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Miss Michelle Fynes MB BAO BCH (Hons) MRCOG DU DipUs MD (Research)
Consultant Subspecialist Urogynaecologist
Department of Reconstructive Pelvic Surgery
& Urogynaecology
St George’s Hospital and
Honorary Senior Lecturer St. Georges University of London
Presented to: RCOG Urogynaecology Surgical Masterclass 2012
Anterior Compartment Prolapse:
Biological Grafts
Introduction
 Assessment and management of anterior
vaginal wall defects presents a unique
surgical challenge
 It is the most common site of initial
prolapse in women and the most common
site of recurrence
Background
 POP surgery undertaken in 11% of women
 Surgical POP rates will increase with aging
population
 Anterior vaginal wall is both the most common
site of POP (81% of surgical repairs)
 Cystocele repair fails most frequently (up to
41%) Olsen AL. Obstet Gynecol. 1997;89:501–506.
Jelovsek JE. Lancet. 2007;369:1027–1038.
He. USA 2005 special studies 65+ www.census.gov.
Benson JT. Am J Obstet Gynecol. 1996;175:1418–1421.
Nguyen JN. Obstet Gynecol. 2008;111:891–898.
Nguyen JK. Obstet Gynecol Surv. 2001;56:239–246.
Maher C. IUJ 2006;17:195–201.
Cystocele
 Analysis of “Well women” population
 For women who entered the WHI protocol
without cystocele. At some point during the
study the following type of POP was diagnosed:
 1 in 4 Cystocele
 1 in 6 Rectocele
 1 in 100 Uterine prolapse
Hendrix SL, Clark A, Nygaard I, et al.
POP in the Women's Health Initiative: gravity and gravidity.
Am J Obstet Gynecol. 2002;186:1160–1166.
What’s wrong with anterior
vaginal wall support?
 Is the anterior compartment not as well supported by
the levator plate countering the effects of gravity &
abdominal pressure as for the posterior
compartment?
 Are the attachments of the anterior compartment to
the pelvic sidewall or to the apex weaker?
 Is the anterior wall more elastic or less dense when
compared with the posterior wall?
 Is the anterior wall more susceptible to damage during
childbirth or weakening with aging or loss of
oestrogen?
George White
(1866-1926)
 On reviewing the failure of
anterior repair:
The reason for failure seems to be that the normal
support of the bladder has not been sought for and
restored, but instead an irrational removal of part
of the anterior vaginal wall has been resorted to,
which could only result in disappointment and
failure.
Objectives
 The anatomy of anterior vaginal wall support
 Patho-anatomy of Cystocele
 Classification and types of Cystocele
 Institute appropriate surgical repair techniques
 Identify those with high risk of failure based on patho-
anatomy
For successful surgical
intervention in women with
Cystocele we need to
understand:
Anatomy Anterior
Compartment Support
Illustration From Article by Brincat et al 2010
Trapezoidal support Anterior Vaginal Compartment
Anatomy Anterior Compartment
Support
 Anterior vaginal wall resembles a
trapezoidal plane because of the ventral
and more medial attachments near the
pubic symphysis and dorsal and more
lateral attachments near the ischial spine
 The trapezoidal anterior wall is suspended
both sides to the parietal fascia overlying
the levator ani muscles at the arcus
tendineus fascia pelvis (ATFP)
Cystocele: Midline Defect
 Damage to pubocervical fascia
 Fascia stretches and weakens
 Bladder sinks into the middle of the upper
vaginal wall
Cystocele: Lateral Defect
 Detachment of fascia from arcus tendineus
 Fascia tears away from their attachments to
the sidewalls of the pelvis
Clinical Presentation
FIGURE A. A transverse defect
with loss of the anterior fornix.
FIGURE B. A cephalad defect
with loss of apical attachment
at the level of the ischial spine.
Surgical Intervention -
Midline Defect
 Disappointing results with
“standard” vaginal repair
 Recurrence rates vary with
definition of failure: Weber et al
2001 (56%) & Sand et al
2001(43%)
 Mesh kits: commercial success
but significant concerns
regarding mesh erosion,
dyspareunia and other adverse
events
Anterior Vaginal Wall Fascial Plication
Biological Grafts?
