IVC Filters When to Place One When to Remove One. Objectives. Clinical Problem Venous Thromboembolic Disease (VTED)

Transcription

1 IVC Filters When to Place One When to Remove One Frank C. Lynch, M.D., FSIR Professor of Radiology, Surgery, and Medicine Division Of Interventional Radiology The Penn State Heart &Vascular Institute Milton S. Hershey Medical Center Hershey, PA Objectives Review Venous Thromboembolic Disease (VTED) Discuss indications for IVC filter Placement Discuss role of retrievable IVC filters in the treatment of VTED Clinical Problem Venous Thromboembolic Disease (VTED) DVT begins in Calf Veins If untreated, 25% will extend into the popliteal and femoral veins If untreated, 50% of femoral popliteal DVT will result in Pulmonary embolism VTED is often clinically silent until Pulmonary embolism occurs 70% of patients with symptomatic PE have asymptomatic DVT Only 11% of people with PE have clinical evidence of DVT 1

2 Pulmonary Embolism ~100 cases of PE per 100,000 persons / year in USA 200,000 PE related deaths / year in USA Mortality 11% with acute PE die in one hour 30% if untreated Only 29% of patients with PE are accurately diagnosed $1.5 Billion / year in health care costs Treatment and Prophylaxis of VTED Anticoagulation Low cost Low risk Noninvasive IVC interruption Does not treat DVT Significant Long term complications Poorly studied Clinical Studies Prospective Randomized Trial patients with VTED Recurrent PE rate at 12 days (+DVT / PE) 4.8% without filter, 1.1% with filter (+DVT / +PE) 8.6% without filter, 1.1% with filter No difference in mortality, but.. 2 & 8 year follow up No difference in recurrent PE, mortality, or post thrombotic syndrome Increased rate of recurrent DVT in Filter Group 20.8% vs. 11.6% 1 Decousus H, Leizorovicz, A, 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:

3 Long Term Complications of IVC Filtration Historic data based on permanent IVC filters Thrombotic Events Recurrent DVT ~20% IVC Thrombosis % Filter Fracture /Embolization 2 5% IVC Penetration 41% Optional (aka Retrievable) IVC Filters Rationale Offer protection from PE in patients whose contraindication to anticoagulation therapy is temporary. Avoid long term complications of permanent IVC filtration Recurrent DVT Caval Occlusion Filter Fracture / embolization Caval Perforation 3

4 ACCP Recommendations Grading System ACCP Recommendations Grading System Strength of Evidence A B C Consistent Evidence Randomized Controlled Trials Evidence from Randomized Controlled Trails with Limitations Strong Observational Data Evidence from One Critical Outcome or Observational Data Flawed Randomized Controlled Studies Strength of Recommendation 1 Strong 2 Week Applies to most patients / most circumstances Benefits Outweigh Risks New Evidence Unlikely to Change Recommendation Best action may differ based on patient / circumstances Risk / benefits closely matched New Evidence Unlikely to Change Recommendation Applies to most patient / most circumstances Benefits Outweigh Risks Higher Quality Evidence May Change Recommendation Best action may differ based on patient / circumstances Risk / benefits closely matched Higher Quality Evidence May Change Recommendation Applies to most Patients / many circumstances Benefits Outweigh Risks Higher Quality Evidence Likely to Change Recommendation Alternative Therapies may be equally reasonable Uncertain risks/ benefits Higher Quality Evidence Likely to Change Recommendation TREATMENT RECOMMENDATIONS 4

5 Vena Cava Filters for the Initial Treatment of Patients With DVT In patients with acute DVT of the leg, we recommend against the use of an IVC filter in addition to anticoagulants. In patients with acute proximal DVT of the leg and contraindication to anticoagulation, we recommend the use of an IVC filter. Grade 1B: Applies to most patient / most circumstances Benefits Outweigh Risks Higher Quality Evidence May Change Recommendation Vena Cava Filters for the Initial Treatment of Patients With PE In patients with acute PE who are treated with anticoagulants, we recommend against the use of an IVC filter. In patients with acute PE and contraindication to anticoagulation, we recommend the use of an IVC filter Grade 1B: Applies to most patient / most circumstances Benefits Outweigh Risks Higher Quality Evidence May Change Recommendation Vena Cava Filters for the Initial Treatment of Patients With DVT In patients with acute proximal DVT of the leg and an IVC filter inserted as an alternative to anticoagulation, we suggest a conventional course of anticoagulant therapy if their risk of bleeding resolves. Grade 2B Best action may differ based on patient / circumstances Risk / benefits closely matched Higher Quality Evidence May Change Recommendation Remarks: We do not consider that a permanent IVC filter, of itself, is an indication for extended anticoagulation. 5

