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2
• >600,000 Americans are diagnosed with DVT annually
• 300,000 will develop Post Thrombotic Syndrome (PTS)
• 120,000 will suffer recurrent VTE (DVT/PE)
• VTE is the leading cause of preventable hospital death (DVT and PE)
• DVT is the third most common CV Disease4
• U.S. spends $2.4B to Treat DVT annually2
 Age
 Travel
 Immobilization
 History of DVT
 Malignancy
 Surgery
 Trauma
 Hypercoagulable
States
 Pregnancy
 Oral
Contraceptives
 Central venous
catheters
 SLE
 Pulmonary Embolism (PE).
 Post Thrombotic Syndrome (PTS).
Observations
• Dilation of superficial
veins
• Reticular or varicose
veins
• Edema
• Skin changes
• Asymptomatic
Treatment Goals
• Prevention of:
• Pulmonary Embolism (PE)
• Thrombus propagation
• DVT recurrence
• Post Thrombotic Syndrome
• Maintain valve competence
Symptoms
• Varying Pain levels
• Swelling
• Aching
• Leg fatigue
• Cramping, Itching,
Burning
2/3 Deep
Vein
Thrombosis
(DVT)
1/3 Pulmonary
Embolism (PE)
Venous
Thromboembolism
(VTE)
Goldhaber, NATF, 3/08
 Anatomic
Criteria-
Proximal
Thombus
› Caval
› Iliac vein
› Femoral
vein
 Clinically Symptomatic
 Active/functional patients.
 Patients with massive
swelling
 venous gangrene.
 Tolerate anticoagulation.
 Optimal outcome with
acute DVT (2 weeks).
 Improve quality of life.
 Preserve valve function and decrease
post thrombotic syndrome (PTS)
 Anticoagulation
(Gold Standard).
 Inferior vena cava
filter (Greenfield
Filter)
 Interventional
treatment.
…does prevent clot propagation1.
…does reduce risk of pulmonary embolism.
But, it typically…
…does NOT resolve clot.16
…does NOT rapidly resolve symptoms.16
…does NOT prevent PTS (Post Thrombotic Syndrome
ANTICOAGULATION ALONE IS NOT ENOUGH
 Catheter directed lytics.
 EKOS catheter.
 Angiojet.
 Trellis Pharmaco-mechanical
thrombectomy.
Isolated Pharmacomechanical
Thrombolysis Treatments (Isolated
PMT)
•Thrombus isolated between
occluding balloons
•Lytic isolated between occluding
balloons
•Reduction in thrombolytic dosing
• Aspiration of thrombus and lytic
•Single setting thrombus removal
•No reported major bleeding
• Reduces/eliminates ICU time
Pharmacomechanical
Thrombolysis Treatments (PMT)
•Thrombolytic infusion with
mechanical energy
• Dissolves and macerates
thrombus
• Reduces the thrombolytic
dose & time
1. Proximal and distal balloons, with
balloon
2. inflation syringes, a thrombolysis
infusion port, the thrombus
3. aspiration syringe, and a drive unit
for mechanical dispersion
4. of the thrombolytic agent
Potential Advantages of Local Thrombolysis and Mechanical Thrombectomy
• Local delivery of thrombolytic agent
• Smaller doses of thrombolytic agent
• Shorter duration of thrombolysis
• Avoid risks of systemic effects of thrombolytic agents
- Can be used in patients with relative contraindications
to thrombolysis
- Decreases bleeding complications
• Less costly
The Trellis thrombectomy system
(Covidien)
 Done in a Cardiovascular cathlab.
 Prone position (Popliteal vein approach).
 Percutaneous via 8 French Sheath.
 General vs. local with sedation (patient
preference).
Thrombus
isolated &
targeted delivery
of thrombolytic
drug
Single-setting
treatment in
83% of cases*
Isolated Pharmacomechanical Thrombolysis using the Trellis Peripheral Infusion System
As presented at VEITH 11/2008 ~ 1,304 Venous Patients Commercial Registry
Catheter
delivered over
guidewire
 54 year old male with recent resection of
brain tumor presents to ER with massive
right leg swelling that had been present
for 24 hours. Denied chest pain or SOB.
 Venous US-extensive acute occlusive
venous thrombus from ankle up to
common femoral vein.
 Initiated on anti-coagulant
(Heparin(LMW),Thienopyridine,tPATissue
Plasminogen activators ) in ER.
 Venogram
 Trellis Mechanical Thrombectomy
Planned.
 Can be done as an outpatient.
 Bedrest for 2-4 hours.
 Thigh high ACE wrap for 3 days, then
compression stocking.
 Still need anticoagulation!!
