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The Clinical Rationale for the Sentry Bioconvertible Inferior Vena Cava Filter for the Prevention of Pulmonary Embolism.
Int J Vasc Med 2019; 2019:5795148IJ

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.

Authors+Show Affiliations

Departments of Medical Imaging and of Surgery, University of Arizona Health Sciences, Tucson, Arizona, USA.Department of Cardiology & Vascular Medicine, OhioHealth/Riverside Methodist Hospital, Columbus, Ohio, USA.Department of Vascular & Interventional Radiology, Indiana University School of Medicine, Indianapolis, Indiana, USA.Department of Vascular Surgery, UNC Rex Hospital, NC Heart and Vascular Research, Raleigh, North Carolina, USA.Department of Interventional Radiology, OSF Saint Francis Medical Center, Peoria, Illinois, USA.

Pub Type(s)

Journal Article
Review

Language

eng

PubMed ID

31263598

Citation

Dake, Michael D., et al. "The Clinical Rationale for the Sentry Bioconvertible Inferior Vena Cava Filter for the Prevention of Pulmonary Embolism." International Journal of Vascular Medicine, vol. 2019, 2019, p. 5795148.
Dake MD, Ansel GM, Johnson MS, et al. The Clinical Rationale for the Sentry Bioconvertible Inferior Vena Cava Filter for the Prevention of Pulmonary Embolism. Int J Vasc Med. 2019;2019:5795148.
Dake, M. D., Ansel, G. M., Johnson, M. S., Mendes, R., & Smouse, H. B. (2019). The Clinical Rationale for the Sentry Bioconvertible Inferior Vena Cava Filter for the Prevention of Pulmonary Embolism. International Journal of Vascular Medicine, 2019, p. 5795148. doi:10.1155/2019/5795148.
Dake MD, et al. The Clinical Rationale for the Sentry Bioconvertible Inferior Vena Cava Filter for the Prevention of Pulmonary Embolism. Int J Vasc Med. 2019;2019:5795148. PubMed PMID: 31263598.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - The Clinical Rationale for the Sentry Bioconvertible Inferior Vena Cava Filter for the Prevention of Pulmonary Embolism. AU - Dake,Michael D, AU - Ansel,Gary M, AU - Johnson,Matthew S, AU - Mendes,Robert, AU - Smouse,H Bob, Y1 - 2019/05/26/ PY - 2019/01/21/received PY - 2019/03/27/accepted PY - 2019/7/3/entrez PY - 2019/7/3/pubmed PY - 2019/7/3/medline SP - 5795148 EP - 5795148 JF - International journal of vascular medicine JO - Int J Vasc Med VL - 2019 N2 - 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. SN - 2090-2824 UR - https://www.unboundmedicine.com/medline/citation/31263598/The_Clinical_Rationale_for_the_Sentry_Bioconvertible_Inferior_Vena_Cava_Filter_for_the_Prevention_of_Pulmonary_Embolism L2 - https://dx.doi.org/10.1155/2019/5795148 DB - PRIME DP - Unbound Medicine ER -