Outcomes of Fibroids

Outcome And Prongosis

Despite a long history of using myomectomy and extensive literature on this procedure, data are actually poor because of 2 important issues related to outcome. In particular, both the recurrence rate and the impact on fertility have been poorly studied.

Abdominal myomectomy

In 1998, Vercellini et al extensively reviewed abdominal myomectomy as a fertility-enhancing procedure. They noted that although numerous papers report on fertility outcomes after myomectomy, they all share the same serious flaws. In particular, not a single study included controls or used randomization. Only a few of the studies used life-table analysis. All used differing definitions of infertility and included heterogeneous uses of other infertility treatments. Nonetheless, the studies were fairly consistent, with approximately two thirds of patients with myomas and otherwise unexplained infertility conceiving after myomectomy.

Similar results were noted in both prospective and retrospective studies. However, results were very inconsistent when subgroups were analyzed. Myomectomy continues to be offered routinely to patients with uterine fibroids and infertility, but until controlled studies with expectantly managed controls are performed, the benefit of this procedure for patients remains unclear.

The risk of myoma recurrence is similarly poorly studied. Patients undergoing myomectomy should be counseled that they are at risk for fibroid recurrence and the potential for additional surgery in the future. Unfortunately, proper studies to determine recurrence risk are not available. Most studies are limited because they include heterogeneous study groups composed of a mixture of symptomatic patients who are treated for fibroids and asymptomatic patients who are treated for infertility. Follow-up in all of these studies is poor, with many patients lost to follow-up and most with very short follow-up periods. Because fibroids may recur slowly over a long period, studies with short follow-up times do not yield the necessary information.

In addition, the studies use different definitions of recurrence, some limited only to symptomatic recurrence and some including patients with asymptomatic fibroids detected after ultrasound or pelvic examination. Most do not use life-table analysis.

Many women are likely to experience recurrence of myomas after myomectomy. In 1995, Fedele et al reported on the use of ultrasound to help diagnose recurrences and noted a cumulative recurrence rate of 51% over 5 years. However, asymptomatic recurrence is not generally a relevant outcome. Limiting to studies that look at patients who require reintervention after myomectomy and appreciating that most of these studies have short (<5-y) follow-up, recurrence rates of 8-27% are noted (see Table 1). Most of the higher rates are noted in older studies, when hysterectomy was performed for much more liberal indications and was performed much more frequently. Looking at these studies, the medium-term risk for the need for repeat surgery after myomectomy is 5-10%. In the only recent study of risk factors for subsequent surgery (Stewart, 2002), the reported repeat surgery rate was 35%, with most of these being endoscopic procedures.

Several studies established particular risk factors for reoperation. In 1969, Malone noted that removal of multiple myomas was a strong risk factor for reoperation. Future repeat surgery was required in 26% of patients with multiple myomas, compared with 11% of patients with single myomas. Also, pregnancy after myomectomy appears to be protective. In 1991, Candiani et al noted that over 10 years following myomectomy, 15% of patients achieving pregnancy and 30% of patients not achieving pregnancy required repeat surgery. In 2002, Stewart et al noted a decreased risk of repeat surgery if the uterus was greater than 12 weeks' size at the time of the initial surgery (hazard ratio, 0.1; 95% confidence interval, 0.01-0.4) and an increased risk with weight gain of more than 30 pounds since age 18 years.

Table 1. Summary of Studies Reporting Need for Future Surgery for Myomas After Myomectomy

Laparoscopic myomectomy

Fertility rates after laparoscopic myomectomy have been reported in several studies, and, overall, the pregnancy rates and spontaneous abortion rates with laparoscopic myomectomy seem to be comparable to those with abdominal myomectomy. A few studies have reported on the risk of recurrence after laparoscopic myomectomy.

One study (Nezhat, 1998) followed 114 women for a mean of 37 months and defined recurrence as the return of any myoma. The cumulative recurrence risk was 10.6% at 1 year, 31.7% at 3 years, and 51.4% at 5 years. Eight patients underwent repeat laparoscopic myomectomies. One patient underwent 2 laparoscopic myomectomies. One patient had a myomectomy and then a total abdominal hysterectomy, and 6 had total abdominal hysterectomies. Of the patients, 14% required repeat surgery.

Another group (Doridot, 2001) followed 192 women after laparoscopic myomectomy and found a cumulative recurrence risk, based on symptoms and ultrasound findings, of 16.7% at 5 yrs. Approximately 4% of their patients required further surgery. Interestingly, another study (Rossetti, 2001) noted that the preoperative use of GnRH agonist increased the risk of myoma recurrence after laparoscopic myomectomy.

In 1992, Goldfarb presented data on patients who underwent myolysis with the Nd:YAG laser. He studied 75 patients and reported 50% shrinkage of the myomas at 6 months. This series, similar to most others on minimally invasive techniques, reported no medium- or long-term data on pregnancy or need for future procedures. In 1998, Chapmanreported on a similar procedure performed on 293 patients. Of these, 6 patients required hysterectomy and 30 had future pregnancies. In 1995, Goldfarb reported on myolysis with bipolar cautery and reported 83% shrinkage over 6 months. One series reported 2 of 3 patients with uterine rupture after they became pregnant within 3 months of the procedure (Vilos, 1998).

