Endometrial ablation with a vaporizing electrode II. Clinical outcome of a pilot study

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1 Acta Obstet Gynecol Scand 1998; 77: Copyright C Acta Obstet Gynecol Scand 1998 Printed in Denmark all rights reserved Acta Obstetricia et Gynecologica Scandinavica ISSN ORIGINAL ARTICLE Endometrial ablation with a vaporizing electrode II. Clinical outcome of a pilot study PAOLO VERCELLINI 1, SABINA OLDANI 1, OLGA DE GIORGI 1, MARINA MILESI 2, DANIELA MERLO 2 AND PIER GIORGIO CROSIGNANI 1 From the 1 Clinica Ostetrica e Ginecologica Luigi Mangiagalli, University of Milano, and the 2 Servizio di Istologia ed Anatomia Patologica, Istituti Clinici di Perfezionamento, Milano, Italy Acta Obstet Gynecol Scand 1998: 77: C Acta Obstet Gynecol Scand 1998 Background. As a vaporizing electrode has been successfully used to treat submucous myomas, we evaluated its safety and efficacy in performing endometrial ablation. Methods. Forty consecutive women with established menorrhagia with (nω26) and without (nω14) submucous myomas were enrolled in a prospective, noncomparative, pilot study. Hysteroscopic endometrial vaporization was performed with pure cutting current set at 200 watts. Results. All procedures were completed without complications. Median (interquartile range, IQR) fluid deficit was 90 (0 200) ml and median (IQR) operating time 10 (7 12.5) min. A significant correlation was observed between operating time and fluid absorption (Spearman s test by ranks, rω0.47; pω0.002). The degree of difficulty of the operation was classified as none on 28 (70%) occasions, mild on 11 (27.5%) and moderate on one (2.5%). After a mean s.d. follow-up of months, amenorrhea or spotting were reported by 23 (57.5%) subjects, hypomenorrhea by 10 (25%), normal flows by six (15%), and menorrhagia by one (2.5%). The median (IQR) menstrual score calculated according to a pictorial blood loss assessment chart dropped from ( ) to 0 (0 15) (p ). Six (15%) subjects were very satisfied with the effect of surgery, 30 (75%) satisfied, two (5%) uncertain, one (2.5%) dissatisfied and one (2.5%) very dissatisfied. Conclusions. The vaporizing electrode seems to combine the benefits of the cutting loop (speed, efficacy and possibility of removing myomas) and the roller-ball electrode (safety and limited fluid absorption) while avoiding their respective disadvantages, and may be considered an interesting alternative in the hysteroscopic treatment of menorrhagia. Key words: endometrial ablation; hysteroscopy; menorrhagia; metrorrhagia; uterine leiomyomas Submitted 25 August, 1997 Accepted 14 December, 1997 Hysteroscopic endometrial resection is becoming routine treatment for menorrhagia not responding to medical therapy (1 4). However, excessive absorption of the distension fluid through the myometrial veins exposed and sectioned by the cut- Abbreviations: IQR: interquartile range; s.d.: standard deviation; US: ultrasonography. ting loop remains a potentially severe complication (2 9). The use of a spherical roller-ball electrode results in coagulation of the tissues with immediate hemostatic vaso-occlusion. This limits intravasation of the distension fluid but is more time-consuming, the long-term results may be suboptimal (14), and a cutting loop is required for resection of the frequently encountered submucous myomas (10 14). A cylindrical corrugated electrode or

2 Outcome of endometrial vaporization 689 vaporizer (Vaportrode, Circon Acmi, Stamford, CT, USA; Fig. 1) has been developed which, due to its peculiar physical characteristics, should allow faster and more radical endometrial ablation than the classic roller-ball electrode. The object of the grooves is to take advantage of the elevated energy concentrated corresponding to the lines of intersection of contiguous surfaces. The three grooves on this electrode provide eight edges along which the current is concentrated, allowing vaporization of the cells upon contact. In a recent urologic study, transurethral vaporization of the prostate was more rapid and involved less bleeding and less deficit of urologic solution than usually occurs during classic resection with the cutting loop (15). The vaporizer has proved effective also in the treatment of submucous myomas (16) but there are no published clinical data on its use for endometrial ablation. For this reason we conducted a prospective, noncomparative pilot study to evaluate the feasibility, efficacy and safety of the procedure in menorrhagic women. Material and methods Women aged Ø35 years referred for menorrhagia not responding to medical treatments and requiring hysterectomy, were considered for recruitment to the trial. Institutional approval was