Laparoscopic hysterectomy has grown tremendously in the 30 years since the first was performed.1 Minimally invasive surgery is now standard of care, and laparoscopy is the most common mode of hysterectomy.2,3
The electric power morcellator was developed to remove bulky specimens from the abdomen through laparoscopic incisions. Safety concerns regarding dissemination of occult gynecologic malignancy with power morcellation were reported in The Wall Street Journal on December 18, 2013.4 On April 17, 2014, the U.S. Food and Drug Administration (FDA) issued a safety communication recommending discontinuation of power morcellation in hysterectomy and myomectomy.5 Most surgeons stopped using power morcellation,6,7 and many reported increasing their practice of laparotomy.6 Improvements in safe alternatives to power morcellation is an area of rich ongoing discussion, research, and innovation.
Minimally invasive hysterectomy has fewer complications than laparotomy (8.2% vs 25.8%).8 The increase in abdominal hysterectomy after the FDA safety communication was accompanied by increased complications.9 Multiple groups reported that minimally invasive hysterectomy and myomectomy decreased after the FDA communication, and laparotomy increased.9–12 A limitation of these studies is that they evaluated only immediate changes to practice patterns and not long-term effects.
This study aims to characterize longer-term national trends in surgical approach for hysterectomy after the FDA warning against power morcellation. We hypothesized that, after an adjustment period to update surgical technique, laparoscopic hysterectomy would return to its prior rate of growth while supracervical hysterectomy would undergo a sustained decline, because these cases do not have access to a colpotomy for specimen removal.
A descriptive study was performed using data from the American College of Surgeons National Surgical Quality Improvement Program Participant Use Data Files from 2012 to 2016. The National Surgical Quality Improvement Program Participant Use Data Files contain de-identified data from adult patients undergoing inpatient or outpatient major surgical procedures, as well as the 30-day postoperative course. Data were collected from patient charts and entered into the National Surgical Quality Improvement Program database by a trained surgical clinical reviewer at each of the more than 600 participating academic and community-based hospitals throughout the United States.13
We identified all hysterectomies performed from January 1, 2012, through December 31, 2016, in the National Surgical Quality Improvement Program Participant Use Data Files using Current Procedural Terminology (CPT) codes. Specific procedure codes used to define our sample are reported in Table 1. The primary outcome was mode of surgery. Secondary outcomes were utilization of abdominal, vaginal, and supracervical hysterectomy.
Incision type also was determined from CPT codes. For the minority of cases containing more than one CPT code for hysterectomy, cases were categorized as follows: Cases coded as both abdominal hysterectomy and laparoscopic or vaginal hysterectomy were categorized as abdominal. Cases coded as both laparoscopic hysterectomy and vaginal hysterectomy were categorized as laparoscopic-assisted vaginal hysterectomy. Cases coded as robotic-assisted laparoscopic hysterectomy were included with laparoscopic hysterectomy.
Data are presented as mean with standard deviation, median with interquartile range, or frequency with percent, as appropriate. We stratified the data into four time periods: roughly 2 years before The Wall Street Journal article, the interval between The Wall Street Journal article and the FDA safety communication, the first year after the FDA safety communication through March 2015, and more than 1 year after the FDA safety communication. We compared surgical characteristics and morbidity for each of the time periods after the FDA safety communication with the time period before The Wall Street Journal article using the χ2 test for proportions, the t-test for means, and the Wilcoxon rank sum test for medians. We excluded the interval between The Wall Street Journal article and the FDA safety communication from these comparisons, consistent with prior work.12 To compare trends in surgical approach from 2012 through 2016, we used an interrupted time series analysis; for the interrupted time series, we included all quarters from 2012 through 2016, including the interval between The Wall Street Journal article and the FDA safety communication.
This study used only de-identified data and thus was exempt from institutional review board review.
We identified 179,950 hysterectomies from 2012 to 2016. Demographic characteristics of the population are shown in Table 2. Across the study period in this large population, there was a small, statistically significant increase in age, body mass index, and hypertension, as well as a decrease in smoking status; however, there were no meaningful clinical demographic differences among the different time periods studied.
Mode of surgery for hysterectomy was significantly different both within 1 year of the April 2014 FDA safety communication and more than 1 year after the FDA safety communication, as compared with the period before The Wall Street Journal article (Table 3). The proportion of hysterectomies performed abdominally was at its maximum (29.8%) at the start of the study (quarter 1 of 2012) and its minimum (23.7%) at the study's conclusion (quarter 4 of 2016). Overall, from 2012 through 2016, the proportion of hysterectomies performed laparoscopically increased and the proportion of abdominal and vaginal hysterectomies decreased.
Laparoscopy was the most common mode of hysterectomy in every quarter included (Fig. 1 and Table 4). Before the December 2013 article in The Wall Street Journal, there was no change in the proportion of abdominal hysterectomies by (0.3% decrease/quarter, P=.14). Between The Wall Street Journal article and the FDA safety communication, abdominal hysterectomy increased significantly by 1.1% per quarter (P<.001). The proportion of abdominal hysterectomies then remained stable for three quarters until March 2015 (0.1% decrease/quarter, P=.65). After March 2015, the proportion of abdominal hysterectomies decreased by 0.8% per quarter through the end of 2016 (P<.001).
The overall proportion of vaginal hysterectomies decreased over the 5-year study period, falling from 17.3% of all hysterectomies in the first quarter of 2012 to 15.2% in the fourth quarter of 2016.
Before the December 2013 article in The Wall Street Journal, there was a 0.3% decrease in vaginal hysterectomies per quarter (P=.002). After that, there was a significant increase in the next two quarters through the April 2014 FDA safety communication (0.5%/quarter, P<.001), followed by a significant decrease in the next three quarters (0.6%/quarter, P<.001). After March 2015, there was no change in the proportion of vaginal hysterectomies (0.2% decrease/quarter, P=.22).
