Myomectomy to Conserve Fertility: Seven-Year Follow-Up

Transcription

1 GYNAECOLOGY Myomectomy to Conserve Fertility: Seven-Year Follow-Up Roopina Sangha, MBBS, MD, MPH, 1 Ronald Strickler, MD, FRCSC, MBA, 1 Marisa Dahlman, MD, 2 Suzanne Havstad, MA, 3 Ganesa Wegienka, PhD 3 1 Department of Women s Health Services, Henry Ford Health System, Detroit MI 2 Virginia Mason Medical Center, Seattle WA 3 Department of Public Health Services, Henry Ford Health System, Detroit MI Abstract Objective: To observe the occurrence of pregnancy in women undergoing minimally invasive and open myomectomy for symptoms attributed to uterine fibroids and who desire future pregnancy. Methods: We performed a retrospective chart review of women who had undergone myomectomy at least two years previously within the Henry Ford Health System in Detroit, MI. We reviewed the subsequent fertility outcomes according to the fertility goals identified by each woman. Results: During the seven-year observation window, 310 women underwent myomectomy and 124 (40%) of these women desired pregnancy. Forty-nine women desiring pregnancy (40%) conceived, and 30 (61% of those who conceived) delivered a viable infant from their first pregnancy. In addition, two women had a live birth after a miscarriage, and one had a live birth after an ectopic pregnancy. Five women had a second live-born baby. There were no differences in the occurrence of pregnancy or pregnancy outcome according to surgical approach, patient age or race, number of uterine incisions, or whether the endometrial cavity was entered. In addition, five of 186 women who did not have a fertility goal (3%) conceived, and one woman delivered two babies. Conclusion: Myomectomy performed to preserve fertility resulted in approximately one in four women having a live birth, independent of surgical technique. Résumé Objectif : Se pencher sur la probabilité d obtenir une grossesse chez les femmes qui ont subi une myomectomie (ouverte ou à effraction minimale) en raison de symptômes ayant été attribués à la présence de fibromes utérins et qui souhaitent encore connaître une grossesse. Méthodes : Nous avons mené une analyse rétrospective des dossiers des femmes qui avaient subi une myomectomie au moins deux ans au préalable au sein du Henry Ford Health System de Détroit, au Michigan. Nous avons analysé les issues de fertilité subséquentes en fonction des objectifs génésiques identifiés par chacune de ces femmes. Résultats : Au cours de la période d observation de sept ans, 310 femmes ont subi une myomectomie et 124 (40 %) de ces femmes souhaitaient obtenir une grossesse. Parmi ces dernières, 49 (40 %) y sont parvenues et 30 d entre elles (soit 61 % des femmes ayant obtenu une grossesse) ont accouché d un enfant viable dès leur première grossesse. De plus, deux femmes en sont venues à accoucher d un enfant vivant après avoir d abord connu une fausse couche et une femme en est venue à accoucher d un enfant vivant après avoir d abord connu une grossesse ectopique. Cinq femmes en sont venues à accoucher d un deuxième enfant vivant. Aucune différence n a été constatée en ce qui concerne l obtention d une grossesse ou en matière d issue de grossesse en fonction de l approche chirurgicale, de l âge ou de l origine ethnique de la patiente, du nombre d incisions utérines ou de la pénétration ou non de la cavité endométriale. De surcroît, cinq des 186 femmes qui n avaient pas d objectifs génésiques (3 %) en sont venues à connaître une grossesse (une de ces femmes a même accouché de deux enfants). Conclusion : La myomectomie menée dans le but de préserver la fertilité a permis à environ une femme sur quatre d accoucher d un enfant vivant, peu importe la technique chirurgicale utilisée. Key Words: Fibroids, abdominal myomectomy, pregnancy, robotic-assisted laparoscopic myomectomy Competing Interests: None declared. Received on June 26, 2014 Accepted on September 10, 2014 J Obstet Gynaecol Can 2015;37(1): JANUARY JOGC JANVIER 2015

2 Myomectomy to Conserve Fertility: Seven-Year Follow-Up INTRODUCTION Myomectomy is the recommended treatment for symptomatic uterine fibroids when women wish to preserve their fertility. 1 3 Traditionally, this procedure has been performed by laparotomy or mini-laparotomy. Using a laparoscopic technique provides a shorter hospital stay and a faster recovery for patients undergoing elective myomectomy. 1,2,4 8 Some authors have reported improved fertility outcomes following minimally invasive myomectomy procedures. 9,10 However, Palomba et al. reported in 2007 that fertility and obstetric outcomes were similar for patients undergoing mini-laparotomy or laparoscopy for myomectomy. 11 Robotically assisted laparoscopy has been shown to be non-inferior to traditional laparoscopy in terms of both surgical outcomes and complications. 