Study: New closure device alleviates manual wound pressure after coronary procedures

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A recent study examines the benefits of a new device that cardiologists can use to stitch arterial puncture wounds after coronary procedures.

The Rapid Ambulation After Closure (RADE) study evaluated the X-Press device from X-Site Medical, of Blue Bell, Pa., in the final steps of angioplasty, stenting and other catheter-based heart procedures.

The study was lead by Timothy Sanborn, MD, cardiology head at Evanston Northwestern Healthcare in Illinois, and involved approximately 400 patients who either underwent cardiac catheterization or percutaneous coronary intervention (PCI). Two-thirds of the group was randomly assigned to have the physicians use the X-Press device while the remaining one-third received manual pressure on the puncture site.

Conventional methods require that firm pressure be applied to a punctured artery after a coronary procedure. Closure can take upwards to 20 to 30 minutes after the catheter is removed and the patient must lie in bed for at least six to eight hours.

The X-Press is inserted into an arterial hole created by the treatment catheters and guides the cardiologist in passing stitching needles through the skin and into the artery, both above and below the catheter puncture site. The X-Press captures the needles inside the artery and, as the device is removed from the body, pulls the leading end of each stitching thread out with it, creating a loop. The cardiologist then ties a knot in the threads and slides the knot into place, cinching together and closing the arterial hole.

Sanborn and his colleagues concluded that the patients in the X-Press group were able to get up out of bed and walk around 2.2 hours, as compared to 6.2 hours in the group treated with manual wound pressure. Even more revealing, those who underwent PCI waited an average of four hours in the X-Press group, as compared to nearly 15 hours in the manual pressure group.

The X-Press device is not yet commercially available in the United States and is not the only other alternative to manual wound pressure. The report will be published in the March 2004 issue of Catheterization and Cardiovascular Interventions: Journal of the Society for Cardiovascular Angiography and Interventions.