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Intervention for Deep Venous Thrombosis and Pulmonary Embolus

Michael R. Jaff, DO

Paul and Phyllis Fireman Endowed Chair in Vascular Medicine

Massachusetts General Hospital

Professor of Medicine

Harvard Medical School

Boston, Massachusetts USA

Michael R. Jaff, D.O.

Conflicts of Interest

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• Consultant

– Abbott Vascular (non-compensated)

– AOPA

– Boston Scientific (non-compensated)

– Cardinal Health

– Cordis Corporation (non-compensated)

– Janacare, Inc

– Medtronic (non-compensated)

– Micell, Inc

– Novella (DSMB)

– Primacea

– Valiant

– Volcano

• Equity

– Access Closure, Inc

– Embolitech

– I.C.Sciences, Inc

– Janacare, Inc

– MC10

– Northwind Medical, Inc.

– PQ Bypass, Inc

– Primacea

– Sano V, Inc.

– Vascular Therapies, Inc

• Board Member

-VIVA Physicians (Not For Profit

501(c) 3 Organization)

• www.vivapvd.com

-Intersocietal Accreditation Commission

-CBSET

January 2016

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Current Management of DVT Diagnosis of DVT IVC Filter:

•Contraind. to Anticoag.

•Protection during Lysis Anticoagulation

Distal (Calf Vein)

Serial DUS to Exclude

Propagation

Iliac/CFV

•Pharmacologic Lysis (no contraind.)

•Mechanical Thrombectomy

•(+ Lysis)

•Iliac Stent (if residual stenosis)

•Surgical Thrombectomy

•Failed Lysis

•Contraind. to Lysis

•Failed Thrombectomy

Circulation 2004;110 [Suppl I]:I-27-I-34

So, Why Consider Intervention? • Here is your challenge:

– There are so many physicians who believe that they are experts in the management of DVT

– Their perception?

• Patients do quite well with standard anticoagulation

– And now with NOACs????

• We can keep patients out of the hospital

– (Who would argue with that?)

• Why incur the risks associated with intervention?

• Why incur the costs associated with intervention?

• Is this all trumped up to generate another procedure for interventionists?

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Goals of endovascular therapy for DVT

• More rapid lysis via local administration of drug

• Relieve acute pain and edema

• Prevent PE and recurrent thrombosis

• Prevent post-thrombotic syndrome

• Restore vessel patency

• Preserve valve function

• Correct underlying anatomic lesions

Indications for Endovascular Venous Intervention

• Phlegmasia cerulea dolens

• Extensive or proximal DVT: IVC, iliofemoral

– Young, highly-functional ptshigh risk of PTS

– Symptomatic IVC filter occlusion

– Early intervention is best, but benefit may still be derived months after acute occlusion

• High risk for fatal PE

• Propagation of DVT despite conventional therapy

• High likelihood of underlying anatomic lesion

– May-Thurner syndrome (MTS)

– Compression by pelvic tumor

– Prior pelvic DVT

Percutaneous mechanical thrombectomy: Advantages vs. CDT

• Shorter treatment time to patency?

• Potentiator of thrombolytic therapy for subacute or chronic thrombus?

• Application when to lysis contraindicated?

• Cheaper?

• Safer?

The ATTRACT Trial • Acute Venous Thrombosis: Thrombus Removal with Adjunctive

Catheter-Directed Thrombolysis

– NHLBI-funded, Phase III, open-label, multicenter RCT

– Pharmacomechanical Catheter-Directed Thrombolysis

– 692 patients with symptomatic, acute proximal DVT

– 28 U.S. Centers, currently enrolling

– PI = Dr. Suresh Vedantham (Washington University)

– Study Chair = Dr. Samuel Z. Goldhaber (Harvard)

The ATTRACT Trial

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Symptomatic Proximal DVT

(iliac, common femoral, femoral vein)

PCDT plus rtPA

AND

Standard DVT Therapy Standard DVT Therapy

• 209 patients with symptomatic, first iliofemoral DVT

– Randomized to “conventional treatment” alone or additional catheter-directed thrombolysis

• Primary endpoints

– Villalta Score at 24 months

– Iliofemoral patency at 6 months

10 Lancet 2012;379:31-8

CaVent Study--Demographics

11 Lancet 2012;379:31-8

CaVent Study--Outcomes

• 20 Bleeding Events – 3 major (rectus sheath hematoma, compartment

syndrome, access site hematoma) – 5 clinically relevant – No deaths, PE, intracerebral hemorrhage

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Lancet 2012;379:31-8

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J Vasc Surg 2012;55:1449-62

SVS/AVF Guidelines

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Guideline Grade Recommendation Quality of Evidence

Early Thrombus Removal in the following scenarios: --First episode of acute iliofem DVT --Symptoms <14 days --Low Bleeding Risk --Ambulatory, good functional capacity, ‘acceptable’ life expectancy

2-Weak C-Low/very low

Early Thrombus Removal in Phlegmasia Cerulea Dolens

1-Strong A-High

Percutaneous Techniques Preferred as Thrombus Removal Strategy

2-Weak C-Low/very low

Pharmacomechanical thrombolysis preferred to Catheter-Directed Thrombolysis

2-Weak C-Low/very low

J Vasc Surg 2012;55:1449-62

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Highlights from the AHA Guidelines Iliofemoral Deep Venous Thrombosis

• Defined as complete or partial thrombosis of any segment of the iliac vein or the common femoral vein, with or without involvement of other lower extremity veins or inferior vena cava.

Circulation 2011

Intervention for Deep Venous Thrombosis

• Deep Venous Thrombosis

– Anticoagulation does not prevent development of post-thrombotic venous insufficiency

– Morbidity of post-thrombotic venous insufficiency is significant and costly

– Consider endovenous intervention for iliofemoral DVT, advanced symptoms, and low bleeding risk

– Experienced interventionist is critical

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J Thromb Thrombolysis 2016;41:68-81

What About PE?

J Thromb Thrombolysis 2016;41:68-81

What Are The Goals of Thrombolytic Therapy for Acute PE?

J Thromb Thrombolysis 2016;41:68-81

The Contraindications to Lytic Therapy

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Chest 2012;141

This is What You Have to Deal With…

So, How To Decide?

ED / ICU / Floor Team

Pulmonary

Vascular Medicine/Cardiology

Cardiac Surgery

Pulmonary Embolism Response

Team (PERT)

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Intervention for Deep Venous Thrombosis and Pulmonary Embolus

Michael R. Jaff, DO

Paul and Phyllis Fireman Endowed Chair in Vascular Medicine

Massachusetts General Hospital

Professor of Medicine

Harvard Medical School

Boston, Massachusetts USA