Dataset Information

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

ABSTRACT: 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.

SUBMITTER: Dake MD

PROVIDER: S-EPMC6556320 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

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

Dake Michael D MD Ansel Gary M GM Johnson Matthew S MS Mendes Robert R Smouse H Bob HB

International journal of vascular medicine 20190526

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 ...[more]

PMID: 31263598

Similar Datasets

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.

Project description:ImportanceVenous thromboembolism is the second overall leading cause of death for patients with cancer, and there is an approximately 2-fold increase in fatal pulmonary embolism (PE) in patients with cancer. Inferior vena cava (IVC) filters are designed to prevent PE, but defining the appropriate use of IVC filters in patients with cancer remains a substantial unmet clinical need.ObjectiveTo evaluate the association of IVC filters with the development of PE in patients with cancer and deep venous thrombosis (DVT).Design, setting, and participantsA population-based cohort study was conducted using administrative data on 88 585 patients from the state inpatient databases for California (2005-2011) and Florida (2005-2014). Based on diagnostic and procedure codes, patients with cancer and acute lower extremity DVT were identified. All subsequent hospital visits for these patients were evaluated for the placement of an IVC filter, the development of new PE, the development of new DVT, and in-hospital mortality. Data analysis was performed from September 1 to December 1, 2019.ExposuresPlacement of an IVC filter.Main outcomes and measuresThe association of IVC filter placement with rates of new PE and DVT was estimated using a propensity score matching algorithm and competing risk analysis.ResultsThe study cohort comprised 88 585 patients (45 074 male; median age, 71.0 years [range, 1.0-104.0 years]) with malignant neoplasms who presented to a health care institution with a diagnosis of acute lower extremity DVT. Of these patients, 33 740 (38.1%) underwent IVC filter placement; patients with risk factors such as upper gastrointestinal bleeding (odds ratio, 1.32; 95% CI, 1.29-1.37), intracranial hemorrhage (odds ratio, 1.21; 95% CI, 1.19-1.24), and coagulopathy (odds ratio, 1.09; 95% CI, 1.08-1.10) were more likely to receive an IVC filter. A total of 4492 patients (5.1%) developed a new PE after their initial DVT diagnosis. There was a significant improvement in PE-free survival for these patients compared with those who did not receive IVC filters across the full, unbalanced study cohort as well as after propensity score matching and competing risk analysis (hazard ratio, 0.69; 95% CI, 0.64-0.75; P < .001). Furthermore, IVC filter placement reduced the development of PE in patients with very high-risk malignant neoplasms (eg, pancreaticobiliary cancer), high-risk malignant neoplasms (eg, lung cancer), and low-risk malignant neoplasms (eg, prostate cancer). After accounting for anticoagulation use and imbalanced risk factors, IVC filter placement did not increase the risk of new DVT development.Conclusions and relevanceThis study suggests that, for patients with cancer and DVT and bleeding risk factors, IVC filter placement is associated with an increased rate of PE-free survival.

Dataset Information

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

Publications

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

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets