IVC Filter Indications When Who Why J Stephen

IVC Filter Indications - ”When, Who, Why” J. Stephen Jenkins M. D. , FACC, FSCAI, FSVM Associate Section Head, Interventional Cardiology Director, Interventional Cardiology Research John Ochsner Heart and Vascular Institute

J. Stephen Jenkins Financial Relationships: Abbott Vascular Speaker/Honoraria St. Jude/AGA Proctor/Honoraria Endologix Proctor/Honoraria

Background • 1868 - Trousseau suggested placing a barrier in the IVC to prevent PE arising from venous thrombi. • 1893 - First surgical interruption performed by Bottini. • 1960’s – Mobin-Uddin and original Greenfield filters first introduced. • 1998 – Decousus et al recognized an increase rate of lower extremity DVT with permanent IVC filters. • 2002 - Retrieval filters developed to reduce IVC filter complications. Trousseau A. Clinique medicale de Hotel Dieu de Paris. 1868: 652 -695. Greenfield LJ. Surgery. 1988; 104: 706 -712 Decousus H. N Engl J Med. 1998; 338: 409 -415.

IVC Filters: When, Who, Why Ochsner, A. , J. L. Ochsner, and H. S. Sanders, Prevention of pulmonary embolism by caval ligation. Ann Surg, 1970. 171(6): p. 923 -38.

Mobin-Uddin Filter Mobin-Uddin, K. , et al. , Caval interruption for prevention of pulmonary embolism. Long-term results of a new method. Arch Surg, 1969. 99(6): p. 711 -5.

Kimmell-Greenfield Filter

Initial Greenfield Filter Results 469 133 Deaths 190 Lost to follow up • 25 Recurrent PE’s ------- 4% • Chronic venous stasis -- 44% Greenfield, L. J. and B. A. Michna, Twelve-year clinical experience with the Greenfield vena caval filter. Surgery, 1988. 104(4): p. 706 -12. 146 followed for 43 months

Initial Greenfield Filter Results Initial Consensus Indications: • Venothromboembolism with a contraindication to anticoagulation • Recurrent PE while on anti-coagulation Liberalized indications: 1. 2. 3. 4. 5. Chronic recurrent PE + pulmonary hypertension Large free floating proximal venous thrombosis Patient undergoing embolectomy Patients with recent PE and poor cardiopulmonary reserve Prophylaxis in patients with cancer, trauma, burns, long-bone fractures, or joint replacement. Greenfield, L. J. and B. A. Michna, Twelve-year clinical experience with the Greenfield vena caval filter. Surgery, 1988. 104(4): p. 706 -12.

Filter variety

Retrievable IVC Filter • Appeared on market in early 2000’s. • Specifically designed to have less secure implantation to facilitate retrieval. • 1999 USFDA downgraded risk from Class III to II. • Permitted market approval more readily: Assumption that new filters are substantially equivalent. • Several retrievable filters approved as permanent filters with an option for retrieval.

30 Year US Filter Usage IVC Filters x 1000 300 225 150 75 0 1981 1984 1987 1990 1993 1996 Year 1999 2002 2005 2008 2012

Scope of Problem • 259 K IVC filters estimated in US in 2012. • Many placed prophylactically for: • Bariatric surgery • Spinal surgery • Trauma

IVC Filter Related Complications • Filter migration • Retroperitoneal hematoma • Perforation • Nerve impingement • Fracture • Vena caval syndrome • IVC thrombosis • Air embolism • Misplacement • Embolization • Insertion site thrombosis • Death

FDA Advisory Letter August 2010

Types of Filters Permanent Removable Optional Retrievable

Currently Available IVC Filters Permanent Retrievable B Braun Vena. Tech LP Bard G 2 x B Braun Vena. Tech LGM Bard G 2 Cook Gianturco-Roehm Bird’s Nest Bard Eclipse Cordis Trap. Ease Cook Gunther Tulip Rafael Medical Safe. Flo Cook Celect Bard Simon Nitinol Cordis Opt. Ease Boston Titanium Greenfield ALN Boston Stainless Steel Greenfield Rex Medical Option

PREPIC Trial • Only prospective randomized study of IVC filter placement for prevention of PE. • 400 patient with proximal DVT at high risk for PE. • 2 x 2 factorial design • UFH vs LMWH • With or without IVC filter • Parental anticoagulation for 8 to 12 days. • Vitamin K antagonists x 3 months. • 8 year follow-up. Decousus H. N Engl J Med. 1998; 338: 409 -415. PREPIC Study Group. Circulation. 2005; 112: 416 -422.

Long Term Vitamin K Antagonist Use Decousus H. N Engl J Med. 1998; 338: 409 -415. PREPIC Study Group. Circulation. 2005; 112: 416 -422.

