Safety aspects of gadofosveset in clinical practice--analysis of acute and long-term complications.

PURPOSE: The purpose of this retrospective study was to systematically search for acute adverse reactions and long-term complications in all patients that had been administered gadofosveset at our hospital. MATERIALS AND METHODS: We identified 67 gadofosveset administrations during 2006-2009 in 62 patients from 8 to 84years of age. Radiological information system (RIS) and clinical patient records were analyzed for suspected acute adverse reactions and long-term complications including nephrogenic systemic fibrosis (NSF). The gadofosveset doses ranged between 0.024 and 0.060mmol/kg bodyweight with a mean dose of 0.031-mmol/kg bodyweight. Follow-up time of the patients ranged from less than 1year up to 4years with a mean follow-up time of 2.1years. RESULTS: No acute adverse events or technical failures related to the contrast medium were recorded in the RIS. No dermatological and nephrological diseases related to the gadofosveset administration were found in the clinical patient records. Four patients died during follow-up without any apparent relation to the gadofosveset exposure. CONCLUSIONS: Based on our clinical material we conclude that gadofosveset is safe for a mixed patient population with no acute adverse events or any indications of long-term complications during the follow-up time up to four years.

The value of tomographic ventilation/perfusion scintigraphy (V/PSPECT) for follow-up and prediction of recurrence in pulmonary embolism.

BACKGROUND: Pulmonary embolism (PE) is diagnosed with imaging techniques such as ventilation/perfusion (V/P) lung scintigraphy or multidetector computed tomography of the pulmonary arteries (MDCT). Lung scintigraphy can be performed with planar (V/P PLANAR) and tomographic (V/P SPECT) techniques. V/P SPECT has higher sensitivity and specificity than V/P PLANAR. As nephrotoxic contrast media are not used during V/P SPECT, examinations can be repeated for evaluation of resolution of perfusion defects after PE. However, the value of residual perfusion defects identified using V/P SPECT for the prediction of recurrent PE has not been thoroughly evaluated. MATERIAL AND METHODS: We evaluated resolution and recurrence of PE in 227 patients (mean age 63 ± 17 years, 134[59%] women) with PE undergoing ≥ 2 SPECT examinations in 2005-2007. PE was defined as minor (<20% perfusion defect on SPECT, n=86), medium (20-50% perfusion defect on SPECT, n=99), or major (>50% perfusion defect on SPECT, n=42). RESULTS: At second V/P SPECT examination, complete resolution of perfusion defects had occurred in 45 (52%) patients with minor PE after 8.2 ± 7.4 months, in 29 (29%) of patients with medium PE after 6.2 ± 5.9 months, and in 2(5%) of patients with major PE after 6.5 ± 0.7 months. During 47 ± 24 months of follow up, 37(16 %) patients suffered recurrent PE. Of these 37, 34 (92%) showed residual perfusion defects at the second V/P SPECT examination. Recurrence of PE was also predicted by advanced age and female gender. However, in multivariate regression analysis, recurrence was only predicted by age (p=0.0013) and residual perfusion defect on V/P SPECT (p=0.0039). CONCLUSION: In conclusion, complete resolution of PE was common in patients with minor PE, whereas residual perfusion defects were widespread in patients with medium and major PE. PE patients identified with persistent perfusion defects at follow-up SPECT have a high risk of PE recurrence.

Erythromelalgia: Incidence and clinical experience in a single centre in Sweden.

BACKGROUND: Erythromelalgia (EM) incidence has not been well studied and there are only two studies published on this subject as far as we know. The aims are to study the incidence of this rare condition in the south of Sweden, to report the clinical experience from a single centre including characterisation of comorbidity and to report on prognosis. PATIENTS AND METHODS: Retrospective study of a population-based analysis of data from the southernmost part of Sweden corresponding to the median age of the patients (Statistics Sweden). The diagnosis of EM is based on the medical record reflecting the triad of redness, burning pain and increased temperature of the feet or hands or both. We evaluated the presence or absence of EM triad by recording the history, physical examination, laboratory analysis, cold provocation test and laser Doppler imaging, and by searching for any confounding disease in cases of suspected EM. RESULTS: During a 10.5 year period we clinically identified 27 patients with EM. Median age was 49 [IQR (34 - 68)] years, 19 (70 %) were women. The mean delay from the onset of the symptoms to the time of diagnosis was 4.5 (SD ± 3.9) years. Gender and age adjusted incidence of EM for our region was calculated to be 0.36 per 100 000 persons per year. Three patients developed intraabdominal cancer during the follow up, but there was no mortality directed related to EM. CONCLUSIONS: The overall population-based incidence of erythromelalgia was 0.36 per 100 000 which is identical with a previous report in a Scandinavian population.