obtained as was informed consent of the patients. Excessive Fig. 1. The cylindrical, corrugated, vaporizing electrode. The three grooves provides eight edges along which electrons concentrate. uterine bleeding was diagnosed on the basis of the history, serum hemoglobin and iron levels, and a pictorial blood loss assessment chart devised by Higham et al. (17) to evaluate menstrual flow in which a monthly score of Ø100 has been demonstrated to be significantly associated with a uterine blood loss of ±80 ml as measured by the alkaline hematin method. The women underwent a complete physical examination, transvaginal ultrasonography (US), diagnostic hysteroscopy and endometrial biopsy. Subjects were eligible if they had a uterine volume less than a 12-week pregnancy, no evidence of atypical hyperplasia at endometrial biopsy, and no adnexal tumors at clinical and US examination. Women who were uncertain about a future wish for children were excluded. Other exclusion criteria were recent use of hormonal agents or of drugs that may affect menstrual blood loss, and the presence of submucous myomas with prevalent intramural development or of myomas of diameter over 5 cm independently of their site. Tryptorelin in a 3.75 mg depot preparation was used preoperatively for 2 months to obtain endometrial thinning. Endometrial vaporization was performed under general anesthesia and video monitoring. The cervical canal was dilated and a 25-French gauge rigid resectoscope (model G25-ST-CFR, Circon Acmi, Stamford, CT, USA) equipped with a 12æfore-oblique telescope (model M3-12) and a cylindrical, 3-mm-wide vaporizing electrode (model VE-B) was introduced. The uterine cavity was distended with a nonconductive, hypo-osmolar solution of 2.7% sorbitol and 0.54% mannitol, instilled under manometric control, with a pressure of 100 to 120 mmhg generated by a pneumatic cuff for intrauterine irrigation and a vacuum of ª30 to ª40 mmhg applied for suction. After examination of the cavity the endometrium was vaporized with pure cutting waveform current set at 200 watts power. The mucosa of the cornual areas was first treated in a radial fashion starting from the tubal ostia and withdrawing the electrode towards the surgeon at a speed of cm/s, applying minimal pressure on the uterine wall. Vaporization was then completed on the fundus and remaining cavity down to the isthmus. The submucosal portion of myomas was reduced in small segments according to Brooks technique. The vaporizer was positioned behind the myoma and then simultaneously activated and withdrawn towards the surgeon. A deep furrow was made through the middle of the lesion all the way down to its stalk, then two or three small portions were sculpted (16). Any intramural extension present was then vaporized until normal myometrium was observed. Polyps were left

3 690 P. Vercellini et al. floating in the uterine cavity until the end of the procedure after vaporization of their base. Tissue fragments were removed with ovum forceps and curette and sent for histologic examination. Fluid deficit was calculated as the difference between the total amount of solution instilled into the uterus and the amount of fluid recovered from the suction bottle and from the plastic draping that funneled fluid escaping through the cervix into a calibrated pouch. The operating time was defined as the interval between the initial insertion and final removal of the hysteroscope. After the intervention the surgeon classified the degree of difficulty of the procedure (based on easiness and completeness of vaporization of endometrium and myomas as well as intracavitary bleeding) as none, minimal, moderate or severe; any intra- and postoperative complications were also recorded. Follow-up visits were scheduled every 3 months. On these occasions the women were asked about menstrual variations after surgery (amenorrhea (absence of any bleeding), hypomenorrhea or spotting (scanty, regular flows or a few drops of blood), normal flows (blood loss consistently reduced with respect to preoperative conditions, no clots), and menorrhagia (menstrual pattern unchanged, blood clots)), and the monthly pictorial blood loss assessment chart score was monitored. At 6 months a transvaginal US scan was scheduled to determine the postoperative endometrial sonographic pattern and a repeat hysteroscopy was offered to define repair of the uterine cavity. Serum hemoglobin and iron levels were also checked. At 18 months the women were requested to rate their overall degree of satisfaction with treatment on a 5-level scale (very satisfied, satisfied, uncertain, dissatisfied, very dissatisfied). Baseline and 18-month follow-up menstrual scores were analyzed with the Wilcoxon