Interventional radiologists report 100% clinical success using absorbable IVC filters in first human study
Implanting absorbable vena cava filters in patients with increased risk of pulmonary embolism resulted in a 100% clinical success rate, according to the results of a first in-human study published Tuesday.
Such filters resorb within months, eliminating the need for invasive retrieval procedures and long-term complications. Recent research has shown the feasibility of these IVC filters in animals, but the findings published Sept. 29 in the Journal of Vascular and Interventional Radiology validated the approach in eight patients, with zero filter-related adverse events.
Co-author of the study, Joseph Steele, MD, with the University of Texas MD Anderson Cancer Center’s Department of Interventional Radiology, and colleagues noted that the risk associated with absorbable filters actually decreases over time. Complications stemming from conventional IVC filters, meanwhile, tend to rise, they explained.
“Specifically, the absorbable filter is incapable of perforating the caval wall as a result of the flexible braided suture construction of the stent portion that exerts 300 times less pressure against the caval wall than a conventional conical metallic filter of similar chronic radial force,” Steele et al. added.
Interventional radiologists implanted seven IVC filters made of polydioxanone prior to five orthopedic and two gynecological surgeries. Each of the eight patients included in the prospective, single-arm study had a higher than average risk of venous thromboembolism. The authors noted that one procedure was not completed due to stenotic pelvic veins.
For the follow-up, participants underwent CT cavography and radiography prior to receiving the filter and five, 11, and 36 weeks afterward. No complications related to filter movement, embolization, or caval perforation were found. Two patients were lost to follow-up before the last visit, a limitation of the study, according to the researchers.
Additional limitations included a small sample size that consisted of nearly all female participants, the authors noted.
“In conclusion, eight absorbable filters were successfully deployed and assessed during a 36-week period in the first in-human trial of an absorbable IVC filter,” Steele and colleagues wrote. “Primary and secondary endpoints were successfully met, with a 100% clinical success rate and no PE or filter-related complications.”
Adient Medical, a leader in absorbable medical devices, funded the research and the authors acknowledged that Accelerated Clinical Research monitored the study and generated reports.
Matt joined Chicago’s TriMed team in 2018 covering all areas of health imaging after two years reporting on the hospital field. He holds a bachelor’s in English from UIC, and enjoys a good cup of coffee and an interesting documentary.