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1.
Health Technol Assess ; 26(22): 1-74, 2022 04.
Artículo en Inglés | MEDLINE | ID: mdl-35435818

RESUMEN

BACKGROUND: Uterine fibroids are the most common tumour in women of reproductive age and are associated with heavy menstrual bleeding, abdominal discomfort, subfertility and reduced quality of life. For women wishing to retain their uterus and who do not respond to medical treatment, myomectomy and uterine artery embolisation are therapeutic options. OBJECTIVES: We examined the clinical effectiveness and cost-effectiveness of uterine artery embolisation compared with myomectomy in the treatment of symptomatic fibroids. DESIGN: A multicentre, open, randomised trial with a parallel economic evaluation. SETTING: Twenty-nine UK hospitals. PARTICIPANTS: Premenopausal women who had symptomatic uterine fibroids amenable to myomectomy or uterine artery embolisation were recruited. Women were excluded if they had significant adenomyosis, any malignancy or pelvic inflammatory disease or if they had already had a previous open myomectomy or uterine artery embolisation. INTERVENTIONS: Participants were randomised to myomectomy or embolisation in a 1 : 1 ratio using a minimisation algorithm. Myomectomy could be open abdominal, laparoscopic or hysteroscopic. Embolisation of the uterine arteries was performed under fluoroscopic guidance. MAIN OUTCOME MEASURES: The primary outcome was the Uterine Fibroid Symptom Quality of Life questionnaire (with scores ranging from 0 to 100 and a higher score indicating better quality of life) at 2 years, adjusted for baseline score. The economic evaluation estimated quality-adjusted life-years (derived from EuroQol-5 Dimensions, three-level version, and costs from the NHS perspective). RESULTS: A total of 254 women were randomised - 127 to myomectomy (105 underwent myomectomy) and 127 to uterine artery embolisation (98 underwent embolisation). Information on the primary outcome at 2 years was available for 81% (n = 206) of women. Primary outcome scores at 2 years were 84.6 (standard deviation 21.5) in the myomectomy group and 80.0 (standard deviation 22.0) in the uterine artery embolisation group (intention-to-treat complete-case analysis mean adjusted difference 8.0, 95% confidence interval 1.8 to 14.1, p = 0.01; mean adjusted difference using multiple imputation for missing responses 6.5, 95% confidence interval 1.1 to 11.9). The mean difference in the primary outcome at the 4-year follow-up time point was 5.0 (95% CI -1.4 to 11.5; p = 0.13) in favour of myomectomy. Perioperative and postoperative complications from all initial procedures occurred in similar percentages of women in both groups (29% in the myomectomy group vs. 24% in the UAE group). Twelve women in the uterine embolisation group and six women in the myomectomy group reported pregnancies over 4 years, resulting in seven and five live births, respectively (hazard ratio 0.48, 95% confidence interval 0.18 to 1.28). Over a 2-year time horizon, uterine artery embolisation was associated with higher costs than myomectomy (mean cost £7958, 95% confidence interval £6304 to £9612, vs. mean cost £7314, 95% confidence interval £5854 to £8773), but with fewer quality-adjusted life-years gained (0.74, 95% confidence interval 0.70 to 0.78, vs. 0.83, 95% confidence interval 0.79 to 0.87). The differences in costs (difference £645, 95% confidence interval -£1381 to £2580) and quality-adjusted life-years (difference -0.09, 95% confidence interval -0.11 to -0.04) were small. Similar results were observed over the 4-year time horizon. At a threshold of willingness to pay for a gain of 1 QALY of £20,000, the probability of myomectomy being cost-effective is 98% at 2 years and 96% at 4 years. LIMITATIONS: There were a substantial number of women who were not recruited because of their preference for a particular treatment option. CONCLUSIONS: Among women with symptomatic uterine fibroids, myomectomy resulted in greater improvement in quality of life than did uterine artery embolisation. The differences in costs and quality-adjusted life-years are very small. Future research should involve women who are desiring pregnancy. TRIAL REGISTRATION: This trial is registered as ISRCTN70772394. FUNDING: This study was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme, and will be published in full in Health Technology Assessment; Vol. 26, No. 22. See the NIHR Journals Library website for further project information.


