RESUMEN
BACKGROUND: Cyanoacrylate endovenous ablation and closure of incompetent saphenous veins have become increasingly utilized since its approval for use in the United States in 2015. This increase in usage necessitates a societal update to guide treatment and ensure optimal and consistent patient outcomes. METHOD: The American Vein and Lymphatic Society convened an expert panel to write an updated Position Statement with explanations and recommendations for the appropriate use of cyanoacrylate endovenous ablation for patients with venous insufficiency. RESULT: A Position Statement was produced by the expert panel with recommendations for appropriate use, treatment technique, outcomes review, and potential adverse events. Their recommendations were reviewed, edited, and approved by the Guidelines Committee of the Society. CONCLUSION: This societal Position Statement provides a useful document for reference for physicians and venous specialists to assist in the appropriate use of cyanoacrylate endovenous ablation in the treatment of patients with venous insufficiency.
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Procedimientos Endovasculares , Várices , Insuficiencia Venosa , Humanos , Estados Unidos , Cianoacrilatos/uso terapéutico , Várices/cirugía , Resultado del Tratamiento , Insuficiencia Venosa/cirugía , Procedimientos Endovasculares/efectos adversos , Vena Safena/cirugíaRESUMEN
OBJECTIVE: To evaluate the efficacy of acrylamido polyvinyl alcohol microspheres (a-PVAM) as an embolic agent for uterine artery embolization (UAE) compared with Tris-acryl gelatin microspheres (TAGM). DESIGN, SETTING, PARTICIPANTS: Prospective randomized double-blind noninferiority trial. Conducted at two sites both with regional UAE practices. Forty-six women with symptomatic leiomyomas. INTERVENTION: UAE procedure was performed with either of the two embolic agents. Either 700-900-µm a-PVAM or 500-700-µm TAGM was used. MAIN OUTCOME MEASURES: Changes in leiomyoma perfusion, overall uterine volume, and dominant leiomyomas volume measured by contrast-enhanced magnetic resonance imaging at 1 week, 3 months, and 6 months after UAE by a reader blinded to the embolic agent used. Changes in Uterine Fibroid Symptoms and Quality of Life questionnaire scores were measured at 3, 6, and 12 months after UAE. RESULTS: Forty-six patients were randomized and treated under the study protocol (a-PVAM n=22, TAGM n=24). There were no procedure-related complications. Two patients were excluded from analysis (one technical failure of the procedure, one withdrawal from study). Successful (>90%) leiomyoma devascularization was observed in 81% of subjects at 1 week after UAE, 97% at 3 months after UAE, and 95% at 6 months after UAE. No significant differences were observed in 14 of 15 outcome measurements, consistent with noninferiority. TAGM was slightly superior to a-PVAM on one comparison (overall quality of life at 3 months after UAE).
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Acrilamidas/uso terapéutico , Resinas Acrílicas/uso terapéutico , Gelatina/uso terapéutico , Leiomioma/terapia , Alcohol Polivinílico/uso terapéutico , Embolización de la Arteria Uterina/métodos , Neoplasias Uterinas/terapia , Adulto , Método Doble Ciego , Femenino , Humanos , Leiomioma/irrigación sanguínea , Persona de Mediana Edad , Estudios Prospectivos , Calidad de Vida , Encuestas y Cuestionarios , Resultado del Tratamiento , Neoplasias Uterinas/irrigación sanguínea , Útero/irrigación sanguínea , Útero/patologíaRESUMEN
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.
