Sponsored by
AAGLAdvancing Minimally Invasive Gynecology Worldwide
Didactic: No More Fibs: The Truth about Fibroids
PROGRAM CHAIR
Hye-Chun Hur, MD, MPH
PROGRAM CO-CHAIR
Stephanie N. Morris, MD
Togas Tulandi, MD
GLOBAL CONGRESSON MINIMALLY INVASIVE GYNECOLOGYNOV. 17-21, 2014 | Vancouver, British Columbia
43rd AAGL
Professional Education Information Target Audience This educational activity is developed to meet the needs of residents, fellows and new minimally invasive specialists 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 ...................................................................................................................................................... 2 Which Fibroids Should You Treat? Understanding Fibroid Anatomy, Range of Diagnoses, and Associated Clinical and Reproductive‐Sequelae to Tailor the Plan H‐C Hur .......................................................................................................................................................... 3 Simplifying Laparoscopic Myomectomy: Setting the Stage for Effective Suturing and General Tips and Tricks S.N. Morris .................................................................................................................................................... 9 Robot‐Assisted Laparoscopic Myomectomy: Different Strategies Compared to Conventional Laparoscopic Myomectomy H‐C Hur ........................................................................................................................................................ 14 When to Opt for Laparotomy: Minimally Invasive Techniques for Open Myomectomy, Strategies for Minimizing Blood Loss and Adhesions T. Tulandi ..................................................................................................................................................... 20 Strategies for Safe and Effective Tissue Removal, Controversies of Fibroid Morcellation S.N. Morris .................................................................................................................................................. 25 Hysteroscopic Myomectomy: How to Approach the Type 2 Submucosal Fibroid S.N. Morris .................................................................................................................................................. 29 How to Tackle the Challenging Fibroid Presentation: Adenomyomas, Deeply Intramural, Broad Ligament, and Cervical Fibroids H‐C Hur ........................................................................................................................................................ 34 Other Fibroid Treatment Options: Single‐Port Myomectomy, Uterine Artery Embolization, and Myoma Ablation Procedures (MRI‐focused US, Radiofrequency Ablation) T. Tulandi ..................................................................................................................................................... 40 Cultural and Linguistics Competency ......................................................................................................... 46
FIBR-‐711 Didactic: No More Fibs: The Truth about Fibroids
Hye-‐Chun Hur, Chair
Stephanie N. Morris, Co-‐Chair
Faculty: Togas Tulandi This course will provide participants with a systematic approach to managing symptomatic patients with both simple and complex fibroid presentations. An algorithm for deciding routes of surgical treatment (conventional laparoscopy, robot-‐assisted laparoscopy, laparotomy, or hysteroscopy) will be discussed. Radiologic imaging as well as nonsurgical treatment options will be addressed. Techniques and specific approaches for the treatment of more challenging fibroids, such as broad ligament, cervical, deep intramural, and submucosal fibroids, will be presented. Tips and tricks for laparoscopic suturing, minimizing blood loss, and tissue extraction techniques will be reviewed. Learning Objectives: At the conclusion of this course, the clinician will be able to: 1) Summarize currently available treatment options for conservative fertility-‐sparing fibroid management; 2) apply strategies, tips and tricks for resecting various fibroid presentations, including submucosal, deeply intramural, broad ligament, and cervical fibroids; 3) describe strategies to minimize blood loss; and 4) describe laparoscopic suturing and tissue extraction techniques essential for laparoscopic myomectomy.
Course Outline 12:30 Welcome, Introductions and Course Overview H-‐C Hur
12:35 Which Fibroids Should You Treat? Understanding Fibroid Anatomy, Range of Diagnoses, and Associated Clinical and Reproductive-‐Sequelae to Tailor the Plan H-‐C Hur
1:00 Simplifying Laparoscopic Myomectomy: Setting the Stage for Effective Suturing and General Tips and Tricks S.N. Morris
1:25 Robot-‐Assisted Laparoscopic Myomectomy: Different Strategies Compared to Conventional Laparoscopic Myomectomy H-‐C Hur
1:50 When to Opt for Laparotomy: Minimally Invasive Techniques for Open Myomectomy, Strategies for Minimizing Blood Loss and Adhesions T. Tulandi
2:15 Questions & Answers All Faculty
2:25 Break
2:40 Strategies for Safe and Effective Tissue Removal, Controversies of Fibroid Morcellation S.N. Morris
3:05 Hysteroscopic Myomectomy: How to Approach the Type 2 Submucosal Fibroid S.N. Morris
3:30 How to Tackle the Challenging Fibroid Presentation: Adenomyomas, Deeply Intramural, Broad Ligament, and Cervical Fibroids H-‐C Hur
3:55 Other Fibroid Treatment Options: Single-‐Port Myomectomy, Uterine Artery Embolization, and Myoma Ablation Procedures (MRI-‐focused US, Radiofrequency Ablation) T. Tulandi
4:20 Questions & Answers All Faculty
4:30 Adjourn
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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* Kimberly A. Kho* Frank D. Loffer, Medical Director, AAGL* Linda Michels, Executive Director, AAGL* M. Jonathon Solnik* Johnny Yi* SCIENTIFIC PROGRAM COMMITTEE Arnold P. Advincula Consultant: Blue Endo, Intuitive Surgical, SurgiQuest Other: Royalties: CooperSurgical William M. Burke* Rosanne M. Kho* Ted T.M. Lee Consultant: Ethicon Endo-‐Surgery Javier F. Magrina* Ceana H. Nezhat Consultant: Karl Storz Other: Medical Advisor: Plasma Surgical Other: Scientific Advisory Board: SurgiQuest Kevin J.E. Stepp Consultant: CONMED Corporation, Teleflex Other: Stock Ownership: Titan Medical Robert K. Zurawin Consultant: Bayer Healthcare Corp., CONMED Corporation, Ethicon Endo-‐Surgery, Hologic, Intuitive 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). Hye-‐Chun Hur Other: Author: UpToDate Stephanie N. Morris* Togas Tulandi Consultant: Actavis Asterisk (*) denotes no financial relationships to disclose.
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A teaching hospital of Harvard Medical School
Which Fibroids Should You Treat?Understanding fibroid anatomy, range of diagnoses, and associated clinical & reproductive sequelae to tailor the plan.
Hye-Chun Hur, MD, MPHAssistant Professor, Harvard Medical SchoolDirector, Division of Minimally Invasive GynecologyBeth Israel Deaconess Medical Center
A teaching hospital of Harvard Medical School
Disclosures
Other: Author: UpToDate
A teaching hospital of Harvard Medical School
Objectives
• Review process for selecting which fibroids to treat surgically.
• Review fibroid anatomy, diagnoses and clinical sequelae.
• Algorithm for planning fibroid treatment.
A teaching hospital of Harvard Medical School
Fibroid Consult
35yo G2P0020 (SAB x1, TAB x1) female newly diagnosed with fibroid uterus during elective pregnancy termination.