WHAT IS THE PROBLEM?: Uterine fibroids are the most common non-cancerous tumour in women of childbearing age. Uterine fibroids are associated with heavy bleeding, lower chances of having children and reduced quality of life. Traditional surgical options were either to remove the fibroids (via myomectomy) or to completely remove the womb. A newer approach, known as uterine artery embolisation, involves blocking the blood supply to the fibroids in the womb. WHAT DID WE PLAN TO DO?: We compared myomectomy with uterine artery embolisation in women with fibroids who wanted to keep their womb. We wanted to see which treatment improved quality of life, was associated with the fewest complications and was the best value for money for the NHS. We also wanted to see if either treatment had an impact on women's ability to get pregnant and give birth. We included 254 women in a clinical trial. Women were assigned to have myomectomy or uterine artery embolisation at random to ensure a fair comparison. Women completed questionnaires about their symptoms and quality of life at intervals up to 4 years after treatment. WHAT DID WE FIND?: We found that myomectomy improved women's quality of life more than uterine artery embolisation. Complications from the treatments occurred in a similar proportion of women. There appeared to be no difference on reproductive hormone levels between treatments. Too few women in the trial got pregnant for any difference in the numbers of women having children to be seen. The differences in costs and overall disease burden were small. WHAT DOES THIS MEAN?: Both treatments improve quality of life and cost about the same to the NHS but, on average, myomectomy will provide greater benefit to women. There is no evidence to suggest that either treatment is unsuitable for women wanting to get pregnant, but more research is needed in younger women.


Asunto(s)
Leiomioma , Embolización de la Arteria Uterina , Miomectomía Uterina , Femenino , Humanos , Histerectomía , Leiomioma/cirugía , Masculino , Embarazo , Calidad de Vida
2.
Cardiovasc Intervent Radiol ; 45(2): 207-215, 2022 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-34984488

RESUMEN

PURPOSE: The PURE study is a randomised controlled trial (RCT) comparing the clinical and MRI outcomes of patients treated with non-spherical polyvinyl alcohol, ns-PVA (Contour PVA-Boston Scientific-355-500 & 500-700 microns) versus calibrated hydrogel microspheres (Embozene-Varian Inc-700 & 900 microns) for symptomatic uterine fibroids. MATERIALS AND METHODS: Prospective, ethically approved non-sponsored RCT in 84 patients in a single UK tertiary IR unit, ISRCTN registry trial number ISRCTN18191539 in 2013 and 2014. All patients with symptomatic fibroid disease were eligible. UAE followed a standardised protocol with UFS-QOL and contrast-enhanced MRI before and 6 months post UAE. Outcome measures included: (1) Uterine Fibroid Symptom and Quality of Life questionnaire (UFS-QOL). (2) Percentage total and dominant fibroid infarction. (3) Uterine and dominant fibroid volume reduction. (4) Volume of embolics. RESULTS: Sixty-three patients completed the QOL follow-up (33 ns-PVA vs 30 Embozenes), the groups were equivalent at baseline. Patients were followed up for 6 months following UAE. There was no significant difference in symptom scores or HR-QOL between ns-PVA and Embozenes, p = 0.67 and 0.21, respectively. 92.7% of patients treated with ns-PVA achieved > 90% dominant fibroid infarction versus 61.8% treated with Embozenes (p = 0.0016). 66% of patients treated with ns = PVA achieved > 90% total fibroid percentage infarction compared with 35% in the Embozene group (p = 0.011). The mean vials/syringes used were 5.2 with Embozenes versus 4.1 using PVA (p = 0.08). CONCLUSION: The PURE study informs IRs regarding the efficacy of embolic agents in UAE, with superior fibroid infarction on MRI using ns-PVA versus Embozenes however no significant difference in clinical outcomes at 6 months after UAE.


