Pros & Cons of Closure Devices: Its Nip & Tuck

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Source: Closure_1340814278.jpg - Mynx vascular closure device
The Mynx vascular closure device uses a bioabsorbable sealant to cover an incision and stop bleeding. 1. The Mynx is inserted into the existing sheath and a small balloon is inflated. 2. The sealant is delivered and unsleeved. 3. The balloon is deflated and removed. 4. The sealant dissolves within 30 days.
Utilization of vascular closure devices after cardiac catheterization procedures may have edged up in recent years, thanks to the devices’ two leading attributes: comfort and convenience. But safety remains a stumbling block, with many operators skeptical of the evidence and questioning the value of these devices compared with less costly alternatives. As technologies and techniques evolve, so do the devices’ pros, cons—and competition.  

The pros

Vascular closure devices (VCDs) are generally recognized as offering a few advantages over manual compression for achieving hemostasis after femoral-access catheterization. Top of the list is patient comfort; the closure devices obviate the need for a period of manual pressure followed by six or more hours of bed rest that may require an overnight stay. One meta-analysis of 30 studies covering six different devices found they trimmed time to hemostasis by 17 minutes, bed rest duration by up to 11 hours and time in the hospital by 0.6 days (JAMA 2004;291:350-357).

“We can send them home earlier in many cases, and in most cases we can provide a superior comfort level for the patient,” says Zoltan G. Turi, MD, director of the Cooper Vascular Center at Cooper University Hospital in Camden, N.J.

VCDs appear to be in a dead heat with manual and mechanical compression in the cath lab. Usage increased 5 percentage points between 2005 and 2009, according to an analysis of post-PCI bleeding trends among more than 1.7 million patients (J Am Coll Cardiol 2012;59:1861-1869). In that study, which relied on the CathPCI Registry, 49 percent of the procedures used a VCD.

Closure devices can be applied in both diagnostic and interventional procedures, but operators tend to favor their use in diagnostics, where anticoagulants are less of a factor and patients may be discharged earlier. Personal preference also plays a role. Turi prefers to oversee the process when the sheath is pulled, which with manual compression in the interventional setting requires a delay while the anticoagulants deactivate sufficiently for blood to clot.

“I find the argument for closure devices most compelling in patients who are undergoing interventional procedures,” he says. “It particularly makes sense if you are going to send the patient home the same day.”

The cons

The safety profile of VCDs remains an area of concern for many physicians, who describe the literature covering complications as weak, conflicting and possibly biased. The vast majority of clinical trials for VCDs have been small, nonrandomized, of variable design and relevant only to the device being studied.

“Superior safety has not been clearly established,” says Turi. “This is where the evidence base is inconsistent, although there are some studies that suggest that we are getting there.”

In a 2010 review of VCDs, Bryan G. Schwartz, MD, of the Heart Institute at Good Samaritan Hospital in Los Angeles, and colleagues noted the majority of trials were sponsored by industry and used a selected patient population (J Invasive Cardiol 2010;22:599-607). “We are limited in the scientific evidence,” Schwartz says. “There was a limited patient population.”

Other challenges include the evolution of technologies; many studies focused on early-generation devices that have changed over time. Operator skill also may have improved as physicians became more adept.

Even meta-analyses are limited if the quality of the individual studies is lacking, Schwartz points out. “The meta-analyses had the same biases as the smaller studies,” he says. “They tended to exclude the high-risk patients.”   

Such limitations make it particularly difficult to evaluate events such as retroperitoneal hemorrhage, infections and occlusions, complications that may be rare but have a high mortality rate. For example, the incidence rate for retroperitoneal hemorrhage ranges from 0.5 to 1.0 percent, yet the mortality rate is 4 percent (J Am Coll Cardiol 2005:45:363-368). Another meta-analysis noted the incidence of groin infections was more frequent in VCDs, at 0.6 percent compared with 0.2 percent for manual or mechanical compression (Am Heart J 2010;159[4]:518-531), while one single-center study placed the mortality rate for infection complications from VCDs at 6 percent (Mayo Clin Proc 2005;80:1011-1015).

“Groin infections, although rare, are nasty infections and they predominantly have been in the setting of closure devices,” Turi says.

In the absence of a large, randomized clinical trial, researchers have turned to propensity analyses to try to tease out answers. One large study from Wake Forest School of Medicine in Winston-Salem, N.C., concluded that the use of VCDs did not increase complications for either diagnostic catheterizations or PCI (J Invasive Cardiol 2007;19[4]:164-170). Another propensity analysis from Brigham and Women’s Hospital in Boston, found that the risk of complications was lower using VCDs compared with manual compression in both diagnostic and PCI settings (Am Heart J 2007;153[4]:606-611).

“Operator technique, not just for closure, but for access, can affect whether complications occur or not,” cautions Turi, adding that the operators in the two propensity analyses used high-quality access techniques. “The problems you have with closure very much are influenced by the quality of the access.”

Weighing VCDs against Manual Compression
Reasons for choosing a closure device over manual compression include: Reasons operators may avoid using these devices include:
  • Reduced time to hemostasis;
  • Patient comfort;
  • Ambulation, which is especially important for patients who cannot lie on their backs for prolonged periods;
  • Convenience—patients can go home earlier; and
  • Resources—shorter stays free up staff and hospital beds.
  • Concerns about the safety profile;
  • A weak evidence base;
  • Potential risks to patients, especially those at risk of infection, such as diabetics and patients who are immune suppressed, and patients with significant coronary disease and those who don’t offer an ideal location for a femoral puncture; and
  • Cost.

Costs & competition

Buying the devices also may be a deterrent for some budget-conscious operators and administrators. Manual compression takes up staff time, but it requires no device purchases. Costs, like the VCDs themselves, vary. One cost analysis pegged the price tag for an Angio-Seal (St. Jude Medical) vascular closure device at $190. The study concluded that use of the device post-PCI saved the hospital $44 per patient compared with routine mechanical (not manual) compression (Am J Cardiol 2007;99[6]:766-770). The mechanical compression device cost $110.

“Whether it is worth several hundreds of dollars for a [vascular]closure device remains an area of discussion,” Turi says. “There is some literature that suggests there are some cost benefits.”

In the competitive arena of VCDs, vendors have refined their devices in an attempt to eliminate or minimize complications such as infections. But with cardiac catheterizations, the biggest challenge to VCD use may come from the growing adoption of methods that bypass use of the femoral artery—that is, the transradial approach.

Like VCDs, transradial procedures offer the advantage of not requiring manual compression of the femoral artery. Patients generally can be ambulatory earlier than those who undergo a femoral procedure with manual compression, with the potential of making it a same-day procedure. The radial approach requires a wrist band or other bandage to the wrist after the sheath is removed, a less expensive device than the vascular closure devices.     

“There is a trend toward doing less femoral access and more radial access,” Schwartz says. “With more radial, these devices (VCDs) aren’t needed.”