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ORIGINAL RESEARCH |
From the Department of Radiology, Georgetown University Hospital, Washington, DC.
Address reprint requests to: James B. Spies, MD, Georgetown University Hospital, Department of Radiology, 3800 Reservoir Road, NW, CG 201, Washington, DC 20007-2197; E-mail: spiesj{at}gunet.georgetown.edu.
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ABSTRACT |
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 ABSTRACT MATERIALS AND METHODSRESULTSDISCUSSIONREFERENCES |
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METHODS: As part of an ongoing study of outcome after uterine embolization, prospective data regarding complications that occurred in 400 consecutive patients were gathered. Each patient had a minimum of a 3-month interval from the procedure at the time of analysis. Each complication was categorized and graded as to severity and outcome using the complication classification developed by the Society of Cardiovascular and Interventional Radiology (SCVIR) and a modified set of The American College of Obstetricians and Gynecologists (ACOG) criteria for complications of hysterectomy and myomectomy. All adverse events that occurred during the follow-up period were included, including those that occurred after the 3-month minimum interval. Confidence intervals (CIs) were calculated for each complication.
RESULTS: There were no deaths and no major permanent injuries. One patient required hysterectomy as a result of a complication, and one patient had an undiagnosed leiomyosarcoma. There were ten in-hospital complications and an additional 27 complications within the first 30 days, with 34 patients experiencing a periprocedural complication for a rate of 8.5% (95% CI 6.0%, 11.7%). There were five serious complications (SCVIR class D), comprising 1.25% (95% CI 0.3%, 2.5%) of the study group. Using ACOG definitions for perioperative complications, the overall morbidity was 5% (95% CI 3.1%, 7.7%).
CONCLUSION: The short-term complication rate was low in women undergoing uterine embolization.
Since its introduction as a therapy for leiomyomas, case series1–4 have reported that complications from uterine artery embolization have been infrequent. However, as experience with the procedure has grown, several complications have been identified, and some can be quite serious. There has been at least one death that has been reported as a result of embolization (Lanocita R, Patelli G, DiTolla G, Preafico C. A fatal complication of percutaneous transcatheter embolization for treatment of uterine fibroids [abstract]. Presented at the Society of Minimally Invasive Therapy/Center of Minimally Invasive Therapy 11th Annual Scientific Meeting; September 17, 1999; Boston, Massachusetts).5 What is not yet clear is the incidence of the complications because few published series are of sufficient size to determine their true frequency.
As a part of our evaluation of this therapy, we have prospectively gathered data on each patient we have treated, including any complications that may have occurred. We present here a compilation of the complications that have occurred in this group of patients.
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MATERIALS AND METHODS |
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ABSTRACTMATERIALS AND METHODSRESULTSDISCUSSIONREFERENCES |
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Most patients with symptomatic leiomyomas were considered candidates for the procedure and have been described in detail elsewhere.4 In general, patients with leiomyomas causing heavy menstrual bleeding, pelvic pain or pressure, or urinary symptoms were potential candidates. Exclusion criteria included patients currently pregnant, those with infertility attributed to leiomyomas by their gynecologist, women with a primary goal of becoming pregnant whose leiomyomas could be removed by myomectomy without extensive dissection of the uterus, those with pedunculated submucosal leiomyomas that were hysteroscopically resectable, and those with a uterus larger than 24 weeks’ size.
The embolization was performed using the technique we have previously described.7 In brief, bilateral embolization was attempted in each case. In all but four cases bilateral femoral puncture was used, with simultaneous placement of catheters into the uterine arteries. Polyvinyl alcohol particles (500–710 µm) (Contour; Boston Scientific Corporation, Natick, MA) were the embolic agent in the first 300 cases. Either tris acryl gelatin microspheres (Embospheres Microspheres; Biosphere Medical, Rockland, MA) or polyvinyl alcohol particles were used in the final 100 patients. With polyvinyl alcohol particles, the end point of embolization was near stasis of flow in the uterine artery or very sluggish forward flow. For Embospheres, the end point of embolization was slow forward flow in the uterine artery with occlusion of the leiomyoma vascular supply. Each patient received one dose of preprocedure antibiotics consisting of intravenous gentamicin (80 mg) (Schering Corp., Kenilworth, NJ) and clindamycin phosphate (900 mg) (Pharmacia-Upjohn, Kalamazoo, MI). Patients did not routinely receive antibiotics after the procedure.
