ABLAZIONE
ENDOMETRIALE
Massimo Luerti
Unità Operativa di
OSTETRICIA E
GINECOLOGIA 1
U.O. di Ostetricia Ginecologia 1
A.O. della Provincia di Lodi
[email protected]
L’obiettivo dell’ablazione
dell’endometrio (proposta per la
prima volta nel 1937 da
Bardenhauer) è quello di
distruggere lo strato basale
dell’endometrio ed il sottostante
supporto vascolare
INDICAZIONI ALL’ABLAZIONE
ENDOMETRIALE

menorragia resistente alla terapia medica

rifiuto o controindicazioni della terapia medica

alto rischio operatorio

rifiuto dell’isterectomia

complemento alla miomectomia isteroscopica

sanguinamento anomalo in corso di HRT

metrorragia a rischio per la vita resistente alla terapia
medica in adolescente
ABLAZIONE ENDOMETRIALE
Ogni anno il 5 % delle donne in
età tra i 20 ed i 39 anni si
rivolge al proprio ginecologo
per menorragia
L’incidenza è del 30%
In età perimenopausale raggiunge il 70%
Abbott J. et al., Fer. Ster. 80,1,2003:203-208
Savona, 29 marzo 2008
Certe condizioni cliniche come una severa obesità,
malattie cardiovascolari, nefropatie croniche,
epatopatie croniche e coagulopatie, che sono
spesso associate con un aumentato sanguinamento
uterino, comportano un alto rischio chirurgico
ENDOMETRIAL ABLATION
ABNORMAL UTERINE BLEEBING
DIAGNOSIS
 Hysteroscopy
 Endometrial biopsy
cause
 DISFUNCTIONAL (70-80%)
 ORGANIC
ENDOMETRIAL ABLATION
DISFUNCTIONAL UTERINE BLEEDING
What suggest to women?
THERAPY
MEDICAL
 INTOLERANCE
 CONTRAINDICATIONS
SURGICAL
 UNSUCCESSFUL
 CONSERVATIVE
  COMPLIANCE
 HYSTERECTOMY
ABLAZIONE ENDOMETRIALE
CRITERI DI ESCLUSIONE





Lesioni uterine precancerose - maligne
Adenomiosi profonda e diffusa
Lunghezza dell’utero ( < 12 cm )
Miomatosi uterina
Desiderio di prole
CONDIZIONI NECESSARIE
- non desiderio di gravidanza
- biopsia endometriale negativa
TECNICHE I° GENERAZIONE DI
ABLAZIONE ENDOMETRIALE
Elettroresezione ad alta frequenza
con elettrodo
ad ansa
a pallina rotante
a barra rotante
vaporizzatore
Nd-YAG laser
a contatto
non a contatto
ROLLER BALL ABLATION
L’attivazione del passaggio di corrente deve avvenire solo
quando la pallina è a contatto con l’endometrio e la pallina
va tenuta in movimento fino a quando è attivata se non si
vuole rischiare di produrre una necrosi eccessiva con
rischio di perforazione.
da: CD ROM Manuale di Chirurgia Resettoscopica
a cura di Ivan Mazzon
PREPARAZIONE DELL’ENDOMETRIO