• PUS: Uterus 9.5 x 3.3 x 4.1 cm, exophytic fundal fibroid 5.1 x 4.1 x 3.5 cm, EMS 5 mm. Normal ovaries bilaterally.
• Denies menstrual abnormalities or dysmenorrhea. Increasing dyspareunia, urinary frequency, LLQ pain.
• Exam revealed 12 wk sized uterus with anterior fibroid slightly crowding bladder area (mobility).
How do you advise the patient? Should you operate?
A teaching hospital of Harvard Medical School
Selecting Which Fibroids to Treat
Symptomatic Asymptomatic
• Bleeding abnormalities
• Compression symptoms
• Reproductive problems
• Anatomic problems
A teaching hospital of Harvard Medical School
Which Fibroids Should beTreated Surgically?
Symptoms
Reproductive goals
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A teaching hospital of Harvard Medical School
Fibroid Treatment Algorithm
Symptomatic
Asymptomatic
ReproductiveGoals
No ReproductiveGoals
Myomectomy All Therapies
No treatment?A teaching hospital of Harvard Medical School
Fibroid Treatment Algorithm
Symptomatic
Asymptomatic
ReproductiveGoals
No ReproductiveGoals
Myomectomy All Therapies
No treatment?
A teaching hospital of Harvard Medical School
Symptomatic, No Reproductive Goals
All therapies available.
If surgical treatment,
Hysterectomy preferable to myomectomy
• for definitive treatment
• if childbearing complete
Hysterectomy without BSO
• To permit natural menopause
• unless BSO indicated
A teaching hospital of Harvard Medical School
Fibroid Treatment Algorithm
Symptomatic
Asymptomatic
ReproductiveGoals
No ReproductiveGoals
Myomectomy All Therapies
No treatment?
A teaching hospital of Harvard Medical School
Symptomatic, Reproductive Goals
Patients actively trying to conceive have only 1 option:
Myomectomy
• Timingo Immediate myomectomyo Interval myomectomy
• Surgical Approacho Numbero Fibroid location o Size
A teaching hospital of Harvard Medical School
Fibroid Treatment Algorithm
Symptomatic
Asymptomatic
ReproductiveGoals
No ReproductiveGoals
Myomectomy All Therapies
No treatment?
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A teaching hospital of Harvard Medical School
Asymptomatic, Reproductive Goals
Known risk of myomectomy scar
with future pregnancies
Unknown risk of intramural fibroids
on pregnancy outcomes
A teaching hospital of Harvard Medical School
Risk of Uterine Rupture
• 10% risk of uterine rupture with trial of labor after myomectomy.
A teaching hospital of Harvard Medical School
Question
How do you decide when to operate
on asymptomatic fibroid patients?
A teaching hospital of Harvard Medical School
Selecting Which Fibroids to Treat
Symptomatic Asymptomatic
• Bleeding abnormalities
• Compression symptoms
• Reproductive problems
• Anatomic problems
o Infertilityo Pregnancy complications
o Hydronephrosiso Thrombosis
A teaching hospital of Harvard Medical School
Question
How do you decide when to operate
on asymptomatic fibroid patients
before a bad obstetric outcome?
A teaching hospital of Harvard Medical School
Asymptomatic, Reproductive Goals
• Age
• Fibroid location
• Fibroid burden (size, #)
• Findings, “silent” (hydronephrosis, thrombosis)
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A teaching hospital of Harvard Medical School
Age
Source: Management of the Infertile Woman by Helen A. Carcio and The Fertility Sourcebook by M. Sara Rosenthal
Patients age >40 are offered a lower threshold for timely fibroid surgery.
A teaching hospital of Harvard Medical School
Myomas and Pregnancy Outcomes
• Increased risk of malpresentation (OR 2.9)
• Increased risk of cesarean delivery (OR 1.5)
• Increased risk of spontaneous miscarriage (OR 1.6)
• Bleeding in pregnancy
• Placental abruption
• Premature rupture of membranes
References:Klatsky AJOG 2008Rice et al. AJOG 1989Muram D AJOG 1980
A teaching hospital of Harvard Medical School
Fibroid Location
• Cavitary Fibroids
• Submucosal Fibroid
• Intramural fibroids
• Subserosal fibroids
• Exophytic Fibroids
• Pedunculated Fibroids
Like real estate, location matters for fibroids.
A teaching hospital of Harvard Medical School
Fibroid Burden
• 5 cm
• Interestingly, weight of existing literature suggests
o Fibroid size does not affect miscarriage rates
o Fibroid # (multiple fibroids) and fibroid location does
o Mechanism for miscarriage unknown
A teaching hospital of Harvard Medical School
Asymptomatic, Reproductive Goals
Summary:
• Age (> 40)
• Fibroid location (determine approach, submucosal)
• Fibroid burden (size, #)
• “Silent” findings (hydronephrosis, thrombosis)
• History of bad pregnancy outcome (SAB, PTL, abruption)
A teaching hospital of Harvard Medical School
Importance of Fibroid Anatomy
• Knowledge of fibroid anatomy optimizes the myomectomy dissection.
• The fibroid pseudocapsule is a structure which surrounds the uterine fibroid, separates it from the uterine tissue and contains a vascular network rich in neurotransmitters like a neurovascular bundle.
• Identification of the pseudocapsule planeo minimizes blood losso preserves the integrity of the myometriumo better for fertility
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A teaching hospital of Harvard Medical School
Fibroid Anatomy
A teaching hospital of Harvard Medical School
Fibroid Anatomy
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Fibroid Anatomy: Video
A teaching hospital of Harvard Medical School
Which Fibroids Should beTreated Surgically?
Symptoms
Reproductive goals
Age
A teaching hospital of Harvard Medical School
Fibroid Treatment Algorithm
• Symptoms
• Reproductive goals (preserve uterus)
o Immediate myomectomy
o Interim medical treatment with interval myomectomy
• Age (esp > 40)
• Location (determine approach, submucosal)
• Fibroid burden (#, size > 5 cm)
• “Silent” findings (eg. hydronephrosis)
A teaching hospital of Harvard Medical School
Recommendations
• Fibroid surgery just to rule out the possibility of malignancy is not advised as routine practice.
• Frozen section is not reliable for excluding uterine sarcoma (multiple areas must be sampled).
References:Up to Date, Eliz SterwartLeibsohn et al. AJOG 1990Schwartz et al. AJOG 1993
Fibroid treatment plan should be based on:
• Symptoms
• Reproductive goals
• Findings (eg. hydronephrosis)
• Patient preferences, Age
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A teaching hospital of Harvard Medical School
References• Butram VC et al. Uterine Leiomyomata: etiology, symptomatology, and management. Fertility and
Sterility 1981;36:433-5.
• Donnez et al What are the implications of myomas on fertility? A need for a debate? Hum Reprod 2002;17:142-30.
• Farhi J et al. Efect of uterine leiomyomata on the results of in-vitro fertilization treatment. Hum Reprod 1995;10:2576-8.
• Surrey et al. Impact of intramural leiomyomata in patients with normal endometrial cavity on in vitro fertilization enbryo transfer cycle outcome. Fertil Steril 2001;75:405-10.
