Uterine artery embolisation or myomectomy for women with uterine fibroids wishing to avoid hysterectomy: a cost-utility analysis of the FEMME trial.

OBJECTIVES: To assess the cost-effectiveness of uterine artery embolisation (UAE) and myomectomy for women with symptomatic uterine fibroids wishing to avoid hysterectomy. DESIGN: Economic evaluation alongside the FEMME randomised controlled trial. SETTING: 29 UK hospitals. POPULATION: Premenopausal women who had symptomatic uterine fibroids amenable to UAE or myomectomy wishing to avoid hysterectomy. 254 women were randomised to UAE (127) and myomectomy (127). METHODS: A within-trial cost-utility analysis was conducted from the perspective of the UK NHS. MAIN OUTCOME MEASURES: Quality-adjusted life years (QALYs) measured using the EuroQoL EQ-5D-3L, combined with costs to estimate cost-effectiveness over 2 and 4 years of follow-up. RESULTS: Over a 2-year time horizon, UAE was associated with higher mean costs (difference £645; 95% CI -1381 to 2580) and lower QALYs (difference -0.09; 95% CI -0.11 to -0.04) when compared with myomectomy. Similar results were observed over the 4-year time horizon. Thus, UAE was dominated by myomectomy. Results of the sensitivity analyses were consistent with the base case results for both years. Over 2 years, UAE was associated with higher costs (difference £456; 95% CI -1823 to 3164) and lower QALYs (difference -0.06; 95% CI -0.11 to -0.02). CONCLUSIONS: Myomectomy is a cost-effective option for the treatment of uterine fibroids. The differences in costs and QALYs are small. Women should be fully informed and have the option to choose between the two procedures. TWEETABLE ABSTRACT: Fully informed women with uterine fibroids should have a choice between uterine artery embolisation or myomectomy.

The role of interventional radiology in reducing haemorrhage and hysterectomy following caesarean section for morbidly adherent placenta.

AIM: To report experience of prophylactic occlusion balloon catheters (POBCs) in both internal iliac arteries before caesarean section, with or without embolization, to preserve the uterus and reduce haemorrhage. METHODS AND MATERIALS: Twenty-seven women diagnosed with morbidly adherent placenta (MAP) and with suspected placenta percreta underwent POBC placement before caesarean section. The balloons were inflated immediately after delivery of the baby. The patients' case notes were reviewed retrospectively for histological grading of MAP, blood loss, transfusion, requirement of uterine artery embolization (UAE), or hysterectomy, radiation dose, and infant or maternal morbidity and mortality. RESULTS: MAP was confirmed histologically as percreta in 17, accreta in eight, and increta in two women. Mean blood loss was 1.92 l (range 0.5-12 l). Postpartum haemorrhage (PPH) occurred in nine patients. Eight were referred for UAE, which was successful in six. Immediate peri-partum hysterectomy was performed in one patient. Three women in total required hysterectomy, two after recurrent haemorrhage after UAE. No foetal morbidity or mortality occurred. No maternal mortality occurred. There was one case of iliac artery thrombosis, which resolved with conservative therapy. CONCLUSION: POBC, with or without UAE, contributes to reduction of blood loss and preservation of the uterus in women with MAP.

Guidelines on the facilities required for minor surgical procedures and minimal access interventions.

There have been many changes in healthcare provision in recent years, including the delivery of some surgical services in primary care or in day surgery centres, which were previously provided by acute hospitals. Developments in the fields of interventional radiology and cardiology have further expanded the range and complexity of procedures undertaken in these settings. In the face of these changes there is a need to define from an infection prevention and control perspective the basic physical requirements for facilities in which such surgical procedures may be carried out. Under the auspices of the Healthcare Infection Society, we have developed the following recommendations for those designing new facilities or upgrading existing facilities. These draw upon best practice, available evidence, other guidelines where appropriate, and expert consensus to provide sensible and feasible advice. An attempt is also made to define minimal access interventions and minor surgical procedures. For minimal access interventions, including interventional radiology, new facilities should be mechanically ventilated to achieve 15 air changes per hour but natural ventilation is satisfactory for minor procedures. All procedures should involve a checklist and operators should be appropriately trained. There is also a need for prospective surveillance to accurately determine the post-procedure infection rate. Finally, there is a requirement for appropriate applied research to develop the evidence base required to support subsequent iterations of this guidance.

