The HeRO™ Vascular Access Device: A New Solution for · PDF fileInventors of the HeRO™ Vascular Access Device The HeRO™ Vascular Access Device: A New Solution for the AV Access-

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Inventors of the HeRO™ Vascular Access Device

The HeRO™ Vascular Access Device:The HeRO™ Vascular Access Device:A New Solution for the AV Access-Challenged PatientChallenged Patient

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13-0010-02 Rev. B © 2008 Hemosphere, Inc. HeRO is a trademark of Hemosphere, Inc.

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Learning ObjectivesLearning Objectives

Upon completion of this presentation, participants will p p p , p pbe able to:

Relate the significance of long-term catheter use to the i d t f b t i i d f di l i dincreased rate of bacteremia, inadequacy of dialysis and risk of mortality in the catheter patient population

2. Summarize key results from the HeRO™ Clinical Studyy y

3. Recognize a HeRO™ device implant patient

4. Describe the appropriate physical pp p p yassessment/cannulation technique of HeRO™ patients and additional management considerations

5 List characteristics of potential HeRO™ candidates


5. List characteristics of potential HeRO™ candidates

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OutlineOutline

And I will do this by:

1. CPM data will be used to illustrate the growing prevalence of catheters and extrapolated to current HD data from 2008 USRDS data. KDOQI of 2006 goals will be reiterated.

2. Phase 3 clinical trial showing adequacy and infection data leading to FDA approval of this device as a graft

3 Th 3 i i i th t d fi H RO i l t ill b d ib d i3. The 3 incisions that define a HeRO implant will be described in detail along with history evidence

4. KDOQI 2006 graft cannulation guidelines will be reviewed along ith th btl h i l t diff t dwith the subtle physical assessment differences encountered

with HeRO

5.Clear inclusion and exclusion criteria will be given emphasizing th t thi i t ti f th ti t h h AVF


that this is not an access option for those patients who have AVF or AVG upper extremity options

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The Catheter Problem

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Patient StoryPatient Story


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The Catheter Problem: Growing Catheter UtilizationGrowing Catheter Utilization

TimePeriod Incidence Prevalence

AVF AVG CVC AVF AVG CVC

Oct – Dec20051

AVF AVG CVC AVF AVG CVC

54% 10% 36% 44% 26% 27%

Oct – Dec20062 41% 13% 45% 45% 26% 29%

12006 ESRD CPM (Clinical Performance Measures) Project Table 922007 ESRD CPM (Clinical Performance Measures) Project Table 9


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The Catheter Problem: Growing Access-Challenged PopulationAccess Challenged Population

58% G th


58% Growth

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The Catheter Problem: BacteremiaThe Catheter Problem: Bacteremia

Bacteremia is the second leading cause ofBacteremia is the second leading cause ofhemodialysis patient death and catheters are the primary contributing factor

• KDOQI reports an IJ catheter-related overall bacteremia rate of 1.6-5.5 per 1,000 catheter days1

H RO™ li i l d d li l f 2 3 1 000 • HeRO™ clinical study used a literature control of 2.3 per 1,000 catheter days2

• Femoral catheter bacteremia rates are typically 2 times higher3e o al cat ete bacte e a ates a e typ cally t es g e1NKF K/DOQI Clinical Practice Guidelines and Clinical Practice Recommendations 2006 Updates2Oliver, M., Lynch, L. Estimate of the Risk and Rate of Hemodialysis Catheter-Related Bacteremia. 2006. Hemosphere, Inc. document. (Hemosphere

scientific literature review of prospective or randomized studies of tunneled IJ catheters (15 articles) with 20 patients or more).3Lynch, L. Dialysis Catheter Literature Summary. 2007. Hemosphere, Inc. document. (Hemosphere Scientific literature review of non-device related

IJ/SCV catheter infections and device-related femoral catheter infections (4 articles)).


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The Catheter Problem: Adequacy of Dialysis1Adequacy of Dialysis1

% f P i % f P iType of Access Mean Kt/V

% of PatientsKt/V<1.2

% of PatientsKt/V<1.3

AV Fistula 1.57 7% 14%

AV Graft* 1.62 4% 8%

Catheter 1.45 18% 30%

• 2006 KDOQI guidelines establish a mean Kt/V target of 1.4*iIncludes grafts with and without AVFs

• 30% of catheter patients had a delivered Kt/V less than 1.3, leaving this patient population at risk for increased mortality


12007 ESRD CPM Report. Adequacy of Hemodialysis Table 7.

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The Catheter Problem: Increased Patient MortalityIncreased Patient Mortality

The mortality rate increases by 7% for each 0.1unit decrease in Kt/V1

There is a 40% higher mortality rate for catheter g ypatients compared to fistula patients2

1 Dhingra, R., Young, E., Hulbert-Shearon, T., Leavey, S., Port, F. Type of Vascular Access and Mortality in the U.S. Hemodialysis Patients. Kidney International.


g , , g, , , , y, , , yp y y y2001. Vol 60, pp. 1443-1451

2 Pastan, S., et. al. Vascular access and increased risk of death among hemodialysis patients. Kidney International. 2002: 620-626

