Vascular Closure Devices: What the Cath Lab Manager Needs to Know

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Timothy Sanborn, MD, Head of the Division of Cardiology at NorthShore University HealthSystem, Evanston, Ill.
Even though manual compression dates back to the 1950s, the adoptioan of vascular closure devices (VCDs) is rapidly growing, despite modest comparative research. Nevertheless, the extant research—and anecdotal experience—is helping to define best practices for this evolving field.

Closing the gap

In addition to the physical discomfort, manual compression forces patients to lie in bed for two to four hours after a procedure. In comparison, closure devices “hasten ambulation” and tend to decrease patient length of stay, patient discomfort and risk of complication, says George W. Vetrovec, MD, chair of cardiology and professor of medicine at the Pauley Heart Center at Virginia Commonwealth University (VCU) in Richmond, Va.

“Using a closure device gets the patient up sooner [by one to two hours] and, theoretically, the turnover rate for holding area beds can be doubled in one day. This may help in terms of bed availability for an additional patient,” Vetrovec says.

The use of closure devices has been associated with lower costs and lower risks of complications. Research in 2007 conducted by Resnic et al found that the use of the Angio-Seal (St. Jude Medical) closure device reduced costs per case by $44 and decreased vascular complication rates by 3 percent (Am J Cardiol 2007; 99[6]: 766–770). Trial results, presented at ACC09 and conducted by Sanborn et al, found that rates of major access site bleeding were lower in patients who had a VCD deployed than in those who did not.

Inside the lab

The cath lab at VCU stockpiles three types of closure devices: collagen, suture and plug-based. The lab performs about 3,000 diagnostic and interventional procedures per year and keeps a variety of devices in stock to give its fellows a feel for deploying different devices.

Complications, such as infection, device embolization and vascular obstruction, increase with standard suture and plug-based closure devices, says Vetrovec, adding that VCU has limited their use. Instead, VCU most commonly deploys the Catalyst III (Cardiva Medical), a drug-coated VCD that neutralizes the effect of heparin. The Catalyst device “leaves nothing behind,” as opposed to other suture or plug-based devices, which may cause an increased risk for infection, Vetrovec says.

He says the Catalyst has the ability to hasten the removal of the sheath. “We think it’s very safe in the sense that it’s highly unlikely to be associated with developing an infection in the groin at the puncture site.” In fact, VCU has a sheath removal committee to review and track VCD complications.

At NorthShore University HealthSystem in Evanston, Ill., cardiologists close patient puncture sites with the Perclose (Abbott Vascular) and Angio-Seal devices. The Perclose generally is used in large sheath devices and during interventions for structural heart disease, while the Angio-Seal is used in coronary interventions (diagnostic caths get the manual treatment), according to Timothy Sanborn, MD, head of the division of cardiology at NorthShore.

Ken Gorski, RN, assistant manager of the cardiovascular laboratory at the Cleveland Clinic Heart and Vascular Institute, says there may be a few C-clamps scattered around his lab, but primarily, like Sanborn, his facility deploys the Angio-Seal and Perclose devices during interventions.

In a lab where 12 interventional cardiologists work side-by-side to perform more than 3,000 cardiac procedures annually, the Cleveland Clinic utilizes VCDs in certain cardiac procedures. “The use of vascular closure devices is multi-factorial,” says Gorski. Aspects such as the “appropriateness of anatomy, patient demand, patient comfort, physician preference and the convenience of not having to remove a sheath hours after the procedure are all taken into consideration.”

At some points, varied patient populations such as anticoagulated or obese patients, or those with other factors, may influence the use of manual, suture and plug-based devices. “Sometimes you don’t use these devices in the higher risk patients that are more likely to have complications,” suggests Vetrovec.

However, Gorski says that use of manual compression on obese patients is often difficult due to the lack of ability to maintain hemostasis, but these patients also are at the highest risk for closure device failure and infection. “Making the choice to use suture mediated versus collagen plug is determined by patient anatomy, access point of the sheath in the vessel and physician preference,” he says.

A subgroup analysis of the ACUITY Trial revealed that the use of a vascular closure device (VCD) and randomization to bivalirudin were associated with a reduced risk of bleeding. Devices used included AngioSeal, Perclose, VasoSeal, Duett and others unknown. Source: Timothy Sanborn, MD, NorthShore University HealthSystem, Evanston, Ill.

Stocking the shelves

While 15 interventional cardiologists work in the NorthShore cath lab, Sanborn says that stocking the shelves comes down to a matter of personal preference of physicians. “Different doctors like different devices. Some like Perclose, some like Angio-Seal. Utilization is based on physician preference.”

In the Cleveland Clinic, “if the physician staff does not like a product, it will not be on the shelf,” says Gorski. Currently, there are no specific or preferred vendor contracts at his lab. They track usage and data trends to determine orders.

The costs associated with VCDs at the Cleveland Clinic are controlled by contractual agreements set forth by its supply chain management team, and the clinic is often approached by vendors requesting evaluation of their new-generation or existing products. In this case, an allotted evaluation period is allowed and the device may be brought in on a “no-charge trial period” or at an “evaluation price.”

If a contracted vendor develops a new generation of an existing product, the company must offer it at the “current contract price for evaluation,” Gorski says. After the device’s evaluation period ends, physicians give Gorski feedback, who then considers whether the product will be stocked on his shelves. Although price is often a deciding factor, the decision rests heavily on physician evaluation and preference. Products deemed “inferior to other existing products” or those with high failure rates of deployment are no longer considered for contractual pricing, explains Gorski.

Hospital contracts vary from facility to facility. Some device makers offer discounts if the hospital bundles their closure devices with other medical devices. “The hospital certainly negotiates these things with the clinicians,” says Vetrovec, adding that even this process varies. “Some places have very authoritative hospitals that say, ‘This is what you’re getting,’ while others are more liberal.

In most situations, Vetrovec says that facilities have a physician group that meets with the purchasing management sector of the cath lab to reach consensus on which devices are stocked.

No matter which devices cath labs decide to stock, the debate continues as to their efficacy and cost effectiveness. Until comparative effectiveness data emerge, which seems unlikely, the prevailing impetus for choosing devices will remain physician preference.