• Somigliana E et al. Fibroids and female reproduction: a critcal analysis of the evidence. Hum Rprod Update 2007;13:465-76.
• Kolankaya A et al. Myomas and assisted reproductive technologies: when and how to act? Obstet Gynecol Clin North Am 2006;33:145-52. (>5cm)
• Klatsky PC et al. Fibroids and reproductive outcomes: a systematic review from conception to delivery. Am J Obstet Gynceol 2008;198:357-66.
• Rice JP et al. The clinical significance of uterine leiomyomas in pregnancy. AJOG 1989;160:1212-6.
• Muram D et al. Myomas of the uterus in pregnancy: ultrasonographic follow-up. AJOG 1980;138:16-9.
• Leibsohn et al. Leiomyosarcoma in a series of hysterectomies performed for presumed uterine leiomyomas. AJOG 1990;162:968
• Schwartz et al. Leiomyomsarcomas: clincal presentation. Am J Obstet Gynecol 1993;168:180.
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Stephanie Morris, MD
Clinical Instructor, Harvard Medical School
Associate Medical Director, MIGS Center
Newton Wellesley Hospital, Newton, MA
Disclosures
I have no financial relationships to disclose.
Objectives
Demonstrate steps to simplify laparoscopic myomectomy Pre-operative planning
Ways to reduce intra-operative blood loss
Suturing and surgical techniques
Tips for removing different types of fibroids
Planning:Patient selection Number of fibroids
Size of fibroids How big is too big?
Planning: Patient selection Number of fibroids
Size of fibroids How big is too big?
Location
Planning:Pre-Operative Imaging Ultrasound
Limited when numerous fibroids
9cm
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Planning:Pre-Operative Imaging MRI
Great for mapping fibroid location and number
Planning:In the OR
Port placement Higher lateral ports
Higher midline ports
LUQ port
5mm and 10mm
Trocar Placement
Planning:In the OR
Energy SourceBipolar
Monopolar
Ultrasonic Energy
Laser
Planning: In the OR Myoma manipulators
Specimen removal
Reducing Blood Loss:Pre-operative use of GnRH Agonists
Improves pre- and post-op hgb/hct
Decreases uterine volume and fibroid size 35-65%
Decreases procedure related blood loss Does not change need for blood transfusion
+/- Decrease in OR time Studies vary
Several individual RCT studies show less OR time
Meta-analysis, no difference in OR time (Cochrane)
? Affect surgical planes
Cochrane Review 2011; Lethaby A. 2002; Zullo F 1998; Gutmann, 2005;
Reducing Blood Loss:Vasopressin Blood loss:
Cochrane: 300 cc less EBL
Need for transfusion
Dilute vasopressin (0.05-0.3 units/ml)
Most studies for openmyomectomies
Kongnyuy E. Cochrane Review, 2007 (2011); Zhao F 2011; Fletcher H. 1996;
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Vasopressin/20mL NS
Roeder knot using 1-0 vicryl suture Reducing Blood Loss:Tourniquet/Clips
VIDEO TOURNIQUET
Reducing Blood Loss:Barbed suture Decreased OR time (approx 10 miin)
? Decreased blood loss – studies vary
VIDEO BARBED SUTURE
Angioli 2012; Einarsson 2011.
Reducing Blood Loss:Other
Direction of myometrialincision
The “Pedicle”
Electrocautery vs. suture for hemostasis
Walocha JA Hum Reprod 2003
Suturing techniques and aides
Same technique as open
Multiple layer closure
Suturing aides Unidirectional barbed suture – Quill, VLock
Suture clips – Lapra-Ty
Reducing Blood Loss:Closure of defect VIDEO OF MULTI
LAYER CLOSURE VIDEO V LOCK
VIDEO SEROSA
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Pedunculated fibroids
Fibroid
Pedunculated fibroids: Using a loop ligasure
Intramural and subserosal fibroids Multi-layered closure
Suture clips Submucosal fibroids
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Broad ligament fibroid References Angioli R et al. A new type of absorbable suture for use in laparoscopic myomectomy. Inter J Gyn Obstet
2012; 117: 220-223.
Einarsson, J. Use of bidirectional barbed suture in laparosocpic myomectomy: evaluation of perioperative outcomes, safety and efficacy. J Min Invas Gyn 2011; 18: 92-5.
Fletcher H et al. A randomized comparison of vasopressin and tourniquet at hemostatic agents during myomectomy. Obstet Gyencol 1996; 87: 1014-8
Gutmann J et al. GnRH agonist therapy before myomectomy or hysterectomy. JMIG 2005; 12: 529-537.
Kongnyuy E, Wiysonge S. Interventions to reduce hemorrhage during myomectomy for fibroids. Cochran Database System Rev, 2007. Updated 2011
Lethaby A. Pre-operative GnRH analogue therapy before hysterectomy or myomectomy for uterine fibroids. Cochran Database System Rev, 2001. Updated 2011
Walocha JA et al. Vascular system of intramural leimyomata reviewed by corrosion casting and scanning electron microscopy. Hum Reprod 2003; 18: 1088.
Zhao F et al. Evaluation of loop ligation of larger myoma pseedocapsule combined with vasopressin on laparoscopic myomectomy. Fertility and Sterility 2011; 95: 762-766
Zullo F et al. A prospective randomized study to evaluate lueprolide acetate treatment before laparoscopic myoectomy: Efficacy and ultrasonographic predictors. Am J Obstet Gyencol 1998; 178 (1): 108-12.
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Hye-Chun Hur, MDAssistant Professor, Harvard Medical SchoolDirector, Division of Minimally Invasive Gynecologic SurgeryBeth Israel Deaconess Medical Center, Boston , MA
Robotically-assisted Laparoscopic Myomectomy
A teaching hospital of Harvard Medical School
Disclosures
Other: Author: UpToDate
A teaching hospital of Harvard Medical School
Objectives
• Review factors for patient selection for robotically-assisted laparoscopic myomectomy (RA-LSC MMY).
• Identify the basic steps of laparoscopic myomectomy.
o Discuss differences between robotic vs conventional LSC MMY approach
o review practical tips specific for robotic method
• Video Demos
A teaching hospital of Harvard Medical School
Patient Selection: RA-LSC MMY
Any patient who is a candidate for a
conventional laparoscopic myomectomy
is also a candidate for a
robotically-assisted myomectomy.
Who is a good candidate for a robotically-assisted laparoscopic
myomectomy?
A teaching hospital of Harvard Medical School
Patient Selection: LSC MMY
A teaching hospital of Harvard Medical School
Patient Selection
• Poor candidates for beginners:o Multiple fibroids (> 3)o Large uterine/fibroid size (e.g. well-above umbilicus) Ideal: place camera port 8-10 cm above pathologyo Adenomyosis (loss of distinct parameters).
• Consider preoperative imaging too determine myoma size, number, location, and
characteristics (degeneration, central necrosis).o exclude adenomyosis.
