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CLOSER: Vascular access sealing system safe, effective
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A vascular access sealing system was associated with immediate hemostasis and no major complications in patients undergoing transfemoral diagnostic and interventional procedures, according to findings from the CLOSER trial.
The researchers assessed the safety and effectiveness of the system (Closer Vascular Sealing System, Rex Medical) against prespecified performance goals in 220 patients who underwent transfemoral diagnostic (50.5%) or interventional (49.5%) procedures via transfemoral access with 5F to 7F catheters. The system was approved by the FDA in February 2016.
Primary endpoints were time to hemostasis and access site closure-related major complications at 30 days.
Mean time to hemostasis was 1.78 minutes in the intention-to-treat cohort and 0.98 minutes in the per protocol cohort, Shing Chiu Wong, MD, from the division of cardiology at Weill Cornell Medical College/NewYork-Presbyterian Hospital, and colleagues wrote.
Median time to hemostasis was 0 minutes, and 80.5% of patients achieved immediate hemostasis. Mean time to ambulation was 2.5 hours and mean time to discharge eligibility was 2.83 hours, according to the researchers.
At 30 days, there were no access-site major complications in any patient and no minor complications in those who had a diagnostic procedure, whereas 2.75% of those who had an interventional procedure had a minor complication, they wrote.
“Since the majority of invasive procedures are still being performed using the transfemoral approach in the USA, a secure, predictable and easy-to-use [vascular closure device] that may help further reduce [time to hemostasis], mitigate potential complications and enable more patients to be discharged on the same day without an undue increase in risk of access site-related complications would be a welcomed development,” Wong and colleagues wrote. – by Erik Swain
Disclosures: The authors report no relevant financial disclosures.
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