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2.
Semin Intervent Radiol ; 40(5): 399-402, 2023 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-37927514

RESUMEN

Many interventional radiologists express concern about communicating their practice needs to their radiology department chairs. As a result, they may have difficulty getting support for hiring of additional physicians and staff, capital investments in equipment, and marketing of IR services. Some perceive that chairs have a preference for diagnostic radiology initiatives over interventional and want to know why. More importantly, they want to know how to approach their chair and succeed in their advocacy for IR. The key to success is understanding the perspective of the chair and the pressures and demands they face. That understanding allows the IR to propose their initiatives in a form that helps address some of the chair's needs and thus eases their path to success.

3.
Cardiovasc Intervent Radiol ; 46(11): 1583-1593, 2023 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-37605055

RESUMEN

PURPOSE: To evaluate rates of fibroid expulsion after uterine artery embolization (UAE) and risk factors. MATERIALS AND METHODS: Single-center retrospective study of UAEs for fibroids between 2016 and 2020. Preoperative UAE and patients with incomplete follow-up were excluded. Patients underwent MRI before and 3 months after UAE and/or as indicated. Medical records were reviewed, and patient demographics, fibroid characteristics and clinical events were recorded. Fibroid expulsion included fibroid exposure to the endometrial cavity on MRI, and tissue loss/passage as observed clinically or on MRI. Symptoms were considered major if requiring additional clinic visits or treatment. Statistical tests included Chi-square, Fisher's exact test, and logistic regression models. RESULTS: One hundred ninety-nine women were included. Symptomatic fibroid expulsion occurred after 31 (16%) procedures: 16 minor and 15 major. Symptoms included vaginal discharge (n = 23), bleeding (n = 9), tissue passage (n = 9), cramping/pain (n = 3), and fever (n = 4). Fifteen women (8%) needed additional care, of whom 6 (3%) required invasive procedures (4 elective hysterectomies, 1 hysteroscopic resection, 1 transvaginal removal of passing tissue). The International Federation of Gynecology and Obstetrics (FIGO) classification was significantly associated with symptomatic fibroid expulsion (p = 0.001). Odds ratio for symptomatic expulsion and expulsion requiring additional care for FIGO 3-7 versus 0-2 fibroids was 0.32 (95% confidence interval, 0.14-0.71, p = 0.005) and 0.28 (95% confidence interval, 0.10-0.83, p = 0.02), respectively. Other factors were not consistently associated with expulsion. CONCLUSION: Fibroid expulsion after uterine artery embolization was more common than previously reported but mostly asymptomatic or minimally symptomatic. Women with FIGO ≤ 2 fibroids should be appropriately counseled regarding risk for expulsion.


Asunto(s)
Leiomioma , Embolización de la Arteria Uterina , Neoplasias Uterinas , Embarazo , Humanos , Femenino , Embolización de la Arteria Uterina/métodos , Neoplasias Uterinas/diagnóstico por imagen , Neoplasias Uterinas/terapia , Estudios Retrospectivos , Resultado del Tratamiento , Leiomioma/diagnóstico por imagen , Leiomioma/terapia
4.
Am J Obstet Gynecol ; 229(3): 275.e1-275.e17, 2023 09.
Artículo en Inglés | MEDLINE | ID: mdl-37244458

