Abstract
Objective:
To characterize long-term national trends in surgical approach for hysterectomy following the U.S. Food and Drug Administration (FDA) warning against power morcellation for laparoscopic specimen removal.
Methods:
This was a descriptive study using data from American College of Surgeons National Surgical Quality Improvement Program (NSQIP) from 2012 to 2016. We identified hysterectomies using Current Procedural Terminology (CPT) codes. We used an interrupted time-series analysis to evaluate abdominal and supracervical hysterectomy trends surrounding The Wall Street Journal (WSJ) article first reporting morcellation safety concerns and the FDA safety communication. We compared categorical and continuous variables using Chi-square, t and Wilcoxon rank-sum tests.
Results:
We identified 179,950 hysterectomies; laparoscopy was the most common mode of hysterectomy in every quarter. Until the WSJ article, there was no significant change in proportion of abdominal hysterectomies (0.3% decrease per quarter, p=0.14). After the WSJ article, use of abdominal hysterectomy increased 1.1% per quarter for two quarters through the FDA warning (p<0.001), plateaued for three quarters until March 2015 (p=0.65), then decreased by 0.8% per quarter through 2016 (p<0.001). Supracervical hysterectomy volume continuously decreased following the FDA warning (1.0% decrease per quarter, p<0.001) and following three quarters (0.7% decrease per quarter, p=0.01), then plateaued from April 2015 through 2016 (0.05% decrease per quarter, p=0.40). Mode of supracervical hysterectomy was unchanged from 2012 to 2013 (p=0.43), followed by two quarters of significant increase in proportion of supracervical abdominal hysterectomies (11.7% per quarter, p<0.001). This change in mode of supracervical hysterectomy then plateaued through 2016 (p=0.06).
Conclusion:
Despite early studies suggesting that minimally-invasive hysterectomy decreased in response to safety concerns regarding power morcellation, we found that this effect reversed one year following the FDA safety communication. However, there was a sustained decline in supracervical hysterectomy, and the remaining supracervical hysterectomies were more likely to be performed using laparotomy.
Precis
Despite early findings of decreased minimally invasive hysterectomy after power morcellation safety warnings, this effect has reversed since March 2015.
Introduction:
Laparoscopic hysterectomy has grown tremendously in the 30 years since the first was performed1. Minimally invasive surgery is now standard of care, and laparoscopy is the most common mode of hysterectomy2,3.
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 (WSJ) on December 18, 20134. On April 17, 2014, the United States Food and Drug Administration (FDA) issued a safety communication recommending discontinuation of power morcellation in hysterectomy and myomectomy5. Most surgeons stopped using power morcellation6,7, and many reported increasing their practice of laparotomy6. 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 following the FDA safety communication was accompanied by increased complications9. Multiple groups reported that minimally invasive hysterectomy and myomectomy decreased following the FDA communication, and laparotomy increased9-12. A limitation of these studies is that they evaluated only immediate changes to practice patterns, and not long-term impacts.
This study aims to characterize longer-term national trends in surgical approach for hysterectomy following 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, as these cases do not have access to a colpotomy for specimen removal.
Methods:
A descriptive study was performed using data from the American College of Surgeons National Surgical Quality Improvement Program (NSQIP) Participant Use Data Files (PUF) from 2012 to 2016. The NSQIP PUF 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 NSQIP 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 NSQIP PUF 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.
Table 1:
Current Procedural Terminology (CPT) codes used to identify and classify hysterectomy cases.
| Surgery | Current Procedural Terminology (CPT) Codes |
|---|---|
| Total laparoscopic hysterectomy | 58570, 58571, 58572, 58573 |
| Total abdominal hysterectomy | 58150, 58152, 58200, 58210 |
| Laparoscopic-assisted vaginal hysterectomy | 58550, 58552, 58553, 58554 |
| Total vaginal hysterectomy | 58260, 58262, 58263, 58267, 58270, 58290, 58293, 58291, 58292, 58294, 58285, 58275, 58280 |
| Laparoscopic supracervical hysterectomy | 58541, 58542, 58543, 58544 |
| Abdominal supracervical hysterectomy | 58180 |
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 two years before the WSJ article, the interval between the WSJ article and the FDA safety communication, the first year after the FDA safety communication through March 2015, and more than one 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 WSJ article using the Chi-square test for proportions, the t test for means and the Wilcoxon rank-sum test for medians. We excluded the interval between the WSJ article and the FDA safety communication from these comparisons, consistent with prior work12. 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 WSJ article and the FDA safety communication.
This study used only de-identified data and thus was exempt from institutional review board review.
Results
We identified 179,950 hysterectomies from 2012 to 2016. Demographic characteristics of the population are shown in Table 2. The baseline characteristics and history of medical comorbidities are similar in the population across all time periods examined.