The restoration of rapid
inline venous flow was
100%, 50%-82% lysis was
achieved in 82% of cases,
mean tPA dose was 13.4
mg, mean treatment time
was 91 minutes, and
primary patency rate was
100% at 1-month follow-up
A retrospective review (presented b/w April 2010-11)
 Twenty-eight patients (mean age, 46.4 ± 21.2 years)
presented with symptoms with a mean duration of 1.3 ± 1.8
months. Eighty-six percent had 100% occlusion on admission,
while 14.3% had 70%-90% stenosis. The mean lytic dose used
was tPA 20.7 ± 12 mg. The mean Trellis treatment time was
25.1 ± 11.5 minutes.
 Grade 3 lysis was achieved in 23 of 28 patients (85.8%),
 while grade 2 lysis was achieved in 14.2%. Mean total hospital
stay was 2.6 ± 2.7 days.
 Postprocedure symptom resolution was 100%, and there was
no reocclusion in 78.6% of patients at 1 year.
 At 12 months, the patency rate (primary or secondary) was
80% as determined by doppler ultrasound.
 In patients with DVT involving,
 the ilio-femoral and
 the upper-extremity vessels,
The use of the Trellis device was associated with a high technical
success rate as well as a satisfactory 12-month patency rate.
 Reduced lytic dose
 shorter treatment time and hospital stay,
 No bleeding complications ( major bleeding, access-site
pseudoaneurysms, distal embolism, or arteriovenous fistula
formation.)
REFERENCES`)Total preservation of patency and valve function after percutaneous
pharmacomechanical thrombolysis using the Trellis®-8 system for an
acute, extensive deep venous thrombosis.
Wormald JR, Lane TR, Herbert PE, Ellis M, Burfitt NJ, Franklin IJ.
2)Ann R Coll Surg Engl. 2012 Mar;94(2):e103-5. doi:
10.1308/003588412X13171221589496
3)http://www.ncbi.nlm.nih.gov/pubmed/17538133 Pharmacomechanical
thrombectomy of acute deep vein thrombosis with the Trellis-8
isolated thrombolysis catheter.
O'Sullivan GJ1, Lohan DG, Gough N, Cronin CG, Kee ST.
Q&A
THANK YOU 

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Trellis DVT Presentation3

  • 1.
  • 2. 2 • >600,000 Americans are diagnosed with DVT annually • 300,000 will develop Post Thrombotic Syndrome (PTS) • 120,000 will suffer recurrent VTE (DVT/PE) • VTE is the leading cause of preventable hospital death (DVT and PE) • DVT is the third most common CV Disease4 • U.S. spends $2.4B to Treat DVT annually2
  • 3.  Age  Travel  Immobilization  History of DVT  Malignancy  Surgery  Trauma  Hypercoagulable States  Pregnancy  Oral Contraceptives  Central venous catheters  SLE
  • 4.
  • 5.  Pulmonary Embolism (PE).  Post Thrombotic Syndrome (PTS).
  • 6. Observations • Dilation of superficial veins • Reticular or varicose veins • Edema • Skin changes • Asymptomatic Treatment Goals • Prevention of: • Pulmonary Embolism (PE) • Thrombus propagation • DVT recurrence • Post Thrombotic Syndrome • Maintain valve competence Symptoms • Varying Pain levels • Swelling • Aching • Leg fatigue • Cramping, Itching, Burning 2/3 Deep Vein Thrombosis (DVT) 1/3 Pulmonary Embolism (PE) Venous Thromboembolism (VTE) Goldhaber, NATF, 3/08
  • 7.  Anatomic Criteria- Proximal Thombus › Caval › Iliac vein › Femoral vein  Clinically Symptomatic  Active/functional patients.  Patients with massive swelling  venous gangrene.  Tolerate anticoagulation.  Optimal outcome with acute DVT (2 weeks).
  • 8.  Improve quality of life.  Preserve valve function and decrease post thrombotic syndrome (PTS)
  • 9.  Anticoagulation (Gold Standard).  Inferior vena cava filter (Greenfield Filter)  Interventional treatment.
  • 10.
  • 11. …does prevent clot propagation1. …does reduce risk of pulmonary embolism. But, it typically… …does NOT resolve clot.16 …does NOT rapidly resolve symptoms.16 …does NOT prevent PTS (Post Thrombotic Syndrome ANTICOAGULATION ALONE IS NOT ENOUGH
  • 12.  Catheter directed lytics.  EKOS catheter.  Angiojet.  Trellis Pharmaco-mechanical thrombectomy.
  • 13. Isolated Pharmacomechanical Thrombolysis Treatments (Isolated PMT) •Thrombus isolated between occluding balloons •Lytic isolated between occluding balloons •Reduction in thrombolytic dosing • Aspiration of thrombus and lytic •Single setting thrombus removal •No reported major bleeding • Reduces/eliminates ICU time Pharmacomechanical Thrombolysis Treatments (PMT) •Thrombolytic infusion with mechanical energy • Dissolves and macerates thrombus • Reduces the thrombolytic dose & time
  • 14. 1. Proximal and distal balloons, with balloon 2. inflation syringes, a thrombolysis infusion port, the thrombus 3. aspiration syringe, and a drive unit for mechanical dispersion 4. of the thrombolytic agent Potential Advantages of Local Thrombolysis and Mechanical Thrombectomy • Local delivery of thrombolytic agent • Smaller doses of thrombolytic agent • Shorter duration of thrombolysis • Avoid risks of systemic effects of thrombolytic agents - Can be used in patients with relative contraindications to thrombolysis - Decreases bleeding complications • Less costly The Trellis thrombectomy system (Covidien)
  • 15.  Done in a Cardiovascular cathlab.  Prone position (Popliteal vein approach).  Percutaneous via 8 French Sheath.  General vs. local with sedation (patient preference).
