Thrombosis & Hemostasis Summit of North America 2016Apr16. IVC Filters

Transcription

1 Thrombosis & Hemostasis Summit of North America 2016Apr16 IVC Filters Bill Geerts, MD, FRCPC Thromboembolism Consultant, Sunnybrook HSC Professor of Medicine, University of Toronto National Lead, VTE Prevention, Can. Pat. Safety Institute Executive, Thrombosis Canada

2 Disclosures Financial disclosures Off-label use of drugs None No

3 Outline Epidemiology of IVCF use Indications Evidence from clinical trials Complications Suggestions and summary

4 Types of IVC Filters 1. Permanent 2. Temporary A. Retrievable (optional) VENATECH B. Tethered

5 IVC Filters Approved in USA in 2016 Type Filter name Company Permanent Bird s Nest Cook Retrievable (Optional) Greenfield Simon Nitinol TrapEase VenaTech Boston Scientific Bard Cordis Braun

6 IVC Filters Approved in USA in 2016 Type Filter name Company Permanent Bird s Nest Cook Retrievable (Optional) Greenfield Simon Nitinol TrapEase VenaTech ALN Celect Crux Denali Gunther Tulip OptEase OptionElite Boston Scientific Bard Cordis Braun ALN Cook Volcano Bard Cook Cordis Argon

7 IVC Filter Placement in USA 300, , , , , , ,000 50, ,000 49,000 2, Stein Arch Intern Med 2004;164:1541; Smouse Endovasc Today 2010;74; Kuy J Vasc Surg: Ven Lymph 2014:2:15

8 IVC Filters in Acute VTE Rx 263 California hospitals, ,643 patients with acute VTE IVCF in 15% of VTE patients (0-39%) White JAMA Intern Med 2013;173(7):506

9 Cultural differences in IVC Filter use

10 IVC Filters Inserted in 2012 Population in 2012 IVCF placed Germany, France, UK, Italy, Spain 316,600,000 9,070 USA 313,000, , times more Lee Cardiovasc Intervent Radiol 2015;38:1502

11 Regional Variation in IVCF Use Rates of IVCF use/1,000 PE pa<ents 1999 (92à217) 2010 (113à222) New England only region with decrease. Bikdeli J Am Coll Cardiol 2016;67(9):1027

12 Dramatic Increase in IVCF Rates Expanded (off-label) indications Ease of insertion More experienced filter inserters Removable filters must be safer Defensive medicine?financial incentives

13 Dramatic Increase in IVCF Rates Expanded (off-label) indications Ease of insertion More experienced filter inserters Removable filters must be safer Defensive medicine?financial incentives NOT: evidence of benefit evidence of safety

14 Outline Epidemiology of IVCF use Indications Evidence from clinical trials Complications Suggestions and summary

15 What is the purpose of an IVCF?

16 What is the purpose of an IVCF? 1. To prevent PE 2. To prevent fatal PE 3. To prevent fatal and life-threatening PE 4. To prevent fatal and life-threatening PE without causing greater harm than benefit

17 What is the purpose of an IVCF? 1. To prevent PE 2. To prevent fatal PE 3. To prevent fatal and life-threatening PE 4. To prevent fatal and life-threatening PE without causing greater harm than benefit 5. To prevent fatal and life-threatening PE without causing greater harm than benefit and at a cost that is worth it

18 Patients with VTE: 1.Anticoagulation contraindicated 2.In addition to anticoagulation IVC filters Therapeutic indications Primary prophylaxis (no VTE): 1.Trauma 2.Bariatric surgery, orthopedic surgery Prophylactic indications

19 FDA Approved Indications for IVCF 1. Pulmonary thromboembolism when anticoagulant therapy is contraindicated 2. Failure of anticoagulant therapy in thromboembolic diseases 3. Emergency treatment following massive PE when anticipated benefits of conventional therapy are reduced 4. Chronic recurrent PE when anticoagulant therapy has failed or is contraindicated Streiff Thromb Res 2010;125:S128

20 Outline Epidemiology of IVCF use Indications Evidence from clinical trials Complications Suggestions and summary

21 Smoke Spark (N=2) Flame (?)

22 1 st RCT of IVC Filter Use = PREPIC

23 IVC Filter* for Treated Proximal DVT Patients at high risk for PE; anticoagulated >3 mos Outcomes Day 12 No filter (n=200) Filter (n=200) PE 9 (4.8%) 2 (1.0%) 0.03 Death 5 (2.5%) 5 (2.5%) 1.0 P *4 different permanent filters Decousus NEJM 1998;338:409

24 IVC Filter for Treated Proximal DVT Outcomes at Day 12 No filter (n=200) Filter (n=200) All PE 9 (4.8%) 2 (1.0%) 0.03 Asympt PE 4 0 Sympt PE P Fatal PE * 4 0 *autopsy in only 1 Decousus NEJM 1998;338:409

