Previous decision analyses demonstrate the safety of minimally invasive hysterectomy for presumed benign fibroids, accounting for the risk of occult leiomyosarcoma and the differential mortality risk associated with laparotomy. Studies published since the 2014 Food and Drug Administration safety communications offer updated leiomyosarcoma incidence estimates. Incorporating these studies suggests that mortality rates are low following hysterectomy for presumed benign fibroids overall, and a minimally invasive approach remains a safe option. Risk associated with morcellation, however, increases in women age >50 years due to increased leiomyosarcoma rates, an important finding for patient-centered discussions of treatment options for fibroids.
Background
Following a highly publicized case of morcellation–the practice of cutting uterine tissue into pieces or strips in minimally invasive surgery–where the patient was postoperatively diagnosed with leiomyosarcoma (LMS), the US Food and Drug Administration (FDA) issued safety communications in April and November 2014 about the use of morcellator devices. These communications resulted in significant changes in practice patterns among gynecologic surgeons and increasing rates of abdominal hysterectomy (AH), possibly leading to more complications for patients. We previously published a decision analysis that attempted to incorporate risks associated with AH and laparoscopic hysterectomy (LH) using estimates of LMS available to the FDA at the time of the initial communications. Mortality and quality-adjusted life-years favored LH in our model. However, numerous limitations compromised the studies used in the analysis, including the disparate time frames that date back to when some of the cases would not have been classified as cancer and inclusion of cases that were identified preoperatively and thus should never have been subject to potential morcellation.
Objective
We sought to update our decision analysis using studies published since the FDA communications to provide newer, higher-quality estimates of risk. We also added to the original analysis by incorporating the effect of age, which recent data suggest has a significant impact on the risk of malignancy among women undergoing surgery for presumed benign fibroids.
Objective
We sought to update our decision analysis using studies published since the FDA communications to provide newer, higher-quality estimates of risk. We also added to the original analysis by incorporating the effect of age, which recent data suggest has a significant impact on the risk of malignancy among women undergoing surgery for presumed benign fibroids.
Study design
We constructed a decision-tree model comparing clinical outcomes of LH and AH. Our primary outcomes were sarcoma- and hysterectomy-related mortality over a 5-year period following surgical intervention. Model design and clinical event inputs are presented elsewhere. Briefly, we simulated a hypothetical cohort of 100,000 women undergoing LH or AH for presumed benign leiomyomata. We examined the frequency of transfusion, wound infection, venous thromboembolism, incisional hernia, vaginal cuff dehiscence, overall mortality, and complications associated with occult LMS, including death.
In this updated model, we used a weighted average among studies published since the FDA safety communications to inform a new estimate of occult LMS incidence. Sensitivity analysis included the range of LMS incidence among the individual studies. As in our previous model, sarcoma-related mortality estimates were derived from Surveillance, Epidemiology, and End Results Program–based 5-year mortality reporting. We assumed that occult LMS in AH would afford the prognosis of an International Federation of Gynecology and Obstetrics stage I or stage II diagnosis (confined to the pelvis, 5-year mortality of 0.59) and that occult LMS with morcellation in LH, that of stage III (extrapelvic disease, 5-year mortality of 0.72). Thus, all women with occult LMS who underwent LH were given a worse prognosis than those undergoing AH. For our base-case model, we identified studies published after the 2014 FDA statements to calculate a weighted average of occult LMS incidence. In addition to our base-case model, we also compared 5-year mortality outcomes of AH and LH in women age <50 years and ≥50 years. We used recent studies that categorized incidence by age to modify predicted rates of occult LMS according to age subgroup.
The study was considered exempt from institutional review board approval because it involved analysis of previously published data.
Results
We identified 11 studies published since the FDA safety communications of sufficient quality and pertaining to our target population of women undergoing hysterectomy who might be subject to morcellation ( Table ). The number of subjects ranged from 808-241,114 and LMS rates ranged from 0-0.0032 (1:314). In total, 539 cases of LMS were found among 318,006 surgeries for a weighted average of 0.0017. Using this LMS estimate and our base-case estimate for mortality from the procedure itself (LH 0.00012, AH 0.00032), overall mortality remained similar between groups, slightly favoring AH (2 fewer deaths overall). In sensitivity analyses, the number of incremental deaths ranged from 20 fewer in the LH group to 21 fewer in the AH group, with most scenarios favoring LH ( Figure 1 ). We also identified 1 additional study published since our original decision analysis that provided new estimates of mortality from the procedure itself, 0.00013 among 23,956 LH and 0.00034 among 14,616 AH. One-way sensitivity analyses using these estimates favor LH over AH in most scenarios ( Figure 1 ).
| Publication year | Author | Location | Study period | No. of subjects | Study characteristics | Observed leiomyosarcoma incidence |
|---|---|---|---|---|---|---|
| 2015 | Tan-Kim et al | United States | 2001 through 2012 | 941 | Laparoscopic hysterectomy patients with morcellation | 1:314 (0.0032) |
| 2016 | Raine-Bennett et al | United States | 2006 through 2013 | 34,728 | Hysterectomies for presumed benign fibroids | 1:429 (0.0023) |
| 2015 | Graebe et al | United States | 2005 through 2013 | 1361 | Laparoscopic hysterectomy patients with power morcellation | 1:454 (0.0022) |
| 2015 | Mao et al | United States | 2008 through 2011 | 241,114 | Patients undergoing hysterectomy or myomectomy, SEER California registries | 1:585 (0.0017) |
| 2016 | Paul et al | India | 2004 through 2014 | 1781 | Laparoscopic hysterectomy patients with vaginal morcellation | 1:594 (0.0017) |
| 2016 | Rodriguez et al | United States | 2002 through 2011 | 12,226 | Laparoscopic supracervical hysterectomy for fibroids among US insurance claims | 1:763 (0.0013) |
| 2015 | Pritts et al | Various | 1984 through 2014 | 30,193 | Meta-analysis of 133 studies on myomectomy or hysterectomy for fibroids; required histopathology to be explicitly reported; included studies where cancer was not found | 1:1961 (0.00051) |
| 2016 | Kho et al | United States | 2010 through 2014 | 10,119 | Hysterectomies at single institution | 1:2023 (0.00049) |
| 2015 | Bojahr et al | Germany | 1998 through 2014 | 10,731 | Laparoscopic supracervical hysterectomy patients with morcellation | 1:5400 (0.00019) |
| 2016 | Picerno et al | United States | 2004 through 2015 | 1004 | Laparoscopic hysterectomy or laparoscopic myomectomy with morcellation | 0 |
| 2015 | Brown et al | United States | 2002 through 2008 | 808 | Laparoscopic supracervical hysterectomy with morcellation | 0 |
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