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Filtros de Vena Cava:
propósito del uso y manejo de modelos actuales.
Dr. Costantini Ricardo – Cardiología Intervencionista
Jornadas Intervencionistas
Arteriales y Venosas del Hospital Austral
(JAVA) 2019
# Venous thromboembolism (VTE) is common, with a reported incidence of 422 of 100,000 people in the United States.
Deitelzweig SB, Johnson BH, Lin J, Schulman KL. Prevalence of clinical venous thromboembolism in the USA: current trends and future
projections. Am J Hematol 2011;86:217–20.
# Left untreated, pulmonary embolism (PE) will occur in as many as 40% of all proximal deep vein thrombosis (DVT).
Kakkar VV, Howe CT, Flanc C, Clarke MB. Natural history of postoperative deep-vein thrombosis.
Lancet 1969;2:230–2.
# 5 – 8% of patients receiving therapeutics anticoagulations for PE experience a second PE episode.
Douketis JD; Keaton C; Bates S. et al Risk of fatal pulmonary embolism in patients with treated venous thromboembolism.
JAMA 1998, 279: 458 – 462.
Aumento de incidencia según la edad
American Journal of Medicine, 2011;124(7):655-661
Increasing Use of Vena Cava Filters for Prevention of Pulmonary Embolism
1930 Homans femoral vein ligation1940 Oschner IVC ligation 1967 Mobin-Uddin partimentalizationendovascular IVC with umbrella fenestredsilastic.
1973 Greefield filter 29,5 fr
1980 Greenfield filter second generation
Vena Caval Filter Utilization and Outcomes in Pulmonary EmbolismMedicare Hospitalizations From 1999 to 2010
Among 556,658 patients hospitalized with PE, 94,427 underwent IVCF placement
Behnood Bikdeli; Samuel Z. GoldhaberJ Am Coll Cardiol 2016;67:1027–35
In a population-based studyof VCF use, 13% of hospitalized patients
with acute VTEreceived a filter, but consensus remained
among 3 expertsthat the use of a VCF was appropriate in
only 50%of the patients.
Spencer FA, Bates SM, Goldberg RJ, et al. A population-based study of inferior VCF in patients with acute venous thromboembolism.
Arch Intern Med. 2010;170(16):1456-1462.
High Variation Between Hospitals in Vena Cava Filter Use for Venous Thromboembolism
Kearon C, Aki EA, Comerota AJ, et al. Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines.
Chest. 2012;141(2 Suppl):e419S-94S.
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(3):449-459.
Absolute indications :
1 – Recurrent thromboembolism disease despite anticoagulation therapy2 – Significant complication of anticoagulation therapy that ferced therapy to bediscontinued3 – Uncontrolled anticoagulation: sub or supratherapeutic despite patient compliance4 – Contraindication to anticoagulation:
Bleeding complicationRecent bleedingRecent major trauma or surgeryHemorrhagic strokeHeparin associated thrombocytopenia or thrombocytopenia (<50.000/mm3)CNS neoplasm, aneurysm or vascular malformation
5- In conjuntion with pulmonary embolectomy
Relative indications:
1 – Large, free floating iliofemoral thrombus2 – Propating iliofemoral thrombus despite adequate anticoagulation3 – Thromboembolic disease with limited cardiopulmonary reserve4 – Chronic thromboembolic disease (undergoing pulmonary embolectomy)5 – Poor compliance with medications6 – Severe ataxia: at risk for falls on anticoagulations therapy7 – DVT thrombolysis8 – Renal cancer with renal vein or IVC involment9 – Prophylactic in high risk patients: massive trauma, pelvic, or lower extremityfractures, head injury.
The most common indications for insertion of IVC filters are :
Contraindications to anticoagulation (48%),
Prophylactic filter placement in the absence of documented PE/DVT (17%),
Anticoagulation failure (8%).
Aziz F, Comerota AJ. Inferior vena cava filters. Ann Vasc Surg. 2010;24(7)966-979.
Are IVC Filters Effective?
Do They Prevent Pulmonary Emboli?
The PREPIC trial was a prospective, randomized, controlled study
400 patients (44 sites - France) with DVT and high risk for PE to receive anticoagulation medications with or without
permanent IVCF: VenaTech LGM - titanium Greenfield - Bird’s Nest.
Decousus H, Leizorovicz A, Parent F, et al., for the Prévention du Risque D’embolie Pulmonaire par Interruption Cave Study Group. 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.
Patients were actively screened for PE at baseline and after 8 to 12 days, but DVT was defined only with associated symptoms.
At 12 days, there was a significant reduction in PE in the IVCF group(4.8% vs. 1.1%, p=0.03).
