Sentry Bioconvertible Inferior Vena Cava Filter: Study of Stages of Incorporation in an Experimental Ovine Model

Gaines, Peter A.; Kolodgie, Frank D.; Crowley, Gordon; Horan, Steven; MacDonagh, Megan; E, McLucas; Rosenthal, David; Strong, Ashley; Sweet, Michael; Panchal, Deepal K.

doi:10.1155/2018/6981505

Cited by 6 publications

(7 citation statements)

References 39 publications

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“…There were no filter-related deaths through 24 months of follow-up. Through 24 months of followup, there was no evidence of late-stage IVC obstruction or thrombosis after filter bioconversion or of thrombogenicity associated with retracted filter arms, which was a finding that confirmed the results of preclinical studies with the device in an experimental ovine model (23). There was no PE experienced by any patient who had thrombus in the filter in the protocolmandated 1-month CT venography (see Appendix C [available online on the article's Supplemental Material page at www.jvir.…”

Section: Discussionsupporting

confidence: 73%

Final Two-Year Outcomes for the Sentry Bioconvertible Inferior Vena Cava Filter in Patients Requiring Temporary Protection from Pulmonary Embolism

Dake

Murphy

Krämer

et al. 2020

Journal of Vascular and Interventional Radiology

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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 ¼ 126) through 1 year and 2.4% (n ¼ 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 filterrelated 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.

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Section: Discussionsupporting

confidence: 73%

Final Two-Year Outcomes for the Sentry Bioconvertible Inferior Vena Cava Filter in Patients Requiring Temporary Protection from Pulmonary Embolism

Dake

Murphy

Krämer

et al. 2020

Journal of Vascular and Interventional Radiology

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“…The results of the animal studies have been reported by Gaines et al [59]. In all 24 animals that received study devices, deployment and positioning in the filtering configuration in the center of the IVC lumen were successful, and pre- and posttermination examinations confirmed that all filters had bioconverted as intended, leaving the IVC lumens patent.…”

Section: Sentry Ivc Filter Description and Performancementioning

confidence: 61%

“…The reasons for the nonconversion of the Sentry IVC filter in 4 patients as of 12-month follow-up cannot be accurately determined. In preclinical studies, the presence of fibrin strands was occasionally noted at the ends of filter arm, and such a circumstance could delay or prevent separation of the arms [59]. In context, however, the 96.4% rate of bioconversion far surpasses reported retrieval rates for IVC filters [3, 9, 10].…”

Section: Sentry Ivc Filter Description and Performancementioning

confidence: 99%

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The Clinical Rationale for the Sentry Bioconvertible Inferior Vena Cava Filter for the Prevention of Pulmonary Embolism

Dake

Johnson

Mendes

et al. 2019

International Journal of Vascular Medicine

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The Sentry inferior vena cava (IVC) filter is designed to provide temporary protection against pulmonary embolism (PE) during transient high-risk periods and then to bioconvert after 60 days after implantation. At the time of bioconversion, the device’s nitinol arms retract from the filtering position into the caval wall. Subsequently, the stable stent-like nitinol frame is endothelialized. The Sentry bioconvertible IVC filter has been evaluated in a multicenter investigational-device-exemption pivotal trial (NCT01975090) of 129 patients with documented deep vein thrombosis (DVT) or PE, or at temporary risk of developing DVT or PE, and with contraindications to anticoagulation. Successful filter conversion was observed in 95.7% of patients at 6 months (110/115) and 96.4% at 12 months (106/110). Through 12 months, there were no cases of symptomatic PE. The rationale for development of the Sentry bioconvertible device includes the following considerations: (1) the period of highest risk of PE for the vast majority of patients occurs within the first 60 days after an index event, with most of the PEs occurring in the first 30 days; (2) the design of retrievable IVC filters to support their removal after a transitory high-PE-risk period has, in practice, been associated with insecure filter dynamics and time-dependent complications including tilting, fracture, embolization, migration, and IVC perforation; (3) most retrievable IVC filters are placed for temporary protection, but for a variety of reasons they are not removed in any more than half of implanted patients, and when removal is attempted, the procedure is not always successful even with advanced techniques; and (4) analysis of Medicare hospital data suggests that payment for the retrieval procedure does not routinely compensate for expense. The Sentry device is not intended for removal after bioconversion. In initial clinical use, complications have been limited. Long-term results for the Sentry bioconvertible IVC filter are anticipated soon.

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“…devices were all bioconverted and stably incorporated, leaving all IVCs patent (23). Interim results are reported here from a prospective trial undertaken to evaluate the safety and efficacy of the Sentry IVC filter in patients with documented DVT or PE, or at temporary risk of developing DVT or PE, and with a contraindication to anticoagulation.…”

mentioning

confidence: 99%

One-Year Analysis of the Prospective Multicenter SENTRY Clinical Trial: Safety and Effectiveness of the Novate Sentry Bioconvertible Inferior Vena Cava Filter

Investigators

2018

Journal of Vascular and Interventional Radiology

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Sentry Bioconvertible Inferior Vena Cava Filter: Study of Stages of Incorporation in an Experimental Ovine Model

Cited by 6 publications

References 39 publications

Final Two-Year Outcomes for the Sentry Bioconvertible Inferior Vena Cava Filter in Patients Requiring Temporary Protection from Pulmonary Embolism

Final Two-Year Outcomes for the Sentry Bioconvertible Inferior Vena Cava Filter in Patients Requiring Temporary Protection from Pulmonary Embolism

The Clinical Rationale for the Sentry Bioconvertible Inferior Vena Cava Filter for the Prevention of Pulmonary Embolism

One-Year Analysis of the Prospective Multicenter SENTRY Clinical Trial: Safety and Effectiveness of the Novate Sentry Bioconvertible Inferior Vena Cava Filter

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