Management of Tarlov cysts: an uncommon but potentially serious spinal column disease-review of the literature and experience with over 1000 referrals.

Tarlov cysts were thought to be anatomic variants of uncertain etiology and clinical significance when initially described over 80 years ago. They are often detected in routine lumbosacral imaging and generally not reported in a differential diagnosis. There is increasing evidence that at least some Tarlov cysts are symptomatic and can have a significant adverse impact on patients' health and well-being. Women are disproportionately affected with this condition, often presenting with long-standing pain and neurological dysfunctions. Significant gender bias has been a concern in the management of these patients. Unfortunately, there is no consensus on patient selection or management approaches for symptomatic Tarlov cysts. This review article updates information on the prevalence, diagnosis, clinical significance, and treatments of these cysts. Based on these findings and experience with over 1000 patient referrals, a treatment decision algorithm for symptomatic Tarlov cysts was constructed to provide guidance for appropriate management of patients with these complex cysts.

Lead-Dust Contamination on Radiation Protection Apparel.

PURPOSE: To evaluate the prevalence of surface lead-dust contamination on radiation protection apparel (RPAs) in the radiology department and compare findings with those from other studies of RPA lead-dust contamination. MATERIALS AND METHODS: A survey of RPAs was conducted between June and December 2021 in radiology departments at a tertiary-care university hospital. A convenience sample of RPAs located on wall-mounted racks outside the angiography suite and emergency department was surveyed. Surface lead dust on RPAs was detected using a rapid qualitative test. RESULTS: A total of 69 RPAs included full-length frontal lead aprons (n = 11), full-length frontal lead aprons (n = 25) with thyroid collars (n = 25), and thyroid collars alone (n = 8). Garments consisted mainly of a lead/antimony composite core with a 0.5-mm lead equivalency. One RPA failed radiologic quality inspection, and 8 garments were in poor or worn condition. The overall prevalence of surface lead-dust contamination on RPAs was 60.9% (95% CI, 49.1%-71.5%) and was significantly (P = .0035) higher on thyroid collars (78.8% [95% CI, 62.2%-89.3%]) than on lead aprons (44.4% [95% CI, 29.5%-60.4%]). CONCLUSIONS: A high prevalence of surface lead-dust contamination was detected on RPAs using a rapid qualitative test. There is currently no established safe level of lead, and these findings suggest RPAs be monitored frequently not only for physical defects limiting radiation protection but also for lead-dust contamination.

PUBLIC AND PATIENT INVOLVEMENT IN HEALTH TECHNOLOGY ASSESSMENT: A FRAMEWORK FOR ACTION.

OBJECTIVE: As health technology assessment (HTA) organizations in Canada and around the world seek to involve the public and patients in their activities, frameworks to guide decisions about whom to involve, through which mechanisms, and at what stages of the HTA process have been lacking. The aim of this study was to describe the development and outputs of a comprehensive framework for involving the public and patients in a government agency's HTA process. METHODS: The framework was informed by a synthesis of international practice and published literature, a dialogue with local, national and international stakeholders, and the deliberations of a government agency's public engagement subcommittee in Ontario, Canada. RESULTS: The practice and literature synthesis failed to identify a single, optimal approach to involving the public and patients in HTA. Choice of methods should be considered in the context of each HTA stage, goals for incorporating societal and/or patient perspectives into the process, and relevant societal and/or patient values at stake. The resulting framework is structured around four actionable elements: (i) guiding principles and goals for public and patient involvement (PPI) in HTA, (ii) the establishment of a common language to support PPI efforts, (iii) a flexible array of PPI approaches, and (iv) on-going evaluation of PPI to inform adjustments over time. CONCLUSIONS: A public and patient involvement framework has been developed for implementation in a government agency's HTA process. Core elements of this framework may apply to other organizations responsible for HTA and health system quality improvement.

Cost-effectiveness and willing-to-pay thresholds for vertebral augmentation of osteoporotic vertebral fractures, what are they based on: a systematic review.

