AngioDynamics AngioVac Slide Deck Outline
ICD-10 Coordination and Maintenance Committee Meeting

Slide 1:

A New ICD-10-PCS Code for Extracorporeal Removal of Thrombi and Emboli from Venous System

Presented by:  John Moriarty, MD
Vascular & Interventional Radiology
UCLA Medical Center
Presented to: ICD-10-CM/PCS Coordination and Maintenance Committee Meeting Centers for Medicare & Medicaid Services

March 18, 2015

Slide 2:

Agenda 

• Coding Issue: Currently no ICD-9 or ICD-10 code to describe this unique intervention
• About Deep Vein Thrombosis
• Traditional Treatments
• Extracorporeal Removal of Thrombi & Emboli
• Rational for ICD-10-PCS
• ICD-10-PCS Code Options
• New Technology Add on Payment
• Questions and Answers

Slide 3:

Venous Blood Clots

• Blood clots (thrombus) that form within a vein
 DVT: Deep Vein Thrombosis
 PTS: Post Thrombotic Syndrome
 VTE: Venous Thromboembolism

Slide 4:

Deep Vein Thrombosis (DVT)

DVTs occur in large venous structures: 
• Superior Vena Cava (SVC), 
• Inferior Vena Cava (IVC), 
• Right Atrium (RA) 
• Iliofemoral venous system.
• DVTs occur as a result of:
• Venous stasis (low or no blood flow), 
• Vascular injury 
• Hypercoagulable state (cancer, protein C or S deficiency)

Diagram of venous structures in the human leg.  

Image of a Deep Vein Thrombosis

Slide 5:

VTE Statistics

• 1 to 3 per 1000 in general population per year
• 900,000-1,000,000 events in US per year
• Third most common cause of cardiovascular mortality
• 20% mortality at 1 year
• In-hospital VTE fatality is 12%, rising to 21% in elderly population

Slide 6:

VTE Incidence

The table demonstrates incidence of VTE, DVT and PE.  There are over 1 million incidence of VTE per year in the United States.

Source: Helt, JA et al. Blood. 2005; 106:267A.

Slide 7:

VTE Mortality

The table demonstrates the VTE Mortality in United States. There are 300,000 VTE deaths per year in the United States.  VTE is the #3 cause of death in the US.

Source: Helt, JA et al. Blood. 2005; 106:267A.
Murphy, SL et al, Deaths: Preliminary Data for 2010: National Vital Statistics Reports; 2012.

Slide 8:

VTE in 2015

• DVT is very common
• Post Thrombotic Syndrome (PTS) is the most common complication of DVT
• PTS causes large scale:
 Morbidity
 Societal cost
 Reduction in patient QOL
PTS is inadequately prevented and treated by current regimes

Slide 9:

Post Thrombotic Syndrome (PTS)

• Leg swelling
• Limb pain 
• Edema
• Skin Changes
• Leg Ulceration

The image shows two examples of what PTS looks like. 

Slide 10:

Extremely Common

• 20 – 50% of patients with DVT develop PTS despite optimal anticoagulation
 In most cases, within 12 months
 Cumulative incidence 10 – 20 years post
• 5 – 10% develop severe PTS…ulcers
• Probability of developing venous ulcer over 10 years following DVT = 5%

Kahn, Circ, 2014 
Zidane, Arch Int Med, 2000
Kahn, Ant Int Med, 2008
Hencke, J Vac Surg, 2011

Slide 11:

Causes of PTS

Image of a flow chart explaining the causes of PTS.  Outflow Obstruction is the main cause of PTS.

Source:  Kahn, Circ, 2014

Slide 12:

Extreme Societal Cost

• 2 million workdays lost per year in US as a result of leg ulcers
• QOL impairment = COPD, HF
• 2 year initial total per-patient cost of PTS was Canadian $4527
 X2 if DVT without PTS
• Estimate mean adjusted annualized cost of developing PTS…$11,667
 AF $6697
 MI $9716

Source:  Bergen, NEJM, 2006
Guanella, JTH, 2011
McDougal, AMJHT, 2006 

Slide 13:

Current Treatments for VTE

• Systemic anticoagulation
• Surgical thrombectomy/embolectomy
• Systemic thrombolysis
• Catheter-directed thrombolysis (CDT)

Slide 14:

