Does Combining Myoma Coagulation with Endometrial Ablation Reduce Subsequent Surgery?

From the Montclair Reproductive Center, Department of OB/GYN, Mountainside Hospital

Approximately 750,000 hysterectomies are performed annually in the United States, with a mortality rate of about 12 per 10,000 operations.1 Costs to consumers and insurers have been estimated at approximately $1.7 billion per year.2 Thus, alternative procedures that are safer and less invasive, preserve the uterus, and cost less are increasingly in demand. In recent years, several such techniques have been introduced.

Endometrial ablation was first performed in 1981 by Goldrath and colleagues, using the Nd:YAG laser.3 Vancaille subsequently published a report of rollerball ablation in 1989.4 Amenorrhea rates following ablation have been 25 to 84%,3,5-14 with patient satisfaction reported at up to 80% after 1 year.6,7,15 However, a study by Unger and Meeks16 indicated that as many as 34% of women required hysterectomy within 5 years of ablation, a number that increased with time. A recent report by Martyn and Allan17 on long-term follow-up of 301 patients having endometrial ablation revealed that after 5 years 27% had required further surgery because of bleeding, and 38% because of pain.

In 1990, the author first reported the technique of myoma coagulation (myolysis) in the United States.18 It was combined with endometrial ablation in patients who had symptomatic fibroids and also exhibited excessive and recurrent uterine bleeding refractory to medical therapy. The procedure was first performed with the Nd:YAG laser,19 but in 1992 the technique was altered by the use of a 5-cm modified bipolar needle (B. Resnick & Company, Skokee, IL, and J.E.M.D. Medical, Hicksville, NY) to pierce the myoma, using bipolar current at 50 to 75 watts.20

Materials and Methods

Patients in this study were selected from the author's private practice, and complained of abnormally heavy, recurrent uterine bleeding. All wished to preserve the uterus, and most had uterine fibroids. Those presenting between 1986 and 1990 (Table 1) were considered for ablation with or without resection, while those seen between 1990 and 1995 were offered the same procedure with the addition of myoma coagulation. Otherwise the two groups were entirely homogeneous.

All women were given a preoperative evaluation consisting of medical history, physical and pelvic examination, as well as abdominal and vaginal ultrasound scan, endometrial biopsy, and hysteroscopy to determine uterine pathology.21 Patients were considered surgical candidates if the biopsy revealed no hyperplastic tissue, if fibroids measured no more than 10 cm, and if they were premenopausal.

Women meeting these criteria and providing informed consent were given a trial of gonadotropin-releasing hormone (GnRH) agonist in depot form 10 to 14 weeks prior to surgery as a therapeutic test. Surgery was conducted only on those having a good response to the GnRH agonist (i.e., symptoms disappeared and myoma volume was reduced 30 to 40%).

Various endometrial ablation techniques were employed, including the Nd:YAG laser and the resectoscope; these have been described elsewhere.6,22 Myoma coagulation was performed using either the Nd:YAG laser or bipolar needles, as previously described.20,23,24 Resection of submucosal myoma was also performed as previously described.10

Amenorrheic patients were encouraged to return yearly for vaginal ultrasound, to ensure that hematometra was not present. Patients who did not return at least twice postoperatively were considered lost to follow-up.

The primary end point of this study was adequate relief of symptoms following the initial procedure. In addition, menstrual outcome and complication rates were assessed in both groups.

Results

Ablation Alone Group

These 52 patients were followed for an average of 47 months (range, 2 to 105 mo). Mean age at the time of surgery was 43.5 years, and mean parity was 1.87 children. Postoperatively, 19 women (36%) became amenorrheic, and 12 (23%) had bleeding within the normal range. Thus, 59% experienced improvement in bleeding severity. However, 20 women (38%) developed heavy bleeding during the period of observation, and required subsequent surgery, five of them (9.6% of the total) undergoing hysterectomy.

Serious complications were experienced by four patients (7.7%), including: pulmonary congestion, hyponatremia, and degenerating myoma; fever, endometritis, and bleeding at 1 month postablation; uterine and intestinal perforation secondary to attempted fundal submucosal resection early in the series (repaired by laparotomy); and peritonitis, hyponatremia, fluid overload, and pleural effusion. One woman became pregnant 17 months after surgery.

Myolysis and Ablation Group

These 116 patients were followed for a mean of 25 months (range, 4 to 65 months). Mean age at the time of surgery was 45 years, and mean parity was 1.35 children.

Following surgery, 55 women (47%) were amenorrheic, 51 (44%) had normal menstrual levels, and 10 (8.6%) had continued heavy bleeding. In all, 16 (13.8%) elected to undergo subsequent procedures due to inadequate control of symptoms with myoma coagulation plus endometrial ablation. Six of these 16 women (5.2% of the total) underwent hysterectomy. The other procedures included one case each of laparoscopic myomectomy; myomectomy performed hysteroscopically to remove a prolapsed fibroid; hysteroscopy and lysis of adhesions; repeat ablation, laparoscopic myomectomy, and bilateral salpingectomy for myoma degeneration and continued heavy bleeding; repeat endometrial coagulation and hysteroscopic resection of a submucosal leiomyoma; and five cases of repeat ablation due to pain, hematometria, and/or fibroid growth.

Volumetric analysis was performed in 43 patients (37%). In 30 of them, preoperative fibroid size ranged from 12 to 630 cm3 with a mean of 230 cm3 and a median of 205 cm3. Following treatment with the GnRH agonist and surgery, fibroids ranged in size from 3 to 483 cm3, with a mean and median of 103 and 81 cm3 respectively. The 30 patients experienced an average 54.5% reduction in fibroid size, with half the group having a shrinkage of at least 68%.

