Combination Risk-Reducing Breast,Gynecologic and Reconstructive Surgery Among High-Risk Women: Does Surgical Order Impact Outcome?

Abstract

Background: As the number of patients diagnosed with BRCA mutations increases, the number of risk-reducing procedures also increasing. Previous researchers have documented that it is safe to perform combination surgery, including risk-reducing mastectomies and salpingo-oophorectomies, under the same anesthesia. Objective: The aim of this study was to examine, retrospectively, surgical outcomes of women undergoing combination cancer–risk reducing breast, gynecologic, and breast-reconstruction surgery. Design: This was a retrospective cohort study. Materials and Methods: Two hospital databases were searched from January 2011, to March 2014. Charts of women undergoing risk-reducing breast-gynecologic surgery together with breast reconstruction were identified. All patients had the gynecologic portion of the surgery preceding the breast surgery. High-risk qualifiers for study inclusion were: BRCA mutation; personal history of breast or gynecologic cancer; or first-degree relative with breast or gynecologic cancer. All surgeries were performed by the same team of surgeons, and Surgical Care Improvement Project guidelines were followed. Charts were reviewed to identify rates of surgical-site infections (SSIs), intraoperative complications, postoperative infection, and readmissions within 30 days of surgery. Results: Twelve high-risk patients underwent risk-reducing breast/gynecologic surgery together with first-stage breast reconstruction. No cases of SSI were documented within 30 days following the procedures in any of the 12 patients. One patient returned to the operating room for vaginal-cuff reapproximation and 1 was readmitted for a postoperative ileus that resolved with conservative management. Conclusions: This retrospective cohort demonstrates that, in high-risk women undergoing risk-reducing breast and gynecologic surgery together with breast reconstruction, operative teams can consider performing the gynecologic portion of the procedure first. This preliminary data should be confirmed with multicenter randomized controlled trials. (J GYNECOL SURG 32:124)

Introduction

As the number of patients diagnosed with BRCA mutations increases, the number of risk-reducing procedures offered to women are also on the rise.¹ To accommodate risk-reducing mastectomies and salpingo-oophorectomies in one surgical setting, previous investigators have documented that it is safe to perform combination surgery under the same anesthesia.^2–5 To the current authors' knowledge, the earliest case report dates back to 1999 in a 45-year-old female with a BRCA 2 mutation who successfully underwent bilateral, prophylactic, simple skin-sparing mastectomies; bilateral prophylactic oophorectomy; a hysterectomy; and bilateral single pedicle transverse rectus abdominis muscle flap breast reconstruction.² In the current series of patients, the breast portion of the procedure preceded the gynecologic portion of the surgery.

Since that case report was published, several additional series have been published documenting combination breast/gynecologic surgery under the same anesthesia. A 2008 series including 12 patients demonstrated that it is safe to perform prophylactic mastectomy at the time of bilateral salpingo-oophorectomy in high-risk patients who desire to undergo surgery in one operative setting.³ In that review, the breast portion of the combination surgery was performed first. The researchers concluded that there was an acceptable rate of morbidity in this setting to be deemed safe. In addition, in a 2010 review of 32 patients, researchers also concluded that is safe to perform combined hysterectomy/bilateral salpingo-oophorectomy and bilateral mastectomy in a single operation for female-to-male transsexuals.⁴ In 28 of the patients the hysterectomy/bilateral salpingo-oophorectomy operations were performed first. In 4 cases in that series, the mastectomy was performed first for logistical reasons. None of these patients had a breast reconstruction component to their operations. Finally, researchers who performed a 2014 review of 6 high-risk women also concluded that breast surgery and simultaneous laparoscopic bilateral salpingo-oophorectomy was safe.⁵ In that series, the mastectomies were performed first.

While other researchers have documented the safety of combination breast–gynecologic procedures under the same anesthesia,⁶ to the current authors' knowledge, no researchers have demonstrated that, in high-risk women undergoing risk-reducing breast/gynecologic surgery in combination with breast reconstruction, it is safe to perform the gynecologic (clean-contaminated) portion before breast surgery. Surgical dogma stresses that when combination procedures are performed. One should progress from clean to clean-contaminated to contaminated sites because of concern for increased risk of surgical-site infections (SSIs).⁷ However, an increased risk of SSIs has not been demonstrated in the literature. The aim of the current research was to examine retrospectively surgical outcomes of combination gynecologic, mastectomy, and breast reconstruction at the current authors' institutions.

