A Safe and Effective Method of Controlling

A Safe and Effective Method of Controlling Abnormal Uterine Bleeding D.E. Townsend for the Endometrial Ablation Study Group* Park City, Utah, U.S.A. * The Cryoablation study Group: C. Coddington, Denver Health Medical Center, Denver, Colorado, U.S.A.; A.J. Duleba, Yale University Medical Center, New Haven, Conneticutt, U.S.A.; M. Heppard, Columbia Rose Medical Center, Denver, Colorado, U.S.A.; P.D. Inman, Private Practice. Los Gatos, California, U.S.A.; B.W. Welsh and K.B Isaacson, Brigham and W
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  A Safe and Effective Method of Controlling Abnormal UterineBleeding D.E. Townsend for the Endometrial Ablation Study Group *Park City, Utah, U.S.A.* The Cryoablation study Group: C. Coddington, Denver Health Medical Center, Denver, Colorado,U.S.A.; A.J. Duleba, Yale University Medical Center, New Haven, Conneticutt, U.S.A.; M. Heppard,Columbia Rose Medical Center, Denver, Colorado, U.S.A.; P.D. Inman, Private Practice. Los Gatos,California, U.S.A.; B.W. Welsh and K.B Isaacson, Brigham and Women’s Hospital and MassachusettsGeneral Hospital, Boston, Massachusetts, U.S.A.; B. Ray Love, Women’s Wellness Center, MontgomeryAlabama, U.S.A.; D. Shoupe, University of Southern California School of Medicine, Los Angeles,California, U.S.A.; R.M. Soderstrom, Swedish Medical Center, Seattle Washington, U.S.A.; D.E.Townsend, Park City, Utah, U.S.A.; J.J. Williams, Scripps Clinic, La Jolla, California, U.S.A.SummaryA prospective randomized study between cryosurgical endometrial ablation and rollerball ablation was performed in over 200 premenopausal women. Preoperative evaluation included endometrial biopsy as wellas pelvic ultrasound. Half of the patients who had cryoablation had light sedation and paracervical block asanesthesia. All patients who had cryoablation had pelvic ultrasound to monitor the progress of the ice-zone.Post operative, mild cramps were noted in less that ¼ of the cryo-treated patients, Significant vaginaldischrge did not occur in any of the cryosurgical treated patients. At 12 months after treatment 44% of thewomen managed by cryosurgery had only amenorrhea or spotting.Four sites that performed over half of the cases had an amenorrhea or spotting rate of 54%. When the firstcryosurgical session was longer that the protocol required 67% had a 90% reduction in their bleeding.The results of this study demonstrate the ease, effectiveness and safety of cryosurgical endometrial ablationin managing women with menomenorrhagia.IntroductionOf the 0ver 600,000 hysterectomies performed in the United States annually, over 1/3 are performed for abnormal uterine bleeding. It is estimated that endometrial ablation for abnormal uterine bleeding is performed in no more that 35,000 to 40,000 cases annually in the United States. A major impediment toendometrial ablation has been the availability of an effective, safe and easily performed technique.Cryosurgical endometrial ablation was first reported in the late 1960s[1] and early 1970s [2]. Nitrous oxidecryosurgical systems, used primarily for treating cervical disease [3], were found to have a 71% satisfactoryoutcome in women with abnormal uterine bleeding [4]. Rutherford [5], using a liquid nitrogen system,achieved an initial amenorrhea rate of 75.5%, which was 50.3% at 6 months.Recently a new cryosurgical unit [Her/Option] was introduced [6]. The coolant or gas used is a propriety blend of commonly used coolants, which are non-toxic, non-corrosive and non-inflammable. A compressor system, which is hermetically sealed, drives the unit. The coolant is re-circulated and replenishment is notnecessary. The operation is based on the Joules-Thompson principal in which pressurized gas is expandedthrough a small orifice to produce coolingFollowing completion of a hysterectomy study [7] which confirmed the effectiveness of the system in producing a significant zone of cryonecrosis, a multi-center study was undertaken to determine theefficiency and safety of endometrial cryoablation in a large group of women who complained of severemenomenorrahagia. The 12-month results are the focus of this paper.Materials and MethodsEleven sites participated in the study. Four sites performed the majority of the cases. At all sites the studywas approved by an IRB. The target enrollment was 222 premenopausal women with a documented historyof menomenorrhagia i.e. PBAC score of at least 150. All had refused or failed traditional medical therapy.Treatment was by either cryoblation or rollerball with a 2:1 randomization.Preoperative evaluation included