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The Catheter Problem: SummaryThe Catheter Problem: Summary

Catheter utilization is growing Catheter utilization is growing

Number of patients who have exhausted all fistula and graft sites is growing graft sites is growing

High incidence of bacteremia is associated with long-term catheter use

Measured Kt/V is lower in catheter patients

Mortality rates are significantly higher in catheter Mortality rates are significantly higher in catheter patients compared to fistula patients


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The HeRO™ Vascular Access lDevice Solution

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HeRO™ Device DescriptionHeRO Device Description

The HeRO™ device is the new long-term permanent The HeRO device is the new long term permanent access solution for access-challenged and catheter-dependent patients

• Fully subcutaneous surgical implant

• AV access with continuous outflow • AV access with continuous outflow into the central venous system

• Traverses central venous stenosis allowing for long term hemodialysis accessallowing for long-term hemodialysis access


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HeRO™ Vascular Access Device


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HeRO™ Vascular Access Device I t d d U & FDA Cl ifi tiIntended Use & FDA Classification

The HeRO™ is intended for use in maintaining long-term vascular access for chronic hemodialysis patients who have exhausted peripheral venous access sites suitable for fistulas or grafts

The FDA classified the HeRO™ device as a graft


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HeRO™ Right-Sided Implant Visual

Graft Component

Dialysis Access

Area

Outflow Component

AreaRadiopaque Tip

Arterial Anastomosis


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HeRO™ Implantation: Step 1p p

Venous Outflow Component pPlacement

• The outflow component is pinserted into the IJV under ultrasound and fluoroscopic guidance and advanced into the mid to upper right atrium

• The outflow component is then t l d t t i i i t tunneled to connector incision at the deltopectoral groove


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HeRO™ Graft Tunneling gand Component Connection

• The graft is tunneled from the connector incision to the brachial artery incision y

• The outflow component is trimmed to size and connected to the graft component via the titanium connector


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Arterial Anastomosis

• The ePTFE graft component is trimmed to size and the arterial anastomosis is completed

A h d f h • At the end of the procedure, fluoroscopy is used to reconfirm proper outflow component tip outflow component tip placement and absence of kinking with arm movement


movement

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HeRO™ Titanium Connector


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HeRO™ Device Clinical Study

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HeRO™ Device Clinical Study: OverviewOverview

HeRO™ Studies 86 total subjects

Bacteremia Study Enrollment started March ‘06

Patency Study Enrollment started July ‘04

HeRO™ 50 subjects

ePTFE Control20 subjects

HeRO™ 36 subjects

2:1 randomizationGraft eligible subjects12 month follow-up

Non-randomized to literature controlCatheter-dependent/poor venous outflow subjects

12 month follow-up


p

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HeRO™ Device Clinical Study: DemographicsDemographics

D g hi HeRO™ Bacteremia P l t P l tiDemographics Study Prevalent Population

Average years on dialysis 5.1 ± 4.0 5 yr life expectancy2

Previous bacteremias 1.8 Not reportedp

Mean age (years) 62.7 60.81

Caucasian 50.0% 55.3%1

African American 36 8% 37 2%1African-American 36.8% 37.2%1

Hispanic 13.2% 14.8%1

Diabetes Mellitus 68.4% 42.9%1

• Enrolled patients averaged over five years on dialysis and almost 70% of enrolled patients were diabetic


1U.S. Renal Data System, USRDS 2007 Annual Data Report: Atlas of Chronic Kidney Disease and End-Stage Renal Disease in the United States, National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, 2007. Table 2.

2http://www.outcomes-trust.org/monitor/sum99mon.htm

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HeRO™ Device Clinical Study: Access HistoryAccess History

Access History % of Patients Range of Prior Accesses

Previous Fistula 66% 1 - 2

Previous Graft 79% 1 - 5

Previous Catheter 100% 1 - 16

• Enrolled patients had a mean of 5.4 prior vascular accesses


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HeRO™ Device Clinical Study Results: 70% Reduction in Bacteremia Rates70% Reduction in Bacteremia Rates

A l d C h tHeRO™

B i HeRO™ Bacteremia Catheter LiteratureAnalyzed Cohorts BacteremiaEvents

HeRO BacteremiaRate/1,000 days

Catheter LiteratureControl/1,000 Days

HeRO™ w/Bridging TDC(1,373 days) 7 5.1 1.6 – 6.91

HeRO™ Alone(8,525 days) 0 0.0 2.34

HeRO™ Overall(9 931 d ) 7 0 7 2 32(9,931 days) 7 0.7 2.3

• 59% of patients with a bridging TDC had a femoral catheter

NO d i l t d b t i t t d ft b id i th t

1Combined bacteremia rate range for femoral and IJ TDCs; IJ TDC range from 2006 K/DOQI Guidelines and femoral TDC range from Lynch, L. Dialysis Catheter Literature Summary. 2007. Hemosphere, Inc. document

2Oliver M Lynch L Estimate of the Risk and Rate of Hemodialysis Catheter-Related Bacteremia 2006

• NO device-related bacteremia events were reported after bridging catheter was removed