Table 2:
Baseline characteristics of patients undergoing hysterectomy before Wall Street Journal Article and after the U.S. Food and Drug Administration safety communication
| Characteristic | Pre-WSJ Article | 1 Year Post- FDA Warning |
>1 Year Post- FDA Warning |
|---|---|---|---|
| n=57569 | n=42203 | n=80178 | |
| Age (years)—mean ± SD | 50.3 ± 12.0 | 49.6 ± 12.0 | 49.5 ± 11.9 |
| BMI (kg/m2)—mean ± SD | 30.6 ± 8.1 | 31.0 ± 8.0 | 31.0 ± 8.0 |
| Race | |||
| Black | 7262 (12.6) | 6166 (14.6) | 11380 (14.2) |
| White | 40600 (70.5) | 28533 (67.6) | 53406 (66.6) |
| Asian | 2182 (3.8) | 1551 (3.7) | 2812 (3.5) |
| Other | 686 (1.2) | 661 (1.6) | 1006 (1.3) |
| Unknown or not reported | 6837 (11.9) | 5292 (12.5) | 11574 (14.4) |
| Comorbidities | |||
| Diabetes | |||
| Insulin | 1365 (2.4) | 1065 (2.5) | 2048 (2.6) |
| Non-insulin | 3857 (6.7) | 2893 (6.9) | 5675 (7.1) |
| Hypertension (with medication) | 17404 (30.2) | 12759 (30.2) | 23930 (29.8) |
| Current smoker (within one year) | 9705 (16.9) | 6957 (16.5) | 12815 (16.0) |
WSJ=Wall Street Journal; FDA=Food and Drug Administration; BMI=body mass index; SD=standard deviation
Data are presented as mean ± standard deviation or n (%)
Mode of surgery for hysterectomy was significantly different both within one year of the April 2014 FDA safety communication, and more than one year following the FDA safety communication, as compared with the period before the WSJ 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, while the proportion of abdominal and vaginal hysterectomies decreased.
Table 3:
Characteristics of surgical approach and morbidity before Wall Street Journal article and after the U.S. Food and Drug Administration safety communication
| Characteristic | Pre-WSJ Article |
1 Year Post- FDA Warning |
p | >1 Year Post-FDA Warning |
p |
|---|---|---|---|---|---|
| n=57569 | n=42203 | n=80178 | |||
| Mode of surgery | <0.001 | <0.001 | |||
| Abdominal | 15977 (27.8) | 12297 (29.1) | 20840 (26.0) | ||
| Laparoscopic | 22936 (39.8) | 17245 (40.9) | 36718 (45.8) | ||
| Vaginal | 9261 (16.1) | 6512 (15.4) | 12301 (15.3) | ||
| Laparoscopic-assisted vaginal | 9395 (16.3) | 6149 (14.6) | 10319 (12.9) | ||
| Type of hysterectomy | <0.001 | <0.001 | |||
| Total hysterectomy | 49954 (86.8) | 39030 (92.5) | 74498 (92.9) | ||
| Supracervical hysterectomy | 7615 (13.2) | 3173 (7.5) | 5680 (7.1) | ||
| Abdominal supracervical | 2208 (29.0) | 1469 (46.3) | 2553 (44.9) | ||
| Laparoscopic supracervical | 5407 (71.0) | 1704 (53.7) | 3127 (55.1) | ||
| Operative time (min) | 122 (88-172) | 122 (88-170) | 0.43 | 121 (88-169) | 0.01 |
| Reoperation within 30 days | 1000 (1.7) | 649 (1.5) | 0.01 | 1317 (1.6) | 0.18 |
| Readmission within 30 days | 2147 (3.7) | 1493 (3.5) | 0.11 | 2901 (3.6) | 0.28 |
| Length of stay (days) | 1.0 (1.0-2.0) | 1.0 (1.0-2.0) | <0.001 | 1.0 (1.0-2.0) | <0.001 |
| Medical morbidity | |||||
| VTE (DVT or PE) | 131 (0.2) | 96 (0.2) | 1.0 | 167 (0.2) | 0.45 |
| Sepsis | 391 (0.7) | 259 (0.6) | 0.20 | 488 (0.6) | 0.10 |
| Surgical morbidity | |||||
| Blood transfusion | 2699 (4.7) | 1761 (4.2) | <0. 001 | 3054 (3.8) | <0.001 |
| Surgical site infection | |||||
| Superficial | 810 (1.4) | 563 (1.3) | 0.33 | 1092 (1.4) | 0.48 |
| Deep | 208 (0.4) | 179 (0.4) | 0.11 | 255 (0.3) | 0.17 |
| Wound dehiscence | 220 (0.4) | 145 (0.3) | 0.32 | 255 (0.3) | 0.05 |
WSJ=Wall Street Journal; FDA=Food and Drug Administration; VTE=Venous thrombotic event; DVT=Deep venous thrombosis; PE=Pulmonary embolism
Data are presented as median (interquartile range) or n (%)
Compares Pre-WSJ period to 1 year post-FDA warning
Compares Pre-WSJ period to >1 year post-FDA warning
Laparoscopy was the most common mode of hysterectomy in every quarter included (Figure 1, Table 4). Prior to the December 2013 WSJ article, there was no change in the proportion of abdominal hysterectomies by (0.3% decrease per quarter, p=0.14). Between the WSJ article and the FDA safety communication, abdominal hysterectomy increased significantly by 1.1% per quarter (p<0.001). The proportion of abdominal hysterectomies then remained stable for three quarters until March 2015 (0.1% decrease per quarter, p=0.65). After March 2015, the proportion of abdominal hysterectomies decreased by 0.8% per quarter through the end of 2016 (p<0.001).
