Evaluating endometrial ablation options: a guide for evidence-based decision making.Idiopathic menorrhagia menorrhagia /men·or·rha·gia/ (men?ah-ra´jah) hypermenorrhea.
See hypermenorrhea. affects an estimated 10% to 30% of women of reproductive age, (1) and at least 22% of gynecologic gynecologic /gy·ne·co·log·ic/ (gi?ne-) (jin?e-kah-loj´ik) pertaining to the female reproductive tract or to gynecology. referrals are related to menstrual disorders. (2) In the United States, it is estimated that menorrhagia is responsible for about $1 billion in direct costs and $12 billion in indirect costs annually. Additionally, approximately 30% of the 600,000 hysterectomies performed annually in the United States are for heavy menstrual bleeding. (3), (4)
As gynecologists strive to incorporate more minimally invasive options, global endometrial ablation (GEA) technology is now providing an alternative to traditional surgical extirpative ex·tir·pate
tr.v. ex·tir·pat·ed, ex·tir·pat·ing, ex·tir·pates
1. To pull up by the roots.
2. To destroy totally; exterminate. See Synonyms at abolish.
3. To remove by surgery. management. However, there is now wide variation in the preferred endometrial ablation device and whether GEA should be done under general anesthesia in a hospital setting or under local anesthesia/sedation in an office setting. (5) Unfortunately, despite a variety of GEA options, randomized trials comparing clinical outcomes among these ablative technologies are infrequent. We, therefore, sought to review the peer-reviewed literature addressing clinical outcomes between GEA devices so that obstetrician/gynecologists will have better information to make clinical decisions.
The Evolution of Thermal Balloon Therapy
Although endometrial endometrial /en·do·me·tri·al/ (en?do-me´tre-il) pertaining to the endometrium.
n relating to the end-ometrium or cavity of the uterus. destructive options had previously been described, (6)-(8) the first global ablation device was reported by Neuwirth et al in 1994. (9) "The Endometrial Ablatot" provided an alternative to point-specific endometrial resection techniques that were time consuming and highly dependent upon the surgeon's hysteroscopic skill level (Figure 1 on page 2). The device used a latex balloon containing dextrose dextrose: see glucose. 5% in water to ablate the endometrial lining. This technological concept provided the foundation for the first GEA device to be approved by the US Food and Drug Administration (FDA) for clinical use, the Thermachoice Thermal Balloon Ablation system (Gynecare, Inc) in 1997. In 2001, there was the introduction of other GEA technologies, including NovaSure radiofrequency ablation (Hologic Corporation), cryoablation (American Medical Systems, Inc), and hydrothermablation (Boston Scientific Corporation). The latest technology to enter the practice field was microwave ablation (Microsulis) in 2003.
The original pivotal trial of Thermachoice I supporting the efficacy of the thermal balloon device was a prospective randomized trial that compared the device to rollerball (RB) resection at 12, 24, and 36 months. (10) In this multisite study, an amenorrhea amenorrhea (āmĕn'ərē`a, əmĕn'–), cessation of menstruation. Primary amenorrhea is a delay in or a failure to start menstruation; secondary amenorrhea is an unexpected stop to the menstrual cycle. rate of 14.2%, based on an intent-to-treat (ITT ITT Initial Teacher Training (UK)
ITT I Think That
ITT Invitation To Tender
ITT Individual Time Trial (professional cycling)
ITT In This Thread (forums) ) analysis, was observed at 12 months, comparable to RB outcomes. Conclusions from this trial stated that thermal balloon ablation was associated with fewer intraoperative complications and shorter procedure times than was RB resection, while being as effective as RB ablation in reducing menstrual bleeding to a clinically acceptable level.
Similarly, long-term outcome measures from a patient population treated with this original Thermachoice I design were reported by Amso et al. (11) Results from this multicenter study stated that at 4 to 6 years after uterine balloon therapy, the probability of avoiding hysterectomy was 86%, and the probability of avoiding reablation was 88%. Overall, the probability of avoiding any surgery was 75%. Among the participants, 47% of the nonhysterectomized women were amenorrheic a·men·or·rhe·a or a·men·or·rhoe·a
Abnormal suppression or absence of menstruation.
[a-1 + Greek m , 30% of these women were hypomenorrheic, and 13.6% of these women were eumenorrheic.