RESUMEN

BACKGROUND: Few studies have directly compared different surgical procedures for uterine fibroids with respect to long-term health-related quality of life outcomes and symptom improvement. OBJECTIVE: We examined differences in change from baseline to 1-, 2-, and 3-year follow-up in health-related quality of life and symptom severity among patients who underwent abdominal myomectomy, laparoscopic or robotic myomectomy, abdominal hysterectomy, laparoscopic or robotic hysterectomy, or uterine artery embolization. STUDY DESIGN: The COMPARE-UF registry is a multiinstitutional prospective observational cohort study of women undergoing treatment for uterine fibroids. A subset of 1384 women aged 31 to 45 years who underwent either abdominal myomectomy (n=237), laparoscopic myomectomy (n=272), abdominal hysterectomy (n=177), laparoscopic hysterectomy (n=522), or uterine artery embolization (n=176) were included in this analysis. We obtained demographics, fibroid history, and symptoms by questionnaires at enrollment and at 1, 2, and 3 years posttreatment. We used the UFS-QoL (Uterine Fibroid Symptom and Quality of Life) questionnaire to ascertain symptom severity and health-related quality of life scores among participants. To account for potential baseline differences across treatment groups, a propensity score model was used to derive overlap weights and compare total health-related quality of life and symptom severity scores after enrollment with a repeated measures model. For this health-related quality of life tool, a specific minimal clinically important difference has not been determined, but on the basis of previous research, a difference of 10 points was considered as a reasonable estimate. Use of this difference was agreed upon by the Steering Committee at the time when the analysis was planned. RESULTS: At baseline, women undergoing hysterectomy and uterine artery embolization reported the lowest health-related quality of life scores and highest symptom severity scores compared with those undergoing abdominal myomectomy or laparoscopic myomectomy (P<.001). Those undergoing hysterectomy and uterine artery embolization reported the longest duration of fibroid symptoms with a mean of 6.3 years (standard deviation, 6.7; P<.001). The most common fibroid symptoms were menorrhagia (75.3%), bulk symptoms (74.2%), and bloating (73.2%). More than half (54.9%) of participants reported anemia, and 9.4% women reported a history of blood transfusion. Across all modalities, total health-related quality of life and symptom severity score markedly improved from baseline to 1-year with the largest improvement in the laparoscopic hysterectomy group (Uterine Fibroids Symptom and Quality of Life: delta= [+] 49.2; symptom severity: delta= [-] 51.3). Those undergoing abdominal myomectomy, laparoscopic myomectomy, and uterine artery embolization also demonstrated significant improvement in health-related quality of life (delta= [+]43.9, [+]32.9, [+]40.7, respectively) and symptom severity (delta= [-]41.4, [-] 31.5, [-] 38.5, respectively) at 1 year, and the improvement persisted from baseline for uterine-sparing procedures during second (Uterine Fibroids Symptom and Quality of Life: delta= [+]40.7, [+]37.4, [+]39.3 SS: delta= [-] 38.5, [-] 32.0, [-] 37.7 and third year (Uterine Fibroids Symptom and Quality of Life: delta= [+] 40.9, [+]39.9, [+]41.1 and SS: delta= [-] 33.9, [-]36.5, [-] 33.0, respectively), posttreatment intervals, however with a trend toward decline in degree of improvement from years 1 and 2. Differences from baseline were greatest for hysterectomy; however, this may reflect the relative importance of bleeding in the Uterine Fibroids Symptom and Quality of Life, rather than clinically meaningful symptom recurrence among women undergoing uterus-sparing treatments. CONCLUSION: All treatment modalities were associated with significant improvements in health-related quality of life and symptom severity reduction 1-year posttreatment. However, abdominal myomectomy, laparoscopic myomectomy and uterine artery embolization indicated a gradual decline in symptom improvement and health-related quality of life by third year after the procedure.


Asunto(s)
Leiomioma , Embolización de la Arteria Uterina , Miomectomía Uterina , Neoplasias Uterinas , Humanos , Femenino , Masculino , Miomectomía Uterina/métodos , Calidad de Vida , Neoplasias Uterinas/cirugía , Estudios Prospectivos , Leiomioma/cirugía , Histerectomía , Resultado del Tratamiento
5.
J Vasc Surg Venous Lymphat Disord ; 11(3): 573-585.e6, 2023 05.
Artículo en Inglés | MEDLINE | ID: mdl-36872169