Endpoints • Primary efficacy outcome • • Objectively documented PE at 8 years. Secondary outcome • recurrent DVT • death • major filter complications • bleeding complications Decousus H. N Engl J Med. 1998; 338: 409 -415. PREPIC Study Group. Circulation. 2005; 112: 416 -422.

PREPIC 2 JAMA. 2015; 313(16): 1627 -1635.

PREPIC 2 Trial • Randomized, open-label, end point blinded study of retrievable IVC filter placement for prevention of PE. • 399 patient with symptomatic PE and lower extremity VTE and (1 criteria for severity). • Assigned to: • retrievable IVC filter + anticoagulation • anticoagulation alone • All patients received anticoagulation x 6 months. • Filter removed at 3 months. • 6 month follow-up. JAMA. 2015; 313(16): 1627 -1635.

Endpoints • Primary efficacy outcome: symptomatic recurrent PE at 3 mo. • Secondary outcomes: recurrent PE at 6 mo. symptomatic DVT major bleeding death at 3 and 6 mo. filter complications JAMA. 2015; 313(16): 1627 -1635.

JAMA. 2015; 313(16): 1627 -1635.

Jaff MR. Management of Massive and Submassive Pulmonary Embolism, Iliofemoral Deep Vein Thrombosis, and Chronic Thromboembolic Pulmonary Hypertension: AHA Scientific Statement. Circulation. April 2011; 123: 1788 -1830.

Recommendations for IVC Filters in the Setting of Acute PE • Confirmed acute PE (or DVT) with contraindications to anticoagulation or active bleeding. (1 B) • Resume anticoagulation when contraindications and bleeding have resolved. (IB) • Retrievable filters should be periodically evaluated for removal. (IC) • Recurrent PE despite therapeutic anticoagulation. (IC) • DVT or PE with long-term contraindication to anticoagulation should receive permanent IVC filter. (IIa. C) • DVT or PE with short-term contraindication to anticoagulation should receive retrievable IVC filter. (IIa. C) • Acute PE with poor cardiopulmonary reserve and massive PE. (IIb. C) • Adjuvant to anticoagulation and systemic fibrinolysis for treatment of acute PE. (IIIC) Jaff MR. Management of Massive and Submassive Pulmonary Embolism, Iliofemoral Deep Vein Thrombosis, and Chronic Thromboembolic Pulmonary Hypertension: AHA Scientific Statement. Circulation. April 2011; 123: 1788 -1830.

Recommendations for IVC Filters in IFDVT • Acute proximal DVT (or acute PE) with contraindications to anticoagulation or active bleeding complications. (IB) • Resume anticoagulation when contraindications and bleeding have resolved. (IB) • Retrievable filters should be periodically evaluated for removal. (IC) • Recurrent PE despite therapeutic anticoagulation. (IIa. C) • IFDVT with long-term contraindication to anticoagulation should receive permanent IVC filter. (IIa. C) • IFDVT with short-term contraindication to anticoagulation should receive retrievable IVC filter. (IIa. C) • Recurrent DVT (without PE) despite therapeutic anticoagulation. (IIb. C) • IVC filter should not be used for routine treatment for IFDVT. (IIIC) Jaff MR. Management of Massive and Submassive Pulmonary Embolism, Iliofemoral Deep Vein Thrombosis, and Chronic Thromboembolic Pulmonary Hypertension: AHA Scientific Statement. Circulation. April 2011; 123: 17881830.

ACC AHA ACCP SIR ACR ESC British EAST Contraindication to anticoagulation R R R Failure/Complication of anticoagulation, recurrent PE despite anticoagulation R - R R - - Failure of anticoagulation R - R R - - Recurrent PE in patients with adequate anticoagulation R - R R R - Inability to achieve adequate anticoagulation - - R - - - Propagation of DVT despite adequate anticoagulation R - R R R - Massive PE with residual DVT at risk for further PE - - R - - - Free floating iliofemoral or IVC thrombus - - R - - - Severe cardiopulmonary disease and DVT R - - - Adjunct to therapeutic anticoagulation - NR - Therapeutic Indications for IVC Filter Use R NR - Recommended Not Recommended No Position Pregnancy with contraindication to anticoagulation and DVT < 2 wk prior to delivery - - R - NR - - - NR - Preop patients requiring anticoagulation interruption with prior DVT (<1 mo) - - R - CTEP undergoing pulmonary endarterectomy - - R - ACC AHA ACCP SIR ACR ESC British EAST Primary DVT prevention in patients undergoing surgery - NR - - Ortho surgery receiving IVC filter over anticoagulation - NR - - Severe trauma without documented PE or DVT - NR R - - R Closed head injury - - R Spinal cord injury - - R Multiple long-bone or pelvic fractures - - R High-risk patients admitted to ICU - - R - - - NR - PE undergoing thrombolysis Prophylactic Indications for IVC Filter Use Free-floating thrombus

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