GnRH agonisti per 1 o 2 mesi

Danazolo

Fase immediatamente post-mestruale

Aspirazione o curettage meccanico
preoperatorio

Estroprogestinici

Minipillola
ESITO DEL TRATTAMENTO
Most gynecologists consider normal menstrual
bleeding a successful therapeutic treatment
outcome.
SUCCESS
Symptoms: Heavy
Bleeding
Normal
Menses
Reduced
Menses
Spotting No Bleeding
Clinical
Conditions: Menorrhagia Eumenorrhea Hypomenorrhea
Amenorrhea
ENDOMETRIAL RESECTION
N°patients
Follow-up
Therapeutic success
Amenorrhea
525
5 yrs
79%
40%
78%
87%
95%
47%
50%
70%
O’Connor
Browne
Res
Res & roller
Res, roller &
Lps diathermy
12 months
238
470
219
Vilos
800
12 months
93%
60
Yin
163
6-18 months
90%
18%
RESEZIONE ENDOMETRIALE
IL SUCCESSO A 5 ANNI E’ DELL’80 %
Entro 5 anni dal trattamento circa il 15% delle donne è
sottoposta ad una seconda ablazione ed il 20% ha
un’isterectomia.
(M.C. Sowter. Lancet 2003)
Follow up 4 -10 years : Hysterectomy 16.6%
Boe Engelsen, Acta Ob-Gyn Scand, 2006
RESEZIONE ENDOMETRIALE
RISULTATI (106 casi)
ETA’
SUCCESSI
INSUCCESSI
n.
%
n.
%
< 44a
28
70
12
30
44 – 49a
23
69.7
10
30.3
> 49b
31
93.9
2
6.1
a-b: P < 0.01
RESEZIONE ENDOMETRIALE
RISULTATI
ISTOLOGIA
CASI
SUCCESSI
INSUCCESSI
n.
n.
%
n.
%
IPERPLASIA
40
30
75
10
25
ADENOMIOSI
14
11
78.6
3
21.4
FIBROSI
12
7
58.3
5
41.7
IPO-ATROFIA
40
34
85
6
15
ENDOMETRIAL ABLATION
Long term results of Endometrial Resection
Length of
Follow-up
(yrs)
5
6
7
8
Cases with DUB only
n. 27 %
24
22
18
9
(88.6)
(91.6)
(90)
(81.8)
Cases with DUB plus
Endometrial polyps
or Myomas
n. 28 %
21
18
12
7
(75)
(78.2)
(75)
(77.7)
Comino R. et al., AAGL 9,3,2002:268-271
CONSIDERAZIONI PER LE CANDIDATE
ALL’ABLAZIONE ENDOMETRIALE
Migliori
risultati nelle donne con
BMI > 30
Il
dolore pelvico non migliora
Le
donne più giovani hanno
maggiori probabilità di recidiva
F. Loffer, 1996
ISTEROSCOPIA 2008
KAPLAN-MEIER CURVES FOR INTERVENTION-FREE SURVIVAL AFTER
HYSTEROSCOPIC POLYPECTOMY
D.D.C.A. Henriquez. 2007
ABLAZIONE ENDOMETRIALE
E MIOMECTOMIA
L’ablazione
endometriale migliora il risultato
dopo miomectomia isteroscopica
La
rimozione completa del mioma migliora il
risultato
L’ablazione
endometriale non migliora il risultato
dopo miomectomia parziale
77,5%
delle pazienti dopo miomectomia parziale
non hanno ulteriori problemi di sanguinamento
F. Loffer, 1996
IMPROVING RESULTS OF HYSTEROSCOPIC SUBMUCOSAL
MYOMECTOMY FOR MENORRHAGIA BY CONCOMITANT
ENDOMETRIAL ABLATION
D. Loffer, 2005
SVANTAGGI DELLE TECNICHE DI I°
GENERAZIONE DI ABLAZIONE
ENDOMETRIALE
alto
costo
alto
livello di esperienza operativa isteroscopica
uso di sorgenti di energia potenzialmente
pericolose
anestesia
generale o sedazione
sala operatoria attrezzata
alto rischio operatorio e anestesiologico in pazienti
spesso contemporaneamente affette da gravi malattie
sistemiche (insufficienza epatica, insufficienza renale,
coagulopatie, LES, emopatie, AIDS, cardiopatie)
COMPLICANZE INTRAOPERATORIE-POSTOPERATORIE
DELL’ABLAZIONE ENDOMETRIALE CON
ELETTRORESETTORE

Variano dal 7 % al 9%.

