fvc estado del arte - universidad austral · hemorrhagic stroke heparin associated thrombocytopenia...

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

Muchas gracias