Didactic: No More Fibs: The Truth about Fibroids

Transcription

43rd AAGL
GLOBAL CONGRESS
ON MINIMALLY INVASIVE GYNECOLOGY
NOV. 17-21, 2014 | Vancouver, British Columbia
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
Sponsored by
AAGL
Advancing Minimally Invasive Gynecology Worldwide
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 4:30 Adjourn All Faculty Page 1
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. Page 2
Disclosures
Which Fibroids Should You Treat?
Other: Author: UpToDate
Understanding fibroid anatomy, range of diagnoses, and
associated clinical & reproductive sequelae to tailor the plan.
Assistant Professor, Harvard Medical School
Director, Division of Minimally Invasive Gynecology
Beth Israel Deaconess Medical Center
A teaching hospital of
Harvard Medical School
Objectives
Fibroid Consult
35yo G2P0020 (SAB x1, TAB x1) female newly diagnosed
with fibroid uterus during elective pregnancy termination.
• Review process for selecting which fibroids to
treat surgically.
• 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).
• Review fibroid anatomy, diagnoses and clinical
sequelae.
• Algorithm for planning fibroid treatment.
How do you advise the patient? Should you operate?
Selecting Which Fibroids to Treat
Symptomatic
Asymptomatic
• Bleeding abnormalities
• Reproductive problems
• Compression symptoms
• Anatomic problems
Which Fibroids Should be
Treated Surgically?
Reproductive goals
Symptoms
Page 3
Fibroid Treatment Algorithm
Reproductive
Goals
Symptomatic
No Reproductive
Goals
Reproductive
Goals
Myomectomy
All Therapies
Symptomatic
Myomectomy
All Therapies
?
No treatment
Asymptomatic
?
No treatment
Asymptomatic
Symptomatic, No Reproductive Goals
 All therapies available.
Reproductive
Goals
No Reproductive
Goals
Symptomatic
Myomectomy
All Therapies
Asymptomatic
?
No treatment
 If surgical treatment,
Hysterectomy preferable to myomectomy
•
•
for definitive treatment
if childbearing complete
Hysterectomy without BSO
•
•
No Reproductive
Goals
To permit natural menopause
unless BSO indicated
Symptomatic, Reproductive Goals
Patients actively trying to conceive have only 1 option:
Myomectomy
• Timing
o Immediate myomectomy
o Interval myomectomy
Symptomatic
• Surgical Approach
o Number
o Fibroid location
o Size
Asymptomatic
Reproductive
Goals
No Reproductive
Goals
Myomectomy
All Therapies
?
No treatment
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Asymptomatic, Reproductive Goals
Risk of Uterine Rupture
• 10% risk of uterine rupture with trial of labor after
myomectomy.
Known risk of
myomectomy scar
with future
pregnancies
Unknown risk of
intramural fibroids
on pregnancy
outcomes
Question
Selecting Which Fibroids to Treat
How do you decide when to operate
Symptomatic
on asymptomatic fibroid patients?
• Bleeding abnormalities
• Reproductive problems
o Infertility
o Pregnancy complications
• Compression symptoms
• Anatomic problems
o Hydronephrosis
o Thrombosis
Asymptomatic
Question
• Age
• Fibroid location
How do you decide when to operate
• Fibroid burden (size, #)
on asymptomatic fibroid patients
• Findings, “silent” (hydronephrosis, thrombosis)
before a bad obstetric outcome?
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Age
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
Patients age >40 are offered
a lower threshold for timely fibroid surgery.
Source: Management of the
Infertile Woman by Helen A.
Carcio and The Fertility
Sourcebook by M. Sara
Rosenthal
Fibroid Location
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
Like real estate, location matters for fibroids.
•
•
•
•
•
•
References:
Klatsky AJOG 2008
Rice et al. AJOG 1989
Muram D AJOG 1980
Cavitary Fibroids
Submucosal Fibroid
Intramural fibroids
Subserosal fibroids
Exophytic Fibroids
Pedunculated Fibroids
Importance of Fibroid Anatomy
Summary:
• Knowledge of fibroid anatomy optimizes the
myomectomy dissection.
• Age (> 40)
• Fibroid location (determine approach, submucosal)
• 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.
• Fibroid burden (size, #)
• “Silent” findings (hydronephrosis, thrombosis)
• History of bad pregnancy outcome (SAB, PTL, abruption)
• Identification of the pseudocapsule plane
o minimizes blood loss
o preserves the integrity of the myometrium
o better for fertility
Page 6
Fibroid Anatomy
Fibroid Anatomy
Fibroid Anatomy: Video
Which Fibroids Should be
Treated Surgically?
Reproductive goals
Symptoms
Age
Recommendations
• Symptoms
• Reproductive goals (preserve uterus)
o Immediate myomectomy
o Interim medical treatment with interval myomectomy
•
•
•
•
• 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).
 Fibroid treatment plan should be based on:
• Symptoms
• Reproductive goals
• Findings (eg. hydronephrosis)
• Patient preferences, Age
Age (esp > 40)
Location (determine approach, submucosal)
Fibroid burden (#, size > 5 cm)
“Silent” findings (eg. hydronephrosis)
References:
Up to Date, Eliz Sterwart
Leibsohn et al. AJOG 1990
Harvard Medical School Schwartz et al. AJOG 1993
Page 7
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.
Page 8
Disclosures
I have no financial relationships to disclose.
Stephanie Morris, MD
Clinical Instructor, Harvard Medical School
Associate Medical Director, MIGS Center
Newton Wellesley Hospital, Newton, MA
Planning:
Patient selection
Objectives