After the embolization, most patients (391 of 400) were hospitalized overnight and discharged the next morning. Each patient was treated with a combination of intravenous narcotics and parenteral ketorolac (Toradol; Roche Laboratories, Nutley, NJ). After discharge, each patient was treated with either oral ibuprofen (Motrin; McNeil Consumer, Fort Washington, PA), 800 mg every 6 hours for 4 days and then every 6 hours as needed, or oral ketorolac (Toradol), 10 mg every 6 hours. In addition, oxycodone hydrochloride (HCl)/ acetaminophen (5/325 mg) (Percocet; Endo Pharmaceuticals Inc., Chadds Ford, PA) was prescribed orally every 3–4 hours as needed for pain. Beginning approximately one third of the way through the study, patients were also given a prescription for hydromorphone (Dilaudid; Knoll Laboratories, Mount Olive, NJ), 2 mg orally every 3–4 hours as needed, as a backup if the oxycodone/ acetominophen was insufficient for pain control. Patients were also given a prescription for promethazine HCl (Phenergan; Wyeth-Ayerst Pharmaceuticals, Philadelphia, PA), 25 mg orally every 4–6 hours as needed, to control nausea.
Each complication was recorded as it occurred while in the hospital. Each patient was called 24 hours after discharge and seen in most cases 1 week after discharge and asked about problems or complications. Each patient had both written and oral instructions to call the interventional radiology service directly should any problems arise. Each patient was also queried by questionnaire at 3 months and, in those with a 12-month interval since treatment, 1 year after the procedure.
For the purpose of this study, an in-hospital complication was defined as an adverse event that resulted in the need for additional imaging evaluation, increased level of care, or additional medical treatment or in persisting disability or injury. For those complications that occurred after discharge postprocedure, events were defined as complications if they resulted in unanticipated physician office visits, unanticipated imaging studies, emergency room visits, or readmissions to the hospital for evaluation or care for an adverse event. Problems identified at the routine follow-up office visit that required new therapy were also included. These definitions are similar to those that have been used in the FIBROID registry. The severity of each complication was rated according to the standard definitions of outcome created by the SCVIR, which are included in Table 1
. Finally, operative morbidity as defined in a recent summary of complications of hysterectomy and myomectomy for leiomyomas8 was used to summarize the set of complications. The definitions used in that study were based on The American College of Obstetricians and Gynecologists (ACOG) quality indicators for perioperative morbidity and are provided in Table 2. Each complication in the present study was assigned to each category that applied, resulting in double or triple recording of some adverse events. For example, a patient with a fever associated with passage of a leiomyoma who was admitted (even to a same-day surgery or overnight observation unit) for a dilation and curettage would be counted three times, once each in febrile morbidity, readmission, and unintended procedure. However, in calculating the overall morbidity by ACOG criteria, each complication was only counted once. This is the same approach taken by Sawin.8 All complications that occurred, including those that occurred after the traditional 30-day perioperative morbidity period, were included.
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Clopper-Pearson exact confidence intervals (CIs) were calculated for each of the complications classes in each of the classification systems. The Pearson 
2 statistic was used to determine if age or race affected frequency of complications. Data analysis was completed using SAS 8 (SAS Institute, Cary, NC).
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RESULTS |
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A total of 42 women (10.5%; 95% CI 7.7, 13.9) experienced complications, five of whom had two complications, resulting in a total of 47 adverse events. Although this study was intended to summarize every complication that occurred within 3 months of the procedure, six complications occurred more than 3 months after the procedure and are included here for completeness. The SCVIR definitions and the frequency of complications in each class are listed in Table 1
. The perioperative morbidity rate (all complications occurring within 30 days of the procedure) was 8.5% (95% CI 6.0, 11.7).
Table 3 provides a summary of all complications. The most frequently encountered minor complication was allergic reaction or rash. It comprised 21% of all adverse events and occurred in 2.5% (95% CI 1.2, 4.5) of the study population. All of these reactions required only pharmacologic treatment (either diphenhydramine or corticosteroids). Most of these reactions were directly attributable to medications given, although the specific etiology was unknown in three. There were a variety of other minor complications (SCVIR classes A and B), which comprised 64% of the total complications.