“Arcus to Arcus” Graft
Suture Placement:
“6-Point Suspension”
/ /
Paravaginal
Defect Repair
Fascial Reconstruction
Repairing Enterocele
Central Defect
Covered
Level I
Support
Restored
Apical
Suspension:
Comparing
Devices
Posterior IVS
Apogee
Prolift
Capio
• Cut suture in 2 to get 2 throws
• Remember needle tip
Placement of Capio Sutures
Xenform™ Tissue Repair Matrix
Fetal Bovine Dermis
Biological Grafts and Cystocele Repair
Advantages
 Avoid erosion
 Minimise wound healing
issues
 Improved sexual function
Disadvantages
 Cost
 Anchoring technique
 Longevity of graft
 Host versus graft
interaction
 Outcome data
Clinical History
 53 yrs Para 3
 Referred with recurrent
cystocele in 2009
 Symptoms
 Vaginal bulge &
discomfort worse at
the end of the day
 Urgency & occasional
UI but no SUI
 No voiding difficulties
 Past surgery
Vaginal Hysterectomy &
Pelvic Floor Repair
(1980)
Posterior repair &
sacrospinous fixation
(2006)
 Examination
Grade 2 cystocele,
Grade 1-2 vault prolapse,
Grade 1 low rectocele
High perineum
Operative Procedures
 Anterior colporrhaphy incorporating Arcus to Arcus
attachment with Xenoform
 Sacro-spinous ligament pudendal nerve block
 Low rectocele repair with revision of perineum
Arcus Anchored Acellular Dermal Graft Compared to Anterior
Colporrhaphy for Stage II Cystoceles and Beyond
Aim: Compare acellular dermal matrix to standard colporrhaphy for repair cystoceles.
Methods: 102 patients with > Stage II anterior prolapse (Aa or Ba 0) underwent anterior
colporrhaphy with acellular dermal implant attached to arcus, between 10/2003 and
02/2007 were compared to 89 controls who received standard anterior colporrhaphy.
Objective recurrence was defined as > Stage II (Aa or Ba -1).
Results: The dermal graft and colporrhaphy groups were comparable in age, parity, BMI
and concomitant surgeries except hysteropexy and hysterectomy. Regression was
performed for possible confounders. Postoperatively, 14 (19%) recurrences were identified
in the dermal graft group vs. 26 (43%) in the colporrhaphy group (p=0.004). Two patients
underwent reoperations for cystocele recurrence in the study group versus four in the
control group. Time to normal voiding, subjective stress urinary incontinence, EBL and
length of hospital stay did not differ between groups.
Conclusion: Dermal acellular matrix provides benefit over standard colporrhaphy.
S Botros, P Sand, J Beaumont, Y Abramov, JJ Miller, RP Goldberg
IJPFD 2009
Table 1: Concomitant Surgeries
Arcus Graft
(n=102)
Controls
(n=89) p-value
Hysterectomy 37 (36%) 60 (67%) <0.001
Hysteropexy 33 (32%) 9 (10%) <0.001
Apical suspensions 0.004
McCall’s 6 (6%) 40 (45%)
Uterosacral 26 (25%) 5 (6%)
Iliococcygeous 7 (7%) 6 (7%)
Sacrospinous vault 17 (17%) 16 (19%)
Compartment Repair - Posterior 88 (86%) 79 (89%) 0.61
Compartment Repair - Anterior 102 (100%) 89 (100%) --
Incontinence Operation - TVT 10 (10%) 13 (15%) 0.31
Incontinence Operation - TOT 42 (41%) 34 (38%) 0.68
S Botros, P Sand, J Beaumont, Y Abramov, JJ Miller, RP Goldberg
IJPFD 2009
Table 2: Postoperative Outcomes
Arcus Graft
(n=72)
Controls
(n=61) p-value
N (%) N (%)
Anterior recurrence (Aa or Ba to -1) 14(19%) 26 (43%) 0.004
Anterior recurrence (Aa or Ba to 0) 7 (10%) 14 (23%) 0.04
Anterior recurrence (Aa or Ba past 0) 3 (4%) 2 (3%) 1.0
Posterior recurrence (Ap or Bp to -1) 9 (13%) 4 (7%) 0.25
Posterior recurrence (Ap or Bp to 0) 4 (6%) 3 (5%) 1.0
Apical recurrence (c or d to -1) 6 (8%) 6 (10%) 0.69
Postoperative UUI1 26 (41%) 11 (22%) 0.04
Postoperative SUI1 14 (22%) 5 (10%) 0.10
Postoperative dyspareunia1 (n=21 missing) 7 (14%) 8 (19%) 0.49
Mean (SD) Mean (SD)
Estimated Blood loss (mls) (n=11 missing) 246 (161) 288 (182) 0.10
Median (range) Median (range)
Length of Hospital stay (days) (n = 3 missing) 1 (0– 11) 1 (1 – 4) 0.24
1n=64 arcus graft and 50 controls with subjective follow-up
S Botros, P Sand, J Beaumont, Y Abramov, JJ Miller, RP Goldberg
IJPFD 2009
Efficacy and safety of using mesh or grafts in surgery for anterior and/or
posterior vaginal wall prolapse: systematic review and meta-analysis.
