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Thursday, November 1, 2018

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


Summary


Complications associated with Inferior Vena Cava (IVC) filters including Caval thrombosis, device tilting, fracture, migration, embolization, IVC perforation and death are well established and occur with increasing frequency with longer filter indwelling time. Unfortunately, despite increased awareness and filter follow up initiatives, as many as 65-80% of retrievable filters remain in place. The Sentry (Novate Medical, Galway, Ireland) IVC filter is designed to provide temporary protection against PE during transient high-risk periods and then bioconvert, avoiding the need for a second (retrieval) intervention and leaving behind a patent IVC lumen. Bioconversion occurs after approximately 60 days with hydrolysis of an absorbable filament that holds the filter arms together, allows them to retract against the IVC wall.  

This is a prospective, multi-center evaluation including 23 sites and 129 patients from the United States, Belgium and Chile. Early experience with the Sentry IVC filter, including safety and efficacy of the device and success with subsequent bioconversion were studied. Patients included were those with deep vein thrombosis or PE, or at temporary risk for venous thromboembolism and PE who could not use anticoagulation. The primary end point was clinical success, including filter deployment, freedom from new symptomatic PE before filter bioconversion at 60 days and filter related complications.  

Clinical success was achieved in 111 of 114 patients. There were no new cases of PE identified through 12 months of follow up. 2 patients developed symptomatic IVC thrombosis within the first month, which did not recur after successful intervention. There were no filter related complications through 12 months. Filter bioconversion was successful in 110/115 patients (95.7%) at 6-months and 106/100 patients (96.4%) at 12-months.



Figure 1
Photographs of the Sentry IVC filter in coronal view and representations of the axial view: (left) filtering configuration; (right) bioconverted configuration. In the filtering configuration, the 6 pairs of filter arms are held together in the center of the lumen by means of the bioabsorbable filament composed of poly-p-dioxanone. In the bioconverted configuration, the bioabsorbable filament will have been degraded via hydrolysis, allowing the filter arms to release from the cone and retract toward the IVC wall to be endothelialized, leaving an unobstructed IVC lumen.  

Commentary


This prospective, multi-center single arm evaluation of the bioconvertible Sentry filter is an interesting early experience with this device. The complications of IVC filters are widely established and even with a push towards aggressive follow up and filter retrieval, a large proportion of filters remain in place. This bioconvertible device negates the need for a second retrieval procedure in that automatic filter conversion occurs after approximately 2 months, leaving an intact IVC lumen. One potential downside of the device is that the filter does in fact remain in place in the patient’s IVC following bioconversion and so long-term patency and changes in IVC diameter at this level, as well as other potential complications will need extended evaluation. The authors reported that this will be addressed at the 24-month follow up as CT venography will be performed at that time. Additionally, patients who develop a new indication for IVC filtration following bioconversion could be an interesting point of discussion. Does the bioconverted device endothelialize to a point allowing subsequent filter placement at that level or does a new filter need to be placed above or below the bioconverted device, as was done in 2 patients in this study? Some self-reported limitations include its non-randomized, single-arm design as well as the inherent potential bias of a manufacturer funded regulatory device trial. Overall the safety and efficacy of this device appear to be acceptable and in-line with retrievable IVC filters that are available. Bioconversion rates are high and this novel IVC filtration option may prove to be ideal for some patients.   

Click here for abstract

Dake M, Murphy T, Kramer A, Darcy M, Sewall L, Curi M, Johnson M, Arena F, Swischuk J, Ansel G, Silver M, Saddekni S, Brower J, and Mendes R. One Year Analysis of the Prospective Multicenter SENTRY Clinical Trial: Safety and Effectiveness of the Novate Sentry Bioconvertible Inferior Vena Cava Filter. J Vasc Interv Radiol. 2018 Oct;29(10):1350-1361

Post Author:
Jordan Tasse, MD
Assistant Professor, Vascular and Interventional Radiology
Associate Program Director, Integrated VIR residency and VIR fellowship programs
Rush University Medical Center, Chicago, IL
Email: Jordan_C_Tasse@Rush.edu
Twitter: @JTassMD, @VIR_RUSH

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