VERTOS II: percutaneous vertebroplasty versus conservative therapy in patients with painful osteoporotic vertebral compression fractures; rationale, objectives and design of a multicenter randomized controlled trial.

BACKGROUND: The standard care in patients with a painful osteoporotic vertebral compression fracture (VCF) is conservative therapy. Percutaneous vertebroplasty (PV), a minimally invasive technique, is gaining popularity as a new treatment option. Many prospective and retrospective studies have reported on the effectiveness and safety of PV, but no large randomized controlled trial (RCT) has been published. OBJECTIVE: To estimate cost-effectiveness of PV compared to conservative therapy in terms of: pain reduction, quality of life, complications, secondary fractures and mortality. MATERIALS AND METHODS: The VERTOS II study is designed as a prospective, multicenter RCT. Patients with a painful VCF with bone edema on MR imaging, local back pain for 6 weeks or less, osteopenia and aged 50 years or older, after obtaining informed consent are included and randomized for PV or conservative therapy. In total 200 patients will be enrolled. Follow-up is at regular intervals during a 1-year period with standard questionnaires, addressing: clinical symptoms, pain medication, Visual Analogue Scale (VAS) score, quality of life and cost-effectiveness. Secondary fractures, necessary additional therapies and complications are recorded. CONCLUSION: The VERTOS II study is the first methodologically sound RCT designed to assess the cost-effectiveness of PV compared to conservative therapy in patients with an acute osteoporotic VCF. TRIAL REGISTRATION: http://www.clinicaltrials.gov, NCT00232466.

Percutaneous vertebroplasty compared with optimal pain medication treatment: short-term clinical outcome of patients with subacute or chronic painful osteoporotic vertebral compression fractures. The VERTOS study.

PURPOSE: To prospectively assess the short-term clinical outcome of patients with subacute or chronic painful osteoporotic vertebral compression fractures (VCF) treated with percutaneous vertebroplasty (PV) compared with optimal pain medication (OPM). METHODS: Randomization of patients in 2 groups: treatment by PV or OPM. After 2 weeks, patients from the OPM arm could change therapy to PV. Patients were evaluated 1 day and 2 weeks after treatment. Visual analog score (VAS) for pain and analgesic use were assessed before, and 1 day and 2 weeks after start of treatment. Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO) and Roland-Morris Disability (RMD) questionnaire scores were assessed before and 2 weeks after start of treatment. Follow-up scores in patients requesting PV treatment after 2 weeks OPM treatment were compared with scores during their OPM period. RESULTS: Eighteen patients treated with PV compared with 16 patients treated with OPM had significantly better VAS and used less analgesics 1 day after treatment. Two weeks after treatment, the mean VAS was less but not significantly different in patients treated with OPM, whereas these patients used significantly less analgesics and had better QUALEFFO and RMD scores. Scores in the PV arm were influenced by occurrence of new VCF in 2 patients. After 2 weeks OPM, 14 patients requested PV treatment. All scores, 1 day and 2 weeks after PV, were significantly better compared with scores during conservative treatment. CONCLUSION: Pain relief and improvement of mobility, function, and stature after PV is immediate and significantly better in the short term compared with OPM treatment.

Pain response in the first trimester after percutaneous vertebroplasty in patients with osteoporotic vertebral compression fractures with or without bone marrow edema.

BACKGROUND AND PURPOSE: Presence of bone marrow edema (BME) in osteoporotic vertebral compression fractures (VCF) detected by MR imaging as selection criterion for percutaneous vertebroplasty (PV) is speculative. To clarify significance of BME in VCF, we assessed pain response after PV in patients with VCF with full BME versus patients with VCF with absent BME. METHODS: From a cohort of patients with painful VCF selected for PV, pain response in 14 patients with absent BME in VCF was prospectively compared with pain response in 31 patients with full BME in VCF. Pain was evaluated before PV and at 1 and 3 months after PV with visual analog scores and analgesics used. Back pain in general and at treated vertebral levels was assessed. RESULTS: Pain decrease after PV at treated levels was observed in 10 (71%) patients with absent BME in VCF at both follow-up periods and in 29 (94%) patients with full BME 1 month after PV and 30 (97%) at 3 months after PV. Differences between the groups were significant (P = .04 at 1 month; P = .01 at 3 months). Pain response was not affected by other patient or imaging characteristics. General back pain after PV was comparable in both groups after PV (P = .08 at 1 month; P = .4 at 3 months). CONCLUSION: Pain decrease after PV in patients with VCF is more frequently observed when full BME is present. Because 71% of patients with VCF with absent BME responded favorably on pain, PV should not be withheld based on absence of BME alone.

Bone marrow edema in osteoporotic vertebral compression fractures after percutaneous vertebroplasty and relation with clinical outcome.