In 1999, Thermachoice II entered clinical use with a redesigned uterine balloon, now composed of silicone rather than latex. The switch to silicone allowed the device to conform more thoroughly to the endometrial cavity wall, which in turn allowed for improved heat transfer between the balloon and uterine wall, increasing the resulting amenorrhea rate among an ITT population to 26%. (12) In 2006, however, Thermachoice III was approved for clinical use and is the only commercially available thermal balloon currently approved by the FDA. The FDA-approved indication for all GEA devices is menorrhagia in a premenopausal pre·me·no·paus·al
Of or relating to the years or the stage of life immediately before the onset of menopause.
premenopausal adjective woman who is not pregnant, does not wish to become pregnant, and has not had a classical transmural transmural /trans·mu·ral/ (trans-mu´ral) through the wall of an organ; extending through or affecting the entire thickness of the wall of an organ or cavity.
adj. cesarean section. Other contraindications include a known or suspected endometrial carcinoma or premalignant premalignant /pre·ma·lig·nant/ (pre?mah-lig´nant) precancerous.
precancerous. change of the endometrium endometrium /en·do·me·tri·um/ (-me´tre-um) pl. endome´tria the mucous membrane lining the uterus.
n. pl. , a previous transmural myomectomy, an active genital or urinary tract infection urinary tract infection (UTI),
n infection in one or more of the structures that make up the urinary system. Occurs more often in women and is most commonly caused by bacteria. at the time of the procedure, or the presence of an intrauterine device (IUD IUD Definition
An IUD is an intrauterine device made of plastic and/or copper that is inserted into the womb (uterus) by way of the vaginal canal. One type releases a hormone (progesterone), and is replaced each year. ). (10)
The latest generation of this thermal balloon allows for even more global contact with the uterine wall because of its more conforming silicone material. In a multicenter, prospective trial of patients diagnosed with menorrhagia, Garza-Leal et al (13) compared Thermachoice III to a historic control group treated with Thermachoice I. The study found statistically significant differences in amenorrhea rates with the third-generation balloon. In this 12-site, 250-patient cohort analysis, menstrual pattern results at 12 months were as follows: 81%, eumenorrhea (94%, ITT analysis) and 37%, amenorrhea (44.6%, ITT analysis), with a preexisting dysmenorrhea dysmenorrhea
Pain or cramps before or during menstruation. In primary dysmenorrhea, caused by endocrine imbalances, severity varies widely. Irritability, fatigue, backache, or nausea may also occur. reduction rate of 89% (Thermachoice III has been proven to treat heavy bleeding and shown to reduce pain associated with menorrhagia as a second quality-of-life end point). In this study, although patients were to undergo preablation dilation and curettage dilation and curettage
Abbr. D & C A surgical procedure in which the cervix is expanded using a dilator and the uterine lining scraped with a curette, performed for the diagnosis and treatment of various uterine conditions. (as per Thermachoice I trial design), not all patients underwent preprocedure dilation and curettage (D&C) because of individual physician practice. ITT analysis showed no significant impact of preprocedure curertage on treatment outcomes. (10)
A recently published study by Varma et al (5) confirmed differences in clinical outcome between Thermachoice I and Thermachoice III. Their prospective cohort study found significant differences over a mean follow-up period of 30 months. Multivariate analysis, correcting for all baseline and periprocedure characteristics, showed that Thermachoice III, when compared to Thermachoice I, increased the likelihood of amenorrhea (P=0.001). Interestingly, the authors also noted that regardless of Thermachoice design/generation, higher mean procedural intrauterine intrauterine /in·tra·uter·ine/ (-u´ter-in) within the uterus.
Within the uterus.
Situated or occuring in the uterus. pressure correlated with better long-term patient satisfaction. Over the course of the study period, 92% of patients treated with Thermachoice III required no further therapy for abnormal uterine bleeding (AUB AUB Auburn (University)
AUB Alstublieft (Dutch: please)
AUB American University of Beirut (Beirut, Lebanon)
AUB Abnormal Uterine Bleeding
AUB Ahli United Bank ) versus 70.6% of patients treated with Thermachoice I.
In a separate US prospective study using Thermachoice III, Chapa et al (14) reported evaluable amenorrhea rates of 63% and eumenorrhea rates of 33% at 24 months in a cohort of 148 women who had not reached menopause. The average patient age in this study was 41 years, with a range of 29 to 48 years. A total of 122 patients (82%) were available for evaluation at 12 and 24 months. The research team also reported that amenorrhea and the reduction in dysmenorrhea persisted for 2 years after thermal balloon ablation, and 96% of these patients required no further treatment. The study provides the firsr prospective 2-year outcome data for Thermachoice III performed under local anesthesia with lower uterine block in an office setting.
The 4% failure rate in the study by Chapa et al (14) compares favorably with published failure rates of therapy with prior generations of thermal balloons. A hysterectomy rate of 2.4% at 24 months was documented for this cohort after Thermachoice III therapy (Table 1). This hysterectomy rate is in contrast to the 10% probability of hysterectomy reported for 24 months by Longinotti et al (15) after therapy with prior generations of Thermachoice. Similar to the study by Garza-Leal et al, (13) the trial by Chapa et al (14) found statistically significant dysmenorrhea reductions at both 12 and 24 months following Thermachoice III therapy (Table 2).