matched pairs signed rank sum test and serum hemoglobin and iron levels with the paired t test. Median fluid absorption and operating time in women with a regular uterine cavity were compared to those in women with submucous myomas using the Mann- Whitney U test. The Spearman rank correlation coefficient was employed to examine the relation between fluid deficit and operating time. All tests were 2-tailed. Probability values of less than 5% were regarded as significant. in four a small endometrial polyp was present), and partly occupied by submucous myomas in 14. The myomas were partly intramural ( 50%) in 11 women and pedunculated in three. All the procedures were completed without complications. Median (interquartile range, IQR) fluid deficit was 90 (0 200) ml and median (IQR) operating time 10 (7 12.5) min. Spearman s rank test revealed a significant correlation between operating time and fluid absorption (rω0.47, 95% confidence interval, 0.18 to 0.68; pω0.002). The median (IQR) distension fluid deficit and operating time were significantly higher in the group of women with submucous myomas than in those with a regular uterine cavity, being, respectively, 200 ( ) and 50 (0 110) ml (pω0.0009; Fig. 2), and 14.5 (11 16) and 8 (7 10) min (pω0.0001). In ten of the latter subjects no fluid absorption was detected. The maximum deficit observed was 500 ml in a patient with a 4-cm leiomyoma. The degree of difficulty of the operation was classified as none in 28 (70%) women (21 with a regular cavity), mild in 11 (27.5%; five with a regular cavity) and moderate in the patient (2.5%) with the 4-cm, pedunculated myoma. All the women completed the 18-month evaluation. After a mean s.d. follow-up of months, amenorrhea or spotting was reported by 23 (57.5%) subjects, hypomenorrhea by ten (25%), normal flows by six (15%), and menorrhagia by one (2.5%) with an intramural myoma whose diameter doubled in 1 year after surgery. The median (IQR) pictorial blood loss assessment chart score dropped from 282 ( ) to 0 (0 15) 18 months Results Between July 1995 and February menorrhagic women of mean age 45.3 s.d. 4.7 years were recruited for the study. Mean uterine volume at US was 138 s.d. 49 ml. The uterine cavity was considered regular in 26 cases (although Fig. 2. Distension medium deficit in women undergoing endometrial vaporization with (nω14, closed circles) or without (nω 26, open circles) submucous myomas. Horizontal bars are medians.

4 Outcome of endometrial vaporization 691 after surgery (p ), with a mean 95% reduction compared with baseline. At 6 months mean s.d. serum hemoglobin levels rose by 25% from to g/dl, and serum iron by 224% from to g/dl (p ) without further appreciable modifications. The above variables did not differ significantly in subjects with and without submucous myomas. Mild/ moderate pelvic pain relieved by usual analgesics was experienced occasionally by three previously asymptomatic patients. At 18-month evaluation, six women (15%) were very satisfied with the effect of surgery, 30 (75%) satisfied, two (5%) experiencing unwelcome amenorrhea were uncertain, one (2.5%) with recurrent menorrhagia was dissatisfied, and one (2.5%) with psychiatric complaints was very dissatisfied because amenorrhea caused her depression to worsen. Women with regular, scanty flows underwent transvaginal US examination in the late luteal phase whereas those in amenorrhea were scanned on the day of clinical assessment. In all cases an endometrial layer could be visualized, although sometimes patchy and irregular. The maximum mean s.d. endometrial thickness measured in the longitudinal uterine plane was mm in the former group and mm in the latter, although we cannot exclude that postoperative fibrosis could have reduced the accuracy of our US findings. Thirteen patients refused follow-up hysteroscopy. In the remaining 27 women, nine of whom had had submucous myomas, the cavities could be explored and myoma remnants were not seen. The hysteroscopic pattern was heterogeneous, ranging from a normal uterine cavity with slightly hypotrophic mucosa (11 women including eight still menstruating) to a moderately shrunken, fibrotic cavity with very thin endometrium (13 women, ten of them amenorrheic) to grossly unhealed cavities in which the endometrium had regrown in the central area of the anterior and posterior uterine walls but not on the fundus, cornual recesses or lateral margins where burned myometrium was still visible (three menstruating women). The endometrial sample removed with a sharp curette was sufficient for histologic evaluation in 19 cases, which revealed proliferative (nω12) or secretory (nω7) mucosa. On the other occasions only amorphous material with inflammatory