ABLAZIONE ABLAZIONE ENDOMETRIALEENDOMETRIALE

Massimo Luerti

U.O. di Ostetricia Ginecologia 1

A.O. della Provincia di Lodi

massimo.luerti@ao.lodi.it

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