Many patients died of causes unrelated to VTE, and IVCF did not show a mortality benefit.
By 2 years, more patients in the filter group developed a symptomatic DVT (20.8% vs. 11.6%, p=0.02) and mortality remained similar between groups (21.6% vs. 20.1%, p=0.65).
Prévention du Risque d’Embolie Pulmonaire par Interruption Cave Study GroupN Engl J Med 1998;338:409-15
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; 338:409–415.
Eight-year follow-up of patients with permanent vena cava filters in the prevention of pulmonary embolism: the PREPIC (Prevention du Risque d’Embolie Pulmonaire par Interruption Cave) study.
Circulation. 2005;112(3):416-422.
Ptes con FVC Ptes sin FVC p
EP sintomática 6,2% 15,2% 0,04
Recurrencia TVP 35,7% 27,5% 0,04
Role of IVC Filters in Endovenous Therapy for Deep Venous Thrombosis:
The FILTER-PEVI (Filter Implantation to Lower Thromboembolic Risk in Percutaneous Endovenous Intervention) Trial
8
Mohsen Sharifi, Curt Bay, Laura Skrocki, David Lawson, Shahnaz MazdehCardiovasc Intervent Radiol (2012) 35:1408–1413
Vena cava filters use in acute thrombosis of large veins
Vena cava filters use in acute thrombosis of large veins.
Costantini Ricardo; Juan Manuel Telayna Jr; Juan Manuel Telayna.
Cardiovascular Research Technologies (CRT) – March 2 – 5, 2019 - Washington DC. - Poster 200.04
0
5
10
15
20
25
30
35
40
2008 - 2010 2011 - 2012 2013 - 2014 2015 - 2016 2017 - 2018
Use VCF in venous PTA
Total PTA with VCF
22%
42%42%
Vena cava filters use in acute thrombosis of large veins Group A:
PTA with FVCR
(n=30)
Group B:
PTA without
FVCr (n=20)
p
Age, years 39,6 ± 15,8 36 ± 15
Female, n(%) 19 (63) 13 (65) NS
Deep vein thrombosis prior, n(%) 1 (3) 0 NS
Malignancy, n(%) 5 (17) 4 (20) NS
Recent surgery, n(%) 8 (27) 3 (15) NS
Long trip, n(%) 5 (17) 1 (5) NS
Pregnancy, n(%) 2 (7) 0 NS
DVT plus pulmonary embolism, n(%) 15 (50%) 2 (10%) 0,005
May Thurner syndrome, n(%) 13 (43%) 10 (50%) NS
symptoms DVT inside 21 days, n(%) 29 (97%) 7 (35%) 0,001
Iliac veins, n(%) 21(70) 13 (65) NS
Femoral veins, n(%) 15 (50) 10 (50) NS
Inferior vena cava, n(%) 6 (20) 3 (15) NS
Mechanic tromboaspiration, n(%) 28 (93) 7 (35) 0,001
Indigo Penumbra system, n(%) 11(37) 2 (10) 0,04
Litic use, n(%) 26 (87) 5 (25) 0,001
Balloon angioplasty, n(%) 21 (70) 7 (35) 0,02
Venous dedicated stents, n(%) 17 (57) 14 (70) NS
Vena cava filters use in acute thrombosis of large veins
Vena cava filters use in acute thrombosis of large veins.
Costantini Ricardo; Juan Manuel Telayna Jr; Juan Manuel Telayna.
Cardiovascular Research Technologies (CRT) – March 2 – 5, 2019 - Washington DC. - Poster 200.04
97
07 10
100
05
00
20
40
60
80
100
120
Clinical Success Re - PE Major Bleeding Re - DVT
MACE (%)
PTA with VCF PTA without VCF
p= NS
Sentry Bioconvertible Inferior Vena Cava Filter
Michael D. Dake, et al by SENTRY Trial Investigators J Vasc Interv Radiol 2018; 1–12.
Sentry Bioconvertible Inferior Vena Cava Filter
Michael D. Dake, et al by SENTRY Trial Investigators J Vasc Interv Radiol 2018; 1–12.
Sentry Bioconvertible Inferior Vena Cava Filter
Survival Effects of Inferior Vena CavaFilter in Patients With Acute Symptomatic
Venous Thromboembolism and aSignificant Bleeding Risk
Manuel Monreal for the RIETE InvestigatorsJ Am Coll Cardiol 2014;63:1675–83
ALN Implants Chirurgicaux (ALN Vena Cava Filter)- Closed Argon Medical Devices, Inc/Rex Medical (Option Elite Retrievable Vena Cava Filter)- Closed B. Braun Interventional Systems Inc (VenaTech LP Vena Cava Filter/VenaTech Convertible
Filter)- OpenCook Incorporated (Gunther Tulip Vena Cava Filter)- Closed
CR Bard Peripheral Vascular, Inc (DENALI Vena Cava Filter)- Closed Cordis Corporation (OPTEASE Retrievable Vena Cava Filter/TRAPEASE Permanent Vena
Cava Filter)- Open
Multi-center, prospective, open-label, non-randomized investigation of commercially available IVC filters from 6 manufacturers placed in subjects for the prevention of PE.