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A teaching hospital of Harvard Medical School
Objectives
• Review factors for patient selection for robotically-assisted laparoscopic myomectomy (RA-LSC MMY).
• Identify the basic steps of laparoscopic myomectomy.
o Discuss differences between robotic vs conventional LSC MMY approach
o review practical tips specific for robotic method
• Video Demos
A teaching hospital of Harvard Medical School
Robotic Approach
Advantages
• Surgeon comfort (obese patients)
• Myometrial incision (any direction)
• Magnification (identifying pseudocapsule planes)
• More comfortable when suturing
A teaching hospital of Harvard Medical School
Robotic Approach
Disadvantages
• Larger trocar incision size (8 mm vs 5 mm)
• Additional trocar (4 vs 3 accessory trocars)
• Lack of tactile feedback (visual haptics)
• Space limitations (upper abdomen vs lower pelvis)
A teaching hospital of Harvard Medical School
Differences
Robotic Approach
• 8 mm trocar size
• 4 accessory trocars
• Higher trocar placement (M configuration)
• Visual haptics
• Small movements with lots of clutching
• Surgeon sitting
Conventional Laparoscopy
• 5 mm trocar size
• 3 accessory trocars
• Lower trocar placement (diamond configuration)
• Tactile feedback
• Large movements with sweeping gestures
• Surgeon standing
A teaching hospital of Harvard Medical School
Port Placement
Accessory Port (5-10 mm)10-12 mm port direct needle delivery
5 mm port back load the needle
Rainbow Configuration
8 mm port
10-12 mm port
M- Configuration
A teaching hospital of Harvard Medical School
Port Placement: L-sided Docking
Left-sided Docking
Camera
Arm #1: Scissors or Harmonic
Arm #3: Teneculum
Arm #2:Bipolar
Accessory Port (suction irrigator)
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A teaching hospital of Harvard Medical School
Port Placement: R-sided Docking
Right-sided Docking
Camera
Arm #1: Scissors or Harmonic
Arm #3: Teneculum
Arm #2:Bipolar
Accessory Port (suction irrigator)
A teaching hospital of Harvard Medical School
Right-sided Docking
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Right-sided Docking
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Right-sided Docking
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Basic Steps of LSC Myomectomy
Myomectomy Procedure (4 basic steps):
1. Myometrial incision
2. Fibroid enucleation
3. Myometrial closure
4. Fibroid morcellation
5. (Adhesion barrier)
Adhere to same surgical principles as open myomectomy.
Apply different techniques to achieve these principles
robotically.
A teaching hospital of Harvard Medical School
Step 1: Myometrial IncisionWhat direction is best for
myometrial incision?
• Transverse • Vertical • Oblique incision
Anatomy
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Step 2: Enucleation
• Pseudocapsule
o Identify and dissect within pseudocapsule plane
o Diminishes blood loss
o Preserves normal myometrium
o Avoids entry into endometrial cavity
• Push, don’t pull
o push myometrium away from fibroid, rather than pull fibroid out towards you.
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Video: Incision, Enucleation
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Video: Harmonic
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Step 3: Myometrial Closure
• Adhere to same surgical principles as abdominal myomectomy closure
• Check for adjacent myomas prior to closure
• Multi-layer closure is essential
• If endometrial cavity is entered, avoid endometrium in suture line (target endomyometrial junction) o IU dye (methylene blue, indigo carmine)o Uterine manipulator
• Consider adhesion barrier over suture line (esp if you use barb suture)
A teaching hospital of Harvard Medical School
Suture SelectionUnidirectional Barb Suture Bi-directional Barb Suture
• e.g. V-Loc (Covidien)
• Pre-formed loop
• Polyglyconate (~Maxon)
• e.g. Quill (Angiotech)
• Needle on both ends
• Polydioxanone (~PDS)
Advantages:No knots
Maintains tissue tension by itselfEasy to achieve multi-layer closure
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Video: Myometrial Closure
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Step 4: Morcellation
• Options:o Mechanical morcellatorso Laparoscopic scalpelo Manual morcellation via mini-laparotomy
• Must account for all removed fibroids (string myomas together w/ long suture using Keith needle if necessary)
• Perform thorough survey to prevent iatrogenic disseminated leiomyomatosis
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Video: Morcellation
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Morcellation Tips
• Grab an edge to start
• Avoid swiss cheeseo Place coreguard at 12 o’clock o Pulse the blade and adjust direction of tip
• Tissue tensiono Don’t pull too hard (pops off or morsel breaks off)o Regrasp tissue outside of body when it gets really long
• Avoid helicopter effecto Pulse the blade, then pull tissue, oro Truncate specimen
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Port Placement: Morcellation
M- configuration
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Hybrid Procedure
• Combined approach with conventional laparoscopic and robotic myomectomy techniques
o Myometrial incision and myoma enucleation performed laparoscopically
o Robot docked for myometrial closure only
o Attempt only when robotic learning curve well-established (ie. efficient docking)
A teaching hospital of Harvard Medical School
Hybrid Procedure
Benefits of combined approach • May preserve tactile sensation• May allow faster enucleation of myoma• Fewer accessory ports
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A teaching hospital of Harvard Medical School
Conclusions
• Adhere to the same surgical principles for all myomectomies regardless of mode of incision
• Use pre-operative imaging to aid surgical planning
• Allow anatomy to guideo port placement (let fundal height guide trocar locations)o location and direction of myometrial incision (for ergonomic
closure, to minimize risk to adjacent structures)
• Always dissect within pseudocapsule plane
• Push myometrium away from fibroid, rather than pull fibroid out
• Barbed suture is an excellent tool for both beginners and advanced laparoscopic surgeons alike
A teaching hospital of Harvard Medical School
Questions?
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When to Opt for Laparotomy: What Limits a Laparoscopic Approach, and Strategies for a
Minimally Invasive Approach to Open Myomectomy
Togas Tulandi MD, MHCM
Professor and Academic Vice Chairman of Obstetrics and Gynecology, Milton Leong Chair in Reproductive Medicine
McGill University
Conflict of interests
Consultant: Actavis
Educational objectives
At the conclusion of this session, the participant should be able to:
1. Describe when to opt for laparotomy and the reasons.
2. Describe strategies for minimally invasive approach to open
myomectomy.
3. Describe the concept of laparoscopically assisted myomectomy.
Case:
• A 30 year old woman with symptomatic uterine myomas and skin lesions.
• Aunt: leiomyomasarcoma and a renal cyst, and her mother underwent a hysterectomy due to
uterine fibroids.
• CT scan and MRI demonstrated uterine myomata, a right renal simple cyst of 3x3.2 cm and left
adrenal adenoma.
• Hereditary leiomyomatosis and renal cell cancer (HLRCC), Multiple cutaneous and uterine
leiomyomatosis syndrome (MCUL1) or Reed's syndrome
• Genetic testing revealed a c. 139C>T, p.Gln47Stop mutation in the fumarate hydratase (FH)
gene, consistent with the diagnosis of HLRCC syndrome.
When to opt for a laparotomy?
