Vascular Closure Devices Aid Closure of Large Access Sites

Off-label use of closure devices speeds hemostasis following TEVAR, TAVR and pVAD use
By: 
Dave Fornell

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September 13, 2013

There is no shortage of debate among interventional cardiologists over whether vascular closure devices should be used for standard cath lab procedures. However, some say these devices have a definite niche in areas where they were not originally intended but have found frequent off-label use because of their utility. 

The larger sizes of devices used for transcatheter endovascular aortic repair (TEVAR) and transcatheter aortic valve replacement (TAVR) requires a much larger arteriotomy site than standard percutaneous coronary interventions (PCI). However, these larger holes also make it more difficult to achieve hemostasis using manual compression alone. 

Some of these devices are as large as 24 French, and anything larger requires a surgical cut-down, said Chris Malaisrie, M.D., assistant professor of surgery, division of cardiac surgery, Northwestern University Memorial Hospital, Chicago. “You can’t just hold pressure on a hole that size,” Malaisrie explained. “I use the preclose technique for large bore access for TEVAR and TAVI. I currently use Abbott Prostar or Abbott Perclose Proglide off-label. I prefer the ProGlide, even though you need two of them to close.”

The Abbott Perclose ProGlide suture-mediated closure system provides a suture for vascular closure of 5 – 21 French femoral artery access sites. The vendor says for sheath sizes greater than 8 French, at least two devices and the pre-close technique are required. The system helps reduce time to hemostasis, ambulation and discharge. 

Another off-label application of these devices has been found when using percutaneous ventricular assist devices (pVADs), such as the Abiomed Impella or the CardiacAssist TandemHeart systems. The TandemHeart system uses cannula sizes up to 17 French. 

“We primarily use two ProGlides for Impella 13 French closure using an off-label pre close technique,” said Mladen Vidovich, M.D., FACC, FSCAI, chief, section of cardiology, Jesse Brown VA Medical Center, and associate professor of medicine, University of Illinois, Chicago. 

He said cath labs at both Jesse Brown VA and UIC used closure devices on a regular basis for femoral access PCI in the past to speed patient ambulation and cut nursing time. However, he said both facilities have drastically reduced the need for these devices. 

“Due to our high radial access volume, our closure device use has dwindled, but for the rare groin I’ll use Proglide,” Vidovich said.   

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Study Supports Use of Closure Devices After Valvuloplasty

After reading this article, Mauricio G. Cohen, M.D., director, cardiac cath lab at thye University of Miami Health System, Fla., sent DAIC a link to a recent article on a study (www.ncbi.nlm.nih.gov/pubmed/23436434)  he helped with regarding the positive use of closure devices following valvuloplasty procedures. 

"The use of vascular closure devices and impact on major bleeding and net adverse clinical events (NACEs) in balloon aortic valvuloplasty: A sub-analysis of the BRAVO study" had the objective to determine the impact of suture-mediated vascular closure devices (VCDs) on net adverse clinical events (NACEs) after balloon aortic valvuloplasty (BAV).
 In the subanalysis of 428 consecutive patients who underwent BAV (with 10-13 French sheaths), they compared the effect of hemostasis with VCDs versus manual compression utilizing standardized definitions. The study suggests suture-mediated vascular closure is associated with a substantial reduction in NACE after transfemoral BAV.