Randomised trial of two embolic agents for uterine artery embolisation for fibroids: Gelfoam versus Embospheres (RAGE trial).

BACKGROUND: Uterine artery embolisation (UAE) is an established treatment option for women with symptomatic uterine fibroids who wish to avoid surgery. However the most efficacious embolic agent remains uncertain. METHODS: We conducted a pilot double blind randomized controlled trial comparing Gelfoam with Embospheres in women undergoing UAE. Outcomes recorded at baseline, 24-h, 1 and 6 months included complications, inflammatory, haematological markers and ovarian function. Contrast enhanced MRI (CEMRI) was acquired at baseline, 24-h and 6 months. Pain score (visual analogue) was measured at 24-h, quality of life (UFS-Qol) at baseline, 1 and 6 months. All patients were followed to 6 months. RESULTS: Twenty patients were randomized 1:1 to receive either Gelfoam (G) or Embospheres (E). The UFS-Qol symptom score improved in both groups at 6 months mean of 64 ± 18 to 23 ± 16 and 54 ± 15 to 32 ± 26 in the E and G groups respectively. UFS-Qol HRQL also improved in both groups at 6 months, mean 41 ± 28 to 79 ± 20 and 53 ± 19 to 78 ± 21 in the E and G groups respectively.Uterine volume at 6 months reduced from 1018 ± 666mls to 622 ± 436 (p = 0.001) and from 1026 ± 756 to 908 ± 720 (p = 0.15) in the E and G groups respectively. There was a significant difference between groups for this parameter p = 0.01. All uterine arteries were patent at 24-h and 6 months. Complete (100%) fibroid infarction rates were 5(50%) and 2(20%) in the E and G groups respectively. None of the other outcome measures showed any between group differences. There were no re-interventions in either group. CONCLUSION: The only significant between group differences was for a greater reduction in uterine volume at 6 months in the E group. A larger trial (estimate 172 subjects) is required to determine whether other apparent differences are clinically and statistically significant. TRIAL REGISTRATION: ISRCTN67347987.

Can (1)H MR Spectroscopy be Used to Assess the Success of Uterine Artery Embolisation?

PURPOSE: Absence of contrast on contrast enhanced MRI (CEMRI) and reduction in uterine volume at 6 months post-uterine artery embolisation (UAE) currently indicate the successful disruption of the fibroid blood supply by UAE. This study assesses whether (1)H MR spectroscopy ((1)H MRS) can also indicate the success of UAE. METHOD: 20 patients with symptomatic fibroids were randomised 1:1 to undergo UAE with either Gelfoam or Embospheres. CEMRI and spectra (1.5 T) were acquired pre-, 24-h and 6 months post-UAE. LCModel was used to detect significant levels of choline, creatine and lactate in fibroid spectra. Uterine volumes were measured and paired t tests (p < 0.05) assessed volume reduction over time. Qualitative assessments of CEMRI were performed. RESULTS: Choline was detected in 17/18 spectra pre-UAE, 12/14 at 24-h and 6/16 at 6 months post-UAE. Choline was not detected in the 7/7 spectra available for the Embospheres group at 6 months. These fibroids were non-enhancing on CEMRI and associated with a significant reduction in mean uterine volume at 6 months (mean/min/max 396.5/84.1/997.5 cm(3), p = 0.003). Choline was detected in 6/9 fibroid spectra available for the Gelfoam group at 6 months. Of these fibroids, four demonstrated persistent enhancement on CEMRI and two were non-enhancing. This group did not demonstrate significant uterine volume reduction (mean/min/max 117.2/-230.6/382.6 cm(3), p = 0.15). The negative minimum value indicates fibroid growth. CONCLUSIONS: This study has demonstrated the potential of (1)H MRS to provide an additional marker of the success of UAE.

Mortality reporting in interventional radiology: experience of a pilot audit with the Scottish Audit of Surgical Mortality.