OBJECTIVE: Although there is substantial clinical evidence on the safety and effectiveness of vertebral augmentation for osteoporotic vertebral fractures, cost-effectiveness is less well known. The objective of this study is to provide a systematic review of cost-effectiveness studies and policy-based willingness-to-pay (WTP) thresholds for different vertebral augmentation (VA) procedures, vertebroplasty (VP) and balloon kyphoplasty (BK), for osteoporotic vertebral fractures (OVFs). DESIGN: A systematic review targeting cost-effectiveness studies of VA procedures for OVFs. DATA SOURCES: Six bibliographic databases were searched from inception up to May 2021. ELIGIBILITY CRITERIA FOR STUDY SELECTION: Studies were eligible if meeting all predefined criteria: (1) VP or BK intervention, (2) OVFs and (3) cost-effectiveness study. Articles not written in English, abstracts, editorials, reviews and those reporting only cost data were excluded. DATA EXTRACTION AND SYNTHESIS: Information was extracted on study characteristics, cost-effective estimates, summary decisions and payer WTP thresholds. Incremental cost-effective ratio (ICER) was the main outcome measure. Studies were summarised by a structured narrative synthesis organised by comparisons with conservative management (CM). Two independent reviewers assessed the quality (risk of bias) of the systematic review and cost-effectiveness studies by peer-reviewed checklists. RESULTS: We identified 520 references through database searching and 501 were excluded as ineligible by titles and abstract. Ten reports were identified as eligible from 19 full-text reviews. ICER for VP versus CM evaluated as cost per quality-adjusted life-year (QALY) ranged from €22 685 (*US$33 395) in Netherlands to £-2240 (*US$-3273), a cost-saving in the UK. ICERs for BK versus CM ranged from £2706 (*US$3954) in UK to kr600 000 (*US$90 910) in Sweden. ICERs were within payer WTP thresholds for a QALY based on historical benchmarks. CONCLUSIONS: Both VP and BK were judged cost-effective alternatives to CM for OVFs in economic studies and were within WTP thresholds in multiple healthcare settings.

Cost-effectiveness studies of vertebral augmentation for osteoporotic vertebral fractures: a systematic review.

BACKGROUND CONTEXT: Osteoporotic vertebral fractures (OVF) dramatically increase with age and are serious life altering adverse events for seniors resulting in increased rates of institutionalization, morbidity and mortality. Given the expanding population of the elderly and increasing prevalence of OVFs, cost-effective treatment strategies need to be considered. Percutaneous vertebral augmentation (VA) procedures such as vertebroplasty (VP) or balloon kyphoplasty (BK) are increasingly employed to treat painful vertebral fractures not responding to conservative management (CM) of bedrest and analgesia. Both VA procedures have been shown to be effective treatments for OVFs in multiple systematic reviews of randomized controlled trials. In this systematic review, analytical strategies, designs and results were compared for health economic studies evaluating cost-effectiveness of VA procedures, VP or BK for OVFs. Furthermore, assessments of quality (risk of bias) were conducted for the systematic review and the individual studies with peer-reviewed checklists recommended for cost-effectiveness studies. PURPOSE: To provide an up-to-date systematic review of peer-reviewed studies evaluating cost-effectiveness of VA procedures, VP or KP for OVFs to support treatment and health care funding decisions. STUDY DESIGN: This study is a systematic literature review and structured narrative synthesis. STUDY SAMPLE: Peer reviewed health economic studies reporting cost-effectiveness for VA procedures, VP or BK for OVFs OUTCOME MEASURES: The following information extracted from the studies included: report country and year, study design, comparators, population, perspective, health valuations, costing sources and cost-effectiveness measures. For economic studies involving modeling, information was also extracted for model type, time horizon, key model drivers, and handling of uncertainty. Incremental cost-effectiveness ratio (ICER), the ratio of differences between comparator treatment groups in costs and health benefits, was considered the main cost-effectiveness measure. METHODS: A systematic review was conducted of MEDLINE, EMBASE, CINAHL, ECONLIT, Cochrane Library and DARE databases up to the review date May 2021. Studies were reviewed for those reporting cost-effectiveness analyses on VA procedures including VP or BK for OVFs. Studies including only costs, abstracts, editorials, methodologies and reviews were not included. The selection of articles was reported in line with PRISMA guidance. A descriptive framework was developed to classify types of cost-effectiveness studies based on methodological differences and a structured narrative synthesis was used to summarize studies. Quality assessments were made with British Medical Journal checklist for individual cost-effectiveness studies and the CiCERO checklist for systematic reviews of cost-effectiveness studies. RESULTS: In this systematic review, 520 references were identified through database searching and 501 were excluded as ineligible by titles and abstract based on prior eligibility criteria. From full-text reviews of 19 reports, ten were identified as eligible for the systematic review evaluating cost-effectiveness of VA procedures for OVFs. All references were published between 2008 and 2020. The ten cost-effectiveness studies, three for VP, three for BK and four for both VP and BK, all involved CM for OVFs as a treatment comparator. The studies involved different methods of economic analysis, modeling assumptions, cost and health valuations conducted in different health care setting over different time periods. A framework for the review outlines key features of cost-effectiveness study designs consisting of unmatched, matched, or randomized controls involving cost-effectiveness or cost-utility) analyses. Both VP and BK were cost-effective alternatives to CM for OVFs with earlier health gains and significantly shorter hospital stays. Cost-effectiveness estimates, ICERs, remained relatively stable and within willingness-to-pay thresholds under a range of sensitivity analyses. Comparisons between VP and BK were variable depending on modeling assumptions, but generally the procedures had similar health benefit gains with VP having lower acute procedural costs. CONCLUSIONS: Both VP and BK, have been shown to be cost-effective alternatives to CM for osteoporotic vertebral fractures in diverse cost-effectiveness studies conducted in multiple health care settings. Trial-based cost-utility contributed the strongest evidence supporting cost-effectiveness determination for VP and BK for OVFs.