6 Vena Cava Filters for the Initial Treatment of Patients With PE In patients with acute PE and an IVC filter inserted as an alternative to anticoagulation, we suggest a conventional course of anticoagulant therapy if their risk of bleeding resolves. Grade 2B Best action may differ based on patient / circumstances Risk / benefits closely matched Higher Quality Evidence May Change Recommendation Remarks: We do not consider that a permanent IVC filter, of itself, is an indication for extended anticoagulation. Relative IVC Filter Placement Indications? Large, free floating proximal DVT Iliocaval DVT VTED in the setting of limited cardiopulmonary reserve Massive PE treated by thrombectomy / thrombolysis Chronic PE treated by thromboendarterectomy Thrombolysis for iliocaval DVT PREVENTION RECOMMENDATIONS 6

7 Prevention of VTE in Nonorthopedic Surgical Patients Patients Undergoing General, GI, Urological, Gynecologic, Bariatric, Vascular, Plastic, or Reconstructive Surgery For general and abdominal pelvic surgery patients (any risk level), we suggest that an inferior vena cava (IVC) filter should not be used for primary VTE prevention. Grade 2C Alternative Therapies may be equally reasonable Uncertain risks/ benefits Higher Quality Evidence Likely to Change Recommendation Prevention of VTE in Trauma Patients For major trauma patients, we suggest that an IVC filter should not be used for primary VTE prevention. Grade 2C Alternative Therapies may be equally reasonable Uncertain risks/ benefits Higher Quality Evidence Likely to Change Recommendation Trauma patients with high risk of VTED (EAST 2002 Criteria) Cannot receive anticoagulation because of bleeding risk AND injury leading to immobilization for a prolonged period: 1. Severe closed head trauma 2. Incomplete spinal cord injury with para/quadraplegia 3. Complex pelvic fractures with associated long bone fractures. 4. Multiple long bone fractures Prevention of VTE in Orthopedic Surgery Patients In patients undergoing major orthopedic surgery (any risk level), we suggest against using IVC filter placement for primary prevention over no thromboprophylaxis in patients with an increased bleeding risk or contraindications to both pharmacologic and mechanical thromboprophylaxis. Grade 2C Alternative Therapies may be equally reasonable Uncertain risks/ benefits Higher Quality Evidence Likely to Change Recommendation 7

8 WHEN TO REMOVE AN IVC FILTER Criteria for Discontinuation of Filtration An indication for a permanent IVC filter is not present The risk of clinically significant PE is acceptably low as a result of achieved / sustained appropriate primary treatment or a change in clinical status. No anticipated return to high risk status due to interruption of primary treatment, change in management or change in clinical status. The life expectancy of the patient is long enough that the presumed benefits of discontinuation of filtration can be realized (generally > 6 months) The device can be safely removed or converted 8

9 Discontinuation of Filtration Procedure Outcomes Once the decision is made to discontinue filtration, what is the likelihood of success? 85% success rate stated in literature reviews >98% in published data from HMC Factors that contribute to failed removal include: Thrombosis of the IVC / Filter Filter embedded in the caval wall Tilted filter Perceived Barriers to IVC Filter Removal There are probably no finite implantation times after which IVC filter removal is either unsafe or unlikely to be successful. It is no more difficult to removal an IVC filter the longer that it has been implanted. Depends on the device and patient specific factors. Probably no absolute time limits for any device IVC Filter Removal after Extended Implantation Periods Device Author Days of Implantation (Literature) HMC Experience ALN 1 / ALN Pellerin Angiotech 2 / Option McGuckin days Bard 3 / Recovery Kuo days Bard 3 / G2 Lynch days Bard 3 G2x / Eclipse / 2083 days Cordis 4 / Optease Rimon days Cook 5 / Günther Tulip Lynch days Cook / Celect Lyon days 1 ALN Implants, Chirurgicaux, Ghisonaccia France 2 Angiotech, Vancouver, British Columbia Canada 4 Cordis Corporation, Bridgewater, New Jersey United States 5 Cook Medical, Bloomington, Indiana United States 3 Bard Peripheral Vascular, Tempe Arizona, United States 9