Stretta dipendenza tra l’esperienza del
chirurgo e l’indice terapeutico del
metodo.
(O’Connor H, Magos A. N Engl J Med 1996; 335: 151-156)
(Overton C, Maresh MJA. Clin Obstet Gynaecol 1995; 9: 357-371)
COMPLICATIONS OF HYSTEROSCOPY: A PROSPECTIVE, MULTICENTER
STUDY
Frank Willem Jansen, Obstet Gynecol, 2000
13,600 isteroscopie
Procedura
Lisi di sinechie
Ablazione endometriale
Miomectomia
Polipectomia
Complicanze (%)
4.48
0.81
0.75
0.38
A NATIONAL SURVEY OF THE COMPLICATIONS OF ENDOMETRIAL
DESTRUCTION FOR MENSTRUAL DISORDERS:
THE MISTLETOE STUDY
Laser
Resection
cases 3776
Resection &
fundal rollerball
cases 4291
Rollerball
alone
cases 650
Complication
cases 1793
Hemorrhage
20 (1.17)
129 (3.53)
99 (2.57)
6 (0.97)
Perforation
11 (0.65)
88 (2.47)
52 (1.29)
4 (0.64)
CV/Respiratory
8 (0.47)
20 (0.5)
22 (0.54)
3 (0.48)
0
3 (0.08)
3 (0.07)
0
Additional
emergency procedures † 6 (0.34)‚‡
69 (2.39)
50 (1.36)
6 (1.11)
Total
229 (6.4)
171 (4.2)
13 (2.1)
Visceral burn
46 (2.7)*
* P < 0.01, laser, rollerball, vs. resection and resection & rollerball
† P < 0.01, laser vs. resection and resection & rollerball
‡ Includes hysterectomy, laparoscopy, laparotomy end cervical tears requiring repair
British Journal of Obstetrics and Gynaecology, December 1997,Vol. 104,pp. 1351-1359
BIPOLAR ELECTROSURGERY
La corrente non passa attraverso il corpo della
paziente
Ridotto rischio lesioni iatrogene termiche
Ridotto rischio di intravasazione
Buona emostasi con scarsa o assente distruzione di
tessuto
TECNICHE DI ABLAZIONE ENDOMETRIALE
I° GENERAZIONE
Elettroresezione ad alta
frequenza
con elettrodo monopolare
ad ansa
a pallina rotante
a barra rotante
vaporizzatore
Nd-YAG laser
a contatto
non a contatto
II° GENERAZIONE
Elettroresezione bipolare
Radio-frequenza
Crioterapia
Microonde
Polielettrodi (VESTA)
Diodinio laser ablazione
(ELITT)
Ablazione bipolare globale
(NOVASURE)
Tecniche a balloon
Idrotermoablazione
Second generation ablation techniques
 operation
skill
 complication
 learning
rate
curve
PROFONDITA’ MASSIMA TEMPERATURA
COAGULAZIONE SIEROSA PERIUTERINA
THERMA CHOICE
CAVATERM
HTA
5.3 mm
(range 3.3-10 mm)
37.7°C
6-7 mm
37°C
4.3 mm
36.28°C
(range 2.4 mm – 5.1 mm) (range 28°C – 45°C)
THERMACHOICE
Sistema per ablazione termica con palloncino
consistente di:
Unità di controllo
Cavo di collegamento tra unità controllo e
dispositivo intrauterino
Catetere a palloncino monouso
More than 10 years of clinical experience
Une évaluation positive (ASR II) de la Commission
d’Evaluation des Produits et Prestations en février 2002
Conclusions of Cochrane review « Endometrial
destruction techniques for heavy menstrual
bleeding », 2007

Endometrial ablation techniques continue to play an important role in
the management of heavy menstrual bleeding

The rapid development of new methods of endometrial destruction has
made systematic comparisons between these methods and with the « gold
standard » of resection

Most of the newer techniques are technically easier and quicker than
hysteroscopy and can be performed under local anesthesia

