A SINGLE-CENTER RANDOMIZED TRIAL ASSESSING USE OF A VASCULAR HEMOSTASIS DEVICE VERSUS CONVENTIONAL MANUAL COMPRESSION FOLLOWING PTCA - WHATARE THE POTENTIAL RESOURCE SAVINGS (REPRINTED FROM CATHETERIZATION AND CARDIOVASCULAR DIAGNOSIS, VOL 34, PG 210-214, 1995)

We undertook a randomized controlled trial comparing VasoSeal(TM), a c ollagen vascular hemostasis device (VHD), with manual compression to a ssess its role and potential cost savings in the PTCA population. Of 4 60 patients, 359 were excluded due to clinical instability (30%), groi n problems (18%), suboptimal PTCA result (15%), and other reasons (37% ). The remaining 101 patients were randomized to either VHD (51) or ma nual compression (50). Hemostasis time, time to ambulation, duration o f hospital stay, and nursing time and intensity mere significantly red uced in the VHD group. There were no major groin complications in eith er treatment arm but there was a trend toward more minor groin complic ations in the VHD patients. The application of VasoSeal(TM) reduced re source use in this randomized study and may translate into significant cost reductions in the general coronary angioplasty population.