Perclose Proglide safe and effective for EVAR/TEVAR procedures

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According to a recent study, totally percutaneous access for endovascular abdominal (EVAR) and thoracic aortic repairs (TEVAR) are safe and feasible using the Perclose ProGlide device (Abbott). The report is featured in the June 2007 issue of the Journal for Vascular Surgery. “To our knowledge the study represents the largest series of percutaneous endovascular aortic repairs using the Perclose technique and the first using the ProGlide device,” commented Dr W Anthony Lee, Associate Professor of Surgery, Gainsville, FL.

The Perclose ProGlide features a polypropylene monofilament suture. The Perclose closure devices are designed to close femoral artery puncture sites following diagnostic or interventional procedures. With monofilament suture, the ProGlide knot easily advances to the opening in the artery, allowing a single operator to rapidly deliver a pre-tied knot to close the access site in the femoral artery following a catheterization procedure. This secure stitch provides rapid hemostasis and allows patients to recover comfortably by providing the ability to get out of bed in a shorter amount of time. According to the company, the Monofilament suture is also a preferred suture for vascular surgeons due to its high-knotted tensile strength and minimized tissue reaction.

Additional features on Perclose ProGlide include the QuickCut mechanism, which is built into the device to trim the suture after deployment, making it unnecessary to use additional sharps during the procedure. The trimmer facilitates both suture trimming and knot advancement, eliminating a potentially time-consuming step in the vessel closure procedure for many operators. ProGlide also features numbered procedure deployment steps that are printed on the device.

Between December 2004 and August 2006, a total of 262 endovascular aortic aneurysm repairs were performed with percutaneous access at the Division of Vascular Surgery and Endovascular Therapy, University of Florida. The technique involved deployment of two ProGlide devices prior to insertion of the sheath with the sutures left extracorporeally for closure following conclusion of the procedure (Preclose Technique). A total of 559 ProGlide devices were used to close 279 femoral arteries. Of those, 175 femoral arteries required insertion of 18-24F sheaths (6.7-8.6mm outer diameter).

For EVAR and TEVAR repairs, the success rates when using 12-16F sheaths were higher than for the larger 18-24F sheaths (99% vs. 91.4%). Also, the Perclose technique resulted in shorter overall procedure times as compared to a similar cohort using open femoral exposures (EVAR, 115 vs. 128 and TEVAR, 80 vs. 112). The researchers noted that using ProGlide with larger sheaths in a select group of patients showed higher technical success rate (94.6%) than historically reported when using the ProStar XL device.

“Percutaneous access during endovascular aneurysm repair has been difficult due to the large size of the delivery catheters. Although the success rates are slightly higher for smaller size sheaths, we found that successful closures may be obtained for up to 24F sheaths,” commented Lee.

Lee added that EVAR and TEVAR aortic repairs typically involve sheaths and delivery catheters, which are beyond the treatable range of arteriotomies of most closure devices, “However, although we were successful when using the larger sheaths, and despite this reduction of procedure time and potential savings on the cost of operating room time offered by use of smaller sheaths, the overall savings was diminished by the price of the ProGlide device.”