Devices may be safer than manual closure during PCI

Using vascular closure devices (VCDs) during PCI may be safer than manual closure, according to a study published online Nov. 18 in Annals of Internal Medicine. The devices were associated with fewer vascular complications and a reduced need for transfusions in patients undergoing transfemoral PCI.

The investigators, led by Hitinder S. Gurm, MD, of the Blue Cross Blue Shield of Michigan Cardiovascular Consortium (BMC2), identified consecutive BMC2 patients who had PCIs between 2007 and 2009. There were 85,048 who met their criteria and 68,874 were analyzed.

Their outcomes were vascular complications related to the access site, defined as either an acute thrombosis, loss of limb, retroperitoneal bleeding, surgical repair, pseudoaneurysm or hematoma that needed transfusion or arteriovenous fistula. Death was considered post-PCI death before discharge.

Thirty-seven percent of the procedures used VCDs. There was an association between VCDs and a lower risk of vascular complications (odds ratio [OR] 0.78) and post-PCI transfusions (OR 0.85). The reductions were attenuated among patients with a low body mass index (less than 25 kg/m2) and patients treated with a platelet glycoprotein IIb/IIIa inhibitor, however.

Although there was a lower risk of hematomas (OR 0.69) and pseudoaneurysms (OR 0.54), there was a higher risk of retroperitoneal bleeding (OR 1.57).

Gurm and colleagues noted that the use of VCDs is controversial and their findings should be interpreted with caution, given their study’s observational nature and the fact that these devices can be used with only certain patients.

However, they also highlighted the importance of their results.

“Vascular closure devices are better-tolerated and permit more rapid ambulation than manual closure,” they wrote. “Although VCD use is not reimbursed by most third-party payers, their relatively low cost (approximate list price of 1 device, $275 to $350) combined with these factors probably account for the widely prevalent use of VCDs despite a relative paucity of high-quality data supporting their efficacy.”