BACKGROUND AND PURPOSE: Little is known about the evolution of bone marrow edema (BME) in osteoporotic vertebral compression fractures (VCF) after percutaneous vertebroplasty (PV) or about its relation with relief of pain. In this study, we prospectively assessed changes in BME with MR imaging at 3, 6, and 12 months after PV and related changes in BME with pain evolution and analgesic use over time. METHODS: BME percentage was assessed in 64 patients after PV of 89 VCF with serial MR imaging follow-up at 3, 6, and 12 months. Pain was assessed before PV and at every follow-up interval by visual analog scale for pain and type of analgesic used. Relation between changes in BME and pain evolution was assessed in a subgroup of 31 patients with a single treated VCF and neither new VCF at follow-up nor pain at another untreated level. RESULTS: BME gradually decreased over time. At 1 year after PV, 29% of treated VCF still demonstrated BME. Once BME disappeared, it did not return. Pain relief was most striking the first 3 months after PV and remained constant thereafter. There was no relation between relief of pain and extent, presence, or absence of BME after PV. CONCLUSION: A gradual decrease of BME in osteoporotic VCF treated with PV is apparent during 12 months of MR imaging follow-up. Decrease of BME is unrelated to relief of pain.

Endovascular stenting in neoplastic superior vena cava syndrome prior to chemotherapy or radiotherapy.

BACKGROUND: The standard conventional palliative treatment of choice for patients with neoplastic superior vena cava syndrome (SVCS) is chemotherapy, radiotherapy or surgery. In our study, palliative stenting was used as a first-line therapeutic measure in all cases using self-expanding stents prior to any antitumour therapy. METHODS: 17 patients, 10 men and 7 women, all of whom presenting with the clinical diagnosis of SVCS confirmed by phlebography combined with CT, were referred for stenting of the superior caval vein. All procedures were performed after local anaesthesia without sedatives or general anaesthesia in the angiosuite at the radiology department. Symptom response was evaluated directly after the procedure at several intervals by clinical and nursing staff. RESULTS: 19 self-expanding Symphony stents were successfully implanted in 15 of 17 cancer patients with SVCS in a period of five years. All 15 individuals remained free from SVCS after the successful stenting procedure. No stent-related complications occurred. CONCLUSION: This study demonstrates that palliative SVC stenting prior to any antitumour therapy is feasible, easily performed without serious complications and provides a quicker symptom response than obtained with radiation therapy or chemotherapy alone. Primary stenting also provides the opportunity to establish a correct diagnosis before starting antitumour therapy.

Uterine fibroids: targeted embolization, an update on technique.

Uterine fibroid embolization has become an attractive alternative therapy for symptomatic uterine fibroids. Since its introduction, the applied embolization technique has undergone several refinements. Complete fibroid devascularization to block uterine arteries was the initial goal. Thereafter, more sophisticated techniques for targeted embolization of the fibroid to preserve cervical and vaginal branches and ovarian anastomosis were being performed by more and more interventionists. In addition, the use of calibrated embolic agents has become more and more popular. In this article we provide an update on the modern uterine fibroid, targeted embolization technique, including a summary of catheterization-related problems, flaws, and tricks.

[Percutaneous vertebroplasty in the treatment of osteoporotic vertebral compression fractures: first short term results]. / Percutane vertebroplastiek bij osteoporotische wervelinzakkingsfracturen: eerste kortetermijnresultaten.

OBJECTIVE: To describe the technique of percutaneous vertebroplasty and the short-term results in patients with symptomatic, osteoporotic vertebral compression fractures. DESIGN: Prospective follow-up study. METHOD: In a pilot-study to evaluate the short-term safety and effectiveness of percutaneous vertebroplasty, 18 consecutive patients with a total of 33 osteoporotic thoracic or lumbar vertebral compression fractures were treated from October 2001 to June 2002 with a follow-up of 3-6 months. The indication for treatment was a symptomatic, therapy-resistant osteoporotic vertebral compression fracture. Percutaneous vertebroplasty was performed under radiographic control, after previous intraossal venography, using bone cement mixed with barium sulphate. Post-procedural follow-up consisted of radiological evaluation with conventional thoracolumbar X-rays and MRI scans, and interviews of the patients. RESULTS: Percutaneous vertebroplasty was technically successful in 31 of 33 vertebral fractures (94%), and in 16 of 18 patients (89%). One patient with extreme venous contrast leakage could not be treated. Sixteen patients had less or no pain after treatment. One patient retained thoracolumbar back pain after inadequate cementations and refused further treatment. None of the patients reported aggravation of symptoms following the procedure. Contrast leakage was absent in 18 vertebrae. In 8 vertebrae there was contrast leakage to paravertebral veins. In three of these cases the leakage was so severe that embolisation was performed, with success in one case. In 13 vertebrae, cement leakage to intervertebral and paravertebral spaces and pedicular cement spurs were seen, without clinical consequences. Immediately after the procedure and during follow-up there were no clinically relevant complications. CONCLUSION: Percutaneous vertebroplasty was a technically feasible treatment in these patients with symptomatic, therapy-resistant, osteoporotic vertebral fractures. The first short-term results were comparable with results in the literature. A prospective randomised intervention study will be needed to compare percutaneous vertebroplasty with optimal conservative treatment.