Succes and satisfaction rates are similar and 2nd generation became the
new « GOLD STANDARD »
What’s New?
A new conforming non-latex balloon combined with circulation
leads to improved coverage and treatment of the endometrial
cavity*
• Treats even closer to the extremes of the
cavity than THERMACHOICE 1
• Allows for more even necrosis of tissue throughout the
entire cavity through better treatment of Posterior, Lower
Uterine Segment, and Cornua
T.J. Clark
Fertil Steril
2004;82,1395
CAVATERM
Catetere con palloncino in silicone che
necessita di una dilatazione del collo
dell’utero fino a Hegar 8 o 9;
Durata della procedura 15 min;
Temperatura del liquido 75°C;
Pressione all’interno del palloncino tra
200 mmhg e 220 mmhg;
Controindicazione per pazienti con uteri
inferiori a 4 cm e superiori a 10 cm.
Uterine thermal balloon therapy for the treatment of menorrhagia:
the first 300 patients from a multi-centre study
NN Amso, SA Stabinsky, P McFaul, B Blanc, L Pendley, R Neuwirth
On behalf of the International Collaborative Uterine Thermal Balloon Working Group
British Journal of Obstetrics and Gynaecology 1998;105:517-523
Monika Schaffer, M.D.
Peter J. Maher, M.D.
Claude Fortin, M.D.
George Vilos, M.D.
Barry Sanders, M.D.
Bernard Blanc, M.D.
Gilles Body, M.D.
Dominique Dallay, M.D.
Hervé Fernandez, M.D.
H.A.M. Brölmann, M.D.
D. van der Heijden, M.D.
Massimo Luerti, M.D.
Peter McFaul, M.D.
Michael Parker, M.D.
Bjorn Busund, M.D.
Nazar Amso, M.D.
John Cullimore, M.D.
Graz, Austria
Melbourne, Australia
Montreal, Canada
London, Canada
Vancouver, Canada
Marseille, France
Tours, France
Bordeaux, France
Clamart, France
Veldholven, The Netherlands
Almeno, The Netherlands
Lodi, Italy
Belfast, N. Ireland
Belfast, N. Ireland
Oslo, Norway
Jesmond, U.K.
Wiltshire, U.K.
University of Graz
University of Melbourn
Chateguay Hospital
University of Western Ontario
University of British Columbia
Hopitaux de Marseille
Hopitaux de Tours
Hopitaux de Bordeaux
Hospital Beclere
St. Josephs Hospital
Twenteborg Hospital
Ospedale di Lodi
Belfast City Hospital
Altnagelvin Area Hospital
Aker University Hospital
Queen Elizabeth Hospital
Princess Margaret Hospital
UBT Success Per International Site
120%
100%
80%
60%
40%
20%
0%
Cullimore
Amso
Maher
Parker
McFaul
Busund
Brolmann
Luert i
Fernandez
Blanc
Vilos
Sanders
Fort in
n=260; >150 mmHg Start Pressure; 8 min. treatment
Post Operative Bleeding Patterns
After Uterine Thermal Balloon Therapy
N.N. Amso, 1998, Br J Obstet Gynaecol 105,517-523
Menstrual pattern
Amenorrhoea
At 3
At 6
At 12
At last
months
months
months
follow up
n=269(%) n=291(%) n=163(%) n=296(%)
39 (15)
40 (14)
25 (15)
40 (14)
Spotting
44 (16)
39 (13)
27 (17)
39 (13)
Hypomenorrheoa
74 (28)
102 (35)
50 (31)
101 (34)
Eumenorrhoea
79 (29)
84 (29)
41 (25)
84 (28)
Failure
33 (12)
26 (9)
20 (12)
32 (11)
Logistic regression analysis of factors affecting
odds of success after thermal balloon therapy
Odds increased
Success
Last available follow up
GnRH agonist
Anteverted uterus
Failure
Sharp curettage
Suction curettage
Larger cavity volumes
Greater levels of pre-op bleeding
SAFETY MEASURES OF ENDOMETRIAL
ABLATION USING BALLOON
A decrease or increase of intrauterine pressure of
temperature automatically shut the system down and
immediately stop the heating and circulating of fluid

