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Research Papers

Feasibility and Acute Safety Study of Radiofrequency Energy Delivery to the Vena Caval Wall Via an Inferior Vena Cava Filter in Swine

[+] Author and Article Information
Reza Seifabadi

Center for Interventional Oncology,
Radiology, and Imaging Sciences,
Clinical Center,
National Institutes of Health,
10 Center Drive,
Room 3N320, MSC 1182,
Bethesda, MD 20892
e-mail: reza.seifabadi@nih.gov

William F. Pritchard

Center for Interventional Oncology,
Radiology, and Imaging Sciences,
Clinical Center,
National Institutes of Health,
Bethesda, MD 20892
e-mail: william.pritchard@nih.gov

Shelby Leonard

Center for Interventional Oncology,
Radiology, and Imaging Sciences,
Clinical Center,
National Institutes of Health,
Bethesda, MD 20892
e-mail: shelby.leonard726@gmail.com

Ivane Bakhutashvili

Center for Interventional Oncology,
Radiology, and Imaging Sciences,
Clinical Center,
National Institutes of Health,
Bethesda, MD 20892
e-mail: ivane.bakhutashvili@nih.gov

David L. Woods

Center for Interventional Oncology,
Radiology, and Imaging Sciences,
Clinical Center,
National Institutes of Health,
Bethesda, MD 20892
e-mail: dlw38@cornell.edu

Juan A. Esparza-Trujillo

Center for Interventional Oncology,
Radiology, and Imaging Sciences,
Clinical Center,
National Institutes of Health,
Bethesda, MD 20892
e-mail: juan.esparza.trujillo@nih.gov

John W. Karanian

Center for Interventional Oncology,
Radiology, and Imaging Sciences,
Clinical Center,
National Institutes of Health,
Bethesda, MD 20892
e-mail: john.karanian@nih.gov

Bradford J. Wood

Center for Interventional Oncology,
Radiology, and Imaging Sciences,
Clinical Center,
National Institutes of Health,
Bethesda, MD 20892
e-mail: bwood@nih.gov

1Both the authors have contributed equally.

Manuscript received January 24, 2019; final manuscript received May 6, 2019; published online June 12, 2019. Assoc. Editor: Douglas Dow.This material is declared a work of the U.S. Government and is not subject to copyright protection in the United States. Approved for public release; distribution is unlimited.

ASME J of Medical Diagnostics 2(3), 031005 (Jun 12, 2019) (7 pages) Paper No: JESMDT-19-1002; doi: 10.1115/1.4043901 History: Received January 24, 2019; Revised May 06, 2019

Retrievable inferior vena cava (IVC) filters are self-expanding metallic devices implanted in the IVC to prevent migration of thrombi from the deep veins of the legs and pelvis to the lungs. The risk of complications from the filters increases with duration of implantation, but retrieval may be difficult due to intimal hyperplasia around the components of the filter. In this study, the potential for delivery of radiofrequency (RF) energy to the IVC wall via the filter was investigated. IVC filters were deployed in four swine while attached to a snare connected to a 480 kHz RF generator. Energy ranging from 0 to 48 kJ was applied via the filter followed by resheathing and withdrawal of the filter while connected to a force measurement device. Resheathing forces for the zero-energy cohort and pooled data from the 6–24 kJ cohorts were 4.50 ± 0.70 N and 4.50 ± 0.75 N, respectively. Petechial hemorrhages and variable nonocclusive thrombi were noted in some cohorts including the zero-energy cohort, consistent with delivery and acute retrieval of an IVC filter. Histologically, the extent of RF-induced injury was subtle at 6 kJ with focal areas of homogenized collagen while the 12 kJ cohort showed segmental tissue charring with coagulation necrosis, which was more extensive for the 24 kJ cohort. The 48 kJ energy caused more extensive and nontarget organ damage. The study demonstrated feasibility of delivery of RF to the IVC wall via a deployed filter, supporting further study of the ability of local RF heating of the IVC wall to inhibit the neointimal hyperplasia or as an aid in retrieval.

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Figures

Grahic Jump Location
Fig. 1

IVC filter attached to the conductive snare within the delivery and retrieval sheath. The snare is modified with a connector for electrical connection to RF generator using an alligator clip.

Grahic Jump Location
Fig. 2

Force measuring apparatus secured to the angiography table using a flexible arm. The top linear stage is coupled to a bidirectional force gauge and is capable of bidirectional motorized movement to separately resheath and withdraw the IVC filter. The bottom linear stage is capable of bidirectional motorized movement to adjust the overall position of the top stage to permit connection to the sheath and retrieval snare. Clamps attach the outer sheath and modified retrieval snare to the system. The IVC filter attached to the retrieval snare is shown in the inset. Electrical connection to the RF generator is by a cable extending from the proximal end of the snare.

Grahic Jump Location
Fig. 3

Measured force. Resheathing forces (a) are shown for each energy cohort studied in a single animal. Resheathing begins with the tip of the sheath (arrow) over the proximal end of the IVC filter, shown before resheathing begins (t = 0 s) (b). The sheath is advanced until the tip of the sheath (arrow) reaches the filter anchors (c) whereupon the advance is halted, corresponding to the time of the peak force.

Grahic Jump Location
Fig. 4

IVC filter following retrieval. (a) Filter from the 6000 J cohort free of charring and (b) filter from the 24,000 J energy cohort shows some charring of tissue or blood on the filter legs and anchors (arrow).

Grahic Jump Location
Fig. 5

Adverse events after 48,000 J. (a) Filter anchors adherent to the IVC wall. (b) Nontarget tissue injury in adjacent small intestine at the highest energy level studied (arrows).

Grahic Jump Location
Fig. 6

Gross and histopathology of IVC explants. Representative gross, en face (a); low power (b) and high power (c) modified Movat pentachrome staining; and, high power H&E staining (d). 6000 J energy group. Gross en face view (a) shows a relatively smooth luminal surface with an absence of injury except for focal denudation of the luminal endothelium and minimal focal areas of homogenized collagen. Scale bar = top = 2 mm; bottom = 0.1 mm. 12,000 J energy group. Gross en face view (a) shows a relatively smooth luminal surface with a relative absence of injury. The light microscopy images show focal areas of the IVC wall exhibiting thermal injury (black arrows) characterized by a transmural loss of medial SMCs accompanied by homogenized collagen and thinning as observed in the higher power images ((b) and (c)). Scale bar = top = 2 mm; bottom = 50 μm 24,000 J energy group. Gross en face view (a) shows a relatively smooth luminal surface with focal discoloration (arrow). Histologic sections ((b) and (c)) show segmented regions of tissue charring (gray discoloration on Movat, black arrows) as a result of thermal injury. H&E stain shows the loss of medial SMCs and homogenized collagen consistent with coagulation necrosis together with the loss of medial SMCs involving ∼15–20% of the vessel wall circumference (d). Scale bar = top = 2 mm; bottom = 100 μm.

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