Anticoagulation

• Glucosaminoglycans (GAGs)
 Heparin/heparin sulfate
• Vitamin K Agonists (VKAs)
 Coumadin/warfarin
• Low Molecular Weight Heparin (LMWH)
 enoxaparin (Lovenox)
• New Oral Anticoagulants (NOACs) approved for:
 Reduction of recurrent DVT
 Prevention of PE
 dabigatran (Pradaxa)
 rivaroxaban (Xarelto)
 apixaban (Eliquis)

Source:  
Prandoni, Ann Intern Med, 2009
Shulman, NEJM, 1997
Schulman, NEJM, 2009

Slide 15:

New Oral Anticoagulants (NOACs)

• DVT Prophylaxis
 2008: RECORD 1,2,3 (rivaroxaban: knee, hip, hip) --> superior, fewer bleeds (knees)
 2008-10: ADVANCE 1,2,3 (apixaban: knee, knee, hip) --> superior with EU dosing, inferior with US dosing
• VTE (DVT/PE)
 2010 EINSTEIN (rivaroxaban) --> noninferior
 2012: EINSTEIN-PE (rivaroxaban) --> noninferior, fewer bleeds in PE trial
 2013: EINSTEIN-EXTEND (rivaroxaban) --> superior, more bleeds than placebo
 AMPLIFY (apixaban) --> noninferior, fewer bleeds
 AMPLIF-EXT (apixaban) --> superior, 2.5 mg dose equal placebo bleeds
Slide 16:

Open Vein Hypothesis

• Rapid thrombus elimination and restoration of unobstructed deep venous flow may prevent valvular damage, reflux, venous obstruction and PTS.
 Meissner (1993): venous segments that developed valvular reflux had longer (2.3 to 7.3 times) endogenous clot clearance than segments that did not (P<0.04)
 Prandoni (2005): PTS developed more frequently in proximal DVT patients who had residual venous thrombus or popliteal valvular reflux at 6-mo follow-up (n=180, 47% vs. 23%, P<0.01)
 Hull (20056): metaanalysis of 11 randomized DVT treatment trials and found a strong correlation between the amount of residual trhombus after a course of anticoagulant therapy and the subsequent incidence of recurrent VTE.

Slide 17:

Systemic Thrombolysis

Significant (18%) or complete clot lysis (45%) can be achieved by giving systemic lysis, but with an unacceptably high risk of bleeding complications (14%)

Source:  
Goldhaber, Am J med, 1984
Elliot, BJS, 1979,
Turpie, Chest, 1990

Slide 18:

Catheter-Directed Thrombolysis (CDT)

• CDT allows higher intrathrombus drug concentration, enhancing drug concentration and reducing total dose
• “CDT has been consistently successful in the removal of thrombus in acute iliofemoral DVT, with approximately 90% of patients experiencing significant thrombolysis.”

Source: Vedantham, JVIR, 2006
Slide 19:

Catheter-Directed Thrombolysis (CDT)

Image of a catheter-directed thrombolysis.

• Urokinase – N/A
• tPA (alteplase)
• rtPA (reteplase)
 0.5mg/hr
Source: 
Semba, JVIR, 2000
Sugimoto, Jvasc Surg, 2003
Bladwin, vasc Endo Surg, 2004

Slide 20:

Pre/Post

Image one pre-treatment with AngioVAC.  Image two post-treatment with AngioVAC.

Slide 21:

 What else apart from lysis? 

• Lysis doesn’t work
• Lysis contraindicated
• Acute limb threat

? Faster, Cheaper

Image of patient with an unresolved DVT.

Slide 22:

Extracorporeal Removal of Thrombi and Emboli: the AngioVac Procedure

• Typically performed in inpatient  hospital setting
• General anesthesia
• Percutaneous procedure with real-time fluoroscopy
• Multidisciplinary team:
 Interventionalist
 Surgeon
 Anesthesiologist
 Perfusionist

Slide 23:

AngioVac

Image of AngioVAC cannula and tip.

22 F coil-reinforced Cannula
Designed with balloon actuated, expandable funnel shaped distal tip

Slide 24:

Standard AngioVac Cannula and Set Up
Image of AngioVac Cannula and setup

Access points are any combination of internal jugular (IJ) or common femoral vein (CFV). The above illustrates AngioVac (right IJ), reinfusion cannula (right CFV).