The most persistent changes after the FDA safety communication regarding power morcellation were noted among supracervical hysterectomies. The overall proportion of supracervical hysterectomies decreased from 13.2% before The Wall Street Journal article to 7.4% (within 1 year) and 7.1% (more than 1 year) after the FDA safety communication (P<.001; Table 3). From 2012 to publication of The Wall Street Journal article in December 2013, the proportion of all hysterectomies that were supracervical decreased by 0.2% per quarter (P=.005; Fig. 2). After The Wall Street Journal article, there was a significant change in the rate of decrease in the proportion of supracervical hysterectomies, at a 1.0% decrease per quarter until the April 2014 FDA safety communication (P<.001), and then a 0.7% decrease per quarter for the after three quarters (P=.01). The proportion of supracervical hysterectomies remained stable after March 2015 (0.05% decrease/quarter, P=.40).
Of the supracervical hysterectomies that were performed, the proportion of abdominal supracervical hysterectomies increased from 34.4% before the FDA safety communication to 46.4% after, with an associated decrease in laparoscopic supracervical hysterectomy from 65.6% to 53.6%, respectively (P<.001). In 2012 and 2013, there was no significant change in the proportions of supracervical hysterectomies that were performed abdominally compared with laparoscopically (abdominal supracervical hysterectomy increased 0.2%/quarter, P=.43). For the next two quarters, after The Wall Street Journal article, there was a significant increase in the proportion of abdominal supracervical hysterectomies, 11.7% per quarter (P<.001). The proportion of abdominal supracervical hysterectomies then remained stable through the end of 2016, with a 0.3% per quarter decrease in abdominal supracervical hysterectomies (P=.06).
Differences in perioperative morbidity were either not significant or not clinically effective when comparing outcomes from hysterectomies before The Wall Street Journal article with those either within 1 year of the FDA warning or more than 1 year after the FDA warning (Table 3).
Contrary to previous studies reporting an increase in laparotomy in response to the FDA safety communication regarding power morcellation,9–12 we found that laparoscopic hysterectomy has steadily increased since March 2015, a year after the FDA safety communication. Although our results are consistent with the initial 6-month period in which the proportion of hysterectomies that were performed using laparotomy increased nationwide after The Wall Street Journal article reporting power morcellation safety concerns, by looking at data through 2016, we found a complete reversal of the previously reported effect; in fact, minimally invasive hysterectomy was at its peak incidence at the end of the 5-year study period.
Consistent with other reported trends in hysterectomy, we found that the proportion of vaginal hysterectomies decreased overall across the 5-year study period. Although there was a brief 6-month increase in utilization of vaginal hysterectomy after The Wall Street Journal article, vaginal hysterectomy then returned to its prior trend of overall decrease in utilization. This result is surprising, as the vaginal route of specimen removal is a safe alternative to power morcellation. This suggests that there are forces other than the FDA safety communication influencing utilization of vaginal hysterectomy in the United States; possible explanations include increased utilization of robotic surgery and decreased teaching of vaginal hysterectomy in residency training programs.14
Supracervical hysterectomy overall was less likely to be performed after the safety warnings, but the proportion of remaining supracervical hysterectomies that were performed using laparotomy increased significantly. A possible explanation for these findings is that without the vaginal route for specimen extraction, surgeons are less likely to recommend supracervical hysterectomy in response to concerns over the safety of power morcellation. When supracervical hysterectomy is specifically indicated, surgeons may be more likely to perform laparotomy to aid in safe specimen removal.
This study has several strengths. Unlike prior studies reporting an increase in laparotomy, by examining a longer study period, we find that this phenomenon was temporary, and that minimally invasive surgery was more prevalent at the end of the study than at the beginning. We specifically examined practice patterns in supracervical hysterectomy, which would be expected to be especially vulnerable to additional challenges in laparoscopic specimen removal. Additionally, this study is unique in that we offer an interrupted time series analysis of hysterectomy trends during the study period before and after The Wall Street Journal article and FDA safety communication regarding power morcellation.
A weakness of this study is the inherent limitation of research using large databases, including restriction to predetermined data fields and reliance on data input from site-based reviewers with whom this research team has no contact. A specific downside to the National Surgical Quality Improvement Program Participant Use Data Files is that it incompletely captures the use of robotic surgery. Although there exists a modifying CPT code for robotic-assistance, it is not consistently used or logged into the database. In our sample of nearly 200,000 hysterectomies, only 926 contained the robotic surgery CPT code, which is a gross underestimation of the prevalence of robotic-assisted laparoscopic hysterectomy. We were thus unable to separate robotic approaches from other laparoscopic approaches in this analysis. The National Surgical Quality Improvement Program database did not include information on uterine weight until 2014; ability to substratify changes to surgical approach based on uterine weight would have added richness to this study. Moreover, there is no CPT code for minilaparotomy for large specimen removal; the gynecologic community would benefit from future investigation on the role of minilaparotomy in this changing landscape of specimen extraction. Hysterectomy practice is influenced by multiple factors including training, access to resources and technology, reimbursement, research, patient education, and political issues; future studies to further crystallize the precise effect of each of these factors are needed.
Despite early findings suggesting that minimally sinvasive hysterectomy decreased in response to safety concerns regarding power morcellation, this effect appears to have reversed 1 year after the FDA safety communication. In this same time period, there has been an explosion of literature on safe, contained alternatives to electric power morcellation. We find that the gynecologic community has continued to advance minimally invasive hysterectomy despite largely ending the practice of power morcellation for specimen removal.6,7
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