Technique and outcomes of isolated limb infusion for locally advanced malignant melanoma--a radiological perspective.

AIM: Isolated limb infusion (ILI) is a novel, minimally invasive technique for delivering high-dose regional chemotherapy in patients with recurrent and in-transit melanoma. The aim of this study was to review our single-centre experience in treating eleven patients. We emphasize the role of radiologists in setting up this service, including pre-treatment workup and placement of vascular catheters. MATERIALS AND METHODS: A retrospective analysis of 11 patients who underwent 12 procedures between 2005 and 2009 was performed. Pre-procedural staging computed tomography (CT), CT angiography, and duplex studies were performed. All patients received a cytotoxic combination of melphalan and actinomycin-D via radiologically placed arterial and venous catheters in the affected limb under mild hyperthermic conditions. The outcome measures include response rates, limb toxicity, complications, and survival. RESULTS: All patients were female with a mean age of 72 years. Three patients had American Joint Committee on Cancer (AJCC) stage IIIB melanoma, seven had stage IIIC melanoma, and one had a stage IIIB Merkel cell tumour. Complete response was seen in five patients (46%), partial response in four (36%), and progressive disease in two (18%). One patient developed grade 4 toxicity requiring a fasciotomy and another experienced systemic toxicity. CONCLUSION: These outcomes are comparable to previous studies and shows that ILI is effective in locoregional control of unresectable melanoma. It is a relatively safe procedure but not without risk. Our experience shows the importance of radiological input to ensure safe and effective delivery of services.

Does size really matter? Analysis of the effect of large fibroids and uterine volumes on complication rates of uterine artery embolisation.

The purpose of this study was to determine whether there is a correlation between large uterine fibroid diameter, uterine volume, number of vials of embolic agent used and risk of complications from uterine artery embolisation (UAE). This was a prospective study involving 121 patients undergoing UAE embolisation for symptomatic uterine fibroids at a single institution. Patients were grouped according to diameter of largest fibroid and uterine volume. Results were also stratified according to the number of vials of embolic agent used and rate of complications. No statistical difference in complication rate was demonstrated between the two groups according to diameter of the largest fibroid (large fibroids were classified as > or = 10 cm; Fisher's exact test P = 1.00), and no statistical difference in complication rate was demonstrated according to uterine volume (large uterine volume was defined as > or = 750 cm(3); Fisher's exact test P = 0.70). 84 of the 121 patients had documentation of the number of vials used during the procedure. Patients were divided into two groups, with > or = 4 used defined as a large number of embolic agent. There was no statistical difference between these two groups and no associated increased risk of developing complications. This study showed no increased incidence of complications in women with large-diameter fibroids or uterine volumes as defined. In addition, there was no evidence of increased complications according to quantity of embolic material used. Therefore, UAE should be offered to women with large fibroids and uterine volumes.

Transcatheter pelvic arterial embolisation for control of obstetric and gynaecological haemorrhage.

We present a 5-year experience of pelvic arterial embolisation at two centres in the UK, and emphasise the role of interventional radiology in the treatment of obstetric and gynaecological haemorrhage. A total of 31 women underwent pelvic embolization:19 patients had complete medical records, and of these, two women had antepartum haemorrhage, 12 women had primary postpartum haemorrhage (PPH), four women had secondary PPH and one woman had a haemorrhage following termination of pregnancy (TOP). The source of the haemorrhage was only identified in four women (21.1%). All patients underwent selective embolisation of the uterine artery or anterior divisional branch of the internal iliac artery with successful haemorrhage control in 17 patients (89.4%) and no immediate complications. Haemorrhage continued despite embolisation in two patients; both proceeded to surgery. Selective pelvic embolisation is a safe and effective treatment for acute obstetric or gynaecological haemorrhage and should be part of the management algorithm for PPH.

Post-traumatic pelvic pseudoaneurysm and arterio-venous fistula: combined endovascular and surgical approach.

