ABLAZIONE ENDOMETRIALE Massimo Luerti U.O. di Ostetricia Ginecologia 1 A.O. della Provincia di Lodi...
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Transcript of ABLAZIONE ENDOMETRIALE Massimo Luerti U.O. di Ostetricia Ginecologia 1 A.O. della Provincia di Lodi...
ABLAZIONE ABLAZIONE ENDOMETRIALEENDOMETRIALE
Massimo Luerti
U.O. di Ostetricia Ginecologia 1
A.O. della Provincia di Lodi
Unità Operativa diOSTETRICIA E GINECOLOGIA 1
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
Ogni anno il 5 % delle donne in età tra i 20 ed i 39 anni si
rivolge al proprio ginecologo per menorragia
Abbott J. et al., Fer. Ster. 80,1,2003:203-208
ABLAZIONE ENDOMETRIALE
Savona, 29 marzo 2008
L’incidenza è del 30% In età perimenopausale raggiunge il 70%
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
DIAGNOSIS
ABNORMAL UTERINE BLEEBING
DISFUNCTIONAL (70-80%) ORGANIC
ENDOMETRIAL ABLATION
cause
Hysteroscopy Endometrial biopsy
What suggest to women?
MEDICAL
SURGICAL INTOLERANCE
CONTRAINDICATIONS
UNSUCCESSFUL
COMPLIANCE
CONSERVATIVE
HYSTERECTOMY
ENDOMETRIAL ABLATION
THERAPY
DISFUNCTIONAL UTERINE BLEEDING
CRITERI DI ESCLUSIONE
Lesioni uterine precancerose - maligne
Adenomiosi profonda e diffusa Lunghezza dell’utero ( < 12 cm ) Miomatosi uterina Desiderio di prole
ABLAZIONE ENDOMETRIALE
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
da: CD ROM Manuale di Chirurgia Resettoscopicaa cura di Ivan Mazzon
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.
ROLLER BALL ABLATION
GnRH agonisti per 1 o 2 mesi
Danazolo
Fase immediatamente post-mestruale
Aspirazione o curettage meccanico
preoperatorio
Estroprogestinici
Minipillola
PREPARAZIONE DELL’ENDOMETRIO
ESITO DEL TRATTAMENTO
Symptoms: Heavy Normal ReducedBleeding Menses Menses
ClinicalConditions: Menorrhagia Eumenorrhea Hypomenorrhea Amenorrhea
Most gynecologists consider normal menstrual bleeding a successful therapeutic treatment
outcome. SUCCESS
Spotting No Bleeding
ENDOMETRIAL RESECTION
N°patients Follow-up Therapeutic success Amenorrhea
O’Connor 525 5 yrs 79% 40%
Browne 12 months Res 238 78% 47% Res & roller 470 87% 50% Res, roller & 219 95% 70% Lps diathermy
Vilos 800 12 months 93% 60
Yin 163 6-18 months 90% 18%
Entro 5 anni dal trattamento circa il 15% delle donne è sottoposta ad una seconda ablazione ed il 20% ha un’isterectomia.
RESEZIONE ENDOMETRIALE
IL SUCCESSO A 5 ANNI E’ DELL’80 %
(M.C. Sowter. Lancet 2003)
Follow up 4 -10 years : Hysterectomy 16.6%
Boe Engelsen, Acta Ob-Gyn Scand, 2006
a-b: P < 0.01
RISULTATI (106 casi)
< 44a
44 – 49a
> 49b
n. %ETA’
28
23
31
70
69.7
93.9
n. %
12
10
2
30
30.3
6.1
SUCCESSI INSUCCESSI
RESEZIONE ENDOMETRIALE
RISULTATI
IPERPLASIA
ADENOMIOSI
FIBROSI
IPO-ATROFIA
ISTOLOGIA
40
14
12
40
CASI INSUCCESSI
10
3
5
6
25
21.4
41.7
15
SUCCESSI
30
11
7
34
75
78.6
58.3
85
n. % n. %n.
