In a nationwide observational study published this month in The Journal of the American Medical Association (JAMA), cardiologists from the Smith Center for Outcomes Research at Beth Israel Deaconess Medical Center (BIDMC) were commissioned by the U.S. Food and Drug Administration (FDA) to examine trends in the use and long-term safety of a device widely used to treat pulmonary embolism, or blood clots in the lungs. While the investigators found the device to have an extremely low rate of complication, they also identified a disconnect between federal recommendations and actual practice regarding removing the device that highlighted existing inequalities in cardiovascular care among vulnerable populations.
Led by Enrico G. Ferro, MD, and Eric A. Secemsky, MD, MSc, and conducted in collaboration with the FDA, the investigators analyzed data from more than 270,000 Medicare beneficiaries to assess post-market trends over time in insertion and retrieval of inferior vena cava filters, a device used for the treatment of pulmonary embolism since the 1960s. The team also evaluated the device’s longitudinal safety.
A blood clot in the lungs, or pulmonary embolism, can have serious complications, including death. Designed to prevent blood clots from traveling to the lungs, inferior vena cava filters, or IVCFs, are small, whisk-like devices inserted into the large vein that carries blood from the lower half of the body to the heart. However, despite their widespread use since the 1960s, results from trials assessing IVCFs’ effectiveness or safety remain inconclusive.
Ferro, Secemsky and colleagues demonstrated that rates of IVCF insertion declined between 2013 and 2021, dropping from an annual volume of 44,680 insertions in 2013 to 19,501 insertions in 2021. The study’s authors also found that the absolute number of annual IVCF retrievals remained largely stagnant during that time, suggesting the devices are not being removed in keeping with FDA recommendations.
“This finding came as a surprise, especially in light of the safety guidelines released by the FDA in 2010 and again in 2014, which strongly advised the prompt removal of IVCFs after their clinical utility has waned, for example when anticoagulation can be safely restarted. However, this study’s analyses suggest that IVCF retrieval procedures have an overall low risk of complications, which should reassure patients and physicians when performing these procedures to align with guidelines” said Ferro, a Cardiology and Electrophysiology Fellow at BIDMC and researcher at the Smith Center.
Importantly, when trends in device retrieval were stratified by patient demographics and device placement setting, the authors found that patients were less likely to have their IVCF retrieved if they were older, with more comorbidities, or were Black or lower income. IVCF retrieval was more likely if placement occurred at a large teaching hospital.
“These disparities in retrieval rates point to possible barriers to access to care for vulnerable populations, corresponding with poorer health outcomes within these demographics; for example, this study showed that Black patients had a higher incidence of IVCF-related complications over the study period,” said Secemsky, Section Head of Interventional Cardiology and Vascular Research at the Smith Center at BIDMC. “This novel research identifies a disconnect between federal recommendations and actual practice and underscores existing inequalities in access to cardiovascular care that demand more robust mitigation measures.”
The authors hope that the SAFE-IVC study will lend significant momentum to efforts to improve IVCF retrieval rates per the FDA’s advisories.
Co-authors included Nathan W. Watson, MD; Anna K. Krawisz, MD; Brett J. Carroll, MD; Marc L. Schermerhorn, MD; Robert W. Yeh, MD, MSc; Siling Li, MSc of BIDMC; and Yang Song, MSc. Julie B. Mackel, MS; Renee D. Kramer, PhD; Rebecca Torguson, MPH; Eleni M. Whatley, PhD; Gregory O’Connell, MS; Brian Pullin, MS; Jeffrey L. Weinstein, MD; Andrew Farb, MD; and Bram Zuckerman, MD of the Center for Devices and Radiological Health, Food and Drug Administration.
This work was funded by the Food and Drug Administration. Dr. Secemsky is supported in part by a grant serviced by International Consulting Associates, Inc., The National Heart, Lung and Blood Institute (grant K23H L 150290, RO1 HL 136708) and the Smith Center for Outcomes Research in Cardiology.
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