43rd AAGL GLOBAL CONGRESS ON MINIMALLY INVASIVE GYNECOLOGY NOV. 17-21, 2014 | Vancouver, British Columbia
Didactic (Live Cadaveric Demo): Advanced Urogynecology: Overcoming Challenges in the Patient with Pelvic Organ Prolapse
PROGRAM CHAIR Kevin J.E. Stepp, MD
PROGRAM CO-CHAIR Patrick J. Culligan, MD
Matthew Clark, MD Catherine A. Matthews, MD Nazema Siddiqui, MD Bernard Taylor, MD
AAGL acknowledges that it has received support in part by educational grants and equipment (in-kind) from the following companies: Coloplast, CONMED Corporation, CooperSurgical, Covidien, Inc., Ethicon US, LLC, Intuitive Surgical, Olympus America, Inc., Karl Storz Endoscopy-America, Inc., Stryker Endoscopy, Welmed
Sponsored by
Advancing MinimallyAAGL 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
Anatomy of Pelvic Organ Support K.J.E. Stepp ...... 4
Approach to Pelvic Organ Prolapse – Patient Selection P.J. Culligan ...... 10
What about Retropubic Surgery? Paravaginal Repairs – When and How? B. Taylor ...... 13
Complications of Laparoscopic Repairs – How to Manage Laparoscopically N. Siddiqui ...... 18
Future Trends for Prolapse Surgery C.A. Matthews ...... 23
Pearls for Sacral Colpopexy – Techniques for Difficult Anterior Dissection M. Clark ...... 33
Pearls for Sacral Colpopexy – Techniques for Posterior Dissection – How Far Do I Go? N. Siddiqui ...... 36
Pearls for Sacral Colpopexy – What about the Patient with a Uterus? Matthews ...... 37
Pearls for Sacral Colpopexy – Techniques for Sacrum Exposure and Tensioning the Mesh M. Clark ...... 42
Cultural and Linguistics Competency ...... 45
URO-708 Didactic (Live Cadaveric Demo): Advanced Urogynecology: Overcoming Challenges in the Patient with Pelvic Organ Prolapse
Kevin J.E. Stepp, Chair Patrick J. Culligan, Co-Chair Faculty: Matthew Clark, Catherine A. Matthews, Nazema Siddiqui, Bernard Taylor
This is a ½-day didactics course focusing on building an in-depth understanding of pelvic organ prolapse and its treatment.
This course is targeted to the advanced pelvic surgeon who treats patients with pelvic organ prolapse but is looking to understand the three dimensional anatomy that plays a role in pelvic support. This course will begin with a detailed anatomic discussion of pelvic support. Then experts will discuss their approach and techniques for treating prolapse. A step-by-step explanation of the sacral colpopexy, including each expert’s tips and tricks will be presented.
The unique design of this course includes an interactive cadaveric demonstration of robotic sacral colpopexy. Clinical pearls and experts technique will be demonstrated live.
Patient selection, tips for shortening the learning curve, technique nuances, and prevention / management of complications will be covered.
Learning Objectives: At the conclusion of this course, the clinician will be able to: 1) Discuss the anatomy of pelvic organ support including the ischio-anal fossa, deep pelvic spaces, space of Retzius, and pre- sacral space; 2) discuss the current theories of pelvic support and how to apply these for individual patients; 3) identify the selection criteria for sacral colpopexy; 4) articulate the complications associated with pelvic organ prolapse procedures; and 5) identify steps to avoid and manage complications of prolapse surgery. Course Outline 7:00 Welcome, Introductions and Course Overview K.J.E. Stepp 7:10 Anatomy of Pelvic Organ Support K.J.E. Stepp 7:35 Approach to Pelvic Organ Prolapse – Patient Selection P.J. Culligan 8:00 What about Retropubic Surgery? Paravaginal Repairs – When and How? B. Taylor 8:25 Complications of Laparoscopic Repairs – How to Manage Laparoscopically N. Siddiqui 8:50 Future Trends for Prolapse Surgery C.A. Matthews 9:15 Break 9:25 Pearls for Sacral Colpopexy M. Clark • Techniques for Difficult Anterior Dissection 9:45 Pearls for Sacral Colpopexy N. Siddiqui • Techniques for Posterior Dissection – How Far Do I Go? 10:05 Pearls for Sacral Colpopexy C.A. Matthews • What about the Patient with a Uterus? 10:25 Pearls for Sacral Colpopexy M. Clark • Techniques for Sacrum Exposure and Tensioning the Mesh 10:45 Panel Discussion / Tricks of the Trade: All Faculty • Surgical Nuances • New Technology • Same Day Surgery? 11:00 Adjourn
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). Matthew Clark Grants/Research: American Medical Systems Speakers Bureau: Allergan, American Medical Systems, Bard Medical Division, Intuitive Surgical Patrick J. Culligan Grants/Research: American Medical Systems, Intuitive Surgical Consultant: Boston Scientific Corp. Inc., Bard Urological Division Other: Stock Ownership: Origami Surgical Catherine A. Matthews Grants/Research: Boston Scientific Corp. Inc. Nazema Siddiqui Other: Honorarium: Intuitive Surgical Grants/Research: Medtronic
Page 2
Kevin J.E. Stepp Consultant: CONMED Corporation, Teleflex Other: Stock Ownership: Titan Medical Bernard Taylor Speakers Bureau: American Medical Systems, Boston Scientific Corp. Inc., Intuitive Surgical
Asterisk (*) denotes no financial relationships to disclose.
