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.

Prevention of postpartum hemorrhage and hysterectomy in patients with morbidly adherent placenta: a cohort study comparing outcomes before and after introduction of the Triple-P procedure.

OBJECTIVES: To evaluate patient outcomes and need for further interventions in women with a morbidly adherent placenta (MAP), before and after introduction of the Triple-P procedure involving placental non-separation, myometrial excision and reconstruction of the uterine wall. METHODS: Between December 2007 and February 2014, 30 patients with MAP were treated at our center. In 2007, we instituted a policy of bilateral prophylactic occlusion balloon catheter placement in both internal iliac arteries followed by Cesarean section with non-placental separation and preservation of the uterus. In 2010, the surgical technique was modified and the Triple-P procedure introduced. As a result, 19 women in our study received the Triple-P protocol (study group) and 11 did not (control group). The quantity of blood replacement products, estimated blood loss, and necessity for uterine arterial embolization and/or hysterectomy were recorded retrospectively and compared between the two groups. RESULTS: Placenta percreta was confirmed in six (54.5%) patients in the control group and 13 (68.4%) in the study group. Estimated mean blood loss during the procedure was lower in the study group than in the control group (1.70 L vs 2.17 L, respectively), but the difference was not statistically significant (P = 0.445). The risks of postpartum hemorrhage (PPH) and hysterectomy were statistically significantly lower in the study group (PPH, 54.5% vs 15.8%; P = 0.035; hysterectomy, 27.3% vs 0.0%; P = 0.045). As a consequence, there was a significant decrease in duration of inpatient stay in the study group (P = 0.044). CONCLUSION: Introduction of the Triple-P procedure conveyed a significantly reduced rate of hysterectomy, PPH and duration of hospital stay in patients with MAP. .

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.

Outcome of aortoiliac, femoropopliteal and infrapopliteal endovascular interventions in lesions categorised by TASC classification.

AIM: To analyse lower limb angioplasty results using the defined anatomical classification of the Trans-Atlantic Inter-Society Consensus (TASC) in a training environment and to compare the results with published data. MATERIALS AND METHODS: Retrospective, consecutive data were collected for a period of 1 year for all patients undergoing lower limb endovascular interventions. The radiology information system and notes were used to obtain clinical data, and angiograms were reviewed in all cases. All cases were performed or supervised by five vascular interventional consultants assisted by fellows or registrars. Patient demographics, the indication for treatment, the TASC classification of the treated lesion, calcification, use of stent, technical success (residual stenosis <20% on completion angiography), and complications were assessed. RESULTS: Two hundred and sixty-two lesions were treated. Of the aortoiliac lesions (83), the overall primary technical success rate was 91.6% (TASC A and B: 96.7%, TASC C and D: 77.3%). Sixty-one lesions were stented and no complications recorded. Of the femoropopliteal lesions (n = 123), the overall primary technical success rate was 91.9% (TASC A and B: 98.7%, TASC C and D: 80.9%). There were four major and five minor complications in this group (five groin haematomas, two vessel ruptures, one retroperitoneal haematoma, and one distal embolization). Five patients were stented. In the infrapopliteal group (n = 56), the overall primary technical success rate was 91.1% (TASC A and B: 96.3%, TASC C and D: 86.2%). There was one complication (small retroperitoneal hematoma) and two stents were used. CONCLUSION: The results of the present study showed good technical success and low complication rates in lower limb endovascular interventions with variable operator expertise. The results are comparable to published data. Use of the TASC classification system is encouraged as it allows an objective assessment of severity and enables standardized comparison.

Radiology-led follow-up system for IVC filters: effects on retrieval rates and times.

PURPOSE: Successful IVC filter retrieval rates fall with time. Serious complications have been reported following attempts to remove filters after 3-18 months. Failed retrieval may be associated with adverse clinical sequelae. This study explored whether retrieval rates are improved if interventional radiologists organize patient follow-up, rather than relying on the referring clinicians. METHODS: Proactive follow-up of patients who undergo filter placement was implemented in May 2008. At the time of filter placement, a report was issued to the referring consultant notifying them of the advised timeframe for filter retrieval. Clinicians were contacted to arrange retrieval within 30 days. We compared this with our practice for the preceding year. RESULTS: The numbers of filters inserted during the two time periods was similar, as were the numbers of retrieval attempts and the time scale at which they occurred. The rate of successful retrievals increased but not significantly. The major changes were better documentation of filter types and better clinical follow-up. After the change in practice, only one patient was lost to follow-up compared with six the preceding year. CONCLUSIONS: Although there was no significant improvement in retrieval rates, the proactive, radiology-led approach improved follow-up and documentation, ensuring that a clinical decision was made about how long the filter was required and whether retrieval should be attempted and ensuring that patients were not lost to follow-up.

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.

Cardiovascular and Interventional Radiological Society of Europe commentary on the treatment of chronic cerebrospinal venous insufficiency.

