BACKGROUND: The United States Food and Drug Administration recently issued a warning about adverse events in patients receiving inferior vena cava (IVC) filters. OBJECTIVE: To assess relationships between IVC filter insertion and complications while controlling for differences in baseline patient characteristics and medical venous thromboembolism prophylaxis. DESIGN: Propensity-matched cohort study. SETTING: The prospective, statewide, clinical registry of the Michigan Bariatric Surgery Collaborative. PATIENTS: Bariatric surgery patients (n=35,477) from 32 hospitals during the years 2006 through 2012. INTERVENTION: Prophylactic IVC filter insertion. MEASUREMENTS: Outcomes included the occurrence of complications (pulmonary embolism, deep vein thrombosis, and overall combined rates of complications by severity) within 30 days of bariatric surgery. RESULTS: There were no significant differences in baseline characteristics among the 1,077 patients with IVC filters and in 1,077 matched control patients. Patients receiving IVC filters had higher rates of pulmonary embolism (0.84% vs 0.46%; odds ratio [OR], 2.0; 95% confidence interval [CI], 0.6-6.5; P=0.232), deep vein thrombosis (1.2% vs 0.37%; OR, 3.3; 95% CI, 1.1-10.1; P=0.039), venous thromboembolism (1.9% vs 0.74%; OR, 2.7; 95% CI, 1.1-6.3, P=0.027), serious complications (5.8% vs 3.8%; OR, 1.6; 95% CI, 1.0-2.4; P=0.031), permanently disabling complications (1.2% vs 0.37%; OR, 4.3; 95% CI, 1.2-15.6; P=0.028), and death (0.7% vs 0.09%; OR, 7.0; 95% CI, 0.9-57.3; P=0.068). Of the 7 deaths among patients with IVC filters, 4 were attributable to pulmonary embolism and 2 to IVC thrombosis/occlusion. CONCLUSIONS: We have identified no benefits and significant risks to the use of prophylactic IVC filters among bariatric surgery patients and believe that their use should be discouraged.
BACKGROUND: The United States Food and Drug Administration recently issued a warning about adverse events in patients receiving inferior vena cava (IVC) filters. OBJECTIVE: To assess relationships between IVC filter insertion and complications while controlling for differences in baseline patient characteristics and medical venous thromboembolism prophylaxis. DESIGN: Propensity-matched cohort study. SETTING: The prospective, statewide, clinical registry of the Michigan Bariatric Surgery Collaborative. PATIENTS: Bariatric surgery patients (n=35,477) from 32 hospitals during the years 2006 through 2012. INTERVENTION: Prophylactic IVC filter insertion. MEASUREMENTS: Outcomes included the occurrence of complications (pulmonary embolism, deep vein thrombosis, and overall combined rates of complications by severity) within 30 days of bariatric surgery. RESULTS: There were no significant differences in baseline characteristics among the 1,077 patients with IVC filters and in 1,077 matched control patients. Patients receiving IVC filters had higher rates of pulmonary embolism (0.84% vs 0.46%; odds ratio [OR], 2.0; 95% confidence interval [CI], 0.6-6.5; P=0.232), deep vein thrombosis (1.2% vs 0.37%; OR, 3.3; 95% CI, 1.1-10.1; P=0.039), venous thromboembolism (1.9% vs 0.74%; OR, 2.7; 95% CI, 1.1-6.3, P=0.027), serious complications (5.8% vs 3.8%; OR, 1.6; 95% CI, 1.0-2.4; P=0.031), permanently disabling complications (1.2% vs 0.37%; OR, 4.3; 95% CI, 1.2-15.6; P=0.028), and death (0.7% vs 0.09%; OR, 7.0; 95% CI, 0.9-57.3; P=0.068). Of the 7 deaths among patients with IVC filters, 4 were attributable to pulmonary embolism and 2 to IVC thrombosis/occlusion. CONCLUSIONS: We have identified no benefits and significant risks to the use of prophylactic IVC filters among bariatric surgery patients and believe that their use should be discouraged.
Authors: David R Anderson; Gian Paolo Morgano; Carole Bennett; Francesco Dentali; Charles W Francis; David A Garcia; Susan R Kahn; Maryam Rahman; Anita Rajasekhar; Frederick B Rogers; Maureen A Smythe; Kari A O Tikkinen; Adolph J Yates; Tejan Baldeh; Sara Balduzzi; Jan L Brożek; Itziar Etxeandia- Ikobaltzeta; Herman Johal; Ignacio Neumann; Wojtek Wiercioch; Juan José Yepes-Nuñez; Holger J Schünemann; Philipp Dahm Journal: Blood Adv Date: 2019-12-10