November 26, 2013
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Vascular closure devices reduced complications, transfusions in PCI

The use of vascular closure devices was associated with significant reductions in vascular complications and need for transfusion in patients undergoing transfemoral PCI, according to findings in a recent study.

Researchers evaluated results from 85,048 emergent and nonemergent PCI procedures, including 28,528 procedures (37%) that incorporated vascular closure devices. The PCIs were performed across 32 hospitals in Michigan between 2007 and 2009. Incidences of in-hospital death, transfusion or vascular complications were compared between procedures that did and did not incorporate closure devices.

Researchers observed an association between vascular closure device use and reduced incidence of vascular complications (OR=0.78; 95% CI, 0.67-0.9) and postoperative transfusion (OR=0.85; 95% CI, 0.74-0.96). The impact of device use on vascular complications was particularly pronounced among patients treated with bivalirudin (Angiomax, The Medicines Company). This link between device use and reduced complications and transfusions was consistent across all evaluated subgroups, excluding patients with a BMI <25 and those who received treatment with platelet glycoprotein IIb/IIIa inhibitors.

The researchers also evaluated specific subtypes of vascular complications. Hematoma was the most frequent vascular complication (1.3% of cases), followed by pseudoaneurysms (0.5%) and retroperitoneal bleeding (0.3%). Procedures that incorporated vascular closure devices were associated with reduced risk for hematomas (OR=0.69; 95% CI, 0.58-0.83) or pseudoaneurysms (OR=0.54; 95% CI, 0.38-0.76). However, retroperitoneal bleeding was significantly more common among cases involving closure devices (OR=1.57; 95% CI, 1.12-2.2). The researchers also noted that, although device use did not benefit platelet glycoprotein IIb/IIIa inhibitor users overall, risk for pseudoaneurysms was significantly reduced in this subgroup (OR=0.53; 95% CI, 0.31-0.9 compared with non-use), while retroperitoneal bleeding risk was significantly increased (OR=1.88; 95% CI, 1.25-2.83).

Use of vascular closure devices did not have a significant effect on mortality (OR=0.82; 95% CI, 0.45-1.48). However, mortality occurred infrequently across the cohort, reducing the precision of this analysis.

“Vascular closure devices were associated with clinically meaningful reductions in vascular complications and transfusions, especially in overweight patients, albeit at an increased risk for retroperitoneal bleeding,” the researchers concluded. “Our data should help guide patients and physicians in choosing between manual closure and [vascular closure devices] in persons having transfemoral PCI.”

Disclosure: See the study for a full list of relevant financial disclosures.