Dataset Information

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

ABSTRACT: The Sentry inferior vena cava (IVC) filter is designed to provide temporary protection from pulmonary embolism (PE) and then bioconvert to become incorporated in the vessel wall, leaving a patent IVC lumen. Objective. To evaluate the performance and stages of incorporation of the Sentry IVC filter in an ovine model. Methods. Twenty-four bioconvertible devices and 1 control retrievable filter were implanted in the infrarenal IVC of 25 sheep, with extensive daily monitoring and intensive imaging. Vessels and devices were analyzed at early (?98 days, n = 10) and late (180 ± 30 days, n = 14 study devices, 1 control) termination and necropsy time-points. Results. Deployment success was 100% with all devices confirmed in filtering configuration, there were no filter-related complications, and bioconversion was 100% at termination with vessels widely patent. By 98 days for all early-incorporation analysis animals, the stabilizing cylindrical part of the Sentry frame was incorporated in the vessel wall, and the filter arms were retracted. By 180 days for all late-incorporation analysis animals, the filter arms as well as frames were stably incorporated. Conclusions. Through 180 days, there were no filter-related complications, and the study devices were all bioconverted and stably incorporated, leaving all IVCs patent.

SUBMITTER: Gaines PA

PROVIDER: S-EPMC6077616 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature

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

Gaines Peter A PA Kolodgie Frank D FD Crowley Gordon G Horan Steven S MacDonagh Megan M McLucas Emily E Rosenthal David D Strong Ashley A Sweet Michael M Panchal Deepal K DK

International journal of vascular medicine 20180719

The Sentry inferior vena cava (IVC) filter is designed to provide temporary protection from pulmonary embolism (PE) and then bioconvert to become incorporated in the vessel wall, leaving a patent IVC lumen. <i>Objective.</i> To evaluate the performance and stages of incorporation of the Sentry IVC filter in an ovine model. <i>Methods.</i> Twenty-four bioconvertible devices and 1 control retrievable filter were implanted in the infrarenal IVC of 25 sheep, with extensive daily monitoring and inten ...[more]

PMID: 30112213

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Project description: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.

Project description:Background: Previous observational studies suggest that inferior vena cava filter placement in pulmonary embolism patients complicated with congestive heart failure, mechanical ventilation, and shock may have a mortality benefit. We sought to analyze the survival benefits of inferior vena cava filter in pulmonary embolism patients complicated with acute myocardial infarction, acute respiratory failure, shock, or requiring treatment with thrombolytics. Methods: This retrospective observational study used hospital discharge data from the National Inpatient Sample Data (NIS). ICD-9-CM coding was used to identify complicated pulmonary embolism patients (N = 254,465) in NIS from 2002 to 2014, including the subgroups of acute myocardial infarction, acute respiratory failure, shock, and thrombolytics. Inferior vena cava filter recipients were 1:1 propensity score-matched on age, sex, race, deep vein thrombosis, Elixhauser comorbidities, and other pulmonary embolism comorbidities (45 covariates) to non-inferior vena cava filter recipients in complicated pulmonary embolism patients and separately in each subgroup. Clinical outcomes were compared between the inferior vena cava filter group and the non-inferior vena cava filter group. Results: Mortality rate in complicated pulmonary embolism patients with inferior vena cava filter placement was lower (20.9% vs. 33%; NNT = 8.28, 95% confidence interval (CI) 7.91-8.69, E-value = 2.53) and in the subgroups; acute myocardial infarction (17.9% vs. 30.1%; NNT = 8.19, 95% CI 7.52-8.92, E-value = 2.76), acute respiratory failure (19.5% vs. 29.7%; NNT = 9.76, 95% CI 8.67-11.16, E-value = 2.38), shock (30.7% vs. 47.1%; NNT = 6.08, 95% CI 5.73-6.47, E-value = 2.43), and with the use of thrombolytics (7% vs. 12.9 %; NNT 17.1, 95% CI 14.88-20.12, E-value = 3.01) (p < 0.001 for all). Conclusion: Inferior vena cava filter placement in pulmonary embolism complicated with acute myocardial infarction, acute respiratory failure, shock, or requiring thrombolytic therapy was associated with reduced mortality.

Dataset Information

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

Publications

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

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