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Embolización Terapéutica/métodos , Leiomiomatosis/terapia , Satisfacción del Paciente , Calidad de Vida , Neoplasias Uterinas/terapia , Útero/irrigación sanguínea , Adulto , Femenino , Estudios de Seguimiento , Humanos , Persona de Mediana Edad , Estudios Prospectivos , Sistema de Registros , Índice de Severidad de la Enfermedad , Resultado del TratamientoRESUMEN
PURPOSE: To determine the long-term outcome of uterine fibroid therapy (UFE) using tris-acryl gelatin microspheres (TAGM). MATERIALS: This was a multicenter prospective study of patients undergoing UFE with TAGM, and during this phase of the study, the clinical outcomes 3 years after treatment were assessed. Measures of outcome included the Ruta Menorrhagia Questionnaire, patient self-assessments of symptoms and impact on activities, patient satisfaction and health-related quality of life as measured by the SF-12. Long-term re-intervention rates were also assessed. The data were analyzed at each interval compared to baseline using appropriate statistical tests. RESULTS: Of the 102 patients enrolled, 96 patients had complete baseline data and of these, 69 (72%) had known outcomes at 3 years after treatment. Sixty-one patients (64%) completed long-term follow-up without major intervention. An additional 8 patients (8.3%) underwent fibroid surgery (7 hysterectomies and 1 myomectomy). Among those without intervention, at 3 years after treatment, the mean Ruta Questionnaire Score was 19.3, compared to 47.9 at baseline and 24.5 at 3 months (P <.01). At baseline, 57% of patients had extremely heavy bleeding, while only 2% had that complaint at 36 months. At 36 months, much or moderate improvement in pelvic pain occurred in 83% of patients, pelvic discomfort in 83%, and urinary problems in 69% and 84% were moderately or very satisfied with their outcome. CONCLUSIONS: Over the long-term, UFE using TAGM is effective and safe, with high levels of durable symptom control, improved health-related quality of life and patient satisfaction.
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Resinas Acrílicas/uso terapéutico , Embolización Terapéutica/métodos , Gelatina/uso terapéutico , Leiomioma/terapia , Menorragia/terapia , Adulto , Femenino , Estudios de Seguimiento , Humanos , Histerectomía/estadística & datos numéricos , Persona de Mediana Edad , Satisfacción del Paciente , Dolor Pélvico/terapia , Estudios Prospectivos , Calidad de Vida , Encuestas y Cuestionarios , Resultado del TratamientoRESUMEN
PURPOSE: To prospectively evaluate the safety and effectiveness of polyvinyl alcohol (PVA) microspheres in patients undergoing uterine artery embolization (UAE) to treat uterine fibroid tumors and to compare the long-term changes in health-related quality of life (QOL) after UAE with the changes seen after myomectomy. MATERIALS AND METHODS: One hundred forty-six patients with uterine myomas were enrolled into this multicenter study, with 77 patients undergoing UAE with PVA and 69 patients undergoing myomectomy. Six-month follow-up was completed for the myomectomy, whereas 2-year follow-up was completed for the UAE group. Outcomes were assessed with the Uterine Fibroid QOL Questionnaire and based on adverse event incidence, time to return to normal activity, and changes in tumor symptom scores, QOL scores, and menorrhagia bleeding scores. For the UAE cohort, changes in total uterine volume and dominant tumor size on magnetic resonance (MR) imaging were assessed. RESULTS: In the UAE cohort, 88.3% of patients experienced a reduction of tumor-related symptoms (increase >or=5 points from baseline measurement) at 6 months, with 75.4% of patients in the myomectomy group experiencing similar improvement. Median QOL questionnaire scores at 6 months were found to be significantly higher in patients treated with UAE (P = .041), with sustained improvement seen at 12 and 24 months. Both procedures resulted in significant reductions in 6-month menorrhagia bleeding scores, with sustained improvement in the UAE cohort at 12 and 24 months. MR imaging at 6 months revealed significant uterine and tumor volume reductions after UAE (P < .05). At least one adverse event occurred in 42% of patients in the myomectomy group, compared with 26% in the UAE group (P < .05). CONCLUSIONS: UAE performed with PVA microspheres was associated with greater sustained improvements in symptom severity and health-related QOL and with fewer complications compared with myomectomy. Six-month MR imaging data demonstrated significant reductions in uterine and tumor volumes, although the degree of tissue infarction after UAE was not assessed with contrast medium-enhanced MR imaging.
