Complications of TVT

1
Complications of TVT

• Nader Gad
• MBChB, MChGO, FRCOG, FRANZCOG
• Consultant Senior Lecturer in OG
• Royal Darwin Hospital-Darwin-Australia

2
Mid-Urethral Slings

• Replaced Burch Colposuspension as
• The most frequently performed procedures for
• Treatment of Female SUI

3
Cure/Dry Rates of Most Common Procedures for SUI
PROCEDURE CURE / DRY RATES
Burch 73 at 48 months
Autologus Facial Sling 82 at 48 months
Cadaveric Slings 80 at 24 47 months
Synthetic slings at Bladder Neck 73 at 24 47 months
Synthetic slings at mid-Urethra 84 at 48 months
Collage injection 48 at 12 -23 months 32 at 24 47 months
4
Sling Related ComplicationsComprehensive Review
of 13,700 Patients. Edward et al. J minimally
Invasive Surgery. 2008 15132
Complication No of studies Patients No
Voiding Dysfunction 8 881 16.3
Detrusor overactivity 20 1950 15.4
Urinary retention 13 1200 14.4
Pain 6 597 7.3
Erosion/Extrusion 16 2197 6.0
Infections 19 1487 5.5
Dyspareunia 2 175 4.3
Injury 10 1816 3.3
haematoma 4 3691 2.0
13, 737 8.2
5
USA Federal Drug Administration Manufacturer
User Facility Device Experience Database
(MAUDE)Self-reported in gt  90,000 TVT Procedures
Worldwide
Complication Number
Small Bowel 5
Large Bowel 5
Death due to Bowel Injury 2 of large bowel injury were unrecognised at time of surgery led to sepsis Death 2
Unspecified 1
Urethral Erosion 6
Urethro-Vaginal Fistula 2
Erosion into Bladder 5
Vascular Injury Obturator/External iliac/Femoral/Inferior epigastric 22

6
TVT Related ComplicationsComparison of 3
Different Countries (Finland / Austria / France)
Finnish Nationwide Analysis (1,455) Austrian Registry (2,795) French Survey (12,280)
Bladder Perforation 3.8 2.7 7.34
Urinary Retention 2.3 NP 6.6
Haematoma (Retro-pubic or Vulvo-vaginal) 1.9 0.7 0.3
Vaginal Defect Healing 0.7 NP 0.2
7
Overall Risks of TVT Large Series (38 Hospitals)
Complication Complication
Voiding Difficulty Rsidual gt 100 ml 48 hrs 4 months 7.5 Blood loss gt 200 ml 1.9
Complete Urinary Retention 6 hrs 6 months 2.3 Retropubic Haematoma 1.9
UTI 4.1 Major Vascular Injury 0.1
Bladder Perforation 3.8 Obturator Nerve Injury 0.1
Vesico-vaginal fistula 0.1 Complication requiring Laparotomy 0.3
Data in Kuuva et al. Neurolo Urodyn 2000 19 394 Data in Kuuva et al. Neurolo Urodyn 2000 19 394 Data in Kuuva et al. Neurolo Urodyn 2000 19 394 Data in Kuuva et al. Neurolo Urodyn 2000 19 394 Data in Kuuva et al. Neurolo Urodyn 2000 19 394
8
TVT Most Common Complications

• Intra-operative bladder puncture
• Post-operative voiding difficulty

9
TVT Most Common Long Term ComplicationsNilsson
et al. Obstet Gynecol. 2004 1041259

• Recurrent UTI 7.5
• De Novo DI 6.3
• Asymptomatic POP 7.8

10
Intra-Operative Bladder Perforation

• Mainly with TVT Rare with TVT-O
• Does not cause serious consequences
• Does not affect cure rate

11
Incidence of Bladder Injury in TVT

• Incidence 1 15
• Average 5
• Incidence is related to experience
• By Single Experienced Surgeon 0.8
• In multicentre studies 15

12
Incidence of Bladder Injury in TVT

• When By Residents
• Bladder perforation rate 34
• Diagnosis missed during cystoscopy 37
• Success rate
• lt 20 procedures 74
• gt 20 Procedures 83

13
Bladder Urethral Injury

• More common
• Patient left side when right handed surgeon
• On Side opposite Surgeons dominant hand
• Repeat Procedures
• Concomitant Vaginal Surgery

14
Management of Bladder Injury

• Recognition of injury by Cystoscopy
• Withdrawal
• Repositioning slightly more Lateral
• Bladder Drainage 1-3 days