Demonstrate steps to simplify laparoscopic
myomectomy


 Pre-operative planning
Number of fibroids
Size of fibroids
 How big is too big?
 Ways to reduce intra-operative blood loss
 Suturing and surgical techniques
 Tips for removing different types of fibroids
Planning:
Pre-Operative Imaging
Planning:
Patient selection

Number of fibroids
 Size of fibroids

Ultrasound
 Limited when numerous fibroids
 How big is too big?

Location
9cm
Page 9
Planning:
Pre-Operative Imaging

Planning:
In the OR
MRI
 Port
 Great for mapping fibroid location and number
Trocar Placement
placement
 Higher lateral ports
 Higher midline ports
 LUQ port
 5mm and 10mm
Planning:
In the OR
Planning: In the OR
 Myoma
 Energy Source
manipulators
 Bipolar
 Monopolar
 Ultrasonic Energy
 Laser
 Specimen
Reducing Blood Loss:
Pre-operative use of GnRH Agonists

Improves pre- and post-op hgb/hct
Decreases uterine volume and fibroid size

Decreases procedure related blood loss

Vasopressin

Blood loss:
 Cochrane: 300 cc less EBL
 35-65%


 Does not change need for blood transfusion

removal
Need for transfusion
Dilute vasopressin
 (0.05-0.3 units/ml)
+/- Decrease in OR time

 Studies vary
 Several individual RCT studies show less OR time
Most studies for open
myomectomies
 Meta-analysis, no difference in OR time (Cochrane)

? Affect surgical planes
Kongnyuy E. Cochrane Review, 2007 (2011); Zhao F 2011; Fletcher H. 1996;
Cochrane Review 2011; Lethaby A. 2002; Zullo F 1998; Gutmann, 2005;
Page 10


Vasopressin/20mL NS
Roeder knot using 1-0 vicryl suture
Tourniquet/Clips
VIDEO TOURNIQUET
Other
Barbed suture
 Decreased
?
OR time (approx 10 miin)
Decreased blood loss – studies vary


VIDEO BARBED SUTURE

Direction of myometrial
incision
The “Pedicle”
Electrocautery vs. suture
for hemostasis
Walocha JA Hum Reprod 2003
Angioli 2012; Einarsson 2011.
Closure of defect
Suturing techniques and aides