RESUMEN

OBJECTIVE: To determine the safety and effectiveness of vena cava filters (VCFs). METHODS: A total of 1429 participants (62.7 ± 14.7 years old; 762 [53.3% male]) consented to enroll in this prospective, nonrandomized study at 54 sites in the United States between October 10, 2015, and March 31, 2019. They were evaluated at baseline and at 3, 6, 12, 18, and 24 months following VCF implantation. Participants whose VCFs were removed were followed for 1 month after retrieval. Follow-up was performed at 3, 12, and 24 months. Predetermined composite primary safety (freedom from perioperative serious adverse events [AEs] and from clinically significant perforation, VCF embolization, caval thrombotic occlusion, and/or new deep vein thrombosis [DVT] within 12-months) and effectiveness (composite comprising procedural and technical success and freedom from new symptomatic pulmonary embolism [PE] confirmed by imaging at 12-months in situ or 1 month postretrieval) end points were assessed. RESULTS: VCFs were implanted in 1421 patients. Of these, 1019 (71.7%) had current DVT and/or PE. Anticoagulation therapy was contraindicated or had failed in 1159 (81.6%). One hundred twenty-six (8.9%) VCFs were prophylactic. Mean and median follow-up for the entire population and for those whose VCFs were not removed was 243.5 ± 243.3 days and 138 days and 332.6 ± 290 days and 235 days, respectively. VCFs were removed from 632 (44.5%) patients at a mean of 101.5 ± 72.2 days and median 86.3 days following implantation. The primary safety end point and primary effectiveness end point were both achieved. Procedural AEs were uncommon and usually minor, but one patient died during attempted VCF removal. Excluding strut perforation greater than 5 mm, which was demonstrated on 31 of 201 (15.4%) patients' computed tomography scans available to the core laboratory, and of which only 3 (0.2%) were deemed clinically significant by the site investigators, VCF-related AEs were rare (7 of 1421, 0.5%). Postfilter, venous thromboembolic events (none fatal) occurred in 93 patients (6.5%), including DVT (80 events in 74 patients [5.2%]), PE (23 events in 23 patients [1.6%]), and/or caval thrombotic occlusions (15 events in 15 patients [1.1%]). No PE occurred in patients following prophylactic placement. CONCLUSIONS: Implantation of VCFs in patients with venous thromboembolism was associated with few AEs and with a low incidence of clinically significant PEs.


Asunto(s)
Embolia Pulmonar , Filtros de Vena Cava , Tromboembolia Venosa , Trombosis de la Vena , Humanos , Masculino , Persona de Mediana Edad , Anciano , Femenino , Filtros de Vena Cava/efectos adversos , Estudios Prospectivos , Trombosis de la Vena/diagnóstico por imagen , Trombosis de la Vena/terapia , Trombosis de la Vena/complicaciones , Embolia Pulmonar/etiología , Embolia Pulmonar/prevención & control , Tromboembolia Venosa/etiología , Vena Cava Inferior , Resultado del Tratamiento
6.
J Vasc Interv Radiol ; 34(4): 517-528.e6, 2023 04.
Artículo en Inglés | MEDLINE | ID: mdl-36841633

RESUMEN

OBJECTIVE: To determine the safety and effectiveness of vena cava filters (VCFs). METHODS: A total of 1429 participants (62.7 ± 14.7 years old; 762 [53.3% male]) consented to enroll in this prospective, nonrandomized study at 54 sites in the United States between October 10, 2015, and March 31, 2019. They were evaluated at baseline and at 3, 6, 12, 18, and 24 months following VCF implantation. Participants whose VCFs were removed were followed for 1 month after retrieval. Follow-up was performed at 3, 12, and 24 months. Predetermined composite primary safety (freedom from perioperative serious adverse events [AEs] and from clinically significant perforation, VCF embolization, caval thrombotic occlusion, and/or new deep vein thrombosis [DVT] within 12-months) and effectiveness (composite comprising procedural and technical success and freedom from new symptomatic pulmonary embolism [PE] confirmed by imaging at 12-months in situ or 1 month postretrieval) end points were assessed. RESULTS: VCFs were implanted in 1421 patients. Of these, 1019 (71.7%) had current DVT and/or PE. Anticoagulation therapy was contraindicated or had failed in 1159 (81.6%). One hundred twenty-six (8.9%) VCFs were prophylactic. Mean and median follow-up for the entire population and for those whose VCFs were not removed was 243.5 ± 243.3 days and 138 days and 332.6 ± 290 days and 235 days, respectively. VCFs were removed from 632 (44.5%) patients at a mean of 101.5 ± 72.2 days and median 86.3 days following implantation. The primary safety end point and primary effectiveness end point were both achieved. Procedural AEs were uncommon and usually minor, but one patient died during attempted VCF removal. Excluding strut perforation greater than 5 mm, which was demonstrated on 31 of 201 (15.4%) patients' computed tomography scans available to the core laboratory, and of which only 3 (0.2%) were deemed clinically significant by the site investigators, VCF-related AEs were rare (7 of 1421, 0.5%). Postfilter, venous thromboembolic events (none fatal) occurred in 93 patients (6.5%), including DVT (80 events in 74 patients [5.2%]), PE (23 events in 23 patients [1.6%]), and/or caval thrombotic occlusions (15 events in 15 patients [1.1%]). No PE occurred in patients following prophylactic placement. CONCLUSIONS: Implantation of VCFs in patients with venous thromboembolism was associated with few AEs and with a low incidence of clinically significant PEs.