Chronic cerebrospinal venous insufficiency (CCSVI) is a putative new theory that has been suggested by some to have a direct causative relation with the symptomatology associated with multiple sclerosis (MS) [1]. The core foundation of this theory is that there is abnormal venous drainage from the brain due to outflow obstruction in the draining jugular vein and/or azygos veins. This abnormal venous drainage, which is characterised by special ultrasound criteria, called the "venous hemodynamic insufficiency severity score" (VHISS), is said to cause intracerebral flow disturbance or outflow problems that lead to periventricular deposits [2]. In the CCSVI theory, these deposits have a great similarity to the iron deposits seen around the veins in the legs in patients with chronic deep vein thrombosis. Zamboni, who first described this new theory, has promoted balloon dilatation to treat the outflow problems, thereby curing CCSVI and by the same token alleviating MS complaints. However, this theory does not fit into the existing bulk of scientific data concerning the pathophysiology of MS. In contrast, there is increasing worldwide acceptance of CCSVI and the associated balloon dilatation treatment, even though there is no supporting scientific evidence. Furthermore, most of the information we have comes from one source only. The treatment is called "liberation treatment," and the results of the treatment can be watched on YouTube. There are well-documented testimonies by MS patients who have gained improvement in their personal quality of life (QOL) after treatment. However, there are no data available from patients who underwent unsuccessful treatments with which to obtain a more balanced view. The current forum for the reporting of success in treating CCSVI and thus MS seems to be the Internet. At the CIRCE office and the MS Centre in Amsterdam, we receive approximately 10 to 20 inquiries a month about this treatment. In addition, many interventional radiologists, who are directly approached by MS patients, contact the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) for advice. Worldwide, several centres are actively promoting and performing balloon dilatation, with or without stenting, for CCSVI. Thus far, no trial data are available, and there is currently no randomized controlled trial (RCT) in progress Therefore, the basis for this new treatment rests on anecdotal evidence and successful testimonies by patients on the Internet. CIRSE believes that this is not a sound basis on which to offer a new treatment, which could have possible procedure-related complications, to an often desperate patient population.

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.

Is internal iliac artery embolization essential prior to endovascular repair of aortoiliac aneurysms?

Patients who undergo endovascular repair of aorto-iliac aneurysms (EVAR) require internal iliac artery (IIA) embolization (IIAE) to prevent type II endoleaks after extending the endografts into the external iliac artery. However, IIAE may not be possible in some patients due to technical factors or adverse anatomy. The aim of this study was to assess retrospectively whether patients with aorto-iliac aneurysms who fail IIAE have an increase in type II endoleak after EVAR compared with similar patients who undergo successful embolization. We retrospectively analyzed the records of 148 patients who underwent EVAR from December 1997 to June 2005. Sixty-one patients had aorto-iliac aneurysms which required IIAE before EVAR. Fifty patients had successful IIAE and 11 patients had unsuccessful IIAE prior to EVAR. The clinical and imaging follow-up was reviewed before and after EVAR. The endoleak rate of the embolized group was compared with that of the group in whom embolization failed. After a mean follow-up of 19.7 months in the study group and 25 months in the control group, there were no statistically significant differences in outcome measures between the two groups. Specifically, there were no type II endoleaks related to the IIA in patients where IIAE had failed. We conclude that failure to embolize the IIA prior to EVAR should not necessarily preclude patients from treatment. In patients where there is difficulty in achieving coil embolization, it is recommended that EVAR should proceed, as clinical sequelae are unlikely.

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.

How safe is bilateral internal iliac artery embolization prior to EVAR?

PURPOSE: To assess the outcomes of patients after bilateral internal iliac artery (IIA) embolization prior to endovascular aneurysm repair (EVAR). METHODS: Thirty-nine patients (age range 55-88 years, mean 72.5 years; 2 women) underwent IIA embolization/occlusion before EVAR. There were 28 patients with aorto-biiliac aneurysms and 6 with bilateral common iliac artery (CIA) aneurysms. Five patients with unilateral CIA aneurysms had previous surgical ligation of the contralateral IIA or inadvertent covering by the stent-graft of the contralateral IIA origin. Outcomes were assessed by clinical follow-up. RESULTS: Severe ischemic complications were limited to spinal cord ischemia in 1 patient (3%) who developed paraparesis following EVAR. No other severe ischemic complications such as buttock necrosis, or bowel or bladder ischemia, occurred. Buttock and/or thigh claudication occurred in 12 patients (31%) and persisted beyond 1 year in 3 patients (9%). Sexual dysfunction occurred in 2 patients (5%). Patients who underwent simultaneous embolization had a 25% (3/12) ischemic complication rate versus 41% (11/27) in those with sequential embolization (p = 0.48). Embolization limited to the main trunk of the IIA resulted in a significantly reduced ischemic complication rate of 16% (3/19) versus 55% (11/20) of patients who had a more distal embolization of the IIA (p = 0.019, Fisher's exact test). CONCLUSION: Severe complications after bilateral IIA embolization are uncommon. Although buttock/thigh claudication occurs in around 30% of patients soon after the procedure, this resolves in the majority after 1 year. There is no obvious benefit for sequential versus simultaneous IIA embolization in our series. Occlusion of the proximal IIA trunk is associated with reduced complications compared with occlusion of the distal IIA.

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.

Accurate geometric calibration in stepping-table digital subtraction angiography.

Accurate measurements of vessel dimensions are desirable in many clinical applications. This work uses the known relative motion between X-ray source and the patient in stepping-table digital subtraction angiography (DSA) to provide an accurate geometric calibration for quantitative measurements. The method results in a calibration factor that converts the size of the object measured in pixels on the image to its size in millimetres. The main sources of error relate to: (i) the assessment of relative displacement of a structure in a series of images; (ii) patient motion throughout data acquisition; and (iii) image distortion. Error was evaluated both with a test object consisting of a large grid of ball bearings (2x2 cm spaced) and, in vivo, in five renal DSA examinations performed with identical catheters of known diameter. The calibration factor was calculated with 0.1% accuracy for the test object and at least 2% accuracy in vivo, even with breath holding and pulsatile motion. This demonstrates that the calculation of the calibration factor can be very accurate, and that the method we propose is capable of the submillimetre accuracy required for clinical studies if used in conjunction with an accurate measurement of the vessel size in pixels. In conclusion, accurate geometric measurements can be performed in stepping-table DSA, without the need for external reference objects.