AIM: To describe the initial pilot phase of the 2009 Scottish Audit of Surgical Mortality (SASM), which includes outcomes and difficulties that arose during any interventional radiology (IR) procedure performed on patients in this audit over an 18 month period. MATERIALS AND METHODS: Approximately 40 consultant interventional radiologists from all units in Scotland elected to participate in the audit. Each response was then peer reviewed after anonymisation of the patient and institution. If a relevant ACON (area for consideration or area of concern) was generated, this was checked by one of the other reviewers before communication with the original reporting radiologist and colleagues. There was then a right of reply by the reporting unit before formal documentation was sent out. RESULTS: Initial results were analysed after 18 months period, during which time 95 forms relating to deaths of surgical inpatients were sent to interventional radiologists identified as having been involved in an IR procedure at some time during the patient's admission. Seventy-one forms had been returned by July 2010, of which 46 had gone through the entire SASM process. From these, 10 ACONs were attributed. Anonymised case vignettes and reports from these were used as educational tools. CONCLUSION: Involvement with SASM is a useful process. Significant safety issues and learning points were identified in the pilot. The majority of ACONs identified by the audit were in patients who had undergone percutaneous biliary interventions.

Diffusion-weighted imaging in uterine artery embolisation: do findings correlate with contrast enhancement and volume reduction?

OBJECTIVES: The objective of this study was to determine the role of diffusion-weighted imaging (DWI) in uterine artery embolisation (UAE), and to assess the apparent diffusion coefficient (ADC) of the dominant fibroid and its relationship to contrast enhancement and fibroid volume reduction. METHODS: We carried out a retrospective study of 15 patients who underwent UAE. Calculations were performed at baseline and 6 months post-embolisation. Fibroid ADC (expressed in 10(-3) mm(2) s(-1)) was calculated using b=0 and b=1000 DWI values. Fibroid enhancement was compared with background myometrium by measuring signal-difference-to-noise ratio (SDNR). Fibroid volume was calculated using a prolate ellipse formula. RESULTS: There was a significant reduction (p<0.001) in fibroid ADC at 6 months (0.48; standard deviation, SD=0.26) as compared with baseline (1.01; SD=0.39). No significant change (p=0.07) was identified in 6-month myometrial ADC (1.09; SD=0.28) as compared with baseline (1.24; SD=0.20). Moderately strong and significant positive correlation was identified between baseline ADC and 6-month percentage volume reduction of the fibroid (correlation=0.66, p=0.007). No correlation was identified between SDNR and ADC at baseline or 6 months (r=0.01, p=0.97 and r=-0.13, p=0.64, respectively) or SDNR and percentage volume reduction at 6 months (correlation r=0.18, p=0.51). CONCLUSION: Baseline ADC of dominant fibroids shows a moderately strong correlation with subsequent volume reduction at 6 months following UAE. No correlation was identified between ADC values and contrast enhancement on the baseline or 6-month scans. Further prospective evaluation is needed before DWI can be utilised in clinical practice. Advances in knowledge DWI imaging may provide additional information about UAE and possibly help to predict uterine volume reduction.

Randomised comparison of uterine artery embolisation (UAE) with surgical treatment in patients with symptomatic uterine fibroids (REST trial): 5-year results.

OBJECTIVE: To compare the long-term results of uterine artery embolisation (UAE) with surgery for women with symptomatic uterine fibroids. DESIGN: Pragmatic, open, multicentre, randomised trial. SETTING: Twenty-seven participating UK secondary care centres. SAMPLE: Women aged ≥18 years with symptomatic fibroids who were considered to justify surgical treatment. METHODS: In total, 157 women were randomised (in a 2:1 ratio): 106 to UAE and 51 to surgery (hysterectomy 42; myomectomy nine). MAIN OUTCOME MEASURES: Quality of life at 5 years, as assessed by the Short Form General Health Survey (SF-36). Secondary measures included complications, adverse events and the need for further intervention. RESULTS: There were no significant differences between groups in any of the eight components of the SF-36 scores at 5 years (minimum P = 0.45). Symptom score reduction and patient satisfaction with either treatment was very high, with no group difference. Rates of adverse events were similar in both groups (19% embolization and 25% surgery; P = 0.40). The 5-year intervention rate for treatment failure or complications was 32% (UAE arm) and 4% (surgery arm), respectively. The initial cost benefit of UAE over surgery at 12 months was substantially reduced because of subsequent interventions, with treatments being cost neutral at 5 years. CONCLUSIONS: We have found that UAE is a satisfactory alternative to surgery for fibroids. The less invasive nature of UAE needs to be balanced against the need for re-intervention in almost a third of patients. The choice should lie with the informed patient.

