Bovine thrombin is used as an aid to hemostasis in medical and surgical procedures. At least 500,000 Americans are exposed to this therapeutic annually and reports suggest that exposure is associated with the development of autoreactive antibodies. To determine whether bovine thrombin can induce pathological autoimmunity we exposed nonautoimmuneprone galactose-␣1-3-galactose-deficient mice to the two bovine thrombin preparations currently approved for use in the United States. We found that, like humans exposed to bovine thrombin, mice developed an immune response against the therapeutic and the xenogeneic carbohydrate galactose-␣1-3-galactose, and some mice developed autoantibodies against clotting factors. Further, unexpectedly, a single exposure to this therapeutic also induced autoimmunity with features characteristic of systemic lupus erythematosus including antibodies against nuclear antigens, native DNA, double-stranded DNA, and cardiolipin. High levels of these autoantibodies correlated with glomerulonephritis in all mice evaluated. This autoimmune syndrome was detected in mice 15 weeks after a secondary exposure to bovine thrombin and female mice were found to develop the syndrome at a significantly greater frequency than males. Thus, these studies indicate that exposure to bovine thrombin preparations can induce a pathological systemic autoimmune syndrome with lupus-like serology.
This study demonstrates that SIA of iliac CTOs is feasible and can be performed safely and effectively, even in high-risk patients. Excellent patency and limb salvage rates can be achieved. In our experience, the safety and durability of SIA makes it an attractive first-line therapy for iliac artery occlusive disease.
Background: This randomized prospective study compared the treatment of superficial femoral artery occlusive disease percutaneously with an expanded polytetrafluoroethylene (ePTFE)/nitinol self-expanding stent graft vs surgical femoral to above knee popliteal artery bypass with synthetic graft material.Methods: One hundred limbs in 86 patients with superficial femoral artery occlusive disease were evaluated from March 2004 to May 2005. Patient symptoms included claudication and limb-threatening ischemia with or without tissue loss. Trans-Atlantic InterSociety Consensus (TASC II) A (n ϭ 18), B (n ϭ 56), C (n ϭ 11), and D (n ϭ 15) lesions were included. Patients were randomized prospectively into a percutaneous treatment group (group A; n ϭ 50) with angioplasty and placement of one or more stent grafts or a surgical treatment group (group B; n ϭ50) with a femoral to above knee popliteal artery bypass using synthetic conduit (Dacron or ePTFE). Patients were followed up for 48 months. Follow-up evaluation included clinical assessment, physical examination, ankle-brachial indices (ABI), and color flow duplex ultrasound imaging at 3, 6, 9, 12, 18, 24, 36, and 48 months. Results: Mean (standard deviation) total lesion length of the treated arterial segment in the stent graft group was 25.6 (15) cm. The stent graft group demonstrated a primary patency of 72%, 63%, 63%, and 59% with a secondary patency of 83%, 74%, 74%, and 74% at 12, 24, 36, and 48 months, respectively. The surgical femoral-popliteal group demonstrated a primary patency of 76%, 63%, 63%, and 58%, with a secondary patency of 86%, 76%, 76%, and 71% at 12, 24, 36, and 48 months, respectively. No statistical difference was found between the two groups with respect to primary (P ϭ .807) or secondary patency (P ϭ .891). A statistical difference was found in limb salvage and amputation-free survival at 48 months, however, with limb salvage rates of 98% in the stent graft group and 84% in the surgical group (P ϭ .039).Conclusions: Management of superficial femoral artery occlusive disease with percutaneous stent grafts exhibits similar primary patency at 4-year (48-month) follow-up compared with conventional femoral-popliteal artery bypass grafting with synthetic conduit. This treatment method may offer an alternative to treatment of the superficial femoral artery segment for revascularization when a prosthetic bypass is being considered or when autologous conduit is unavailable.
Objectives: Endovascular revascularization (ER) is currently the preferred treatment method in patients with chronic mesenteric ischemia (CMI). The aim of this study was to compare differences in clinical characteristics, anatomy, and outcomes in patients treated with open mesenteric revascularization (OR) before and after the endovascular era.Methods: Two-hundred and forty-one patients treated for CMI (51.8% ER; 48.2% OR) between 1998 and 2009 were entered into a prospective database. Since 2002, ER was used in 102 patients (63.8%) and OR in 58 (36.3%) because ER was not possible, failed, or the patient had unfavorable lesions. We reviewed the clinical data and outcomes of patients treated with OR before (group A) and after (group B) the preferential use of ER in 2002. Computed tomography angiography with centerline measurement and conventional angiography were used to assess differences in anatomy.Results: OR was used to treat 58 patients in group A and 58 in group B. Both groups had similar demographics, risk factors, and clinical presentation, with the exception of more (P Ͻ .05) cardiac interventions, dysrhythmias, abdominal pain, and food fear in group B. Patients in group B had more extensive disease, including more superior mesenteric artery (SMA) occlusions (45% vs 67%, P ϭ .02). There were no differences in operative mortality (1.7% vs 3.4%), complications (43% vs 53%), and length of stay (both 12 Ϯ 1 days) for group A and B, respectively (P ϭ NS). Symptom improvement was noted in 88% of group A patients and in 86% of group B patients (P ϭ NS). Mean follow up was 56 Ϯ 7 months in group A and 22 Ϯ 3 months in group B (P Ͻ .01). At 1-year, there were no differences in patency and recurrence rates between groups.Conclusions: Open mesenteric revascularization is currently indicated in about 36% of patients with CMI. Despite the presence of more extensive mesenteric disease in patients currently treated with OR, outcomes have not changed compared with those achieved before the preferential use of mesenteric stents.
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