Long-term safety of Gadofosveset in clinical practice.

PURPOSE: The purpose of this study was to systematically search for long-term complications, including Nephrogenic Systemic Fibrosis (NSF), in patients who were previously administered the gadolinium-based contrast agent Gadofosveset at our institute. MATERIALS AND METHODS: All patients who were administered Gadofosveset at our institute between 2006 and 2009 were identified in our Radiological Information System (RIS). Clinical data such as cause of death during follow-up, and dermatological or nephrological diseases were systematically searched for in electronic patient records (EPR). RESULTS: During 2006-2009, Gadofosveset was administered a total of 67 times to 62 patients. One patient was unavailable for follow-up. The remaining 61 patients were followed up for up to 14 (median 12) years based on RIS and EPR data. There were 13 deaths among the 61 patients, all assessed as unrelated to Gadofosveset administration. No dermatological or renal disease suggestive of NSF, or potentially related to Gadofosveset administration, was found. At the time of examination, six patients were diagnosed with various stages of renal insufficiency, three of whom were on hemodialysis. Another three patients were diagnosed with renal insufficiency during the follow-up period, but none of these diagnoses were suspected to be related to the administration of Gadofosveset. CONCLUSIONS: Based on the results of this retrospective safety analysis of up to 14 years following 1-2 exposures, we conclude that Gadofosveset in clinical practice is safe in the long-term.

Thoracic magnetic resonance venography using Gadofosveset in patients with venous pathology-A comparative study of image quality and inter-rater variability.

Background High-quality non-invasive imaging of the deep venous system in the thorax is challenging, but nevertheless required for diagnosis of vascular pathology as well as for patient selection and preoperative planning for endovascular procedures. Purpose To compare the diagnostic quality of Gadofosveset-enhanced thoracic magnetic resonance venography, seven consecutive patients with suspected or known disease affecting the central thoracic veins were compared to seven consecutive magnetic resonance venography using conventional gadolinium-based contrast agents. Materials and methods Diagnostic capability, defined as the ability to assess vessel patency and pathologic conditions, for the major thoracic deep venous segments was assessed by two-independent readers. Both reviewers rated the overall subjective image quality on a four-graded scale, and inter-rater variability was analyzed using unweighted and weighted Cohen's kappa values. Results Diagnostic capability was generally considerably higher in the Gadofosveset group for all examined vessel segments. The overall images quality rating was significantly higher for the Gadofosveset group with a mean rating of 2.9 and 2.7 for the two-independent readers, compared to 1.2 and 1.0 for the control croup. Inter-rater variability showed less variability for the Gadofosveset group with a quadratic-weighted Cohen's Kappa value of 0.58 compared to 0.36 for the control group. Conclusion Our results show that Gadofosveset-enhanced magnetic resonance venography of the central thoracic veins is a reliable technique in clinical routine practice that results in diagnostic images, superior to conventional gadolinium-based contrast medium.

Gadofosveset-enhanced magnetic resonance venography in patients with venous pathology of the lower limbs - Comparison of diagnostic image quality and inter-rater variability with gadobutrol venography and computed tomography venography.

Purpose This study was performed to compare the diagnostic quality of Gadofosveset-enhanced magnetic resonance venography with Gadobutrol-enhanced magnetic resonance venography and computed tomography venography for the deep veins of the lower extremities in patients with iliocaval venous pathology. Materials and methods Diagnostic capability and image quality were assessed by two independent readers. Inter-reader variability was analyzed by unweighted and quadratic weighted Cohen's kappa values. Results The diagnostic capability was equal to or higher in the Gadofosveset group for all examined vessel segments compared with both control groups. The image quality score was significantly higher for the Gadofosveset group compared to both control groups. Inter-reader variability expressed by quadratic weighted Cohen's kappa value (k) showed less variability in the Gadofosveset group compared to the control groups. Conclusion Our results show that Gadofosveset-enhanced magnetic resonance venography is a reliable technique in clinical routine practice, with image quality superior to both Gadobutrol-enhanced magnetic resonance venography and computed tomography venography.

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.

Chronic iliac vein occlusion: midterm results of endovascular recanalization.

