U.O. CHIRURGIA VASCOLARE ED ENDOVASCOLARE

AZIENDA OSPEDALIERA UNIVERSITARIA

ARCISPEDALE S. ANNA, CONA-FERRARA

Prevenzione della SPT

Ruolo della fibrinolisi nella TVP prossimale

Tiberio Rocca

TVP

Terapia anti coagulante orale

Prevenzione recidiva trombotica

e trombo-embolia polmonare

Raccomandazione 1 A

SINDROME POST TROMBOTICA

TVP trattata con TAO e calza elastica

30% SPT

10% SPT grave

9% di recidiva

trombotica

Prandoni et Al. 1996

SINDROME POST TROMBOTICA

Il rischio di SPT severa è elevato in caso di TVP

Prossimale o Multilivello

Franzeck et Al. 1996

Il rischio di SPT severa è ridotto

nella TVP isolata di gamba

La funzione valvolare è conservata più frequentemente

in TVP non occlusiva e con efficace ricanalizzazione

Ripristinare la pervietà vasale

Preservare la funzione valvolare

SINDROME POST TROMBOTICA

Rob Strijkers et al; Phlebology, 2016

SINDROME POST TROMBOTICA

Fattori di rischio

Età

BMI

Sesso

Provoked/Unprovoked

Recidiva

Localizzazione del trombo

Ostruzione residua

Reflusso residuo

Trombofilia

Insufficiente TAO

SINDROME POST TROMBOTICA

Correlazione

Moderata

Moderata

Moderata

Non chiara

Forte

Forte

Forte

Forte

Non chiara

Moderata

Phlebology 2016

Rob Strijkers et al

Classificazione CEAP

SINDROME POST TROMBOTICA Inquadramento Clinico

Villalta Score

SINDROME POST TROMBOTICA

Costo economico

1. Bick RL. Clin Appl Thromb Hemost. 1999;5(1):2–9

2. Medicare & DRG. 1996

Costo medio

per ogni ricovero

negli USA ($)

Stroke2

0

5000 10000

2500 7500 12500

EP(1)

TVP(1)

IMA(2)

Quality of life and economic costs associated with postthrombotic syndrome

Am J Health Syst Pharm April 1, 2012 69:567-572;

Research indicates that the economic burden of PTS in the United States may be as high as $200 million

annually

LINEE GUIDA Trombolisi TVP in fase precoce

Society for Vascular Surgery

And American Venous Forum

J Vasc Surg 2012; 55

LINEE GUIDA Trombolisi TVP in fase precoce

Society for Vascular Surgery

And American Venous Forum

J Vasc Surg 2012; 55

Trombolisi Loco regionale

Farmacologica Urochinasi

rTPA

Meccanica Rotazionale

Idrodinamica

Reolitica

Farmaco Meccanica Fibrinolitico + device

U.S. Guided Fibrinolitico + ultrasuoni

Fibrinolisi Farmacologica Lisi del trombo

Ripristino del flusso venoso

Riduzione del danno valvolare

Prevenzione della recidiva trombotica

Prevenzione dell'ipertensione venosa

Ad oggi non esistono protocolli uniformi per

La scelta del farmaco

Il dosaggio del farmaco

La durata dell'infusione

Fibrinolisi loco regionale

Long-term results using catheter-directed thrombolysis in 103 lower limbs with acute iliofemoral venous thrombosis.

101 patients with 103 extremities A stent was inserted in 57 limbs

At 6 years, 82% of the limbs had patent veins with competent valves and without any skin changes or venous claudication

Treatment with CDT for IFVT achieves good patency and vein function after 6 years of follow-up

in this highly selected group of patients

Baekgaard N et al; Eur J Vasc Endovasc Surg 2010

Of all patients with acute deep vein thrombosis, those with involvement of the iliofemoral segments have the most

severe chronic postthrombotic morbidity. Catheter-based techniques permit percutaneous treatment to eliminate

thrombus, restore patency, potentially maintain valvular function, and improve quality of life.

AJ Comerota; Phlebology 2015

Fibrinolisi loco regionale

CaVenT Multicenter, randomized, open label, controlled clinical trial

Enden T et al (CaVenT study Group); Lancet 2012

189 pazienti

Riduzione rischio assoluto del 14.4%

20 sanguinamenti (10.5%)

3 classificati come maggiori (1.6%)

Fibrinolisi loco regionale

CaVenT Multicenter, randomized, open label, controlled clinical trial

Post-thrombotic syndrome after catheter-directed thrombolysis fordeep vein thrombosis (CaVenT):

5-year follow-up results of an open-label, randomised controlled trial.

Haig Y et al; Lancet Haematol 2016

176 pazienti

87 gruppo CDT 89 gruppo controllo

37 SPT

42%

63 SPT

70%

p<0·0001

Riduzione rischio assoluto del 28%

Controindicazioni alla Fibrinolisi

Trombolisi Meccanica

Trombectomia Rotazionale

Trombectomia Reolitica

Trombectomia con aspirazione diretta

Trombectomia con infusione periferica

Trombolisi Meccanica

Karthikesalingam A. et al; Eur J Vasc Endovasc Surg 2011

Trombolisi Meccanica

Utilizzo di filtri cavali (temporanei)

Anemia transitoria da emolisi

Costi

Complessità di esecuzione

Traumatizzante: alterazione parietale o valvolare

Comparison of vein valve function following pharmacomechanical

thrombolysis versus simple catheter-directed thrombolysis

for iliofemoral deep vein thrombosis. Vogel D et al; J Vasc Surg 2012

Trombolisi Farmaco Meccanica

Trombolisi Farmaco Meccanica

.