Automatic
disposition of time of thermic exposition of
endometrium

No accidental balloon ruptures are described
International Multi-Center Study
Safety and Complications (392 cases )
 No intra-operative or major complications
 Ten minor post-op complications (2.6 %):
 3 hematometra (resolved with cervical dilatation)
 5 fever resolved with antibiotics
 1 overnight hospitalization for pain
 1 post-operative cystitis
 Further treatment for current protocol
 Hysterectomies 6%
 Repeat ablations 4%
THERMABLATE™ EAS™: MAIN FEATURES

a new Endometrial delivery system which is:
– LAST GENERATION HIGH CONFORM
BALLOON
– 105° C CONTACT TEMPERATURE
– QUICK TREATMENT ( 128 SEC.)
– PULSED TREATMENT (PAIN REDUCED)
– CLOSED SINGLE USE CIRCUIT
– PORTABLE (suited for ambulatory)
CLINICAL DATA
Results for Thermablate EAS (N=48 without GnRH)
40%
35%
30%
25%
20%
15%
10%
5%
0%
Amenorrhea
Spotting
Hypomenorrhea
6 months
Eumenorrhea
Menorrhagia
12 months
N. Leyland SOGC Edmonton June 2004 presentation
HYDROTERMOABLATOR®
CAMICIA DELL’ISTEROSCOPIO
•Controllo diretto della procedura sotto visione
•7.8mm (23.5 Fr) O.D.
•Policarbonato isolato
•Accetta isteroscopi < 3mm
HTA - UNITA’ DI CONTROLLO
•Tecnologia molto semplice (un riscaldatore di
fluido)
•Tecnica molto semplice
•Anestesia spinale o locale
•Procedura ambulatoriale
•La normale soluzione fisiologica e’ inviata
riscaldata (90°C) sottogravita’ con recircolazione
endouterina (250 ml/min)
•Il liquido non passa oltre le tube (SI INFONDE A
MENO DI 50mm/Hg)
•Il sistema monitorizza l’invio di fluido durante la
procedura ed automaticamente si spegne, se
viene captata una perdita di flusso > 10 ml.
AMENORRHEA RATE AFTER 1 YEAR
Her
-
CONCLUSION OF COCHRANE REVIEW “ENDOMETRIAL DESTRUCTION
TECHNIQUES FOR HEAVY MENSTRUAL BLEEDING”, 2007

Endometrial ablation techniques continue to play an important
role in the management of heavy menstrual bleeding

The rapid development of new methods of endometrial
destruction has made systematic comparison between these
methods and the “gold standard” of resection

Most of the newer techniques are technically easier and
quicker than hysteroscopy and can be performed under
local anesthesia