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. Of the 47 documented adverse events, 79% occurred within 30 days of the procedure, with 10 occurring during the initial hospitalization and 27 after discharge but before 30 days after the procedure. An additional four complications occurred between 31 and 90 days. As mentioned above, six complications were noted after 3-month follow-up among 300 patients who had at least a 1-year interval since the procedure. Late complications were most likely related to leiomyoma passage.
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lists SCVIR-defined major complications, including the interventions needed. Of the ten complications coded as class C, four were hospitalizations for pain control, four for passage of leiomyoma tissue in the absence of infection, and two for endometritis. Classification D complications occurred in five patients (1.25%). The first of these patients was diagnosed with a pulmonary embolus 3 days after the procedure, treated with anticoagulation, and rehospitalized for 4 days. The second developed bilateral iliac artery thrombosis during the embolization procedure and was treated with thrombolytic therapy in the intensive care unit for 2 days and hospitalized for a total of 4 days. The third acquired a uterine infection 10 weeks after embolization. This occurred as leiomyoma tissue passed, requiring no operative interventions but 5 days of hospitalization for intravenous antibiotics. A fourth patient had infection develop with leiomyoma passage, which required 5 days of hospitalization and hysteroscopic removal. The final patient developed heavy vaginal bleeding during leiomyoma passage 4 months after treatment, requiring hospitalization for 10 days. Despite a dilation and curettage and successful passage of the leiomyoma, the bleeding was not controlled and a hysterectomy was performed. This was the only hysterectomy performed for an ad verse event among this group of patients. No class E or complications occurred.
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. Using this system, 20 complications were recorded for an overall morbidity of 5% (95% CI 3.1, 7.6). If only perioperative procedures are recorded, the recorded morbidity occurred in 12 patients (3%).
Analysis did not detect any difference in the incidence of complications based on age group (2 = 1.247, P = .542) or race (22 = 0.379, P = .828). The specific relative risk for complications for the black group when compared with the white group is 0.91 (95% CI 0.66, 1.26; P = .55)
The analysis of menstrual function was completed among the 250 patients who had a least a 1-year interval since their procedure. At 3 months after the procedure, follow-up responses on menstrual function were available for 231 patients (92%), and at 12 months, 207 patients (83%) responded to this question.
Of this group, 12 were amenorrheic 3 months after embolization. Of these, one was lost to follow-up at 1 year, three remained amenorrheic, and the remaining nine resumed menses. One additional patient became amenorrheic at 1 year after treatment, for a total of four at the12-month follow-up interval. The ages of these four were 49, 51, 50, and 54. One additional patient, aged 34, had an unsuccessful attempt to catheterize her uterine arteries, and as a result, embolization could not be performed. With her menorrhagia unabated, she was referred for hysteroscopic resection of her submucous myoma. This procedure was successful but resulted in amenorrhea that has persisted over 1 year after treatment.
An additional event occurred that is important to record. One patient had a successful embolization for a single large intramural leiomyoma. The leiomyoma decreased in volume and the symptoms abated. This patient attempted to become pregnant, and after over 18 months of failed attempts, she elected a myomectomy. At that surgery, the mass was determined to be a leiomyosarcoma. This discovery occurred 31 months after embolization. The patient has declined hysterectomy despite that recommendation. She was 34 years old and still wanted to become pregnant. She underwent another myomectomy 9 months later to further debulk the residual mass, and the pathologic diagnosis of leiomyosarcoma was confirmed, based on hypercellularity, diffuse cytologic atypia, and significant mitotic activity (eight to ten mitotic figures per high powered field). She declined hysterectomy 6 months after the second surgery (and 46 months after her embolization), and she has not yet developed any symptoms from the neoplasm.