TABLE 1. 24-Month Menstrual Outcomes After Thermachoice III Outcome 12 Months 24 Months (N = 122) P Value (N=125) (84% of (82% of cohort) cohort) Amenorrhea 83 (66%) 77 (63%) 0.8 (1.2 - 2.4) Hypomenorrhea 39 (31%) 40 (33%) 0.7 (-2.3 - 1.0) Failure 3 (2.4%) 5 (4.0%) 0.7 (-0.8 - 1.1) Hysterectomy rate was 3/122 (2.4%) at 24 months. Source: Chapa et al. (14) Used with permission of Journal of Gynecologic Surgery, Mary Ann Liebert, Inc. TABLE 2. Reduction in Dysmenorrhea Based on Visual Analog Scale (VAS) Score Baseline 12 Months 24 Months n/N (%) 79/115 (69) 15/79 (18.9) 14/76 (18.4) Mean VAS * 6.83 2.1 2.3 * VAS Score. Paired T-test for statistical significance. P < 0.05 statistically significant. P = 0.002 between baseline and 12 months; P = 1.1 between 12 and 24 months. Source: Chapa et al. (14) Used with permission of Journal of Gynecologic Surgery, Mary Ann Liebert, Inc.
Critical review of the report by Longinotti et al (15) is necessary for appropriate extrapolation to current clinical practice. For example, based on the time frame for patient treatment, the authors report clinical outcomes following thermal balloon ablation (versions I and II), as well as radiofrequency, hydro-thermablation, and point-specific RB destruction. Follow-up was set for up to 8 years. At 8 years, 20% to 22% of the population required a hysterectomy after ablation therapy as a whole. The authors' conclusion was that patient age at the time of therapy was the most important factor in predicting future hysterectomy. Of those with subsequent hysterectomy, the most common pathological findings were uterine myomas (33.4%), adenomyosis adenomyosis /ad·e·no·my·o·sis/ (-mi-o´sis) benign ingrowth of the endometrium into the uterine musculature, sometimes with hypertrophy of the latter; if the lesion forms a circumscribed tumorlike nodule, it is called adenomyoma. (23.6%), and both uterine myomas and adenomyosis (22.4%). A close review of the life-table analysis from that cohort (Figure 2) reveals a slower rate of increase for hysterectomy probability with thermal balloon ablation, despite an earlier-generation technology being used at that time (Figure 2).
An important difference between prior generations of thermal balloon therapy and Thermachoice III is improved depth of necrosis of the endometrium, basalis layer, and inner myometrium myometrium /myo·me·tri·um/ (-me´tre-um) the tunica muscularis of the uterus.myome´trial
The muscular wall of the uterus. . Perihysterectomy tissue examination has documented an increased depth of tissue necrosis and fibrosis per generation thermal balloon at all cavitary sites (cornua, midbody, and fundus fundus /fun·dus/ (fun´dus) pl. fun´di [L.] the bottom or base of anything; the bottom or base of an organ, or the part of a hollow organ farthest from its mouth. ). (16)
Peer-reviewed published data suggest that improved menstrual outcomes observed after Thermachoice III therapy, when compared to those after Thermachoice I, are the result of enhanced heat transfer Heat exchangers were initially developed to use plain (or smooth) heat transfer surfaces. An Enhanced heat transfer surface has a special surface geometry that provides a higher thermal performance, per unit base surface area than a plain surface. from the balloon device to the inner uterine tissues. (5) This enhanced heat transfer, coupled with the tissue's natural healing after thermal injury, helps explain the mechanism of action after thermal balloon endometrial ablation.
Understanding the Mechanism of Action for Thermal Balloon Therapy
The original mechanism of action for thermal balloon ablation has been described by Jarvela et al. (17) The authors performed color Doppler pulsativity indices at the main branch of the uterine arteries (including the arcuate arcuate /ar·cu·ate/ (ahr´ku-at) arc-shaped; arranged in arches.
Formed in the shape of an arc. arteries) and at the subendometrial spiral arteries at baseline and at 6 months after Thermachoice I. A significant rise from the pretreatment pretreatment,
n the protocols required before beginning therapy, usually of a diagnostic nature; before treatment.
n See predetermination. level was observed in the pulsativity index in the uterine arteries and in the spiral artery 6 months after therapy. They concluded that thermal balloon endometrial ablation therapy induces a rise in uterine blood flow impedance, with maximal change recorded at 6 months posttherapy. According to their published report, no initial rise in vascular impedance was noted during the first 2 to 4 weeks after thermal injury. What ensued thereafter was a gradual process of chronic reparative re·par·a·tive also re·par·a·to·ry
1. Tending to repair.
2. Relating to or of the nature of reparations. myometrial change leading to ultimate fibrosis of the injured area. This development, together with the coagulation of the endometrial lining, translated clinically into reduced menstruation.
Clinical results after thermal balloon ablation are apparent at the next menstrual cycle, yet because of the chronic reparative process described here, maximal reduction may occur from 4 to 6 months postablation as final full fibrosis of the basement membrane and vasculature vasculature /vas·cu·la·ture/ (vas´ku-lah-chur)
1. circulatory system.
2. any part of the circulatory system.
n. is established. The data from Jarvela et al (17) provide a more sophisticated insight into the mechanism of action of thermal balloon therapy. This mechanism of action is specific for the technology and is different from the mechanism of injury after either radiofrequency or cryoablation.