Page 3 Anatomy of Support for the Pelvic Disclosures Surgeon Consultant: CONMED Corporation, Teleflex Kevin J. E. Stepp, MD Director, Advanced Surgical Specialties for Women Other: Stock Ownership: Titan Medical Chief, Urogynecology and Minimally Invasive Surgery
Carolinas Healthcare System Charlotte, North Carolina [email protected] www.drkevinstepp.com
Objectives
• Discuss endopelvic fascia network and supportive structures. • How do they interact to maintain pelvic organ support? • Understand the levels of pelvic support and goals for reconstructive surgery.
Page 4 Role of Levator Ani
• Main mechanism of support
• Maintains constant tone • Rapid contraction with cough, etc. • Relaxation with defecation/urination
Role of the endopelvic fascia and supportive ligaments
Ischium
Page 5 Endopelvic Fascia
• Normal axis of vagina • Collagen, elastin, adipose tissue, nerves, - Upper 2/3 – Nearly horizontal vessels, lymph channels, and smooth muscle - Distal 1/3 – Nearly vertical • Provide stabilization and support yet allow for the mobility
- Endopelvic fascia is responsible for maintaining position of pelvic organs over the levator plate so that they may be supported.
The Dry Dock Analogy
Failure of Level 1 support
Page 6 Endopelvic Fascia Endopelvic Fascia
• Arcus Tendineous Levator Ani • Arcus Tendineous Fascia Pelvis
Endopelvic Fascia
• Arcus Tendineous Rectovaginalis
Page 7 Failure of Level 2 support Endopelvic Fascia
• Arcus Tendineous Fascia Pelvis
Failure of Level 3 support Posterior Support Defects
• Rectocele, Perineocele
Page 8 Rectovaginal Fascia Is all prolapse treated equally? Female analogue of Denonvilliers’ Fascia
Restore Level III Support
Sacral Colpopexy
Carolinas Medical Center Advanced Surgical Specialties for Women
Page 9 Disclosure
Grants/Research: American Medical Systems, Intuitive Surgical Consultant: Boston Scientific Corp. Inc., Bard Urological Division Patient Selection Other: Stock Ownership: Origami Surgical
Patrick J. Culligan, M.D., FACOG, FACS Urogynecology Division & Fellowship Director Atlantic Health System, Morristown & Summit, New Jersey
Professor of Obstetrics, Gynecology & Reproductive Science Mount Sinai School of Medicine New York, NY
In my opinion, this is not a true Sacrocolpopexy Sacrocolpopexy Key Elements
. If your’re just fixing the mesh to the apex, you’re not taking advantage of the possibilities of the sacrocolpopexy When uterus present: procedure. Supracervical Hysterectomy . Worse yet – your mesh may be too light for Anterior dissection to level of trigone this technique Posterior dissection to perineum
Vaginal sutures – CV4 GoreTex 6 to 10 per compartment
Sacral Sutures - Two CV4 GoreTex
Re-peritonealization (Zero Monocryl)
12 August 2014 12 August 2014 Advanced review of anatomy and surgical techniques for sacrocolopopexy Advanced review of anatomy and surgical techniques for sacrocolopopexy
Some Perspective…
(MRI courtesy of Peter Rosenblatt, M.D.)
My progression to robotic surgery
1110‐35
Robotic‐Assisted Laparoscopic Sacrocolpopexy
Page 10 Current approach to reconstructive My approach to prolapse surgery reconstructive prolapse surgery before 2011 . Offer Native Tissue AND Sacrocolpopexy to all . At this point (for me) operative times are the same . Vaginal surgery is “less invasive” – but only technically speaking
. Offer Vaginal Mesh to “older, less active” patients as always . Very few takers these days
. Offer isolated defect repairs as appropriate . (simple cystocele or rectocele repairs without mesh)
1110‐35
Page 8
Recent Case – 130 minutes
75 years old, vibrant, active, otherwise healthy
1st prolapse operation 1985 - TVH A&P repair 2nd Prolapse operation - Vaginal mesh 2006 (me) Patient 3rd Prolapse operation - Robotic Sacrocolpopexy Selection
Isolated Cystocele Perfect Sacrocolpopexy Patient
Page 11 Page 12
Page 11 Anterior axillary line xyphoid Perfect Patient for Native Tissue Repair (or Colpocleisis)
2 cm
R 3
assist
camera 10 cm
4 cm R 1 R 2 8.5 cm 8.5 cm ASIS ASIS
pubis Page 14
Perineal Decent Could go either way (Think Sacrocolpopexy or Vaginal Mesh) (She chose sacrocolpopexy)
Page 15 Page 16
Page 12 Disclosures
Speakers Bureau: American Medical Systems, Boston Scientific Corp. Inc., Intuitive Surgical What About Retropubic Surgery: Paravaginal Repairs – When and How?
Bernard Taylor, MD Assistant Clinical Professor Associate Program Director Female Pelvic Medicine and Reconstructive Surgery Department of Obstetrics and Gynecology Carolinas Medical Center
Learning Objectives Cystocele A Radical Cure by Suturing Lateral Sulci of • Review the anatomy of the retropubic space and Vagina to White Line of Pelvic Fascia paravaginal defect • Discuss the clinical significance of paravaginal support • Discuss when and how to perform laparoscopic and robotic assisted laparoscopic paravaginal repair
G. White. JAMA. 1909;LIII(21):1707‐1710
A New Look at Pelvic Relaxation Anterior Compartment Fascial Defects • Introduced concept that cystoceles result from isolated defects in connective tissue • Identified 4 defects of the anterior compartment – Central Defect – Lateral (Paravaginal), Midline, Transverse, and Pubourethral ligament defect Lateral Defect • Surgical management consist of direct defect closure – Paravaginal Repair • Initial experience – 63 patients with PVD/SUI treated with PVD repair Transverse – Results: Excellent 91.7%; Improved 5%; Failure 3%
A.C. Richardson. AJOG. 1976;126(5):568‐571. A.C. Richardson
Page 13 Paravaginal Defect Pelvic Organ Support Detachment of Arcus Tendineus Fascia • Level I – Uterosacral –Cardinal Ligament Complex • Level II – Pars Endopelvina Faciae Pelvis • Level III – Perineal body
Paravaginal Defect Abdominal Paravaginal Defect Detachment of Arcus Tendineus Fascia
Normal Anterior Compartment Paravaginal Defect
Page 14 Clinical Paravaginal Defect Paravaginal Defect Repair Treatment for SUI?
