Contrast Induced Nephropathy and Long-term Renal Decline After Percutaneous Transluminal Angioplasty for Symptomatic Peripheral Arterial Disease.

OBJECTIVE/BACKGROUND: Administration of iodinated contrast media during endovascular procedures for peripheral arterial disease (PAD) may cause contrast induced nephropathy (CIN). The aim of the present study was to establish the incidence of CIN after these procedures and to study its association with long-term loss of kidney function, cardiovascular events, and death. METHODS: Consecutive patients first presenting with symptomatic PAD (Rutherford classification II-VI) who were treated with an endovascular procedure were included in this prospective observational cohort study. CIN was defined as >25% increase of serum creatinine concentration from baseline at 5 days after the intervention. RESULTS: Some 337 patients were included with a mean estimated glomerular filtration rate (eGFR) of 67 mL/minute. Thirteen percent (95% confidence interval [CI] 9-16) of these patients developed CIN after endovascular interventions for PAD. One year after treatment, eGFR was reduced by 12.4 mL/minute (95% CI 8.6-16.2) in patients with CIN compared with 6.2 mL/minute (95% CI 4.9-7.0) in patients without acute kidney injury (p < .01). After correction for potential confounders, CIN was associated with a 7.8 mL/minute (95% CI 4.5-11.0) reduction of eGFR at 1 year after endovascular intervention (p < .01). Furthermore, patients with CIN were at increased risk of long-term cardiovascular events and mortality. CONCLUSION: Exposure to iodinated contrast media during endovascular procedures for symptomatic PAD frequently results in CIN. Patients with CIN are at increased risk of long-term loss of renal function, cardiovascular events, and death.

Magnetic resonance imaging-derived arterial peak flow in peripheral arterial disease: towards a standardized measurement.

OBJECTIVE: To determine the best location to measure the arterial peak flow (APF) in patients with peripheral arterial disease in order to facilitate clinical standardization. METHODS: Two hundred and fifty-nine patients with varying degrees of peripheral artery disease (PAD) and 48 patients without PAD were included. All patients underwent magnetic resonance phase-contrast imaging of the common femoral artery (CFA), superficial femoral artery (SFA), and popliteal artery (PA). APF values of patients with PAD were compared with patients with no PAD. The discriminative ability to identify PAD was evaluated by means of receiver-operator characteristic curves and the corresponding areas under the curve (AUC). RESULTS: Mean APF values in patients with PAD were reduced by 42%, 55% and 59% compared with non-PAD patients for the CFA, SFA, and PA, respectively (p < .01). The AUC's were 0.84, 0.92, and 0.93 for the CFA, SFA, and PA, respectively. CONCLUSION: The APF measured at the level of the PA shows the largest differences between patients with PAD and patients with no PAD and the best discriminative ability compared with the APF acquired in the CFA or SFA. The PA seems to be the most suitable level for standardized flow measurements in patients with PAD in order to obtain relevant functional information about the vascular status.

Treatment of symptomatic aberrant subclavian arteries.

OBJECTIVE: The aim of this study is to present experience with 10 patients with symptomatic aberrant subclavian artery (ASA) and aneurysm of ASA who underwent surgical treatment. METHODS: From 2008 to 2011 10 patients with symptomatic aberrant subclavian artery (mean age 60 years [range 24-90 years]) were studied. Symptoms were dysphagia (n = 7), dyspnea (n = 4), acute chest pain (n = 1), respiratory distress syndrome (n = 1), superior cava syndrome, and shock (n = 1). Six patients had aneurysm formation of the ASA (mean diameter of 7.1 cm [range 3.0-12.4 cm]; rupture [n = 1], dissection [n = 1]). All data were analyzed retrospectively. RESULTS: Treatment was performed as a hybrid procedure in eight patients. This included thoracic endoluminal graft exclusion with revascularization of the ASA, a pure endovascular procedure with two occluders in one patient, and an open procedure in one patient with ligation of the aberrant artery through a thoracotomy. Three patients died during the early postoperative period owing to pulmonary complications. All three suffered from a symptomatic aneurysm, and two were treated as an emergency procedure. Median follow-up was 20 months (range 12-49 months). CONCLUSION: A symptomatic ASA and its associated aneurysmal formation should be excluded after diagnosis. In most cases, a hybrid procedure consisting of thoracic endografting and revascularization of the ASA is feasible.