  • 16.
  • 17.
  • 18.
  • 19. Thrombus isolated & targeted delivery of thrombolytic drug Single-setting treatment in 83% of cases* Isolated Pharmacomechanical Thrombolysis using the Trellis Peripheral Infusion System As presented at VEITH 11/2008 ~ 1,304 Venous Patients Commercial Registry Catheter delivered over guidewire
  • 20.
  • 21.
  • 22.
  • 23.  54 year old male with recent resection of brain tumor presents to ER with massive right leg swelling that had been present for 24 hours. Denied chest pain or SOB.  Venous US-extensive acute occlusive venous thrombus from ankle up to common femoral vein.
  • 24.  Initiated on anti-coagulant (Heparin(LMW),Thienopyridine,tPATissue Plasminogen activators ) in ER.  Venogram  Trellis Mechanical Thrombectomy Planned.
  • 25.
  • 26.
  • 27.
  • 28.
  • 29.
  • 30.
  • 31.  Can be done as an outpatient.  Bedrest for 2-4 hours.  Thigh high ACE wrap for 3 days, then compression stocking.  Still need anticoagulation!!
  • 32. The restoration of rapid inline venous flow was 100%, 50%-82% lysis was achieved in 82% of cases, mean tPA dose was 13.4 mg, mean treatment time was 91 minutes, and primary patency rate was 100% at 1-month follow-up
  • 33. A retrospective review (presented b/w April 2010-11)  Twenty-eight patients (mean age, 46.4 ± 21.2 years) presented with symptoms with a mean duration of 1.3 ± 1.8 months. Eighty-six percent had 100% occlusion on admission, while 14.3% had 70%-90% stenosis. The mean lytic dose used was tPA 20.7 ± 12 mg. The mean Trellis treatment time was 25.1 ± 11.5 minutes.  Grade 3 lysis was achieved in 23 of 28 patients (85.8%),  while grade 2 lysis was achieved in 14.2%. Mean total hospital stay was 2.6 ± 2.7 days.  Postprocedure symptom resolution was 100%, and there was no reocclusion in 78.6% of patients at 1 year.  At 12 months, the patency rate (primary or secondary) was 80% as determined by doppler ultrasound.
  • 34.  In patients with DVT involving,  the ilio-femoral and  the upper-extremity vessels, The use of the Trellis device was associated with a high technical success rate as well as a satisfactory 12-month patency rate.  Reduced lytic dose  shorter treatment time and hospital stay,  No bleeding complications ( major bleeding, access-site pseudoaneurysms, distal embolism, or arteriovenous fistula formation.)
  • 35. REFERENCES`)Total preservation of patency and valve function after percutaneous pharmacomechanical thrombolysis using the Trellis®-8 system for an acute, extensive deep venous thrombosis. Wormald JR, Lane TR, Herbert PE, Ellis M, Burfitt NJ, Franklin IJ. 2)Ann R Coll Surg Engl. 2012 Mar;94(2):e103-5. doi: 10.1308/003588412X13171221589496 3)http://www.ncbi.nlm.nih.gov/pubmed/17538133 Pharmacomechanical thrombectomy of acute deep vein thrombosis with the Trellis-8 isolated thrombolysis catheter. O'Sullivan GJ1, Lohan DG, Gough N, Cronin CG, Kee ST.

Editor's Notes

  1. Deep Vein Thrombosis (DVT) = a blood clot that forms within a vein and remains in the place where it originated Pulmonary Embolism (PE) = a blood clot that propagates and travels to the heart or lungs 1. Stasis, or stagnant blood flow through veins This increases the contact time between blood and vein wall irregularities. It also prevents naturally occurring anticoagulants from mixing in the blood. Prolonged bed rest or immobility promotes stasis. 2. Coagulation Coagulation is encouraged by the presence of tissue debris, collagen or fats in the veins. Orthopaedic surgery often releases these materials into the blood system. During hip replacement surgery, reaming and preparing the bone to receive the prosthesis can also release chemical substances (antigens) that stimulate clot formation into the blood stream. 3. Damage to the vein walls This can occur during surgery as the physician retracts soft tissues as part of the procedure. This can also break intercellular bridges and release substances that promote blood clotting. Other factors that may contribute to the formation of thrombi in the veins include: Age Previous history of DVT or PE Metastatic malignancy Vein disease (such as varicose veins) Smoking Estrogen usage or current pregnancy Obesity Genetic factors