medwireNews: Only one in six inserted inferior vena cava filters (IVCFs) were retrieved from recipient patients with venous thromboembolism (VTE) in the SAFE-IVC study over a maximum follow-up of 9 years despite FDA endorsement for early retrieval when possible, according to postmarketing surveillance data published in JAMA.
There were a total of 270,866 older Medicare Fee-for-Service (FFS) beneficiaries aged a mean of 75 years who received their first IVCFs between 2013 and 2021 for VTE (64.9%), recurrent VTE (26.3%), or VTE prophylaxis (8.8%). Of these, 63.3% had major contraindications for anticoagulants, namely major bleeds or major trauma.
The number of IVCF insertions per year decreased from 44,680 in 2013 to 19,501 in 2021, but the cumulative incidence of retrieval “remained low” at 15.3% after a median of 1.2 years, with an annual volume of around 4000, increasing to 16.8% at the maximum 9-year follow-up, the researchers report.
In the 30 days following IVCF insertion, 27.3% of patients experienced the primary safety composite outcome of all-cause death, filter-related complications, operating-room visits following the procedure, or a new diagnosis of deep vein thrombosis (DVT). The most common of these was mortality, at a rate of 14.6%, followed by operating room visits in 9.6%. The incidence of IVCF-related complications during insertion was infrequent, at 0.3%.
Among the patients who had their IVCFs inserted during the 60-day study period (30 days before and after IVCF insertion), 14.9% had them retrieved, mostly within 1 year, and more than 90% were successful, with few complications at 30 days post retrieval, at a rate of 3.9%. These included periprocedural operating room visits in 1.4%, mortality in 0.7%, filter-related complications in 0.7%, and DVT requiring hospitalization in 0.5%.
Among the patients whose IVCFs were not retrieved, 88.0% experienced the composite safety outcome at a maximum follow-up of 9 years, including 81.0% who died. A new DVT occurred in 21.2% of patients, including 9.2% who required hospitalization, while 2.2% experienced a caval thrombosis. Investigator Eric Secemsky (Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA) and colleagues say these findings support “current FDA recommendations for retrieval as soon as clinically feasible.”
The finding that only around one in six IVCFs were retrieved during follow-up despite the recommendations for retrieval “highlights a wide implementation gap that needs to be bridged between knowledge of the benefits of filter retrieval and initiatives to actually achieve timely retrieval,” say Secemsky et al.
In all, 14.0% of the study participants were Black and 52.8% were women. Many of the patients had comorbidities, including ischemic heart disease (64.5%), chronic kidney disease (57.7%), and malignancies (30.7%).
The likelihood of IVCF retrieval decreased with older age (hazard ratio [HR]=0.97), the presence of comorbidities such as heart failure (HR=0.72) or malignancies (HR=0.76), low income (HR=0.77), and self-reporting as Black (HR=0.77), whereas placement in a large or teaching hospital increased the likelihood of retrieval by 17–23%.
“These outcomes may be partly explained by structural barriers to care experienced by these vulnerable groups and higher comorbidity burden,” comment the researchers, adding that these findings warrant further investigation to achieve equitable outcomes.
Behnood Bikdeli (Harvard Medical School, Boston, Massachusetts, USA) and Joseph Ross (Yale School of Medicine, New Haven, Connecticut, USA) highlight some of the limitations of the SAFE-IVC study in a related editorial, including a lack of information on patients for whom filters may have been indicated but did not receive them, and that the results may not be applicable to younger patients whose outcomes after filter placement may differ.
They conclude that the study is an important step toward better understanding of IVCF use and safety, while emphasizing that “[e]fforts must continue to enhance medical device postmarketing safety surveillance.”
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JAMA 2024; doi:10.1001/jama.2024.19553
JAMA 2024; doi:10.1001/jama.2024.19542