• Initial indications were for anatomic and functional repair of patients with anterior compartment prolapse and SUI • Initial results for both correction of prolapse and incontinence were 80-90% at up to 2 years video • Objective results (postoperative Urodynamics) reveal only 61% success rate for treatment of SUI • PVD repair not recommended for treatment of SUI
Richardson AC. AJOG. 1976;126(5):568‐571. RichardsonAC. Obstet Gynecol. 1981; 57:357‐363. Bruce RG. Urology. 1999;54(4):647‐651 Colombo M. Am J Obstet Gynecol. 1996; 175(1):78‐84.
Anterior Vaginal Wall Prolapse Paravaginal Defect Repair Paravaginal Defect
Baggish MS, Karram MM, [eds]: Atlas of Pelvic Anatomy and Gynecologic Surgery. New York, Courtesy of John Miklos, MD and Robert Moore, MD Harcourt, 2001.
Abdominal Approach … Indications for MIV Gynecologic Surgery
• Total Abdominal • Adoption of Hysterectomy +/- BSO Robotic/Laparoscopic • Sacral Colpopexy sacral colpopexy • Paravaginal repair parallels other MIV gynecologic procedures • Burch Colposuspension • Posterior repair/perineorrhaphy
Intuitive Surgical
Page 15 Robotic Sacral Colpopexy Abdominal Paravaginal Defect
Intuitive Surgical
Paravaginal Anatomy Paravaginal Defect Repair Step by Step … Obturator artery/vein
• The apical suspension procedure is completed • The abdominal wall peritoneum above the bladder is transversely incised between the medial umbilical ligaments and the retropubic space is developed opened • Dissection of the the retropubic space is carried to the pubic symphysis and then to the paravaginal space lateral to the bladder Arcus Tendineus Fascia Pelvis • A vaginal probe is place to assure proper lateral vaginal suture placement • Beginning just distal to the ischial spine and progressing towards the pubic symphysis 3 to 4 sutures are placed reapproximating the detached vaginal fascia endopelvina to the obturator internus fascia • The repair is performed bilaterally • After completion of the PVDR perform cystoscopy
Bladder Location of Ischial Spine
Cystoscopy Robotic assisted Laparoscopic Paravaginal Defect Repair
video
Page 16 Laparoscopic and Robotic Assisted Goal of Pelvic Organ Prolapse Treatment Paravaginal Repair
• Laparoscopic PVDR associated with low complication rate • Success rate at 2-5 years 76-80% Restore normal anatomical supportive relationships in order to improve function and eliminate symptoms • Initially laparoscopic experience was limited to a small group of expert laparoscopic urogynecologists • Recent popularity of robotic assisted laparoscopic prolapse surgery has renewed interest in PVDR
Miklos J. Urology 56 (suppl 6A) 2000; 64‐69: 64‐69. Behnia‐Willison F. J Minim Invasive Gynecol. 2007;14(4):475‐480. O’Shea RT. J Minim Invasive Gynecolo. 2012;19: S61 (Abstract).
References
1. G. White. JAMA. 1909;LIII(21):1707-1710. Cystocele: A Radical Cure by Suturing Lateral Sulci of Vagina to White Line of Pelvic Fascia. 2. A.C. Richardson. AJOG. 1976;126(5):568-571. A New Look at Pelvic Relaxation. 3. RichardsonAC. Obstet Gynecol. 1981; 57:357-363. Treatment of Stress Urinary Incontinence Due to Paravaginal Fascial Defect 4. Bruce RG. Urology. 1999;54(4):647-651. Paravaginal Defect Repair in the Treatment of Female Stress Urinary Incontinence. 5. Colombo M. Am J Obstet Gynecol. 1996; 175(1):78-84. A Randomized Comparison of Burch Colposuspension and Abdominal Paravaginal Defect Repair for Female Stress Urinary Incontinence. 6. Miklos J. Urology 56 (suppl 6A) 2000; 64-69: 64-69. Laparoscopic Paravaginal Repair Plus Burch Colposuspension: Review and Descriptive Technique. 7. Behnia-Willison F. J Minim Invasive Gynecol. 2007;14(4):475-480. Laparoscopic Paravaginal Repair of Anterior Compartment Prolapse. 8. O’Shea RT. J Minim Invasive Gynecolo. 2012;19: S61 (Abstract). Laparoscopic Paravaginal Repair – Objective Outcomes at Five Years and Beyond.