The additional value of angiography after colour-coded duplex on decision making in patients with critical limb ischaemia. A prospective study.

OBJECTIVE: to investigate prospectively the additional value of intra arterial digital subtraction arteriography (IADSA) for decision making in patients with critical limb ischemia (CLI). Treatment plans based on colour-duplex imaging (CDI) were compared with treatment plans based on IADSA. METHODS: ninety-eight consecutive patients with 112 legs with CLI were investigated by CDI and IADSA. Treatment plans based on CDI and IADSA were made separately during a multidisciplinary meeting. Both plans were retrospectively analysed with the outcome of the operation or the endovascular procedure as a reference. RESULTS: eighty-eight patients with 101 legs could be analysed. In 91 out of the 101 legs (90%) CDI offered the same strategy as the IADSA. In 10 legs IADSA provided additional information. Most of the additional information concerned the crural vessels. CONCLUSION: the preoperative planning of treatment in patients with chronic critical ischaemia of the lower limbs can be based on CDI alone in most patients. For planning crural revascularisation additional information may be needed. If severe calcification prevents adequate visualisation of the crural vessels or no patent anterior or posterior tibial artery with outflow across the ankle is present, IADSA should be performed.

[Embolization as treatment for symptomatic uterus myomata]. / Embolisatie als behandeling bij symptomatische uterus myomatosus.

Selective percutaneous embolisation of the uterine arteries was carried out on three women with hypermenorrhea caused by uterine myomata. Two of the patients experienced resumption of the normal menstrual pattern. In the first case the myoma became 30% smaller and in the second case, the fibroid was expelled into the vagina six months later. The third patient suffered a fever one week after the treatment due to an infected necrotic myoma, after which a hysterectomy was carried out. The embolisation of myomata can offer an alternative to medicinal treatment, myomectomy or hysterectomy. The advantages of embolisation compared to a hysterectomy are a shorter hospital admission time, quick recovery after the procedure and retention of the uterus.

[Embolization as treatment for postpartum hemorrhage]. / Embolisatie als behandeling bij bloedingen post partum.

A 33-year-old woman suffered from an early postpartum bleeding (15 hours after delivery) and a 29-year-old patient from a late one (nine days postpartum). Both women were treated with conservative methods including curettage and surgical evacuation of the haematoma in one case. However, blood loss didn't stop. Instead of hysterectomy it was decided to embolize the appropriate cervicouterine branch of the A. uterina in these young women, which appeared to be effective. In case of non-effective treatment of postpartum bleeding, hysterectomy is not the only remaining therapy. Gynaecologists and radiologists together may consider embolization therapy. This has proved to be a minimally invasive and successful treatment. Unlike hysterectomy, the uterus will be preserved, making an additional pregnancy possible.

Retrieval of malpositioned, dislocated or fractured guglielmi detachable coils from intracranial vessels. A report of seven cases.

SUMMARY: Endovascular treatment of intracranial vascular disorders has become common practice, especially treatment of aneurysms with detachable coils. Detachable coils can be utilized with high success rates but technical complications such as misplacement and displacement of coils and/or fractures may occur.We describe our experience with retrieval of coil material utilizing the Lasso retriever (Balt, Montmorency, France) in seven patients.

False aneurysm of the right internal mammary artery.

False aneurysms of the internal mammary artery are extremely rare. A case of false aneurysm of a branch of the right internal mammary artery after median sternotomy is reported. A large right-sided mediastinal mass was seen on the thoracic radiogram. A false aneurysm was suspected on CT-scan and confirmed by angiography. In the same setting percutaneous embolization was performed.

Stenting in the femoral superficial artery: an overview.

Stenting in the superficial femoral artery is still a controversial treatment in case of occlusive disease. Although the results of percutaneous treatment especially in the Hunter canal region are moderate, balloon angioplasty is nowadays an established technique. Many investigators tried to improve their results with additional stenting of the superficial femoral arteries after inappropriate results of balloon angioplasty and/or stenting. Although the figures of results after stenting are not consistent in literature even when using stent graft material I still feel that especially in the superficial femoral artery stenting procedures should not be performed on a routine basis. The main issue in stent failure is the extensive intima hyperplasia. Many investigators are working on this problem but as long as no real solution is available I feel that we have to act reluctantly in treating superficial femoral arteries with stents.

Haemorrhage due to laceration of an aberrant inferior epigastric artery during femoropopliteal PTA in an obese patient; a rare complication of a high antegrade femoral puncture.

Haemorrhage due to laceration of the proximal inferior epigastric artery during femoro-popliteal PTA in an obese 79-year-old woman is reported as a rare complication of a high antegrade femoral puncture. The post procedural haemorrhage was caused by a high antegrade puncture lacerating a low overriding inferior epigastric artery.