8,12 16 Recently, Pitter et al. 17 published a multicentre descriptive study of the fertility and obstetric outcomes of 107 patients who conceived after undergoing robotically assisted laparoscopic myomectomy. They cautioned that the high prevalence of infertility patients in their cohort limited applicability of the outcomes to a general obstetrics and gynaecology population. The first robotically assisted laparoscopic myomectomy at our institution was performed in January Before then, myomectomies were performed via laparotomy or mini-laparotomy. The most common reason for women to prefer myomectomy to image-guided ablation procedures or hysterectomy at our institution, was the stated desire to conserve future fertility. Accordingly, we wished to determine the fertility outcomes in women who were undergoing minimally invasive or open myomectomy for symptoms attributed to uterine fibroids and who desired a future pregnancy. METHODS We reviewed the records from all patients who underwent myomectomy at our institution from January 2005 to December 2009, and allowed a further 24 months of follow-up time to observe obstetric outcomes. Ours is a teaching institution that provides tertiary care. Women who had undergone myomectomy were identified based on International Classification of Diseases, 9th Revision and Current Procedural Terminology codes for ABBREVIATIONS AM open abdominal myomectomy ART RM assisted reproductive technologies robotically assisted laparoscopic myomectomy uterine fibroids, abnormal bleeding, pain, infertility, and open or laparoscopic myomectomy. We excluded cases of myomectomy performed during hysterectomy to aid with visualization and performed incidentally at the time of Caesarean section. Only women who had their index myomectomy at least two years before chart review were included in the study. All data were abstracted from the electronic medical record used by all practitioners within the Henry Ford Health System. Metrics collected on each patient included demographic data (age, race), objective clinical characteristics (number of fibroids, size of largest fibroid), intraoperative data (number of uterine incisions, number of fibroids removed, and cavity entry), pathology (diagnosis, weight of fibroids), fertility therapy (use of assisted reproductive technologies), and pregnancy outcomes. Patients were included in the fertility goal group if they were actively attempting pregnancy, were undergoing fertility treatment, or reported regular sexual activity without the use of any contraception. Subgroups in our analysis were: 1. patients with a fertility goal who did not achieve pregnancy and did not use any ART, 2. patients with a fertility goal who spontaneously conceived, 3. patients with a fertility goal who used ART, and 4. patients who did not have a fertility goal and who had a pregnancy outcome. Pregnancy was diagnosed when there was ultrasound confirmation of a fetal pole. Patients were classified according to whether they had undergone open abdominal myomectomy or robotically assisted laparoscopic myomectomy. Those who underwent laparoscopic myomectomy were included in the RM group. For AM cases, uterine incisions were made with either monopolar cautery or scalpel; fibroids were dissected bluntly, sometimes with the assistance of monopolar cautery; and uterine defects were repaired in three to four layers, most often using delayed-absorption braided polyglactin suture. At RM cases, uterine incisions were made with monopolar cautery; fibroids were extracted with a combination of cautery (both monopolar and bipolar) and blunt dissection; and uterine defects were repaired in three to four layers with either delayed-absorption braided polyglactin suture or delayed-absorption barbed monofilament polyglyconate suture. Descriptive statistics were calculated to understand the fertility experience of women undergoing myomectomy. Percentages of clinical and surgical characteristics and outcomes were determined within each patient group, JANUARY JOGC JANVIER

3 Gynaecology Table 1. Patient demographics and pertinent treatment outcomes that influenced pregnancy occurrence in 310 women undergoing myomectomy No fertility goal (n = 186) Fertility goal (n = 124) Demographic and treatment outcomes No conception Conceived but not attempting pregnancy No conception No ART Conceived spontaneously Used ART Black 135 (75) 5 (100) 42 (82) 28 (74) 27 (77) White 17 (9) 0 (0) 6 (12) 8 (21) 5 (14) Other 29 (16) 0 (0) 3 (6) 2 (5) 3 (9) Mean age, years (SD) 37.7 (6.7) 34.1 (4.6) 37.6 (5.6) 34.2 (4.4) 36.6 (3.7) Age range, years 21.2 to to to to to 44.8 No. of minimally invasive surgical 79 (44) 1 (20) 20 (39) 17 (45) 8 (23) procedures* No. of open surgical procedures 102 (56) 4 (80) 31 (61) 21 (55) 27 (77) Incision no.: 1 to 2 92 (54) 3 (60) 27 (55) 17 (47) 19 (58) Incision no.: > 3 79 (46) 2 (40) 22 (45) 19 (53) 14 (42) Cavity entry: yes 53 (30) 2 (40) 15 (29) 9 (24) 15 (43) Cavity entry: no 125 (70) 3 (60) 36 (71) 28 (76) 20 (57) Infertility: yes (ICD-9: 628) 0 (0) 0 (0) 18 (35) 4 (11) 17 (49) Values are presented as n (%) unless otherwise indicated. Some women have missing data for number of uterine incisions. *Two laparoscopic myomectomies were included with the robotic myomectomies for analysis. and were qualitatively described and compared. The mean age, standard deviation, and range of age at the time of surgery were calculated for each patient group. All cases and all available data were included in the report; therefore, no prospective sample size calculation was determined. Women whose fertility intention was missing were assigned to the no fertility goal group, and patients lost to followup were assigned to the sub-group of no pregnancy achieved. Approval for this study was obtained from the Henry Ford Health System Institutional Review