Asunto(s)
Embolia Pulmonar , Filtros de Vena Cava , Tromboembolia Venosa , Trombosis de la Vena , Humanos , Masculino , Persona de Mediana Edad , Anciano , Femenino , Filtros de Vena Cava/efectos adversos , Estudios Prospectivos , Trombosis de la Vena/diagnóstico por imagen , Trombosis de la Vena/terapia , Trombosis de la Vena/complicaciones , Embolia Pulmonar/diagnóstico por imagen , Embolia Pulmonar/etiología , Embolia Pulmonar/prevención & control , Tromboembolia Venosa/complicaciones , Vena Cava Inferior , Resultado del Tratamiento
7.
J Womens Health (Larchmt) ; 32(4): 423-433, 2023 04.
Artículo en Inglés | MEDLINE | ID: mdl-36637808

RESUMEN

Objective: To compare 12-month post-treatment health-related quality of life (HR-QoL) and symptom severity (SS) changes among patients with symptomatic uterine fibroids (SUF) not seeking fertility and undergo a hysterectomy, abdominal myomectomy (AM), or uterine artery embolization (UAE). Materials and Methods: The Comparing Options for Management: Patient-Centered Results for Uterine Fibroids (COMPARE-UF) Registry is a multi-institutional prospective observational cohort study of patients treated for SUF. A subset of 1465 women 31-45 years of age, who underwent either hysterectomy (n = 741), AM (n = 446), or UAE (n = 155) were included in this analysis. Demographics, fibroid history, and symptoms were obtained by baseline questionnaires and at 1 year post-treatment. Results were stratified by all treatments and propensity score weighting to adjust for differences in baseline characteristics. Results: Women undergoing UAE reported the lowest baseline HR-QoL and highest SS scores (mean = 40.6 [standard deviation (SD) = 23.8]; 62.3 [SD = 24.2]) followed by hysterectomy (44.3 [24.3]; 59.8 [SD = 24.1]). At 12 months, women who underwent a hysterectomy experienced the largest change in both HR-QoL (48.7 [26.2]) and SS (51.9 [25.6]) followed by other uterine-sparing treatments. Propensity score weighting revealed all treatments produced substantial improvement, with hysterectomy patients reporting the highest HR-QoL score (92.0 [17.8]) compared with myomectomy (86.7 [17.2]) and UAE (82.6 [21.5]) (p < 0.0001). Similarly, hysterectomy patients reported the lowest SS scores (8.2 [15.1]) compared with myomectomy (16.5 [15.1]) and UAE (19.6 [17.5]) (p < 0.0001). Conclusion: All procedures showed improvement in HR-QoL and reduction in SS score at 12 months, hysterectomy showing maximum improvement. Of importance, at 12 months, patients who underwent either a myomectomy or UAE reported comparable symptom relief and HR-QoL. Clinicaltrials.Gov Identifier: NCT02260752.


Asunto(s)
Leiomioma , Calidad de Vida , Embolización de la Arteria Uterina , Miomectomía Uterina , Neoplasias Uterinas , Femenino , Humanos , Histerectomía , Leiomioma/cirugía , Estudios Prospectivos , Sistema de Registros , Resultado del Tratamiento , Embolización de la Arteria Uterina/psicología , Miomectomía Uterina/psicología , Neoplasias Uterinas/cirugía
8.
J Womens Health (Larchmt) ; 30(3): 355-366, 2021 03.
Artículo en Inglés | MEDLINE | ID: mdl-33524308