Post-traumatic pelvic pseudoaneurysms are rare and challenging to manage. We describe the combined endovascular and surgical strategy used, to successfully treat a large internal iliac pelvic pseudoaneurysm combined with arterio-venous fistula, in a patient presenting 20 years following an elective caesarean section.

Radiological treatment of symptomatic uterine fibroids.

Uterine artery embolization (UAE) is a relatively new alternative treatment for symptomatic fibroids. Recent Level 1 evidence from two major randomized controlled trials has established UAE as a safe and effective alternative to hysterectomy. Technical aspects, choice of embolic agent, safety, contra-indications and complications of the procedure will be reviewed. The available data on the effects on ovarian function, fertility and pregnancy outcomes following UAE will be presented.

Endovascular repair of iliac artery injury complicating lumbar disc surgery.

Vascular injury as a complication of disc surgery was first reported in 1945 by Linton and White. It is a rare but potentially fatal complication. The high mortality rate (40-100%) is attributed to a combination of rapid blood loss and the failure to recognise the cause of the deteriorating patient. Early diagnosis and treatment is essential. Treatment has traditionally been by open vascular surgical repair, however with modern imaging and endovascular techniques, minimally invasive treatment should be considered first line in patients who are stable. We present the case of a 51-year-old woman who sustained common iliac artery injury during lumbar spinal surgery that was treated successfully using a covered stent.

Arterial closure devices. A review.

The use of arterial closure devices in achieving haemostasis following arterial puncture has become increasingly popular. This review aims to provide an overview of the currently available closure devices, with an up-to-date summary of the supporting literature. The various devices have their advantages and disadvantages as well as differing mechanisms of actions. Technical aspects of deployment affect the learning curve and ease of use of individual devices. Some complications that arise are device specific where others are related to arterial punctures in general. When choosing a device, all these factors should be taken into account as well as differing clinical requirements and priorities. Most studies of arterial closure devices that are currently in use conclude that the safety profile of closure devices is comparable to manual compression. The literature does not show superiority of any particular device. Caution is advised in extrapolating evidence based on differing patient groups, as many of the study populations are heterogeneous. As physicians become more familiar with the use of closure devices, off-label applications of some devices have emerged, some of which need further evaluation. The ideal closure device should reduce complication rates compared to manual compression, be easy to use with a short learning curve, and have a high rate of deployment success. It should also be usable across a wide range of sheath sizes, not leave any permanent foreign body behind, reduce time to haemostasis and ambulation, allow immediate repuncture, improve patient comfort and be cost effective. In spite of the wide range of devices currently available there remains room for improvement.

Prospective study of elective bilateral versus unilateral femoral arterial puncture for uterine artery embolization.

The purpose of this study was to assess the effect of elective bilateral femoral arterial punctures for uterine artery embolization (UAE) of symptomatic fibroids on fluoroscopy and procedural time, patient dose, and ease of procedure. We conducted a prospective study of UAE with either the intention to catheterize both uterine arteries using a single femoral puncture (n = 12) or elective bilateral arterial punctures from the outset (n = 12). The same two operators undertook each case. Main outcome measures were total procedure time, fluoroscopy time, dose-area product (DAP), and total skin dose. A simulation was then performed on an anthropomorphic phantom using the mean in vivo fluoroscopy parameters to estimate the ovarian dose. Bilateral UAE was achieved in all patients. None of the patients with initial unilateral arterial puncture required further contralateral arterial puncture. The mean fluoroscopy time in the group with elective bilateral punctures was 12.8 min, compared with a mean of 16.6 min in patients with unilateral puncture (p = 0.046). There was no significant difference in overall procedure time (p = 0.68). No puncture-site complications were found. Additional catheters were required only following unilateral puncture. The simulated dose was 25% higher with unilateral puncture. Although there was no significant difference in measured in vivo patient dose between the two groups (DAP, p = 0.32), this is likely to reflect the wide variation in other patient characteristics. Allowing for the small study size, our results show that the use of elective bilateral arterial punctures reduces fluoroscopy time, requires less catheter manipulation, and, according to the simulation model, has the potential to reduce patient dose. The overall procedure time, however, is not significantly reduced.

Endovascular embolization of visceral artery aneurysms with ethylene-vinyl alcohol (Onyx): a case series.