CTA with fluoroscopy image fusion guidance in endovascular complex aortic aneurysm repair.

OBJECTIVES: To evaluate the effect of intraoperative guidance by means of live fluoroscopy image fusion with computed tomography angiography (CTA) on iodinated contrast material volume, procedure time, and fluoroscopy time in endovascular thoraco-abdominal aortic repair. METHODS: CTA with fluoroscopy image fusion road-mapping was prospectively evaluated in patients with complex aortic aneurysms who underwent fenestrated and/or branched endovascular repair (FEVAR/BEVAR). Total iodinated contrast material volume, overall procedure time, and fluoroscopy time were compared between the fusion group (n = 31) and case controls (n = 31). Reasons for potential fusion image inaccuracy were analyzed. RESULTS: Fusion imaging was feasible in all patients. Fusion image road-mapping was used for navigation and positioning of the devices and catheter guidance during access to target vessels. Iodinated contrast material volume and procedure time were significantly lower in the fusion group than in case controls (159 mL [95% CI 132-186 mL] vs. 199 mL [95% CI 170-229 mL], p = .037 and 5.2 hours [95% CI 4.5-5.9 hours] vs. 6.3 hours (95% CI 5.4-7.2 hours), p = .022). No significant differences in fluoroscopy time were observed (p = .38). Respiration-related vessel displacement, vessel elongation, and displacement by stiff devices as well as patient movement were identified as reasons for fusion image inaccuracy. CONCLUSION: Image fusion guidance provides added value in complex endovascular interventions. The technology significantly reduces iodinated contrast material dose and procedure time.

Abdominal aortic aneurysms with high thrombus signal intensity on magnetic resonance imaging are associated with high growth rate.

OBJECTIVES: A layer of intraluminal thrombus is commonly observed in abdominal aortic aneurysms (AAAs). The purpose of this study was to investigate whether AAAs with high thrombus signal intensity (SI) at T1-weighted (T1w) magnetic resonance imaging (MRI) exhibit a faster aneurysm growth rate. METHODS: This was a prospective follow-up study. Patients with a small AAA underwent MRI examinations at 6 month intervals. Aneurysm thrombus and psoas muscle SI at the point of maximal diameter on T1w images were measured and expressed as a ratio (thrombus SI/muscle SI). Based on these measurements, patients were categorized into three groups: AAA with relative thrombus SI above (group A) and below (group B) the mean relative thrombus SI of 1.20. Patients with AAA without thrombus constituted group C. Eight patients were scanned twice within 2 weeks to investigate scan-rescan reproducibility. Aneurysm growth rates were expressed as the change in maximal cross sectional area (cm(2)). RESULTS: A total of 35 patients (m/f: 26/9; age 72 ± 7 years; AAA maximal diameter 4.9 ± 0.5 cm) were included. Mean aneurysm growth rate for patients in group A (n = 11, 1.87 cm(2)/0.5 year) was two-fold higher than group B (n = 17, 0.78 cm(2)/0.5 year, p = .005) and eight-fold higher than group C (n = 7, 0.23 cm(2)/0.5 years, p = .004) at 6 months' follow-up. At 12 months' follow-up, the mean aneurysm growth rate remained significantly higher in group A (n = 7, 3.03 cm(2)/year) than groups B (n = 10, 1.63 cm(2)/year, p = .03) and C (n = 7, 0.73 cm(2)/year, p = .004). The reproducibility for thrombus SI measurements was found to be high with a coefficient of variation of 6.2%. Aneurysm maximal cross-sectional area at baseline was not significantly different for the three groups. CONCLUSIONS: Abdominal aortic aneurysms with high thrombus SI on T1w MR images are associated with higher aneurysm growth rates.

Randomized clinical trial of ultrasound-guided foam sclerotherapy versus surgery for the incompetent great saphenous vein.