Page 17 Disclosures
Other: Honorarium: Intuitive Surgical Grants/Research: Medtronic Sacrocolpopexy complications
Nazema Y. Siddiqui, MD MHSc Assistant Professor, Department of Obstetrics and Gynecology Division of Urogynecology and Reconstructive Pelvic Surgery
2
MIS Sacrocolpopexy Potential Complications
✴ Intraoperative risks
✓ Injury to bladder/ureters
✓ Injury to bowel/rectum
✓ Pre-sacral bleeding
✴Postoperative risks
✓ Sacral discitis/osteomyelitis
✓ Mesh erosion
3 4
Potential Complications
✴ Intraoperative risks
✓ Injury to bladder/ureters Intraoperative Risks ✓ Injury to bowel/rectum
✓ Pre-sacral bleeding
6
5
All Rights Reserved, Duke Medicine 2007
Page 18 Vascular Anatomy Vascular Anatomy
Vascular boundaries and contents of the presacral space:
LCIV: left common iliac vein MSA: middle sacral artery MSV: middle sacral vein LSV: lateral sacral veins * : midsacral promontory
7 Wieslander et al.; AJOG8 2006
Vascular Anatomy Vascular Anatomy
27mm between left common iliac vein and midsacral promontory
9 Wieslander et al.; AJOG10 2006
Vascular Anatomy Vascular Anatomy
Fresh frozen cadaver - blind suture placement
11 12 Flynn et al; AJOG 2005
Page 19 Vascular Anatomy Vascular Anatomy
Fresh frozen cadaver - blind suture placement Fresh frozen cadaver - blind suture placement
✓ Vascular injury in 5/10 cadavers (50%) ✓ Vascular injury in 5/10 cadavers (50%)
✓ 4 sutures through middle sacral artery ✓ 4 sutures through middle sacral artery
✓ 1 suture through left common iliac vein ✓ 1 suture through left common iliac vein
Basics of surgery: Open and dissect the presacral space
13 14 Flynn et al; AJOG 2005 Flynn et al; AJOG 2005
Vascular Anatomy Tips & Tricks
✓ Avoiding injury: Understand your midline Thorough dissection ✓Get under the fat pad early!!! Know where you are
✓Small amounts of monopolar cautery and blunt dissection to get to the ligament
✓Use bipolar on small vessels
✓Complete the presacral dissection before opening the
15 remainder of the peritoneum (reduces need for assistant)16
What if there is bleeding?
✓ PAUSE if you can and don’t lose your cool
✓ Use the heel of an instrument to tamponade Postoperative Risks
✓ Bipolar cautery (parallel to vessel)
✓ Can use FloSeal +/- Raytec
17
18
A ll Rights Reserved, Duke Medicine 2007
Page 20 Potential Complications Sacral discitis/osteomyelitis
✴Postoperative risks
✓ Sacral discitis/osteomyelitis
✓ Mesh erosion
19 20
Managing Mesh Erosion Mesh Erosion
✓ Good surgical technique ✓ Try to avoid it!!! Wise use of cautery on vagina Avoid vaginotomy (...or cystotomy, or proctotomy...)
✓ Consider the type of synthetic material you use
✓ Consider patient factors
21 22
Type of Mesh Type of Mesh
✓ CARE trial (Brubaker et al. NEJM 2006):
✓322 abdominal sacrocolpopexies
✓Surgeons could choose type of mesh
✓ Interim analysis higher rates of erosion with GoreTex mesh
23 ✓ Investigators stopped using GoreTex mesh 24
Page 21 Type of Mesh Mesh Erosion
✓ Good surgical technique Wise use of cautery on vagina Avoid vaginotomy (...or cystotomy, or proctotomy...)
✓ Consider the type of synthetic material you use
✓ Consider patient factors
25 26
Type of Mesh Mesh Erosion
✓Risk factors for mesh erosion in CARE (ASC in 322 women): Smoking (OR 5.2) Concomitant hysterectomy (OR 4.9) Gore-Tex mesh (OR 4.2)
✓Overall 6% mesh erosion 2 years after ASC
✓E-CARE (7 years of follow up): mesh erosion 10.5%
Cundiff et al.; AJOG 2006 Brubaker et al; JAMA 2006 27 28 Nygaard et al; JAMA 2013
Avoiding Mesh Erosion
✓ Good surgical technique
✓ Use Type I polypropylene mesh
✓ Consider patient factors (smoking, concomitant total hysterectomy) that you might be able to avoid
✓ COUNSEL patients on possibility of mesh erosion
29
Page 22 DISCLOSURES
Future trends for prolapse surgery Grants/Research: Boston Scientific Corp. Inc.
Catherine A. Matthews MD, FACOG, FACS Associate Professor and Division Chief Urogynecology and Reconstructive Pelvic Surgery University of North Carolina Chapel Hill, NC
Objectives
• At the conclusion of this activity, the participant will be able to understand the following: • Projected rates of pelvic floor disorders over the next 3 decades • Current rates of prolapse surgery in the US • Short and Long term outcomes of prolapse repairs • Risk factors for surgical failure • Future trends for prolapse surgery with regards to machines, materials, and methods
People are living longer…
And they are getting progressively heavier…
Page 23 PFDs in the Future PFDs in the Future
50 44 million # Older adults 40 2010: 40.2 million 28 million 2030: 72.1 million 30
2050: 88.5 million 20
10
0 2010 2020 2030 2040 2050
U.S. Census Bureau, Population Projections, 2008 Wu et al. Obstet Gynecol, 2009
Lifetime Risk of Surgery (SUI or POP)
80 yrs: 20.2% 20%
15% 60 yrs: 11.4%
10%
5% Cumulative incidence (%)
0% 20 30 40 50 60 70 80 Age (years)
Wu et al. AUGS, Oct 2013.
Lifetime Risk of Surgery (SUI or POP) Age-specific Incidence Rates Either SUI or POP Surgery 80 yrs: 20.2% 6.0 20% 5.0
15% 1 in 5 women will undergo 4.0 surgery for stress incontinence Either 10% 3.0 or prolapse by the age of 80 2.0 5%
1.0 Cumulative incidence (%)
0% Incident surgery rate per 1,000 p-yr 20 30 40 50 60 70 80 0.0 Age (years) 20 30 40 50 60 70 80 90 100 Age (years) Wu et al. Obstet Gynecol, 2014.