Board. RESULTS Of the 310 cases, 124 were classified as having a current fertility goal. The 174 women who self-identified as not attempting pregnancy and the 12 with missing data were combined; thus, 186 women made up the no fertility goal group. The demographics, relevant surgical data, and fertility treatments of these patients are summarized in Table 1. Race and age were similar in patients with and without a fertility goal. Most identified themselves as Black; this reflects the population served by Henry Ford Hospital in the city of Detroit and the known higher occurrence of these tumours in African-American women. The mean ages of the women who had a surprise pregnancy and the women who spontaneously conceived were similar, and these women were younger than the women who participated in ART. There were more open procedures among the patients who used ART, and this subgroup of patients was more likely to have an ICD-9 code for infertility. Both observations reflect the practice pattern of the three reproductive endocrine specialists who provided care during the study time interval. Indeed, only one woman who spontaneously conceived had an ICD- 9 code for infertility as her primary diagnosis, whereas one quarter of those women who failed to conceive and one half of the ART group had this designation. Within the ART group, 24 women used only fertility medications and/or intrauterine insemination (husband or donor sperm) and 13 women participated in an in vitro fertilization procedure. In the 124 women who stated pregnancy was an immediate goal, we identified three groups. The first group (51 women) did not achieve pregnancy. Thirty-eight women who made up the second group conceived spontaneously. The third group of 35 women received assistance ranging from fertility medications and/or artificial insemination to in vitro fertilization. The outcomes of these patient categories, which were similar in size, are summarized in Table 2. The occurrence of pregnancy was highest in the spontaneous conception group. In addition, five women in the group who denied having a pregnancy goal at the time of surgery conceived a pregnancy. In one woman, the first 48 JANUARY JOGC JANVIER 2015

4 Myomectomy to Conserve Fertility: Seven-Year Follow-Up Table 2. Outcomes of the first pregnancy following myomectomy No pregnancy goal Pregnancy goal* Conceived spontaneously, Conceived Pregnancy outcome but not attempting pregnancy n (%) spontaneously n (%) Used ART n (%) No conception 5/186 (3) 0/38 (0) 22/35 (63) Live birth, singleton 1/5 (20) 23/38 (61) 5/35 (14) Live birth, twins 0 (0) 1/38 (3) 1/35 (3) Spontaneous abortion 1/5 (20) 8/38 (21) 5/35 (14) Elective abortion 1/5 (20) 1/38 (3) 0 (0) Ectopic pregnancy 0 (0) 1/38 (3) 0 (0) Unknown 2/5 (20) 3 (8) 1 (3) Vaginal birth 0 2/24 (8) 0 Caesarean section 2 (100) 21/24 (83) 6/6 (100) Total babies (including second conceptions and twins) ART: assisted reproductive technology *Data for 51 patients who had no conception and no ART are not shown Denominator is the total patients in group Some women have missing data for mode of delivery. Percentages do not add to 100% because of rounding. pregnancy outcome was a live birth, and she also delivered a second term pregnancy by Caesarean section. One woman miscarried. Three other women are believed to have had unintended pregnancies, as all were abortions outside our health system (one was documented as a voluntary interruption of pregnancy). The Henry Ford Health System provides elective pregnancy termination only for diagnoses that threaten the life of the mother or the quality of life of the unborn. The overall pregnancy outcomes for all groups, including the surprise pregnancy cluster, are similar. Finally, a small number of women who intended pregnancy conceived more than once. In the ART group, one woman delivered two live-born children, one had a delivery after a miscarriage, and one woman experienced three consecutive early pregnancy losses. In the spontaneous conception group, the woman who first experienced an ectopic pregnancy had a singleton term vaginal delivery. Four women had two singleton deliveries. One woman first had a miscarriage followed by a singleton delivered by Caesarean section. Two women had two and three consecutive early losses respectively. Miscarriages were equally represented among the groups (Table 2). The single ectopic pregnancy occurred in a woman who had undergone RM and then had a natural conception. Similarly, late pregnancy outcomes, including four preterm deliveries (before 37 completed weeks of gestation), symptomatic or asymptomatic thinning of the uterine wall (data not shown), and the likelihood of undergoing Caesarean section, were not different based on the surgical approach used for myomectomy. The single major pregnancy complication (uterine rupture at 39 weeks during a twin gestation, resulting in emergency Caesarean hysterectomy) occurred in a patient who had undergone AM and subsequent in vitro fertilization. The Kaplan Meier estimates for pregnancy rates in those who were trying to become pregnant did not differ by procedure type (P = 0.60), even after adjusting for patient age (P = 0.64). DISCUSSION In this retrospective observational study, we found a high probability that fertility would be conserved in many women who underwent AM or RM to correct symptoms attributed to their fibroids. Furthermore, although patients who undergo RM recover faster, have less blood loss, and may form fewer adhesions, 1,2,4 8 RM did not conserve future fertility better than AM in our population of women managed largely by generalist obstetrics and gynaecology surgeons using community standards in a metropolitan area. Even after adjusting for important clinical factors, including entry into the uterine cavity, rates of conception did not differ between patients undergoing the two surgical approaches. This supports the observation of Palomba et al. 11 JANUARY JOGC JANVIER