Clinically, results from Chapa et al (18) reflect this mechanism of action (Table 3). At 3 months after Thermachoice III ablation, the amenorrhea rate was 52%; an amenotrhea rate of 50% at 6 months was noted in the evaluable cohort (P = 0.09). At 12 months, the evaluable cohort amenorrhea rate was 66% (P = 0.023) compared to the results at 6 months. (19) Results were reported in a patient population whose mean age at initial recruitment was 41 years, with menopause cited as not being a confounding variable.
TABLE 3. Menstrual Outcomes After Thermachoice III Endometrial Ablation 3 Months (Eval 3 Months (Eval P Value 3 and 6 N=134) N=134) Months Amenorrhea 70/134(52%) 68/134(50%) 0.98 (1.0-2.2) Hypomenorrhea 64/134(48%) 63/134(48%) 1.01 (.98-1.9) Failure - 3/134 (2.2%) * 12 Months (Eval N=125) P Value 6 and 12 Months Amenorrhea 83/125(66%) .023 (-2.6 to-1.5) Hypomenorrhea 39/125(31%) .012 (2.1-3.4) Failure McNemar Test for statistical values. Eval=Evaluable cohort. P <0.05 statistically significant. Confidence interval (CI)=95%. * The three failures were noted at 6 months. No additional failures were documented after the 6-month period. At 12 months, the evaluable cohort was N=125; thus, 3/125 is 2.4% failure at 12 months. Mean patient age at recruitment (baseline)=41 years (range, 29-48), median, 43 years. Source: Chapa et al. (19) Used with permission of Journal of Reproductive Medicine.
According to the medical literature, isolated menorrhagia is rare. In fact, quality-of-life--impacting dysmenorrhea has been reported to occur in up to 90% of those suffering with heavy menstrual bleeding. (20) Of those with reported dysmenorrhea, 51% report that it limits their daily activities. (21) Additionally, women with dysmenorrhea have significantly lower scores for virtually all domains of the Short Form-36 (P<0.01), compared to those without menstrual pain. (22) With the original thermal balloon design, Meyer et al (23) reported a 70% reduction in dysmenorrhea following thermal balloon ablation and a 75% reduction in dysmenorrhea following RB, with improved quality-of-life issues. According to a prior published Swedish survey of women with dysmenorrhea, the severity of dysmenorrhea was directly related to the duration and amount of menstrual flow. (24) Speroff et al (25) describes the physiologic increase in prostaglandin [F.sub.2][alpha] levels in the endometrium in women with dysmenorrhea, with a peak in levels during menstruation. It is the belief of the authors that as the endometrial basalis and inner myometruim are fibrosed by ablative therapy, subsequent prostaglandin synthesis and propagation would be reduced. This development, coupled with decreased menstrual flow, would contribute to decreased menstrual pain and cramps. Table 4 on page 6 provides extrapolated data on dysmenorrhea reduction per ablation technology gathered from each device's instructions for use (original pivotal trials) or from original study data.
Importance of Endometrial Cavitary Coverage for Outcome Success
As mentioned previously, paramount to GEA success is the ability of the technology to appropriately cover the entire endometrial cavity and provide complete and thorough thermal hear transfer to affect endometrial tissue destruction. In contrast to the more "global" uterine coverage with a flexible fluid-filled balloon, research from Samuel et al (26) describes uterine coverage with a rigid radio-frequency device. In their cohort of 38 patients treated by radiofrequency ablation, 9 of 38 women (24%) were found to have an "incompletely treated" endometrial surface on immediate postablation hysteroscopy. Although no statistically significant difference in outcomes was noted between the "incompletely treated" and "completely treated" groups, the time end point for the study was only 6 months. Longer-term data are needed to determine the effect of "incompletely treated" endometrium on outcome success. It is presumed that the etiology of the incomplete treatment of the cavity is primarily a function of the rigid design of the array.
A Review of Research on Clinical Efficacy
Although recent publications have addressed the differences in clinical outcomes between the three thermal balloon generations, outcome data from Thermachoice I persist in the current medical literature, despite the absence of Thermachoice I from clinical use since 1999. In a comparative 5-year outcome study, Kleijn et al (27) evaluated the amenorrhea rate, hysterectomy rate, and quality-of-life in patients for 5-year status after therapy with NovaSure or Thermachoice (first generation). Results showed an amenorrhea rate of 48% for NovaSure and an amenorrhea rate of 32% for Thermachoice. Eight subsequent hysterectomies were performed following radiofrequency ablation, whereas five hysterectomies were performed after thermal balloon therapy. Severe dysmenorrhea, which existed in more than 30% of the women at baseline, was reduced in both radiofrequency and thermal balloon treatment groups (P = 0.001). Kleijn et al (27) also found that there were no significant differences in health-related quality-of-life between the bipolar group and the balloon group. Nor was there a significant interaction between time and treatment effect. Equal improvements in overall health-related quality-of-life scores were reported following both therapies at 5 years.