The effects of uterine artery embolisation and surgical treatment on ovarian function in women with uterine fibroids.

OBJECTIVE: The aim of this study was to evaluate and compare both ovarian function and menstrual characteristics following uterine artery embolisation (UAE) and surgery. DESIGN: Subgroup of women from a randomised controlled trial. SETTING: Gynaecology and radiology units in Scotland, UK. POPULATION: Ninety-six women from the randomised controlled trial comparing embolisation with surgery as a treatment for fibroids (REST), which recruited 157 patients (106 UAE; 51 surgery). METHODS: Seventy-three women undergoing UAE and 23 women undergoing surgery (with ovarian conservation) had serum follicle-stimulating hormone (FSH) measurements taken on day 3 of the menstrual cycle prior to treatment, and at 6 and 12 months post-treatment. Data on menstrual cycle characteristics was also collected. MAIN OUTCOME MEASURES: Ovarian failure, as defined by an FSH level of >40 iu/l, and change in duration of menses and length of menstrual cycle. RESULTS: There was no significant difference in the rate of ovarian failure at 12 months between UAE (11%) and surgical patients (18%) (P = 0.44). This finding was not influenced by age. The mean duration of menstrual flow decreased significantly, from baseline to 12 months, by 1.7 days (SD 3.8), (95% CI 0.8-2.6). There was no statistically significant change in mean cycle length at 12 months (0.7 days [SD 4.9]; 95% CI [-0.5, 1.9]). CONCLUSIONS: There is no evidence for UAE accelerating a deterioration in ovarian function at 1 year, when compared with surgery. UAE is associated with a decrease in the duration of menstrual flow at 1 year.

Evaluation of the effect of uterine artery embolisation on menstrual blood loss and uterine volume.

OBJECTIVE: To evaluate the effect of uterine artery embolisation (UAE) on menstrual blood loss (MBL) and uterine volume in women with symptomatic uterine fibroids. DESIGN: Prospective observational study. SETTING: West of Scotland gynaecology and radiology departments. POPULATION: Fifty women (mean age 43 years) with symptomatic fibroids undergoing UAE between January 1999 and June 2003. METHODS: Women collected sanitary protection from one menses pre-embolisation and at regular intervals thereafter. This allowed objective measurement of MBL using the alkaline haematin technique. Uterine volume was calculated using magnetic resonance imaging (MRI) before and six months following embolisation. Interventional radiologists performed bilateral UAE. The Wilcoxon's signed rank test was used for statistical analysis of data. MAIN OUTCOME MEASURES: Post-embolisation MBL and uterine volume changes. RESULTS: Median pretreatment MBL was 162 mL (mean 234, range 9-1339). The median MBL decreased to 60 mL at 3 months (n= 34, range 0-767, P < 0.001), 70 mL at 6-9 months (n= 34, range 0-1283, P < 0.001), 37 mL at 12-24 months (n= 25, range 0-265, P < 0.001), 18 mL at 24-36 months (n= 17, range 0-205, P < 0.001) and 41 mL at 36-48 months (n= 6, range 0-66, P < 0.05). The median reduction in uterine volume was 40% (n= 46, 95% CI 33.0-49.7, P < 0.001). CONCLUSIONS: UAE causes a statistically significant reduction in objectively measured MBL. UAE is also associated with a statistically significant reduction in uterine volume at six months. There was no relationship between the changes in uterine volume and MBL.