Page 24 Age-specific Incidence Rates Cumulative Lifetime Risk
6.0 Either SUI POP Either: 20.2% (95%CI: 19.2, 21.2) 20% 5.0 SUI: 14.5% 4.0 Either 15% (95%CI: 13.4, 15.5)
SUI 3.0 POP: 13.7% POP 10% (95%CI: 12.6, 14.8) 2.0
1.0 5% Cumulative incidence (%) Incident surgery rate per 1,000 p-yr 0.0 20 30 40 50 60 70 80 90 100 0% 20 30 40 50 60 70 80 Age (years) Age (years)
We’re going to be doing a lot of Cumulative Lifetime Risk surgery…
Either SUI POP 80 yrs: 20.2% 20% X • How long can anything last? 70 yrs: 15.9% X 15% • What is the “right” operation? 60 yrs: 11.4% X 10%
5% Cumulative incidence (%)
0% 20 30 40 50 60 70 80 Age (years)
Apical Prolapse: Options Efficacy Morbidity Cost
Vaginal (+/- Sacrocolpopexy +/- Hysterectomy) TAH • Uterosacral Ligament SCH Suspension No TAH • Sacrospinous Fixation • Manchester Repair • Mesh procedure • Colpocleisis
Page 25 Primary Outcome
• Surgical “Success” at 24 months defined as absence of all the following: • Prolapse of anterior or posterior vaginal wall beyond the hymen (POPQ point Aa, Ba, Ap, Bp > 0) • Descent of the vaginal apex more than 1/3 of vaginal length (POPQ point C>- 2/3 TVL) • Bothersome vaginal bulge symptoms • Retreatment for POP with either Barber et al. JAMA, 2014 pessary or surgery
Surgical Success at 24 Months
ULS SSL (95% CI) 90/154 90/152 58.4% 60.5% 0.9 (0.6-1.4)
18% were symptomatic 17.5% had prolapse beyond the hymen 5% retreatment 30% recurrence; 10% mesh exposure
Bulge symptoms
27% 17%
3% reoperation rate
Page 26 Results of 2012 Review
2012 Cochrane review: Surgical • 54 RCTs totaling 5775 women management of Pelvic Organ • 15 new trials 165 women (Altman 2011, Prolapse Farid 2010; Feldner 2010; Hiviid 2010;Maher 2011; Iglesia 2010; Withagen 2011; Menefee 2011; Minassian 2010 abstract; Paraiso 2011; Rondini 2011 abstract; Sung 2012; Thijs 2010 abstract; Vijaya 2011 abstract; Vollebregt 2010 abstract)
• 10 major updates of prior work (Borstad 2010; Carey 2009; Costantini 2008; Culligan Schmid C, Feiner, B, Baessler K, Glazener C, Maher C 2005; Dietz 2010; Guerette 2009; Natale 2010; Nieminen 2008; Pantazis 2011 abstract; Sokol2011) IUGA 2012
Apical (upper) Compartment 3 RCT: Benson 1996; Lo 1998, RCT: TVM vs LSCP Maher 2004 • Prospectively compare Total vaginal mesh Vaginal Approach Abdominal Approach (Prolift) and Lap sacral colpopexy for vaginal vault prolapse • Short & Long-term symptomatic & Objective Follow-up • All pelvic floor symptoms • Validated condition specific & QoL question • Cost Analysis
ASC ↑success rate, ↓dyspareunia Maher et al. AJOG 2010 ↑operating & recovery time & cost
Who is likely to fail surgical Conclusion Vault study repair?
LSC • Anatomic risk factors? ↑ operating time • Genetic risk factors blood loss, admission days, • Epidemiologic risk factors? quicker RADL improved findings at all POPq sites > TVL > patient satisfaction reoperation rate As compared to total prolift
Maher 2010 AJOG
Page 27 Whiteside et. al.
• 1 year post-op, 58% had ≥ Stage II recurrent POP • Identified risk factors: • Age < 60: OR 3.2; 95% CI 1.6-6.4 • Stage III or IV pre-op POP: OR 2.7; 95% CI 1.3- 5.3
Salvatore study
• N= 360 • Mean follow up of 26 months • 10% had ≥ recurrent Stage II POP • Only identified risk factor: Pre-op ≥ Stage III POP: OR 2.4, 95% CI 1.1-5.1
N=212
Main risk factor was advanced prolapse (Grade 3,4)
Page 28 Risk factors of reoperation
• Cumulative incidence 5.6% • Risk factors: • POP in > 2 vaginal compartments: OR 5.2, 95% CI 2.8-9.7 • Sexual activity: OR 2.0; 95% CI 1.5-7.1
Urogenital Hiatus
Urogenital Hiatus Recurrence < 5 cm 10% > 5 cm 34%
Odds ratio 4.7 [95% confidence interval, 1.0-24.1] P=0.02
Summary: The data tells us that
• SCP is superior to a native tissue and a vaginal mesh repair for VAULT prolapse: Unless significant intraperitoneal risk factors exist, use SCP for all VVP • The data for UTERINE prolapse is largely unknown • The greatest risk factors of recurrent prolapse with native tissue repair is YOUNG AGE and > Stage II prolapse • Should one consider SCP as primary approach in these patients or “save” the SCP for a 2nd operation?
Page 29 My Current Approach to Prolapse Surgery
What is the age and activity level of the patient?