Uterine artery embolization for treatment of leiomyomata: long-term outcomes from the FIBROID Registry.

OBJECTIVE: To assess long-term clinical outcomes of uterine artery embolization across a wide variety of practice settings in a large patient cohort. METHODS: The Fibroid Registry for Outcomes Data (FIBROID) for Uterine Embolization was a 3-year, single-arm, prospective, multi-center longitudinal study of the short- and long-term outcomes of uterine artery embolization for leiomyomata. Two thousand one hundred twelve patients with symptomatic leiomyomata were eligible for long-term follow-up at 27 sites representing a geographically diverse set of practices, including academic centers, community hospitals, and closed-panel health maintenance organizations. At 36 months after treatment, 1,916 patients remained in the study, and of these, 1,278 patients completed the survey. The primary measures of outcome were the symptom and health-related quality-of-life scores from the Uterine Fibroid Symptom and Quality of Life questionnaire. RESULTS: Mean symptom scores improved 41.41 points (P<.001), and the quality of life scores improved 41.47 points (P<.001), both moving into the normal range for this questionnaire. The improvements were independent of practice setting. During the 3 years of the study, Kaplan-Meier estimates of hysterectomy, myomectomy, or repeat uterine artery embolization were 9.79%, 2.82%, and 1.83% of the patients, respectively. CONCLUSION: Uterine artery embolization results in a durable improvement in quality of life. These results are achievable when the procedure is performed in any experienced community or academic interventional radiology practice. LEVEL OF EVIDENCE: III.

Pregnancy after uterine artery embolization for leiomyomata: the Ontario multicenter trial.

OBJECTIVE: To report on pregnancies and deliveries occurring in a large cohort of women who underwent uterine artery embolization instead of surgery for symptomatic leiomyomata. METHODS: A total of 555 women underwent uterine embolization in a multicenter clinical trial. The primary embolic agent was 355-500 microm polyvinyl alcohol particles with treatment end-point as bilateral stasis in the uterine arteries. Women desiring pregnancy were informed of the uncertain effect of embolization on fertility and pregnancy. Average age at embolization was 43 years (range 18-59 years). Thirty-one percent were younger than age 40 years. Women were followed up prospectively by telephone, and obstetric records of the women who conceived were reviewed. RESULTS: Twenty-one women of average age 34 years (range 27-42 years) conceived, (3 of these twice), and 13 women were nulliparous. Twenty-three of the 24 pregnancies were conceived spontaneously (1 woman had in vitro fertilization). There were 4 spontaneous abortions (16.7%, 95% confidence interval 5.4-41.9%) and 2 elective pregnancy terminations. Fourteen of the 18 live births were full term and 4 were preterm. There were 9 vaginal deliveries and 9 cesarean deliveries, 4 of which were elective. Abnormal placentation occurred in 3 cases, all nulliparas (12.5% 95% confidence interval 3.1-36.3%). Two cases developed placenta previa (1 had a clinical partial accreta) and the third developed a placenta membranacea with accreta resulting in cesarean hysterectomy. Three postpartum hemorrhages all secondary to placental abnormalities occurred. Four newborns were small for gestational age (< or = 5th percentile); 2 of these pregnancies were complicated by gestational hypertension. CONCLUSION: Women are able to achieve pregnancies after uterine artery embolization, and most resulted in term deliveries and appropriately grown newborns. Close monitoring of placental status, however, is recommended.