Same technique as open
 Multiple layer closure
 Suturing aides

 Unidirectional barbed suture – Quill, VLock
 Suture clips – Lapra-Ty
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VIDEO OF MULTI
LAYER CLOSURE


VIDEO V LOCK
VIDEO SEROSA
Pedunculated fibroids:
Using a loop ligasure
Pedunculated fibroids
Fibroid
Intramural and subserosal fibroids
Multi-layered closure
Suture clips
Submucosal fibroids
Page 12
References
Broad ligament fibroid

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






Page 13
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.
Disclosures
Robotically-assisted
Laparoscopic Myomectomy
Hye-Chun Hur, MD
Director, Division of Minimally Invasive Gynecologic Surgery
Beth Israel Deaconess Medical Center, Boston , MA
Objectives
Patient Selection: RA-LSC MMY
• Review factors for patient selection for roboticallyassisted laparoscopic myomectomy (RA-LSC MMY).
Who is a good candidate for a
robotically-assisted laparoscopic
myomectomy?
• 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
Any patient who is a candidate for a
conventional laparoscopic myomectomy
is also a candidate for a
robotically-assisted myomectomy.
• Video Demos
Patient Selection
Patient Selection: LSC MMY
• 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 pathology
o Adenomyosis (loss of distinct parameters).
• Consider preoperative imaging to
o determine myoma size, number, location, and
characteristics (degeneration, central necrosis).
o exclude adenomyosis.
Page 14
Objectives
Robotic Approach
• Review factors for patient selection for roboticallyassisted laparoscopic myomectomy (RA-LSC MMY).
Advantages
• 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
• Myometrial incision (any direction)
• Surgeon comfort (obese patients)
• Magnification (identifying pseudocapsule planes)
• More comfortable when suturing
• Video Demos
Robotic Approach
Differences
Disadvantages
Robotic Approach
• Larger trocar incision size (8 mm vs 5 mm)
Conventional Laparoscopy
• 8 mm trocar size
• 4 accessory trocars
• Higher trocar placement
(M configuration)
• Visual haptics
• Small movements with
lots of clutching
• Surgeon sitting
• Additional trocar (4 vs 3 accessory trocars)
• Lack of tactile feedback (visual haptics)
• Space limitations (upper abdomen vs lower pelvis)
• 5 mm trocar size
• 3 accessory trocars
• Lower trocar placement
(diamond configuration)
• Tactile feedback
• Large movements with
sweeping gestures
• Surgeon standing
Port Placement
Port Placement: L-sided Docking
Camera
10-12 mm port
Arm #2:
Bipolar
Arm #1:
Scissors or
Harmonic
8 mm port
M- Configuration
Arm #3:
Teneculum
Accessory Port
(suction irrigator)
Accessory Port (5-10 mm)
10-12 mm port  direct needle delivery
5 mm port  back load the needle
Rainbow Configuration
Left-sided Docking
Page 15
Port Placement: R-sided Docking
Right-sided Docking
Camera
Arm #1:
Arm #2:
Bipolar
Scissors or
Harmonic
Arm #3:
Teneculum
Accessory Port
(suction irrigator)
Right-sided Docking
Right-sided Docking
Right-sided Docking
Basic Steps of LSC Myomectomy
Step 1: Myometrial Incision
What direction is best for
myometrial incision?
Myomectomy Procedure (4 basic steps):
1.
Myometrial incision
2.
Fibroid enucleation
3.
Myometrial closure
4.
Fibroid morcellation
5.
(Adhesion barrier)
• Transverse
• Vertical
• Oblique incision
Adhere to
same surgical principles
as open myomectomy.
Apply different techniques
to achieve these principles
robotically.
Anatomy
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Step 2: Enucleation
Video: Incision, 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.
Step 3: Myometrial Closure
Video: Harmonic
