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).
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Autor | Dake, Michael D. Murphy, Timothy P. Kramer, Albrecht H. Darcy, Michael D. Sewall, Luke E. Curi, Michael A. Johnson, Matthew S. Arena, Frank Swischuk, James L. Ansel, Gary M. Silver, Mitchell J. Saddekni, Souheil Brower, Jayson S. Mendes, Robert Feezor, Robert Kalva, Sanjeeva Kies, Darren Bosiers, Marc Ziegler, Werner Farber, Mark Paolini, David Spillane, Robert Jones, Steven Peeters, Patrick SENTRY Trial Investigators |
Título | Final Two-Year Outcomes for the Sentry Bioconvertible Inferior Vena Cava Filter in Patients Requiring Temporary Protection from Pulmonary Embolism |
Revista | JOURNAL OF VASCULAR AND INTERVENTIONAL RADIOLOGY |
ISSN | 1051-0443 |
ISSN electrónico | 1535-7732 |
Volumen | 31 |
Número de publicación | 2 |
Página inicio | 221 |
Página final | 230 |
Fecha de publicación | 2020 |
Resumen | 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. |
Derechos | acceso abierto |
Agencia financiadora | BTG Vascular (Bothell, Washington) |
DOI | 10.1016/j.jvir.2019.08.036 |
Editorial | ELSEVIER SCIENCE INC |
Enlace | |
Id de publicación en Pubmed | MEDLINE:31711748 |
Id de publicación en WoS | WOS:000514221100005 |
Paginación | 10 páginas |
Palabra clave | DENALI TRIAL COMPLICATIONS MULTICENTER PLACEMENT TRAUMA |
Tema ODS | 03 Good Health and Well-being |
Tema ODS español | 03 Salud y bienestar |
Tipo de documento | artículo |