• size, and number of leiomyomas
• surgical expertise
• Myomectomy by laparotomy or laparoscopically assisted myomectomy (LAM)?
• Preoperative GnRHa or ullipristal
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LAM (laparoscopically assisted myomectomy)
• First introduced in 1994
• Less difficult than laparoscopic myomectomy and faster
• Indications: large or multiple myomata not suitable to laparoscopic myomectomy or morcellation
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Buchs et al, 2012
Oxidized Regenerated Cellulose (Surgicel) Imitating Pelvic Abscess
Behbehani & Tulandi, Obstet Gynecol 2013
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Adhesion reducing substance
• Oxidized regenerated cellulose
• Expanded polytetrafluoroethylene
• Hyaluronic acid and carboxymethylcellulose
• Polyglactin
• Icodextrin?
LAM (laparoscopically assisted myomectomy)
Advantages
• Good visualization of the entire abdominal cavity
• The laparoscopic part allows identification and treatment of concomitant pathology.
• Allows conventional suturing
• No need to morcellate
• Thorough irrigation of the abdominal cavity and secruredpositioning of adhesion barrier.
• Short hospital stay
Case:
A 30 year old woman with HLRCC (hereditary leiomyomatosis and renal cell cancer).
GnRHa 4 months before myomectomy
Preop. And Postop. Hgb and Hct with GnRHa higher than without.400 microgram misoprostol vaginally 1 hour prior to surgery
Decreases blood loss
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• 20 iu Vasopressin per 100 mL saline
Decreases blood loss and operating time
50 mL bupivacaine 0.25% and 0.5 ml epinephrine
Tourniquet does not decrease blood loss
Oxytocin does not decrease blood loss.
Loop ligation plus vasopressin
Decreases blood loss and the operating time
Quality of evidence in reducing blood loss
• Moderate:
– misoprostol
– vasopressin
• Low:
– tranexamic acid
– Gelatin-thrombin matrix
– tourniquet
– loop ligation
• No evidence:
– Oxytocin
– Uterine artery ligation
Page 24
Concerns with GnRHa before myomectomy
• Side effects of GnRHa: Addback with estradiol 0.5 mg daily x 3 mths.
• Poor cleavage plane?
• Myoma degeneration
• Delay in diagnosis of sarcoma
• Missed smaller myoma at surgery?
1. Behbehani S, Tulandi T. Oxidized Regenerated Cellulose Imitating Pelvic Abscess. Obstet Gynecol 2013;121:447-9.
2. Benassi L, Lopopolo G, Pazzoni F, et al. Chemically assisted dissection of tissues: an interesting support in abdominal myomectomy. J Am Coll Surg 2000; 191:65.
3. Caglar GS, Tasci Y, Kayikcioglu F, Haberal A. Intravenous tranexamic acid use in myomectomy: a prospective randomized double-blind placebo controlled study. Eur J Obstet Gynecol Reprod Biol 2008; 137:227.
4. Campo S, Garcea N. Laparoscopic myomectomy in premenopausal women with and without preoperative treatment using gonadotrophin-releasing hormone analogues. Hum Reprod 1999; 14:44.
5. Celik H, Sapmaz E. Use of a single preoperative dose of misoprostol is efficacious for patients who undergo abdominal myomectomy. Fertil Steril 2003; 79:1207.
6. Deligdisch L, Hirschmann S, Altchek A. Pathologic changes in gonadotropin releasing hormone agonist analogue treated uterine leiomyomata. Fertil Steril 1997; 67:837.
7. Fletcher H, Frederick J, Hardie M, Simeon D. A randomized comparison of vasopressin and tourniquet as hemostatic agents during myomectomy. Obstet Gynecol 1996; 87:1014.
8. Frishman G. Vasopressin: if some is good, is more better? Obstet Gynecol 2009; 113:476. 9. Ginsburg ES, Benson CB, Garfield JM, et al. The effect of operative technique and uterine size on blood loss
during myomectomy: a prospective randomized study. Fertil Steril 1993; 60:956. 10. Helal AS, Abdel-Hady el-S, Refaie E, et al. Preliminary uterine artery ligation versus pericervical mechanical
tourniquet in reducing hemorrhage during abdominal myomectomy. Int J Gynaecol Obstet 2010; 108:233. 11. Hobo R, Netsu S, Koyasu Y, Tsutsumi O. Bradycardia and cardiac arrest caused by intramyometrial injection of
vasopressin during a laparoscopically assisted myomectomy. Obstet Gynecol 2009; 113:484. 12. Kongnyuy EJ, Wiysonge CS. Interventions to reduce haemorrhage during myomectomy for fibroids. Cochrane
Database Syst Rev 2011; :CD005355. 13. Lurie S, Mamet Y. Transient myocardial ischemia may occur following subendometrial vasopressin infiltration.
Eur J Obstet Gynecol Reprod Biol 2000; 91:87. 14. Nezhat F, Admon D, Nezhat CH, et al. Life-threatening hypotension after vasopressin injection during operative
laparoscopy, followed by uneventful repeat laparoscopy. J Am Assoc Gynecol Laparosc 1994; 2:83. 15. Raga F, Sanz-Cortes M, Bonilla F, et al. Reducing blood loss at myomectomy with use of a gelatin-thrombin
matrix hemostatic sealant. Fertil Steril 2009; 92:356. 16. Stovall TG, Muneyyirci-Delale O, Summitt RL Jr, Scialli AR. 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 1995; 86:65.
17. Taylor A, Sharma M, Tsirkas P, et al. Reducing blood loss at open myomectomy using triple tourniquets: a randomised controlled trial. BJOG 2005; 112:340.
18. Tomlinson IP, Alam NA, Rowan AJ, et al. Germline mutations in FH predispose to dominantly inherited uterine fibroids, skin leiomyomata and papillary renal cell cancer. Nat Genet 2002; 30:406.
19. Tulandi T, Béique F, Kimia M. Pulmonary edema: a complication of local injection of vasopressin at laparoscopy. Fertil Steril 1996; 66:478.
20. Tulandi T, Einarsson JI. The use of Barbed Suture for Laparoscopic Hysterectomy and Myomectomy: A Systematic Review and Meta-analysis. J Minim Invasive Gynecol 2014;21:210-6
21. Tulandi T, Youssef H. Laparoscopy Assisted Myomectomy of Large Uterine Myomas. Gynaecol Endos 6:105-8, 1997.
22. Vercellini P, Trespìdi L, Zaina B, et al. Gonadotropin-releasing hormone agonist treatment before abdominal myomectomy: a controlled trial. Fertil Steril 2003; 79:1390.
23. Wei MH, Toure O, Glenn GM, et al. Novel mutations in FH and expansion of the spectrum of phenotypes expressed in families with hereditary leiomyomatosis and renal cell cancer. J Med Genet 2006; 43:18.
24. Ylisaukko-oja SK, Kiuru M, Lehtonen HJ, et al. Analysis of fumarate hydratase mutations in a population-based series of early onset uterine leiomyosarcoma patients. Int J Cancer 2006; 119:283.