pelvic ultrasound, endometrial biopsy and blood studies to confirm premenopausal state. Women with a uterine cavity volume over 300 cc, uterine sound over 10cm.and thosethat contained uterine myomas over 2 cm. were excluded from the study. All women received a single doseof a GnRh agonist 3-4 weeks prior to treatment. Cryoablation or rollerball was performed either in a physicican office using sedation or in an operating room employing either sedation and paracervial block or general anesthesia. The cryoablation procedure was carried out as an initial four-minute freeze to one cornufollowed by a six-minute freeze to the opposite cornu. Pelvic ultrasound monitoring during cryoablation 171 Townsend  was performed to confirm the location of the cryoprobe as well as to note the advancement of the cryozone.Study subjects were seen at two weeks, three months, six months and 12 months post treatment. Phoneinterviews annually have continued the follow-up. All patients were required to compile PBAC scores before treatment and at three, six and twelve months after treatment. Patients who failed follow-up or  provide PBAC scores at 12 months were considered treatment failures.ResultsCryoablation onlyThe pre-PBAC scores for Cryo [N=174] were 150-2913; mean 576 and rollerball [N=77] was 155-2030;mean 468. Normal menstrual blood loss is defined as a PBAC score of 75 to 100.The post-PBAC scores for Cryo. [N=156] were 0-517; mean 48 and rollerball [N=72] was 0-460; mean 24.At 12 months the results of cryoblation in 156 women were; amenorrhrea-28%, amenorrhea and spotting-44%, hypomenorrhea-42%, eumenorrhea-3% and menorrhagia-12%.The results in 91 cases that were performed in the top four sites was; amenorrhea-35%, amenorrhea andspotting-53%, hypomenorrhea-41%, eumenorrhea-0 and menorrhagia-7%.In 12 patients the first freeze was 6 minutes followed by a 6 minute second freeze, results; 90%or greater reduction in menstrual flow-67%, 80% reduction-92% and 70% reduction 100%. There were no failures inthis group.Anesthesia employed: conscious sedation with or without paracervical block: 54%, andgeneral anesthesia:46%Side effectsThere were no significant complications i.e. infection, bleeding, etc. except for one perforation thatoccurred during sounding of the uterus. No patient had any significant degree of vaginal discharge. Twentytwo percent of the patients reported mild cramping during the intra-operative and immediate post-operative period. Two percent noted nausea/vomiting following the procedure.Of the patients who noted significant quality of life problems associated with their periods i.e. PMS,dysmenorrhea etc. almost all had resolution of the these symptoms after successful reduction in menstrualflowCommentThe results of the multi-center study indicate that endometrial cryoablation is a safe, effective and easily perfomed technique to control abnormal uterine bleeding. The lack of any significant side effects is particularly gratifying. An unexpected finding was the lack of any significant discharge that followscryosurgery of the uterine cervix. This may inpart is due to the less compact myometrium as well as the plethora of lymphatics within the myometrium, which allows the fluid after treatment to pass through thewalls of the uterus instead of out the vagina.When compared to other commonly used techniques for endometrial ablation i.e. rollerball, endometrialresection and thermal balloon, cryoablation has several major advantages.When compared to rollerball or endometrial resection cryoablation is vastly easier to learn and is muchsafer. There is no irrigating fluid required; therefore the chance of hyponatremia is eliminated [8]. Amixture of common gases is the cryogen avoiding the potential dangers of electricity. There is virtually not post-operative discharge. The results in the 11 sites were essentially equal to rollerball in terms of success.When a longer first freeze was used the results of treatment were impressively much better.Ultrasound monitoring may be criticized, but it accurately depicts the precise location of the cryoprobe and permits the surgeon to know whether there is a perforation as well as monitor the advancing edge of thecryozone. The 4.5mm of the cryoprobe essentially eliminates any degree cervical dilation, necessary withrollerball or resection and even thermal balloon ablation.The lack of any significant degree of peri or post-operative discomfort may be related to the knownanalgesic properties of cold.Of particular interest was the better results noted in women who had a 6 minute first freeze followed by asix minute second freeze. This