RANDOMIZED EVALUATION OF AN INFLATABLE FEMORAL-ARTERY COMPRESSION DEVICE AFTER CARDIAC-CATHETERIZATION

Mechanical femoral artery compression devices have several limitations . We compared a novel disposable belt-held pneumatic compression devic e to manual compression alone in 213 patients randomized into two equa l groups. Both were comparable for age, gender, current therapy with a spirin (ASA) and warfarin, diameter of the arterial sheath, previous p rocedures via the same artery, procedure duration, and blood pressure. Manual compression time was 12 +/- 3 minutes. Pneumatic compression w as reduced during 60 minutes. Patient discomfort was assessed as none (82% vs 88%), mild (13% vs 8%), moderate (3% vs 4%), or severe (2% vs 0%) for the manual versus pneumatic group, respectively. Bleeding and hematoma occurred in 7.5% of patients with no difference between the t reatment groups. However, manual compression was significantly more ef fective in the higher range of systolic blood pressure, and pneumatic in the lower range, with a cut point of approximately 170 mmHg. Predic tors for bleeding were systolic blood pressure and dose of ASA. Among 113 patients with systolic blood pressure < 160 mmHg and low dose (75 mg) or no ASA, only 1 patient (0.9%) experienced bleeding while 31% of 16 patients with both elevated systolic blood pressure and high dose ASA (150-330 mg) bled. We conclude that pneumatic femoral artery compr ession does not reduce bleeding and hematoma compared with manual comp ression. The use of low dose (75 mg) or no ASA, as well as giving spec ial attention to patients with elevated systolic blood pressure, may r educe the risk of bleeding after cardiac catheterization.