15
Avoidance of Bladder Injury

• Empty bladder before dissection insertion on
  each side
• Use Bladder Catheter Obturator 45 Degree
• Finger guidance
• Keep TVT needle in a plane
• from Mid-Labia Majora toward
• Ipsi-lateral Shoulder while
• maintaining position directly behind Pubic Bone
• Consider TOT in high risk women (Incidence lt 1)

16
Urethral Injury

• If/When it happens
• Tape Placement is contraindicated for 6 weeks
  for adequate healing

17
Avoidance of Urethral Injury

• Place a catheter
• Infiltrating Ant Vag Wall with LA or N-saline
• Sharp dissection
• Stay superficial to peri-urethral fascia

18
Bleeding

• During
• Vaginal dissection
• Perforation of retropubic space
• Needle further passage
• Injury to external iliac / femoral vessels can
  have serious consequences

19
Bleeding in Retro-pubic Space

• Can be difficult to manage
• Digital pressure for few minutes
• Close vaginal wall
• Pack vagina for several hours
• Persistent heavy bleeding may require
  Trans-Abdominal to access the retro-pubic space

20
Injury to External Iliac/Femoral Vessels

• Sudden rapid bleeding during needle passage
• Caused by
• Exaggerated flexion of the thighs
• Excessive lateral passage of needle

21
Haematoma Symptomatic

• Retro-pubic/Vaginal Haematoma 1 5
• Conservative management
• Rest
• Observation
• Antibiotics
• Blood transfusion
• Exploration Evacuation may be necessary

22
Mesh Extrusion Erosion

• TVT Vs Autologus Slings is associated with
• Quicker recovery
• Shorter operating time
• Shorter hospital stay
• Lower rate of urinary retention
• BUT Mesh Extrusion Erosion is 10 15 times
  more likely to occur

23
Vaginal Extrusion / Urethral Erosion

• Monofilament Woven Polypropylene slings 1
• Gor-Tex, Dacron, silicone 4 30

24
Factors Contribute to Vaginal Extrusion /
Urethral Erosion

• Operative Technique
• Too close to urethra
• Inadequate vaginal tissue coverage
• Poor Vascularity
• Infection haematoma predisposes to infection

25
Factors Contribute to Vaginal Extrusion /
Urethral Erosion

• Size of implant
• Properties of material pore size, stiffness,
  elasticity
• Pores Diameter gt 80 um, permit passage of
  macrophages tissue in growth (? Infection ?
  Integration)
• Extrusion Erosion is rare in TVT/SPARC

26
Urethral Erosion

• Recurrent UTI
• Complete removal of Synthetic sling
• Urethral defect should be closed over a catheter
• Peri-urethral fascia should be approximated
• If Repair is under tension placement of labial
  fat graft
• Inspect for any bladder erosion
• Catheter should remain for 2 weeks
• Post-operative incontinence 44-83

27
Bladder Erosion

• Dysuria
• Bleeding
• Urgency
• Complete removal of synthetic sling
• It may require partial cystectomy

28
Voiding Dysfunction

• Most common Post-Operative complication following
  anti-incontinence surgery
• Incidence 2.8 14

29
Causes

• Inadequate Detrusor Contraction
• Excessive Tension under Urethra
• UDA may be used for Differentiation

30
Management of High Residual Urine

• Timed voiding
• Double voiding
• Change Position during Voiding
• Supra-pubic pressure during voiding
• Consider UDA
• Drugs
• Alpha blockers retentive symptoms/problem
• Anti-muscarinics initiative symptoms/problem

31
Management of High Residual/Urinary Retention

• Intermittent self catheterisation
• Indwelling Foley catheter remove every 3-4 days
  trial of voiding
• Loosen the tape
• Dilator
• Foley Catheter

32
How to Loosen Tape

• Problem persist for gt 2 days
• Office procedure room
• Lithotomy position
• Lignocaine (2 Gel) into Urethra
• Wait 5 min
• Dilator gently but firmly pulled straight down
• Foley catheter Balloon

33
Urinary Retention

• Need of Catheterisation gt 1 week
• 4-8 following sling surgery
• Risk increases with
• Age
• Parity
• Concomitant Vaginal Surgery
• Low Flow
• Low Voiding Pressure