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Quimioembolización Terapéutica , Procedimientos Quirúrgicos Ginecológicos , Leiomioma/terapia , Microesferas , Alcohol Polivinílico/uso terapéutico , Neoplasias Uterinas/terapia , Adulto , Quimioembolización Terapéutica/efectos adversos , Ensayos Clínicos como Asunto , Femenino , Procedimientos Quirúrgicos Ginecológicos/efectos adversos , Humanos , Leiomioma/patología , Leiomioma/cirugía , Imagen por Resonancia Magnética , Alcohol Polivinílico/administración & dosificación , Estudios Prospectivos , Calidad de Vida , Proyectos de Investigación , Índice de Severidad de la Enfermedad , Encuestas y Cuestionarios , Resultado del Tratamiento , Neoplasias Uterinas/patología , Neoplasias Uterinas/cirugía , Útero/irrigación sanguínea , Útero/patologíaRESUMEN
OBJECTIVES: To investigate the change in symptom severity and health-related quality of life among patients treated with uterine artery embolization for leiomyomata. METHODS: Using the Fibroid Registry for Outcomes Data (FIBROID), a multicenter, prospective, voluntary registry of patients undergoing uterine embolization for leiomyomata, we studied changes in symptom status, health-related quality of life, subsequent care, menstrual status, and satisfaction with outcome. Health-related quality-of-life and symptom status were measured using the Uterine Fibroid Symptom and Quality of Life, a leiomyoma-specific questionnaire. Summary statistics were used to describe the data set and multivariate analyses to determine predictors of outcome at 12 months. RESULTS: Of 2,112 eligible patients, follow-up data were obtained on 1,797 (85.1%) at 6 months and 1,701 (80.5%) at 12 months. At 12 months, the mean symptom score had improved from 58.61 to 19.23 (P < .001), whereas 5.47% of patients had no improvement. The mean health-related quality-of-life score improved from 46.95 to 86.68 (P < .001), whereas 5.0% did not improve. In the first year after embolization, hysterectomy was performed in 2.9% of patients, with 3.6% requiring gynecologic interventions by 6 months and an additional 5.9% between 6 and 12 months. Amenorrhea as a result of embolization occurred in 7.3% of patients. Of these, 86% were age 45 or older. Most patients were satisfied with their outcome (82% strongly agree or agree). Predictors of a greater symptom change score include smaller leiomyoma size, submucosal location, and presenting symptom of heavy menstrual bleeding. CONCLUSION: Uterine embolization results in substantial symptom improvement for most patients, with hysterectomy required in only 2.9% of patients in the first 12 months after therapy.
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Embolización Terapéutica/métodos , Leiomioma/patología , Leiomioma/terapia , Calidad de Vida , Neoplasias Uterinas/patología , Neoplasias Uterinas/terapia , Adulto , Intervalos de Confianza , Embolización Terapéutica/efectos adversos , Femenino , Estudios de Seguimiento , Humanos , Leiomioma/epidemiología , Persona de Mediana Edad , Análisis Multivariante , North Carolina/epidemiología , Oportunidad Relativa , Satisfacción del Paciente , Probabilidad , Estudios Prospectivos , Sistema de Registros , Medición de Riesgo , Índice de Severidad de la Enfermedad , Perfil de Impacto de Enfermedad , Factores de Tiempo , Resultado del Tratamiento , Neoplasias Uterinas/epidemiologíaRESUMEN
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.
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Embolización Terapéutica/métodos , Leiomioma/epidemiología , Leiomioma/terapia , Sistema de Registros , Neoplasias Uterinas/epidemiología , Neoplasias Uterinas/terapia , Adulto , Distribución por Edad , Anciano , Embolización Terapéutica/efectos adversos , Femenino , Estudios de Seguimiento , Humanos , Incidencia , Leiomioma/patología , Persona de Mediana Edad , Estudios Multicéntricos como Asunto , Probabilidad , Estudios Prospectivos , Calidad de Vida , Medición de Riesgo , Sensibilidad y Especificidad , Índice de Severidad de la Enfermedad , Sociedades Médicas , Estadísticas no Paramétricas , Resultado del Tratamiento , Estados Unidos , Neoplasias Uterinas/patología , Útero/irrigación sanguíneaRESUMEN
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.
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Embolización Terapéutica/métodos , Leiomioma/terapia , Sistema de Registros , Neoplasias Uterinas/cirugía , Adulto , Anciano , Análisis de Varianza , Embolización Terapéutica/efectos adversos , Femenino , Estudios de Seguimiento , Humanos , Incidencia , Leiomioma/epidemiología , Leiomioma/patología , Persona de Mediana Edad , Estudios Multicéntricos como Asunto , Probabilidad , Estudios Prospectivos , Medición de Riesgo , Índice de Severidad de la Enfermedad , Factores de Tiempo , Resultado del Tratamiento , Neoplasias Uterinas/epidemiología , Neoplasias Uterinas/patologíaAsunto(s)
Embolización Terapéutica , Leiomioma/terapia , Neoplasias Uterinas/terapia , Útero/irrigación sanguínea , Arterias , Embolización Terapéutica/métodos , Embolización Terapéutica/normas , Femenino , Estudios de Seguimiento , Humanos , Ensayos Clínicos Controlados Aleatorios como Asunto , Seguridad , Resultado del TratamientoRESUMEN
Injection sclerotherapy is an important primary and adjunctive therapy in the spectrum of care for superficial venous insufficiency. This article briefly reviews the history of the procedure, agents used, technique, and outcomes. The place of injection sclerotherapy in the treatment of superficial venous disease is discussed.