Figure 1:
Proportion of hysterectomies performed by mode of incision, per quarter. The proportion of abdominal hysterectomies was unchanged prior to the December 18, 2013 Wall Street Journal (WSJ) article (P=.14). Between the WSJ article and the April 17, 2014 U.S. Food and Drug Administration (FDA) safety communication, abdominal hysterectomy increased 1.1% per quarter (P<.001), then remained stable until March 2015 (P=.65). After March 2015, the proportion of abdominal hysterectomies decreased by 0.8% per quarter through the end of 2016 (P<.001). Error bars represent the 95% CI of the proportion of hysterectomies. Dotted lines indicate the WSJ article and the FDA safety communication.
Table 4:
Surgeries by mode of hysterectomy, per quarter
| Year | Quarter | n | Laparoscopic Hysterectomy |
Abdominal Hysterectomy |
Vaginal Hysterectomy |
Laparoscopic- Assisted Vaginal Hysterectomy |
|---|---|---|---|---|---|---|
| 2012 | 1 | 6238 | 2121 (34.0) | 1857 (29.8) | 1078 (17.3) | 1182 (18.9) |
| 2012 | 2 | 6223 | 2257 (36.3) | 1762 (28.3) | 1107 (17.8) | 1097(17.6) |
| 2012 | 3 | 6079 | 2373 (39.0) | 1699 (27.9) | 962 (15.8) | 1045 (17.2) |
| 2012 | 4 | 6438 | 2676 (41.6) | 1695 (26.3) | 1010 (15.7) | 1057 (16.4) |
| 2013 | 1 | 7761 | 3186 (41.1) | 2132 (27.5) | 1271 (16.4) | 1172 (15.1) |
| 2013 | 2 | 8188 | 3302 (40.3) | 2293 (28.0) | 1270 (15.5) | 1323 (16.2) |
| 2013 | 3 | 8181 | 3415 (41.7) | 2259 (27.6) | 1256 (15.4) | 1251 (15.3) |
| 2013 | 4 | 8461 | 3606 (42.6) | 2280 (26.9) | 1307 (15.4) | 1268 (15.0) |
| 2014 | 1 | 9544 | 3896 (40.8) | 2676 (28.0) | 1526 (16.0) | 1446 (15.2) |
| 2014 | 2 | 9946 | 3937 (39.6) | 2903 (29.2) | 1591 (16.0) | 1515 (15.2) |
| 2014 | 3 | 9821 | 3896 (39.7) | 2905 (29.6) | 1529 (15.6) | 1491 (15.2) |
| 2014 | 4 | 9813 | 3972 (40.5) | 2852 (29.1) | 1452 (14.8) | 1537 (15.7) |
| 2015 | 1 | 11200 | 4584 (40.9) | 3300 (29.5) | 1758 (15.7) | 1558 (13.9) |
| 2015 | 2 | 11369 | 4793 (42.2) | 3240(28.5) | 1773 (15.6) | 1563 (13.7) |
| 2015 | 3 | 11771 | 4854 (41.2) | 3403 (28.9) | 1858 (15.8) | 1656 (14.1) |
| 2015 | 4 | 12429 | 5476 (44.1) | 3294 (26.5) | 1933 (15.6) | 1726 (13.9) |
| 2016 | 1 | 13739 | 6191 (45.1) | 3627 (26.4) | 2228 (16.2) | 1693 (12.3) |
| 2016 | 2 | 13595 | 6269 (46.1) | 3516 (25.9) | 2132 (15.7) | 1678 (12.3) |
| 2016 | 3 | 13949 | 6765 (48.5) | 3513 (25.2) | 1916 (13.7) | 1755 (12.6) |
| 2016 | 4 | 14695 | 7163 (48.7) | 3487 (23.7) | 2234 (15.2) | 1811 (12.3) |
Data are presented as n, %
The overall proportion of vaginal hysterectomies decreased over the 5-year study period, falling from 17.3% of all hysterectomies in Quarter 1 of 2012 to 15.2% in Quarter 4 of 2016.
