ABLAZIONE ENDOMETRIALE Massimo Luerti U.O. di Ostetricia Ginecologia 1 A.O. della Provincia di Lodi massimo.luerti@ao.lodi.it Unità Operativa di OSTETRICIA 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

Abbott J. et al., Fer. Ster. 80,1,2003:203-208 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

DIAGNOSIS ENDOMETRIAL ABLATION Hysteroscopy Endometrial biopsy cause ABNORMAL UTERINE BLEEBING DIAGNOSIS Hysteroscopy Endometrial biopsy cause DISFUNCTIONAL (70-80%) ORGANIC

ENDOMETRIAL ABLATION THERAPY MEDICAL SURGICAL What suggest to women? 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 Normal Reduced Bleeding Menses Menses Clinical Conditions: Menorrhagia Eumenorrhea Hypomenorrhea Amenorrhea 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%

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) < 44a 44 – 49a > 49b n. % ETA’ 28 23 31 70 69.7 93.9 12 10 2 30 30.3 6.1 SUCCESSI INSUCCESSI a-b: P < 0.01

RESEZIONE ENDOMETRIALE RISULTATI ISTOLOGIA CASI SUCCESSI INSUCCESSI n. n. % n. % IPERPLASIA ADENOMIOSI FIBROSI IPO-ATROFIA 40 14 12 30 11 7 34 75 78.6 58.3 85 10 3 5 6 25 21.4 41.7 15

ENDOMETRIAL ABLATION Long term results of Endometrial Resection 5 6 7 Cases with DUB only Length of Follow-up (yrs) Cases with DUB plus Endometrial polyps or Myomas n. 28 % 5 6 7 8 24 (88.6) 22 (91.6) 18 (90) 9 (81.8) 21 (75) 18 (78.2) 12 (75) 7 (77.7) n. 27 % 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)

13,600 isteroscopie Procedura Complicanze (%) Lisi di sinechie 4.48 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

Laser Resection Resection & Rollerball fundal rollerball alone A NATIONAL SURVEY OF THE COMPLICATIONS OF ENDOMETRIAL DESTRUCTION 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 The GYNECARE VERSAPOINT Bipolar System features a unique bipolar generator with multiple electrode configurations to deliver energy to tissue using normal saline as the distention medium. Utilizing bipolar electrodes especially engineered for gynecologic applications, a range of tissue effects can be achieved with this versatile system: • A dedicated resectoscope offers both Bipolar Loop Resecting and 0° Vaporizing electrode configurations • Three configurations of 5 Fr. Electrodes deliver bipolar energy for precision tissue effects

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 rate learning curve

PROFONDITA’ MASSIMA TEMPERATURA COAGULAZIONE SIEROSA 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)

THERMACHOICE Unità di controllo 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 The balloon’s special qualities allow it to cover more and treat more.

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. Graz, Austria University of Graz Peter J. Maher, M.D. Melbourne, Australia University of Melbourn Claude Fortin, M.D. Montreal, Canada Chateguay Hospital George Vilos, M.D. London, Canada University of Western Ontario Barry Sanders, M.D. Vancouver, Canada University of British Columbia Bernard Blanc, M.D. Marseille, France Hopitaux de Marseille Gilles Body, M.D. Tours, France Hopitaux de Tours Dominique Dallay, M.D. Bordeaux, France Hopitaux de Bordeaux Hervé Fernandez, M.D. Clamart, France Hospital Beclere H.A.M. Brölmann, M.D. Veldholven, The Netherlands St. Josephs Hospital D. van der Heijden, M.D. Almeno, The Netherlands Twenteborg Hospital Massimo Luerti, M.D. Lodi, Italy Ospedale di Lodi Peter McFaul, M.D. Belfast, N. Ireland Belfast City Hospital Michael Parker, M.D. Belfast, N. Ireland Altnagelvin Area Hospital Bjorn Busund, M.D. Oslo, Norway Aker University Hospital Nazar Amso, M.D. Jesmond, U.K. Queen Elizabeth Hospital John Cullimore, M.D. Wiltshire, U.K. Princess Margaret Hospital

UBT Success Per International Site 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

Odds increased Last available follow up Success GnRH agonist 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)

Results for Thermablate EAS (N=48 without GnRH) CLINICAL DATA Results for Thermablate EAS (N=48 without GnRH) N. Leyland SOGC Edmonton June 2004 presentation

CAMICIA DELL’ISTEROSCOPIO 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 Follow-up Decreased Study Cases Method (months) flow Amenorrhea 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

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. 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

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 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 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

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):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