John R Power1, Kenneth R Nakazawa1, Ageliki G Vouyouka2, Peter L Faries2, Natalia N Egorova3. 1. Department of Medical Education, Icahn School of Medicine at Mount Sinai, New York, NY. 2. Division of Vascular Surgery, Icahn School of Medicine at Mount Sinai, New York, NY. 3. Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, NY. Electronic address: natalia.egorova@mountsinai.org.
Abstract
BACKGROUND: Prophylactic vena cava filter (VCF) use in patients without venous thromboembolism is common practice despite ongoing controversy. Thorough analysis of the evolution of this practice is lacking. We describe trends in VCF use and identify events associated with changes in practice. METHODS: Using the National Inpatient Sample, we conducted a retrospective observational study of U.S. adult hospitalizations from 2000 to 2014. Trends in prophylactic VCF insertion were analyzed both across the entire study population and within subgroups according to trauma status and type of concurrent surgery. Annual percentage change (APC) was calculated, and trends were analyzed using Poisson regression. RESULTS: Among 461,904,314 adult inpatients (median [interquartile range] age, 58.1 [38.5-74.3] years; 39.6% male), the incidence of VCF insertion increased rapidly at first (from 0.19% to 0.35%; APC, 11.2%; 95% confidence interval [CI], 10.3%-12.2%; P < .001), then at a slower rate after the publication of the Prévention du Risque d'Embolie Pulmonaire par Interruption Cave 2 (PREPIC2) trial in 2005 (from 0.35% to 0.42%; APC, 4.4%; 95% CI, 2.8%-6.0%; P < .001), and it began decreasing after the 2010 Food and Drug Administration (FDA) safety alert (from 0.42% to 0.32%; APC, -5.5%; 95% CI, -6.5% to -4.6%; P < .001). The percentage of total VCFs that had a prophylactic indication increased quickly before publication of the PREPIC2 trial (APC, 19.5%; 95% CI, 17.9%-21.0%; P < .001), increased at a slower rate after publication in 2005 (APC, 4.4%; 95% CI, 2.6%-6.2%; P < .001), and dropped after the FDA safety alert, stabilizing at 18.5% for the last 3 years (APC, -0.3%; 95% CI, -2.2% to 1.7%; P = .8). Subgroups most associated with prophylactic VCF insertion were operative trauma (odds ratio [OR], 10.9; 95% CI, 10.2-11.7), orthopedic surgery (OR, 4.7; 95% CI, 4.3-5.2), and neurosurgical procedures (OR, 3.9; 95% CI, 3.6-4.2). All groups except orthopedic surgery experienced a deceleration in prophylactic VCF growth after the publication of PREPIC2. Meanwhile, the FDA safety alert was associated with a decrease in prophylactic VCF insertions for all groups except other major surgery. CONCLUSIONS: Whereas publication of the PREPIC2 trial led to a deceleration in prophylactic VCF insertion growth, the FDA alert had a bigger impact, leading to declining rates of prophylactic VCF use. Further investigations of prophylactic insertion of VCF in trauma, orthopedic, and neurosurgical patients are needed to determine whether current levels of use are justified.
BACKGROUND: Prophylactic vena cava filter (VCF) use in patients without venous thromboembolism is common practice despite ongoing controversy. Thorough analysis of the evolution of this practice is lacking. We describe trends in VCF use and identify events associated with changes in practice. METHODS: Using the National Inpatient Sample, we conducted a retrospective observational study of U.S. adult hospitalizations from 2000 to 2014. Trends in prophylactic VCF insertion were analyzed both across the entire study population and within subgroups according to trauma status and type of concurrent surgery. Annual percentage change (APC) was calculated, and trends were analyzed using Poisson regression. RESULTS: Among 461,904,314 adult inpatients (median [interquartile range] age, 58.1 [38.5-74.3] years; 39.6% male), the incidence of VCF insertion increased rapidly at first (from 0.19% to 0.35%; APC, 11.2%; 95% confidence interval [CI], 10.3%-12.2%; P < .001), then at a slower rate after the publication of the Prévention du Risque d'Embolie Pulmonaire par Interruption Cave 2 (PREPIC2) trial in 2005 (from 0.35% to 0.42%; APC, 4.4%; 95% CI, 2.8%-6.0%; P < .001), and it began decreasing after the 2010 Food and Drug Administration (FDA) safety alert (from 0.42% to 0.32%; APC, -5.5%; 95% CI, -6.5% to -4.6%; P < .001). The percentage of total VCFs that had a prophylactic indication increased quickly before publication of the PREPIC2 trial (APC, 19.5%; 95% CI, 17.9%-21.0%; P < .001), increased at a slower rate after publication in 2005 (APC, 4.4%; 95% CI, 2.6%-6.2%; P < .001), and dropped after the FDA safety alert, stabilizing at 18.5% for the last 3 years (APC, -0.3%; 95% CI, -2.2% to 1.7%; P = .8). Subgroups most associated with prophylactic VCF insertion were operative trauma (odds ratio [OR], 10.9; 95% CI, 10.2-11.7), orthopedic surgery (OR, 4.7; 95% CI, 4.3-5.2), and neurosurgical procedures (OR, 3.9; 95% CI, 3.6-4.2). All groups except orthopedic surgery experienced a deceleration in prophylactic VCF growth after the publication of PREPIC2. Meanwhile, the FDA safety alert was associated with a decrease in prophylactic VCF insertions for all groups except other major surgery. CONCLUSIONS: Whereas publication of the PREPIC2 trial led to a deceleration in prophylactic VCF insertion growth, the FDA alert had a bigger impact, leading to declining rates of prophylactic VCF use. Further investigations of prophylactic insertion of VCF in trauma, orthopedic, and neurosurgical patients are needed to determine whether current levels of use are justified.
Keywords:
Deep vein thrombosis; FDA; Food and Drug Administration; NIS; National Inpatient Sample; Pulmonary embolism; Vena cava filter; Venous thromboembolism
Authors: Ingrid M Bistervels; Abby E Geerlings; Peter I Bonta; Wessel Ganzevoort; IJsbrand A J Zijlstra; Saskia Middeldorp Journal: Blood Adv Date: 2021-10-26