Transcript Dr Nader Gad - Complications

Complications of TVT
Nader Gad
MBChB, MChGO, FRCOG, FRANZCOG
Consultant & Senior Lecturer in O&G
Royal Darwin Hospital-Darwin-Australia
Mid-Urethral Slings
• Replaced Burch Colposuspension as
• The most frequently performed procedures for
• Treatment of Female SUI
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
Sling Related Complications
Comprehensive Review of 13,700 Patients. Edward et al. J minimally Invasive Surgery. 2008; 15:132
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
USA Federal Drug Administration Manufacturer & User
Facility Device Experience Database (MAUDE)
Self-reported in > 90,000 TVT Procedures Worldwide
Complication
Number
Small Bowel
5
Large Bowel
5
Death due to Bowel Injury
2
2 of large bowel injury were unrecognised at time of
surgery & led to sepsis & Death
Unspecified
1
Urethral Erosion
6
Urethro-Vaginal Fistula
2
Erosion into Bladder
5
Vascular Injury
22
Obturator/External iliac/Femoral/Inferior epigastric
TVT Related Complications
Comparison of 3 Different Countries (Finland / Austria / France)
Finnish Nationwide
Analysis
(1,455)
Austrian Registry
French Survey
(2,795)
(12,280)
% Bladder
Perforation
3.8
2.7
7.34
% Urinary
Retention
2.3
NP
6.6
1.9
0.7
0.3
0.7
NP
0.2
% Haematoma
(Retro-pubic or
Vulvo-vaginal)
Vaginal Defect
Healing
Overall Risks of TVT Large Series
(38 Hospitals)
Complication
Voiding
Difficulty
%
Complication
%
Blood loss > 200 ml
1.9
Retropubic Haematoma
1.9
7.5
Rsidual > 100 ml
48 hrs – 4 months
Complete
Urinary
Retention
2.3%
6 hrs – 6 months
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
TVT Most Common Complications
• Intra-operative bladder puncture
• Post-operative voiding difficulty
TVT Most Common Long Term Complications
Nilsson et al. Obstet Gynecol. 2004; 104:1259
• Recurrent UTI 7.5%
• De Novo DI 6.3%
• Asymptomatic POP 7.8%
Intra-Operative Bladder Perforation
• Mainly with TVT
“Rare with TVT-O”
• Does not cause serious consequences
• Does not affect cure rate
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%
Incidence of Bladder Injury in TVT
•
•
-
When By Residents:
Bladder perforation rate: 34%
Diagnosis missed during cystoscopy: 37%
Success rate:
< 20 procedures: 74%
> 20 Procedures: 83%
Bladder & Urethral Injury
• More common:
• Patient left side when right handed surgeon:
On Side opposite Surgeon’s dominant hand
• Repeat Procedures
• Concomitant Vaginal Surgery
Management of Bladder Injury
• Recognition of injury by Cystoscopy
• Withdrawal
• Repositioning slightly more Lateral
• Bladder Drainage 1-3 days
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 < 1%)
Urethral Injury
• If/When it happens:
Tape Placement is contraindicated for 6 weeks
for adequate healing
Avoidance of Urethral Injury
• Place a catheter
• Infiltrating Ant Vag Wall with LA or N-saline
• Sharp dissection
• Stay superficial to peri-urethral fascia
Bleeding
•
-
During:
Vaginal dissection
Perforation of retropubic space
Needle further passage
• Injury to external iliac / femoral vessels can
have serious consequences
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 TransAbdominal to access the retro-pubic space
Injury to External Iliac/Femoral Vessels
• Sudden rapid bleeding during needle passage
• Caused by:
- Exaggerated flexion of the thighs
- Excessive lateral passage of needle
Haematoma “Symptomatic”
• Retro-pubic/Vaginal Haematoma: 1 – 5%
• Conservative management:
-
Rest
Observation
Antibiotics
Blood transfusion
• Exploration & Evacuation may be necessary
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
Vaginal Extrusion / Urethral Erosion
• Monofilament Woven Polypropylene slings: 1%
• Gor-Tex, Dacron, silicone: 4 – 30%
Factors Contribute to
Vaginal Extrusion / Urethral Erosion
• Operative Technique:
-
Too close to urethra
Inadequate vaginal tissue coverage
• Poor Vascularity
• Infection: haematoma predisposes to infection
Factors Contribute to
Vaginal Extrusion / Urethral Erosion
• Size of implant
• Properties of material: pore size, stiffness, elasticity
• Pores Diameter > 80 um, permit passage of
macrophages & tissue in growth (↓ Infection & ↑
Integration)
• Extrusion & Erosion is rare in TVT/SPARC
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%
Bladder Erosion
•
•
•
•
•
Dysuria
Bleeding
Urgency
Complete removal of synthetic sling
It may require partial cystectomy
Voiding Dysfunction