Prospective data collection of a new procedure by a specialty society: the FIBROID registry.

OBJECTIVE: To describe registry methods and baseline patient demographics from a national sample of women undergoing uterine artery embolization for uterine leiomyomata. METHODS: Interventional radiology practices were recruited to submit data by a secure Web site on women undergoing uterine artery embolization for symptomatic leiomyomata. Baseline data included patient demographics, prior medical, surgical, and obstetrical history, uterine anatomy, and quality-of-life measures. Subsequent data collected included details of the uterine artery embolization procedure and hospital stay and outcomes at 30 days; patients were also offered the opportunity to participate in longer-term follow-up. Characteristics of white and African-American women were compared using t tests, chi(2), or Wilcoxon rank-sum tests as appropriate. RESULTS: As of December 31, 2002, 3,319 uterine artery embolization cases had been entered into the registry by 72 sites; number of patients entered by individual sites ranged from 1 to 514. Of these patients, 95.4% consented to participation in the short-term outcomes registry. Forty-eight percent of patients were African American, and 44.4% were white and non-Hispanic. Heavy menstrual bleeding was the single most bothersome symptom in 64.3% of patients. Compared with white non-Hispanic women, African-American women were significantly younger, more likely to be obese, had larger uteri and more numerous leiomyomata, more severe symptoms, and poorer quality-of-life scores before treatment. CONCLUSION: It is feasible to collect prospective data on new technologies. The FIBROID Registry prospectively collected data on more than 3,000 women undergoing uterine artery embolization for symptomatic leiomyomata. Baseline patient characteristics of this patient population seem to be similar to those of women undergoing other procedures for leiomyomata. LEVEL OF EVIDENCE: III.

The Fibroid Registry for outcomes data (FIBROID) for uterine embolization: short-term outcomes.

OBJECTIVE: To investigate the short-term safety of uterine embolization for leiomyomata in a large cohort of patients treated in a variety of clinical settings. METHODS: Examining the FIBROID Registry, a multicenter prospective voluntary registry of patients undergoing uterine embolization for leiomyomata, we studied the frequency of adverse events and predictors of adverse events within 30 days of the procedure. We also report on the technical aspects of the procedure, including details of periprocedural care, technique, and short-term recovery. All adverse events were recorded and classified using standard definitions, both in terms of type and severity. Summary statistics were used to describe the data set, and univariate and multivariate analyses were used to determine which factors might influence the incidence of adverse events. RESULTS: Of the 3,160 patients enrolled at 72 contributing sites, major in-hospital complications occurred in 0.66%, and postdischarge major events occurred in 4.8% within the first 30 days. The most common adverse event after discharge was inadequate pain relief requiring additional hospital treatment (2.4%). Thirty-one patients required additional surgical intervention within 30 days after treatment, 3 of whom required hysterectomy (0.1%). There were no deaths. Multivariate analysis showed modest increased odds for an adverse event for African Americans, smokers, and those with prior leiomyoma procedures. There were no differences in outcome based on the practice site experience, practice type, or any procedure-related factors. CONCLUSION: Uterine embolization for leiomyomata is a low-risk procedure with little variability in short-term outcome based on either patient demographics or practice setting. LEVEL OF EVIDENCE: II-3.

Pathologic features of uteri and leiomyomas following uterine artery embolization for leiomyomas.