finding merely points out that a more intense freezing will likely result in ahigher degree of success. Additional studies along these lines are needed.There is always concern that any modality used within the uterine cavity may cause injury to associatedorgans. Ultrasound monitoring essentially eliminates this potential problem. Moreover, by monitoring thedeveloping cryozone it is possible to more accurately predict the depth of tissue destruction [9]. This permits the operating surgeon to freeze even longer periods of time, particularly in women with suspectedadenomyosis.McCausland reported the depth of destruction by rollerball ablation was around 2-4mm[10]. The same 171 Townsend  depth of destruction was found to true of Hydotherm ablation [11] as well as balloon ablation [12]. Inwomen with “deep” adenomyosis [6mm of glands extending into the uterine wall]], as defined byMcCausland [13], would likely be treatment failures by the preceding techniques. However, withcryoablation the depth of destruction was noted to be between 8 and 12 mm, depths that should be moreeffective in women with adenomyosis.When compared to the thermal balloon cryoblation produced the same level of eumenorrhrea as well as a90% reduction in bleeding but was significantly better in the group of women who noted amenorrhea or spotting after treatment; ie 44% to 13%[12].The Her/Option unit is more like a surgical tool, than just another method to perform endometrial ablation.The treatment can be tailored for the cavity. Shorter freezes for smaller cavities and thinner uterine wallsi.e. menopausal women, and longer or multiple freezes for larger cavities. It can be used in women withsubmucous myomas up to 2-cm [7] and in women with benign intrauterine polyps.Cryosurgery has been used laparoscopically to treat liver metastasis from colon cancer. It may be possibleto treat intramural and subseroal myomas, laparoscopically as reported by Zriek [14].The chance of freezing through the uterine wall is remote, Ultrasound monitoring provides precisemonitoring of the advancing cryo-edge. Moreover, the cryo-unit automatically shuts off after 10 minutes, aduration of time insufficient to freeze through the uterine wall. About the only way to injure adjacentorgans would be to perforate the uterus and then commence treatment,The chance of this occuring because of ultra sounding monitoring is remote.Future studies will focus on longer duration of freezes a well as multiple freezes applications since thedouble freeze technique is more lethal to tissue.References1.Cahan WG, Brockunier AJ: Cryosurgery of the uterine Cavity. Am. J Obstet Gynecol 99[1];138-153,19672.Droegemueller W, Greer BE, Makowski EL: Preliminary observations of cryoablation of theendometrium. Am J Obstet Gynecol 107[6]:958-961,19703.Townsend DE, Ostergard DR, Lickrish, GM, Cryosurgery for benign for benign disease of the cervix. JObstet Gynaecol Br Commonw: 78[7]:667-70,19714.Pittrof R, Majid S, Murray A Transcervical endometrial cryoablation [ECA] for menorrhagia. Int. JGynaecol Obstet 47[2]:135-140,19945.Rutherford TJ, Zreik TG, Troiano RN,et al: Endometrial cryoablation, a minimally invasive procedurefor abnormal uterine bleeding. J Am Assoc Gynecol Laparosc 5[1]:23-28,19986.Dobak JD, Williams J: Extripated uterine endometrial cryoablation with ultrasound visualization: J AmAssoc Gynecol Laparosc 7[1]: 95-101,20007.Dobak JD, Williams J, Howard R, Shea C, Townsend DE: Endometrial cryoablation with ultrasoundvisualization in women undergoing hysterectomy: J Am Assoc Gynecol Laparosc 7{1}:89-938.Townsend DE, RichartRM, PaskowitzRA, WoolforkRE: Rollerball coagulation of the endometrium.Obstet Gynecol 76[2]310-313,19909.Onik G Cooper C, Goldberg HI et al: Ultrsonic charcteristics of frozen liver. Cryobiology 21:321-328,198410.Richart RM, BotacincGD,et al: Histologic studies of the effects of circulating hot saline on the uterus before hysterectomy. J Am Assoc Gynecol Laparosc 5[3] 2659-275,199911.McCausland AM: Hysteroscopic myometrial biopsy: its use in diagnosing adenomyosis and its clinicalapplication. Am J Obstet Gynecol: 166: 1619-28, 199212.Meyer W, et al: Thermal balloon and rollerball ablation to treat menorrhagia, a multicenter comparison:Obstet Gynecol.92:98-102,199813.McCausland AM and McCauslandJK: Depth of endometrial penetration in adenomyosis helpsdetermine outcome of rollerball ablation: Am J Obstet Gynecol 174[6]1786-93,199614.Zreik TG, Rutherford TJ, et al: Cryomyolysis, a new procedure for the conservative treatment of uterine fibroids 5[1]33-38,1998 171 Townsend
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