Asunto(s)
Leiomioma , Embolización de la Arteria Uterina , Neoplasias Uterinas , Femenino , Humanos , Leiomioma/diagnóstico por imagen , Leiomioma/terapia , Microesferas , Alcohol Polivinílico , Resultado del Tratamiento , Neoplasias Uterinas/diagnóstico por imagen , Neoplasias Uterinas/terapia
3.
Eur J Obstet Gynecol Reprod Biol X ; 13: 100139, 2022 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-34877531

RESUMEN

OBJECTIVE: To examine the quality of life experienced by women with symptomatic uterine fibroids who had been treated with UAE in comparison to myomectomy. We report the four-year follow-up of the FEMME randomised trial. Two-year follow-up data has been previously reported. STUDY DESIGN: Premenopausal women who had symptomatic uterine fibroids amenable to myomectomy or uterine artery embolization were recruited from 29 UK hospitals. Women were excluded if they had significant adenomyosis, any malignancy, pelvic inflammatory disease or had had a previous open myomectomy or uterine artery embolization.Participants were randomised to myomectomy or embolization in a 1:1 ratio using a minimisation algorithm. Myomectomy could be open abdominal, laparoscopic or hysteroscopic, according to clinician preference. Embolization of the uterine arteries was performed according to local practice, under fluoroscopic guidance.The primary outcome measure was the Uterine Fibroid Symptom Quality of Life questionnaire, adjusted for baseline score and reported here at four years post-randomisation. Subsequent procedures for fibroids, pregnancy and outcome were amongst secondary outcomes.Trial registration ISRCTN70772394 https://doi.org/10.1186/ISRCTN70772394. RESULTS: 254 women were randomized, 127 to myomectomy (105 underwent myomectomy) and 127 to uterine artery embolization (98 underwent embolization). At four years, 67 (53%) and 81 (64%) completed UFS-QoL quality of life scores. Mean difference in the UFS-QoL at 4 years was 5.0 points (95% CI -1.4 to 11.5; p = 0.13) in favour of myomectomy. There were 15 pregnancies in the UAE group and 7 in the myomectomy group, with a cumulative pregnancy rate to four years of 15% and 6% respectively (hazard ratio: 0.48; 95% CI 0.18-1.28). The cumulative repeat procedure rate to four years was 24% in the UAE group and 13% in the myomectomy group (hazard ratio: 0.53; 95% CI 0.27-1.05). CONCLUSIONS: Myomectomy resulted in greater improvement in quality of life compared with uterine artery embolization, although by four years, this difference was not statistically significant. Missing data may limit the generalisability of this result. The numbers of women becoming pregnant were too small draw a conclusion on the effect of the procedures on fertility.

4.
N Engl J Med ; 383(5): 440-451, 2020 07 30.
Artículo en Inglés | MEDLINE | ID: mdl-32726530

RESUMEN

BACKGROUND: Uterine fibroids, the most common type of tumor among women of reproductive age, are associated with heavy menstrual bleeding, abdominal discomfort, subfertility, and a reduced quality of life. For women who wish to preserve their uterus and who have not had a response to medical treatment, myomectomy and uterine-artery embolization are therapeutic options. METHODS: We conducted a multicenter, randomized, open-label trial to evaluate myomectomy, as compared with uterine-artery embolization, in women who had symptomatic uterine fibroids and did not want to undergo hysterectomy. Procedural options included open abdominal, laparoscopic, or hysteroscopic myomectomy. The primary outcome was fibroid-related quality of life, as assessed by the score on the health-related quality-of-life domain of the Uterine Fibroid Symptom and Quality of Life (UFS-QOL) questionnaire (scores range from 0 to 100, with higher scores indicating a better quality of life) at 2 years; adjustment was made for the baseline score. RESULTS: A total of 254 women, recruited at 29 hospitals in the United Kingdom, were randomly assigned: 127 to the myomectomy group (of whom 105 underwent myomectomy) and 127 to the uterine-artery embolization group (of whom 98 underwent embolization). Data on the primary outcome were available for 206 women (81%). In the intention-to-treat analysis, the mean (±SD) score on the health-related quality-of-life domain of the UFS-QOL questionnaire at 2 years was 84.6±21.5 in the myomectomy group and 80.0±22.0 in the uterine-artery embolization group (mean adjusted difference with complete case analysis, 8.0 points; 95% confidence interval [CI], 1.8 to 14.1; P = 0.01; mean adjusted difference with missing responses imputed, 6.5 points; 95% CI, 1.1 to 11.9). Perioperative and postoperative complications from all initial procedures, irrespective of adherence to the assigned procedure, occurred in 29% of the women in the myomectomy group and in 24% of the women in the uterine-artery embolization group. CONCLUSIONS: Among women with symptomatic uterine fibroids, those who underwent myomectomy had a better fibroid-related quality of life at 2 years than those who underwent uterine-artery embolization. (Funded by the National Institute for Health Research Health Technology Assessment program; FEMME Current Controlled Trials number, ISRCTN70772394.).