25. Zhao F, Jiao Y, Guo Z, et al. Evaluation of loop ligation of larger myoma pseudocapsule combined with vasopressin on laparoscopic myomectomy. Fertil Steril 2011; 95:762.
Zullo F, Palomba S, Corea D, et al. Bupivacaine plus epinephrine for laparoscopic myomectomy: a randomized placebo-controlled trial.
Page 25
Strategies for Safe and Effective Tissue Removal
Stephanie N. Morris, MDAssociate Medical Director, MIGS
Newton Wellesley HospitalClinical Instructor, Harvard Medical School
Disclosure:
I have no financial relationships to disclose.
Objectives
• Plan tissue removal using multiple different techniques
• Picture: Large fibroid
• Picture: L/S incisions
FDA Safety Communication
• April 2014
• Laparoscopic Uterine Power Morcellation in Hysterectomy and Myomectomy: FDA Safety Communication
• When used for hysterectomy or myomectomy in women with uterine fibroids, laparoscopic power morcellationposes a risk of spreading unsuspected cancerous tissue, notably uterine sarcomas, beyond the uterus. Health care providers and patients should carefully consider available alternative treatment options for symptomatic uterine fibroids. Based on currently available information, the FDA discourages the use of laparoscopic power morcellationduring hysterectomy or myomectomy for uterine fibroids.
National/International Organizations weight in….
Page 26
SGO Position Statement: Morcellation• December 2013• power morcellation or other techniques that cut up the uterus in the abdomen
have the potential to disseminate an otherwise contained malignancy throughout the abdominal cavity. For this reason, the Society of Gynecologic Oncology (SGO) asserts that it is generally contraindicated in the presence of documented or highly suspected malignancy, and may be inadvisable in premalignant conditions or risk‐reducing surgery.
• Patients being considered for minimally invasive surgery performed by laparoscopic or robotic techniques who might require intracorporeal morcellationshould be appropriately evaluated for the possibility of coexisting uterine or cervical malignancy. Other options to intracorporeal morcellation include removing the uterus through a mini‐laparotomy or morcellating the uterus inside a laparoscopic bag.
• Uterine leiomyomas are a common indication for power morcellation. Fewer than one out of 1000 women who undergo hysterectomy for leiomyomas will have an underlying malignancy. The SGO recognizes that currently there is no reliable method to differentiate benign from malignant leiomyomas (leiomyosarcomas or endometrial stromal sarcomas) before they are removed. Furthermore, these diseases offer an extremely poor prognosis even when specimens are removed intact.
• Patients and doctors should communicate about the risks, benefits and alternatives of all procedures so that a patient is able to make an informed and voluntary decision about accepting or declining medical care.
ACOG
• Power Morcellation and Occult Malignancy in Gyn Surgery: A special report. May 2014
• MIS, including power morcellation continues to be an option for some patients.
• Critical to minimize risks for patients with occult malignancy
ACOG: Power Morcellation and Occult Malignancy in Gyn Surgery: A special report
• Pre‐op Dx and Eval– Cervical Cytology– Depending on clinical presentation, may include pelvic imaging and endometrial assesment
– NO pre‐op dx tests can reliable detect sarcoma
• Risk factors to consider– Increasing age– Menopausal status– Uterine size and rapid growth (may increase concern, but not been shown to be predictive of leiomyosarcoma)
– Certain treatments (tamoxifen, pelvic radiation)– Certain hereditary conditions
AAGL: Morcellation During Uterine Tissue Extraction. May 2014
• Pre‐op Eval• H&P, noting patient menopause status• Rapid uterine growth NOT a reliable predictor• Cervical cancer screening• AUB – sampled according to ACOG guidelines (PB • Imaging as indicated clinically
– US amd MRI discussed
• Risk Factors– Age: mean diagnosis age 60– Black race: 2x higher incidence of LMS– Tamoxifen (5+ years)– Pelvic Irradatiation– Hx retonoblastoma or HLRCC
Focus on technique….String of pearls:
keeping track of your fibroids
• VIDEO
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Power Morcellation
• VIDEO
In‐Bag Morcellation
• Endocatch VIDEO
In‐bag morcellation
• Ecosac VIDEO
In‐bag, minilap
• VIDEO
Posterior colpotomy
• VIDEO
References
• Laparoscopic Uterine Power Morcellation in Hysterectomy and Myomectomy: FDA Safety Communication. April 17, 2014
• Morcellation During Uterine Tissue Extraction. AAGL. May 2014.
• Power Morcellation and Occult Malignancy in Gynecologic Surgery: A Special Report. ACOG. May 2014.
• SGO Position Statement: Morcellation. December 2013.
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Hysteroscopic Myomectomy: How to Approach the Type 2
Submucosal Fibroid
Stephanie N. Morris, MDAssociate Medical Director, MIGS
Newton Wellesley HospitalClinical Instructor, Harvard Medical School
Disclosure
I have no financial relationships to disclose.
Objectives
• Identify characteristics of a submucosal fibroid during pre‐operative evaluation that can aide in surgical planning
• Plan surgical approach and describe surgical technique for resection of a large submucosalfibroid
Types of submucosal fibroids
• Type 0
– 100% w/in cavity
• Type I
– >= 50% w/in cavity
– < 50% myometrial extension
• Type II
– < 50% w/in cavity
– >= 50% myometrial extension
ESGE Classification
deBlok S, et al: Gynaecol Enosc 4:243-246, 1995 AAGL Practice Report, JMIG 2012
FIGO Classification of Fibroids
Copyright © 2012 AAGL; AAGL Practice Report, JMIG 2012.