BACKGROUND: New minimally invasive treatment modalities, such as ultrasound-guided foam sclerotherapy (UGFS), are becoming more popular. In a multicentre randomized controlled non-inferiority trial, the effectiveness and costs of UGFS and surgery for treatment of the incompetent great saphenous vein (GSV) were compared. METHODS: Patients with primary great saphenous varicose veins were assigned randomly to either UGFS or surgical stripping with high ligation. Recurrence, defined as reflux combined with venous symptoms, was determined on colour duplex scans at baseline, 3 months, 1 year and 2 years after initial treatment. Secondary outcomes were presence of recurrent reflux (irrespective of symptoms), reduction of symptoms, health-related quality of life (EQ-5D(™)), adverse events and direct hospital costs. RESULTS: Two hundred and thirty patients were treated by UGFS and 200 underwent GSV stripping. The 2-year probability of recurrence was similar in the UGFS and surgery groups: 11·3 per cent (24 of 213) and 9·0 per cent (16 of 177) respectively (P = 0·407). At 2 years, reflux irrespective of venous symptoms was significantly more frequent in the UGFS group (35·0 per cent) than in the surgery group (21·0 per cent) (P = 0·003). Mean(s.d.) hospital costs per patient over 2 years were €774(344) per patient for UGFS and €1824(141) for stripping. CONCLUSION: At 2-year follow-up, UGFS was not inferior to surgery when reflux associated with venous symptoms was the clinical outcome of interest. UGFS has the potential to be a cost-effective approach to a common health problem. Registration numbers: NCT01103258 (http://www.clinicaltrials.gov) and NTR654 (http://www.trialregister.nl).

Plasma levels of matrix metalloproteinase-9: a possible diagnostic marker of successful endovascular aneurysm repair.

OBJECTIVE: The aim of the study was evaluating the diagnostic value of plasma matrix metalloproteinase- (MMP)-2 and -9 and tissue inhibitor of MMP-1 (TIMP-1) for endoleak detection after endovascular aneurysm repair (EVAR). REPORT: Consecutive EVAR patients (n = 17) with endoleak and matched controls without endoleak (n = 20) were prospectively enrolled. Increased levels of MMP-9 were observed in patients with endoleak (P < 0.001). Regression analysis showed no significant influence of age, sex or abdominal aortic aneurysm (AAA) size. The receiver operating characteristic (ROC) curve of plasma MMP-9 levels showed that a cut-off value of 55.18 ng ml(-1) resulted in 100% sensitivity and 96% specificity with an AUC value of 0.988 (P < 0.001) to detect endoleak. CONCLUSIONS: Plasma MMP-9 levels appear to discriminate between patients with and without an endoleak with high sensitivity and specificity.

Differential protein expression in serum of abdominal aortic aneurysm patients - a proteomic approach.

OBJECTIVE: The aim of the study is to investigate the differential expression of proteins in serum of abdominal aortic aneurysm (AAA) patients in relation to aneurysm size (D(max)) and progression. METHODS: Two-dimensional differential in-gel electrophoresis (2D-DIGE) together with tandem mass spectrometry (MS/MS) was used to analyse the serum proteome from patients with small (D(max) 30-54 mm) AAA, either stable (increase D(max) <5 mm year⁻¹; n = 8) or progressive (increase D(max) ≥5 mm year⁻¹; n = 8), and large (D(max) ≥ 55 mm; n = 8) AAA. The identified proteins were quantitatively validated in a larger population (n = 80). RESULTS: Several proteins were differentially expressed in serum of small stable, small progressive and large AAA. Three validated proteins (immunoglobulin G (IgG), α1-antitrypsin (α1-AT) and Factor XII activity) showed strong correlation with D(max). Size combined with either Factor XII activity or α1-antitrypsin had minimal effect on the prognostic value in predicting aneurysm progression compared with size alone (area under the curve (AUC), 0.85; 95% confidence interval (CI), 0.73-0.97; p < 0.001 and AUC, 0.85; 95% CI, 0.72-0.98; p < 0.001 vs. AUC, 0.83; 95% CI, 0.71-0.96; p < 0.001, respectively). CONCLUSION: The present study indicates that both Factor XII and α1-antitrypsin are found in increased amounts in the serum of patients with expanding AAA. However, combination of either Factor XII or α1-antitrypsin with aneurysm diameter had little effect on prediction of aneurysm progression versus diameter alone.