Asunto(s)
Leiomioma/cirugía , Calidad de Vida , Embolización de la Arteria Uterina , Miomectomía Uterina , Neoplasias Uterinas/cirugía , Adulto , Femenino , Humanos , Histeroscopía , Análisis de Intención de Tratar , Complicaciones Intraoperatorias , Laparoscopía , Leiomioma/terapia , Tiempo de Internación , Menorragia , Persona de Mediana Edad , Reserva Ovárica , Complicaciones Posoperatorias , Reoperación/estadística & datos numéricos , Embolización de la Arteria Uterina/efectos adversos , Miomectomía Uterina/efectos adversos , Miomectomía Uterina/métodos , Neoplasias Uterinas/terapia , Útero/cirugía
5.
Int J Gynaecol Obstet ; 148(1): 65-71, 2020 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-31593302

RESUMEN

OBJECTIVE: To determine maternal outcomes for women with abnormally invasive placenta (AIP) managed using the Triple P Procedure and establish its safety as a conservative surgical management option. METHODS: A retrospective study of the outcomes of the first 50 patients who underwent the Triple P Procedure for AIP from September 2010 to May 2017 at St George's Maternity Unit. Maternity case notes and the database were reviewed to determine the volume of bleeding, procedure-related complications, hysterectomy rate, and postoperative hospitalization. RESULTS: Mean operative blood loss was 2318 mL (range, 400-7300 mL and the incidence of bladder and ureteric injuries was 2% (n=1) and 0%, respectively. Median length of hospital stay was 4 days (range, 2-8 days). Three women (6.0%) developed arterial thrombosis without any long-term complications and none of the patients required peripartum hysterectomy. CONCLUSION: The Triple P Procedure should be considered as a conservative, less risky alternative to a peripartum hysterectomy during counselling prior to surgery for women with AIP.


Asunto(s)
Cesárea/métodos , Tratamiento Conservador/métodos , Placenta Accreta/cirugía , Adulto , Pérdida de Sangre Quirúrgica/estadística & datos numéricos , Femenino , Humanos , Tiempo de Internación/estadística & datos numéricos , Embarazo , Estudios Retrospectivos
6.
Cardiovasc Intervent Radiol ; 43(3): 453-458, 2020 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-31650245

RESUMEN

AIM: To investigate potential factors on MR imaging that could be used to predict migration of uterine fibroids post-UAE. METHODS AND MATERIALS: We retrospectively reviewed patients referred for UAE having pre-procedural and 6 months post-procedural MRI, at a tertiary centre, over a 1-year period. Pre- and post-UAE images were reviewed in 64 women by two radiologists to identify the sub-type, dimensions, and infarction rate of each dominant fibroid. The shortest distance between the fibroid and the endometrial wall was measured to determine intramural fibroid movement. Paired sample T tests and two-sample T tests were used to compare between pre- and post-embolization variations and between migrated and non-migrated intramural fibroids, respectively. After preliminary results suggested potential predictors of intramural fibroids migration, we tested our findings against the non-dominant intramural fibroids in the same patients. RESULTS: Review of images revealed 35 dominant intramural fibroids, of which eight migrated to become submucosal fibroids, while five were either partially or completely expelled. These 13 migrated fibroids had a shorter pre-procedural minimum endometrial distance (range 1-2.4 mm) and greater maximum fibroid diameter (range 5.1-18.1 cm), when compared to non-migrating fibroids. On image reassessment, the migrated non-dominant intramural fibroids had a minimum endometrial distance and maximum fibroid diameter within the same range. CONCLUSION: Intramural fibroids with a minimum endometrial distance less than 2.4 mm and a maximum fibroid diameter greater than 5.1 cm have a high likelihood of migrating towards the endometrial cavity after UAE.