RESUMEN

Background: To evaluate differences in the proportion of uterine fibroid (UF) treatments that are uterine-sparing between Black women and White women and identify factors that could explain disparities. Methods: Women at age 18-54 years who were enrolled from 10 clinical sites in the United States into the Comparing Options for Management: Patient-Centered Results for UFs (COMPARE-UF) treatment registry completed questionnaires before their UF procedure. UF symptoms and quality of life were assessed by questionnaires. Details on UF imaging and treatment (hysterectomy, myomectomy, or uterine artery embolization [UAE]) were collected from each patient's medical record. Random-effects logistic regression was used to assess the association between race and the odds of having a uterine-sparing procedure versus hysterectomy. Subgroup analyses compared each uterine-sparing procedure with hysterectomy. Results: In this cohort of 1141 White women and 1196 Black women, Black women tended to be younger (median 41.0 vs. 42.0 years) and report worse symptoms, pain, and function on every scale compared with White women. Black women were more likely to have had a prior UF treatment compared with White women (22.8% vs. 14.6%). White women had more hysterectomies (43.6% vs. 32.2%) and myomectomies (50.9% vs. 50.2%) versus Black women. Black women had more UAEs (15.1% vs. 4.7%) than White women. After adjusting for clinical site and other variables, Black women had greater odds than White women of having a myomectomy (odds ratio [OR] = 2.41, 95% confidence interval [CI] = 1.63-3.56) or a UAE versus hysterectomy (OR = 4.24, 95% CI = 2.41-7.46). Conclusion: In these participants, Black women were more likely to schedule a uterine-sparing UF treatment and a nonsurgical UF treatment than their White counterparts; this may not be true for all women. Longer comparative effectiveness studies are needed to inform women about the durability of UF treatments. Greater understanding of factors influencing treatment selection is needed as are studies that include women without access to tertiary care centers. Clinical Trial Registration: Clinicaltrials.gov, NCT02260752 (enrollment start: November 2015).


Asunto(s)
Leiomioma , Miomectomía Uterina , Neoplasias Uterinas , Adolescente , Adulto , Negro o Afroamericano , Femenino , Humanos , Histerectomía , Leiomioma/cirugía , Persona de Mediana Edad , Calidad de Vida , Neoplasias Uterinas/cirugía , Adulto Joven
11.
Cardiovasc Intervent Radiol ; 43(1): 120-126, 2020 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-31511962

RESUMEN

PURPOSE: To determine the range of radiation dose metrics for uterine artery embolization and the impact of patient and procedure factors on those measures. MATERIALS AND METHODS: Procedure records of 515 uterine embolization procedures were reviewed and various metrics recorded, including patient demographics, body mass index (BMI), radiation exposure measures and procedure-related details. Descriptive statistics were used to summarize the measures, and appropriate parametric and nonparametric tests were used to compare and assess the correlation between the measures and the cumulative dose (CD), dose area product and fluoroscopy time (FT). Multivariable regression analysis was used to assess the impact of individual factors on the measures of radiation dose. RESULTS: The strongest correlation among the measures compared were between CD and BMI (r = 0.70), while the correlation between BMI and FT was weak (r = 0.23). Dose was higher for those procedures done with aortography and those who had TAGM as the embolic agent. Multivariable analysis demonstrated an increase of 7.4% in CD for each increase in BMI, 5.9% for each increase in cm uterine length. FT was impacted to a lesser extent, with an increase of 2.8% per unit BMI. Increasing procedure time had a greater impact on FT (r = 0.56) than on CD (r = 0.33). CONCLUSION: Among the measured variables, BMI had the greatest impact on CD and has a substantial impact on the risk of radiation-induced skin injury, even without prolonged FT.


Asunto(s)
Leiomioma/terapia , Exposición a la Radiación/estadística & datos numéricos , Embolización de la Arteria Uterina/métodos , Adulto , Aortografía , Índice de Masa Corporal , Femenino , Fluoroscopía/métodos , Humanos , Persona de Mediana Edad , Dosis de Radiación , Estudios Retrospectivos , Factores de Tiempo
12.
Am J Obstet Gynecol ; 222(4): 345.e1-345.e22, 2020 04.
Artículo en Inglés | MEDLINE | ID: mdl-31678093

