15 research outputs found

    Therapeutic angiogenesis with intramuscular NV1FGF improves amputation-free survival in patients with critical limb ischemia

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    This study evaluated the efficacy and safety of intramuscular administration of NV1FGF, a plasmid-based angiogenic gene delivery system for local expression of fibroblast growth factor 1 (FGF-1), versus placebo, in patients with critical limb ischemia (CLI). In a double-blind, randomized, placebo-controlled, European, multinational study, 125 patients in whom revascularization was not considered to be a suitable option, presenting with nonhealing ulcer(s), were randomized to receive eight intramuscular injections of placebo or 2.5 ml of NV1FGF at 0.2 mg/ml on days 1, 15, 30, and 45 (total 16 mg: 4 Ă— 4 mg). The primary end point was occurrence of complete healing of at least one ulcer in the treated limb at week 25. Secondary end points included ankle brachial index (ABI), amputation, and death. There were 107 patients eligible for evaluation. Improvements in ulcer healing were similar for use of NV1FGF (19.6%) and placebo (14.3%; P = 0.514). However, the use of NV1FGF significantly reduced (by twofold) the risk of all amputations [hazard ratio (HR) 0.498; P = 0.015] and major amputations (HR 0.371; P = 0.015). Furthermore, there was a trend for reduced risk of death with the use of NV1FGF (HR 0.460; P = 0.105). The adverse event incidence was high, and similar between the groups. In patients with CLI, plasmid-based NV1FGF gene transfer was well tolerated, and resulted in a significantly reduced risk of major amputation when compared with placebo

    Centrifugal Pump and Reduction of Neurological Risk in Adult Cardiac Surgery

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    This study was performed to assess if the kind of pump used for CPB (roller vs. centrifugal) can influence neurological outcomes of adult cardiac surgery patients. Between 1994 and 1998, 3438 patients underwent coronary and/or valve surgery at our hospital; of these, 1805 (52.5%) underwent surgery with the use of a centrifugal pump, and 1633 (47.5%) were operated with a roller pump. The effect of the type of the pump and of common preoperative and intraoperative risk factors for five different neurological outcomes (permanent neurological deficit, coma, delirium, transient neurological deficit, overall neurological complications) were assessed with univariate and multivariate analyses in the whole patients population, in patients ≥ 75 years old and in patients with histories of previous neurological events. Centrifugal pump use was the only protective factor for perioperative permanent neurological deficit in multivariable models developed for the whole patient population and for patients ≥ 75 years old. In addition, it resulted as the only protective factor for perioperative coma occurrence in multivariable models developed for patients ≥ 75 years old, and for patients with histories of previous neurological events. The use of the centrifugal pump provided a risk reduction for the considered events ranging from 23 to 84%. Centrifugal pump use can be helpful in reducing the occurrence of some of the most feared neurological complications of adult cardiac surgery patients

    Effect of cryopreservation techniques on aortic valve glycosaminoglycans

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    This study was designed to evaluate the effect of cryopreservation on the glycosaminoglycan (GAG) content of the aortic allografts. Twenty-one porcine aortic valves were obtained. Five aortic roots were immediately analyzed without cryopreservation, eight were cryopreserved in closed leaflet position, and eight in open leaflet position. The groups were compared in terms of GAG concentration and subclass proportion in three different zones including the aortic root wall, the commissures, and the leaflets. GAG content at the commissures was significantly lower in the closed leaflet group than in the other groups (P = 0.001). The electrophoretic analysis did not show any significant difference in the zonal distribution of GAG classes between groups. Quantitative analysis in various aortic valve zones suggests that cryopreservation can alter the GAG content. Cryopreservation of the aortic valve in an open leaflet position can preserve the matrix more efficiently and might prolong the durability of the aortic allograft
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