Materials and Methods

After receiving institutional review board approval from St. Elizabeth Hospital, St. Edgewood, KY, and TriHealth Hospital, both hospital databases were searched for current procedural terminology codes from January, 2011, to March, 2014, to perform this retrospective cohort study. The charts of women undergoing combination breast/gynecologic surgery were identified and included if they had a BRCA mutation, a personal history of breast or gynecologic cancer, or a first degree relative with breast or gynecologic cancer. The primary outcome was SSI within 30 postoperative days. Secondary outcomes included surgical time defined as operating room (OR) start time to out of OR time; incidence of deep venous thrombosis defined by positive venous Doppler studies; pulmonary embolism defined by a positive ventilation perfusion scan; readmission rates within 30 postoperative days; and breast-implant complications defined as infection, breakdown, flap necrosis, or implant replacement. Charts were reviewed by 2 authors (R.G.S. and J.B.B.) to identify the aforementioned outcomes.

The standard procedure used in all of the current authors' cases is for the risk-reducing gynecologic surgery to be performed first by the gynecologic oncologist, followed by the risk-reducing breast surgery performed by the surgical oncologist, and finally the breast-reconstruction component performed by the plastic surgeon. Each patient received preoperative antibiotics selected by the gynecologic surgeon based on the patient's planned surgery and allergies, in accordance with Surgical Care Improvement Project guidelines.⁸ In addition, ∼1 hour prior to breast reconstruction, intravenous vancomycin was given for prophylaxis.⁹ Each patient received mechanical venous thromboembolism prophylaxis with pneumatic compression devices placed prior to induction of anesthesia.

Results

From January 2011, to March 2014, 12 high-risk patients were identified who underwent risk-reducing breast/gynecologic surgery in combination with a breast-reconstructive procedure. All 12 women, whose ages ranged from 33 to 63 and whose body mass index (BMI) ranged from 18.6 to 36 kg/m², had the gynecologic portion of the surgery preceding the breast surgery. Specific patient characteristics and surgical procedures are shown in Table 1. Nine patients had hysterectomy along with risk-reducing salpingo-oophorectomy. Three patients underwent bilateral salpingo-oophorectomy only. Eleven of 12 patients had a minimally invasive approach to the gynecologic portion of the procedure. In addition, 11 of 12 of the women had mastectomies, and all 12 patients underwent a component of breast reconstruction. The duration of OR times, calculated from OR start time to out of OR time, ranged from 197 minutes to 374 minutes, with a mean OR time of 308 minutes.

Table 1.

High-Risk Women Undergoing Combination Risk-Reducing Breast, Gynecologic, and Reconstructive Surgery

Case #	Age (in years)	BMI (kg/m ² )	Gynecologic procedure	Breast procedure	Diagnosis of breast cancer?	Diagnosis of ovarian cancer?	BRCA mutation?	Readmitted within 30 days?	Complications
1	38	27.1	Robotic TLH/BSO	Right modified radical mastectomy/reconstruction	Yes	No	BRCA1 mutation	No	None documented
2	42	33.2	Laparoscopic BSO	Left modified radical mastectomy, right total mastectomy/reconstruction	Yes	No	Unknown	No	None documented
3	52	22.1	Robotic TLH/BSO	Bilateral total mastectomy/reconstruction	Yes	No	BRCA variant of uncertain significance	No	None documented
4	53	26.5	Robotic TLH/BSO	Right modified radical mastectomy/reconstruction	Yes	No	Unknown	No	None documented
5	40	18.6	Laparoscopic BSO	Bilateral total mastectomy/reconstruction	Yes	No	BRCA2	No	None documented
6	54	25.8	Robotic TLH/BSO	Bilateral total mastectomy/reconstruction	Yes	No	BRCA2	No	None documented
7	33	23.0	Robotic TLH	Bilateral total mastectomy/reconstruction	No	Yes (previous BSO/staging)	Unknown	Yes	Vaginal bleeding requiring return to OR for cuff reapproximation
8	34	22.0	Robotic TLH/BSO	Bilateral total mastectomy/reconstruction	No	No	BRCA2	Yes	Ileus on POD # 8, readmission to hospital
9	49	27.0	Laparoscopic BSO/appendectomy	Bilateral mastectomy/ reconstruction	Yes	No	BRCA2	No	None documented
10	51	36.0	Robotic TLH/BSO	Bilateral capsulectomy removal of tissue expander and placement of permanent prosthesis	Yes	No	BRCA2	No	None documented
11	47	24.1	Robotic TLH/BSO	Bilateral total mastectomy, bilateral breast reconstruction	Yes	No	No	No	None documented
12	63	29.0	TAH/BSO	Right modified mastectomy, breast reconstruction with latissimus dorsi flap	Yes	No	No	No	None documented

BMI, body mass index; TLH, total laparoscopic hysterectomy; BSO, bilateral salpingo-oophorectomy; TAH, total abdominal hysterectomy.

