artículo
Final Two-Year Outcomes for the Sentry Bioconvertible Inferior Vena Cava Filter in Patients Requiring Temporary Protection from Pulmonary Embolism
Fecha
2020Registro en:
10.1016/j.jvir.2019.08.036
1535-7732
1051-0443
MEDLINE:31711748
WOS:000514221100005
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
Institución
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.