Research
Original Investigation
Use of Electric Power Morcellation and Prevalence of Underlying Cancer in Women Who Undergo Myomectomy Jason D. Wright, MD; Ana I. Tergas, MD; Rosa Cui, BS; William M. Burke, MD; June Y. Hou, MD; Cande V. Ananth, PhD, MPH; Ling Chen, MD, MPH; Catherine Richards, PhD; Alfred I. Neugut, MD, PhD; Dawn L. Hershman, MD Invited Commentary page 78 IMPORTANCE Myomectomy, the excision of uterine leiomyoma, is now commonly performed
via minimally invasive surgery. Electric power morcellation, or fragmentation of the leiomyoma with a mechanical device, may be used to facilitate extraction of the leiomyoma. OBJECTIVE To analyze the prevalence of underlying cancer and precancerous changes in women who underwent myomectomy with and without electric power uterine morcellation. DESIGN, SETTING, AND PARTICIPANTS We used a US nationwide database to retrospectively analyze women who underwent myomectomy at 496 hospitals from January 2006 to December 2012. Use of electric power morcellation at the time of myomectomy was investigated. The prevalence of uterine cancer, uterine neoplasms of uncertain malignant potential, and endometrial hyperplasia were estimated. Multivariable mixed-effects regression models were developed to examine predictors of use of electric power morcellation and factors associated with adverse pathologic outcomes. MAIN OUTCOMES AND MEASURES Use of electric power morcellation at the time of myomectomy was examined. The occurrence of uterine cancer and precancerous uterine lesions was determined. RESULTS The cohort consisted of 41 777 women who underwent myomectomy at 496 hospitals and included 3220 (7.7%) who had electric power morcellation. Uterine cancer was identified in 73 (1 in 528) women who underwent myomectomy without electric power morcellation (0.19%; 95% CI, 0.15%-0.23%) and in 3 (1 in 1073) women who underwent electric power morcellation (0.09%; 95% CI, 0.02%-0.27%). The corresponding rates of any pathologic finding (cancer, tumors of uncertain malignant potential, or endometrial hyperplasia) were 0.67% (n = 257) (95% CI, 0.59%-0.75%) (1 in 150) and 0.43% (n = 14) (95% CI, 0.21%-0.66%) (1 in 230), respectively. Advanced age was the strongest risk factor for uterine cancer. CONCLUSIONS AND RELEVANCE The prevalence of cancers and precancerous abnormalities of the uterus in women who undergo myomectomy with or without electric power morcellation is low overall, but risk increases with age. Electric power morcellation should be used with caution in older women undergoing myomectomy.
Author Affiliations: Author affiliations are listed at the end of this article.
JAMA Oncol. 2015;1(1):69-77. doi:10.1001/jamaoncol.2014.206 Published online February 19, 2015. Corrected on March 12, 2015.
Corresponding Author: Jason D. Wright, MD, Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Columbia University College of Physicians and Surgeons, 161 Ft Washington Ave, Eighth Floor, New York, NY 10032 ([email protected]).
(Reprinted) 69
Copyright 2015 American Medical Association. All rights reserved.
Downloaded From: http://oncology.jamanetwork.com/ by a University of California - San Diego User on 01/11/2016
Research Original Investigation
Underlying Cancer and Precancer in Myomectomy
U
terine leiomyomas are benign smooth-muscle tumors of the uterus. These neoplasms are common and are thought to occur in 20% to 50% of women.1-5 While leiomyomas are frequently asymptomatic, they may cause pain, menstrual bleeding and dysfunction, and reduced fertility.1-6 First-line therapy for patients with symptomatic leiomyomata typically consists of medical management. A variety of hormonal modulating agents, including progestins, oral contraceptives, and gonadotropin-releasing hormone agonists, have demonstrated efficacy.5-8 A number of nonsurgical procedures, including uterine artery embolization, are now also available as treatment options for some women with symptomatic leiomyoma.9 Definitive treatment is often surgical and consists of either hysterectomy or myomectomy in women who wish to preserve the uterus.5,6,9 Myomectomy can be performed hysteroscopically, abdominally through a laparotomy, and, more recently, via a minimally invasive surgical approach with laparoscopic or robotic assistance.10-12 Removal of large leiomyoma through the small incisions used for minimally invasive myomectomy often poses a challenge. Large leiomyoma can be removed through a small abdominal incision (minilaparotomy), vaginally by colpotomy, or through use of electric power morcellation to fragment the leiomyoma.13 Recently, the use of electric power morcellators has been subject to increased scrutiny after a patient with a presumed leiomyoma underwent hysterectomy with electric power morcellation and was noted to have a uterine sarcoma that was disseminated after the procedure.14 This case has led to increased recognition that while leiomyomas are most commonly benign, these neoplasms can be associated with unrecognized cancers. Use of electric power morcellation at the time of uterine surgery, either myomectomy or hysterectomy, disrupts the underlying malignant neoplasm and may potentiate tumor dissemination.15,16 This case has led to reevaluation of the safety of electric power morcellators for gynecologic surgery.17,18 While the controversy surrounding electric power morcellation predominantly stems from use of the device for hysterectomy, morcellators are also increasingly used for the performance of myomectomy. To date, there are limited data describing the safety or risk of pathologic abnormalities in women undergoing myomectomy with electric power morcellation. We performed a population-based analysis to determine the patterns of use of electric power morcellation at the time of myomectomy and to examine the prevalence and predictors of pathologic abnormalities in women who underwent myomectomy both with and without electric power morcellation.