Similarly, a recent publication by El-Nashar et al (28) described a retrospective cohort analysis of patients treated from 1998 to 2005. Treatment modalities were either NovaSure radiofrequency ablation or Thermachoice. According to years of patient treatment, the thermal balloon generations employed were Thermachoice I and Thermachoice II, as treatment data were gathered prior to clinical use of Thermachoice III. Although amenorrhea rates of up to 70% were noted following radiofrequency ablation, caution is advised in the interpretation of these data as menopausal status was not accounted for in that cohort.
Although Thermachoice III is not approved for use with uterine myomas, two recent reports by Chapa et al (14), (18) concluded that the conforming nature of the Thermachoice III balloon allows for uterine coverage despite submucosal submucosal /sub·mu·co·sal/ (-mu-ko´sal)
1. pertaining to the submucosa.
2. beneath a mucous membrane. distortion by myomas. In a report by Sabbah et al, (29) 12-month clinical follow-up was reported after radiofrequency ablation in patients with similar intra-cavity disease, namely distortion of the endometrial surface by fibroids. Prospective analysis of this 65-patient Caucasian cohort showed an amenorrhea rate of 69%, a hypomenorrhea rate of 20%, and an eumenorrhea rate of 6%. A few cautionary interpretation comments must be mentioned about this study. The median patient age was 45 years (range, 31-58 years). The median uterine sound reported was 7.8, with a median fibroid fibroid /fi·broid/ (fi´broid)
1. having a fibrous structure; resembling a fibroma.
4. in the plural, a colloquial term for leiomyoma of the uterus. size of 1.5 cm (range, 1 - 3 cm). Most important to mention is the inclusion of 13 postmenopausal post·men·o·paus·al
Of or occurring in the time following menopause.
postmenopausal Change of life Gynecology adjective Referring to the time in ♀ when menstrual periods stop for ≥ 1 yr women in the cohort used for statistical analysis (20% of the group).
As a measure of objective comparative review, Table 4 provides a comparative summary of 12-month clinical outcomes based on the FDA pivotal trials for each device.
TABLE 4. Comparative Summary Patient-Reported Patients Patients with Patients Comparisons * Experiencing Normal Levels or Experiencing Amenorrhea at Less Reduction in 12 Months Dysmenorrhea (Pain) GYNECARE 37% 81% 89% THERMACHOICE[R] III(1) NovaSure[R](2) 36% 78% 63% Her Option[R](3) 22% 67% 76%(4) HTA System[R](5) 35% 68% N/A Data not based on a head-to-head clinical study. * Based on intent-to-treat population. Sources: (1) Gynecare Thermachoice III [instructions for use]. Somerville, NT: ETHICON, Inc; 2009; (2) NovaSure [instructions for use]. Bedford, MA: Cytyc Corporation; 2004; (3) Her Option [instructions for use]. Minnetonka, MN: American Medical Systems; 2006; (4) Duleba AJ, Heppard MC, Soderstrom RM, Townsend DE. A randomized study comparing endometrial cryoablation and rollerball electroablation for treatment of dysfunctional uterine bleeding. J Am Assoc Gynecol Laparosc. 2003;10:17-26; (5) Hydro ThermAblator System[R] [instructions for use]. Natick, MA: Boston Scientific Corporation; 2005. N/A=not available.
Thermal Balloon Ablation After Cesarean Section
Currently, the US cesarean section rate has reached an all-rime high of 32%. (30) That begs the question: As multiple cesarean sections may predispose pre·dis·pose
To make susceptible, as to a disease. to a thinner lower uterine segment lower uterine segment
The isthmus of the uterus, the lower extremity of which joins with the cervical canal and during pregnancy expands to become the lower part of the uterine cavity. , is thermal balloon ablation a safe choice in patients presenting with abnormal uterine bleeding with a history of multiple cesarean sections? A recent Israeli descriptive study by Gangadharan et al (31) of thermal balloon ablation in women with a history of cesarean births revealed no immediate intraoperative complications. The conclusion based on these preliminary data was that "thermal balloon ablation is a feasible therapeutic option in women with dysfunctional uterine bleeding Dysfunctional Uterine Bleeding Definition
Dysfunctional uterine bleeding is irregular, abnormal uterine bleeding that is not caused by a tumor, infection, or pregnancy. with one or more previous cesarean deliveries."
Should Thermal Balloon Therapy Be Performed in the Office?
In 2005, an estimated 10 million procedures had been performed annually in a doctor's office, twice the number of office-based surgeries that had been performed in 1995. (32) Since that time, an increasing number of "surgeries" have moved from the traditional operating room to the physicians' own office (endometrial ablations, hysteroscopy, cystoscopy Cystoscopy Definition
Cystoscopy (cystourethroscopy) is a diagnostic procedure that is used to look at the bladder (lower urinary tract), collect urine samples, and examine the prostate gland. , gynecologic/obstetric dilation and curettage, and hysteroscopic sterilizations). As physicians increasingly encounter the need to improve time management and productivity/efficiency, more physicians are performing endometrial ablations in their own office rather than in a hospital or ambulatory surgical center. The concept of thermal balloon ablation under local anesthesia is not a novel concept. In 1997, Fernandez et al (33) first published the successful use of Thermachoice (first generation) under local anesthesia. (33) Since then, others have validated its use in the office setting. (22), (34-36)
The main advantages of office-based procedures include less overall time spent by the patient at the treatment site, familiarity of the surroundings, and the patient's perception of having a "procedure" versus having "surgery."