Prior to the December 2013 WSJ article, there was a 0.3% decrease in vaginal hysterectomies per quarter (p=0.002). Following that, there was a significant increase in the next two quarters through the April 2014 FDA safety communication (0.5% per quarter, p<0.001), followed by a significant decrease in the next three quarters (0.6% per quarter, p<0.001). After March 2015, there was no change in the proportion of vaginal hysterectomies (0.2% decrease per quarter, p=0.22).
The most persistent changes following the FDA safety communication regarding power morcellation were noted among supracervical hysterectomies. The overall proportion of supracervical hysterectomies decreased from 13.2% before the WSJ article to 7.4% (within 1 year) and 7.1% (more than 1 year) after the FDA safety communication (p<0.001; Table 3). From 2012 to the publication of the WSJ article in December 2013, the proportion of all hysterectomies that were supracervical decreased by 0.2% per quarter (p=0.005; Figure 2). Following the WSJ 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<0.001), and then a 0.7% decrease per quarter for the following three quarters (p=0.01). The proportion of supracervical hysterectomies remained stable after March 2015 (0.05% decrease per quarter, p=0.40).
Figure 2:
Supracervical hysterectomy practice patterns. A. Proportion of total and supracervical hysterectomies, per quarter. Prior to the December 18, 2013 Wall Street Journal (WSJ) article, the proportion of supracervical hysterectomies decreased by 0.2% per quarter (P=.005). Between the WSJ article and the April 17, 2014 U.S. Food and Drug Administration (FDA) safety communication, supracervical hysterectomies decreased by 1.0% per quarter (P<.001), followed by a 0.7% decrease per quarter (P=.01) until March 2015, when the proportion stabilized (P=.40). B. Proportion of supracervical hysterectomies performed by mode of incision, per quarter. Prior to the WSJ article, there was no change to the proportion of abdominal supracervical hysterectomies (P=.43). Between the WSJ article and the FDA safety communication, there was a 11.7% per quarter increase in the proportion of abdominal supracervical hysterectomies, (P<.001), which then remained stable through the end of 2016 (P=.06). Error bars represent the 95% CI of the proportion of supracervical hysterectomies. Error bars represent the 95% CI of the proportion of hysterectomies. Dotted lines indicate the WSJ article and the FDA safety communication.
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 of 65.6% to 53.6%, respectively (p<0.0001). In 2012 and 2013, there was no significant change in the proportions of supracervical hysterectomies that were performed abdominally versus laparoscopically (abdominal supracervical hysterectomy increased 0.2% per quarter, p=0.43). For the next two quarters, after the WSJ article, there was a significant increase in the proportion of abdominal supracervical hysterectomies, 11.7% per quarter (p<0.001). 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=0.06).
Differences in perioperative morbidity were either not significant or not clinically impactful when comparing outcomes from hysterectomies prior to the WSJ article to either within one year of the FDA warning or to more than one year after the FDA warning (Table 3).
Discussion
Contrary to previous studies reporting an increase in laparotomy in response to the FDA safety communication regarding power morcellation9-12, we found that laparoscopic hysterectomy has steadily increased since March 2015, a year following the FDA safety communication. While our results are consistent with the initial six-month period in which the proportion of hysterectomies that were performed using laparotomy increased nationwide following the WSJ 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 five-year study period.
Consistent with other reported trends in hysterectomy, we found that the proportion of vaginal hysterectomies decreased overall across the five-year study period. Although there was a brief six-month increase in utilization of vaginal hysterectomy following the WSJ 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 programs14.
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 WSJ 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 pre-determined data fields and reliance on data input from site-based reviewers with whom this research team has no contact. A specific downside to the NSQIP PUF 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 NSQIP 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 impact of each of these factors are needed.
Despite early findings suggesting that minimally-invasive hysterectomy decreased in response to safety concerns regarding power morcellation, this effect appears to have reversed one 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 removal6,7.
Supplementary Material
Acknowledgments
This work was conducted with support from Harvard Catalyst, Harvard Clinical and Translational Science Center (National Center for Advancing Translational Sciences, National Institutes of Health Award UL1 TR001102) and financial contributions from Harvard University and its affiliated academic health care centers.
Footnotes
Presented at the 47th AAGL Global Congress, November 11-15, 2018, Las Vegas, NV.
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