Jia X, Glazener C, Mowatt G, MacLennan G, Bain C, Fraser C, Burr J.
Health Services Research Unit, University of Aberdeen
OBJECTIVES: To systematically review the efficacy and safety of mesh/graft for anterior or posterior
vaginal wall prolapse surgery.
SELECTION CRITERIA: Randomised controlled trials (RCTs), nonrandomised comparative studies,
registries, case series involving at least 50 women, and RCTs published as conference abstracts from 2005
onwards.
ANALYSIS: 3 groups: anterior, posterior, anterior +/- posterior repair (not reported separately).
RESULTS: 49 studies (N=4569) mesh/graft POP repair. Median follow up 13 months (R 1-51) For Anterior
repair, short-term evidence that mesh/graft (any type) significantly reduced objective prolapse recurrence
rates compared with no mesh/graft (relative risk 0.48, 95% CI 0.32-0.72).
BJOG 2008
GRAFTS PROLAPSE
RECURRENCE
EROSION RATE
Non-absorbable synthetic
(8.8%, 48/548)
Non-absorbable
(10.2%, 68/666)
Absorbable synthetic
(23.1%, 63/273)
Absorbable synthetic
(0.7%, 1/147)
Biological graft
(17.9%, 186/1041)
Biological graft
(6.0%, 35/581).
CONCLUSIONS:
Evidence for most outcomes was too
sparse to provide meaningful
conclusions.
Rigorous long-term RCTs are required
to determine the comparative efficacy
of using mesh/graft.
Conclusions
 Arcus to Arcus and SSF with Acellular
Cadaveric Graft repair for ≥Stage 2
Cystocele versus standard ultra-lateral
anterior vaginal repair is associated with a
56% reduction in cystocele recurrences and
46% reduction in recurrence to hymenal ring
at a mean follow-up of 15 months
 Lack of specific complications and objective
reduction in prolapse requires further
evaluation
Role of fascial plication with
augmentation using biological graft?
Anterior Compartment Prolapse: Biological Grafts

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Anterior Compartment Prolapse: Biological Grafts

  • 1. Miss Michelle Fynes MB BAO BCH (Hons) MRCOG DU DipUs MD (Research) Consultant Subspecialist Urogynaecologist Department of Reconstructive Pelvic Surgery & Urogynaecology St George’s Hospital and Honorary Senior Lecturer St. Georges University of London Presented to: RCOG Urogynaecology Surgical Masterclass 2012 Anterior Compartment Prolapse: Biological Grafts
  • 2. Introduction  Assessment and management of anterior vaginal wall defects presents a unique surgical challenge  It is the most common site of initial prolapse in women and the most common site of recurrence
  • 3. Background  POP surgery undertaken in 11% of women  Surgical POP rates will increase with aging population  Anterior vaginal wall is both the most common site of POP (81% of surgical repairs)  Cystocele repair fails most frequently (up to 41%) Olsen AL. Obstet Gynecol. 1997;89:501–506. Jelovsek JE. Lancet. 2007;369:1027–1038. He. USA 2005 special studies 65+ www.census.gov. Benson JT. Am J Obstet Gynecol. 1996;175:1418–1421. Nguyen JN. Obstet Gynecol. 2008;111:891–898. Nguyen JK. Obstet Gynecol Surv. 2001;56:239–246. Maher C. IUJ 2006;17:195–201.
  • 4. Cystocele  Analysis of “Well women” population  For women who entered the WHI protocol without cystocele. At some point during the study the following type of POP was diagnosed:  1 in 4 Cystocele  1 in 6 Rectocele  1 in 100 Uterine prolapse Hendrix SL, Clark A, Nygaard I, et al. POP in the Women's Health Initiative: gravity and gravidity. Am J Obstet Gynecol. 2002;186:1160–1166.
  • 5. What’s wrong with anterior vaginal wall support?  Is the anterior compartment not as well supported by the levator plate countering the effects of gravity & abdominal pressure as for the posterior compartment?  Are the attachments of the anterior compartment to the pelvic sidewall or to the apex weaker?  Is the anterior wall more elastic or less dense when compared with the posterior wall?  Is the anterior wall more susceptible to damage during childbirth or weakening with aging or loss of oestrogen?