RESUMEN
A premenopausal 45-year-old woman underwent uterine artery embolization for suspected symptomatic leiomyomata. Fourteen months later, with renewed symptoms and a new pelvic mass, metastatic leiomyosarcoma was diagnosed. A lack of clinical response to a technically successful embolization should alert care providers that further evaluation and/or therapy is needed.
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Leiomioma/diagnóstico , Recurrencia Local de Neoplasia/diagnóstico , Neoplasias Uterinas/diagnóstico , Arterias/cirugía , Diagnóstico Diferencial , Embolización Terapéutica , Femenino , Humanos , Leiomioma/patología , Leiomioma/terapia , Persona de Mediana Edad , Recurrencia Local de Neoplasia/patología , Recurrencia Local de Neoplasia/terapia , Paridad , Premenopausia , Neoplasias Uterinas/patología , Neoplasias Uterinas/terapiaRESUMEN
OBJECTIVE: The purpose of this study was to estimate the outcomes of uterine embolization and hysterectomy for uterine leiomyomas. Study design This was a multicenter prospective study of patients who were treated with embolization (n=102 patients) and hysterectomy (n=50 patients) for leiomyomas. Changes in symptoms, complications, and quality of life were measured. The data analysis included linear and logistic regression, the Student t and paired t test, Fisher's exact test, and chi-squared test. RESULTS: For patients who underwent embolization, there were marked reductions in blood loss scores (P <.001) and menorrhagia questionnaire scores (P <.001) compared with baseline. At 12 months, a larger proportion of the patients who had undergone hysterectomy experienced improved pelvic pain (P=.021). Both groups had marked improvement in other symptoms and quality of life scores, with no difference between groups. Complications were more frequent in patients who underwent hysterectomy (50% vs 27.5%; P=.01). CONCLUSION: Both procedures substantially improved symptoms for most patients, with an advantage for hysterectomy at 12 months for pelvic pain. Serious complications were infrequent in both groups.
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Embolización Terapéutica , Histerectomía , Leiomioma/terapia , Neoplasias Uterinas/terapia , Adulto , Arterias , Embolización Terapéutica/efectos adversos , Femenino , Indicadores de Salud , Humanos , Histerectomía/efectos adversos , Leiomioma/irrigación sanguínea , Leiomioma/cirugía , Modelos Logísticos , Microesferas , Persona de Mediana Edad , Calidad de Vida , Resultado del Tratamiento , Neoplasias Uterinas/irrigación sanguínea , Neoplasias Uterinas/cirugía , Útero/irrigación sanguíneaRESUMEN
Fibroid disease is common and causes significant health problems in women of childbearing age. Over the past several years, uterine artery embolization (UAE) has emerged as a minimally invasive treatment for symptomatic uterine myomata. Embolotherapy is effective in relieving myoma-related symptoms in 80% to 90% of patients. It requires shorter hospitalizations than traditional surgical therapies for myoma disease and is associated with faster recovery and lower complication risks than surgery. Patient selection, the UAE procedure, and post-UAE management are reviewed.
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Embolización Terapéutica/métodos , Leiomioma/terapia , Neoplasias Uterinas/terapia , Femenino , Humanos , Selección de Paciente , Cuidados Posoperatorios , Complicaciones Posoperatorias , Resultado del TratamientoAsunto(s)
Embolización Terapéutica , Leiomioma/terapia , Radiología Intervencionista/normas , Neoplasias Uterinas/terapia , Útero/irrigación sanguínea , Angiografía , Arterias , Contraindicaciones , Embolización Terapéutica/normas , Femenino , Humanos , Manejo del Dolor , Selección de Paciente , Radiología Intervencionista/educación , Sociedades MédicasRESUMEN
Since the first report in 1995, there has been rapid expansion of uterine artery embolization as a therapy for symptomatic uterine fibroids. The published literature and clinical experience show that this procedure is safe and effective. This article discusses the history of the procedure, current issues in procedure technique, and the state of the literature regarding outcomes of embolization. Current and future research topics also are discussed.