34
Urinary Retention

• If Outflow Obstruction, Identify
• Over-suspension Hyper-suspension of Urethra
• Obstructing Large Cystocele Posteriorly
• Properly placed sling does not produce
  obstruction
• No quantitative measure of proper sling tension
  is universally used
• No ideal method of tensioning has been agreed on

35
Urinary Retention

• Conservative with CIC
• ? Alpha-Adrenergic Blockers
• UDA to demonstrate outlet obstruction is not
  necessary
• Sling incision /or Urethrolysis should be
  offered regardless of presence or absence of
  adequate detrusor contractility

36
Problem Persists for 2 months

• Divide the Tape
• Lignocaine 1 adrenaline 1200,000 under
  mid-urethra and laterally
• Lateral 2 cm cut (8 or 4 oclock) relative to EUM
• Tape is a firm structure lateral to mid-urethra
• Cut it with Metzenbaum scissors

37
Urethrolysis when Problem Persists 1-3 months

• Relieve tension with 50 continence rate
• (1.9 of 1175)
• Laurikainen et al. Int Urogynecol J Pelvic Floor
  Dysfunct 2006 17111
• Another Study 61 remained continent
• (0.6 of 9040)
• Rardin et al. Obstet Gynecol 2002 100898

38
Effect of Delaying Urethrolysis Leng et al. J
Urology. 2004 1721379

• 21 patients had Urethrolysis after 2-66 months
• Average follow up of 17 months
• Association between prolonged time to
  Urethrolysis and more likelihood of persistent
  bladder dysfunction after Urethrolysis

39
Rare BUTSerious Complications
40
Death Due To TVT (1999-2005)

• 8 Deaths
• 2/32 due to Vascular Injury (6)
• 6/33 due to Bowel injury (18)
• TVT-O only one reported death due to sepsis