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Pre‐op Planning
• Type 0, I, II
– Predicts ability to completely resect fibroid
‐ Type 0 96‐97%
‐ Type I 86‐90%
‐ Type II 61‐83%
Wamsteker K, 1993Van Dongen H, 2006
Decrease chance of complete resection
Pre‐op Planning
• Type 0, I, II
– Predicts ability to completely resect fibroid
– Predicts fluid deficit
• Type 0 450ml
• Type I 957ml
• Type II 1682ml
Increasing fluid deficit
Emanuel, 1997AAGL Practice Guidelines for mgmt of hysteroscopic distending media, 2013
Pre‐op Planning
• Women with larger submucosalfibroids (> 3 cm) have higher risk of fibroid related surgery in the future
– <= 3 cm 10%
– > 3 cm 60%
• Risk of fluid overload increases with larger fibroid diameter
• Type 0, I, II
– Predicts ability to completely resect fibroid
– Predicts fluid deficit
• Size matters
Hart, R. 1999
AAGL Practice Report: Practice Guidelines for the Management of Hysterscopic Distention Media, 2013
Patient Consent
• Risk of incomplete resection of fibroid
• Possible need for a second procedure
Office Eval OH Mult fibroids OH
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Intra‐op planning: Equipment
• Resectoscope– Monopolar
• using electrolyte free media
– Bipolar • using isotonic electrolyte‐rich solution (Normal saline)
– Diameter (typically 21/22 Fr and 26/27 Fr)
• Hysteroscopic Morcellator• using isotonic electrolyte‐rich solution (Normal saline)
• RF Vaporization electrodes• using isotonic electrolyte‐rich solution (Normal saline)
Intra‐op Planning: Fluid Deficit
– Electrolyte free media
• Use with monopolarresectoscope
• Sorbitol/Glycine
• Fluid deficit max 1000 ml
Intra‐op Planning: Fluid Deficit
– Monopolar
• using electrolyte free media (sorbitol/Glycine)
• Fluid deficit max 1000 ml
– Bipolar/Mechanical Morcellator
• using physiologic fluid (Normal saline or LR)
• Isotonic electrolyte‐rich solution
• Fluid deficit max 2500 ml
AAGL Practice Report: Practice Guidelines for the Management of Hysterscopic Distention Media, JMIG 2013
Intra‐op planning:Minimizing intravasation
• Intracervical Vasopression
– Decreased fluid deficit
– Dilute vasopression works well (0.05 U/ml)
– RCT
• Phillips DR. 1996
• 106 women – dilute vasopressin (8 ml of 0.05U/ml) vs. placebo
• Less fluid intravasation (450 ml vs. 820 ml)
Intra‐lesion vasopressin
• VIDEO
Intra‐op planning:Minimizing intravasation
• Intrauterine pressure – Higher the pressure, the more the fluid absorption
• Especially when exceeds mean arterial pressure• Typical mean arterial pressure 70‐110 mmHg
– Uterine distention ‐ 45‐60 mmHg
– Venous pressure ‐ 8‐10 mmHg
– Pressure > 75 mmHg increases fluid loss into peritoneal cavity via fallopian tubes
• Use lowest pressure that provides good visualization
AAGL Practice Report: Practice Guidelines for the Management of Hysterscopic Distention Media, JMIG 2013
Page 31
Intra‐op planning:Minimizing intravasation
• Avoid venous sinuses
– Encounter in deep myometrial resection
– Resect intracavitary portion first
– Cauterize if needed
• RF Vaporizing electrodes
– Less fluid absorption than cutting loop
AAGL Practice Report: Practice Guidelines for the Management of Hysterscopic Distention Media, JMIG 2013
Surgical Technique
1. Do complete survey of endometrial cavity first2. Resect intracavitary portion first3. Don’t resect yourself into a hole4. Only remove chips when you need to5. Move whole resectoscope, not just the loop to maintain
visualization6. Don’t leave pieces hanging7. When getting deeper into myometrium
a. Expect fluid deficit to rise more quicklyb. Identify the pseudo‐capsulec. Desiccate bleeders as neededd. Reduce pressure to help more fibroid protrude into cavity
Type I resectionRemove resected pieces under direct visualization
Type II Resection Reducing pressure
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Managing Post‐operative Bleeding
•Intra-uterine balloon
•Intrauterine pitressin soaked gauze
•Embolization
•Hysterectomy
•Rollerball ablation mostly ineffective
Consider laparoscopic myomectomy References
• AAGL Practice Guidelines for mgmt of hysteroscopicdistending media. JIMG 2013; 20: 137‐148.
• AAGL Practice Report: Practice Guidelines of the Diagnosis and Management of Submucosal Leiomyomas. J Minim Invas Gynecol 2012. 19:152‐171.
• deBlok S, et al: Gynaecol Enosc 1995. 4:243-246.• Van Dongen H. Follow-up after incomplete hysterscopic
removal of uterine fibroids. Acta Obstet Gynecol Scand. 2006; 85: 1463-7.
• Wamsteker K. Transcervical hysterscopic resection of submucous fibroids for AUB: results regarding the degree of intrmural extension. Obstet Gynecol. 1993. 82: 736-40.
A Type II submucosal fibroid
• A. Is almost entirely in the endometrial cavity
• B. Cannot be safely removed in its entirety hysteroscopically
• C. Is less than 50% in the endometrial cavity
• D. Is associated with less fluid deficit than a Type 0 submucosal fibroid at the time of hysteroscopic resection
Page 33
A teaching hospital of Harvard Medical School
How to Tackle the Challenging Fibroid: Adenomyomas, Deeply intramural, Broad ligament and Cervical Fibroids.
Hye-Chun Hur, MD, MPHAssistant Professor, Harvard Medical SchoolDirector, Division of Minimally Invasive GynecologyBeth Israel Deaconess Medical Center
A teaching hospital of Harvard Medical School
Disclosures
Other: Author: UpToDate
A teaching hospital of Harvard Medical School
Objectives
• Discuss different fibroid presentations that pose unique surgical challenges
o Broad ligament fibroidso Cervical fibroidso Ectopic Fibroids (bowel, abd wall, pelvic sidewall)o Deep intramural fibroidso Adenomyomas
• Review tips and tricks for optimizing minimally invasive surgical techniques for challenging fibroids.
A teaching hospital of Harvard Medical School
Case #1
A teaching hospital of Harvard Medical School
A teaching hospital of Harvard Medical School
Case #1
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A teaching hospital of Harvard Medical School
Broad Ligament Fibroid
A teaching hospital of Harvard Medical School
Broad Ligament Fibroid: Video
A teaching hospital of Harvard Medical School
Broad Ligament Fibroid: Video
A teaching hospital of Harvard Medical School
Case #2
A teaching hospital of Harvard Medical School
A teaching hospital of Harvard Medical School
Cervical Fibroid
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A teaching hospital of Harvard Medical School
A teaching hospital of Harvard Medical School
A teaching hospital of Harvard Medical School
Case #3: Ectopic Fibroids
• Disseminated Peritonalis
• Uterine Fibroids
• Adenomyosis
• Endometriosis
• Infertility
A teaching hospital of Harvard Medical School
Disseminated Peritonalis
Ectopic Fibroids
• Abdominal Wall
• Left rectosigmoid bowel
• Right rectosigmoid bowel
• Left Pelvic Sidewall, Ureteral
• Right IP ligament
A teaching hospital of Harvard Medical School
A teaching hospital of Harvard Medical School
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A teaching hospital of Harvard Medical School
A teaching hospital of Harvard Medical School
A teaching hospital of Harvard Medical School
A teaching hospital of Harvard Medical School
A teaching hospital of Harvard Medical School
A teaching hospital of Harvard Medical School
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A teaching hospital of Harvard Medical School
A teaching hospital of Harvard Medical School
Disseminated Peritonalis
Ectopic Fibroids
• Abdominal Wall x 2 (1.7 cm, 1.6 cm)
• Left rectosigmoid bowel (3.2 cm)
• Right rectosigmoid bowel (2.6 cm)
• Left Pelvic Sidewall, Ureteral (1.2 cm)
• Right IP ligament (5.2 cm)
A teaching hospital of Harvard Medical School
Case #4: Deep Intramural Fibroids
A teaching hospital of Harvard Medical School
Type 2 Submucosal Myoma
A teaching hospital of Harvard Medical School
A teaching hospital of Harvard Medical School
Case #5: Adenomyomas
• Video
Page 38
A teaching hospital of Harvard Medical School
Questions
Page 39
Alternatives to myomectomy
Togas Tulandi MD, MHCMProfessor & Academic Chairman of Obstetrics and Gynecology
Milton Leong Chair in Reproductive MedicineMcGill University
Disclosure
Consultant: Actavis
Educational objectives
At the conclusion of this session, the participant should be able to:
• Describe different alternatives to myomectomy
• Describe medical treatment of uterine myoma
• Describe new techniques of surgical treatment of myoma
• Summarize advantages and disadvanatages of different treatments of
uterine myoma
Case presentation
• 35 yrs, G0, uterine myoma of 16 gestational weeks
• Ultrasound: multiple intramural myomata
• PH: intestinal obstruction due to volvulus at 1 year old
• “What are my options?”