Slide 25:

RA Thrombus/ IVC Thrombus
Right Atrial (RA) thrombus as indicated by the arrow.

Arrow points to image of RA Thrombus. 

Extensive thrombus in the IVC both above and below the IVC filter

Arrow points to image of IVC Thrombus.

Slide 26:

RA Thrombus Removed with AngioVac

PRE AngioVac
Right Atrial (RA) thrombus as indicated by the arrow

Image of RA Thrombus pre-treatment.

POST AngioVac
Thrombus removed with AngioVac

Image post-treatment with RA Thrombus removed. 

Slide 27:

Material Removed with AngioVac

Image of material removed with AngioVac.

Note the presence of both dark (fresh) thrombus…

…And the lighter, more chronic material

Slide 28:

Evidence

Image of Article:
Hybrid Minimally Invasive Extraction of Arterial Clot Avoids Redo Sternotomy in Jehovah’s Witness

Image of Article:
Initial Use of Large Bore Suction Thrombectomy Cannula for The Treatment of Massive Inferior Vena Cava (IVC) and Iliofemoral Deep Vein Thrombosis (DVT)

Slide 29:

Image of Article:
Vacuum Assisted Debulking of a Prohibitively Large Tricuspid Valve Vegetation Prior to Percutaneous Laser Lead Extraction 

Image of Article:
AngioVac Aspiration for Paradoxical Emboli Protection Through A Fenestrated Fontan During Central Venous Thrombosis Manipulation 

Image of Article:
A Novel Technique for Endovascular Removal of Large Volume Right Atrial Tumor Thrombus

Image of Article:
Thrombectomy Using Suction Filtration And Veno-Venous Bypass: Single Center Experience with A Novel Device. 

Slide 30:

Patient Selection Criteria

• When extracorporeal removal of thrombus should be considered:
 Large thrombus burden not amenable to standard therapy – i.e. thrombolysis or rheolytic therapy (AngioJet)
 Patient is contraindicated for thrombolytic therapy – i.e. recent surgery, history of stroke (CVA)
 Patient is a high-risk or non-surgical candidate – decision made by the treating or consulting physician

Slide 31:

FDA Status

• Original clearance March, 2009 (K091304, K092486)
• Subsequent clearance March 2014 (K133445)
• Intended for use as a venous drainage cannula during extracorporeal bypass for up to 6 hours and for removal of fresh, soft thrombi or emboli during extracorporeal bypass for up to 6 hours.
• It is for the cannula’s expanded indication for removal of fresh, soft thrombi or emboli during extracorporeal bypass for up to 6 hours that the request for ICD-10-PCS code is made.

Slide 32:

Rationale for New ICD-10-PCS Code

• Procedure code needed to describe extracorporeal bypass with removal of thrombi and emboli from venous system
 When used with prophylactic filtering during bypass surgery 
 When used as standalone, destination procedure

Slide 33:

ICD-10-PCS Code Options

1. Description
Do not create new codes for removal of thrombi and emboli that use cardiopulmonary bypass
Comment
This option does nothing to improve the fact that there are no ICD 9 or ICD 10 codes to describe this procedure
2. Description
Create new codes to capture the prophylactic filtering during cardiopulmonary bypass in section 5A1 and removal of thrombus in the Medical Surgical tables 02C,05C and 06C
Comment
If the procedure to remove the thrombus can be coded independent of the prophylactic filtering this option is acceptable.
If not, this option does not provide a means of identifying the destination standalone removal of thrombus.
3. Description
Create new codes in section X New Technology to identify removal of thrombus using the extracorporeal suction technique
Comment
We tentatively support this option but require more detail on this New Technology code section
4. Description
Create new codes in section X New Technology to identify prophylactic filtering using the extracorporeal suction technique, during surgery that uses cardiopulmonary bypass
Comment
We do not support this option because it does not provide a means to code the procedure when performed as a destination therapy

Slide 34:

Conclusion

• This is a novel approach to treat a serious condition
• Not currently coded, not currently forecast for coding under ICD-10-PCS
• Hospitals need code for identification of procedure:
 Data Capture
 Economic Analysis
 Outcomes
 Application for NTAP will be made
 We request consideration of new code(s) for 2017 or as soon as code freeze is lifted

Slide 35:

Questions/Answers/Discussion