The following sample office protocols reflect the authors' opinions. Before the patient arrives in the office, she should have eaten a full meal; this preparation usually helps her tolerate the oral medication cocktail. A negative pregnancy test should be obtained immediately prior to the procedure. Once in the office, the patient's hysteroscopic exam should visualize the uterine cavity; any perforations, abnormalities, and specific intrauterine findings should be documented.
Typically, the patient may receive the oral medication cocktail from about 45 to 60 minutes prior to the procedure to allow for peak serum drug levels. Traditionally, the regimen should include a nonsteroidal anti-inflammatory drug nonsteroidal anti-inflammatory drug, a drug that suppresses inflammation in a manner similar to steroids, but without the side effects of steroids; commonly referred to by the acronym NSAID (ĕn`sĕd). (NSAID NSAID: see nonsteroidal anti-inflammatory drug. ) such as ibuprofen ibuprofen (ī`byprō'fən), nonsteroidal anti-inflammatory drug (NSAID) that reduces pain, fever, and inflammation. , an anxiolytic anxiolytic /anx·io·lyt·ic/ (ang?ze-o-lit´ik)
2. an antianxiety agent.
A drug that relieves anxiety. , antiemetic, and narcotic analgesic.
A lower uterine block is performed immediately before the office procedure. The local anesthetic should be administered at a depth of 1.5 inches just medial to the cervico-vaginal reflection. Administering 5 to 10 cc of the local anesthetic per quadrant is recommended at 4, 8, 2, and 10 o'clock positions. The drugs typically used are lidocaine lidocaine /li·do·caine/ (li´do-kan) an anesthetic with sedative, analgesic, and cardiac depressant properties, applied topically in the form of the base or hydrochloride salt as a local anesthetic; also used in the latter form as a , carbo-caine, and naropin. Evidence for the efficiency of such a protocol can be found in a cohort study by Chapa, (54) in which a patient cohort of 148 patients with Thermachoice III ablation under local anesthesia revealed a mean intraoperative visual analog scale (VAS) score of 2 (range, 1-3) out of a maximal scale value of 10. (34) Typical menses VAS score was recognized as a mean of 3.
Immediately after the procedure, an NSAID, a narcotic, and an antiemetic are recommended. With this approach, patients rarely experience immediate post-operative pain. To cope with late-onset postprocedure pain, most clinicians will prescribe an NSAID and narcotic analgesic at 4 hours after patients receive their first medication and then again at 8 hours.
Important to note, however, is the claim of some investigators that the etiology of postcesarean section abnormal uterine bleeding is an anatomic defect or "isthmocele" that alters the uterine/myometrial blood flow and results in a disorganized bleeding pattern. These authors (37) state that the hysteroscopic resection of this "isthmocele" may be preferred if encountered at preablation hysteroscopy. Therefore, the consensus and that of the authors of the current supplement is to perform routine diagnostic hysteroscopy before thermal balloon ablation as a conservative measure for a lower uterine segment condition. Nonetheless, the study by Gangadharan et al (31) provides evidence that thermal balloon ablation may be a valid treatment option in patients with cesarean intervention. As was mentioned previously, current FDA labeling states that only classical (fundal transmural) cesarean section is a contraindication contraindication /con·tra·in·di·ca·tion/ (-in?di-ka´shun) any condition which renders a particular line of treatment improper or undesirable.
n. for Thermachoice.
Although there are advantages to performing thermal balloon therapy in an office setting, there are certain clinical scenarios in which it may be inappropriate. Those patients with preexisting anxiety or panic disorder, narcotic addiction or past use, suspected endometriosis, or other chronic pain conditions or patients who simply fear an office-based procedure are candidates for considering therapy outside of the office setting.
Currently, with the recent passage of health care reform, physicians will undoubtedly face changes to everyday practice. It is evident that the known adage of "work smarter, not harder" is exemplified by office-based surgical procedures when appropriate. A classic example of this model is GEA. Although physicians are inundated with a variety of treatment options and technologies, their role is to implement evidence-based recommendations for improved patient outcomes. Any implemented technology or treatment plan should produce improved patient quality-of-life measures combined with patient safety and physician operability Operability is the ability to keep a system in a functioning and operating condition. In a computing systems environment with multiple systems this includes the ability of products, systems and business processes to work together to accomplish a common task such as finding and . Currently, there are no head-to-head, peer-reviewed trials reporting on outcomes directly comparing the different technologies. Such trials would be ideal for the gynecologic community. It is important to realize that ALL modalities require proper patient informed consent, patient selection, and physician discretion in order to achieve a favorable outcome. It is, after all, the goal of every physician to have a successful outcome, remembering always to "first do no harm."
