Vascular closure devices after PCI are experiencing an increase in utilization and vendors often speak to their benefits. Yet, complication rates vary widely, with seemingly little intention to explore the root of the problem, particularly in randomized controlled trials.
In the late 1990s, several relatively small studies examined complication rates in a randomized fashion with first- and second-generation vascular closure devices. Modern devices, however, have changed a great deal, as have anticoagulation strategies, but there have been few follow-up studies on these newer-generation devices.
“Unfortunately, minimal new data are likely to emerge on vascular closure management because it’s too expensive to conduct randomized controlled trials,” says David Cox, MD, associate director of the cardiac cath lab and director of interventional cardiology research at Lehigh Valley Hospital in Allentown, Pa. “No current data suggest an increased risk of using vascular closure devices and since they are already FDA approved, there is no regulatory need for the study.”
What are the risks?
Manual compression increases patient discomfort and length of hospital stay, with a small, defined complication risk, primarily hematoma. Closure devices decrease length of stay and contribute to less patient discomfort—but at the risk of more severe complications, whose rates vary between 2 and 20 percent. For instance, closure devices may increase the risk of local infection, endarteritis, vein closures and retroperitoneal bleeds. Considerations in the decision-making process include the location of the groin stick, patient body habitus, anticoagulants and local expertise with a particular closure device.
“The range in complication rates is partially attributable to the diverse definitions of a complication in the various studies,” says Frederic S. Resnic, MD, director of the cardiac cath lab at Brigham and Women’s Hospital in Boston. One study, for example, considers “any oozing from an access, even if it’s momentarily controllable, as a bleed, while another study only includes very active bleeds—causing exponential differences and an inability to draw linear relationships,” he says.
Schnyder and Turi suggested that some of the purported complications of using closure devices after PCI are unfounded and “any recommendation should await the results of prospective randomized studies applying uniform definitions of complications and uniform measurement of end points” (J Am Coll Cardiol 2002;39:1705-1706).
A good team of manual compressors is important, but not every hospital has skilled personnel. In fact, the current U.S. nursing shortage could affect vascular closure decisions. “Large providers who can afford the FTE costs associated with experienced sheath-pulling teams will most likely use less closure devices,” says Cox. At BWH, however, Resnic says that arteriotomy closure devices are used in about 80 percent of patients following PCI. He adds that—anecdotally—complication rates at BWH and other facilities that often use the devices remain “very low, much lower than those treated with manual or mechanical compression.”
Balzer et al found a learning curve of about 350 cases for devices. They wrote that operators could experience a 9 percent complication rate out to almost 100 cases (Cath and Cardio Interv 2001:53;174-181). Cox says that while this volume expectation seems higher than real-world clinical practice, “the complication rate in the first 50 cases is going to be higher than the next 200 cases. There is a learning curve with these devices, and they are not as easy as the manufacturers and animations suggest.”
Resnic concurs, saying that success rates depend on the technical experience of the operator implementing the device. “In addition, part of the strategy is to pick a few closure devices and use them with great frequency, so the staff becomes comfortable with them. After 10 to 20 implants, however, the physician should be in command of the technique,” he says.