• Type and severity of symptoms
• Size of the myoma(s)
• Location of the myoma(s)
• Patient age
• Reproductive plans and obstetrical history
Page 40
Non-surgical management
• Expectant mgmt.
• Medical mgmt.
• Uterine Artery Embolization
• MRgFUS
Medical management
• OCP: no good evidence
• L-norgestrel intrauterine system: may decrease the myoma size
• GnRHa: – most effective
– addback
• GnRH antagonist: daily dose
• SPRM (selective progesterone receptor modulators)
Amino acid composition of native GnRH and GnRHa
Amino acid position 1 2 3 4 5 6 7 8 9 10
GnRH Analog
pGlu His Trp Ser Tyr Gly Leu Arg Pro Gly-NH2
Leuprolide pGlu His Trp Ser Tyr D-Leu6 Leu Arg N-ethyl Pro
Nafarelin pGlu His Trp Ser Tyr D-Nal(2)6 Leu Arg Pro Gly-NH2
Goserelin pGlu His Trp Ser Tyr D-Ser(tBu)6
Leu Arg Pro Aza-Gly-NH10
Buserelin pGlu His Trp Ser Tyr D-Ser(tBu)6
Leu Arg Pro
Histrelin pGlu His Trp Ser Tyr Imbzl-D-His6
Leu Arg Pro
Mifepristone (RU-486)
10
SPRMs
New Class: SPRM
● Ulipristal acetate—1st in a new class—Selective Progesterone Receptor Modulator (SPRM)
● Partial progesterone antagonist effect
ProgesteroneOnapristoneMifepristone
Ulipristal acetate Asoprisnil
Telapristone acetate
AgonistsAntagonists 11 12
Page 41
Time to Control of Bleeding (PBAC < 75)
0
20
40
60
80
100
0 10 20 30 40 50 60 70 80 90 100
Time (days)
Pa
tien
ts (
%) UPA 5 mg
UPA 10 mgLeuprolide 3.75 mg
7 days 30 days
Donnez J, et al. N Engl J Med 2012;366:421‐32
PEARL II
Rates of amenorrhea:
• 73.4% of UPA 5 mg patients (50% in 10 days)
• 81.7% of UPA 10 mg patients
● UPA shows a superior safety profile to GnRHa
● UPA does not induce menopausal symptoms
Pat
ient
s w
ith m
ode
rate
and
sev
ere
hot f
lush
es (
%)
45
Leuprolide0
40
35
30
25
20
15
10
5
UPA 5 mg
UPA 10 mg
Estradiol Hot flushes70
0
60
50
40
30
20
10
Med
ian
seru
m e
stra
diol
(pg/
mL)
LeuprolideUPA 5 mg
UPA 10 mg
Co-primarysafety
endpoints(superiority)
UPA Has a Superior Safety Profile vs. GnRHa as It Does Not Induce Menopausal Symptoms
Safety, Week 13
Donnez J, et al. N Engl J Med 2012;366:421‐32
PEARL II
Effects of UPA on bone• Urinary marker C‐Terminal telopeptide of type I collagen (CTX)
Donnez J, et al. N Engl J Med 2012;366:421‐32
PEARL II
UPA 5 mg
UPA 10 mg
50
100
150
200
250
300
Leuprolide
*
Endometrial effects of SPRMs
Images courtesy of Professor A. Williams
Edinburgh University Medical School
Novel and benign endometrial changes represent a new morphological category whichhas been referred to as
PRM-Associated Endometrial Changes (PAEC).
Hallmark features of PAEC are: ● Low mitotic activity in both glands and stroma
● Abortive subnuclear vacuoles
● Apoptosis
● Absence of stromal breakdown and glandular crowding
● Cystically dilated glands that are linedby flattened epithelium without nuclear pseudostratification
Key features of PAEC
Mutter GL, et al. Modern Pathol 2008;21:591–8
RCT GnRHa vs. aromatase inhibitor
• RCT of women with fibroids of > 5 cm– Letrozole (n: 33) vs. triptorelin (n: 27)x 12 weeks
– Total volume of myoma decreased by 45.6% in letrozole group and 33.3% in GnRHagroup.
Testosterone Estradiol
Androstendione EstroneAromatase
Pituitary gland
Ovary
EstradiolFSH
AromataseInhibitor
Ovary:Androgens ↑FSH receptors ↑IGF I ↑Sensitivity to FSH ↑↑↑
Tulandi, NEJM 2007
Page 42
Both hysterectomy and UAE affect ovarian reserve.
Partial recovery of AMH suggests restoration of follicle cohort from the primordial follicle pool.
AMH remained low in the UAE group suggests irrepairable damage of the primordial follicle pool.
It indicates loss of ovarian reserve that may affect future fertility.
Pregnancy after uterine artery embolization for
leiomyomata: A series of 56 completed pregnancies
56 total pregnancies
33 pregnancies among 108 women trying to conceive
miscarriage rate 30.4%
preterm delivery rate 18.2%
postpartum hemorrhage 18.2%
Walker & McDowell, AJOG 200
Intra-abdominal Adhesions after Uterine Artery Embolization
Case-control study
UAE group (n:30), control group (72)
Intraabdominal adhesions: UAE group (20%) vs. control group (1.4%) P: 0.002, odds ratio 17.2.
Agdi, Valenti, Tulandi, AJOG 2008
From Fennessy & Tempany, 2006
MRgFUS
Funaki et al, 2009
Results
• Stewart et al, 2007: 359 women
Max. shrinkage: 25%Sustained relief: up 24 mths
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Safety Measures
• No beam passes through or near bowel loops
• No beam passes through the bladder or major scar tissue
• No distal beam passes within 4 cm of the sciatic nerve or branches in front of the sacrum
• Constant communication with the patient
Tempany, 2007
Vilos et al, 2005
Lichtinger et al, 2005
Brucker et al, 2014
Radiofrequency volumetric thermal ablation (RFVTA)
Decreased in myoma volume at 3 and 12 mths: 39.8% and 45.1%
Chudnoff et al, 2013 and 2014
Robot assisted vs. laparoscopic myomectomyGargiulo et al, 2012
P<0.001 P<0.04
Page 44
Goebel & Goldberg, 2014
Page 45
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
OtherAsian
Indo-Euro
19.7% of the US Population speaks a language other than English at home In California, this number is 42.5%
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