A comparison of recombinant thrombin to bovine thrombin as a hemostatic ancillary in patients undergoing peripheral arterial bypass and arteriovenous graft procedures.

OBJECTIVES: Recombinant thrombin (rThrombin) is a potential hemostatic alternative to bovine and human plasma-derived thrombin. This report examines the clinical results for the vascular surgery subgroup of patients enrolled in a larger double-blind, randomized, multicenter trial, which evaluated the comparative safety and efficacy of rThrombin and bovine plasma-derived thrombin (bThrombin) when used as adjuncts to surgical hemostasis. METHODS: Data from the 164 vascular patients who underwent either a peripheral arterial bypass (PAB) or arteriovenous graft (AV) procedure are included in this analysis. Time to hemostasis at proximal and distal anastomotic sites at 1.5-, 3-, 6-, and 10-minute intervals was determined by procedure (PAB or AV) and overall (PAB + AV). Baseline and day 29 immunologic sera were analyzed. The incidences of postoperative adverse events were compared between treatment groups. Categorical adverse events were evaluated in relation to thrombin product antibody formation. RESULTS: Patients were randomized to either bThrombin (n = 82) or rThrombin (n = 82). Procedures included PAB (n = 88) and AV (n = 76). The bThrombin and rThrombin groups were well matched for demographics and baseline characteristics. A comparable incidence of anastomotic hemostasis was observed in both treatment groups at 10 minutes (94% bThrombin, 91% rThrombin). The incidence of hemostasis was lower at all time points for PAB procedures compared with AV procedures. In the PAB group, a significantly greater proportion of patients receiving rThrombin (55%) achieved hemostasis at 3 minutes compared with bThrombin (39%; P < .05). Adverse event profiles and laboratory findings were similar between groups. No patients in the rThrombin group developed anti-rThrombin product antibodies at day 29, whereas 27% of patients in the bThrombin group developed antibodies to bThrombin product (P < .0001). CONCLUSIONS: rThrombin or bThrombin used as a hemostatic ancillary for anastomotic bleeding was equally effective at 10 minutes; however, rThrombin compared with bThrombin may provide a more rapid onset of hemostasis at 3 minutes in PAB procedures. Adverse events were similar between the two thrombins. In patients undergoing vascular surgery, both treatments were similarly well tolerated, although rThrombin demonstrated a superior immunogenicity profile.

Carotid endarterectomy in octogenarian veterans: does age affect outcome? A single-center experience.

BACKGROUND: The efficacy of carotid endarterectomy (CEA) in octogenarians is controversial. Recent reports have examined this question in the general population, but little data exist on veterans. With the emergence of carotid artery stenting, we need to evaluate the role of CEA in treating elderly veterans with carotid stenosis. METHODS: Retrospective chart review of all CEAs performed between January 1995 and December 2004. RESULTS: A total of 286 procedures were performed in 239 patients; 39 procedures were performed in 33 octogenarians, and 247 procedures were performed in 206 younger veterans. Both groups had similar preoperative comorbidities. There were no statistically significant differences between octogenarians and younger veterans for postoperative stroke (2% vs. 1%), death (0% vs. 1%), myocardial infarction (5% vs. 2%), length of stay (7 +/- 19 vs. 3 +/- 8 days), or 4-year survival (53% vs. 57%). CONCLUSIONS: CEA can be safely performed in octogenarian veterans with outcomes similar to younger veterans.