cells and foreign-body granulomas were observed. Discussion Endometrial resection is considered a valid and cost-effective conservative surgical alternative in the treatment of dysfunctional uterine bleeding but it requires adequate hysteroscopic experience and may cause serious problems (1 9). Complications with the use of the cutting loop include uterine perforation, damage to adjacent organs, hemorrhage, fluid overload, air embolism, and death (1 10, 18). A combination of technical properties specific to the loop (it easily cuts through myometrium and sections myometrial vessels with direct exposure of the venous lumen to irrigating fluid or room air (11, 18) and limited hysteroscopic experience probably account for most of the reported accidents. The vaporizing electrode seems advantageous for endometrial ablation because it is as rapid and effective as the loop and as simple and safe as the roller-ball. Unlike the latter, the vaportrode can be used to treat myomas and yields fibroid specimens for histology (16). However, vaporization does not allow sampling of the endometrium. Because of this drawback, common to all the ablative techniques with the exception of resection, a thorough preoperative histologic mucosal evaluation is mandatory. The power used for endometrial vaporization (200-watt cutting current) is considerably higher than for resection (usually 100-watt cutting current) or roller-ball coagulation (usually watts) (2 4, 10 12). This high power is necessary to obtain the desired electrical power density to achieve vaporization with physical elimination of tissue and underlying coagulation with sealing of myometrial vessels (10, 15, 19). This should reduce bleeding, improve visibility, speed the operation and limit fluid absorption (15). Furthermore, 200 watts of unmodulated waveform current has been demonstrated to be the optimal setting for myomectomy (16). Holding the electrode activated in the cornual recesses for a long time without moving it can be dangerous and potentially lead to transmyometrial transmission of thermal energy. However, this is also true of the roller-ball electrode as well as the NdYag laser. The application of pure undamped current should limit tissue thermal necrosis beyond the visible effects in comparison with the coagulation modality (19). In any case we recommend keeping the vaporizer moving when activating the electrogenerator. In the present series the operating time and distension solution absorption were much lower than those observed by us in recently published trials in which a cutting loop was used (20 23). The median fluid deficit was only 50 ml in the 26 women with a regular cavity and there was no deficit in ten (38%) of them. The maximum deficit of 500 ml, observed in a patient with a large submucous myoma, is universally considered within the safety limits (1 9). The higher amount of fluid absorption in women with myomas is probably caused by the longer operating time, given the significant correlation between these two variables demonstrated by us. A

5 692 P. Vercellini et al. GnRH agonist was prescribed preoperatively because endometrial thinning seems particularly important when large-contact electrodes are used, to allow complete treatment and avoid mucosal fragments sticking to the instrument (24). Different healing patterns tended to be associated with different menstrual changes. In particular, amenorrhea was more frequent in subjects with a shrunken and fibrotic uterine cavity and thin mucosa. Endometrium was found at histologic examination of most samples obtained 6 months after surgery. We have previously demonstrated that after hysteroscopic metroplasty prompt epithelialization of the incised areas is due to colonization by endometrium of the lateral walls (25). Likewise, the thin mucosa that covers patches of uterine cavity after ablation may derive from colonization of residual endometrium left at the internal cervical os level, but this is only speculation. The paucity of stroma with limited gland formation and the fibrotic distortion of the endomyometrial junction may explain the limited responsiveness of the mucosa found at follow-up hysteroscopy. In fact, most women were either amenorrheic or hypomenorrheic and only one recurrence of menorrhagia, probably caused by substantial growth of an intramural myoma, was reported after a mean follow-up of nearly 10 months. All except four women were satisfied or very satisfied with the effect of their treatment (90% success rate). Admittedly, long-term results may be less favorable, but this trial was designed primarily as a pilot study to define the technical feasibility and safety of endometrial vaporization. The results are encouraging