Asunto(s)
Leiomioma/terapia , Imagen por Resonancia Magnética/métodos , Embolización de la Arteria Uterina/métodos , Neoplasias Uterinas/terapia , Adulto , Femenino , Humanos , Persona de Mediana Edad , Estudios Retrospectivos , Resultado del Tratamiento , Útero/diagnóstico por imagen
7.
Cardiovasc Intervent Radiol ; 41(8): 1241-1253, 2018 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-29789874

RESUMEN

AIM: A prospective online survey was conducted by the Cardiovascular Interventional Radiological Society of Europe (CIRSE) to evaluate the gender gap within interventional radiology (IR) and the barriers facing women in IR. MATERIALS AND METHODS: A questionnaire ("Appendix") was devised by the authors and the CIRSE communication and publication team and sent electronically to 750 identifiable female members of CIRSE. Responses were collected from 7 August to 24 August 2017. RESULTS: The response rate was 19.9% (n = 149) with highest responses from UK (18%), Italy (11%), Germany (11%), Spain (7%), Netherlands (5%), France (5%), Sweden (4%), USA (4%). 91% of the respondents were between 31 and 46 years, 83% work full time, 62% spend > 50% of their working time in IR, and 67% practice in a university or tertiary referral institution. 85% were in the minority in their department. 52% had no leadership role in their department, but 67% expressed willingness to consider a leadership position. Their main concerns were work/family life balance, the risks of radiation exposure, the effect of pregnancy on training and practice and the male-dominated work environment. CONCLUSION: This survey highlights issues experienced by women in IR. Clear guidance on concerns regarding radiation exposure particularly during pregnancy is needed. Structured and supportive training is required for female IRs who may wish to train or work flexibly. The male-dominated environment is discouraging, and a scheme to promote female IRs would encourage women to take on senior leadership positions and attract more women into the specialty.


Asunto(s)
Actitud del Personal de Salud , Satisfacción en el Trabajo , Radiología Intervencionista/estadística & datos numéricos , Encuestas y Cuestionarios , Mujeres , Adulto , Europa (Continente) , Femenino , Humanos , Persona de Mediana Edad , Estudios Prospectivos , Exposición a la Radiación , Sociedades Médicas , Recursos Humanos
9.
Cardiovasc Intervent Radiol ; 41(5): 673-674, 2018 05.
Artículo en Inglés | MEDLINE | ID: mdl-29492632
10.
CVIR Endovasc ; 1(1): 15, 2018.
Artículo en Inglés | MEDLINE | ID: mdl-30652147

RESUMEN

BACKGROUND: Femoral arterial access constitutes the first step in a significant proportion of interventional endovascular procedures. Whilst existing reports describe sheath size as an independent risk factor for bleeding complications in radial arterial access for coronary intervention, the influence of sheath size on overall complication rates and morbidity following femoral arterial access is not well described. This prospective single centre study reports our experience of vascular sheath size, patient and procedural factors in influencing complication rates following femoral arterial access. From April 2010 to May 2013, data was collected prospectively for all femoral arterial access procedures performed in the Interventional Radiology department of a tertiary hospital. For vascular sheath size <6-Fr, haemostasis was achieved by manual compression. For 6-Fr sheath size, a closure device was used in the absence of any contraindication. RESULTS: Of the 320 femoral access cases with eligible inclusion criteria, 52.5% had 4-Fr whilst 47.5% had 6-Fr vascular sheaths inserted. Overall post procedure complications rates were significantly higher following 6-Fr sheath (17/152 (11.2%)) versus 4-Fr systems (3/168 (1.8%)) (p=0.0007) mostly comprising self-limiting hematoma. There was no significant difference in major complications that required escalation of treatment. CONCLUSION: No significant difference has been demonstrated between the use of either sheath systems for major complications. The practical limitations of a smaller system, combined with existing body of evidence, may not justify the routine use of 4-Fr sheath systems as the primary sheath size for all endovascular procedures.

