Biomedical subjects

Eugene R Heyman

Publications and source records attributed to Eugene R Heyman.

3 recordsLinked to original sources

PubMed2006

Prospective randomized study evaluating an absorbable cyanoacrylate for use in vascular reconstructions.

BACKGROUND: An easy-to-use vascular sealant with good safety and efficacy is needed to prevent anastomotic bleeding in vascular surgery. This study evaluated the safety and efficacy of cyanoacrylate surgical sealant in establishing hemostasis of expanded polytetrafluoroethylene to arterial vascular anastomoses in arteriovenous (AV) grafts and femoral bypass grafts. METHODS: This multicenter, randomized, controlled, open-label study was conducted in a hospital setting at 12 sites: 10 in the United States and 2 in Europe. A total of 151 patients undergoing femoral bypass procedures or AV shunt procedures for hemodialysis access using expanded polytetrafluoroethylene grafts were randomized 2:1 to receive cyanoacrylate surgical sealant or the control (oxidized cellulose) between April 26, 2004, and January 18, 2005. Randomization was stratified by clinical site and type of procedure. After the anastomosis, cyanoacrylate surgical sealant or the control was applied to all anastomosis sites for patients undergoing femoral bypass procedures and to only the arterial anastomosis sites for patients undergoing AV shunt procedures. The primary end point was the elapsed time from clamp release to hemostasis. Secondary end points were the proportion of patients achieving hemostasis at t = 0 (immediate), 1, 5, or 10 minutes after clamp release, use of additional adjunctive measures to achieve hemostasis, and occurrence of adverse events. RESULTS: Baseline demographics and clinical characteristics showed that the two treatment groups were similar at baseline. The mean time from clamp release to hemostasis was 119.3 seconds with cyanoacrylate surgical sealant vs 403.8 seconds with the control (P < .001). Immediate hemostasis was achieved in 54.5% of patients receiving cyanoacrylate surgical sealant and in 10% of those receiving the control. The proportion of patients requiring additional adjunctive measures was lower with cyanoacrylate surgical sealant, and the occurrence of adverse events was similar in both groups. CONCLUSIONS: This study demonstrates that cyanoacrylate surgical sealant is effective at reducing the time to hemostasis and achieving immediate hemostasis in AV shunt and femoral bypass procedures and that it is safe for internal use. Cyanoacrylate surgical sealant is an easy-to-use vascular sealant with good safety and efficacy that significantly decreases anastomotic bleeding in vascular surgery.

Arterial Occlusive Diseases↗

PubMed2003

Recombinant variant of ciliary neurotrophic factor for weight loss in obese adults: a randomized, dose-ranging study.

CONTEXT: Obese individuals tend to resist the weight-regulating effects of exogenously administered leptin. A genetically engineered recombinant human variant ciliary neurotrophic factor (rhvCNTF) that signals through leptinlike pathways in the hypothalamus has been shown to bypass leptin resistance in animal models of obesity. OBJECTIVE: To identify a safe and well-tolerated dose of rhvCNTF that causes weight loss in obese adults. DESIGN, SETTING, AND PATIENTS: Twelve-week, double-blind, randomized, parallel-group, dose-ranging, multicenter clinical trial conducted at 2 university obesity clinics and at 5 independent clinical research clinics from March 2000 to August 2001, and including 173 nondiabetic obese adults, 82.6% of whom were women, with a mean (SD) body mass index of 41.1 (4.1). INTERVENTIONS: Patients were randomly assigned to receive daily for 12 weeks subcutaneous injections of placebo (n = 32) or 0.3 microg/kg (n = 32), 1.0 microg/kg (n = 38), or 2.0 microg/kg (n = 33) of rhvCNTF. Another group received 1.0 microg/kg for 8 weeks and placebo for 4 weeks (n = 38), but they were not included in the primary analysis. All participants received instructions for a reduced-calorie diet (World Health Organization formula minus 500 kcal/d). MAIN OUTCOME MEASURES: Change in weight during the 12-week double-blind treatment period and proportion of patients who achieved a weight loss of at least 5%. RESULTS: Of the 173 randomized patients, 123 (71%) completed the double-blind dosing period. Mean (SEM) changes in kilograms from baseline body weights were 0.1 (0.6) for placebo and -1.5 (0.6) for the 0.3, -4.1 (0.6) for the 1.0, and -3.4 (0.7) for the 2.0 microg/kg of rhvCNTF dosage groups (P<.001, test for trend). Two patients (8.7%) in the placebo and 2 (8.3%) in the 0.3- microg/kg, 8 (29.6%) in the 1.0- microg/kg, and 5 (26%) in the 2.0- microg/kg treatment groups achieved a weight loss of at least 5%. Recombinant human variant CNTF was generally well tolerated although adverse events occurred in 75% of patients receiving placebo and 78% to 93% of patients receiving rhvCNTF, in a dose-related fashion, with mild injection site reactions as the most frequently reported adverse event. CONCLUSIONS: In this initial, dose-ranging, 12-week study, treatment with rhvCNTF resulted in more weight loss than placebo. These preliminary findings require confirmation in large prospective clinical trials.

Adult↗

PubMedDate not supplied

Extracorporeal shockwave therapy versus placebo for the treatment of chronic proximal plantar fasciitis: results of a randomized, placebo-controlled, double-blinded, multicenter intervention trial.

Extracorporeal shockwave therapy (ESWT) has demonstrated efficacy in the treatment of recalcitrant proximal plantar fasciitis. The objective of this investigation was to compare the outcomes of participants treated with a new ESWT device with those treated with placebo. A total of 172 volunteer participants were randomized in a 2:1 active-to-placebo ratio in this prospective, double-blind, multicenter trial conducted between October 2003 and December 2004. ESWT (n=115) or placebo control (n=57) was administered on a single occasion without local or systemic anesthesia or sedation, after which follow-up was undertaken. The primary outcomes were the blind assessor's objective, and the participant's subjective assessments of heel pain during the first 3 months of follow-up. Participants were also followed up to 1 year to identify any adverse outcomes that may have been related to the shockwave device. On the visual analog scale, the blind assessor's objective assessment of heel pain displayed a mean reduction of 2.51 in the shockwave group and 1.57 in the placebo group; this difference was statistically significant (P=.045). On the visual analog scale, the participant's self-assessment of heel pain displayed a mean reduction of 3.39 in the shockwave group and 1.78 in the placebo group; this difference was statistically significant (P<.001). No serious adverse events were observed at any time. It was concluded that ESWT was both efficacious and safe for participants with chronic proximal plantar fasciitis that had been unresponsive to exhaustive conservative treatment.

Chronic Disease↗