Journal of Invasive Cardiology

The rationale for the need for rapid and safe hemostasis occurs at three levels. The first level is the patient. Patients want to have the bleeding stopped, but they also want to minimize discomfort associated with sheath dwell time, compression time and bed rest. The second level is the physician. Physicians want adequate hemostasis to decrease vascular complications, reduce procedural times and time to hemostasis and gain expertise with new devices and techniques. On the third level, hospitals and catheterization laboratories want to achieve earlier ambulation and discharges, which in turn will free beds in observations units and hospital rooms and will lead to better utilization of resources and lower costs. Thus, there is a justifiable need at all three levels to improve or to facilitate hemostasis.
The first requisite of an ideal hemostatic device is the ability to achieve complete hemostasis regardless of the level of anticoagulation and other clinical factors, such as in patients with the presence of peripheral vascular disease, bioprosthetic devices or materials in their bodies and different body habitus. Ideally, the hemostatic device should have low complication rates and will not compromise the arterial lumen by either embolization or narrowing. In addition, it will produce minimal sequelae in the surrounding tissues of the arteries so the site can be accessed repeatedly if necessary. Added bonuses include low cost and the ability to ambulate early.
All hemostatic devices are compared with the time-tested standard of care, which is manual compression. Historically, manual compression consisted of 15-minute compression cycles at the arteriotomy sites with 6 to 8 hours of bed rest. This recommendation was based on empiric knowledge; there are no randomized trials to support this. There are, however, observational studies and registries of patients looking at shorter compression times or bedrest, depending on the sheath size. The complication rates for diagnostic procedures range from 0% to 1.1%, and for interventional procedures from 1.3% to 5.9%, depending on the level of anticoagulation and sheath sizes.
Hoffer and Bloch2 reviewed 31 studies reported in the literature that measured efficacy rates of arterial closure devices (VasoSeal, Datascope Corporation, Mahwah, New Jersey; Angio-Seal, St. Jude Medical, Minnetonka, Minnesota; Duett, Vascular Solutions, Inc., Minneapolis, Minnesota; and Perclose, Abbott Vascular Devices, Redwood City, California). They reported success rates above 90%, hemostasis rates between 90% and 95% and failure rates around 5%. The major complication rates of arterial closure devices ranged from 3% to 4%, from 0.5% in the lowest to almost 10% in the highest. The major complications with any of these devices are not trivial; they can be life or limb threatening on occasion. The same report compared arterial closure devices with manual compression and found that there was no difference between the devices and manual compression. Therefore, it is justifiable to evaluate less invasive technologies that utilize the principle of assisted, augmented, or accelerated compression that access the site with a topical patch. Limited clinical experience suggests that assisted compression with pGlcNAc can decrease compression time, can decrease time to ambulation and can be associated with low complication rates.