11.
CVIR Endovasc ; 1(1): 31, 2018.
Artículo en Inglés | MEDLINE | ID: mdl-30652162

RESUMEN

BACKGROUND: Uterine Artery Pseudoaneurysm is a rare cause of pelvic pain and haemorrhage in pregnancy. It should be considered in the differential diagnosis of pregnant women presenting with abdominal pain and is readily diagnosed by colour Doppler ultrasound. If left untreated, they may bleed into the peritoneum causing severe pain and haemorrhagic shock and may progress to maternal and fetal death. CASE PRESENTATION: We describe a case of a woman presenting with severe right iliac fossa pain at 26 weeks gestation attributed to a right uterine artery pseudoaneurysm diagnosed on duplex ultrasound which was successfully treated by uterine artery embolization at 28 weeks gestation without complication to the fetus. CONCLUSION: Uterine artery embolization appears to be a safe and effective method to treat pseudoaneurysm during pregnancy without compromising uteroplacental perfusion.

12.
Gynecol Surg ; 14(1): 11, 2017.
Artículo en Inglés | MEDLINE | ID: mdl-28890674

RESUMEN

BACKGROUND: The demand for uterus-sparing treatments is increasing as more women postpone childbirth to their 30-40s, when fibroids are more symptomatic. With an increasing choice of treatment options and changing care-provider profiles, now is an opportune time to survey current practices and opinions. Using a 25-stem questionnaire, a web-based survey was used to capture the practices and opinions of UK consultant gynecologists on the treatment of symptomatic fibroids, including the types of procedure most frequently used, methods used to reduce blood loss, and awareness and acceptability of treatment options, and to assess the impact of gender and experience of the treating gynecologist. RESULTS: The response rate was 22%. Laparascopic myomectomy is used least frequently, with 80% of the respondents using GnRHa preoperatively to minimize blood loss and correct anemia, while vasopressin is most frequently used to reduce intraoperative blood loss. Female consultants operate significantly less frequently than males. Those with more than 10 years consultant experience are more likely to perform an open myomectomy compared to those with less than 10 years experience. CONCLUSIONS: Compared to a similar survey performed 10 years ago, surgical methods remain to be the most common treatments, but use of less invasive treatments such as UAE has increased. Consultants' attitudes appear to be responding to the patient demand for less radical treatments. However, it is yet to be seen if the changing consultant demographics will keep up with this demand. The low response rate warrants cautious interpretation of the results, but they provide an interesting snapshot of current views and practices.

13.
Radiol Med ; 122(10): 798-806, 2017 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-28551762

RESUMEN

PURPOSE: To evaluate outcomes of uterine conserving surgery with occlusion balloon technique. A critical review of the complications was performed. MATERIALS AND METHODS: Between 2010 and 2016, pregnant women, with a prenatal diagnosis of morbidly adherent placenta (MAP), were treated with occlusion balloon catheters in both internal iliac arteries. Parameters such as need for hysterectomy, incidence of PPH, grade of MAP, estimated blood loss during delivery (EBL) and transfusion requirements, mean recovery time and duration of the balloon inflation, were collected and reviewed. Complications requiring further management were analysed. RESULTS: Thirty-seven women with MAP underwent prophylactic occlusion balloon placement (POBC). Mean recovery was 4.48 days (range 2-10). Catheters were successfully positioned and balloons inflated in obstetric theatre following caesarean delivery in 100% of the cases. The uterus was conserved in every case. The MAP grades were 20 percreta, 3 increta and 14 accreta. The EBL was not statistically different between the different grades of placentation. There was a statistically significant association in the number of patients requiring blood transfusions and the degree of placental invasion (p = 0. 0119). PPH occurred in 5 patients (13.5%) and arterial thrombosis in 4 patients (11%). The EBL during delivery was significantly higher (2811 mL) in patients with complications (p = 0.0102). Furthermore, the group of patients that had complications required statistically significant more blood transfusions compared to those without complications (p = 0.0001). No maternal mortality or foetal morbidity occurred. CONCLUSION: The utilisation of Prophylactic occlusion balloon catheters allows uterine conserving surgery to be performed safely with few maternal complications.