Incidence of nephrogenic systemic fibrosis at a large university hospital in Sweden.

OBJECTIVE: Nephrogenic systemic fibrosis (NSF) is a rare condition that may follow administration of gadolinium-based contrast media (Gd-CM) in patients with renal insufficiency. This study was initiated to determine the incidence of NSF at Skåne University Hospital, Malmö, in Sweden. MATERIAL AND METHODS: During the period January 2001 to December 2008 10 650 patients underwent magnetic resonance imaging (MRI) examinations. The re-expressed four-variable Modification of Diet in Renal Disease (MDRD) equation was used to calculate the estimated glomerular filtration rate (eGFR). The 272 patients with an eGFR <30 ml/min/1.73 m2 who were given Gd-CM were selected for final analysis. A diagnosis of NSF or other dermatological diagnoses in the 272 patients was searched for in the database of the Departments of Dermatology and Pathology. RESULTS: The 272 patients, of whom 26 patients were on dialysis, had undergone 406 MRI examinations with Gd-CM. Mean follow-up time was 3.9 (±2.7 SD) years. Assuming a mean body weight of 70 kg, the overall median dose of the 406 examinations with Gd-CM was 0.14 mmol/kg body weight (0.06, 0.34; 2.5-97.5 percentiles). In this retrospective study of patients with eGFR <30 ml/min/1.73 m(2), none developed NSF (the upper 95% confidence limit for zero cases of NSF in the 272 patients was 2.3%). CONCLUSION: Although it is premature to claim that Gd-CM using the regimen employed in this institution is safe to use in all patients with eGFR <30 ml/min/1.73 m(2), the results.indicate that development of NSF is extremely uncommon.

Iliocaval vein stenting: Long term survey of postthrombotic symptoms and working capacity.

To evaluate the long term effect on lower extremity function and working capacity after stenting of iliocaval vein segments for acute deep venous thrombosis (DVT) or chronic venous occlusive disease. During a 14 year period from November 1994 to October 2008, 114 patients with median age 36 (interquartile range [IQR], 27-48) years, 72 (63%) women, 72 (63%) with hypercoagulable disorders, with acute DVT (n = 44, 39%), or chronic occlusions (n = 70, 61%) in the iliocaval vein segment were treated with venous stent placement after catheter-directed thrombolysis, angioplasty or recanalization. The long term impact on lower extremity function and working capacity was evaluated through retrospective evaluation of a prospectively registered database in combination with a questionnaire sent to all 108 surviving patients. The questionnaire was returned by 91/108(84%) patients, 37 (86%) with acute DVT, and 54(83%) with chronic venous occlusions. After a median follow-up of 6.2 (IQR 3.8-10.5) years, 38 (42%) patients were without anticoagulation therapy. Among patients with acute DVT 29 (78%) reported no lower extremity pain, 31 (84%) reported no ulcerations, and 26 (70%) were without lower extremity swelling, and 33(89%) without pelvic or genital pain. In summary, 22 (59%) were free from any symptomatic postthrombotic symptoms (PTS). Among patients with chronic occlusions, corresponding figures were 22 (41%), 45 (80%), 13 (24%), 39 (72%), and 7 (13%). Among patients treated for acute DVT 27 (73%) were working full- or part time, and 2 (5%) were above retirement age. Corresponding figures among patients treated for chronic venous occlusions were 31 (57%), and 10 (19%). Stenting of iliocaval vein segments with or without catheter-directed thrombolysis is a promising treatment of both acute thrombosis and chronic iliocaval vein occlusion that requires further study in comparison to non-interventional treatment concerning long time effects on postthrombotic symptoms and working capacity.

Pulmonary embolism associated with protein C deficiency and abuse of anabolic-androgen steroids.

We present the case of a 19-year-old male athlete with protein C deficiency who developed proximal deep venous thrombosis and pulmonary embolism while abusing anabolic-androgenic steroids. Anabolic-androgenic steroids have been reported to have anticoagulatory and profibrinolytic effects in patients with protein C deficiency. Despite these antithrombotic effects, the patient developed repeated venous thromboembolism during treatment with low-molecular-weight heparin. The net effect of anabolic-androgenic steroids on the haemostatic system may change from antithrombotic to prothrombotic in male abusers of anabolic steroids with protein C deficiency.