The objectives of this study were to identify the presence/absence and location of any embolic material and to describe the morphologic appearance of the leiomyoma and adjacent tissues of cases undergoing surgical intervention following uterine artery embolization (UAE) for leiomyomas. A total of 555 women underwent UAE using polyvinyl alcohol particles (PVA) in a multicenter clinical trial. The histopathologic slides from 17 of 18 women who subsequently underwent myomectomy or hysterectomy in the follow-up period (median 8.2 months) were reviewed without knowledge of the indication for surgery or time elapsed since UAE. The presence/absence and distribution of PVA emboli, associated inflammatory response, and necrosis were noted. Necrosis of leiomyoma(s) was classified as hyaline-type, coagulative tumor cell necrosis, and/or acute suppurative necrosis. In all cases PVA emboli were identified within smooth muscle tumors of the uterine body, its periphery, cervix, uterine body, myometrium, and/or the adnexa. A florid foreign body giant cell type of chronic inflammatory reaction was seen within 1 week of UAE and persisted with visible PVA for up to 14 months post-UAE. Typically, post-UAE leiomyomas showed hyaline-type, but rarely coagulative tumor cell necrosis and acute suppurative necrosis could be seen as well. Five of eight cases coming to surgery for complications showed necrotizing endomyometritis with tissue infarction. PVA particles are recognizable in post-UAE specimens. Leiomyoma necrosis is typically of the hyaline type; coagulative tumor cell necrosis was rarely seen. In some cases with complications, uterine and/or cervical necrosis occurred. The applicability of these findings for UAE patients who have been successfully treated and not resected is uncertain.

The Ontario Uterine Fibroid Embolization Trial. Part 1. Baseline patient characteristics, fibroid burden, and impact on life.

OBJECTIVE: To determine baseline characteristics of women undergoing uterine artery embolization (UAE) for symptomatic fibroids. DESIGN: Multicenter, prospective, single-arm clinical treatment trial. SETTING: Eight Ontario university and community hospitals. PATIENT(S): Five hundred fifty-five women undergoing UAE for fibroids. INTERVENTION(S): Baseline questionnaires completed before UAE. MAIN OUTCOME MEASURE(S): Questionnaires were analyzed for demographic, medical, and gynecologic histories. Fibroid symptoms, impact of symptoms, previous consultations, and treatments were also analyzed. RESULT(S): The Ontario cohort (66% white, 23% black, 11% other races) had an average age of 43. Thirty-one percent were under age 40. Most women were university educated (68%) and working outside the home (85%). Women reported heavy menstrual bleeding (80%), urinary urgency/frequency (73%), pain during intercourse (41%), and work absences (40%). They experienced fibroid-related symptoms for an average of 5 years and consulted with on average of three gynecologists before UAE. High fibroid life-impact scores were reported by 58%. Black women were significantly younger (40.7 vs. 44.0 years), more likely to experience symptoms longer (7 vs. 5 years), and more likely to undergo myomectomy before UAE (24% vs. 9%) than white women. CONCLUSION(S): Our study illustrates that large numbers of women with highly symptomatic fibroid disease are averse to surgery despite their burden of suffering and are actively seeking alternatives to hysterectomy.

The Ontario Uterine Fibroid Embolization Trial. Part 2. Uterine fibroid reduction and symptom relief after uterine artery embolization for fibroids.

OBJECTIVE: To evaluate fibroid uterine volume reduction, symptom relief, and patient satisfaction with uterine artery embolization (UAE) for symptomatic fibroids. DESIGN: Multicenter, prospective, single-arm clinical treatment trial. SETTING: Eight Ontario university and community hospitals. Five hundred thirty-eight patients undergoing bilateral UAE. INTERVENTION(S): Bilateral UAE performed with polyvinyl alcohol particles sized 355-500 microm. MAIN OUTCOME MEASURE(S): Three-month follow-up evaluations including fibroid uterine volume reductions, patient reported symptom improvement (7-point scale), symptom life-impact (10-point scale) reduction, and treatment satisfaction (6-point scale). RESULT(S): Median uterine and dominant fibroid volume reductions were 35% and 42%, respectively. Significant improvements were reported for menorrhagia (83%), dysmenorrhea (77%), and urinary frequency/urgency (86%). Mean menstrual duration was significantly reduced after UAE (7.6 to 5.4 days). Improvements in menorrhagia were unrelated to pre-UAE uterine size or post-UAE uterine volume reduction. Amenorrhea occurring after the procedure was highly age dependent, ranging from 3% (1%-7%) in women under age 40 to 41% (26%-58%) in women age 50 or older. Median fibroid life-impact scores were significantly reduced after UAE (8.0 to 3.0). The majority (91%) expressed satisfaction with UAE treatment. CONCLUSION(S): UAE reduced fibroid uterine volume and provided significant relief of menorrhagia that was unrelated to initial fibroid uterine size or volume reduction. Patient satisfaction with short-term UAE treatment outcomes was high.