5 Gynaecology It is important to state that this study is not a truly valid comparison of AM and RM. We reviewed our experience with every patient within a single health care system, because the most frequently stated reason for our patients to reject hysterectomy and uterine artery embolization is a desire for future pregnancy. Indeed, only 11 patients who did not use ART and 46 of the 124 who specified a fertility goal (37%) had a recorded diagnosis of infertility, and this was in a health system in which commercial insurance plans largely cover infertility services. It is notable that approximately one third of women who accessed ART achieved pregnancy, whereas after combining the no pregnancy/no ART and spontaneous conception patients, almost one half became pregnant (Table 2). Thus, unlike in the study of Pitter et al., 17 ours was not an infertile cohort of women who happened to have fibroids, nor was it a cohort treated only by using RM. Rather, our study describes a cross-section of women with symptomatic fibroids whose outcomes after myomectomy using any surgical technique were followed for up to seven years and a subset of women who also had infertility. It is notable that 93% of the live births following myomectomy (37/40) were by Caesarean section. From a review of more than pregnancies and nearly deliveries, the risk of uterine rupture after myomectomy is < 0.002%. 18 Weibel at al., from a survey of Canadian obstetricians, reported that seven of 10 accoucheurs would recommend delivery by Caesarean section after violation of the cavity by any surgical technique, 19 despite a complete absence of medical evidence to support this practice. Obstetricians in the Henry Ford Health System seem to be equally committed to Caesarean section following myomectomy. One of the strengths of this study is the inclusion of all women undergoing myomectomy at a single health system that has one of the largest multispecialty medical groups in the United States. The system-wide inpatient and ambulatory care electronic medical record used by all care providers allowed expanded data collection, because most patients continued care with a provider within the Henry Ford Health System. Follow-up extended to seven years beyond the AM or RM procedure. Every patient who underwent myomectomy was included, and, as with an intention-to-treat analysis, patients whose pregnancy goal was not reported were assumed to have had no pregnancy intention at the time of surgery, and patients lost to followup were assumed not to have conceived. Although our review began with 310 patients who were treated surgically, only 124 met our definition for desiring pregnancy. Forty-nine women (40%) conceived and delivered a total of 40 live-born babies. These numbers are small and offer insight into why Pitter et al. performed a multicentre study. 17 Our observations mirror the 127 pregnancies in the 872 women managed with RM in their study. 17 Retrospective chart review is subject to gaps in clinical documentation: neither an electronic health record nor the standardization within a medical group can defeat human behaviour. For example, the most significant metric for fertility impaired by fibroids is having fibroids in a location that compromises endometrial and uterine cavity integrity. 19 Preoperative imaging and operative reports were often mute or ambiguous regarding this metric. Finally, in this multi-year review and follow-up that included both AM and RM surgical approaches to myomectomy for symptomatic fibroids in women who desired future fertility, we found no differences in the occurrence of pregnancy or in obstetrical outcomes. While some will see this as further reason to champion minimally invasive surgery for everyone, the approximately three fourths of gynaecologic surgeons that continue to use traditional open procedures for myomectomy may feel vindicated by these data. 20 Prospective, randomized controlled trials that address the patient (time to full activity), societal (cost of technology/ cost of care/cost of missed productivity), and obstetrical (live born) outcomes, along with medical confounders (size and location of tumours), surgical confounders (cavity entry), secondary diagnoses (infertility, endometriosis), and other related factors confounding outcomes are needed before any surgeon can claim real insight. CONCLUSION Myomectomy performed to preserve fertility resulted in approximately one in four women subsequently having a live birth, independent of surgical technique. Prospective randomized controlled trials of different surgical and therapeutic approaches are indicated. REFERENCES 1. 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