10 Summary IVC filters are an effective second line alternative to anticoagulation therapy for the prevention of PE Long term complications are associated with all devices, the incidence of which increases over time. Patients with Retrievable filters need to be followed Patients with retrievable IVC filters in place without a clear indication for continued IVC filtration should get their devices removed. Almost all retrievable IVC filters can be removed percutaneously References Kaufman JA, Kinney TB, Streiff MB, et al. Guidelines for the use of retrievable and convertible vena cava filters: Report from the Society of Interventional Radiology multidisciplinary consensus conference. J Vasc Interv Radiol 2006; 17: Rogers FB, Cipollee MD, Velmahos G, Rozucki G, Luchetter FA. Practice Management Guidelines for Trauma From the Eastern Association of the Surgery of Trauma (EAST). J Trauma 2002; 53: Crowther MA. Inferior vena cava filters in the management of venous thromboembolism. Amer J of Medicine 2007; Vol 120(10B), S Ray CE, Mitchell E, Zipser S, Kao EY, Brown CF, Moneta GL. Outcomes with retrievable inferior vena cava filters: A multicenter study. J Vasc Interv Radiol 2006; 17: Additional References by Request IVC Filters When to Place One When to Remove One Frank C. Lynch, M.D., FSIR Professor of Radiology, Surgery, and Medicine Division Of Interventional Radiology The Penn State Heart &Vascular Institute Milton S. Hershey Medical Center Hershey, PA 10

11 FACT VS. FICTION Fact vs Fiction There are currently one or more retrievable IVC filter designs that are on recall by the manufacturer. Fiction! 11

12 Filter Recall? Retrievable IVC Filter technology has made it justifiable to place an IVC filter in younger patient populations under the premise that the device will be removed ,000 IVC filters placed ,000 IVC filters placed 2012 est. 259,000 IVC filters to be placed Retrieval rates have historically been between 15% 25% Large number of devices needlessly left in place in young patients for years / decades 189 filters placed After a mean follow up time of 38 months 10 IVC filters retrieved (5.3%) 80 patients with filters in placed screened 13 (16%) fractured Of those 80 patients Mean Age early 50 s 56 (70%) had filters placed either for unknown indications (n=18), trauma (n=17) or electively in high risk surgery patients (n=21). 12

13 Filter Recall? Fact vs Fiction Anticoagulation should be held for the IVC filter removal procedure Fiction! Multiple series with anecdotal reports of safe removals with INR < IVC filter removals, 62 with INR between 2 and /62 (87%) success rate for IVC filter removal No operative bleeding complications 1 Schmelzer TM, Christmas AB, Taylor DA, Heniford BT, Sing RF. Vena cava filter retrieval in therapeutically anticoagulated patients. Am J Surg Dec;196(6):944-6; discussion Fact vs Fiction IVC filters that are embedded in the caval wall, have perforated the IVC or are fractured cannot and should not be removed Fiction! 13

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16 Relative IVC Filter Placement Indications Examples Iliocaval DVT Large, free floating proximal DVT Massive PE treated by thrombectomy / thrombolysis Chronic PE treated by thromboendarterectomy Thrombolysis for iliocaval DVT VTED in the setting of limited cardiopulmonary reserve Poor compliance with anticoagulation medications High risk of complication of anticoagulation (eg. Ataxia, frequent falls) Thrombectomy and IVC Filter Use in Pediatric Patients With DVT In children with life threatening VTE, we suggest thrombectomy (Grade 2C). In children who have had a thrombectomy, we suggest anticoagulant therapy as per recommendation (2.22)(Grade 2C). In children >10 kg body weight with lower extremity VTE and a contraindication to anticoagulation, we suggest placement of a retrievable IVC fi lter (Grade 2C). In children who receive a filter, we suggest that the filter be removed as soon as possible if thrombosis is not present in the basket of the filter and when contraindication to anticoagulation is resolved (Grade 2C). In children who receive an IVC filter, we recommend appropriate anticoagulation for VTE (see 1.2) as soon as the contraindication to anticoagulation is resolved (Grade 1C). 16