Open repair for ruptured abdominal aortic aneurysm and the risk of spinal cord ischemia: review of the literature and risk-factor analysis.

OBJECTIVES: Spinal cord ischemia after open surgical repair for rAAA is a rare event. We estimated the current incidence and tried to identify risk factors. We also report a new case. METHODS: Group A consisted of 10 reports on open repair for rAAA from 1980 until 2009. Only series of ≥100 patients were considered to estimate the incidence. Thirty three case reports from 1956 until 2009 were identified (group B). Case reports from group B were not encountered in group A. Group B patients were stratified according to the type of neurological deficit as described by Gloviczki (type I complete infarction and type II infarction of the anterior two third). RESULTS: Group A consisted of 1438 patients. In group A 86% were male with a mean age of 72.1 years. The incidence of post-operative paraplegia was 1.2% (range 0-2.8%). In-hospital mortality was 46.9%. Of the 33 patients of group B were 86% male with a mean age of 68.0 years. Most patients developed a type I (42%) or type II (33%) deficit. In-hospital mortality was 51.6%. No significant differences between different types were encountered. CONCLUSION: Spinal cord ischemia after ruptured AAA is a rare complication with an incidence of 1.2% (range 0-2.8%).

Blocking the saphenofemoral junction during ultrasound-guided foam sclerotherapy-- assessment of a presumed safety-measure procedure.

OBJECTIVES: Ultrasound-guided foam sclerotherapy (UGFS) is a technique in which a mixture of sclerosing drug and gas is used to treat varicose veins. Several authors have demonstrated transient systemic effects after UGFS. These effects are not well understood but probably originate from a systemic distribution of the sclerosing foam. Therefore, safety measures have been developed to prevent foam from flowing into the deep venous system. The aim of the study is to evaluate whether blockage of the saphenofemoral (SF) junction by either manual compression or surgical ligation prevents microbubbles from leaking into the deep venous circulation. METHODS: To detect the distribution of microbubbles, radioactive pertechnetate (99mTcO4-) was added to the foam solution. Initially, in vitro trials were performed in the laboratory to investigate the effect of 99mTc on foam stability. The time taken for foam to liquefy was measured for foam alone and for the mixture with 99mTc. In subsequent research, eight varicose great saphenous veins (GSVs) were treated by UGFS. In three patients, this treatment was preceded by surgical ligation of the SF junction. In three patients, the groin was manually compressed during UGFS. In two patients, UGFS was performed without compression of the groin. RESULTS: In vitro, 99mTc did not influence foam stability; after 2.6 min all foam had reduced to liquid, regardless of whether 99mTc had been added or not. In vivo trials showed that all patients showed a decrease in the cumulative amount of 99mTc detected in the GSV following polidocanol-99mTc mixture injection. However, the decrease of radioactivity was slightly reduced when compression or ligation of the SF junction was performed. CONCLUSIONS: Blocking the SF junction during UGFS using either manual compression or ligation does not prevent, but may reduce the flow of foam into the femoral vein.

The influence of wall stress on AAA growth and biomarkers.