25 IVC Filter for Proximal DVT Patients at high risk for PE; anticoagulated >3 mos Outcomes Day 12 No filter (n=200) Filter (n=200) All PE 9 (4.8%) 2 (1.0%) 0.03 Symptomatic PE 5 (2.5%) 2 (1.0%) 0.25 Death 5 (2.5%) 5 (2.5%) years Symptomatic PE 12 (6.3%) 6 (3.4%) 0.16 Recurrent DVT 21 (12%) 37 (21%) 0.02 Death 40 (20%) 43 (22%) 0.65 P Decousus NEJM 1998;338:409

26 JAMA 2015;313(16): nd RCT of IVC Filter Use = PREPIC-2

27 Retrievable IVCF in PE (PREPIC-2) RCT at 18 centers in France; N=399 Patients with unprovoked PE + DVT/SVT + Age >75 RV dysfunction Active cancer Bilateral or iliocaval DVT Cardiorespiratory failure Anticoagulation Anticoagulation + ALN IVCF 3 mos Mismetti JAMA 2015:313(16):1627

28 Retrievable IVCF in PE (PREPIC-2) RCT at 18 centers in France; N=399 Patients with unprovoked PE + DVT/SVT + >1 additional risk factor(s) Anticoagulation Anticoagulation + ALN IVCF 3 mos 3 mos Anticoagulation (n=199) Anticoagulation + IVCF (n=200)* P Recurrent PE 3 (1.5%) 6 (3%) 0.5 Fatal PE 2 6 DVT Death 6.0% 7.5% 0.55 *21% of filters not removed Mismetti JAMA 2015:313(16):1627

29 2016;4(1): ;4:127 No Class I evidence to support prophylactic IVCF placement in any patient group

30 SIR/SVS/Industry/FDA IVC Filter Study (PRESERVE) Objectives: 1. Document current IVCF practice 2. Evaluate safety and effectiveness Design: prospective, national cohort study with long-term follow-up in ~60 sites Study population: ~2,100 patients (7 filters x >300 patients each), all indications

31 SIR/SVS/Industry/FDA IVC Filter Study (PRESERVE) venogram or IVUS abd film venogram IVCF insertion discharge retrieval 1 mo IVCF not removed venogram or IVUS 3 mos abd film 6 mos (phone) 1 year CT scan 18 mos (phone) 2 years CT scan

32 FDA Approved Indications for IVCF evidence 1. Pulmonary thromboembolism when no anticoagulant therapy is contraindicated 2. Failure of anticoagulant therapy in no thromboembolic diseases 3. Emergency treatment following massive PE when anticipated benefits of no conventional therapy are reduced 4. Chronic recurrent PE when anticoagulant therapy has failed or is contraindicated no

33 What is the purpose of an IVCF? 1. To prevent PE 2. To prevent fatal PE 3. To prevent fatal and life-threatening PE 4. To prevent fatal and life-threatening PE without causing greater harm than benefit 5. To prevent fatal and life-threatening PE without causing greater harm than benefit and at a cost that is worth it Probably vs nothing No evidence No evidence No evidence; estimates show complic>benefit No evidence (There never will be)

34 Outline Epidemiology of IVCF use Indications Evidence from clinical trials Complications Suggestions and summary

35 IVC-Related Complications Procedure-related Access site bleeding 2-4% Misplacement 1-5% Contrast nephropathy 1% Acute embolization Access site thrombosis Short-term Delayed anticoagulation Filter thrombosis 5-40% Filter migration PE 0-1% Long-term Inability to remove (5-20%) DVT Fracture & embolization Perforation (aorta, RPH, etc) IVC thrombosis IVC stenosis Related to long-term anticoagulation Major complications: 3-5% (minimum)

36 Complications of Retrievable IVCFs Systematic review of 37 studies; N=6,834 Mean follow-up only 9.9 mos Complication Filters Frequency DVT 1, % Filter migration 2, % IVC thrombosis or stenosis 4, % Unable to remove 1, % Not removed 5,043 66% Angel JVIR 2011;1522

37 JVIR 2014;25(8):1181 FDA MAUDE (Manufacturer and User Device Experience) : 1,606 reported AEs

38 Complications of IVC Filters FDA MAUDE (Manufacturer and User Device Experience) Complications No. of AEs Perm IVCFs Retrievable IVCFs p All 1,606 13% 87% < Fracture 350 5% 95% < Placement issue % 69% < IVC penetration 228 6% 94% < Migration >2 cm % 79% < Tilt 197 2% 98% < Limb embolization 154 3% 97% < IVC thrombosis 41 20% 80% <0.001 VTE/PE 30 27% 73% <0.007 < < < < < < < < < Andreoli JVIR 2014;25:1181

39 Complications of Retrievable Filters Complications All 1,394 Fracture 334 (24%) Placement issue 219 (16%) IVC penetration >3 cm 214 (15%) Tilt 194 (14%) Migration >2 cm 169 (12%) Limb embolization 150 (11%) IVC thrombosis 33 (2%) VTE/PE 22 (2%) Duodenum 28 Aorta 14 Vertebra 12 RPH 9 Andreoli JVIR 2014;25:1181