Randomized clinical trial comparing self-expanding metallic stents with plastic endoprostheses in the palliation of oesophageal cancer.

BACKGROUND: There is little evidence of the clinical and cost effectiveness of self-expanding metallic stents in the palliation of oesophageal cancer. The aims of this randomized trial were to evaluate the immediate and medium-term clinical outcomes following palliative intubation, examine patient quality of life, and evaluate costs and benefits from the perspective of the health service. METHODS: Fifty patients with inoperable oesophageal cancer were randomly allocated a metallic stent (n = 25) or plastic endoprosthesis (n = 25). Patients were followed up monthly until death. RESULTS: There was no significant difference in procedure-related complications or mortality rate between the two groups. There was a trend towards significance in favour of metallic stents with respect to quality of life and survival (median survival 62 versus 107 days for plastic prosthesis and metallic stent respectively). The cost of the initial placement of metallic stents was significantly higher than that of plastic endoprostheses ( pound 983 versus pound 296). After 4 weeks, cost differences were no longer significant. CONCLUSION: Metallic stents may contribute to improved survival and quality of life in patients with oesophageal cancer. Although initially more expensive, this cost difference does not last beyond 4 weeks. A larger trial involving approximately 300 patients would be required to detect a quality of life benefit of the magnitude observed in this trial.

Common iliac artery access during endovascular thoracic aortic repair facilitated by a transabdominal wall tunnel.

PURPOSE: To describe a technique for common iliac artery (CIA) access during endovascular aortic aneurysm repair when unfavorable angulation between the CIA and the delivery sheath precludes direct arterial access. TECHNIQUE: After retroperitoneal exposure of the CIA, a puncture site is chosen inferolateral to the surgical incision, and an 18-G trocar/cannula is advanced in alignment with the CIA through the anterior abdominal wall or skin of the upper thigh into the retroperitoneal space. Serial dilatation is performed over a guidewire placed through the cannula to create the subcutaneous tract. The trocar/cannula is replaced over the wire, and the CIA is punctured under direct vision. The guidewire is then advanced into the proximal aorta. A CIA arteriotomy is performed and the delivery system introduced over the guidewire through the tunnel into the iliac artery. CONCLUSIONS: Retroperitoneal exposure of the CIA with tunneled transabdominal wall delivery of the stent-graft avoids both external iliac artery injury and creation of a temporary access conduit in patients with iliac tortuosity and/or occlusive disease.

Patient tolerance of cervical esophageal metallic stents.

PURPOSE: To demonstrate that proximal esophageal stenoses and tracheoesophageal fistulas can be adequately palliated with use of metallic stents without significant foreign-body sensation. MATERIALS AND METHODS: Between June 1994 and March 1999, 22 patients with lesions within 3 cm of the cricopharyngeus were treated by placement of metallic stents. The series was reviewed retrospectively. Twenty patients had surgically unresectable malignant lesions, two patients had benign disease. Ten patients had associated tracheoesophageal fistulas. In all, the upper limit of the stent was between C5 vertebral body inferior endplate and the T2 vertebral body superior endplate. The case-notes were reviewed until patient death (range, 6-198 days), or to date in the two surviving patients with benign disease. RESULTS: Immediate technical success was 93% (27 of 29). Dysphagia scores improved from a median of 3 to 2 after stent placement. Eighteen of 22 (82%) patients reported no foreign-body sensation. There have been no cases of proximal migration, periprocedural perforation, or deaths. The two patients with benign disease experienced significant complications. CONCLUSION: Lesions in proximity to the cricopharyngeus can be successfully palliated without significant foreign-body sensation in the majority of patients with use of metallic stents. The authors urge caution in placing stents in patients with benign disease.

Percutaneous transluminal angioplasty and stenting of coeliac artery stenosis in the treatment of mesenteric angina: a case report and review of therapeutic options.

We report the case of a 72-year-old gentleman with mesenteric angina who was successfully treated with stenting of a coeliac artery stenosis using a Palmaz stent, and review the therapeutic options in the management of mesenteric angina.