RESUMEN

BACKGROUND: Uterine fibroids may decrease quality of life in a significant proportion of affected women. Myomectomy offers a uterine-sparing treatment option for patients with uterine fibroids that can be performed abdominally, laparoscopically (with or without robotic assistance), and hysteroscopically. Quality of life information using validated measures for different myomectomy routes, especially hysteroscopic myomectomy, is limited. OBJECTIVE: To compare women's perception of their short-term health-related quality of life measures and reported time to return to usual activities and return to work for different routes of myomectomy. MATERIALS AND METHODS: Comparing Options for Management: Patient-centered Results for Uterine Fibroids (COMPARE-UF) is a prospective nationwide fibroid registry that enrolled premenopausal women seeking treatment for uterine fibroids at 8 clinical sites. For this analysis, we included women undergoing hysteroscopic, abdominal, or laparoscopic myomectomy who completed the postprocedure questionnaire scheduled between 6 and 12 weeks after surgery. Health-related quality of life outcomes, such as pain, anxiety, and return to usual activitie, were assessed for each route. The hysteroscopic myomectomy group had large differences in demographics, fibroid number, and uterine size compared to the other groups; thus, a direct comparison of quality of life measures was performed only for abdominal and laparoscopic approaches after propensity weighting. Propensity weighting was done using 24 variables that included demographics, quality of life baseline measures, and fibroid and uterine measurements. RESULTS: A total of 1206 women from 8 COMPARE-UF sites underwent myomectomy (338 hysteroscopic, 519 laparoscopic, and 349 abdominal). All women had substantial improvement in short-term health-related quality of life and symptom severity scores, which was not different among groups. Average symptom severity scores decreased about 30 points in each group. Return to usual activities averaged 0 days (interquartile range, 0-14 days) for hysteroscopic myomectomy, 21 days (interquartile range, 14-28 days) for laparoscopic myomectomy, and 28 days (interquartile range, 14-35 days) for abdominal myomectomy. After propensity adjustment, quality of life outcomes in the laparoscopic and abdominal myomectomy groups were similar except for more anxiety in the laparoscopic myomectomy group and slightly more pain in the abdominal myomectomy group. After propensity weighting, return to usual activities favored laparoscopic compared to abdominal procedures; median time was the same at 21 days, but the highest quartile of women in the abdominal group needed an additional week of recovery (interquartile range,14.0-28.0 for laparoscopic versus 14.0-35.0 for abdominal, P < .01). Time to return to work was also longer in the abdominal arm (median, 22 days; interquartile range, 14-40 days, versus median, 42; interquartile range, 27-56). CONCLUSION: Women who underwent myomectomy had substantial improvement in health-related quality of life, regardless of route of myomectomy. After propensity weighting, abdominal myomectomy was associated with a nearly 2-week longer time to return to work than laparoscopic myomectomy.


Asunto(s)
Leiomioma/cirugía , Calidad de Vida , Miomectomía Uterina/métodos , Neoplasias Uterinas/cirugía , Adulto , Ansiedad/etiología , Femenino , Humanos , Histeroscopía/efectos adversos , Histeroscopía/psicología , Laparoscopía/efectos adversos , Laparoscopía/psicología , Persona de Mediana Edad , Dolor Postoperatorio/etiología , Periodo Posoperatorio , Calidad de Vida/psicología , Sistema de Registros , Reinserción al Trabajo/estadística & datos numéricos , Procedimientos Quirúrgicos Robotizados/efectos adversos , Procedimientos Quirúrgicos Robotizados/psicología , Índice de Severidad de la Enfermedad , Encuestas y Cuestionarios , Factores de Tiempo , Miomectomía Uterina/efectos adversos , Miomectomía Uterina/psicología
13.
J Vasc Surg Venous Lymphat Disord ; 8(2): 187-194.e1, 2020 03.
Artículo en Inglés | MEDLINE | ID: mdl-31636051

RESUMEN

BACKGROUND: Death from venous thromboembolism remains a significant cause of death worldwide. Although anticoagulation is the cornerstone of treatment in patients at risk for venous thromboembolism, inferior vena cava (IVC) filter use has increased exponentially over the last decade driven predominantly by the prophylactic use in patients at risk for venous thromboembolism despite limited evidence supporting this practice. The Predicting the Safety and Effectiveness of Inferior Vena Cava Filters (PRESERVE) Study is being implemented by the Society for Vascular Surgery, Society of Interventional Radiology, U.S. Food and Drug Administration, and several IVC filter manufactures to better understand the safety, effectiveness, and current patterns of real-world use of IVC filters. METHODS: The PRESERVE Study includes IVC filters from seven manufacturers: ALN (ALN ± hook), Argon (Option Elite), B. Braun (LP, Vena Tech Convertible), CR Bard (Denali), Cook (Gunther Tulip), Cordis (OptEase, TrapEase), and Philips Volcano (Crux). The indications for filter placement, filter brand, complications, stability, frequency and success of retrieval, and clinical effectiveness of each filter will be recorded. Approximately 2100 patients (300 for each filter brand included in the study) are intended to be enrolled at 60 U.S. centers. RESULTS: Men and women age 18 years or older requiring IVC filters for prevention of venous thromboembolism will be included in the study if no contrast allergy is present and they are willing to commit to the prescribed study follow-up. Participants will be evaluated at discharge, 3, 6, 12, 18, and 24 months after filter placement and/or 1 month after retrieval, which ever occurs first. Intravascular ultrasound examination or venography will be done before and after IVC filter placement, with abdominal plain film at 3 months, and contrast enhanced computed tomography scans at 12 and 24 months to evaluate filter stability. The primary safety end point is a composite of clinical end points, including freedom from perforation, embolization, thrombosis, recurrent DVT, and defined serious adverse events. Secondary end points include mechanical stability and procedure related complications at 3 months, major adverse events at 6, 12, 18, and 24 months, and filter tilt of more than 15° at any point. CONCLUSIONS: The PRESERVE Study represents the largest prospective study ever undertaken to investigate real-world outcomes with contemporary use of IVC filters. The investigators await results with the hope that it can improve patient care.