Complications occurred in 16 of the 116 women (13.8%) and included one case each (0.8%) of pelvic infection, uterine perforation, bladder perforation, bacteremia, and fibroid prolapse; two cases (1.7%) of urinary tract infection; four cases (3.4%) of fever; and five cases (4.3%) of hematometra.

Comparing the Two Groups

The incidence of hysterectomy in the ablation alone group (5 of 52 = 9.6%) was somewhat higher than that in the myolysis group (6 of 116 = 5.2%). When all subsequent surgical procedures including hysterectomy were evaluated, the incidence in the ablation group (20 of 52 = 38%) was significantly higher than that in the myolysis-ablation group (16 of 116 = 13.8%) (X2N = 116 = 13.84 p < 0.01).

Survival analyses were carried out for both possible end points: hysterectomies (Table 3), and subsequent surgical procedures (Table 4), in order to observe the yearly incidence rates, and to determine if there were differences between them. The incidence of hysterectomies in the ablation-only group appeared to be fairly uniform over the first 4 years, at roughly 4% yearly. The rates in the myolysis-ablation group also appeared quite uniform, at about 2.5% yearly.

When Life Table analysis was carried out using all subsequent surgical procedures as the end point (Table 4), the difference between ablation alone and myolysis-ablation was striking. For ablation only, the yearly rate was roughly 10% for at least 9 years, whereas for myolysis-ablation the yearly rate was only 3% for the first 3 years. These analyses correct for length of participation, and confirm that the difference between ablation only and myolysis-ablation is significant (p < 0.05).

Discussion

In a series of 52 patients who underwent ablation alone, 38% required at least one repeat surgery. The hysterectomy rate was 9.6%. The length of follow-up available for the myolysis group is 6 years, and if data for the ablation-only group are considered only for the same 6-year period, just three women had hysterectomy beyond the sixth year. The chi square analysis remains unchanged, however, with the significance still < 0.05.

In a similar series of patients treated with rollerball ablation by Unger and Meeks,16 some 14 of 41 women (34%) underwent hysterectomy within 5 years of the surgery. (No other type of repeat surgery was permitted by their study protocol.) They reported that the decision for hysterectomy following ablation was associated with continued abnormal bleeding and menstrual pain as well as gross abnormalities such as uterine myoma. Seven (70%) of 10 women with severe menstrual pain and probable adenomyosis underwent hysterectomy. It should also be noted that all 14 of the women who had hysterectomy had significant pelvic disease; 10 had myoma, adenomyosis, or endometriosis. Additionally, Unger and Meeks reported a linear relationship between hysterectomy and time, projecting that all of their ablation patients would undergo hysterectomy within 13 years of the initial procedure.

A comparison of the current data with those of Unger and Meeks is provided in Table 1. In the current series, the majority of women undergoing ablation and all of those in the myolysis group had uterine fibroids. Resection was performed when submucosal myomas required significant resculpturing of the endometrial cavity.

An important point to consider is the motivation of the patient and the physician. Those women with continued abnormal bleeding usually had migration of intramural or submucosal myomas to the uterine or submucosal areas. In the current study, these patients were offered repeat ablation or resection and even myomectomy as an alternative to hysterectomy, and were encouraged to choose whichever one they preferred. This contrasts with the series by Unger and Meeks, in which only hysterectomy was offered as a second procedure.

Those authors also noted that because the uterine cavity may be scarred by the procedure and no longer patent with the vagina, any subsequent menstrual flow may be forced into the fallopian tubes, causing pain and endometriosis. In this study, cavity patency was maintained by performing an endometrial endosuction 1 month after surgery; also, amenorrheic patients were followed with yearly vaginal ultrasound examinations to ensure that hematometra had not developed.

A comparison of our data across patient groups reveals that the addition of myolysis to ablation increased the rate of postsurgical amenorrhea from 36 to 47% and reduced the rate of continued heavy bleeding from 38 to 8.6% (Table 2). Second procedures including hysterectomies were reduced from 38 to 13.7%, and the hysterectomy rate from 9.6 to 5.2%.

Although ablation as a single procedure was performed several years earlier than the combination, patients appeared to be fairly well matched with regard to demographic variables. It should be noted that a variety of techniques was used in performing ablation, and that two different techniques were used in performing myoma coagulation. In addition, duration of follow-up varied across the two patient groups.

This article represents the author's experience with several recently developed surgical techniques that are successful in relieving symptoms related to leiomyomas and menorrhagia, while leaving the uterus in place and reducing recovery time.

Physicians should note that myolysis performed on an extremely enlarged uterus (fibroids >10 cm or 14 weeks gestation) is unlikely to succeed. Similarly, myolysis probably will not have a satisfactory outcome in patients with disseminated leiomyomatosis. Endometrial ablation alone should be reserved for those women with persistent abnormal bleeding refractory to medical therapy and who are without significant fibroids or adenomyosis; submucosal and intrauterine myomas must be identified and resected. The addition of myolysis to endometrial ablation or resection in patients with fibroid tumors markedly improves the success rate of these minimally invasive alternatives to hysterectomy.

Acknowledgments

The author wishes to thank Dr. Charles Lockwood, professor and chair, Department of Ob/Gyn at New York University School of Medicine, New York, NY, for his manuscript review and invaluable suggestions. The author also thanks Stephanie L. Grasso, BS, for assistance with data collection, Aenov Lance for assistance with manuscript preparation, and Patrick Ross, PhD, for performing the statistical analysis.

Dr. Herbert A. Goldfarb is the director of the Montclair Reproductive Center and an advocate of alternative solutions to hysterectomy.

References:

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