“Younger” “Older” “Very Active” “Less Active”
Laparoscopic Sacral Colpopexy Vaginal surgery (+/- hyst) Mesh for recurrent anterior compartment only
Performance Times Analysis of Robotic Performance First 10 Cases vs Later Cases Times to Improve Operative Efficiency
Elizabeth J. Geller, MD Catherine A. Matthews, MD
J Min Invasive Gynecol. 2012 Nov 8
Page 30 Performance Times First 10 Cases vs Later Cases Trends in machines
Robots are big and expensive
WEIGHT: 2.2 LBS (1 KG) PRICE: $4000
Materials?
• Is ultra-lightweight Type 1 mesh the answer? Probably not
• Is permanent suture for mesh attachment the answer? 200 g Probably not
$25 • I suspect that future trends will see the use of new graft materials
Page 31 Conclusions References
• 1. Wu JM, Matthews CA, Conover MM, Pate V, Jonsson Funk M. Lifetime Risk of Stress Urinary Incontinence or Pelvic Organ Prolapse Surgery. Obstet Gynecol 2014. • 2. Wu JM, Vaughan CP, Goode PS, et al. Prevalence and trends of symptomatic pelvic floor disorders in U.S. • Future trend will likely be more native tissue repairs for women. Obstet Gynecol 2014;123:141-8. • 3. Barber MD, Brubaker L, Burgio KL, et al. Comparison of 2 transvaginal surgical approaches and primary prolapse perioperative behavioral therapy for apical vaginal prolapse: the OPTIMAL randomized trial. Jama 2014;311:1023-34. • 4. Geller EJ, Matthews C. Impact of robotic operative efficiency on profitability. Am J Obstet Gynecol 2014. • 5. Crane AK, Geller EJ, Matthews CA. Trainee performance at robotic console and benchmark operative times. Int Urogynecol J 2013;24:1893-7. • Robotic surgery will have to be cost equivalent to sustain • 6. Geller EJ, Lin FC, Matthews CA. Analysis of robotic performance times to improve operative efficiency. J Minim Invasive Gynecol 2013;20:43-8. use • 7. Nygaard I, Brubaker L, Zyczynski HM, et al. Long-term outcomes following abdominal sacrocolpopexy for pelvic organ prolapse. Jama 2013;309:2016-24. • 8. Whiteside JL, Weber AM, Meyn LA, Walters MD. Risk factors for prolapse recurrence after vaginal repair. Am J Obstet Gynecol 2004;191:1533-8. • Mesh materials will evolve beyond polypropylene • 9. Salvatore S, Athanasiou S, Digesu GA, et al. Identification of risk factors for genital prolapse recurrence. Neurourol Urodyn 2009;28:301-4. • 10. Jeon MJ, Chung SM, Jung HJ, Kim SK, Bai SW. Risk factors for the recurrence of pelvic organ prolapse. Gynecol Obstet Invest 2008;66:268-73. • 11. Dallenbach P, Jungo Nancoz C, Eperon I, Dubuisson JB, Boulvain M. Incidence and risk factors for • SCP will remain a good operation, but it’s not fail-proof reoperation of surgically treated pelvic organ prolapse. Int Urogynecol J 2012;23:35-41. • 12. Medina CA, Candiotti K, Takacs P. Wide genital hiatus is a risk factor for recurrence following anterior vaginal repair. Int J Gynaecol Obstet 2008;101:184-7. • 13. Dietz HP, Chantarasorn V, Shek KL. Levator avulsion is a risk factor for cystocele recurrence. Ultrasound Obstet Gynecol 2010;36:76-80. •
Page 32 Disclosure “Pearls for sacrocolpopexy ‐ Techniques for difficult anterior Grants/Research: American Medical Systems dissection” Speakers Bureau: Allergan, American Medical Systems, Bard Medical Division, Intuitive Surgical
Matthew H Clark MD Hoag Hospital Newport Beach, CA
Learning Objectives: Anterior Objectives dissection challenges • Learn about difficult dissections • Learn how to handle scarred • Demonstrate how to repair cystotomy – S/P C section, hysterectomy or prolapse repair • See the cystocele • See how to surgically treat large cystocele • Demonstrate how to avoid cystotomy
Anterior dissection challenges Anterior dissection challenges
• Scarred • Scarred – Technique similar regardless the cause of the – Technique similar regardless the cause of the scarring scarring • See the bladder / vaginal border by filling the bladder • Right hand with scissors or pulling the Foley bulb or tube • Left with grasper • Vaginal dilator • Lift up the bladder flap with assistant • Pull the vaginal wall tight • Scissor tip 90 degree to the vagina and push forward • Start with sharp dissection to establish the plane and spread and pull backward.
Page 33 Cystotomy
• Cadaveric Demonstration Live • Mechanical or cautery? – Mechanical should heal without concerns – Cautery beware of poor healing • Where? – At dome or the superior border ( not in contact with mesh ) Vs. between the bladder and vagina
Cystotomy
• Repair multilayer, tension free and using2‐0 • Cadaveric Demonstration Live of cystotomy vicryl and repair • Drain bladder x days – Dependent vs. Non dependent • I do not place mesh in direct contact with the cystotomy repair • Confirm Ureter is not envolved
Large cystocele Large Cystocele
• Cystocele is the most likely location for a Colpopexy to fail • FDA transvaginal mesh warning pushing providers and patients to avoid TVM for repairs • Apical Dominate Prolapse • Cystocele Dominate Prolapse • Extended the indications for ASC to include large cystocele dominate prolapse
Page 34 Evolving indications for dVSC in light of the FDA mesh warning letters Cystocele with ASC
• Challenge of ASC: Controlling the Cystocele Recurrent ‘slide off cystocele’
Seeing the Cystocele Cystocele with ASC
• Pull on anterior wall – Without a Lucite rod
• Release the anterior wall – Without a Lucite rod
– “see the cystocele”
• Video vs Live demonstration: seeing the cystocele and sewing the anterior mesh
Page 35 Disclosures
Posterior Wall Dissection Other: Honorarium: Intuitive Surgical Grants/Research: Medtronic
Nazema Y. Siddiqui, MD MHSc Assistant Professor, Department of Obstetrics and Gynecology Division of Urogynecology and Reconstructive Pelvic Surgery
2
MIS Sacrocolpopexy Posterior Wall Dissection
✴ Use a manipulator to distend the posterior fornix
✴ Incise the peritoneum
✴ Small pulses of electrocautery with blunt dissection
✴ Stay on the back of the vagina
✴ Consider a small manipulator (e.g. EEA sizer) if unsure of rectal anatomy
3 4
Page 36 DISCLOSURES
Pearls for Sacral Colpopexy: What Grants/Research: Boston Scientific Corp. Inc. about the patient with a uterus?