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DISCUSSION |
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To place these complications in context with other reported interventions for leiomyomas, we also classified them according to modified ACOG criteria used in Sawin’s recent report on the complications of hysterectomy and myomectomy for leiomyomas.8 In that study, using these same criteria, myomectomy had an overall morbidity of 38.6% and hysterectomy, 40.1%. The large majority of these events were febrile (33% of myomectomy and 25.9% of hysterectomy procedures). If one focuses on more severe complications, there were 1.5% life-threatening events with myomectomy and 1.0% of hysterectomy. Unintended operative procedures occurred in 4.5% of myomectomies and 9.6% of hysterectomies, and there were readmissions in 1.5% of myomectomies and 2.5% of hysterectomies. This compares with 2.5% unintended procedures, 3.5% readmissions, and 0.5% life-threatening events for uterine embolization in the present study. Although such a comparison might suggest that embolization has a lower rate of morbidity than surgical interventions, direct comparison in this setting is difficult. The surgical series recorded events in patients treated between 1994 and 1996, and complication rates may have decreased in that interval because of improvements in operative and perioperative care. In addition, our inclusion of all the known events (including those beyond 30 days) may overstate the relative risk of embolization. There may be late complications from surgery, such as urinary tract injury, bowel obstruction from adhesions, or even late infection that might not occur in the first 30 days. A study directly comparing the relative of the morbidity of these procedures is necessary before conclusions. Two such studies are currently underway, both Phase II comparative Food and Drug Administration–monitored trials, one comparing embolization with myomectomy and the other comparing embolization with hysterectomy. With their completion, more reliable estimates of relative safety will be possible.
Our most common complication requiring hospitalization was leiomyoma tissue passage, often associated with significant pain, infection, or bleeding. First reported by Abbara and Berkowitz in separate reports,15,17 it appears to occur only in leiomyomas in contact with the endometrial surface, including submucosal leiomyomas and intramural leiomyomas that have at least some submucosal component. This is one complication that may not be limited to the perioperative period, and we have seen this occur as late as 1 year after embolization. In all our cases but one, treatment was limited to an office visit, hospitalization, dilation and curretage, and/or hysteroscopy. Others have had similar occurrences.1,2,11,13 Given the frequent need for hospitalization in this setting, it is important to evaluate for expulsion when patients present with severe pain, fever, or recurrent severe bleeding weeks or months after treatment. Many of these leiomyomas do not pass through the cervix spontaneously, but can be identified as having been advanced toward the cervix from their original position on magnetic resonance imaging (MRI) examination. Although those that pass into the vagina usually can be removed during an office visit, some remain firmly attached to the uterine wall or never enter the vagina and require dilation and evacuation by a gynecologist. Perhaps surprisingly, the only patient we had who required a hysterectomy for a complication related to the procedure did not need it because of a periprocedural infection or ischemic injury to the uterus. Rather, it occurred approximately 4 months after embolization when severe hemorrhage occurred during passage of a leiomyoma. We believe that uterine ischemic injury is rare after embolization because the occlusion of the uterine arteries is usually not complete, but terminated when the leiomyomas’ vasculature is occluded. There are also sources of collateral flow from ovarian, round ligament, cervical, and other pelvic vessels. We perform a contrast-enhanced MRI on each patient 3 months after therapy; we have yet to see any evidence of myometrial ischemic injury (other than to the leiomyomas) in any patient.
One question that immediately arises in relation to leiomyoma tissue passage is whether submusocal leiomyomas are more likely to be expelled than others. This is a difficult question to answer because there is no uniform system to describe the exact relation of leiomyomas to the endometrium and the degree of distortion related to it. Most patients who passed tissue in this group did not have a pedunculated submucous leiomyoma, but rather a leiomyoma that was a combination of submucosal and intramural positions. We did not include an analysis of this complication based on the position (as reported on preprocedure MRI) because of the extreme variability in the use of descriptors of position. Before this type of analysis can be completed, a uniform system of describing leiomyoma disease severity, including information as to the extent of endometrial distortion and contact, must be developed. Such a classification system would also greatly aid in assessing which therapies are most effective in subgroups of patients in comparative studies.
Most patients experience several hours of moderate to severe pain after this procedure. This usually requires intravenous narcotics to control. However, it is unusual that substantial pain continues beyond the first 4–5 postprocedure days. On occasion patients will present with the "complication" of recurrent or prolonged severe pain, which occurred much more frequently early in our experience, with four of the five patients reported here among the first 60 patients we treated. Changes in our pain control protocol, as well as a trend toward less extensive occlusion of the uterine vasculature, have made this problem much less common. Now, in our experience, the most common cause of recurrent pain more than a week after embolization is severe cramping associated with leiomyoma passage.