Hysteroscopic myoma resection

Many studies have assessed fertility rates after hysteroscopic myomectomy and have noted pregnancy rates similar to those after abdominal myomectomy, approximately 60% (see Table 2). Again, no studies include expectantly managed control groups.

Table 2. Pregnancy Rates in Patients Undergoing Hysteroscopic Myomectomy

Reoperation after hysteroscopic myomectomy has also been studied. As usual, these studies are limited by short follow-up periods. In 1995, Ubaldi et al reviewed older studies, which had reoperation rates of 5-25% after as long as 3 years of follow-up. In 1999, Vercellini et al studied 108 women who had hysteroscopic resection of submucous, pedunculated, sessile, or intramural leiomyomas. After a mean follow-up of 41 months, 27 patients had myoma recurrence based on ultrasound findings, with a 3-year cumulative recurrence rate of 34%. Twenty women had recurrent menorrhagia, with a 3-year rate of 30%.

In 1999, Emanuel et al reported on 285 women who had submucous myomas treated with hysteroscopic myoma resection without endometrial ablation. Several patients required multiple procedures. Patients were monitored for a median of 46 months. Forty-one patients (14.5%) required repeat surgery. Patients who required repeat surgery were more likely to have larger uteri and higher numbers of submucous myomas. Hysterectomy was required in 20 of the 41 patients who required repeat surgery. Most (90.3%) patients with normal-sized uteri and 2 or fewer myomas did not require future surgery at 5 years.

In a second series from Britain, also reported in 1999, Hart et al studied 122 women for a mean of 2.3 years. Of these women, 21% required repeat surgery by 4 years and 0% thereafter. Their regression analysis suggested that outcome was better in older women in whom the uterus was smaller than or equal to 6 weeks' gestational size or the fibroid was smaller than or equal to 3 cm and mainly intracavitary. In 1994, Donnez et al studied the recurrence of menorrhagia based on the site of the myoma. They noted that women who had multiple submucosal myomas were much more likely to have recurrent symptomatic menorrhagia than women who had only 1-2 myomas. Having the largest diameter inside the uterine cavity and the largest portion of the uterine wall were less accurate predictors.

Vaginal removal of a prolapsed myoma

Management of a prolapsed vaginal myoma can also be problematic. A single study (Ben-Baruch, 1988) noted that removal of prolapsed myomas represented 2.5% of all procedures for myomas. Approximately 93.5% of these procedures were successful with transvaginal removal, and 6.5% of patients needed a total abdominal hysterectomy. Of the failures, only 1 had very serious complications. After the initial vaginal myomectomy, 34 patients were monitored for a median of 5.5 years. In these patients, 79% had no further symptoms from their fibroids. Of those remaining, 21% developed other symptoms, of whom 6% required a hysterectomy, 6% had a single repeat prolapsed myoma, and 3% (1 patient) had multiple repeat procedures.

FUTURE AND CONTROVERSIES

Many questions remain regarding the natural course of untreated fibroids, the efficacy of medical management, and the unanswered questions regarding surgery as discussed. The 2001 Agency for Health Care Research and Quality evidence-based review provides a superb review of these topics.

Current controversies include the role of minimally invasive procedures. In particular, laparoscopic myomectomy has many theoretical advantages, including lower cost and avoidance of prolonged hospitalizations. However, whether the repair of the defect is as effective as that performed with abdominal myomectomy remains unclear, and the procedure may be associated with an increased risk of uterine rupture during pregnancy.

Medical therapy is also being explored. At present, data for medical management, particularly new treatments such as tibolone or older treatments such as controlling symptoms with birth control pills, are very scant. The role of GnRH analogs also requires further clarification. The advantages in terms of making the fibroids smaller must be balanced against the high cost and the subsequent inability to locate fibroids that were previously reduced by treatment.

A number of newer treatments are being explored. Uterine artery embolization, in particular, may be an especially promising minimally invasive approach to fibroids (Siskin, 2000; Hurst, 2000). In this procedure, angiographic catheters are introduced in the groin and passed to the uterine artery under fluoroscopic guidance. Microspheres are then injected, which lodge in the blood supply to the myomas and cause them to infarct. Significant pain from the acute infarction of the myomas usually requires hospital admission for pain control.

A number of complications have been reported, including prolapsing myomas, infection and hematoma at the catheter placement site in the groin, and bleeding and infection requiring hysterectomy. However, short-term results for relief of heavy bleeding and pelvic pain and pressure have been good. Because this is a newer procedure, only a small number of follow-up evaluations past 2 years are available to estimate recurrence rates. One study suggested that women are able to achieve successful pregnancies after uterine fibroid embolization without significant adverse outcomes. However, data are extremely limited and larger prospective studies are needed (Pron, 2005). In 2004, the US Food and Drug Administration approved a new technology, ExAblate 2000. Studies with this new technique, which uses high-intensity focused ultrasound waves under MRI guidance to induce coagulation necrosis in fibroids, are ongoing (Stewart, 2003).

Also conceivable is that as more is learned about the genetics of leiomyomas, targeting the specific genetic defect to help prevent or treat myomas may eventually be possible.

Prognosis

Fibroids often shrink after menopause because they need female hormones to grow. Many women have small- to moderate-size fibroids throughout their childbearing years that cause them few or no problems. Several medical and surgical options are available to treat or remove troublesome fibroids without having to remove the uterus.