Final Two-Year Outcomes for the Sentry Bioconvertible Inferior Vena Cava Filter in Patients Requiring Temporary Protection from Pulmonary Embolism
| Autor: | Michael D. Dake, Timothy P. Murphy, Albrecht H. Krämer, Michael D. Darcy, Luke E. Sewall, Michael A. Curi, Matthew S. Johnson, Frank Arena, James L. Swischuk, Gary M. Ansel, Mitchell J. Silver, Souheil Saddekni, Jayson S. Brower, Robert Mendes, Robert Feezor, Sanjeeva Kalva, Darren Kies, Marc Bosiers, Werner Ziegler, Mark Farber, David Paolini, Robert Spillane, Steven Jones, Patrick Peeters |
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| Rok vydání: | 2020 |
| Předmět: |
Adult
Male medicine.medical_specialty Time Factors Vena Cava Filters Computed Tomography Angiography Deep vein Perforation (oil well) Inferior vena cava filter Vena Cava Inferior Prosthesis Design Inferior vena cava 030218 nuclear medicine & medical imaging Prosthesis Implantation Young Adult 03 medical and health sciences 0302 clinical medicine Belgium Risk Factors Multicenter trial medicine Humans Radiology Nuclear Medicine and imaging Chile Aged Aged 80 and over Venous Thrombosis business.industry Phlebography Middle Aged medicine.disease Thrombosis United States Pulmonary embolism Surgery Venous thrombosis Treatment Outcome medicine.anatomical_structure medicine.vein 030220 oncology & carcinogenesis Female Pulmonary Embolism Cardiology and Cardiovascular Medicine business |
| Zdroj: | Journal of Vascular and Interventional Radiology. 31:221-230.e3 |
| ISSN: | 1051-0443 |
| DOI: | 10.1016/j.jvir.2019.08.036 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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