• Most common Post-Operative complication
following anti-incontinence surgery
• Incidence: 2.8 – 14%
Causes
• Inadequate Detrusor Contraction
• Excessive Tension under Urethra
• UDA may be used for Differentiation
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
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
How to Loosen Tape
•
•
•
•
•
•
Problem persist for > 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
Urinary Retention
• Need of Catheterisation > 1 week:
4-8% following sling surgery
•
-
Risk increases with:
Age
Parity
Concomitant Vaginal Surgery
Low Flow
Low Voiding Pressure
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
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
Problem Persists for 2 months
• Divide the Tape
• Lignocaine 1% + adrenaline 1:200,000 under midurethra and laterally
• Lateral 2 cm cut (8 or 4 o’clock) relative to EUM
• Tape is a firm structure lateral to mid-urethra
• Cut it with Metzenbaum scissors
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; 17:111
• Another Study: 61% remained continent
(0.6% of 9040)
Rardin et al. Obstet Gynecol 2002; 100:898
Effect of Delaying Urethrolysis
Leng et al. J Urology. 2004; 172:1379
• 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
Rare
“BUT”
Serious Complications
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
Complicatio
n
Small Bowel
Perforation
Presentation
•56 yrs, Previous TAH +BSO, TVT under epidural
Source
• 3 Hours after TVT: Acute Lower Abd pain
Meschia et al.
Int Urogyn J
2002; 13: 263
•Only abnormal findings: tender RIF + increasing WCC
Italy
•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
Complication
Small Bowel
Perforation
Presentation
•73 yrs, Previous TAH + BSO. TVT during POP
repair
Source
Huffaker et al.
Int Urogynecol
J. 2010; 21: 251
•Discharged home day 2,
USA
•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
Complication
Small Bowel
Obstruction
Presentation
•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
Source
Leboeuf L et al.
Urology.
2004;63: 1182
USA
Complication
“Delayed”
Small Bowel
Obstruction
Presentation
•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
Source
Phillips et al.
Int Urogynecol
J. 2009; 20: 367
Canada
Complication
TransUrethral
Penetration
Presentation
Source
•45 yrs, Uneventful TVT, Normal Cystoscopy
Koeble et al.
•On removal of Catheter 3rd day: urinary retention
BJOG.
2001;
108:763
•Supra-pubic catheter : urinary retention continued
Germany
•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
Complication
TransUrethral
Penetration
Presentation
•One year later: severe urgency, dysuria, nocturia, pelvic pain
Source
•Cystoscopy: tape passing through upper 3rd of urethra
(from 5 – 7 o’clock)
Koeble et al.
BJOG.
2001;
108:763
•Failure to remove by cystoscopy
Germany
•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
Complication
Uretreral
injury
Presentation
•2 ureteral injury in French Survey of immediate Complications of
TVT
•Limited details were available in only one injury:
Source
Agostini et al.
Eur j Obstet
Gynecol
Reprod Biol.
2006;124: 237
•One week following TVT: Ureteral fistula with pelvic cellulites
France
•Required surgical treatment
•May be due to Too Medial & Deep passage of needle
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; 14:291
USA
Complication
Severe
Haemorrhage
Presentation
•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
Source
Vierhout ME.
Int Urogyn J
2001; 12: 139
Netherlands
Complication
External Iliac
Artery
Laceration
Presentation
•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
Source
Zilbert et al.
Int Urogyn J.
2001;12: 141
Canada
Complication
External Iliac
Artery
Laceration
Presentation
•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
Source
Zilbert et al.
Int Urogyn
J. 2001;12:
141
Canada
Complicatio
n
External
Iliac Artery
Laceration
Presentation
Source
•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
Zilbert et al.
Int Urogyn J.
2001;12: 141
•48 hours in ICU
•2 weeks in hospital
•5 months FU:
-Intermittent claudication Rt leg
-Inguinal hernia
-Persistent Urinary Incontinence
Canada
How to Avoid Complications in TVT
Muir et al. Obstet Gynecol 2003; 101:933
• 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
How to Avoid Complications in TVT
Muir et al. Obstet Gynecol 2003; 101:933
•
-
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
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