Percutaneous pharmacomechanical thrombectomy offers lower risk of post-thrombotic syndrome than catheter-directed thrombolysis

in patients with acute deep vein thrombosis of the lower limb.

Thirty-four patients, 16 in PMT and 18 in CDT, were followed up for more than 1 year Thrombolysis rate was 81.5 ± 8.5% and 67.7 ± 21.0% in the PMT and CDT groups, respectively (P = 0.059).

There were no differences in complications, thrombus score

CONCLUSIONS: Both PMT and CDT are effective treatment modalities in patients with acute proximal DVT. Compared with CDT, PMT provides similar treatment success, but with lower risk of PTS at 1-year follow-up

Huang CY et al; Ann Vasc Surg 2015

Mechanical thrombectomy with Trerotola compared with catheter-directed

Thrombolysis for treatment of acute iliofemoral deep vein thrombosis.

Conclusions

MT with the Trerotola device for acute iliofemoral DVT required shorter procedure times and lower urokinase

doses than conventional CDT, while providing the same results.

Procedure time was shorter in the MT with CDT group (18.2 ± 8.2 hr) or in the MT only group (2.7 ± 2.0 hr)

compared with the CDT group (29.3 ± 9.4 hr; P < 0.001).

Urokinase dose was lower in MT only (0 million units) or in the MT with CDT group (5.13 ± 3.72 million units)

Than in the CDT group (7.51 ± 4.54 milion units; P < 0.001).

Park KM et al; Ann Vasc Surg 2014

LINEE GUIDA Trombolisi TVP in fase precoce

Society for Vascular Surgery

And American Venous Forum

Trombolisi U.S. Guided

EkoSonic: maggiore permeabilità del trombo al farmaco

Trombolisi U.S. Guided

La trombolisi accelerata dagli ultrasuoni può rappresentare una

evoluzione della terapia farmacologica loco-regionale

J Vasc Interv Rad, 2008

J Endovasc Therapy, 2007

Riduzione dei costi

Trombolisi U.S. Guided

Engelberger RP et al; Thromb Haemost. 2014

Fixed low-dose ultrasound-assisted

catheter-directed thrombolysis followed

by routine stenting of residual stenosis

for acute ilio-femoral deep-vein thrombosis

87 pazienti sottoposti a fibrinolisi u.s. assistita con 20 mg rt-PA in 15 ore

70 (80%) sottoposti a stentig iliaco per stenosi residua > 50%

1 caso (1%) di sanguinamento maggiore

Pervietà primaria e secondaria a 1 anno del 87% e 96%

Clinica negativa per SPT nell’94% a 1 anno

Trombolisi

Conclusion: Patients with extensive DVT treated with catheter-based interventions to eliminate thrombus suffer relatively

little postthrombotic morbidity. The degree of clot lysis directly correlates with long-term outcome. Improved QOL, the

Villalta scale, and clinical class of CEAP are linearly correlated with the amount of clot resolution.

Grewal K, Comerota AJ; J Vasc Surg 2010

Trombolisi

Conclusions: In patients with iliofemoral DVT treated with catheter-based techniques of thrombus removal, postthrombotic

morbidity is related to residual thrombus. When thrombus clearance was complete, the postthrombotic syndrome

was avoided. Residual thrombus is associated with an increasing risk of postthrombotic syndrome.

Comerota AJ et al; J Vasc Surg 2012

Trombolisi

Conclusions: The burden of residual thrombus at completion of CDT correlates with the risk of DVT recurrence.

Patients having CDT for IFDVT had a lower risk of recurrence than expected. Successful clearing of acute clot in IFDVT

Patients significantly reduces the recurrence risk compared to patients with a large residual thrombus burden.

Aziz F, Comerota AJ; Eur J Vasc Endovasc Surg 2012

Trombolisi

Comerota AJ et al; JAMA 2014

Trombolisi

Trombolisi Farmaco Meccanica

ATTRACT Multicenter, randomized, open label, assessor-blinded, parallel tow arm, controlled clinical trial

692 pazienti arruolati

Dispositivi trombolitici Trellis peripheral infusion System

Angiojet Rheolytic Thrombectomy System

Fibrinolitico rt-PA

(recombinant tissue plasminogen activator)

Trombosi venosa dell'asse popliteo femorale

Trombolisi Farmaco Meccanica

Vedantham S; Tech Vasc Interv Radiol 2014

Trombolisi TVP arti inferiori Conclusioni

Opzione terapeutica importante

Adeguata selezione

Approccio terapeutico in tempi brevi

Deve essere eseguito in Centri con adeguate risorse ed esperienza

Necessità di ulteriori trials

Risultati Trombolisi TVP arti inferiori

Approccio terapeutico

Tipo, dose e durata del fibrinolitico

Tipo device utilizzato per la lisi meccanica o fisica

Risposta del paziente

Anatomia vascolare venosa

Estensione del processo trombotico

Tempo intercorso dall'esordio della TVP

Entità e sviluppo dei circoli collaterali

Entità della ricanalizzazione

Entità del reflusso da alterazione valvolare

Sensibilità al fibrinolitico

Assetto coagulativo: eventuali deficit

Presenza di materiale tromboplastinico

Terapie aggiuntive

Angioplastica / Stent

TAO / NAO

Elastocompressione

Compliance del paziente

Follow up

VARIABILI

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