OBJECTIVES: This study investigated the relation between abdominal aortic aneurysm (AAA) wall stress, AAA growth rate and biomarker concentrations. With increasing wall stress, more damage may be caused to the AAA wall, possibly leading to progression of the aneurysm and reflection in up- or downregulation of specific circulating biomarkers. Levels of matrix metalloproteinase-9, tissue inhibitor of matrix metalloproteinase-1, C-reactive protein and alpha 1-antitrypsin were therefore evaluated. METHODS: Thirty-seven patients (maximum AAA diameter 41-55mm) with two, three or four consecutive computed tomography angiography (CTA) scans were prospectively included. Diameter growth rate in mm/year was determined between each pair of two sequential CTA scans. AAA wall stress was computed by finite element analysis, based on the first of the two sequential CTA scans only (n=69 pairs). Biomarker information was determined in 46 measurements in 18 patients. The relation between AAA diameter and wall stress was determined and the AAA's were divided into three equally sized groups (relative low, medium and high stress). Growth rate and biomarker concentrations were compared between these groups. Additionally, correlation coefficients were computed between absolute wall stress, AAA growth and biomarker concentrations. RESULTS: A relative low AAA wall stress was associated with a lower aneurysm growth rate. Growth rate was also positively related to MMP-9 plasma concentration (r=0.32). The average MMP-9 and CRP concentrations increased with increasing degrees of relative wall stress, although the absolute and relative wall stress did not correlate with any of the biomarkers. CONCLUSION: Although lower relative wall stress was associated to a lower AAA growth rate, no relation was found between biomarker concentrations and wall stress. Future research may focus on more and extensive biomarker measurements in relation to AAA wall stress.

Assessment of behavioral determinants influencing success of supervised exercise therapy in patients with intermittent claudication: A cross sectional survey.

BACKGROUND: Supervised exercise therapy is the first step in treatment of intermittent claudication. However, adherence to supervised exercise therapy is low. Limited access and reimbursement issues are known reasons, though lack of motivation is often leading. Behavioral determinants influencing motivation and thus adherence to supervised exercise therapy remain to be investigated. In this study we sought to determine which behavioral determinants would be of influence on the long-term adherence of supervised exercise therapy. METHODS: 200 patients, newly diagnosed with peripheral arterial disease Rutherford classification II-III, were sent a questionnaire to assess motivation and behavior with regard to supervised exercise therapy. The questionnaire was constructed using the I-CHANGE model for explaining motivational and behavioral change. Baseline characteristics were acquired from medical records. Alpha Cronbach's was calculated to test reliability of the questionnaire. RESULTS: 108 (54%) patients returned their questionnaire. A total of 79% patients followed supervised exercise therapy. Patients who increased their walking distance after supervised exercise therapy have significantly greater knowledge (p = 0.05), positive attitude (p = 0.03) and lower negative attitude (p = 0.01). Patients with a higher self-efficacy remained significantly more active after participating in supervised exercise therapy (p = 0.05). CONCLUSION: Increasing the determinants knowledge, attitude and self-efficacy will improve adherence to supervised exercise therapy and result in delayed claudication onset time.

Thoracoabdominal aortic aneurysm repair in patients with marfan syndrome.

OBJECTIVE: We assessed the surgical outcome of descending thoracic aortic aneurysm repair (DTAA) and thoracoabdominal aortic aneurym (TAAA) repair in patients with Marfan syndrome. METHODS: During a six year period, 206 patients underwent DTAA and TAAA repair. In 22 patients, Marfan syndrome was confirmed. The median age was 40 years with a range between 18 and 57 years. The extend of the aneurysms included 6 DTAA (1 with total arch, 2 with distal hemi-arch), 11 type II TAAA (2 with total arch, 3 with distal hemi-arch), 4 type III and one type IV TAAA. All patients suffered from previous type A (n=6) or type B (n=16) aortic dissection and 15 already underwent aortic procedures like Bentall (n=7) and ascending aortic replacement (n=8). All patients were operated on according to the standard protocol with cerebrospinal fluid drainage, distal aortic and selective organ perfusion and monitoring motor evoked potentials. In patients undergoing simultaneous arch replacement (via left thoracotomy), transcranial Doppler and EEG assessed cerebral physiology during antegrade brain perfusion. In four patients circulatory arrest under moderate hypothermia was required. RESULTS: In-hospital mortality did not occur. Major postoperative complications like paraplegia, renal failure, stroke and myocardial infarction were not encountered. Mean pre-operative creatinine level was 125mmol/L, which peaked to a mean maximal level of 130 and returned to 92mmol/L at discharge. Median intubation time was 1.5 days (range 0.33-30 days). Other complications included bleeding requiring surgical intervention (n=1), arrhythmia (n=2), pneumonia (n=2) and respiratory distress syndrome (n=1). At a median follow-up of 38 months all patients were alive. Using CT surveillance, new or false aneurysms were not detected, except in one patient who developed a visceral patch aneurysm six years after open type II repair. CONCLUSION: Surgical repair of descending and thoracoabdominal aortic aneurysms provides excellent short- and mid-term results in patients with Marfan syndrome. In this series, a surgical protocol with cerebrospinal fluid drainage, distal aortic and selective organ perfusion and monitoring motor evoked potentials resulted in low morbidity and absent mortality. These outcomes of open surgery should be considered when discussing endovascular aneurysm repair in Marfan patients.

