CRT 2012 Venous Disease

IVC Filters: Are Class Differences Meaningful?

Anthony C. Venbrux, MD Professor of Radiology and Surgery Director, Vascular and Interventional Radiology The George Washington University Medical Center Washington, DC

Anthony Venbrux, MD Cook, Inc. Cordis Endovascular Honoraria received for medical lectures: Cook, Inc. Cordis Endovascular Bard Peripheral Vascular Terumo Interventional Systems Medrad-Possis Interventional Rex Medical Consultant - Bard Peripheral Vascular Consultant - ArtVentive Medical

Special Thanks To: Shawn N. Sarin, MD Andrew S. Akman, MD Albert K. Chun, MD Amy P. Harper, ACNP-BC Noel Clay Haskins, MD Frank Lynch, MD John Kaufman, MD Shundra D. Dinkins

Objectives 2) Techniques of deployment 3) Clinical applications 1) Background 2) Techniques of deployment 3) Clinical applications 4) Complications

Classic Filter Indications Thrombo-embolic disease (TED) with Contraindication for anticoagulation. Complication of anticoagulation. Failure of anticoagulation. Massive pulmonary embolism. Chronic, recurrent pulmonary embolism.

Extended Indications – Off Label DVT/PE with poor compliance. “Widow maker” thrombus. Poor respiratory/pulmonary reserve. Unsteady patient (fall risk). No DVT/PE but at high risk for development .

Use of IVC Filters Marked increase in the last 20 years. Estimates: 2,000 implanted in 1979. 49,000 implanted in 1999. Stein PD et al, Arch Intern Med 2004;164:1541-1545.

Growth of IVC Filter Use Retrievable IVC Filter technology has made it justifiable to place an IVC filter in patient populations under the premise that the device will be removed1. 1979 – 2,000 IVC filters placed 2007 – 167,000 IVC filters placed 2012 – est. 259,000 IVC filters to be placed Retrieval rates have historically been about 20%2 Large number of devices needlessly left in place in patients for years / decades. U.S. Food and Drug Administration Alerts and Notices (Medical Devices). Removing Retrievable Inferior Vena Cava Filters: Initial Communication (Accessed 12-20-2011). http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm221676.htm Karmy-Jones R, Jurkovich GJ, Velmahos GC, et al. Practice patterns and outcomes of retrievable vena cava filters in trauma patients: An AAST multicenter study. J Trauma 2007; 62:17-24.

Long Term Complications of IVC Filters (as seen with permanent devices) Recurrent DVT ~20%1 IVC Thrombosis 6-30%2 Filter Migration 3-69%2 Filter Fracture / Embolization 1-6+%2,3 IVC Penetration 9-24%2 As previously mentioned, there are associated complications of IVC filter placement Thrombotic complications are by far the most common. An increased risk of recurrent DVT, presumably due to a reduction of blood flow in the IVC, has also been documented with an overall rate of about 20%. Most partial IVC thromboses, documented by CT or US are asymptomatic and may actually be evidence of successful filter function. Complete IVC thrombosis is rare but may lead to phlegmasia. Movement of the filter from its original deployed position has also been reported in multiple series. Frank embolization of all or part of the filter to the heart or pulmonary artery has been reported in 2-5% of cases and is usually associated with guide wire entanglement during a central line placement procedure. Penetration of the filter legs trough the caval wall becomes more likely the longer a filter remains in place. Fortunately, filter leg penetration is associated with injury to adjacent structures less than 1% of the time. Decousus H, Leizorovicz A, Parent F, et al. A clinical trial of vena caval filters in the prevention of pulmonary embolism in patients with proximal deep-vein thrombosis. N Engl J Med 1998; 338: 409-15. Kinney TB. Update on inferior vena cava filters. J vasc Interv Radiol 2003; 14:425-440. Vijay K, Hughes JA, Lynch FC, et al. Fractured Bard Recovery, G2 and G2 Express Inferior Vena Cava Filters: Incidence, clinical consequences and outcomes of removal attempts. J Vasc Interv Radiol 2011. Epub ahead of print.

Vena Cava Filters Definitions Permanent Cannot be removed. Temporary Implies the filter must be removed. Optional Either permanent or retrievable.

History: A Perspective

Greenfield Meditech-Boston Scientific

Permanent Caval Filters In the USA Kimray-Greenfield stainless Titanium Greenfield Over-the-wire stainless steel Greenfield Gianturco-Rhoem Bird’s Nest

Greenfield Meditech-Boston Scientific

Meditech-Boston Scientific

Meditech-Boston Scientific

Cook Inc.

Cook Inc.

Permanent Caval Filters In the USA Simon Nitinol Vena Tech Low Profile (LP) Vena Tech

Bard Peripheral Vascular

B Braun Medical Inc.

Permanent Caval Filters In the USA TrapEase OptEase Gunther Tulip, Celect Recovery, G 2, Eclipse, Meridian Option Aln

Gunther Tulip Cook Inc.

Cook Celect

ev3

Cordis Endovascular

Opt Ease Cordis Endovascular

Recovery Filter (Discontinued 9/2005) Bard Peripheral Vascular

Recovery Filter Cone Bard Peripheral Vascular.

Bard Peripheral Vascular.

G2™ Filter System Bard Peripheral Vascular.

G 2 X, and Eclipse Bard Peripheral Vascular.

Meridian™ Vena Cava Filter Bard Peripheral Vascular

Option IVC Filter Rex Medical

Aln Aln Implants

Non-Permanent Filters: An Old Idea 1968:

Gross Pathology 6 weeks in situ

Histopathology Transmural Incorporation

12 weeks post-removal 8 weeks healing

8 Week Healing IVC Diameters mm

Optional Filters

Current U.S. Optional Filter Designs Meridian™ OptEase™ Tulip™ ALN Celect™ Option™

Vena Cava Filters

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Take Home Points