Asunto(s)
Oclusión con Balón/métodos , Arteria Ilíaca , Enfermedades Placentarias/terapia , Placenta/irrigación sanguínea , Hemorragia Posparto/prevención & control , Adulto , Femenino , Humanos , Embarazo , Radiografía Intervencional , Resultado del Tratamiento
14.
J Hypertens ; 34(12): 2303-2304, 2016 12.
Artículo en Inglés | MEDLINE | ID: mdl-27755387

RESUMEN

Renal denervation (RDN) was reported as a novel exciting treatment for resistant hypertension in 2009. An initial randomized trial supported its efficacy and the technique gained rapid acceptance across the globe. However, a subsequent large blinded, sham arm randomized trial conducted in the USA (to gain Food and Drug Administration approval) failed to achieve its primary efficacy end point in reducing office blood pressure at 6 months. Published in 2014 this trial received both widespread praise and criticism. RDN has effectively stopped out with clinical trials pending further evidence. This joint consensus document representing the European Society of Hypertension and the Cardiovascular and Radiological Society of Europe attempts to distill the current evidence and provide future direction and guidance.


Asunto(s)
Vasoespasmo Coronario/cirugía , Desnervación , Hipertensión/cirugía , Riñón/inervación , Presión Sanguínea , Consenso , Humanos , Riñón/fisiopatología , Guías de Práctica Clínica como Asunto
16.
Cardiovasc Intervent Radiol ; 39(4): 500-6, 2016 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-26860717

RESUMEN

Interventional Radiology (IR) is an essential part of modern medicine, delivering minimally invasive patient-focused care, which has been proven to be safe and effective in both elective and emergency settings. The aim of this document is to outline the core requirements and standards for the provision of Interventional Radiological services, including training, certification, manpower, and accreditation. The ultimate challenge will be the adoption of these recommendations by different countries and health economies around the world, in turn ensuring equal access to IR treatments for all patients, the appropriate distribution of resources for IR service provision as well as the continued development of safe and high-quality IR services in Europe and beyond.


Asunto(s)
Radiología Intervencionista/normas , Competencia Clínica , Europa (Continente) , Humanos , Radiología Intervencionista/educación , Recursos Humanos
17.
Cardiovasc Intervent Radiol ; 39(1): 36-43, 2016 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-26040255

RESUMEN

PURPOSE: To report a single centre's experience of the endovascular treatment of renal arterial aneurysms, including techniques and outcomes. MATERIALS AND METHODS: This is a retrospective analysis of true renal arterial aneurysms (TRAAs) treated using endovascular techniques over a period of 12 years and 10 months. The clinical presentations, aneurysm characteristics, endovascular techniques and outcomes are reported. RESULTS: There were nine TRAA cases with a mean aneurysm size of 21.0 mm, located at the main renal arterial bifurcation in all cases. Onyx(®) was used as the embolic agent of choice (88.9 % cases), with concurrent balloon remodelling. The overall primary technical success rate was 100 %. Repeat intervention was carried out in 1 case, secondary to reperfusion >8 years post-initial treatment. Long-term clinical follow-up was available in 55.6 % of cases (mean 29.8 months; range 3.3-90.1 months). Early post-procedural renal function, as measured by serum creatinine, remained within the normal reference range. Renal parenchymal loss post-embolisation was ≤20 % in 77.8 % of cases, as estimated on imaging. Minor complications included non-target embolization of Onyx(®) with no clinical sequelae (n = 1), transient pain requiring only oral analgesia with no prolongation of hospital stay (n = 2). No major complications occurred as a consequence of embolisation. CONCLUSION: Endovascular therapy is an effective and safe primary therapy for TRAA with high success rate and low morbidity, supplanting surgery as primary therapy. Current experience in the use of Onyx(®) in TRAA is primarily limited to individual case reports, and this represents the largest case series of Onyx(®)-treated TRAAs to date.


