The study--the first published report in humans--tested the safety and effectiveness of the StarClose Extravascular Closure System (Abbott Vascular Devices, Redwood City, Calif.). This star-shaped nitinol ring helps seal the entry hole left behind after a coronary catheter snakes its way from an artery in the groin to the arteries of the heart. Only 4 mm across--about half the diameter of a ballpoint pen--the StarClose is positioned against the outside arterial wall at the puncture site and then released.
"This device has little pins that grab the arterial tissue from the outside, then fold inward, causing it to pucker a little and seal the puncture. It's a novel and exciting approach," said Dr. Peter N. Ruygrok, cardiology director at Auckland City Hospital in Auckland, New Zealand.
Dr. Ruygrok led a study of 25 patients who were treated with the StarClose device after having coronary stenting. All patients were taking the recommended regimen of blood-thinning drugs to prevent clots from forming during the procedure.
Use of the StarClose device was successful in 23 of 25 patients. On average, it took only 36 seconds to insert the clip and close the arterial puncture. Despite the aggressive blood-thinning regimen, it took an average of only 37 seconds for bleeding to completely stop. There were no serious complications.
Without the StarClose or another type of arterial closure device, the patient must rest quietly for approximately four hours after a coronary intervention before it is safe for a nurse to remove the sheath that guides treatment catheters into and out of the artery. Manual pressure must then be applied above the puncture site for 20 minutes or more, until a blood clot seals the wound. The patient must lie flat for another four to six hours to keep from disturbing the fresh clot.
A key advantage of the StarClose device is that, in an era of overworked nursing staff and scarce hospital beds, the interventional cardiologist can remove the guiding sheath immediately after the coronary procedure, potentially speeding both transfer of the patient to a regular hospital room and discharge from the hospital.
"We can move patients out of the cardiac care area more quickly," Dr. Ruygrok said. "Four hours of lying quietly waiting for the sheath to be pulled is a lot of down time for the patient and for the hospital bed."
Headquartered in Bethesda, Md., the Society for Cardiovascular Angiography and Interventions is a 3,400-member professional organization representing invasive and interventional cardiologists. SCAI's mission is to promote excellence in invasive and interventional cardiovascular medicine through physician education and representation, and advancement of quality standards to enhance patient care. SCAI was organized in 1976 under the guidance of Drs. F. Mason Sones and Melvin P. Judkins. The first SCAI Annual Scientific Sessions were held in Chicago in 1978.
To conduct an interview with Dr. Ruygrok, call 64-9-307-4949, ext. 23662, or send an email to Pruygrok@adhb.govt.nz.
The Society for Cardiovascular Angiography and Interventions provides news reports of clinical studies published in Catheterization and Cardiovascular Interventions: Journal of the Society for Cardiovascular Angiography and Interventions (CCI) as a service to physicians, the media, the public, and other interested parties. However, statements or opinions expressed in these reports reflect the view of the author(s) and do not represent official policy of SCAI unless so stated.
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Catheterization and Cardiovascular Interventions