Methods Patient written informed consent and ethical approval for this retrospective analysis were waived by the Columbia University institutional review board.
Data Source We analyzed data from the Perspective database (Premier Inc), a large, all-payer database that includes hospitals from across 70
At a Glance • The overall risk of cancer associated with electric power morcellation at the time of myomectomy is 1 in 1073. • The risk of cancer in women who undergo myomectomy performed by electric power morcellation is lower than what has been reported for hysterectomy. • Advanced age is the strongest risk factor for pathologic abnormalities associated with use of electric power morcellation for myomectomy. • Electric power morcellation should be used with caution in older women undergoing myomectomy.
the United States. Initially developed to measure resource utilization and quality, the Perspective database collects comprehensive data from over 500 acute care facilities, including clinical and demographic characteristics, diagnoses and procedures, and all billed services rendered during hospitalization. In 2006, Perspective captured approximately 5.5 million hospital discharges, representing approximately 15% of hospitalizations in the United States.19 The data undergo a rigorous, multistep quality-control process and have been utilized in a number of outcomes studies.19-21
Patients and Procedures Our cohort consisted of women who underwent inpatient or outpatient myomectomy from January 2006 to December 2012. Patients with an International Classification of Diseases, Ninth Revision (ICD-9) code of 68.29 (excision or destruction of lesion of the uterus) in combination with a code for uterine leiomyoma (218.x) were identified. We excluded patients who underwent endometrial polypectomy (endometrial polyp 621.0, 622.7, 219.0) and those who underwent a hysteroscopic procedure (68.12) from the cohort. Patients who had concomitant ICD-9 codes for an abdominal, vaginal, laparoscopic, radical, or unspecified hysterectomy were also excluded. To capture uterine morcellation, we searched each patient’s recorded charge codes for use of any commercially available electric power morcellation device.22 Within the Perspective database, all drugs and devices used during a patient’s hospitalization are recorded. This method has previously been used and validated to capture drug and device use in patients recorded in the database.20,21,23-26 Concurrent use of robotic assistance for the hysterectomy was recorded using ICD-9 procedure codes and charge codes as previously described.21 Demographic data including year of the procedure, patient age at the time of the procedure (
Original Investigation
Use of Electric Power Morcellation and Prevalence of Underlying Cancer in Women Who Undergo Myomectomy Jason D. Wright, MD; Ana I. Tergas, MD; Rosa Cui, BS; William M. Burke, MD; June Y. Hou, MD; Cande V. Ananth, PhD, MPH; Ling Chen, MD, MPH; Catherine Richards, PhD; Alfred I. Neugut, MD, PhD; Dawn L. Hershman, MD Invited Commentary page 78 IMPORTANCE Myomectomy, the excision of uterine leiomyoma, is now commonly performed
via minimally invasive surgery. Electric power morcellation, or fragmentation of the leiomyoma with a mechanical device, may be used to facilitate extraction of the leiomyoma. OBJECTIVE To analyze the prevalence of underlying cancer and precancerous changes in women who underwent myomectomy with and without electric power uterine morcellation. DESIGN, SETTING, AND PARTICIPANTS We used a US nationwide database to retrospectively analyze women who underwent myomectomy at 496 hospitals from January 2006 to December 2012. Use of electric power morcellation at the time of myomectomy was investigated. The prevalence of uterine cancer, uterine neoplasms of uncertain malignant potential, and endometrial hyperplasia were estimated. Multivariable mixed-effects regression models were developed to examine predictors of use of electric power morcellation and factors associated with adverse pathologic outcomes. MAIN OUTCOMES AND MEASURES Use of electric power morcellation at the time of myomectomy was examined. The occurrence of uterine cancer and precancerous uterine lesions was determined. RESULTS The cohort consisted of 41 777 women who underwent myomectomy at 496 hospitals and included 3220 (7.7%) who had electric power morcellation. Uterine cancer was identified in 73 (1 in 528) women who underwent myomectomy without electric power morcellation (0.19%; 95% CI, 0.15%-0.23%) and in 3 (1 in 1073) women who underwent electric power morcellation (0.09%; 95% CI, 0.02%-0.27%). The corresponding rates of any pathologic finding (cancer, tumors of uncertain malignant potential, or endometrial hyperplasia) were 0.67% (n = 257) (95% CI, 0.59%-0.75%) (1 in 150) and 0.43% (n = 14) (95% CI, 0.21%-0.66%) (1 in 230), respectively. Advanced age was the strongest risk factor for uterine cancer. CONCLUSIONS AND RELEVANCE The prevalence of cancers and precancerous abnormalities of the uterus in women who undergo myomectomy with or without electric power morcellation is low overall, but risk increases with age. Electric power morcellation should be used with caution in older women undergoing myomectomy.