41
Complication Presentation Source
Small Bowel Perforation 56 yrs, Previous TAH BSO, TVT under epidural 3 Hours after TVT Acute Lower Abd pain Only abnormal findings tender RIF increasing WCC 5 Hours from TVT laparoscopy for persistent severe pain Trans-fixation of loop of ileum Tape cut Stitches to both sides of ileal loop Discharged day 5 At 6 12 months patient is dry Meschia et al. Int Urogyn J 2002 13 263 Italy
42
Complication Presentation Source
Small Bowel Perforation 73 yrs, Previous TAH BSO. TVT during POP repair Discharged home day 2, Day 3 re-admitted nausea, vomiting Abd distension, bowel contents from TVT exit site Free air under diaphragm on X-Ray Laparotomy, tape perforated small bowel through through Tape cut entirely removed 3 cms of small bowel was resected 1ry anastomosis was performed PFE helped her incontinence Huffaker et al. Int Urogynecol J. 2010 21 251 USA
43
Complication Presentation Source
Small Bowel Obstruction 73 yrs Vag Hyst TVT GA Day 3 Low grade temp mild abdominal distension Day 5 persistence of LGT Elevated WCC CT scan severe intestinal distension Laparotomy Massive bowel distension Perforation of Mesentery by TVT No bowel perforation Tape was cut ileum freed Normal recovery Follow up no incontinence Leboeuf L et al. Urology. 200463 1182 USA
44
Complication Presentation Source
Delayed Small Bowel Obstruction 51 yrs, had uneventful TVT 3 Years later presented with small bowel obstruction Laparotomy Tape violating peritoneum and Causing distal ileum to adhere to pelvic side wall Compromised bowel was resected primary anastomosis performed Phillips et al. Int Urogynecol J. 2009 20 367 Canada
45
Complication Presentation Source
Trans-Urethral Penetration 45 yrs, Uneventful TVT, Normal Cystoscopy On removal of Catheter 3rd day urinary retention Supra-pubic catheter urinary retention continued Suburethral Tape division after 3 weeks retention continued 2nd attempt of Tape division One week later for 2weeks managed to pass urine but high residual of 200mls Complete retention returned suprapubic catheter 2 months Urethral dilation passed urine with about 70 ml residual Koeble et al. BJOG. 2001 108763 Germany
46
Complication Presentation Source
Trans-Urethral Penetration One year later severe urgency, dysuria, nocturia, pelvic pain Cystoscopy tape passing through upper 3rd of urethra (from 5 7 oclock) Failure to remove by cystoscopy Colpotomy impossible to remove due to excessive fibrosis Tape divide embedded ends of tape were removed from urethral wall Urethra closed with 4/0 polyglactin single knot sutures Catheter for 10 days, No post-operative complications Complete emptying of Bladder, continent Koeble et al. BJOG. 2001 108763 Germany
47
Complication Presentation Source
Uretreral injury 2 ureteral injury in French Survey of immediate Complications of TVT Limited details were available in only one injury One week following TVT Ureteral fistula with pelvic cellulites Required surgical treatment May be due to Too Medial Deep passage of needle Agostini et al. Eur j Obstet Gynecol Reprod Biol. 2006124 237 France
Necrotizing Fasciitis Uneventful TVT in 62 yrs old 11 days post surgery presented to ED severe lower abd pain, elbow pain, Fever, drainage from suprapubic exit sites Diagnosis of Necrotizing Fasciitis Johnson et al. Int Urogyn J. 2003 14291 USA
48
Complication Presentation Source
Severe Haemorrhage Uneventful TVT in 59 yrs with minimal blood loss Postoperatively Growing suprapubic mass Hb declining down to 8.4 then 5.2 Conservative approach with blood transfusion Growing and more painful Suprapubic mass Laparotomy 19 hours after TVT Large clots in space of Retzius (1,500 gm) Tape was easily removed Only source of active bleeding was some oozing in area where Tape enters space of Retzius from under the urethra These places were sutured Drain inserted 10 units of blood in total Discharged on 9th day after laparotomy with still palpable mildly painful suprapubic swelling 4 months after surgery SUI was similar to before surgery Vierhout ME. Int Urogyn J 2001 12 139 Netherlands
49
Complication Presentation Source
External Iliac Artery Laceration 41yrs old undergoing TVT under LA Sedation When attempt was made to insert Trochar on Rt side, patient experienced considerable discomfort Analgesia adjusted 2nd attempt still in discomfort During 3rd attempt to pass trochar patient flexed her abdominal ms Lifted her buttocks of the operating table As patient relaxes, trochar was passed through ant abd wall Brisk bleeding was observed from the right abd trochar exit site Bleeding was controlled by application of pressure by assistant Cystoscopy intact bladder Left side was uneventful Anaesthetist noted drop of BP, corrected by IV fluids Zilbert et al. Int Urogyn J. 200112 141 Canada
50
Complication Presentation Source
External Iliac Artery Laceration Patient continued to bleed from right side more uncomfortable Exploration of Rt abd incision, under GA, down to level of Fascia Figure-of-8 suture appeared to stop bleeding It was noted that when drapes were removed patient unable to move her Rt leg BP at start 110/70 at the end 90/60 Patient transfered to recovery Pre-operative Hb 12.7 gm, in recovery down to 2.4 gm Within next 20 min patient unstable BP 64/32, no pulse in in RT leg Zilbert et al. Int Urogyn J. 200112 141 Canada
51
Complication Presentation Source
External Iliac Artery Laceration Return to theatre exploration of Rt side abd incision Puncture of Rt ext iliac artery Attempt to oversew the injury by Vascular Surgeon was unsuccessful Resection anastomosis of artery was successful The tape on Rt side was cut 6 units of blood FFP 48 hours in ICU 2 weeks in hospital 5 months FU Intermittent claudication Rt leg Inguinal hernia Persistent Urinary Incontinence Zilbert et al. Int Urogyn J. 200112 141 Canada
52
How to Avoid Complications in TVTMuir et al.
Obstet Gynecol 2003 101933

• Empty Bladder
• Insert Bladder Catheter Obturator angled at 45
  degree
• TVT needle must be directed in close proximity to
  Posterior surface of Pubic bone
• Do not deviate lateral to Pelvic side wall
• Major vessels lie as close as 0.9 cm from Needle
  insertion site

53
How to Avoid Complications in TVTMuir et al.
Obstet Gynecol 2003 101933

• If Needle tip is TOO Cephalad to Pubic Bone ?
  injury to
• Bladder
• Bowel
• Blood Vessel
• Keep TVT needle in a plane from
• Mid-Labia Majora toward
• Ipsi-lateral Shoulder while
• maintaining position directly behind Pubic Bone

54
How to Avoid Complications

• Use 70 Degree Cystoscope
• Tape must be placed with no tension
  Tension-Free
• Hyper-elevation
• Voiding dysfunction
• Urinary retention
• De Novo DI
• Urethral Erosion
• Gap approximately 0.5 cm between Tape Urethra
• My advice based on my own experience is Cough
  Test in Theatre