Two studies question benefit of embolic protection devices
The use of embolic protection devices increased in interventional procedures, but the devices did not provide improved outcomes in patients with severe carotid stenosis or those requiring lower-extremity revascularizations, according to two abstracts presented at the Society for Vascular Surgery Vascular Annual Meeting.
In one study, Cassius Iyad Ochoa Chaar, MD, MS, RPVI, assistant professor of surgery at Yale University School of Medicine, and colleagues analyzed data from 10,875 lower-extremity revascularization procedures from 2010 to 2014. Researchers compared patients treated with embolic protection devices (2%) with those who did not receive a device. Embolic protection was most often used in conjunction with atherectomy (59.5%) of the femoropopliteal artery (86.8%).
Outcomes of interest included distal embolization, technical success, patency, hospital length of stay, mortality, amputation and procedure survival time.
The use of embolic protection devices increased from 1.07% to 3.51% during the study period (P < .0001).
After matching of 182 procedures with an embolic protection device with 604 without one, type of distal embolization and incidence did not differ between groups. Those treated with embolic protection devices had an increase in fluoroscopy time (P < .0001).
Patency, length of stay, technical success, mortality, amputation and procedure survival time did not differ between the device and control groups in unadjusted or multivariable analyses.
“Additional research to characterize patients who benefit from [embolic protection devices] is needed to justify their use,” Chaar and colleagues wrote.
In another abstract, Anand Dayama, MD, a surgical resident at San Joaquin General Hospital in French Camp, California, and colleagues reviewed data from 257 patients (mean age, 69 years) with asymptomatic carotid artery stenosis from 2012 to 2015. Patients were treated with carotid artery stenting alone (n = 57) or with CAS with a cerebral protection device (n = 200).
Postoperative complications such as restenosis, distal embolization, transient ischemic attack, MI, stroke and 30-day mortality were compared within the two groups.
Distal embolization occurred in 3.5% of patients who received CAS alone vs. 1% of those who were treated with stenting and a cerebral protection device, although it was not statistically significant.
Rates of stroke in the CAS group (7%) did not differ significantly compared with the stenting and device group (3.5%). The stenting (1.8%) and stenting plus device groups (0.5%) did not have a significant difference for 30-day mortality.
“These data suggest that further study into the use of cerebral protection device during [CAS] is needed for asymptomatic patients with carotid stenosis,” Dayama and colleagues wrote. – by Darlene Dobkowski
Chaar CO, et al. Abstract IP287.
Dayama A, et al. Abstract IP109. Both presented at: Society for Vascular Surgery Vascular Annual Meeting; May 31-June 3, 2017; San Diego.
Disclosures: Chaar and Dayama report no relevant financial disclosures.