RESEZIONE ENDOMETRIALE
Long term results of Endometrial Resection
Cases with DUB only
Length of Follow-up (yrs)
Cases with DUB plusEndometrial polypsor Myomas n. 28 %
567
8
24 (88.6) 22 (91.6)
18 (90) 9 (81.8)
21 (75) 18 (78.2)
12 (75) 7 (77.7)
Comino R. et al., AAGL 9,3,2002:268-271
ENDOMETRIAL ABLATION
n. 27 %
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 recidivaF. 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 sanguinamentoF. 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
ENDOMETRIALEalto costo alto livello di esperienza operativa isteroscopica uso di sorgenti di energia potenzialmente
pericoloseanestesia generale o sedazione sala operatoria attrezzataalto 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 Complicanze (%)Lisi di sinechie 4.48
Ablazione endometriale 0.81
Miomectomia 0.75
Polipectomia 0.38
A NATIONAL SURVEY OF THE COMPLICATIONS OF ENDOMETRIALDESTRUCTION FOR MENSTRUAL DISORDERS:
THE MISTLETOE STUDY
Laser Resection Resection & Rollerball fundal rollerball alone
Complication cases 1793 cases 3776 cases 4291 cases 650
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)
Visceral burn 0 3 (0.08) 3 (0.07) 0
Additional emergency procedures † 6 (0.34)‚‡ 69 (2.39) 50 (1.36) 6 (1.11)
Total 46 (2.7)* 229 (6.4) 171 (4.2) 13 (2.1)
* 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 monopolaread ansa
a pallina rotante
a barra rotante
vaporizzatore
Nd-YAG laser
a contatto
non a contatto
II° GENERAZIONE
Elettroresezione bipolareRadio-frequenza CrioterapiaMicroondePolielettrodi (VESTA)Diodinio laser ablazione
(ELITT)Ablazione bipolare globale
(NOVASURE)Tecniche a balloon Idrotermoablazione
Second generation ablation techniques
operation skill
complication rate
learning curve
PROFONDITA’ PROFONDITA’ MASSIMA TEMPERATURA MASSIMA TEMPERATURA COAGULAZIONECOAGULAZIONE SIEROSA PERIUTERINASIEROSA PERIUTERINA
THERMA CHOICE 5.3 mm 37.7°C
(range 3.3-10 mm)
CAVATERM 6-7 mm 37°C
HTA 4.3 mm 36.28°C
(range 2.4 mm – 5.1 mm) (range 28°C – 45°C)
THERMACHOICESistema per ablazione termica con palloncinoconsistente di:
Unità di controlloCavo di collegamento tra unità controllo e dispositivo intrauterinoCatetere 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. ClarkFertil Steril2004;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 NeuwirthOn behalf of the International Collaborative Uterine Thermal Balloon Working Group
British Journal of Obstetrics and Gynaecology 1998;105:517-523
Monika Schaffer, M.D. Graz, Austria University of Graz Peter J. Maher, M.D. Melbourne, Australia University of MelbournClaude Fortin, M.D. Montreal, Canada Chateguay HospitalGeorge Vilos, M.D. London, Canada University of Western
OntarioBarry Sanders, M.D. Vancouver, Canada University of British
ColumbiaBernard Blanc, M.D. Marseille, France Hopitaux de MarseilleGilles Body, M.D. Tours, France Hopitaux de ToursDominique Dallay, M.D. Bordeaux, France Hopitaux de BordeauxHervé Fernandez, M.D. Clamart, France Hospital BeclereH.A.M. Brölmann, M.D. Veldholven, The Netherlands St. Josephs HospitalD. van der Heijden, M.D. Almeno, The Netherlands Twenteborg HospitalMassimo Luerti, M.D. Lodi, Italy Ospedale di LodiPeter McFaul, M.D. Belfast, N. Ireland Belfast City HospitalMichael Parker, M.D. Belfast, N. Ireland Altnagelvin Area HospitalBjorn Busund, M.D. Oslo, Norway Aker University HospitalNazar Amso, M.D. Jesmond, U.K. Queen Elizabeth HospitalJohn Cullimore, M.D. Wiltshire, U.K. Princess Margaret Hospital
UBT Success Per International Site
n=260; >150 mmHg Start Pressure; 8 min. treatment
0%
20%
40%
60%
80%
100%
120%
Fortin
Sanders
Vilos
Blanc
Fernandez
Luerti
Brolmann
Busund
McFaul
Parker
Maher
Am
so
Cullimore
van der Heijden
Post Operative Bleeding Patterns Post Operative Bleeding Patterns After Uterine Thermal Balloon TherapyAfter Uterine Thermal Balloon Therapy
N.N. Amso, 1998, Br J Obstet Gynaecol 105,517-523
Post Operative Bleeding Patterns Post Operative Bleeding Patterns After Uterine Thermal Balloon TherapyAfter Uterine Thermal Balloon Therapy
N.N. Amso, 1998, Br J Obstet Gynaecol 105,517-523
Menstrual pattern At 3months
n=269(%)
At 6months
n=291(%)
At 12months
n=163(%)
At lastfollow upn=296(%)
Amenorrhoea 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)
Menstrual pattern At 3months
n=269(%)
At 6months
n=291(%)
At 12months
n=163(%)
At lastfollow upn=296(%)
Amenorrhoea 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 Last available follow up
Success 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
0%
5%
10%
15%
20%
25%
30%
35%
40%
Amenorrhea Spotting Hypomenorrhea Eumenorrhea Menorrhagia
6 months 12 months
Results for Thermablate EAS (N=48 without GnRH)
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
0% 10% 20% 30% 40% 50% 60% 70%
ELITT Laser
NovaSure RF Mesh
MEA Microwave
HTA Circulating Fluid
Vesta Elect. Balloon
Cavaterm Balloon
First-Option Cryo
Thermachoice Balloon
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
Follow-up DecreasedStudy Cases Method (months) flowAmenorrhea
Amso 296 TH 12 88% 14%Meyer 128 TH 12 80% 15%Sodestrom 43 BAL 3-6 89% 40%Thijssen 1280 RF 6-58 77% 19%Hodgson 43 MIC >36 86% 37%Rutheford 15 CR 3-22 ? 67%Goldrath 177 HTA 53 92% 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
Complications Associated With Global Endometrial Ablation: The Utility of the MAUDE DatabaseShawn 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 techniques are used.
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)
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
COMPLICANZE DELL’ABLAZIONE ENDOMETRIALE
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
SARCOMASVilos GA et al. J Am Assoc Gynecol Laparosc
8(4):545-551, 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