  • 6. George White (1866-1926)  On reviewing the failure of anterior repair: The reason for failure seems to be that the normal support of the bladder has not been sought for and restored, but instead an irrational removal of part of the anterior vaginal wall has been resorted to, which could only result in disappointment and failure.
  • 7. Objectives  The anatomy of anterior vaginal wall support  Patho-anatomy of Cystocele  Classification and types of Cystocele  Institute appropriate surgical repair techniques  Identify those with high risk of failure based on patho- anatomy For successful surgical intervention in women with Cystocele we need to understand:
  • 8. Anatomy Anterior Compartment Support Illustration From Article by Brincat et al 2010 Trapezoidal support Anterior Vaginal Compartment
  • 9. Anatomy Anterior Compartment Support  Anterior vaginal wall resembles a trapezoidal plane because of the ventral and more medial attachments near the pubic symphysis and dorsal and more lateral attachments near the ischial spine  The trapezoidal anterior wall is suspended both sides to the parietal fascia overlying the levator ani muscles at the arcus tendineus fascia pelvis (ATFP)
  • 10. Cystocele: Midline Defect  Damage to pubocervical fascia  Fascia stretches and weakens  Bladder sinks into the middle of the upper vaginal wall
  • 11. Cystocele: Lateral Defect  Detachment of fascia from arcus tendineus  Fascia tears away from their attachments to the sidewalls of the pelvis
  • 12. Clinical Presentation FIGURE A. A transverse defect with loss of the anterior fornix. FIGURE B. A cephalad defect with loss of apical attachment at the level of the ischial spine.
  • 13.
  • 14. Surgical Intervention - Midline Defect  Disappointing results with “standard” vaginal repair  Recurrence rates vary with definition of failure: Weber et al 2001 (56%) & Sand et al 2001(43%)  Mesh kits: commercial success but significant concerns regarding mesh erosion, dyspareunia and other adverse events Anterior Vaginal Wall Fascial Plication
  • 16. “Arcus to Arcus” Graft Suture Placement: “6-Point Suspension” / / Paravaginal Defect Repair Fascial Reconstruction Repairing Enterocele Central Defect Covered Level I Support Restored
  • 18. • Cut suture in 2 to get 2 throws • Remember needle tip
  • 20. Xenform™ Tissue Repair Matrix Fetal Bovine Dermis
  • 21. Biological Grafts and Cystocele Repair Advantages  Avoid erosion  Minimise wound healing issues  Improved sexual function Disadvantages  Cost  Anchoring technique  Longevity of graft  Host versus graft interaction  Outcome data
  • 22. Clinical History  53 yrs Para 3  Referred with recurrent cystocele in 2009  Symptoms  Vaginal bulge & discomfort worse at the end of the day  Urgency & occasional UI but no SUI  No voiding difficulties  Past surgery Vaginal Hysterectomy & Pelvic Floor Repair (1980) Posterior repair & sacrospinous fixation (2006)  Examination Grade 2 cystocele, Grade 1-2 vault prolapse, Grade 1 low rectocele High perineum
  • 23. Operative Procedures  Anterior colporrhaphy incorporating Arcus to Arcus attachment with Xenoform  Sacro-spinous ligament pudendal nerve block  Low rectocele repair with revision of perineum
  • 24.