• 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)
Suture Selection
Unidirectional Barb Suture
Video: Myometrial Closure
Bi-directional Barb Suture
• e.g. V-Loc (Covidien)Advantages:• e.g. Quill (Angiotech)
No knots • Needle on both ends
• Pre-formed loop
Maintains tissue tension
by itself
• Polyglyconate (~Maxon)
• Polydioxanone (~PDS)
Easy to achieve multi-layer closure
Page 17
Step 4: Morcellation
Video: Morcellation
• Options:
o Mechanical morcellators
o Laparoscopic scalpel
o 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
Port Placement: Morcellation
Morcellation Tips
• Grab an edge to start
• Avoid swiss cheese
o Place coreguard at 12 o’clock
o Pulse the blade and adjust direction of tip
• Tissue tension
o Don’t pull too hard (pops off or morsel breaks off)
o Regrasp tissue outside of body when it gets really long
• Avoid helicopter effect
o Pulse the blade, then pull tissue, or
o Truncate specimen
M- configuration
Hybrid Procedure
Hybrid Procedure
Benefits of combined approach
• May preserve tactile sensation
• May allow faster enucleation of myoma
• Fewer accessory ports
• 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 wellestablished (ie. efficient docking)
Page 18
Conclusions
Questions?
• 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 guide
o 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
Page 19
Conflict of interests
When to Opt for Laparotomy: What Limits a
Laparoscopic Approach, and Strategies for a
Minimally Invasive Approach to Open Myomectomy
Consultant: Actavis
Togas Tulandi MD, MHCM
Professor and Academic Vice Chairman of Obstetrics and Gynecology,
Milton Leong Chair in Reproductive Medicine
McGill University
Case:
• A 30 year old woman with symptomatic uterine myomas and skin lesions.
Educational objectives
• Aunt: leiomyomasarcoma and a renal cyst, and her mother underwent a hysterectomy due to
uterine fibroids.
At the conclusion of this session, the participant should be able to:
• CT scan and MRI demonstrated uterine myomata, a right renal simple cyst of 3x3.2 cm and left
1. Describe when to opt for laparotomy and the reasons.
adrenal adenoma.
2. Describe strategies for minimally invasive approach to open
myomectomy.
3. Describe the concept of laparoscopically assisted myomectomy.
When to opt for a laparotomy?
• Hereditary leiomyomatosis and renal cell cancer (HLRCC), Multiple cutaneous and uterine
• size, and number of leiomyomas
leiomyomatosis syndrome (MCUL1) or Reed's syndrome
• surgical expertise
• Genetic testing revealed a c. 139C>T, p.Gln47Stop mutation in the fumarate hydratase (FH)
gene, consistent with the diagnosis of HLRCC syndrome.
• Myomectomy by laparotomy or laparoscopically assisted myomectomy (LAM)?
• Preoperative GnRHa or ullipristal
Page 20
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
Page 21
Buchs et al, 2012
Oxidized Regenerated Cellulose (Surgicel) Imitating
Pelvic Abscess
Behbehani & Tulandi, Obstet Gynecol 2013
Page 22
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 secrured
positioning 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
400 microgram misoprostol vaginally 1 hour prior to surgery
Preop. And Postop. Hgb and Hct with GnRHa higher than without.
Decreases blood loss
Page 23
•
50 mL bupivacaine 0.25% and 0.5 ml epinephrine
20 iu Vasopressin per 100 mL saline
Decreases blood loss and operating time
Oxytocin does not decrease blood loss.
Tourniquet does not decrease blood loss
Quality of evidence in reducing blood loss
Loop ligation plus vasopressin
Decreases blood loss and the operating time
Page 24
•
Moderate:
– misoprostol
– vasopressin
•
Low:
– tranexamic acid
– Gelatin-thrombin matrix