Thrombus embolization into IVC filters during catheter-directed thrombolysis for proximal deep venous thrombosis.

PURPOSE: To assess the frequency of embolization into retrievable inferior vena cava (IVC) filters during catheter-directed thrombolysis (CDT) and stent placement for acute iliocaval deep venous thrombosis (DVT). METHODS: Serial phlebograms from 40 patients (28 women; median age 32 years) consecutively treated with CDT for DVT during a 12-year period were retrospectively evaluated for visible emboli in the IVC filter. Clinical and procedural data extracted from a prospectively maintained database were evaluated to identify predictors for embolization into the filter. RESULTS: Visible emboli were found in 18 (45%) patients. Visible embolization to the IVC filter was less frequent in patients with a hypercoagulable disorder (n = 29, 31%) than in patients without a hypercoagulable disorder (n = 11, 69%; OR 0.1, 95% CI 0.02 to 0.56, p = 0.006). No patient developed clinical symptomatic pulmonary embolism or a complication related to the placement or retrieval of the IVC filter. CONCLUSION: Thrombus embolization during CDT is a common phenomenon in patients with proximal DVT. Placement of a retrievable IVC filter during thrombolytic therapy can prevent silent and symptomatic pulmonary embolism.

Renal angioplasty causes a rapid transient increase in inflammatory biomarkers, but reduced levels of interleukin-6 and endothelin-1 1 month after intervention.

OBJECTIVE: To examine prospectively whether inflammatory biomarkers and endothelin (ET)-1 are increased in patients with renal artery stenosis (RAS), and to investigate how treatment with percutaneous transluminal renal angioplasty (PTRA) affects these variables during the first month after intervention. METHODS: One hundred patients with suspected RAS undergoing renal angiography were included. PTRA was performed if the trans-stenotic mean arterial pressure gradient was>or=10 mmHg. High-sensitivity C-reactive protein (hs-CRP), interleukin-6 (IL-6), tumor necrosis factor-alpha (TNFalpha), neopterin, CD40 ligand (CD40L) and endothelin-1 (ET-1) were measured before, and 1 day and 1 month after PTRA (n=61) or diagnostic angiography only (n=39). RESULTS: At baseline there were no significant differences in inflammatory biomarkers or ET-1 levels between patients subsequently undergoing PTRA or angiography only. After angiography, IL-6 and hs-CRP had increased in both groups compared to baseline (P<0.001). At this time point hs-CRP (10.90+/-1.48 versus 6.37+/-1.61 mg/l; P<0.05) and IL-6 (13.70+/-0.94 versus 13.00+/-0.17 pg/ml; P<0.01) were higher in the PTRA group than in patients subjected to angiography only. One month after PTRA, systolic blood pressure and levels of IL-6 and ET-1 were lower than before intervention (P<0.05), whereas CD40L had increased compared to baseline (P<0.01). CONCLUSION: In patients with RAS, PTRA triggers rapid transient increases in hs-CRP and IL-6; however, 1 month after PTRA, both IL-6 and ET-1 had decreased compared to before intervention, indicating beneficial effects of PTRA on inflammation and the endothelin system.

[Vena cava filters in complicated venous thromboembolism. Ten years' experiences at Malmo University Hospital]. / Vena cava-filter vid komplicerad venös tromboembolisk sjukdom. Tio års erfarenheter från Universitetssjukhuset MAS.

All 74 patients treated with vena cava filter insertion during 1991-2000 at Malmö University Hospital were reviewed. Thirty-nine patients (53%) died during follow-up. Indications for permanent filter insertion (n = 63, age 25-89 years, 35 men) were contraindication for or side effects of anticoagulant treatment, or pulmonary embolism during anticoagulant treatment. Temporary vena cava filters (n = 11, age 19-85 years, three men) were inserted during surgery or thrombolysis. No complications occurred during temporary filter insertion. During 33 (1-120) months of follow-up of patients with permanent vena cava filters 37 patients (59%) died, thrombosis of the inferior vena cava occurred in 14 patients (22%), and recurrent pulmonary embolism in five patients (8%). Vena cava filter insertion should be considered as an alternative treatment in a selected group of patients with contraindications to or insufficient effect of anticoagulant treatment.