Asunto(s)
Implantación de Prótesis/instrumentación , Filtros de Vena Cava , Vena Cava Inferior , Tromboembolia Venosa/prevención & control , Remoción de Dispositivos , Humanos , Estudios Multicéntricos como Asunto , Pautas de la Práctica en Medicina , Estudios Prospectivos , Diseño de Prótesis , Falla de Prótesis , Implantación de Prótesis/efectos adversos , Recurrencia , Factores de Riesgo , Factores de Tiempo , Resultado del Tratamiento , Estados Unidos , Vena Cava Inferior/diagnóstico por imagen
14.
J Patient Rep Outcomes ; 3(1): 57, 2019 Aug 23.
Artículo en Inglés | MEDLINE | ID: mdl-31444600

RESUMEN

BACKGROUND: To evaluate the psychometric characteristics of the 1-month recall Uterine Fibroid Symptom and Health-Related Quality of Life questionnaire (UFS-QOL), including the Revised Activities subscale. METHODS: VENUS I and II were phase III, randomized, double-blind, placebo-controlled trials of ulipristal acetate in women with uterine fibroids (UF) and abnormal uterine bleeding. Women completed the 1-month recall UFS-QOL at baseline and after 12 weeks' treatment. Uterine bleeding was assessed via a daily diary (both studies); the Patient Global Impression of Improvement scale (PGI-I) was completed in VENUS II. Psychometric analyses examined internal consistency reliability and construct validity of the UFS-QOL; confirmatory factor analysis (CFA) compared model fit of the original and Revised Activities subscales. Analyses were conducted separately for VENUS I and II. RESULTS: One hundred and fifty-seven patients in VENUS I and 429 in VENUS II were included. Changes in mean Symptom Severity and health-related quality of life (HRQoL) scale scores indicated symptom burden reductions and HRQoL improvements. Cronbach's alpha coefficients were high at baseline and after 12 weeks' treatment (all ≥0.76, meeting the >0.70 threshold), demonstrating strong internal consistency reliability. Correlations between UFS-QOL scores and bleeding diary responses (range: -0.35 to -0.63), and UFS-QOL scores and PGI-I responses (range: -0.48 to -0.70), ranged from moderate to strong after 12 weeks' treatment (all p < 0.0001). Patients with absence of bleeding or controlled bleeding after 12 weeks' treatment scored significantly better (p < 0.001) on each UFS-QOL scale than patients not achieving those end points, supporting construct validity. CFA confirmed model fit for the Revised Activities subscale. CONCLUSIONS: The 1-month recall UFS-QOL, including the Revised Activities subscale, is a valid, reliable measure to assess UF symptoms and their impact on HRQoL. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02147197 . Registered May 26, 2014; retrospectively registered. ClinicalTrials.gov, NCT02147158 . Registered May 26, 2014; retrospectively registered.

15.
J Vasc Interv Radiol ; 30(5): 627-637.e1, 2019 May.
Artículo en Inglés | MEDLINE | ID: mdl-30926185
16.
Semin Intervent Radiol ; 35(1): 48-55, 2018 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-29628616

RESUMEN

Uterine fibroids (leiomyomas) are the most common benign neoplasm of the female pelvis and have a lifetime prevalence exceeding 80% among African American women and approaching 70% among Caucasian women. Approximately 50% of women with fibroids experience symptoms which may include menorrhagia that may result in anemia, bulk symptoms with bladder and bowel dysfunction and abdominal protrusion, dysmenorrhea, and infertility. Hysterectomy remains the most common treatment option for fibroids and concerns have been raised about the overuse of this procedure. Uterine artery embolization (UAE) is now a well-established uterine preserving and minimally invasive therapy for symptomatic fibroids. Since its introduction, strong evidence for safety and efficacy of UAE has been generated with low rates of complications. This review will discuss UAE for the management of symptomatic uterine fibroids with special focus on emerging technical approaches and novel periprocedural patient care.