– tourniquet
– loop ligation
•
No evidence:
– Oxytocin
– Uterine artery ligation
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.
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.
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 6:1058, 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 populationbased 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. 2.
3.
Page 25
Disclosure: I have no financial relationships to disclose.
Strategies for Safe and Effective Tissue Removal
Associate Medical Director, MIGS
Newton Wellesley Hospital
Objectives
• Plan tissue removal using multiple different techniques
• Picture: Large fibroid • Picture: L/S incisions
National/International Organizations weight in…. 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 morcellation
poses 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 morcellation
during hysterectomy or myomectomy for uterine fibroids.
Page 26
SGO Position Statement: Morcellation
•
•
•
•
•
ACOG
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 morcellation
should 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.
• 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
AAGL: Morcellation During Uterine Tissue Extraction. May 2014
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
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
– 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
• Risk Factors
–
–
–
–
–
Age: mean diagnosis age 60
Black race: 2x higher incidence of LMS
Tamoxifen (5+ years)
Pelvic Irradatiation
Hx retonoblastoma or HLRCC
String of pearls: keeping track of your fibroids
Focus on technique….
• VIDEO
Page 27
Power Morcellation
In‐Bag Morcellation
• VIDEO
• Endocatch VIDEO
In‐bag morcellation
In‐bag, minilap
• Ecosac VIDEO
• VIDEO
Posterior colpotomy
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. • VIDEO
Page 28
Disclosure
I have no financial relationships to disclose.
Hysteroscopic Myomectomy: How to Approach the Type 2 Submucosal Fibroid
Associate Medical Director, MIGS
Newton Wellesley Hospital
Objectives
Types of submucosal fibroids
• 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 submucosal
fibroid
• 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.
Page 29
Pre‐op Planning
Pre‐op Planning
• Type 0, I, II • Type 0, I, II – Predicts ability to completely resect fibroid
‐ Type 0 96‐97% ‐ Type I 86‐90%
‐ Type II 61‐83%
– Predicts ability to completely resect fibroid
– Predicts fluid deficit
Decrease chance of complete resection
• Type 0
• Type I • Type II
450ml 957ml
1682ml Increasing fluid deficit
Emanuel, 1997
AAGL Practice Guidelines for mgmt of hysteroscopic distending media, 2013
Wamsteker K, 1993
Van Dongen H, 2006
Pre‐op Planning
Patient Consent
• Risk of incomplete resection of fibroid
• Possible need for a second procedure
• Type 0, I, II – Predicts ability to completely resect fibroid
– Predicts fluid deficit
• Women with larger submucosal
• Size matters
fibroids (> 3 cm) have higher risk of fibroid related surgery in the future
– <= 3 cm
– > 3 cm
10%
60%
Hart, R. 1999
• Risk of fluid overload increases with larger fibroid diameter
AAGL Practice Report: Practice Guidelines for the Management of Hysterscopic Distention Media, 2013
Office Eval OH
Mult fibroids OH
Page 30
Intra‐op planning: Equipment
Intra‐op Planning: Fluid Deficit
• Resectoscope
– Electrolyte free media
– Monopolar
• Use with monopolar
resectoscope
• Sorbitol/Glycine
• Fluid deficit max 1000 ml
• 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:
Minimizing intravasation
Intra‐op Planning: Fluid Deficit
– Monopolar
• Intracervical Vasopression
• using electrolyte free media (sorbitol/Glycine)