(1.) de Souza S, Camargos AF, de Rezende CP, Pereira FA, Araujo CA, Silva Filho AL. A randomized prospective trial comparing the levonorgesterol-releasing intrauterine system with thermal balloon ablation for the treatment of heavy menstrual bleeding. Contraception. 2010;81:226-231.
(2.) Gath D, Osborn M, Bungay G, et al. Psychiatric disorder and gynaecological adj. 1. Of or pertaining to gynecology; same as gynecological.
Adj. 1. gynaecological - of or relating to or practicing gynecology; "gynecological examination"
gynecologic, gynecological symptoms in middle aged women; A community survey. Br Med J. 1987;294:213-218.
(3.) Clarke A, Black N, Rowe P, Mott S, Howle K. Indications for and outcome of total abdominal hysterectomy to·tal abdominal hysterectomy
n. Abbr. TAH
An abdominal hysterectomy in which the uterus and cervix are removed.
total abdominal hysterectomy for benign disease: A prospective cohort study. Br J Obstet Gynaecol. 1995; 102: 611-620.
(4.) Falcone T, Walters MD. Hysterectomy for benign disease. Obstet Gynecol. 2008;111:753-767.
(5.) Varma R, Soneja H, Samuel N, Sangha sangha: see Buddhism.
Buddhist monastic order, traditionally composed of four groups: monks, nuns, laymen, and laywomen. Established by the Buddha, it is the world's oldest body of celibate clerics. E, Clark TJ, Gupta JK. Outpatient Thermachoice endometrial balloon ablation: Long-term, prognostic and quality-of-life measures. Gynecol Obstet Invest. 2010;70:145-148.
(6.) Munro MG. Dysfunctional uterine bleeding: Advances in diagnosis and treatment. Curr Opin Obstet & Gynecol. 2001;13:475-489.
(7.) Goldrath MH, Fuller TA, Seqal S. Laser photovaporization of endometrium for the treatment of menorrhagia. Am J Obstet Gynecol. 1981;140:14-19.
(8.) DeCherney AH, Polan ML. Hysteroscopic management of intrauterine lesions and intractable uterine bleeding. Obstet Gynecol. 1983;61:392-397.
(9.) Neuwirth RS, Duran AA, Singer A, McDonald R, Bolduc L. The endometrial ablator: A new instrument. Obstet Gynecol, 1994;83(5 pt 1):792-796.
(10.) Gynecare Thermachoice III [instructions for use]. Somerville, NJ: Ethicon, Inc; 2009.
(11.) Amso NN, Fernandez H, Vilos G, et al. Uterine endometrial thermal balloon, therapy for the treatment of menorrhagia; Long-term multicentre follow-up study. Hum Reprod. 2003; 18: 1082-1087.
(12.) Feitoza SS, Gebhart JB, Gosrout BS, Wilson TO, Cliby WA. Efficacy of thermal balloon ablation in patients with abnormal uterine bleeding. Am J Obstet Gynecol. 2003;189:453-457.
(13.) Gatza-Leal J, Dena A, Donovan A, et al. Clinical evaluation of a third-generation thermal uterine balloon therapy system for menorrhagia coupled with curettage curettage /cu·ret·tage/ (ku?re-tahzh´) [Fr.] the cleansing of a diseased surface, as with a curet.
medical curettage . J Minim Invasive Gynecol. 2010;17:82-90.
(14.) Chapa H, Venegas G, Antometti AG, Van Duyne CP, Sandare J, Bakker K. In-office Thermachoice III ablations: 24-month prospective follow-up on menstrual patterns and dysmenorrhea impact. J Gynecol Surg. In press.
(15.) Longinotti MK, Jacobson GF, Hung YY, Learman LA. Probability of hysterectomy after endometrial ablation. Obstet Gynecol. 2008;112:1214-1220.
(16.) Summary Report: An ex-vivo study to evaluate the V1.2, V2.0 & V3.0 (Circulating and Non-Circulating) Thermachoice UBT UBT Ultimate Blackjack Tour
UBT Urea Breath Test
UBT Universal Bus Transceiver
UBT Ubiquitous Blue Tarp
UBT Ubatuba, Sao Paulo, Brazil (Airport Code)
UBT Unit Business Team
UBT User-Based Tracking Catheters in Extirpated Uterei. Ethicon, 2002.
(17.) Jarvela I, Tekay A, Santala M, Jouppila P. Thermal balloon endometrial ablation therapy induces a rise in uterine blood flow impedance: A randomized prospective color Doppler study. Ultrasound Obstet Gynecol. 2001;17:65-70.
(18.) Chapa HO, Venegas G, Antonetti AG, Van Duyne CP, Sandate J, Bakker K. In-office endometrial ablation and clinical correlation of reduced menstrual blood loss and effects of dysmenorrhea and premenstrual premenstrual /pre·men·stru·al/ (pre-men´stroo-al) occurring before menstruation.
