Assessment of safety and efficacy of homemade vascular hemostasis device

Objective To determine the safety and efficacy of the homemade extravascular hemostasis device in comparison with standard manual compression after diagnostic and interventional coronary procedures.Methods Two hundred and ninety-nine patients who underwent diagnostic or interventional coronary procedures were randomized to the homemade extravascular hemostasis device or standard manual compression.The primary study end points were time to hemostasis and ambulation and the incidence of major vascular complications.Results Both time to hemostasis and ambulation were significantly reduced in the homemade extravascular hemostasis device,respectively(5.2±4.7)min vs(15.1±12.6)min,(187.4±125.6)min vs(324.8±212.4)min(P0.001).But the incidence of vascular complications was similar between the homemade extravascular hemostasis device group and manual compression group.Conclusion The homemade extravascular hemostasis device allows immediate arterial sheath removal after both diagnostic and interventional procedures,dramatically reducing time to hemostasis and patient ambulation without compromising patient safety in comparison with standard compression techniques.