M. Flannery

Controlled clinical trial of a novel hemostatic agent in cardiac surgery

Abstract Background: . We performed a prospective randomized trial to compare FloSeal Matrix (Fusion Medical Technologies, Inc, Mountain View, CA), a gelatin-based hemostatic sealant, with Gelfoam-Thrombin (Gelfoam, Pharmacia and Upjohn, Kalamazoo, MI; Thrombin, Gentrac Inc, Middeton, WI) (control group) to control perioperative bleeding. Methods: . A total of 93 patients undergoing cardiac operations were randomized into the FloSeal or control group after standard surgical means to control bleeding had failed. The bleeding site was evaluated at 1, 2, 3, 6, and 10 minutes after applying the hemostatic agent. If bleeding stopped within 10 minutes, the application was considered to be successful. In the case of a failure, the surgeon could use any means preferred (except FloSeal) to achieve hemostasis. All bleeding sites in a patient were treated with the hemostatic agent to which the patient was randomized. Follow-up evaluation was performed at 12 to 36 hours and 6 to 8 weeks after operation. Results: . FloSeal stopped bleeding in 94% of the patients (first bleeding site only) within 10 minutes, compared to 60% in the control group ( p = 0.001). At 3 minutes, successful hemostasis was achieved in 72% of the FloSeal group compared with 23% in the control group ( p = 0.0001). There was no difference in the adverse event profile between the two groups. Conclusions: . FloSeal Matrix demonstrated efficacy superior to that of Gelfoam-Thrombin and had a safety profile similar to that of Gelfoam-Thrombin when used as a topical hemostatic agent during cardiac surgery procedures.

Effects of changes in UNOS policy regarding left ventricular assist devices

Over the last 6 years, 161 patients underwent implantation of HeartMate single-lead vented electric (SLVE) devices as a bridge to transplantation. SLVE patients were retrospectively analyzed before and after United Network for Organ Sharing (UNOS) policy changes, and designated SLVE-1 and SLVE-2, respectively. Mean support time decreased significantly from 79.7 +/- 72.0 days to 55.3 +/- 60.5 days (p = 0.022). Although not statistically significant, rate of successful bridging to transplant increased from 70.3% to 74.7%, and post-transplant 1- and 3-year survival increased from 90.0% and 86.0%, respectively, to 92.9% and 87.3%, respectively.