Patient-specific AAA wall stress analysis: 99-percentile versus peak stress.

OBJECTIVE: Biomechanically, rupture of an Abdominal Aortic Aneurysm (AAA) occurs when the stress acting on the wall due to the blood pressure, exceeds the strength of the wall. Peak wall stress estimations, based on CT reconstruction, may be prone to observer variation. This study focuses on the robustness and reproducibility of AAA wall stress assessment and the relation with geometrical features of the AAA. METHODS: The AAAs of twenty patients were reconstructed by three operators. Both the peak and 99-percentile stress were used for intra- and inter-operator variability using the intraclass correlation coefficient (ICC). A regression analysis was performed to relate the stress parameters with the maximum diameter. Outliers were analyzed by their geometrical characteristics. RESULTS: The intra-operator ICC was 0.73-0.79 for the peak stress and 0.94 for the 99-percentile stress. The inter-operator ICC was 0.71 for the peak stress and 0.95 for the 99-percentile stress. A significant linear relation with the diameter was found only for the 99-percentile stress. CONCLUSIONS: The 99-percentile stress is more reproducible than peak wall stress. A significant relation between wall stress and diameter was found. Other geometrical features had no statistical relation with high stress.

Surgical repair of thoracoabdominal aortic aneurysms.

Morbidity and mortality following thoracoabdominal aortic aneurysm (TAAA) repair are tremendous. Preoperative assessment is essential in detecting cardiac and pulmonary risk factors in order to reduce cardiopulmonary complications. Paraplegia and renal failure are main determinants of postoperative mortality and therefore gained substantial attention during the last decades. Left heart bypass, cerebrospinal fluid (CSF) drainage and epidural cooling have significantly reduced paraplegia rate, however, this dreadful event still occurs in up to 25% of patients undergoing type II repair. Renal failure has been partly prevented by means of retrograde aortic perfusion and cooling but renal failure still remains a significant problem. We have evaluated the effects of protective measures aiming for reduction of paraplegia and renal failure. Monitoring motor evoked potentials (MEPs) is an accurate technique to assess spinal cord integrity during TAAA repair, guiding surgical strategies to prevent paraplegia. Selective volume- and pressure controlled perfusion is a technique to continuously perfuse the kidneys during aortic cross clamping and subsequent circulatory exclusion In patients with atherosclerotic thoracoabdominal aortic aneurysms, blood supply to the spinal cord depends on a highly variable collateral system. In our experience, monitoring MEPs allowed detection of cord ischemia, guiding aggressive surgical strategies to restore spinal cord blood supply and reduce neurologic deficit: overall paraplegia rate was less than 3%. We believe that these protective measures should be included in the surgical protocol of TAAA repair, especially in type II cases. Renal and visceral ischemia can be reduced significantly by continuous perfusion during aortic cross clamping in TAAA repair. Not only sufficient volume flow but also adequate arterial pressure appears to be essential in maintaining renal function.Obviously, endovascular modalities have been successfully applied in TAAA patients, the majority of which as part of hybrid procedures. Technological innovation will eventually cause a shift from open to minimal invasive surgical repair. At present, however, open surgery is considered the gold standard for TAAA repair, especially in (relatively) young patients and patients suffering from Marfan's disease.

Assessment of endoleak significance after endovascular repair of abdominal aortic aneurysms: a lumped parameter model.