Asunto(s)
Aneurisma/terapia , Embolización Terapéutica/métodos , Procedimientos Endovasculares/métodos , Arteria Renal , Adulto , Anciano , Anciano de 80 o más Años , Combinación de Medicamentos , Femenino , Humanos , Masculino , Persona de Mediana Edad , Polivinilos/administración & dosificación , Estudios Retrospectivos , Tantalio/administración & dosificación , Resultado del Tratamiento
18.
Cardiovasc Intervent Radiol ; 38(6): 1487-93, 2015 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-25902859

RESUMEN

OBJECTIVE: To assess foetal absorbed radiation dose (FAD) during prophylactic occlusion balloon catheter (POBC) placement before surgery for morbidly adherent placenta (MAP). METHODS: Retrospective cohort study of women with MAP undergoing POBC before surgery. Women were divided into two groups. Group 1 treated between 2008 and 2011, Group 2 between 2012 and 2014 when fluoroscopy pulse rate reduced from 7.5 to 2 pulses per second. Median and interquartile range (IQR) of dose area product (DAP) and FAD were compared using the Mann-U-Whitney test. FAD was calculated using the PCXMC Monte-Carlo calculation. All procedures were performed using the same equipment (Siemens Axiom Artis dTA) by the same experienced interventional radiology team. RESULTS: Thirty-four women underwent POBC. 16 procedures were performed in Group 1 and 18 in Group 2. Median DAP overall was 1025.10 µGym(2) (IQR 532.1-1775.3): Group 1, 1713.25 µGym(2) (IQR 1164.5-2274.5) and Group 2, 660.70 µGym(2) (IQR 440.9-1020.9) (p = 0.027). Median FAD overall was 4.65 mGy (IQR 2.7-8.2): Group 1, 6.25 mGy (IQR 4.4-10.6) and Group 2, 3.05 mGy (IQR 2.0-5.4) (p = 0.031). CONCLUSIONS: FAD during POBC insertion is low overall. The only change between the two groups was in pulsed fluoroscopy rate which resulted in a significant reduction in FAD. This reinforces the importance of implementation of dose reduction techniques.


Asunto(s)
Oclusión con Balón , Feto/diagnóstico por imagen , Enfermedades Placentarias/terapia , Dosis de Radiación , Radiología Intervencionista , Adulto , Estudios de Cohortes , Femenino , Fluoroscopía , Humanos , Embarazo , Estudios Retrospectivos
20.
Cardiovasc Intervent Radiol ; 38(4): 871-7, 2015 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-25522982

RESUMEN

AIM: A clear understanding of operator experience is important in improving technical success whilst minimising patient risk undergoing endovascular procedures, and there is the need to ensure that trainees have the appropriate skills as primary operators. The aim of the study is to retrospectively analyse uterine artery embolisation (UAE) procedures performed by interventional radiology (IR) trainees at an IR training unit analysing fluoroscopy times and radiation dose as surrogate markers of technical skill. METHODS: Ten IR fellows were primary operator in 200 UAE procedures over a 5-year period. We compared fluoroscopy times, radiation dose and complications, after having them categorised according to three groups: Group 1, initial five, Group 2, >5 procedures and Group 3, penultimate five UAE procedures. We documented factors that may affect screening time (number of vials employed and use of microcatheters). RESULTS: Mean fluoroscopy time was 18.4 (± 8.1), 17.3 (± 9.0), 16.3 (± 8.4) min in Groups 1, 2 and 3, respectively. There was no statistically significant difference between these groups (p > 0.05) with respect to fluoroscopy time or radiation dose. Analysis after correction for confounding factors showed no statistical significance (p > 0.05). All procedures were technically successful, and total complication rate was 4%. CONCLUSION: UAE was chosen as a highly standardised procedure followed by IR practitioners. Although there is a non-significant trend for shorter screening times with experience, technical success and safety were not compromised with appropriate Consultant supervision, which illustrates a safe construct for IR training. This is important and reassuring information for patients undergoing a procedure in a training unit.


Asunto(s)
Competencia Clínica/estadística & datos numéricos , Curva de Aprendizaje , Radiología Intervencionista/educación , Embolización de la Arteria Uterina/estadística & datos numéricos , Arteria Uterina/diagnóstico por imagen , Becas , Femenino , Fluoroscopía , Humanos , Dosis de Radiación , Estudios Retrospectivos , Estudiantes de Medicina , Factores de Tiempo , Reino Unido
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