Evaluation of a biocompatible sealant for on-demand repair of vascular defects—a chronic study in a large animal model

OBJECTIVES Existing surgical sealants fail to combine design requirements, such as sealing performance, on-demand activation and biocompatibility. The aim of this study was to compare the effectiveness and safety of the SETALIUM™ Vascular Sealant (SVS), a novel, on-demand activatable sealant, with the commercial sealant, BioGlue®, for the repair of vascular defects. METHODS In an in vivo porcine model, the use of SVS was compared with BioGlue, for sealing 2-mm defects of the carotid artery and jugular vein. Animals were followed for 7 days and 5 weeks (each time point and per experimental group, n = 4), respectively. The degree of stenosis and flow velocity was determined, and the local tissue response was evaluated. RESULTS In vivo incision closure succeeded in all cases, and SVS was superior in clinical usability, enabled by its on-demand activation. Unlike BioGlue, SVS use did not induce stenosis and was associated with physiological blood flow in all cases. Moreover, closure with SVS was associated with a low inflammatory reaction and no thrombus formation or intima proliferation, in contrast to BioGlue. CONCLUSIONS SVS demonstrated effective and rapid sealing of 2-mm vascular defects, with favourable biocompatibility compared to BioGlue. Thus, SVS seems to be an effective and safe vascular sealant.

Superficial vein thrombophlebitis – serious concern or much ado about little?

Superficial vein thrombophlebitis (SVTP) appears in two distinct forms: varicose vein thrombophlebitis (TP) represents the principal cause. It is characterized by a large thrombus in a varicose vein and a modest inflammatory process localized in the vessel surrounding but not in its wall. Rarely, SVTP affects a non-varicose vein. Abundant intima proliferation and media fibrosis with non-important thrombosis are the hallmark of this form which may be associated with a systemic disease. Although SVTP is perceived as trivial and benign coexistence of (mostly distal) deep venous thrombosis (DVT), propagation to popliteal or femoral DVT, and even pulmonary embolism (PE) have been reported. Data for prevalence vary greatly: 6–53% for coexistence, 2.6–15% for propagation, and 0–33% for (asymptomatic) PE. Risk factors for these complications are those known for DVT. SVTP is diagnosed in a clinical setting but ultrasonography is useful to check for concomitant DVT. Anticoagulant treatment is mandatory if DVT is present and thrombectomy should be considered in cases of thrombus propagation into the deep veins. Historical therapy of uncomplicated SVTP consists of compression with bandages or stockings and local or systemic anti-inflammatory agents. Low-molecular-weight heparin (LMWH) has been given in high-prophylactic doses and found equally effective when compared with anti-inflammatory agents and full-therapeutic dose LMWH. Prophylactic saphenous vein ligation alone was found less effective than conservative therapy. Ligation combined with stripping proved the potential of eliminating at once all problems associated with SVTP but was associated with a complication rate of 10% or higher. Careful patient selection and saphenous vein thrombectomy prior to stripping may be the clue for better results.