We report the application of the liquid embolic agent ethylene-vinyl alcohol (Onyx; MicroTherapeutics, Irvine, CA, USA) in the management of visceral artery aneurysms. The technique and indications for using Onyx are discussed with emphasis on the management of wide-necked aneurysms and maintenance of patency of the parent vessel. None of the cases was considered suitable for stent-grafting or embolization with conventional agents. Two aneurysms of the renal artery bifurcation and one aneurysm of the inferior pancreaticoduodenal artery were treated. Following treatment there was complete exclusion of all aneurysms. There was no evidence of end-organ infarction. Follow-up with intervals up to 6 months has shown sustained aneurysm exclusion. Onyx is known to be effective in the management of intracranial aneurysms. Our experience demonstrates the efficacy and applicability of the use of Onyx in the treatment of complex visceral artery aneurysms.

Comparison of particle penetration with non-spherical polyvinyl alcohol versus trisacryl gelatin microspheres in women undergoing premyomectomy uterine artery embolization.

AIM: The purpose of this study was to compare the depth of vascular penetration of non-spherical polyvinyl alcohol (PVA) versus trisacryl gelatin microspheres (MS) in women undergoing uterine artery embolization (UAE) immediately before transabdominal myomectomy. MATERIALS AND METHODS: A total of 17 patients who had been referred for embolization before myomectomy underwent bilateral uterine artery embolization using either 355-500 microm PVA (group A) or 700-900 microm MS (group B). The depth of penetration of the particles was assessed by identifying their presence and location in the resected specimen. RESULTS: Of the 17 women enrolled in this study, 10 were in group A and 6 in group B. One woman underwent embolization using both types of particle and was excluded from the analysis. Embolic particles were significantly (p = 0.048) more frequently located within the fibroid (4/6, 67%) in Group B than Group A (1/10, 10%). Particles were also identified in the perifibroid tissues in 4/6 (67%) in Group B and 4/10 (40%) in Group A, with no statistical difference. There were no procedural complications. CONCLUSION: MS particles (700-900 microm) penetrate significantly deeper into leiomyomata compared with non-spherical PVA (355-500 microm). MS may therefore confer advantages in UAE, as they may more specifically target the fibroid, allowing an earlier end-point to embolization and minimizing ischaemic damage to normal myometrium and ovaries.

The role of infrapopliteal angioplasty.

Infrapopliteal percutaneous transluminal angioplasty (PTA) is currently indicated in patients with critical limb ischaemia (CLI). It may be performed after femoral angioplasty or bypass surgery, to improve outflow and hence patency of the proximally treated segment. Patients with CLI are typically elderly with multiple co-morbidities and limited life expectancy and therefore, a procedure, which is minimally invasive with reduced morbidity and mortality but lesser long-term patency, may be more appropriate than a more invasive procedure with better long-term patency. Clinical success is superior to angiographic patency, because once healing has occurred, should the artery restenose or occlude, collateral flow can be sufficient to preserve tissue integrity if there is no further injury. Although no prospective randomized trials have been performed, the reported limb-salvage rates of PTA are comparable with surgery. As PTA carries a lower morbidity and mortality, shorter hospital stay and does not preclude surgery, it is ideal for this group of patients who are high-risk surgical candidates. Improvements in guide-wire and catheter technology and recanalization techniques mean that very long stenoses or occlusions, and multiple lesions can be treated successfully. At the current time, PTA is the treatment of choice for infrapopliteal occlusive disease; experience with the use of stents in this territory is increasing but currently insufficient to justify their primary use.

Demonstration of renal arterial anatomy and tumour neovascularity for vascular mapping of renal cell carcinoma: the value of CO2 angiography.

The aim of this study was to compare the efficacy of CO(2) angiography with that of iodinated contrast angiography for vascular mapping prior to partial nephrectomy for presumed renal cell carcinoma. 13 consecutive patients were studied and all patients underwent selective renal angiography using both CO(2) and iodinated contrast medium. Digitally subtracted images were acquired and compared. Seven male and six female patients, with a median age of 58 years (range 46-74 years), were examined. On comparing images the main renal artery was visualized in all cases with both contrast agents. The segmental vessels were seen in 7 of 13 CO(2) studies and 12 of 13 iodinated contrast studies. CO(2) was also inferior in the depiction of tumour circulation, showing it in 4 of 13 cases compared with 9 of 13 cases using iodinated contrast. It therefore appears that CO(2) angiography offers no diagnostic advantage and is also inferior to iodinated contrast angiography in the pre-operative vascular mapping of renal tumours.