Author Affiliations: Author affiliations are listed at the end of this article.
JAMA Oncol. 2015;1(1):69-77. doi:10.1001/jamaoncol.2014.206 Published online February 19, 2015. Corrected on March 12, 2015.
Corresponding Author: Jason D. Wright, MD, Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Columbia University College of Physicians and Surgeons, 161 Ft Washington Ave, Eighth Floor, New York, NY 10032 ([email protected]).
(Reprinted) 69
Copyright 2015 American Medical Association. All rights reserved.
Downloaded From: http://oncology.jamanetwork.com/ by a University of California - San Diego User on 01/11/2016
Research Original Investigation
Underlying Cancer and Precancer in Myomectomy
U
terine leiomyomas are benign smooth-muscle tumors of the uterus. These neoplasms are common and are thought to occur in 20% to 50% of women.1-5 While leiomyomas are frequently asymptomatic, they may cause pain, menstrual bleeding and dysfunction, and reduced fertility.1-6 First-line therapy for patients with symptomatic leiomyomata typically consists of medical management. A variety of hormonal modulating agents, including progestins, oral contraceptives, and gonadotropin-releasing hormone agonists, have demonstrated efficacy.5-8 A number of nonsurgical procedures, including uterine artery embolization, are now also available as treatment options for some women with symptomatic leiomyoma.9 Definitive treatment is often surgical and consists of either hysterectomy or myomectomy in women who wish to preserve the uterus.5,6,9 Myomectomy can be performed hysteroscopically, abdominally through a laparotomy, and, more recently, via a minimally invasive surgical approach with laparoscopic or robotic assistance.10-12 Removal of large leiomyoma through the small incisions used for minimally invasive myomectomy often poses a challenge. Large leiomyoma can be removed through a small abdominal incision (minilaparotomy), vaginally by colpotomy, or through use of electric power morcellation to fragment the leiomyoma.13 Recently, the use of electric power morcellators has been subject to increased scrutiny after a patient with a presumed leiomyoma underwent hysterectomy with electric power morcellation and was noted to have a uterine sarcoma that was disseminated after the procedure.14 This case has led to increased recognition that while leiomyomas are most commonly benign, these neoplasms can be associated with unrecognized cancers. Use of electric power morcellation at the time of uterine surgery, either myomectomy or hysterectomy, disrupts the underlying malignant neoplasm and may potentiate tumor dissemination.15,16 This case has led to reevaluation of the safety of electric power morcellators for gynecologic surgery.17,18 While the controversy surrounding electric power morcellation predominantly stems from use of the device for hysterectomy, morcellators are also increasingly used for the performance of myomectomy. To date, there are limited data describing the safety or risk of pathologic abnormalities in women undergoing myomectomy with electric power morcellation. We performed a population-based analysis to determine the patterns of use of electric power morcellation at the time of myomectomy and to examine the prevalence and predictors of pathologic abnormalities in women who underwent myomectomy both with and without electric power morcellation.
Methods Patient written informed consent and ethical approval for this retrospective analysis were waived by the Columbia University institutional review board.
Data Source We analyzed data from the Perspective database (Premier Inc), a large, all-payer database that includes hospitals from across 70
At a Glance • The overall risk of cancer associated with electric power morcellation at the time of myomectomy is 1 in 1073. • The risk of cancer in women who undergo myomectomy performed by electric power morcellation is lower than what has been reported for hysterectomy. • Advanced age is the strongest risk factor for pathologic abnormalities associated with use of electric power morcellation for myomectomy. • Electric power morcellation should be used with caution in older women undergoing myomectomy.
the United States. Initially developed to measure resource utilization and quality, the Perspective database collects comprehensive data from over 500 acute care facilities, including clinical and demographic characteristics, diagnoses and procedures, and all billed services rendered during hospitalization. In 2006, Perspective captured approximately 5.5 million hospital discharges, representing approximately 15% of hospitalizations in the United States.19 The data undergo a rigorous, multistep quality-control process and have been utilized in a number of outcomes studies.19-21
Patients and Procedures Our cohort consisted of women who underwent inpatient or outpatient myomectomy from January 2006 to December 2012. Patients with an International Classification of Diseases, Ninth Revision (ICD-9) code of 68.29 (excision or destruction of lesion of the uterus) in combination with a code for uterine leiomyoma (218.x) were identified. We excluded patients who underwent endometrial polypectomy (endometrial polyp 621.0, 622.7, 219.0) and those who underwent a hysteroscopic procedure (68.12) from the cohort. Patients who had concomitant ICD-9 codes for an abdominal, vaginal, laparoscopic, radical, or unspecified hysterectomy were also excluded. To capture uterine morcellation, we searched each patient’s recorded charge codes for use of any commercially available electric power morcellation device.22 Within the Perspective database, all drugs and devices used during a patient’s hospitalization are recorded. This method has previously been used and validated to capture drug and device use in patients recorded in the database.20,21,23-26 Concurrent use of robotic assistance for the hysterectomy was recorded using ICD-9 procedure codes and charge codes as previously described.21 Demographic data including year of the procedure, patient age at the time of the procedure (