– Decreased fluid deficit
– Dilute vasopression works well (0.05 U/ml)
– RCT – Bipolar/Mechanical Morcellator
• using physiologic fluid (Normal saline or LR)
• Isotonic electrolyte‐rich solution
• Phillips DR. 1996
• 106 women – dilute vasopressin (8 ml of 0.05U/ml) vs. placebo
• Less fluid intravasation (450 ml vs. 820 ml) AAGL Practice Report: Practice Guidelines for the Management of Hysterscopic Distention Media, JMIG 2013
Intra‐lesion vasopressin
• Intrauterine pressure • VIDEO
– 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
Surgical Technique
1.
2.
3.
4.
5.
Do complete survey of endometrial cavity first
Resect intracavitary portion first
Don’t resect yourself into a hole
Only remove chips when you need to
Move whole resectoscope, not just the loop to maintain visualization
6. Don’t leave pieces hanging
7. When getting deeper into myometrium
• Avoid venous sinuses – Encounter in deep myometrial resection
– Resect intracavitary portion first
– Cauterize if needed
• RF Vaporizing electrodes
– Less fluid absorption than cutting loop
a.
b.
c.
d.
Expect fluid deficit to rise more quickly
Identify the pseudo‐capsule
Desiccate bleeders as needed
Reduce pressure to help more fibroid protrude into cavity
AAGL Practice Report: Practice Guidelines for the Management of Hysterscopic Distention Media, JMIG 2013
Remove resected pieces under direct visualization
Type I resection
Type II Resection
Reducing pressure
Page 32
Managing Post‐operative Bleeding
•Intra-uterine balloon
•Intrauterine pitressin soaked
gauze
•Embolization
•Hysterectomy
•Rollerball ablation mostly
ineffective
References
Consider laparoscopic myomectomy
• AAGL Practice Guidelines for mgmt of hysteroscopic
distending 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
Disclosures
How to Tackle the Challenging Fibroid:
Adenomyomas, Deeply intramural, Broad ligament and
Cervical Fibroids.
Director, Division of Minimally Invasive Gynecology
Beth Israel Deaconess Medical Center
Objectives
Case #1
• Discuss different fibroid presentations that pose unique
surgical challenges
o Broad ligament fibroids
o Cervical fibroids
o Ectopic Fibroids (bowel, abd wall, pelvic sidewall)
o Deep intramural fibroids
o Adenomyomas
• Review tips and tricks for optimizing minimally invasive
surgical techniques for challenging fibroids.
Case #1
Page 34
Broad Ligament Fibroid
Broad Ligament Fibroid: Video
Broad Ligament Fibroid: Video
Case #2
Cervical Fibroid
Page 35
Case #3: Ectopic Fibroids
•
•
•
•
•
Disseminated Peritonalis
Uterine Fibroids
Adenomyosis
Endometriosis
Infertility
Ectopic Fibroids
• Abdominal Wall
• Left rectosigmoid bowel
• Right rectosigmoid bowel
• Left Pelvic Sidewall, Ureteral
• Right IP ligament
Page 36
Page 37
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)
Type 2 Submucosal Myoma
Case #4: Deep Intramural Fibroids
Case #5: Adenomyomas
• Video
Page 38
Questions
Page 39
Alternatives to myomectomy
Disclosure
Consultant: Actavis
Togas Tulandi MD, MHCM
Professor & Academic Chairman of Obstetrics and Gynecology
Milton Leong Chair in Reproductive Medicine
McGill University
Case presentation
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
• 35 yrs, G0, uterine myoma of 16 gestational weeks
• Ultrasound: multiple intramural myomata
• PH: intestinal obstruction due to volvulus at 1 year old
uterine myoma
• “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
Medical management
• OCP: no good evidence
• L-norgestrel intrauterine system: may decrease
the myoma size
• GnRHa:
• Expectant mgmt.
• Medical mgmt.
– most effective
– addback
• Uterine Artery Embolization
• GnRH antagonist: daily dose