Of or occurring in the period just before menstruation. symptomatology symptomatology /symp·to·ma·tol·o·gy/ (simp?to-mah-tol´ah-je)
1. the branch of medicine dealing with symptoms.
2. the combined symptoms of a disease.
n. . J Reprod Med. 2009;54:232-238.
(19.) Chapa HO, Venegas G, Antonetti AG, Van Duyne CP, Sandate J, Bakker K. In-office endometrial ablation using a third-generation uterine balloon therapy system: 12-month prospective follow-up on menstrual patterns and dysmenorrhea impact. J Repord Med. 2009:54: 678-684.
(20.) Committee on Practice Bulletins--Gynecology. Practice Bulletin 110: Nonhormonal uses of hormonal contraception. Obstet Gynecol. 2010; 115:206-218.
(21.) Burnett MA, Antao V, Black A, et al. Prevalence of primary dysmenorrhea in Canada. J Obstet Gynaecol Can. 2005;27:765-770.
(22.) Barnard K, Frayne SM, Skinner KM, Sullivan LM. Health status among women with menstrual symptoms. J Worms Health. 2003:12:911-919.
(23.) Meyer WR, Walsh BW, Grainger DA, Peacock LM, Loffer FD, Steege JF. Thermal balloon and rollerball ablation to treat menorrhagia: A multicenter comparison. Obstet Gynecol. 1998;92:98-103.
(24.) Andersch B, Milsom I. An epidemiologic study of young women with dysmenorrhea. Am J Obstet Gynecol. 1982; 144:655-660.
(25.) Speroff L, Glass RH, Kase NG, eds. Clinical Gynecologic Endocrinology and Infertility. 6th ed. Baltimore, MD; Lippincott, Williams & Wilkins; 1999.
(26.) Samuel NC Karragianniadou E, Clark TJ. Outpatient versus day-case endometrial ablation using the NovaSure impedance-controlled ablative system. Gynecol Surg. 2009;6:3-9.
(27.) Kleijn JH, Engels R, Bourdrez P, Mol BW, Bongers MY. Five-year follow up of a randomised Adj. 1. randomised - set up or distributed in a deliberately random way
irregular - contrary to rule or accepted order or general practice; "irregular hiring practices" controlled trial comparing NovaSure and ThermaChoice endometrial ablation. Br J Obstet Gynaecol. 2008; 115:193-198.
(28.) El-Nashar SA, Hopkins MR, Creedon DJ, et al. Prediction of treatment outcomes after global endometrial ablation. Obstet Gynecol. 2009;113:97-106.
(29.) Sabbah R, Desaulniers G. Use of the NovaSure Impedance Controlled Endometrial Ablation System in patients with intracavitary disease: 12-month follow-up results of a prospective, single-arm clinical study. J Minim Invasive Gynecol. 2006;13:467-471.
(30.) Menacker K, Hamilton BE. Recent trends in cesarean delivery in the United States. NCHS NCHS National Center for Health Statistics
NCHS Naperville Central High School (Illinois)
NCHS North Central High School
NCHS Natrona County High School (Wyoming)
NCHS National Center for Health Services Data Brief, No. 35. March 2010.
(31.) Gangadharan A, Revel A, Shushan A. Endometrial thermal balloon ablation in women with previous cesarean delivery: Pilot study. J Minim Invasive Gynecol. 2010;17:358-360.
(32.) American Society of Anesthesiology and the Society's Committee on Communication and the Committee on Ambulatory Surgical Care. Office-Based Anesthesia and Surgery; 2006.
(33.) Fernandez H, Capella S, Audibert F. Uterine thermal balloon therapy under local anaesthesia for the treatment of menotrhagia: A pilot study. Hum Reprod. 1997;12:2511-2514.
(34.) Chapa HO. Utility of in-office endometrial ablation: A prospective cohort study of endometrial ablation under local anesthesia, J Repro Med. 2008;53:827-831.
(35.) Clark TJ, Gupta JK. Outpatient thermal balloon ablation of the endometrium. Feril Steril. 2004;82:1395-1401.
(36.) Marsh F, Thewlis J, Duffy S. Thermachoice endometrial ablation in the outpatient selling, without local anesthesia or intravenous sedation: A prospective cohort study. Fertil Steril. 2005;83:715-720.
(37.) Gubbini G, Casadio P, Marra E. Resecioseope correction of the "isthmocele" in women with postmenstrual post·men·stru·al
Of or occurring in the time following menstruation. abnormal uterine bleeding and secondary infertility. J Minim Invasive Gynecol. 2008;15:172-175.
For complete indications, contraindications, warnings, precautions, and adverse reactions, please reference full package insert.
Hector O. Chapa, MD
Medical Director and Outreach Coordinator Women's Specialty Cente Clinical Faculty
Methodist Medical Center Department of Obstetrics and Gynecology Residency Program Dallas, TX
Lowell L. McCauley, MD, PC