Catherine A. Matthews, MD Associate Professor and Division Chief Urogynecology and Reconstructive Pelvic Surgery University of North Carolina Chapel Hill, NC
Objectives Case
• At the end of this presentation, the audience • 57 yo with Stage III uterine prolapse is expected to understand the following: • Wants “the best” surgical treatment • Rate of unanticipated uterine pathology in • Had episode of PMP VB which was women undergoing surgery for POP evaluated with EMBx- benign • Risks and benefits of uterine preserving • Should she have: surgery • Sacrohysteropexy • Comparative outcomes of uterine preserving surgery • SCH + SCP • Appropriate pre-operative case selection for •TLH + SCP hysteropexy • TVH/USS
Not all uterine prolapse is Effect of concurrent created equally hysterectomy
• Does concurrent hysterectomy affect recurrence rates? • Does concurrent hysterectomy affect mesh exposure rates? • Is there a difference between total and supracervical hysterectomy in anatomic outcomes? • What is the risk of unanticipated uterine pathology? • If the uterus is left in situ, what is the risk of developing future uterine pathology?
Page 37 Hysteropexy
Uterine pathology Supracervical Cervical elongation Patient preference hysterectomy Compromised result Lower mesh erosion Total laparoscopic Decreased blood loss hysterectomy Lower OR time
AUTHOR Subjects Overall mesh OR TAH Risks of mesh exposure exposure
Cundiff, 2008 322 6% 4.9
Akyol, 2014 292 6.5% 2.0
Warner, 2012 390 2.8% 2.0
Cvach, 2012 27 11% 33.0
Bensinger, 2005 121 3.3% 7.0
Nosti, 2009 264 5.7% 0.95
Brizzolara, 2003 124 0.8% No diff
Stepanian, 2008 446 2.3% No diff
Borahay, 2014 20 0% No diff
Marinkovic, 2008 67 0% No diff
OVERALL RATE OF MESH EXPOSURE ASCP 3.4% RATES OF MESH EXPOSURE RANGE FROM 0-33%
Conclusions regarding mesh exposure with concurrent TLH
• TLH does increase the risk, but to what degree? • Mesh materials play a big role: Impact of lighter weight Type 1 polypropylene? • Sutures seem to play a big role too: Permanent vs delayed absorbable suture material? Rates of mesh exposure with • RCT funded supracervical hysterectomy + cervicosacropexy = 0%
Page 38 3.2%
Unanticipated uterine pathology Frick et al. AJOG 2010 Ramm et al. Int Urogynecol J, 2012 N = 708
97.1% no concerning pathology (2.9%) Unanticipated premalignant or malignant pathology
15 16
Preoperative assessment: Preoperative assessment: Transvaginal US
Endometrial biopsy University of Pisa, Gambacciani et al. • Pipelle (aspiration) endometrial Retrospective review of 850 postmenopausal sampling devise women taking hormone therapy who underwent • Detection rates of 67-92% hysteroscopy • Observed in symptomatic women with known endometrial malignancy • Total surface area sampled is low: • 148 asymptomatic patients who underwent average 4% (0-12%) hysteroscopy secondary to transvaginal US stripe >4.5mm • 20% of postmenopausal women can have uterine pathology with specimen • Adenocarcinoma - 1 (0.7%) patient Stoval et al., Ob&Gyn, 1991 ‘insufficient’ for analysis • Transvaginal Ultrasound generated 93% Rodriguez et al, AJOG, 1993 • High rate of false negatives in patients false positive rate Guido et al., J Repro Med, 1995 with tumors less than 50% of endometrial surface area 17 18
Page 39 Regarding uterine pathology Cervical elongation
• There is no good way to screen for it pre- operatively • Expect a 3% rate over time • New patient awareness regarding morcellation complicates your pre-operative discussion • Management once disease is detected is challenging and controversial
Efficacy?