This study will enroll approximately 1,800 IVC filter subjects at up to 60 sites in the US.
Clinicaltrials.gov NCT02381509
Tromboembolismo venosoTVP recurrentePropagación de trombosTEP recurrenteTrombosis del sitio de inserción
Complicaciones del sitio de inserciónTrombosisHematoma / hemorragiaInfección
Complicaciones del implanteTilting (inclinación)Malaposición en vaso incorrectoImplante incompleto
Complicaciones del dispositivoFractura
Atrapamiento de la guía co-axial
Migración (proximal o distal)
Extrusión a través de la vena cava a estructuras adyacentes
Complicaciones en el retiroFallo de la remociónFractura del dispositivo
4% to 15%
Eventos adversos relacionados con FVC
The retrieval rate increased over time, from roughly every 1-out-7 VCFs being retrieved in 2010 up to 1-out-4 retrieved in 2014.
Vena Cava Filter Retrieval Rates and Factors Associated With Retrieval in a Large US CohortJoshua D. Brown,et al. - J Am Heart Assoc. 2017;6:e006708. DOI: 10.1161
Recent data from a systematic review of 37 studies confirm the increased rate of complications when filters are left in place for longer than 30 days and indicate a retrieval rate of approximately 34%.1
Risks of unretrieved filters include recurrent DVT, vena cava thrombosis, organ penetration, and mechanical filter complications, such as migration and strut fracture up to 40% at 5.5 years.2
These risks seem to increase with the length of time that the filter is in place.3
. 1-Angel LF, Tapson V, Galgon RE, Restrepo MI, Kaufman J. Systematic review of the use of retrievable inferior vena cava filters. J Vasc Interv Radiol. 2011;22 (11):1522-1530.e3.
2 -Tam MD, Spain J, Lieber M, Geisinger M, Sands MJ, Wang W.Fracture and distant migration of the Bard Recovery filter: a retrospective review of 363 implantations for potentially life-threatening
complications. J Vasc Interv Radiol. 2012;23(2):199-205.e1.
3- Zhou D, Spain J, Moon E, Mclennan G, Sands MJ, Wang W. Retrospective review of 120 Celect inferior vena cava filter retrievals: experience at a single institution.
J Vasc Interv Radiol. 2012;23(12):1557-1563.
Decision analysis of retrievable inferior vena cava filters in patients without pulmonary embolism
Quantitative decision analysis suggests that if the patient’s
transient risk for PE has passed, the risk-benefit profile begins to favor removal between 1 and 2 months.
There is an optimal net clinical benefit if a VCF is retrieved within 29
to 54 days after placement in prophylactic indications.
Morales JP, Li X, Irony TZ, Ibrahim NG, Cavanaugh KJ. J Vasc Surg Venous Lymphat Disord. 2013;1:376–384 4.
Filtro de Vena Cava: procedimientos (n= 407)
01
2
4 4
7
18
10
17
15
28
1413
0
25
1615
38
22
0 0 0 0
2
0
3 3
5
2
10
6
9
0
14 14
12
22
14
0 0 0 0 0 0
4
2
12
1
3
1
4 4
6
3 3
10
5
10
15
20
25
30
35
40
2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018
Colocación Extracción Reposición
16
84
Tipos de FVC (%)
FVC Definitivos FV Removibles
0
20
40
60
80
100
FVC Removibles
11
89
Convertibles Transitorios
FVC removibles (%)
Retiro no exitoso2 / 249 = (0,7%)
Filtros de Vena Cava: procedimientos (n = 407)
TromboaspiraciónTrombosis FVC
Resultado finalAtrapado con lazo
NOSI
Riesgo significativo de TEP
NO SIACO efectiva o profilaxisNO FVC
Corta duración de riesgo de TEP o
contraindicación ACO
ACO standard
o Profilaxis
FVC transitorio
NO SI
InciertoFVC
definitivo
• Trombosis iliacas o iliaco femoral, uni o
bilateral.
• Trombosis uni o bilateral iliaco o iliaco
femoral pre intervención.
Conclusiones:
Toma de decisiones basada en la ecuación evidencia =/= experiencia
La performance de los FVC varia con su configuración.
Seguimiento cercano de los pacientes tras implante FVC