• SPRM (selective progesterone receptor
modulators)
• MRgFUS
Amino acid composition of native GnRH and GnRHa
Amino acid
position
1
2
3
4
5
7
8
GnRH
Analog
pGlu
His
Trp
Ser
Tyr
Gly
6
Leu
Arg
Pro
9
Leuprolide
pGlu
His
Trp
Ser
Tyr
D-Leu6
Leu
Arg
N-
10
Gly-NH2
Mifepristone (RU-486)
et
hyl
Pr
o
Nafarelin
pGlu
His
Trp
Ser
Tyr
D-Nal(2)6
Leu
Arg
Pro
Gly-NH2
Goserelin
pGlu
His
Trp
Ser
Tyr
D-
Leu
Arg
Pro
Aza-GlyNH1
0
Buserelin
pGlu
His
Trp
Ser
Tyr
D-
Leu
Arg
Pro
Leu
Arg
Pro
Histrelin
pGlu
His
Trp
Ser
Tyr
Ser(tB
u)6
SPRMs
Ser(tB
u)6
Imbzl-DHis6
10
New Class: SPRM
● Ulipristal acetate—1st in a new class—Selective
Progesterone Receptor Modulator (SPRM)
● Partial progesterone antagonist effect
Onapristone
Mifepristone
Antagonists
Ulipristal acetate
Asoprisnil
Telapristone acetate
11
Progesterone
Agonists
12
Page 41
PEARL II
PEARL II
Time to Control of Bleeding (PBAC < 75)
UPA Has a Superior Safety Profile vs. GnRHa as It Does Not Induce Menopausal Symptoms
Safety, Week 13
UPA 5 mg
UPA 10 mg
Leuprolide 3.75 mg
60
40
20
60
Co-primary
safety
endpoints
(superiority)
50
40
30
20
10
0
0
10
20
30
30 days
7 days
40
50
60
70
80
90
0
100
Time (days)
Rates of amenorrhea:
• 73.4% of UPA 5 mg patients (50% in 10 days)
• 81.7% of UPA 10 mg patients
UPA
5 mg
Patients with moderate and severe
hot flushes (%)
Median serum estradiol
(pg/mL)
70
80
Patients (%)
Hot flushes
Estradiol
100
UPA Leuprolide
10 mg
45
40
35
30
25
20
15
10
5
0
UPA
5 mg
UPA Leuprolide
10 mg
● UPA shows a superior safety profile to GnRHa
● UPA does not induce menopausal symptoms
Donnez J, et al. N Engl J Med 2012;366:421‐32
PEARL II
Endometrial effects of SPRMs
Effects of UPA on bone
•
Urinary marker C‐Terminal telopeptide of type I collagen (CTX)
Novel and benign endometrial
changes represent a new
morphological category which
has been referred to as
PRM-Associated Endometrial
Changes (PAEC).
*
Key features of PAEC
Hallmark features of PAEC are:
300
●
●
●
●
Low mitotic activity in both glands and stroma
Abortive subnuclear vacuoles
Apoptosis
Absence of stromal breakdown and glandular
crowding
● Cystically dilated glands that are lined
by flattened epithelium without nuclear
pseudostratification
UPA 5 mg
250
UPA 10 mg
200
Leuprolide
150
100
50
Images courtesy of Professor A. Williams
Edinburgh University Medical School
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 GnRHa
group.
Pituitary
gland
Estradiol
FSH
Ovary
Testosterone
Ovary:
Androgens ↑
FSH receptors ↑
IGF I ↑
Sensitivity to FSH ↑↑↑
Estradiol
Aromatase
Androstendione
Estrone
Aromatase
Inhibitor
Tulandi, NEJM
2007
Page 42
Pregnancy after uterine artery embolization for
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.
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
MRgFUS
Results
• Stewart et al, 2007: 359 women
Sustained relief: up 24 mths
From Fennessy & Tempany, 2006
Funaki et al, 2009
Page 43
Max. shrinkage: 25%
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
Lichtinger et al,
2005
• Constant communication with the patient
Tempany, 2007
Vilos et al, 2005
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
Brucker et al, 2014
Robot assisted vs. laparoscopic myomectomy
Gargiulo et al, 2012
P<0.001
Page 44
P<0.04
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).
US Population
Language Spoken at Home
California
Language Spoken at Home
Spanish
English
Spanish
Indo-Euro
Asian
Other
Indo-Euro
English
Asian
Other
19.7% of the US Population speaks a
language other than English at home
In California, this number is 42.5%
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.
Page 46

Didactic: No More Fibs: The Truth about Fibroids

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