Success and satisfaction rates are similar and 2nd
generation became the new “GOLD STANDARD”
STUDIES OF THERMAL ENDOMETRIAL AND
CRYOENDOMETRIAL ABLATION
Study
Cases
Amso
Meyer
Sodestrom
Thijssen
Hodgson
Rutheford
Goldrath
296
128
43
1280
43
15
177
Follow-up Decreased
Method (months)
flow Amenorrhea
TH
TH
BAL
RF
MIC
CR
HTA
12
12
3-6
6-58
>36
3-22
53
88%
80%
89%
77%
86%
?
92%
14%
15%
40%
19%
37%
67%
53%
BAL=Thermalballoon ablation; MIC= Microwave; CR = Cryotherapy;
RF= Radiofrequency; HTA=Hydro ThermAblator™, TH=Thermachoice™
Complications Associated With Global Endometrial Ablation: The Utility of the MAUDE Database
Shawn E. Gurtcheff, MD, and Howard T. Sharp, MD, Obstet Gynecol 2003;, 102:1278–82
 First,
previous cesarean delivery: One
serious complication occurred in a patient
with a prior cesarean delivery. Because the
hysterotomy repair site is thin in some cases,
patients with a prior history of cesarean
delivery might not be appropriate for these
devices.
 Second, prophylactic antibiotics: Due to the
infections reported and the significant
subsequent morbidity, prophylactic
antibiotics might be useful when these
Complications Associated With Global Endometrial Ablation: The Utility of the MAUDE Database
techniques
are
used.
Shawn E. Gurtcheff,
MD, and
Howard T. Sharp, MD, Obstet Gynecol 2003;, 102:1278–82
FACTORS AFFECTING ODDS OF SUCCESS IN
THERMAL ABLATION
 Definition of success
 Endometrial preparation
 Patient age
 Lenght of follow up
 Intrauterine pressure
 Uterine distension
 Fluid temperature
 Time of exposure
 Shape of cavity
 Cavity volume
 Uterine position
 Level of pre-procedure bleeding
 Placement of sheath tip (for HTA)
COMPLICANZE DELL’ABLAZIONE ENDOMETRIALE
POSTABLATION TUBAL STERILIZATION SYNDROME
Nelle pazienti con pregressa occlusione tubarica un’ostruzione
bassa della cavità uterina può portare ad una mestruazione
retrograda all’interno del segmento tubarico prossimale
residuo e causare dolore uni o bilaterale severo
HYSTERECTOMY AFTER ENDOMETRIAL
ABLATION-RESECTION
(R. Comino. J Am Assoc Gynecol Laparosc 2004,11(4):495-499
With
long-term follow-up (more than 5 years),
almost one in every five women undergoing EA-R
will undergo hysterectomy, and most of these will
require the hysterectomy within 2 years of the EA-R.
The
existence of uterine myomas has been related to
a greater possibility of the need for subsequent
hysterectomy
ENDOMETRIAL CARCINOMA AFTER ENDOMETRIAL
ABLATION
Author
Age
Preop. biopsy
End. Abl. method
Interval
Dwyer
38
Secr. endometr.
End. Resection
At resection
Copperman
56
Adenomat. hyper.
Coagulation
5 years
Ramey
39
Cistic hyperplasia
Coagulation
5 months
Horowitz
64
Atypic End. Hyper.
Coagulation
14 months
Margolis
58
Atypic adenom. Hyperpl.
Coagulation
30 months
Baggish
52
Adenomat. hyper.
Coagulation
6 months
Klein
52
Prolifer. endometrium
Coagulation
At end. ablation
Iqbal
53
Normal
End. resection
36 months
Colafranceschi
39
51,68
Prolifer. Endometrium
Simple Hyperplasia
End. resection
At end. ablation
RISK OF DISCOVERING ENDOMETRIAL CARCINOMA OR
ATYPICAL HYPERPLASIA DURING HYSTEROSCOPIC
SURGERY IN POSTMENOPAUSAL WOMEN
Agostini A et al. J Am Assoc Gynecol Laparosc 2001 Nov;8(4):533-535
Two cases each (0.6%) of endometrial carcinoma
and endometrial atypical hyperplasia were
discovered that were missed by preoperative
evaluations.
Outpatient hysteroscopy and endometrial biopsy do
not eliminate the finding of carcinoma or endometrial
atypical hyperplasia, as these disorders may be
discovered during hysteroscopic surgery.
HYSTEROSCOPIC ENDOMYOMETRIAL
RESECTION OF THREE UTERINE SARCOMAS
Vilos GA et al. J Am Assoc Gynecol Laparosc 8(4):545551, 2001
From our experience the incidence of uterine
sarcomas is approximately 1/800 women undergoing
hysteroscopic ablation for abnormal uterine bleeding.
Complete endomyometrial resection is feasible and
may be offered as diagnostic and palliative therapy
in women at high risk for hysterectomy