There were no intraoperative complications and no documented postoperative infections, deep venous thromboses, or pulmonary emboli. Two patients were readmitted to the hospital. One patient returned to the operating room on postoperative day 28 secondary to bleeding from the vaginal cuff after sexual intercourse. The vaginal bleeding could not be controlled adequately in the outpatient office setting. Upon return to the operating room, the vaginal cuff was oversewn, and there was no evidence of vaginal cuff dehiscence. A second patient was readmitted on postoperative day 7 for nausea and vomiting. A postoperative ileus was diagnosed and the patient was managed nonsurgically and discharged to go home after a 2-day hospital stay. After a follow-up range of 6–44 months, none of the 12 patients had breast-implant complications.

Discussion

Since identification of the BRCA genes in the 1990s,¹⁰ there has been a tremendous growth of knowledge in the field of hereditary breast and ovarian cancer syndromes. Patients have more access to genetic testing and therapeutic options to decrease their risk of cancer than ever before. As genetic testing becomes more widespread, there is an anticipated increase in the identification of women with BRCA mutations and therefore an anticipated increased need for risk-reducing surgery in accordance with recommendations by the American College of Obstetricians and Gynecologists (ACOG).¹¹ However, the ACOG does not comment on combination risk-reducing surgery for breast and gynecologic cancers nor on the surgical order of combined procedures. There are many potential benefits of combination surgery, including one operative setting, one postoperative recovery period, reduced cost, and less time missed from work and other life activities.

Previous published accounts^3–5 have reported satisfactory outcomes among women undergoing risk-reducing breast and gynecologic surgery under the same anesthesia. However, the current cohort uniquely involved high-risk women who underwent combination risk-reducing breast and gynecologic surgery with the gynecologic portion performed before the breast reconstruction. These data from small retrospective cohorts raises questions about existing dogma that one must always progress from clean to clean-contaminated in combination cases.

There were several strengths of this retrospective cohort. First, this was the first case series involving women undergoing risk-reducing surgery in combination with breast reconstruction wherein the gynecologic portion was performed first. While, in another case series researchers reported combination surgery with the gynecologic surgery first in a transsexual population, none of those patients had breast reconstruction, which acts as a nidus for infection and increases the risk profile of the patient. Second, all patients in the current series were cared for by the same surgical team, removing operator variation as a potential confounding variable.

Inherent with a retrospective series there were limitations to this study that affect the generalizability of the findings. First, the study population represents women served in the Greater Cincinnati area and may not be generalizable to other populations. Second, given that all of the combination procedures were carried out in the same manner, there were no controls for comparing outcomes. Third, the study was limited by its small sample size.

An adequately powered, randomized controlled trial (RCT) would provide the strongest evidence on the best surgical method for these complex cases. Performing a randomized, noninferiority trial with the primary outcome of SSI among breast-reconstruction patients, assuming a baseline SSI rate of 5% based on the current literature, a total sample size of 472 patients would be needed to achieve 80% power, 5% alpha, and a noninferiority limit of 5%. Conducting a trial showing a 50% reduction in infection rates would require 903 patients in each arm for a total of 1806 participants. To perform a noninferiority trial in a reasonable length of time would require a multicenter approach with a strong research infrastructure. Demonstrating that one surgical method is superior to the other does not seem feasible.^12–14

An important characteristic of the cohort that might lend itself to satisfactory outcomes is the BMI of the patients in this study. Other researchers have documented the negative effects of obesity on combination gynecologic surgery and abdominoplasty¹⁵ as well as on breast reconstruction.^16,17 It is important to highlight that the BMI range of this cohort was 18.6–36.1 kg/m². The current authors encourage surgeons to include this information in their preoperative decision-making and patient counseling.

Conclusions

This study produced satisfactory results among high-risk women undergoing combination gynecologic, mastectomy, and breast reconstruction in a retrospective cohort of 12 women. Ultimately, a properly powered blinded RCT could help determine if the order of surgery affects patients' outcomes. Until such a trial is completed, based on promising results from a small cohort, with appropriate counseling, combination surgery with the gynecologic portion performed first can be offered as an option to a patient desiring management in one operative setting.

Footnotes

Acknowledgment

The authors would like to thank Donna Lambers, MD, for her assistance with manuscript preparation.

Author Disclosure Statement

The authors report no conflicts of interest.

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