  • 25. Arcus Anchored Acellular Dermal Graft Compared to Anterior Colporrhaphy for Stage II Cystoceles and Beyond Aim: Compare acellular dermal matrix to standard colporrhaphy for repair cystoceles. Methods: 102 patients with > Stage II anterior prolapse (Aa or Ba 0) underwent anterior colporrhaphy with acellular dermal implant attached to arcus, between 10/2003 and 02/2007 were compared to 89 controls who received standard anterior colporrhaphy. Objective recurrence was defined as > Stage II (Aa or Ba -1). Results: The dermal graft and colporrhaphy groups were comparable in age, parity, BMI and concomitant surgeries except hysteropexy and hysterectomy. Regression was performed for possible confounders. Postoperatively, 14 (19%) recurrences were identified in the dermal graft group vs. 26 (43%) in the colporrhaphy group (p=0.004). Two patients underwent reoperations for cystocele recurrence in the study group versus four in the control group. Time to normal voiding, subjective stress urinary incontinence, EBL and length of hospital stay did not differ between groups. Conclusion: Dermal acellular matrix provides benefit over standard colporrhaphy. S Botros, P Sand, J Beaumont, Y Abramov, JJ Miller, RP Goldberg IJPFD 2009
  • 26. Table 1: Concomitant Surgeries Arcus Graft (n=102) Controls (n=89) p-value Hysterectomy 37 (36%) 60 (67%) <0.001 Hysteropexy 33 (32%) 9 (10%) <0.001 Apical suspensions 0.004 McCall’s 6 (6%) 40 (45%) Uterosacral 26 (25%) 5 (6%) Iliococcygeous 7 (7%) 6 (7%) Sacrospinous vault 17 (17%) 16 (19%) Compartment Repair - Posterior 88 (86%) 79 (89%) 0.61 Compartment Repair - Anterior 102 (100%) 89 (100%) -- Incontinence Operation - TVT 10 (10%) 13 (15%) 0.31 Incontinence Operation - TOT 42 (41%) 34 (38%) 0.68 S Botros, P Sand, J Beaumont, Y Abramov, JJ Miller, RP Goldberg IJPFD 2009
  • 27. Table 2: Postoperative Outcomes Arcus Graft (n=72) Controls (n=61) p-value N (%) N (%) Anterior recurrence (Aa or Ba to -1) 14(19%) 26 (43%) 0.004 Anterior recurrence (Aa or Ba to 0) 7 (10%) 14 (23%) 0.04 Anterior recurrence (Aa or Ba past 0) 3 (4%) 2 (3%) 1.0 Posterior recurrence (Ap or Bp to -1) 9 (13%) 4 (7%) 0.25 Posterior recurrence (Ap or Bp to 0) 4 (6%) 3 (5%) 1.0 Apical recurrence (c or d to -1) 6 (8%) 6 (10%) 0.69 Postoperative UUI1 26 (41%) 11 (22%) 0.04 Postoperative SUI1 14 (22%) 5 (10%) 0.10 Postoperative dyspareunia1 (n=21 missing) 7 (14%) 8 (19%) 0.49 Mean (SD) Mean (SD) Estimated Blood loss (mls) (n=11 missing) 246 (161) 288 (182) 0.10 Median (range) Median (range) Length of Hospital stay (days) (n = 3 missing) 1 (0– 11) 1 (1 – 4) 0.24 1n=64 arcus graft and 50 controls with subjective follow-up S Botros, P Sand, J Beaumont, Y Abramov, JJ Miller, RP Goldberg IJPFD 2009
  • 28. Efficacy and safety of using mesh or grafts in surgery for anterior and/or posterior vaginal wall prolapse: systematic review and meta-analysis. Jia X, Glazener C, Mowatt G, MacLennan G, Bain C, Fraser C, Burr J. Health Services Research Unit, University of Aberdeen OBJECTIVES: To systematically review the efficacy and safety of mesh/graft for anterior or posterior vaginal wall prolapse surgery. SELECTION CRITERIA: Randomised controlled trials (RCTs), nonrandomised comparative studies, registries, case series involving at least 50 women, and RCTs published as conference abstracts from 2005 onwards. ANALYSIS: 3 groups: anterior, posterior, anterior +/- posterior repair (not reported separately). RESULTS: 49 studies (N=4569) mesh/graft POP repair. Median follow up 13 months (R 1-51) For Anterior repair, short-term evidence that mesh/graft (any type) significantly reduced objective prolapse recurrence rates compared with no mesh/graft (relative risk 0.48, 95% CI 0.32-0.72). BJOG 2008 GRAFTS PROLAPSE RECURRENCE EROSION RATE Non-absorbable synthetic (8.8%, 48/548) Non-absorbable (10.2%, 68/666) Absorbable synthetic (23.1%, 63/273) Absorbable synthetic (0.7%, 1/147) Biological graft (17.9%, 186/1041) Biological graft (6.0%, 35/581). CONCLUSIONS: Evidence for most outcomes was too sparse to provide meaningful conclusions. Rigorous long-term RCTs are required to determine the comparative efficacy of using mesh/graft.
  • 29. Conclusions  Arcus to Arcus and SSF with Acellular Cadaveric Graft repair for ≥Stage 2 Cystocele versus standard ultra-lateral anterior vaginal repair is associated with a 56% reduction in cystocele recurrences and 46% reduction in recurrence to hymenal ring at a mean follow-up of 15 months  Lack of specific complications and objective reduction in prolapse requires further evaluation
  • 30. Role of fascial plication with augmentation using biological graft?