Risk Reduction Salpingectomy for Permanent Contraception: Ready for Prime Time?

ABSTRACT & COMMENTARY

Risk Reduction Salpingectomy for Permanent Contraception: Ready for Prime Time?

By Jeffrey T. Jensen, MD, MPH

Synopsis: After a province-wide educational campaign advocating salpingectomy at the time of benign gynecologic surgery for ovarian cancer risk reduction, the incidence of salpingectomy rose sharply in British Columbia. This was associated with a modest increase in operative time but no increase in overall surgical morbidity.

Source: McAlpine JN, et al. Opportunistic salpingectomy: Uptake, risks, and complications of a regional initiative for ovarian cancer prevention. Am J Obstet Gynecol 2014;210:471.e1-11.

In 2010, after considering evidence supporting a tubal etiology for ovarian epithelial cancer, the gynecologic tumor group in British Columbia (BC) initiated a province-wide ovarian cancer prevention initiative. An informational and instructional DVD was distributed to all obstetricians and gynecologic surgeons in BC. This DVD outlined the role of the fallopian tube in ovarian cancer and explained the association of high-grade
serous cancer with inherited BRCA1/2 mutations.
Three recommendations were made to clinicians:
1) consideration of bilateral salpingectomy (BS) at the time of hysterectomy, even with ovarian preservation; 2) consideration of excisional BS for permanent contraception; and 3) referral of all patients with high-grade serous cancer for hereditary cancer counselling and genetic testing for BRCA1/2 mutations. In combination, these recommendations were projected to reduce ovarian cancer rates in the province of BC by 40% over 20 years.

In this paper, the authors performed a population-based retrospective cohort study to assess the effects of the educational campaign on surgical outcomes (operating time, surgical approach, indication, length of hospital stay, and perioperative complications) of 43,931 women in British Columbia from 2008-2011 who underwent hysterectomy that was performed with and without BS or bilateral salpingo-oophorectomy (BSO) or who underwent permanent contraception by means of BS or tubal ligation. The cohorts were defined by surgical technique (± BS).

Over the time period studied, the proportion of surgeries at which BS was performed increased significantly for both hysterectomy (5% in 2008 to 35% in 2011, P < 0.001) and permanent contraception (0.5-33%, P < 0.001). The greatest increase was in women younger than age 50 years. BS required significantly more operative time for both procedures (hysterectomy mean increase 16 minutes; sterilization 10 minutes, P < 0.001 for both). No significant differences were observed in the risks of hospital stay, readmission or blood transfusions in women who underwent hysterectomy, or permanent contraception with BS.

The authors concluded that an educational campaign to increase risk-reduction salpingectomy at the time of benign gynecologic surgery was effective in increasing the number of procedures performed, and this change in practice did not result in an increased risk of operative or perioperative complications.

Commentary

Ovarian cancer is an awful disease with a grim prognosis, as most tumors are diagnosed at an advanced stage. The recent interest in prophylactic salpingectomy as a risk-reduction strategy follows from clinical data that have demonstrated that prophylactic bilateral salpingo-oophorectomy reduces the risk of serous ovarian cancer associated with germline BRCA mutations.¹ Detailed serial sectioning of the fallopian tubes removed from BRCA-positive women have revealed the presence of precursor lesions in the fimbria called "tubal intraepithelial carcinomas (TICs)," with no correlating precursor lesions within the ovary.² More recent studies from women not tested for BRCA with serous ovarian cancers have documented similar lesions in the fimbriated end of the tube in at least 40-60% of cases.³ Taken together, these are compelling evidence to consider risk-reduction salpingectomy when the tubes are accessible during benign gynecologic surgery in low-risk women.

But should women considering permanent contraception be counseled to undergo BS? Arguments for this position are that the technique is simple and within the scope of most surgeons who perform surgical permanent contraception procedures by either laparoscopy or mini-laparotomy. A recent commentary published in Obstetrics & Gynecology cited the McAlpine paper as sufficient demonstration of safety to advocate routine BS for permanent contraception.⁴ However, my take on the results of McAlpine et al suggest a more conservative approach is warranted. While the paper documents that the number of BS procedures increased during the time period studied and that morbidity was low, this was not a randomized study or even a prospective cohort design. Imagine your last easy case and last very difficult case. Would you have made the same decision to proceed with an elective BS at the time of each of these surgeries? Given this, the fact that surgical morbidity was not increased in the BC study likely reflects case selection bias. If the decision was to proceed with BS even with difficult cases (as might be the case if you convince yourself and your patient that this is the goal of the operation), the results may have been different. In addition, the surgical time (already significantly longer with BS) may have been considerably longer. An additional 10 minutes may not seem like a long time, but operating room charges are by the minute, and additional surgical equipment is also needed to perform BS. Will insurers increase reimbursement if BS if performed for permanent contraception? Probably not.

Perhaps the most serious limitation of the Canadian study is the absence of data on the safety of BS in the postpartum setting. Visualization of the fallopian tube is limited during mini-laparotomy, and the veins within the broad ligament are greatly distended (more so if the uterus is exteriorized at the time of cesarean section). In my opinion, data from well-designed prospective studies are needed to gauge the safety of BS in the postpartum setting.

Most women will never develop ovarian cancer, and the number of BS procedures needed to prevent one case of serous ovarian cancer in low-risk women has not been established. Nor has the cost, overall safety, and long-term risks of the intervention. Remember that while the hypothesis of a tubal etiology for serous ovarian cancer is compelling, there are no clinical or epidemiologic data that support the benefit of risk reduction BS in low-risk women. While McAlpine and her coauthors hypothesize that routine BS will reduce ovarian cancer rates in BC by 40% over the next 20 years, this estimate does not excuse the lack of data. We do have robust epidemiologic data supporting a risk reduction with oral contraceptive use⁵ and traditional tubal ligation,⁶ so alternatives to BS exist and need to be factored into the conversation.

We recommend this approach in our Family Planning Clinic when women at low risk for ovarian cancer present for consultation on permanent contraception. First, consider a LARC method as these involve no surgery, provide a contraceptive benefit similar to permanent contraception, and some methods offer additional health benefits (e.g., LNG IUS treatment of heavy menstrual bleeding, endometrial protection). Next, decide if an abdominal or hysteroscopic approach is preferred. For pregnant women, a postpartum procedure is usually the best choice for overall efficacy, cost, and convenience. For interval procedures, many women elect to avoid abdominal surgery by undergoing hysteroscopic permanent contraception and are not candidates for BS. For women who wish to proceed with laparoscopy, we present a discussion of simple tubal interruption with Filshie clips or bilateral salpingectomy. We counsel that the latter procedure is offered for the additional health benefit of risk reduction for ovarian cancer, but that the evidence for this benefit is preliminary and based on results from high-risk women. They are told that BS will require more surgical time, involves an additional trocar site, and may increase risks of bleeding or injury to adjacent organs, in particular the ovary (although this risk is likely very small). We also mention that the feasibility and safety of BS may be affected by surgical findings. Given this discussion, about a quarter of our patients elect BS as a primary abdominal approach.

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