Michael D Dake1, Timothy P Murphy2, Albrecht H Krämer3, Michael D Darcy4, Luke E Sewall5, Michael A Curi6, Matthew S Johnson7, Frank Arena8, James L Swischuk9, Gary M Ansel10, Mitchell J Silver11, Souheil Saddekni12, Jayson S Brower13, Robert Mendes14. 1. Department of Cardiothoracic Surgery, Stanford University School of Medicine, Falk Cardiovascular Research Center, 300 Pasteur Drive, Stanford, CA 94305. Electronic address: mddake@email.arizona.edu. 2. Department of Vascular & Interventional Radiology, Rhode Island Hospital, Providence, Rhode Island. 3. Department of Vascular & Endovascular Surgery, Pontificia Universidad Católica de Chile, Santiago, Chile. 4. Department of Vascular & Interventional Radiology, Washington University, St. Louis, Missouri. 5. Department of Vascular & Interventional Radiology, Adventist Midwest Health, Hinsdale, Illinois. 6. Department of Vascular Surgery, Rutgers-New Jersey Medical School, Newark, New Jersey. 7. Department of Vascular & Interventional Radiology, Indiana University, Indianapolis, Indiana. 8. Department of Cardiac & Vascular Disease, Lakeview Regional Heart Center, Covington, Louisiana. 9. Department of Vascular & Interventional Radiology, OSF Saint Francis Medical Center, Peoria, Illinois. 10. Department of Interventional Cardiology & Vascular Medicine, Riverside Methodist Hospital, Columbus, Ohio. 11. Department of Interventional Cardiology &Vascular Medicine, OhioHealth Heart and Vascular Physicians, Columbus, Ohio. 12. Department of Interventional Radiology & Oncology, University of Alabama, Birmingham, Alabama. 13. Department of Vascular & Interventional Radiology, Providence Sacred Heart Medical Center, Spokane, Washington. 14. Department of Vascular Surgery, UNC Rex Hospital, NC Heart and Vascular Research, Raleigh, North Carolina.
Abstract
PURPOSE: To report final 2-year outcomes with the Sentry bioconvertible inferior vena cava (IVC) filter in patients requiring temporary protection against pulmonary embolism (PE). MATERIALS AND METHODS: In a prospective multicenter trial, the Sentry filter was implanted in 129 patients with documented deep vein thrombosis (DVT) and/or PE (67.5%) or who were at temporary risk of developing DVT/PE (32.6%). Patients were monitored and bioconversion status ascertained by radiography, computed tomography (CT), and CT venography through 2 years. RESULTS: The composite primary 6-month endpoint of clinical success was achieved in 97.4% (111/114) of patients. The rate of new symptomatic PE was 0% (n = 126) through 1 year and 2.4% (n = 85) through the second year of follow-up, with 2 new nonfatal cases at 581 and 624 days that were adjudicated as not related to the procedure or device. Two patients (1.6%) developed symptomatic caval thrombosis during the first month and underwent successful interventions without recurrence. No other filter-related symptomatic complications occurred through 2 years. There was no filter tilting, migration, embolization, fracture, or caval perforation and no filter-related deaths through 2 years. Filter bioconversion was successful for 95.7% (110/115) of patients at 6 months, 96.4% (106/110) of patients at 12 months, and 96.5% (82/85) of patients at 24 months. Through 24 months of follow-up, there was no evidence of late-stage IVC obstruction or thrombosis after filter bioconversion or of thrombogenicity associated with retracted filter arms. CONCLUSIONS: The Sentry IVC filter provided safe and effective protection against PE, with a high rate of intended bioconversion and a low rate of device-related complications, through 2 years of follow-up.
PURPOSE: To report final 2-year outcomes with the Sentry bioconvertible inferior vena cava (IVC) filter in patients requiring temporary protection against pulmonary embolism (PE). MATERIALS AND METHODS: In a prospective multicenter trial, the Sentry filter was implanted in 129 patients with documented deep vein thrombosis (DVT) and/or PE (67.5%) or who were at temporary risk of developing DVT/PE (32.6%). Patients were monitored and bioconversion status ascertained by radiography, computed tomography (CT), and CT venography through 2 years. RESULTS: The composite primary 6-month endpoint of clinical success was achieved in 97.4% (111/114) of patients. The rate of new symptomatic PE was 0% (n = 126) through 1 year and 2.4% (n = 85) through the second year of follow-up, with 2 new nonfatal cases at 581 and 624 days that were adjudicated as not related to the procedure or device. Two patients (1.6%) developed symptomatic caval thrombosis during the first month and underwent successful interventions without recurrence. No other filter-related symptomatic complications occurred through 2 years. There was no filter tilting, migration, embolization, fracture, or caval perforation and no filter-related deaths through 2 years. Filter bioconversion was successful for 95.7% (110/115) of patients at 6 months, 96.4% (106/110) of patients at 12 months, and 96.5% (82/85) of patients at 24 months. Through 24 months of follow-up, there was no evidence of late-stage IVC obstruction or thrombosis after filter bioconversion or of thrombogenicity associated with retracted filter arms. CONCLUSIONS: The Sentry IVC filter provided safe and effective protection against PE, with a high rate of intended bioconversion and a low rate of device-related complications, through 2 years of follow-up.
Authors: Gerard Lambe; Johnny O' Mahony; Michael Courtney; Noel Donlon; Claire Donohoe; JMark Ryan Journal: Ir J Med Sci Date: 2021-11-02 Impact factor: 2.089