• TLH vs SCH / Hysteropexy
5/8 (62.5%) had cervical elongation by 12 months
Anterior failure noted in 55% of ASH Subsequent uterine pathology in 22%
Page 40 Higher failure rate in hysteropexy group “evidence on safety and efficacy is lacking”
Summary of data Conclusions • Do not do SCH in a PMP woman with any vaginal bleeding • Carefully consider the unique risks of SCP when • Counsel all women regarding the overall 3% counseling for use as a primary operation for young risk of unanticipated uterine pathology women with advanced uterovaginal prolapse • Recognize that this rate is similar to rates of • Don’t leave a big, bulky cervix behind mesh exposure: Individualize risk/benefit ratio • Practice any minimally-invasive technique and do it often: • Only offer SCH to women with a small cervix volume and repetition count • Think about native tissue repair or TLH/SCP with large anterior wall prolapse
References
• Matthews CA, Carroll A, Hill A, Ramakrishnan V, Gill EJ. Prospective evaluation of surgical outcomes of robot-assisted sacrocolpopexy and sacrocervicopexy for the management of apical pelvic support defects. South Med J. May 2012;105(5):274-278. • Nosti PA, Umoh Andy U, Kane S, et al. Outcomes of abdominal and minimally invasive sacrocolpopexy: a retrospective cohort study. Female Pelvic Med Reconstr Surg. Jan-Feb 2014;20(1):33-37. • Osmundsen BC, Clark A, Goldsmith C, et al. Mesh erosion in robotic sacrocolpopexy. Female Pelvic Med Reconstr Surg. Mar-Apr 2012;18(2):86-88. • Hill AJ, Carroll AW, Matthews CA. Unanticipated uterine pathologic finding after morcellation during robotic-assisted supracervical hysterectomy and cervicosacropexy for uterine prolapse. Female Pelvic Med Reconstr Surg. Mar-Apr 2014;20(2):113-115. • Borahay MA, Oge T, Walsh TM, Patel PR, Rodriguez AM, Kilic GS. Outcomes of robotic sacrocolpopexy using barbed delayed absorbable sutures. J Minim Invasive Gynecol. May-Jun 2014;21(3):412-416. • Culligan PJ, Murphy M, Blackwell L, Hammons G, Graham C, Heit MH. Long-term success of abdominal sacral colpopexy using synthetic mesh. Am J Obstet Gynecol. Dec 2002;187(6):1473-1480; discussion 1481-1472. • Cundiff GW, Varner E, Visco AG, et al. Risk factors for mesh/suture erosion following sacral colpopexy. Am J Obstet Gynecol. Dec 2008;199(6):688 e681-685. • Akyol A, Akca A, Ulker V, et al. Additional surgical risk factors and patient characteristics for mesh erosion after abdominal sacrocolpopexy. J Obstet Gynaecol Res. May 2014;40(5):1368-1374. • Bensinger G, Lind L, Lesser M, Guess M, Winkler HA. Abdominal sacral suspensions: analysis of complications using permanent mesh. Am J Obstet Gynecol. Dec 2005;193(6):2094-2098. • Stepanian AA, Miklos JR, Moore RD, Mattox TF. Risk of mesh extrusion and other mesh-related complications after laparoscopic sacral colpopexy with or without concurrent laparoscopic-assisted vaginal hysterectomy: experience of 402 patients. J Minim Invasive Gynecol. Mar- Apr 2008;15(2):188-196. • Brizzolara S, Pillai-Allen A. Risk of mesh erosion with sacral colpopexy and concurrent hysterectomy. Obstet Gynecol. Aug 2003;102(2):306- 310. • Nosti PA, Lowman JK, Zollinger TW, Hale DS, Woodman PJ. Risk of mesh erosion after abdominal sacral colpoperineopexy with concomitant hysterectomy. Am J Obstet Gynecol. Nov 2009;201(5):541 e541-544. • Shepherd JP, Higdon HL, 3rd, Stanford EJ, Mattox TF. Effect of suture selection on the rate of suture or mesh erosion and surgery failure in abdominal sacrocolpopexy. Female Pelvic Med Reconstr Surg. Jul 2010;16(4):229-233. • Marinkovic SP. Will hysterectomy at the time of sacrocolpopexy increase the rate of polypropylene mesh erosion? Int Urogynecol J Pelvic Floor Dysfunct. Feb 2008;19(2):199-203.
Page 41 Disclosure Pearls for sacral colpopexy ‐ Techniques for sacrum exposure Grants/Research: American Medical Systems and securing the mesh. Speakers Bureau: Allergan, American Medical Systems, Bard Medical Division, Intuitive Surgical
Matthew H Clark MD Hoag Hospital Newport Beach, CA
Objectives Anatomy Pearls
Learn the Anatomy • Bones Review the Timing • Lumbar Disc Teach Technique • Vessels Talk about Tying – Large: IVC‐Aorta to the common iliac – Small: Middle Sacral • Ureter • Sigmoid Colon
Anatomy Pearls Anatomy Pearls
• Video vs. Live demo of anatomy of sacrum
Page 42 Technique Pearls Technique Pearls
• Find the correct place to start the dissection • Video Vs Live demo of Depth sounding and – Avoid the sigmoid colon mesentery posterior dissection – 30 down scope if steep sacrum – Depth sound – Look up then down – Look lateral then in
Technique Pearls Technique Pearls
• Dissection • Cadaveric Live Demonstration – Pick up and cut and spread – Pick up fat, vessels don’t usually follow – Expose the promontory first – Move down the sacrum – Cauterize middle sacral vessels – Stuff a raytec if needed to dry up mild oozing
Timing Pearls Tying Pearls
• Timing • Suture – Always look first to see if possible – Permanent braided vs. monofilament – IF patient is having a subtotal hysterectomy – 90 degrees, then skim the bone, then turn up sacrum is my last space dissected – Loop vessels – If patient has post op hysterectomy prolapse then • Placement sacrum is the first space dissected – Anterior longitudinal ligament – Two separate sutures if both are solid, Three if needed – Sacral body one and two
Page 43 Tying Pearls Tying Pearls
• Video of Pulley Suture vs. Live Cadaveric • Tying Demonstration – Slip knot or pulley stitch – Pull up on the tail or push up the prolapse
• Tensioning – Check below – 1‐2 cm draw.
Challenges
• History of – Diverticular Disease – Sigmoid resection – Rectopexy – Lumbosacral fusion • Obese • Low riding great vessels
Page 44 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 California Language Spoken at Home Language Spoken at Home
Spanish English Spanish
Indo-Euro English Indo-Euro Asian Other 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.
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