40 Strut Penetration with Celect Filters 595 Celect IVCF at U. Chicago Follow-up abdominal CT in 193 (mean 176 days aver inser<on) Strut penetra<on >3 mm (range: 4-9 mm) 55 (29%)* *rate increased with dwell time Bos JVIR 2015;26(1):101

41 Risk of Recovery IVCF Fracture Cleveland Clinic, Recovery filters; 73% not retrieved Dwell time Fracture rate 2 yrs 10% 4 yrs 20% 5.5 yrs 40% Tam JVIR 2012;23:199

42 Tricuspid valve Caval + Aortic thrombosis Spinal canal Right atrium Aorta Duodenum

43 Filter thrombosis à amputation Filter thrombosis Right atrium Pericardial tamponade Caval stenosis

44 What does the IVC look like after a filter is removed? Major head injury Prophylactic IVCF inserted Filter removed at 14 days Died following day (unrelated to filter) Ashley J Trauma 2005;59:847

45 Additional Adverse Consequences of IVCF Placement Unjustified delays in initiating anticoagulant prophylaxis or therapy Risks of long-term anticoagulation related to presence of the filter alone Potential risks during pregnancy, exercise (or hockeyj) Huge costs

46 Long-Term Safety?

47 Outline Epidemiology of IVCF use Indications Evidence from clinical trials Complications Suggestions and summary

48 10 th ACCP Guideline IVCF Use (Therapeutic) 17. In patients with acute DVT or PE who are treated with anticoagulants, we recommend AGAINST the use of an inferior vena cava (IVC) filter [Grade 1B] Kearon Chest 2016;149:315

49 9th ACCP Conference on Antithrombotic Therapy IVC Filter Use (Prophylactic): Recommend AGAINST IVCF as thromboprophylaxis in trauma or spinal cord injury [Grade 2C] Gould - Chest 2012;141(Suppl 1):e227S

50 All IVCFs inserted at Sunnybrook, No. of IVC Filters Not removed Removed 21/yr 60% Mean 21/yr (None prophylactic) 60% removed

51 All IVC Filter Use/Hospital/Year Consecutive patients with filters placed, North America Author, year Group Time period No. IVCF/ yr IVCF retriev Dabbagh, 2010 U. Missouri % Mission, 2010 UCSF Med Center % Meisner, 2012 Stony Brook UH % Eifler, 2013 Northwestern U % Desai, 2014 North-Shore U , % Duffett, 2014 U. Ottawa % Inagaki, 2016 Boston Med Cntr , % Combined 7 major HSC , % Sunnybrook HSC %

52 IVCFs in Trauma at Sunnybrook, Permanent Op<onal No. of IVC Filters Mean 4.1/yr (None prophylactic) 76% removed during trauma admission

53 IVCF Practice in Trauma, Consecutive papers reporting IVCF use in trauma, North America Author, year Location Total IVCF IVCF/yr Proph IVCF/yr IVCF retrieved Helling, 2009 Johnstown, PA % Johnson, 2009 Walter Reed MC % Smoot, 2010 Mayo Clinic % Kalina, 2012 Newark, DE NR 24% Rogers, 2012 Lancaster, PA NR NR % Sarosiek, 2013 Boston, MA % Charlton-Ouw, 2015 UT, Houston ~60 34% Combined 7 centers 1, % Sunnybrook, Toronto % *average/center

54 Single Indication for an IVC Filter Recent PROXIMAL DVT PLUS an absolute contraindication to full anticoagulation

55 NOT Indicators for IVC Filters 1. PE with contraindication to therapeutic anticoagulation (if no DVT) 2. Primary prophylaxis in trauma / major surgery 3. Anticoagulant failure = a contraindication 4. Extensive proximal DVT or VTE with poor cardiopulmonary reserve 5. During catheter-directed management of DVT

56

57 Considering an IVC Filter... The 4 steps (+ 1) 1. Is the indication appropriate? 2. Only use a removable filter 3. Start anticoagulation as soon as it s safe often escalating the dose as bleeding risk 4. Remove filter after therapeutic anticoagulation achieved almost always same admission + Mandatory, regular follow-up of all nonretrieved filters

58 Additional Costs of IVCF in USA Germany, France, UK, Italy, Spain Population in 2012 IVCF placed 316,600,000 ~10,000 USA 313,000,000 >250,000 ~240,000 more filters in USA/yr vs Europe Lee Cardiovasc Intervent Radiol 2015;38:1502 Cost $5,000 Cost $10,000 Additional cost* $1.2 billion $2.4 billion *NOT considering costs of retrieval, complications, medical-legal

59 IVC Filter Use: Summary 1. Exponential increased use past 15 years 2. No evidence of benefit for the indications in which they are used (and there never will be) 3. Many filters are placed for inappropriate indications 4. Most retrievable filters are not removed 5. Retrievable filters can be dangerous if not removed promptly 6. Enormous, unjustified costs