Although we have presented the data on a large cohort of patients, only limited demographic subgroup analysis could be undertaken because of the infrequency of the complications. In this limited study, neither age group nor race appeared to predict complications. We believe a much larger study is needed for more detailed analysis. Such a study is under way in the FIBROID registry, a national multicenter registry that is a joint effort of the Cardiovascular and Interventional Radiology Research and Education Foundation and the Duke Clinical Research Institute. With a current enrollment of 2500 patients, it is anticipated that it will have entered 3000 patients by the conclusion of entry in March 2003. With that dataset, it is hoped that estimates of morbidity based on various presenting parameters can be completed.
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Footnotes |
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Received March 1, 2002. Received in revised form April 25, 2002. Accepted May 13, 2002.
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REFERENCES |
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2. Pelage J, LeDref O, Soyer P, Kardache M, Dahan H, Abitol M, et al. Fibroid-related menorrhagia: Treatment with superselective embolization of the uterine arteries and midterm follow-up. Radiology 2000;215:428–31.
3. Siskin G, Stainken B, Dowling K, Meo P, Ahn J, Dolen E. Outpatient uterine artery embolization for symptomatic uterine fibroids: Experience in 49 patients. J Vasc Interv Radiol 2000;11:305–11.[Medline]
4. Spies J, Ascher SA, Roth AR, Kim J, Levy EB, Gomez-Jorge J. Uterine artery embolization for leiomyomata. Obstet Gynecol 2001;98:29–34.
5. Vashisht A, Studd J, Carey A, Burn P. Fatal septicaemia after fibroid embolisation. Lancet 1999;354(9175):307–8.[Medline]
6. Spies J, Bennati J, Worthington-Kirsch R, Pelage J. Initial U.S. experience using trisacryl gelatin microspheres for uterine artery embolization for leiomyomata. J Vasc Interv Radiol 2001;12:1059–63.[Medline]
7. Spies J, Scialli A, Jha R, Imaoka I, Ascher S, Fraga V, et al. Initial results from uterine fibroid embolization for symptomatic leiomyomata. J Vasc Interv Radiol 1999;10: 1149–57.[Medline]
8. Sawin S, Pilevsky N, Berlin J, Barnart K. Comparability of perioperative morbidity between abdominal myomectomy and hysterectomy for women with uterine leiomyomas. Am J Obstet Gynecol 2000;183:1448–55.[Medline]
9. Andersen PE, Lund N, Justesen P, Munk T, Elle B, Floridon C. Uterine artery embolization for symptomatic uterine fibroids: Initial success and short-term results. Acta Radiol 2001;42:234–8.[Medline]
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11. Hutchins F, Worthington-Kirsch R, Berkowitz R. Selective uterine artery embolization as primary treatment for symptomatic leiomyomata uteri. J Am Assoc Gynecol Laparosc 1999;6:279–84.[Medline]
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13. Ravina J, Ciraru-Vigneron N, Aymard A, Ferrand J, Merland J. Uterine artery embolisation for fibroid disease: Results of a 6 year study. Minim Invasive Ther Allied Technol 1999;8:441–7.
14. Worthington-Kirsch R, Popky G, Hutchins F. Uterine arterial embolization for the management of leiomyomas: Quality-of-life assessment and clinical response. Radiology 1998;208:625–9.[Abstract]
15. Abbara S, Spies J, Scialli A, Jha R, Lage J, Nikolic B. Transcervical expulsion of a fibroid as a result of uterine artery embolization for leiomyomata. J Vasc Interv Radiol 1999;10:409–11.[Medline]
16. Goodwin S, Bonilla S, Sacks D, Reed R, Spies J, Landow W, et al. Reporting standards for uterine artery embolization for the treatment of uterine leiomyomata. J Vasc Interv Radiol 2001;12:1011–20.[Medline]
17. Berkowitz R, Hutchins F, Worthington-Kirsch R. Vaginal expulsion of submucosal fibroids after uterine artery embolization: A report of three cases. J Reprod Med 1999;44:373–6.[Medline]
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