in this regard, because the procedure was easy (97.5% of cases with no or only mild difficulties at operation), rapid and safe, with no complications and low fluid absorption. It cannot be excluded that results similar to ours might be obtained also with the NdYAG laser (1), although at greatly increased costs and probably with a less user-friendly technique. The findings of this pilot study suggest that the vaportrode may be safer and easier than the cutting loop, considered by many as the gold standard, and that a randomized controlled trial would be appropriate to compare these two electrodes in hysteroscopic treatment of women with menorrhagia. References 1. Garry R. Good practice with endometrial ablation. Obstet Gynecol 1995; 85: Istre O. Transcervical resection of endometrium and fi- broids: The outcome of 412 operations performed over 5 years. Acta Obstet Gynecol Scand 1996; 75: O Connor H, Magos AL. Endometrial resection for the treatment of menorrhagia. N Engl J Med 1996; 335: O Connor H, Broadbent JAM, Magos AL, McPherson K. Medical Research Council randomised trial of endometrial resection versus hysterectomy in management of menorrhagia. Lancet 1997; 349: Istre O, Schiotz H, Sadik L, Vormdal J, Vangen O, Forman A. Transcervical resection of endometrium and fibroids. Initial complications. Acta Obstet Gynecol Scand 1991; 70: Istre O, Skajaa K, Schoensbye A, Forman A. Changes in serum electrolytes after transcervical resection of endometrium and submucous fibroids with use of glycine 1.5% for uterine irrigation. Obstet Gynecol 1992; 80: Witz CA, Silverberg KM, Burns WN, Schenken RS, Olive DL. Complications associated with the absorption of hysteroscopic fluid media. Fertil Steril 1993; 60: Istre O, Jellum E, Skajaa K, Forman A. Changes in amino acids, ammonium, and coagulation factors after transcervical resection of the endometrium with a glycine solution used for uterine irrigation. Am J Obstet Gynecol 1995; 172: Hahn R, Olsson J, Englund K, Seppälä M. Serum levels of endometrial proteins during transcervical resection of the endometrium. Br J Obstet Gynaecol 1996; 103: Sutton CJG, Macdonald R, Magos AL, Broadbent JAM. Endometrial resection. In: Lewis BG, Magos AL, eds. Endometrial ablation. Edinburgh, UK: Churchill Livingstone, 1993: Vancaillie TG. Electrocoagulation of the endometrium. In: Lewis BG, Magos AL, eds. Endometrial ablation. Edinburgh, UK: Churchill Livingstone, 1993: Valle RF. Rollerball endometrial ablation. Baillière s Clin Obstet Gynaecol 1995; 9: Chullapram T, Song LY, Fraser IS. Medium-term followup of women with menorrhagia treated by rollerball endometrial ablation. Obstet Gynecol 1996; 88: Unger JB, Meeks GR. Hysterectomy after endometrial ablation. Am J Obstet Gynecol 1996; 175: Kaplan SA, Te AE. Transurethral electrovaporization of the prostate: a novel method for treating men with benign prostatic hyperplasia. Urology 1995; 45: Brooks PG. Resectoscopic myoma vaporizer. J Reprod Med 1995; 40: Higham JM, O Brien PMS, Shaw RW. Assessment of menstrual blood loss using a pictorial chart. Br J Obstet Gynaecol 1990; 97: Corson SL, Brooks PG, Soderstrom RM. Gynecologic endoscopic gas embolism. Fertil Steril 1996; 65: Soderstrom R. Principles of electrosurgery as applied to gynecology. In: Rock JA, Thompson JD, eds. Te Linde s Operative Gynecology. Philadelphia: Lippincott-Raven, 1996: Vercellini P, Trespidi L, Bramante T, Panazza S, Mauro F, Crosignani PG. Gonadotropin releasing hormone agonist treatment before hysteroscopic endometrial resection. Int J Gynecol Obstet 1994; 45: Vercellini P, Perino A, Consonni R, Trespidi L, Parazzini F, Crosignani PG. Treatment with a gonadotrophin releasing hormone agonist before endometrial resection: a multicentre, randomised controlled trial. Br J Obstet Gynaecol 1996; 103: Crosignani PG, Vercellini P, Apolone G, De Giorgi O, Cortesi I, Meschia M. Endometrial resection versus vaginal hysterectomy for menorrhagia. Am J Obstet Gynecol 1997; 177:

6 Outcome of endometrial vaporization Crosignani PG, Vercellini P, Oldani S, De Giorgi O, Aimi G, Cortesi I. A levonorgestrel-releasing intrauterine device versus hysteroscopic endometrial resection in the treatment of dysfunctional bleeding. Obstet Gynecol 1997; 90: Sutton CJG, Ewen SP. Thinning the endometrium prior to ablation: is it worthwhile? Br J Obstet Gynaecol 1994; 101 Suppl: Candiani GB, Vercellini P, Fedele L, Carinelli SG, Merlo D, Arkaini L. Repair of the uterine cavity after hysteroscopic septal incision. Fertil Steril 1990; 54: Address for correspondence: Paolo Vercellini, M.D. Clinica Ostetrica e Ginecologica Luigi Mangiagalli Università di Milano Via Commenda, Milano, Italy

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