Review of readmissions due to complications from uterine fibroid embolization.

AIM: To determine the frequency, nature and outcome of complications resulting in readmission to hospital following uterine artery embolization (UAE). MATERIAL AND METHODS: A retrospective review of the medical notes and available imaging of 42 consecutive patients who had undergone elective uterine artery embolization for the treatment of fibroid disease was performed. RESULTS: The mean age of the patients was 42 years (range 31--54 years) and seven patients (17%) were readmitted to hospital. The median time to readmission was 3 weeks (range 1-29 weeks). All seven patients were admitted with signs and symptoms of infection. In four patients an organism was isolated from high vaginal swabs, and in one patient the midstream urine sample was confirmed as the source of infection. In the other two patients no definite source of infection was identified. All patients were treated with intravenous antibiotics. Six of the seven patients responded to treatment. The remaining patient required hysterectomy for uncontrolled uterine sepsis. CONCLUSION: Readmission following UAE is common and arises secondary to infection. Infection can occur several months after the procedure.

Percutaneous transluminal renal artery angioplasty: who benefits most?

We set out to assess the long-term benefits of renal percutaneous transluminal angioplasty (PTA) in 107 consecutive hypertensive patients with atheromatous renal artery stenosis. During 12-month follow-up, blood pressure fell to normal levels in 10 (8.8%) patients and improved in 76 (67.3%); renal function improved or remained stable in 74% of patients. In patients with atheromatous disease, renal angioplasty was most successful in those with stenosis in a single functioning kidney, and in nine patients who presented with symptoms and signs of heart failure, in the absence of overt ischaemic or valvular heart disease. In the latter group, renal PTA resulted in a large loss of sodium and water, resolution of the 'apparent' heart failure, and a marked improvement in blood pressure and renal function. It is suggested that all hypertensive patients with haemodynamically significant renal artery stenosis (and/or mild to moderate impairment in renal function), should be considered for renal PTA. Patients with atheromatous stenosis in a single functioning kidney, and those who present with signs of sodium and water retention, are likely to benefit most.

Rotational digital subtraction angiography of the renal arteries: technique and evaluation in the study of native and transplant renal arteries.

Rotational digital subtraction angiography (RDSA) allows multidirectional angiographic acquisitions with a single injection of contrast medium. The role of RDSA was evaluated in 60 patients referred over a 7-month period for diagnostic renal angiography and 12 patients referred for renal transplant studies. All angiograms were assessed for their diagnostic value, the presence of anomalies and the quantity of contrast medium used. The effective dose for native renal RDSA was determined. 41 (68.3%) native renal RDSA images and 8 (66.7%) transplant renal RDSA images were of diagnostic quality. Multiple renal arteries were identified in 9/41 (22%) native renal RDSA diagnostic images. The mean volume of contrast medium in the RDSA runs was 51.2 ml and 50 ml for native and transplant renal studies, respectively. The mean effective dose for 120 degrees native renal RDSA was 2.36 mSv, equivalent to 1 year's mean background radiation. Those RDSA images that were non-diagnostic allowed accurate prediction of the optimal angle for further static angiographic series, which is of great value in transplant renal vessels.

Diagnostic angiography performed by nurses.

The aim of this study was to assess the feasibility of a nurse performing diagnostic angiography. After a theoretical and practical training course on the techniques of arterial catheterization, the nurse performed diagnostic angiography under supervision on 68 patients. Patients with impalpable femoral pulses or scarred groins as well as obese patients were excluded. Successful arterial catheterization was achieved in 58 (85%) patients. Complications were limited to a severe haematoma requiring surgery in one patient and seven minor self-limiting haematomas. On this evidence, it is feasible and safe for appropriately trained nurses to perform angiography in radiology departments that have limited radiology staffing levels and no non-invasive alternations to catheter-based angiography.