New uterine-preserving therapies raise questions about interdisciplinary management and the role of surgery for symptomatic fibroids.

Mounting evidence to support the safety and effectiveness of new uterine-preserving fibroid therapies is raising questions not only about changing indications for surgery but also about gynecologists' role in therapies offered by other specialists. New collaborative relationships are needed to provide the best possible treatment; without them, those lag times of 10-15 years often cited as the time it takes for advances in clinical research to diffuse into clinical practice will be even longer for women with symptomatic fibroids.

Administration of goserelin acetate after uterine artery embolization does not change the reduction rate and volume of uterine myomas.

OBJECTIVE: To determine if goserelin immediately after uterine artery embolization (UAE) affected myoma reduction. DESIGN: Randomized pilot study (level 1). SETTING: Teaching hospital. PATIENT(S): Twenty-six women. INTERVENTION(S): All patients underwent UAE, and then 12 patients received 10.8 mg of goserelin 24 hours later. The treatment group was 5 years older: 43 versus 37.7 years. Uterine and myoma volumes were measured by ultrasound 2 weeks before UAE and at 3, 6, and 12 months. MAIN OUTCOME MEASURE(S): Uterine and fibroid volumes. RESULT(S): Pretreatment uterine volume was 477 versus 556 cm3, and dominant fibroid volume was 257 versus 225 cm3 in the control versus goserelin groups. Analysis of variance measurements indicated that the change over time did not significantly differ between the two groups. By 12 months, the control group had a mean uterine volume reduction of 58%, while the goserelin group had a reduction of 45%. Dominant fibroid changes over time did not differ between the two groups. At 12 months, the mean fibroid volume had decreased by 86% and 58% in the control and goserelin groups, respectively. CONCLUSION(S): The addition of goserelin therapy to UAE did not alter the reduction rate or volume of uterine myomas.

Oropharyngeal dysphagia: surveying practice patterns of the speech-language pathologist.

The present study was designed to obtain a comprehensive view of the dysphagia assessment practice patterns of speech-language pathologists and their opinion on the importance of these practices using survey methods and taking into consideration clinician, patient, and practice-setting variables. A self-administered mail questionnaire was developed following established methodology to maximize response rates. Eight dysphagia experts independently rated the new survey for content validity. Test-retest reliability was assessed with a random sample of 23 participants. The survey was sent to 50 speech-language pathologists randomly selected from the Canadian professional association database of members who practice in dysphagia. Surveys were mailed according to the Dillman Total Design Method and included an incentive offer. High survey (64%) and item response (95%) rates were achieved and clinicians were reliable reporters of their practice behaviors (ICC>0.60). Of all the clinical assessment items, 36% were reported with high (>80%) utilization and 24% with low (<20%) utilization, the former pertaining to tongue motion and vocal quality after food/fluid intake and the latter to testing of oral sensation without food. One-third (33%) of instrumental assessment items were highly utilized and included assessment of bolus movement and laryngeal response to bolus misdirection. Overall, clinician experience and teaching institutions influenced greater utilization. Opinions of importance were similar to utilization behaviors (r = 0.947, p = 0.01). Of all patients referred for dysphagia assessment, full clinical assessments were administered to 71% of patients but instrumental assessments to only 36%. A hierarchical model of practice behavior is proposed to explain this pattern of progressively decreasing item utilization.

Hysterectomy for complications after uterine artery embolization for leiomyoma: results of a Canadian multicenter clinical trial.

STUDY OBJECTIVE: To determine the complication-related hysterectomy rate after uterine artery embolization (UAE) for symptomatic uterine leiomyomas. DESIGN: Prospective, multicenter, nonrandomized, single-arm clinical trial (Canadian Task Force classification II-2). SETTING: Eight Ontario University-affiliated teaching and community hospitals. PATIENTS: Five hundred fifty-five women. INTERVENTION: Polyvinyl alcohol particles were delivered through a catheter into uterine arteries under fluoroscopic guidance. MEASUREMENTS AND MAIN RESULTS: Prospective follow-up investigations consisted of telephone interviews, ultrasound examinations, and reviews of pathology and surgery reports. Median follow-up was 8.1 months, and all but five patients had complete 3-month follow-up. At 3 months, eight women (1.5%, 95% CI 0.6-2.8) underwent complication-related hysterectomy. Half of the surgeries were performed at institutions other than where UAE had been performed. Indications for hysterectomies were infections (2), postembolization pain (4), vaginal bleeding (1), and prolapsed leiomyoma (1). CONCLUSIONS: The 3-month complication rate resulting in hysterectomy after UAE in a large cohort of women was low. Hysterectomy after UAE is an important measure of safety and a key outcome measure of this new therapy.

