Pulmonary vascular disease & thromboembolism

Postmarketing Surveillance of Inferior Vena Cava Filters Among US Medicare Beneficiaries: The SAFE-IVC Study

JAMAPublished Retrospective cohort study

Authors' conclusion

In this large, US real-world analysis, IVCF insertion declined, yet retrievals remained low.

Study context

Population
US Medicare Fee-for-Service (FFS) beneficiaries with first-time IVC filter insertion, 2013–2021
Participants
270,866 beneficiaries
Outcome
Composite of:
  • All-cause death
  • Filter-related complications
  • Operating room visits after filter-related procedures
  • New DVT (periprocedural ≤30 days; long-term >30 days)
Methodological detailsprespecified, observational, Medicare FFS claims, 100% sample
  • Prespecified
  • Observational
  • Medicare FFS claims, 100% sample

Main finding

As reported in the abstract

IVCF insertions per year, 2013

44 680

IVCF insertions per year, 2021

19 501

Cumulative incidence of retrieval at median 1.2 years

15.3%

Cumulative incidence of retrieval at maximum follow-up of 9.0 years

16.8%

Observational data: associations, not effects.

Further findings

Indication for insertion

First-time venous thromboembolism (VTE)
64.9%
Recurrent VTE
26.3%
VTE prophylaxis
8.8%
Major bleeds or trauma within 30 days of insertion
63.3%

Predictors of retrieval

Older age, more comorbidities and Black race associated with decreased likelihood of retrieval; placement at a large teaching hospital with increased likelihood

Retrieval success

Successful retrieval attempts
93.5%

Safety

Caval thrombosis and DVT, nonretrieved inferior vena cava filters (IVCFs)

Caval thrombosis
2.2% (95% CI, 2.1%-2.3%)
DVT
9.2% (95% CI, 9.0%-9.3%)

30-day complications after retrieval

Mortality
0.7% [95% CI, 0.6%-0.8%]
Filter-related complications
1.4% [95% CI, 1.2%-1.5%]

Original publication

Postmarketing Surveillance of Inferior Vena Cava Filters Among US Medicare Beneficiaries: The SAFE-IVC Study. JAMA. Published 24 December 2024. doi:10.1001/jama.2024.19553

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