Transcript Referring M.D. Talk
ABLAZIONE ENDOMETRIALE
Massimo Luerti
Unità Operativa di
U.O. di Ostetricia Ginecologia 1 A.O. della Provincia di Lodi
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 età tra i 5 % 20 ed i delle donne in 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
UNSUCCESSFUL
COMPLIANCE
SURGICAL
CONSERVATIVE
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 O’Connor N°patients 525 Follow-up 5 yrs Therapeutic success Amenorrhea 79% 40% Browne Res Res & roller Res, roller & Lps diathermy Vilos 238 470 219 800 Yin 163 12 months 12 months 6-18 months 78% 87% 95% 93% 90% 47% 50% 70% 60 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 ETA’ < 44 a
RISULTATI (106 casi)
SUCCESSI n. % 28 70 INSUCCESSI n. % 12 30 44 – 49 > 49 b a 23 31 69.7
93.9
10 2 30.3
6.1
a-b: P < 0.01
RESEZIONE ENDOMETRIALE ISTOLOGIA IPERPLASIA ADENOMIOSI FIBROSI IPO-ATROFIA
RISULTATI
CASI n.
40 14 12 40 SUCCESSI n. % 30 75 11 7 34 78.6
58.3
85 INSUCCESSI n. % 10 25 3 5 6 21.4
41.7
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 (88.6) 22 (91.6) 18 (90) 9 (81.8) Cases with DUB plus Endometrial polyps or Myomas n. 28 % 21 (75) 18 (78.2) 12 (75) 7 (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
Complication Hemorrhage Laser cases 1793 20 (1.17) Resection cases 3776 Resection & fundal rollerball cases 4291 Rollerball alone cases 650 129 (3.53) 99 (2.57) 6 (0.97) Perforation CV/Respiratory 11 (0.65) 8 (0.47) Visceral burn 0 Additional emergency procedures † 6 (0.34)‚‡ 88 (2.47) 20 (0.5) 3 (0.08) 52 (1.29) 22 (0.54) 3 (0.07) 4 (0.64) 3 (0.48) 0 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 II° 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 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 rate
learning curve
PROFONDITA’ COAGULAZIONE MASSIMA TEMPERATURA SIEROSA PERIUTERINA
37.7°C THERMA CHOICE 5.3 mm (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)
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
C
ommission d’
E
valuation des
P
roduits et
P
restations 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 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 Veldholven, The Netherlands St. Josephs Hospital Almeno, The Netherlands Twenteborg Hospital
Lodi, Italy
Belfast, N. Ireland Belfast, N. Ireland
Ospedale di Lodi
Belfast City Hospital Altnagelvin Area Hospital Oslo, Norway Jesmond, U.K.
Wiltshire, U.K.
Aker University Hospital Queen Elizabeth Hospital Princess Margaret Hospital
UBT Success Per International Site
120% 100% 80% 60% 40% 20% 0%
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 months n=269(%)
39 (15)
At 6 months n=291(%)
40 (14)
At 12 months n=163(%)
25 (15)
At last follow up n=296(%)
40 (14)
Spotting Hypomenorrheoa Eumenorrhoea
44 (16) 74 (28) 79 (29) 39 (13) 102 (35) 84 (29) 27 (17) 50 (31) 41 (25) 39 (13) 101 (34) 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 Failure
GnRH agonist Anteverted uterus 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
40% 35% 30% 25% 20% 15% 10% 5% 0%
Results for Thermablate EAS (N=48 without GnRH)
Amenorrhea Spotting Hypomenorrhea Eumenorrhea Menorrhagia 6 months 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 Follow-up Decreased Method (months) flow Amenorrhea Amso Meyer Sodestrom Thijssen Hodgson Rutheford Goldrath 296 128 43 1280 43 15 177 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.
–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. Copperman Ramey Horowitz Margolis Baggish 56 39 64 52 Adenomat. hyper. Cistic hyperplasia Atypic End. Hyper. 58 Atypic adenom. Hyperpl. Adenomat. hyper. Klein Iqbal 52 53 Prolifer. endometrium Normal Colafranceschi 39 51,68 Prolifer. Endometrium Simple Hyperplasia End. Resection Coagulation Coagulation Coagulation Coagulation Coagulation Coagulation End. resection End. resection At resection 5 years 5 months 14 months 30 months 6 months At end. ablation 36 months 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 evaluations.
atypical hyperplasia were discovered that were missed by preoperative 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):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