The outcome of endovascular repair of abdominal aortic aneurysms (AAAs) is greatly compromised by the possible occurrence of endoleak. Previously, the causes and effects of endoleak on a patient-specific basis have mainly been investigated in experimental studies. In order to both reconcile and physically substantiate the various experimental findings, a lumped parameter model of an incompletely excluded AAA was developed. After experimental validation, the model was applied to study the effects on the intrasac pressure of the degree of endoleak, the degree of stent-graft compliance, and the resistance of a possible outflow tract formed by a branching vessel. It is concluded that the presence of endoleak leads to elevated intrasac pressure, the mean of which is mainly governed by the outflow tract resistance, while the pulse pressure is governed by both the endoleak resistance and the stent-graft compliance. Based on the agreement of the current results with previous findings, it is further concluded that the lumped parameter modelling method provides a useful numerical tool for validating experimental endoleak studies.

[Findings in 67 patients with recurrent or persistent symptoms after implantation of a disc prosthesis for low back pain]. / Bevindingen bij 67 patiënten met recidiverende of persisterende klachten na het plaatsen van een discusprothese wegens lage rugpijn.

OBJECTIVE: To determine the symptoms in patients who presented with persistent or recurrent backache or leg pain after implantation of an artificial disc prosthesis. DESIGN: Descriptive. METHOD: During the past II years in the Maastricht University Hospital (n=65) and the Utrecht University Medical Centre (n=2), 67 patients were seen with persistent or recurrent backache or leg pain in whom, an average of 53 months previously, one or more SB Charité-III lumbar-disc prostheses had been implanted elsewhere. The results were evaluated. RESULTS: The most prominent findings were: migration of the prosthesis (n=6); subsidence into the vertebra (n=35); disc degeneration at one or more neighbouring levels (n=34) and arthrosis of facet joints (n=24). In 9 cases, rupture of the metal wire around the polyethylene core was observed and in 5 cases there were radiological signs of polyethylene wear. Re-operation (spondylodesis) was generally unsatisfactory if the prosthesis was left in place. In 21 patients, the prosthesis was removed; all specimens showed polyethylene wear or rupture. CONCLUSION: Published results are mostly case series and suffer from observer bias; moreover, the benefits are moderate. Given the uncertain role ofdisc degeneration in patients with chronic backache, the real risk of complications and the uncertain advantages, the implantation ofa disc prosthesis is difficult to defend.

[Peripheral artery disease: clinical and cost comparison between duplex ultrasonography and contrast-enhanced magnetic resonance angiography--a multicenter randomized trial]. / De kosten en de effecten van magnetischeresonantieangiografie en duplexechografie bij patiënten met perifeer arterieel vaatlijden: een multicentrische gerandomiseerde studie.

OBJECTIVE: To determine the clinical and economic consequences of replacing duplex ultrasonography (DUS) by contrast-enhanced magnetic resonance angiography (CE-MRA) for the initial diagnostic work-up of patients with peripheral artery disease (PAD). DESIGN: Randomised multicentre study. METHOD: In the period from January 2002 to August 2003, consecutive patients with PAD were randomly assigned to CE-MRA or DUS. The primary outcome measure was the costs. Secondary outcome measures included the confidence with which the specialist could take a therapeutic decision on the basis of the imaging study, the change in disease severity, and the change in quality of life (QOL) assessed during 6 months of follow-up. In addition, all costs of imaging, therapeutic interventions and outpatient visits were calculated. RESULTS: After 6 months of follow-up the data on 352 patients were analysed. Use of CE-MRA reduced the number of additional vascular-imaging procedures by 42% ((69-40)/69) and the specialists felt more confident about their therapeutic decisions. The diagnostic costs of all imaging studies taken together were Euro 167,- higher, on average, in the CE-MRA group (p < 0.001). However, after 6 months of follow-up, no statistically significant differences were found between the two groups with regard to the change in disease severity, the QOL, or the total costs (p > 0.05). CONCLUSION: Based on these findings, a specialist that replaces DUS by CE-MRA will feel more confident about taking a therapeutic decision and will feel less need for additional imaging. However, the diagnostic costs were higher with CE-MRA.