Laser sheath retrieves IVC filters with few complications in real-world population
Click Here to Manage Email Alerts
An excimer laser sheath successfully removed inferior vena cava filters with low complication rates, according to data from a real-world study presented at the Society of Interventional Radiology Annual Meeting.
As Healio previously reported, the laser sheath (CavaClear, Philips) became the first device approved for advanced IVC filter removal by the FDA in December.
“The use of the excimer laser sheath has been off-label in expert single centers for retrieval of IVC filters, which have published single-center data that shows it is safe and efficacious in experienced hands,” Kush R. Desai, MD, FSIR, associate professor of radiology, surgery and medicine and director of deep venous interventions in the division of interventional radiology at Northwestern University Feinberg School of Medicine, told Healio. “The purpose of this study was to show broader generalizability, that the device is something that can be used at centers which start gaining experience, and they are able to get similar success rates” to the expert centers.
Desai and colleagues collected retrospective data from 265 patients who underwent procedures with the laser sheath at seven centers between October 2012 and February 2021.
The primary safety endpoint was the device-related major complication rate based on Society of Interventional Radiology (SIR) classification criteria C-E. The primary efficacy endpoint was technical success of IVC filter retrieval, defined as the retrieval of the filter body and any fragments deemed retrievable.
Patients were stratified by whether they had their procedure at Northwestern University, a high-volume center (n = 139; mean age, 56 years; 56% women), or elsewhere (n = 126; mean age, 56 years; 60% women).
Patients treated at Northwestern University had a shorter mean filter dwell time than patients treated elsewhere (57.1 months vs. 69.7 months), Desai said during the presentation.
The technical success rates were 95.7% at Northwestern University (P = .007) and 95.2% at the other centers (P = .016), beating the performance goal of 89.4%, he said.
The rates of device-related major complications were lower than the performance goal of 10%: 2.9% at Northwestern University (P = .001) and 4% at the other centers (P = .011), he said.
The rates of procedure-related major complications were 3.6% at Northwestern University and 4% at other centers, according to the researchers.
Average case volume was 19 per year at Northwestern University and 4.7 per year at other centers, which varied widely between centers, Desai said, noting operators said they took an average of four cases to become comfortable with the technique.
The study showed that “embedded IVC filters can be removed safely and successfully after some experience is gained with the device,” Desai told Healio. “This is the first and only available device for advanced IVC filter retrieval.”
He told Healio that in 2010 and 2014 safety communications, the FDA identified embedded IVC filters as a concern. “They are frequently left in place beyond their intended use or indication, and at that point they go from being a net clinical benefit to a net clinical hazard, and they are no longer clinically indicated,” he said. “For years, the problem was that embedded IVC filters could not be retrieved successfully, and the longer they were in, the more likely they were to be associated with complications in situ. This device is the first to answer the FDA’s recommendations, enabling physicians to retrieve filters that have been in for a long time."
Collapse
Desai KR, et al. Late-breaking abstracts. Presented at: Society of Interventional Radiology Annual Meeting; June 11-16, 2022; Boston.
Read more about
Click Here to Manage Email Alerts