and pathogenesis of uterine leiomyomas: a review. Environ Health Perspect. 111:1037–1054.

• Fletcher H et al (1996) A randomized comparison of vasopressin and tourniquet as hemostatic agents

2222


Surgery

( ) p p q gduring myomectomy. Obstet Gynecol. 87:1014–1018.

• Gerris J et al (1996) The place of Zoladex in deferred surgery for uterine fibroids. Zoladex Myoma Study Group. Horm Res. 45:279–284.

• Ginsburg ES et al (1993) The effect of operative technique and uterine size on blood loss during myomectomy: A prospective randomized study. Fertil Steril. 60:956–962.

• Goto A et al (2002) Usefulness of Gd‐DTPA contrast‐enhanced dynamic MRI and serum determination of LDH and its isozymes in the differential diagnosis of leiomyosarcoma from degenerated leiomyoma of the uterus. Int J Gynecol Cancer. 12:354–361.

• GuarnacciaMM, Rein MS (2001) Traditional surgical approaches to uterine fibroids: abdominal myomectomy and hysterectomy. Clin Obstet Gynecol 44(2):385‐400.

• Ingersoll FM, Malone LJ (1970) Myomectomy: An alternative to hysterectomy. Arch Surg 100:557‐561.

References• Iverson RE et al (1996) Relative morbidity of abdominal hysterectomy and myomectomy for management

of uterine leiomyomas. Obstet Gynecol 88:415‐419.

• Leibsohn S et al (1990) Leiomyosarcoma in a series of hysterectomies performed for presumed uterine leiomyomas. Am J Obstet Gynecol 162(4):968‐74.

• Parker WH (2008) Uterine fibroids: childbearing, cancer, and hormone effects. OBG Management 20(5):42‐52.

• Olive DL (2011) The surgical treatment of fibroids for infertility. Seminars in Reprod Med 29(2):113‐123.

• Parker WH, Fu YS, Berek JS (1994) Uterine sarcoma in patients operated on for presumed leiomyoma and rapidly growing leiomyoma. Obstet Gynecol. 83:414–418.

• Pritts EA (2001) Fibroids and infertility: asystmatic rviewof the evidence. Obstet Gynecol Surv 56:483‐491.

2233


Surgery

• Sawin SW et al (2000) Comparability of perioperative morbidity between abdominal myomectomy and hysterectomy for women with uterine fibroids. Obstet Gynecol 183:1448‐1455.

• Seracchioli R et al (2000) Fertility and obstetric outcome after laparoscopic myomectomy of large myomata: a randomized comparison with abdominal myomectomy. Hum Reprod 15(12):2663–2668

• Soriano D et al (2003) Pregnancy outcome after laparoscopic and laparoconverted myomectomy. Eur J Obstet Gynecol Reprod Biol 108(2):194–198.

• Stewart EA (2001) Uterine Fibroids. Lancet 357:293‐98.

• Stovall TG et al (1995) GnRH agonist and iron versus placebo and iron in the anemic patient before surgery for leiomyomas: A randomized, controlled trial. Leuprolide Acetate Study Group. Obstet Gynecol 86:65–71.

54

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%

55

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

Fibroids: Myomectomy and New Approaches (Didactic) › 2012syllabus › PG113.pdf · 2020-01-30 ·...

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