Technical results and effects of operator experience on uterine artery embolization for fibroids: the Ontario Uterine Fibroid Embolization Trial.

PURPOSE: To document the technical results and spectrum of practice of uterine artery embolization (UAE) for fibroids in the health care setting in Canada. The effects of interventional radiologist's (IR's) experience with UAE on procedure and fluoroscopy time were also investigated. MATERIALS AND METHODS: The study involved a multicenter prospective single-arm clinical treatment trial and included the practices of 11 IRs at eight university-affiliated teaching and community hospitals. Vascular access with percutaneous femoral artery approach was followed by transcatheter delivery of polyvinyl alcohol (PVA) particles into uterine arteries with fluoroscopic guidance. Technical success, complications, procedural time, fluoroscopy time, and effects of operator experience were outcomes analyzed. RESULTS: Between November 1998 and November 2000, 570 embolization procedures were performed in 555 patients. UAE was bilaterally successful in 97% (95% CI: 95%-98%). Variant anatomy was the most common reason for failure to embolize bilaterally. The procedural complication rate was 5.3% (95% CI: 3.6%-7.4%). Of the 30 events, three involved major complications (one seizure and two allergic reactions) that resulted in additional care or extended hospital stay. Procedure time and fluoroscopy time averaged 61 minutes (95% CI; 58-63 minutes) and 18.9 minutes (95% CI; 18-19.8) and varied significantly among IRs (P <.001; P <.001). The average 27% reduction in procedure time (20 minutes; P <.001) and 24% reduction in fluoroscopy time (5.1 minutes; P <.001) with increasing UAE experience were significant. CONCLUSIONS: A high level of technical success with few complications was obtained with a variety of operators in diverse practice settings. Increased experience in UAE significantly reduced procedure and fluoroscopy time.

Tolerance, hospital stay, and recovery after uterine artery embolization for fibroids: the Ontario Uterine Fibroid Embolization Trial.

PURPOSE: Uterine artery embolization (UAE) is gaining popularity as an alternative to hysterectomy for the treatment of fibroids. Although minimally invasive treatments such as UAE offer the potential of fewer complications, shorter hospital stay, and quicker recovery than surgery, there have been few published data on tolerance and recovery in patients undergoing UAE. MATERIALS AND METHODS: This was a multicenter prospective single-arm clinical treatment trial involving the practices of 11 interventional radiologists in eight Ontario university-affiliated and community hospitals. Between November 1998 and November 2000, 555 women underwent UAE for symptomatic uterine fibroids. Follow-up included ultrasound examinations and telephone interviews. UAE was performed under conscious sedation. Polyvinyl alcohol particles (355-500 micro m) were the primary embolic agent, and the procedural endpoint involved stasis in the uterine arteries. Pain protocols included antiinflammatory medications and narcotics and a planned overnight hospital admission. Tolerance and recovery were measured by patient-reported pain intensity (10-point numeric rating and five-point descriptor scale), hospital length of stay (LOS), and time until return to work. RESULTS: Intraprocedural pain was reported by 30% of patients and postprocedural pain was reported by 92% of patients (mean pain rating +/- SD, 7.0 +/- 2.47). The mean hospital LOS was 1.3 nights. Postprocedural pain was the most common indication for an LOS greater than 1 night (18%) or 2 nights (5%). Return visits to the hospital (10%) and readmissions (3%) were primarily for pain. The overall postprocedural complication rate was 8.0% (95% CI: 5.9%-10.6%). Of the 44 complications, 32 (73%) were pain-related. The mean recovery time after UAE was 13.1 days (median, 10.0 d). CONCLUSION: The majority of patients had a 1-night LOS after UAE and recovered within 2 weeks. Postprocedural pain varied considerably and was the major indication for extended hospital stay and recovery.