PURPOSE: To evaluate patency and clinical outcome in patients treated with endovascular recanalization and stent placement for chronic iliac vein occlusions. METHODS: During a 14-year period (1994-2008), 59 (38 women; median age 39 years) of 62 patients with chronic occlusion of the iliac vein segment in 66 limbs were successfully treated with endovascular recanalization and stent placement. A prospectively maintained database was analyzed retrospectively to obtain information on clinical details, endovascular techniques, and outcome. RESULTS: Three (5%) procedures failed for technical reasons. Three (5%) complications occurred, 2 (3%) of which were perforations requiring transfusion and procedure termination. Initial clinical success after 6 months was achieved in 49 (83%) of the 59 patients successfully treated initially. Primary patency after a median imaging follow-up of 25 months was 67% (44/66), assisted primary patency was 75% (49/66), and secondary patency was 79% (52/66). Fifteen (23%) of 66 limbs were asymptomatic after a median clinical follow-up of 32 months, 34 (52%) limbs were improved, 13 (20%) were unchanged, and 4 (6%) were worse compared to before intervention. Actuarial primary, assisted primary, and secondary patency rates using Kaplan-Meier survival analysis were 70%, 73%, and 80%, respectively, at 5 years. CONCLUSION: Endovascular recanalization and stent placement is a safe and effective treatment for occluded iliac veins and adjacent segments. Clinical midterm results are encouraging. Recanalized and stented segments remain patent in the majority of patients after 2 years. Endovascular treatment can ease symptoms and prevent further deterioration of patients with post-thrombotic syndrome.

Kissing stents in the common femoral artery bifurcation for critical limb ischemia: technical description and report of three cases.

The purpose of this article is to describe three cases of kissing stent placement in the common femoral artery bifurcation in patients unsuitable for open endarterectomy and patch plasty. In three patients with critical limb ischemia, caused by primary atherosclerotic disease or dissection-related injury when performing a lower extremity intervention, a technique of kissing stents was used to treat the flow-obstructing lesion in the common femoral artery bifurcation. Technical success was uniform, and during follow-up (4.5-8 months), all patients showed improved symptoms, wound healing, and duplex ultrasonography-verified patency of the stents. Kissing stents in the common femoral artery bifurcation are a feasible treatment option in patients with limited mobililty or contraindications to open repair. The short-term results seem promising, but longer follow-up and an increased number of patients will be needed to assess the durability of the reconstruction.

Subintimal angioplasty of infrainguinal arterial occlusions for critical limb ischemia: long-term patency and clinical efficacy.

PURPOSE: To evaluate long-term patency and clinical efficacy of subintimal angioplasty (SAP) of occluded infrainguinal arteries 3 years post procedure. METHODS: One hundred eighty-one patients (92 men; median age 79 years) underwent attempted SAP in 193 limbs with occluded infrainguinal arteries during the period 1999 to 2001. Nearly half (83, 46%) of the patients had diabetes. Most (172, 95%) had critical ischemia (Fontaine classification>II). All patients surviving at least 3 years after the procedures were followed in January 2005 with questionnaires, clinical examinations, ankle-brachial index measurements, and duplex ultrasonography. All data were collected prospectively and analyzed retrospectively. RESULTS: The primary technical success in the entire cohort was 77% (148/193). Thirty-day mortality was 10% (19/181); 113 (62%) patients died before the 3-year follow-up. In the 68 (38%) survivors (71 limbs), patency at 49.2 months (IQR 40.8-57.6) was 40% (26/65 limbs imaged by duplex). The TASC classification did not affect technical or clinical outcomes. Forty-six (68%) of the survivors presented with clinical improvement (lower Fontaine classification at postoperative follow-up versus baseline). The limb salvage at >3 years was 86% in the 58 primarily successful SAPs and 38% in the 13 procedures that failed initially. CONCLUSION: SAP is a minimally invasive option for patients with critical limb ischemia. A primary technical success is essential for good clinical outcome and primary technical failure is more devastating than late occlusion. TASC classification and length of the SAP are of poor predictive value. More data are needed to confirm the efficacy of SAP.