18.
Artículo en Inglés | MEDLINE | ID: mdl-29128204

RESUMEN

Uterine artery embolization (UAE) has gained traction as a safe and effective treatment modality for symptomatic uterine leiomyomata since its introduction nearly two decades ago. This review includes an overview of current concepts with regard to patient selection, technique, and outcomes following UAE. Specific topics also include the impact of this procedure on fertility and pregnancy, the emerging role of UAE in the treatment of adenomyosis, and how UAE compares with surgical intervention for the treatment of symptomatic leiomyomata.


Asunto(s)
Leiomioma/cirugía , Embolización de la Arteria Uterina/métodos , Neoplasias Uterinas/cirugía , Adenomiosis/complicaciones , Adenomiosis/cirugía , Femenino , Fertilidad , Humanos , Leiomioma/complicaciones , Leiomioma/diagnóstico por imagen , Imagen por Resonancia Magnética , Selección de Paciente , Embarazo , Ensayos Clínicos Controlados Aleatorios como Asunto , Estudios Retrospectivos , Literatura de Revisión como Asunto , Resultado del Tratamiento , Embolización de la Arteria Uterina/efectos adversos , Neoplasias Uterinas/complicaciones , Neoplasias Uterinas/diagnóstico por imagen
19.
PLoS One ; 12(9): e0183861, 2017.
Artículo en Inglés | MEDLINE | ID: mdl-28863147

RESUMEN

PURPOSE: To review the initial imaging responses after drug-eluting embolic trans-arterial chemoembolization (DEE-TACE) delivered with the Surefire Infusion System ® for the treatment of hepatocellular carcinoma (HCC). METHODS: Single center retrospective evaluation of patients who underwent DEE-TACE for HCC, delivered with SIS. Information was gathered from available medical records. Treatment response rates were assessed using the modified Response Evaluation Criteria in Solid Tumors criteria. Assessment of adverse events was categorized per Common Terminology Criteria for Adverse Events version 4.03. RESULTS: Twenty-two patients with 39 hepatocellular carcinoma lesions were treated with the surefire infusion system. Complete response was demonstrated in 32% of patients and 54% of lesions after a single treatment session. Overall disease response was demonstrated in 91% of patients and 85% of lesions after a single treatment. No grade 3 or higher elevations in liver function tests were demonstrated in the short-term. CONCLUSION: SIS delivered DEE-TACE leads to a higher than expected initial response in patients with HCC.


Asunto(s)
Carcinoma Hepatocelular/tratamiento farmacológico , Quimioembolización Terapéutica/métodos , Stents Liberadores de Fármacos , Neoplasias Hepáticas/tratamiento farmacológico , Adulto , Anciano , Carcinoma Hepatocelular/patología , Diagnóstico por Imagen/métodos , Doxorrubicina/administración & dosificación , Registros Electrónicos de Salud , Femenino , Humanos , Pruebas de Función Hepática , Neoplasias Hepáticas/patología , Masculino , Persona de Mediana Edad , Estudios Retrospectivos , Resultado del Tratamiento
20.
Cardiovasc Intervent Radiol ; 40(11): 1796-1799, 2017 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-28536870

RESUMEN

Benign metastasizing leiomyomas (BMLs) are rare sequelae of common uterine leiomyomas and most frequently found in the lungs. Most cases of BMLs occur with a history of prior gynecologic procedures; however, none have yet been reported in association with uterine artery embolization (UAE). This case report highlights the disease course for a 48-yo female with a history of both myomectomy and UAE for uterine fibroids who presented later with bilateral pulmonary BMLs. Though the pathophysiology of BMLs is poorly understood and this case is confounded by prior myomectomy, it does bring into question whether UAE has a role in BML development. Regardless, UAEs have become a routine procedure and interventionalists should be aware of the possibility of BMLs in post-fibroid treatment patient populations.


Asunto(s)
Leiomioma/patología , Leiomioma/terapia , Neoplasias Pulmonares/secundario , Embolización de la Arteria Uterina/métodos , Miomectomía Uterina , Neoplasias Uterinas/terapia , Femenino , Humanos , Pulmón/diagnóstico por imagen , Neoplasias Pulmonares/diagnóstico por imagen , Persona de Mediana Edad , Tomografía Computarizada por Rayos X/métodos , Resultado del Tratamiento
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