Oliver, M., Lynch, L. Estimate of the Risk and Rate of Hemodialysis Catheter-Related Bacteremia. 2006. Hemosphere, Inc. document

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HeRO™ Device Clinical Study Results: PatencyPatency

HeRO™ Bacteremia Study Catheter Literature Graft LiteraturePatency Patency at 6.8

HeRO™ MonthsPatency

at 6 Months1Patency

at 6 Months1

Primary Patency 44.4% 50% 58%

Secondary Patency 100.0% 55% 76%

Functional Patency 72.2% Not Reported Not Reportedp p

• No devices were removed due to patency during the study

• Loss of functional patency refers to devices abandoned due to reasons other than patency


1Lucas, G. Scientific Literature Review for Primary, Primary-Assisted and Secondary Patency in Hemodialysis Catheters and Grafts. 2007. Hemosphere, Inc. document

2One clinically hypercoagulable subject excluded from this analysis

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HeRO™ Device Clinical Study Results: Adequacy of DialysisAdequacy of Dialysis

HeRO™ Bacteremia Study (N=36) Catheter Literature2 Graft

Literature2

KDOQIAdequacy of

Hemodialysis Guidelines1

Kt/VKt/V(mean) 1.7 1.29 – 1.46 1.37 – 1.62 1.4 Target

• HeRO™ device blood flow rates comparable to a graft

• Exceeds KDOQI target Kt/V by 0.3

E h 0 1 d i K /V 7% i i li • Each 0.1 decrease in Kt/V = 7% increase in mortality rate


12006 K/DOQI – Clinical Practice Guidelines for Hemodialysis Adequacy Guideline 4. Minimally Adequate Hemodialysis2Lucas, G. Scientific Literature Review for Hemodialysis Adequacy Reporting Methods and Results 2007. Hemosphere, Inc. document

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The HeRO™ Device Clinical Study: SSummary

Primary endpoint to reduce bacteremia was met!Primary endpoint to reduce bacteremia was met!

• 70% reduction in device/procedure-related bacteremia compared to catheter literature controlp

1.7 mean Kt/V exceeded the KDOQI target for adequate dialysis y

• Significantly improved vs. the catheter literature control

No devices were removed due to patency issuesNo devices were removed due to patency issues

• Although the HeRO™ device may require declot intervention similar to a graft


similar to a graft

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Clinical Investigational Sites

I ti t Sit L ti

Clinical Investigational Sites

Investigators Sites Locations

Marc Glickman, MD (PI) Sentara Hospital Norfolk, VA

John Ross MD (PI) Bamberg County Hospital Bamberg SCJohn Ross, MD (PI) Bamberg County Hospital Bamberg, SC

Jeffrey Lawson, MD Duke University Medical Center Raleigh-Durham, NC

Howard Katzman, MD Univ. of Miami Hospital Miami, FL

Robert McLafferty, MD

Colleen Johnson, MDSouthern Illinois University Springfield, IL

Kevin Croston, MD North Memorial Medical Center Robbinsdale, MN

Jeffrey Martinez, MD Baptist Medical Center San Antonio, TX

Eric Peden, MD Baylor Medical Center Houston, TX

Joseph Zarge MD St Joseph’s Hospital Atlanta GA


Joseph Zarge, MD St. Joseph s Hospital Atlanta, GA

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Recognizing HeRO™ Device Patients

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Recognizing HeRO™ Device PatientsRecognizing HeRO Device Patients

Look for three incisions:Look for three incisions:

• Internal jugular incisionInternal jugular incision

• Deltopectoral groove incision l f d(palpate for device connector)

• Brachial artery incisiony


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Recognizing HeRO™ Device PatientsRecognizing HeRO Device Patients

HeRO™ identification items are HeRO identification items are provided in the implant kit for the patient to receive post-procedure

• Identification Information Card

• Patient Information Handbook• Patient Information Handbook

• HeRO™ Wristband

P id C & M B h• Provider Care & Management Brochure

• Implant Notification Fax Form


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HeRO™ Device Care & HeRO™ Device Care & Cannulation

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AVG Physical Assessment:L k Li t & F lLook, Listen & Feel

LookLook• Uniform sized graft • No irregular areas or aneurysm formations• Organized cannulation site rotationOrganized cannulation site rotation

Listen• Low pitch continuous diastolic and systolic• HeRO™ bruit may be slightly softer due to absence HeRO bruit may be slightly softer due to absence

of venous anastomosis

Feel• Thrill and/or pulse strongest at the arterial Thrill and/or pulse strongest at the arterial

anastomosis, but should be felt over the course of the entire graft

• Easy to compress


• HeRO™ thrill may also be less prominent

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HeRO™ Device CannulationHeRO Device Cannulation

Follow KDOQI Guidelines for cannulation:

• Wait until swelling has subsided so the course of the graft can be palpated (at least two weeks prior to first cannulation)

• Use standard fistula needles at a 45-degree angle• Use standard fistula needles at a 45-degree angle

• Rotate cannulation sites

• Stay 2-3 cm from the arterial anastomosisStay 2 3 cm from the arterial anastomosis


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Techniques for AVG Cannulation

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Technique RationaleTechnique Rationale

For routine AVGs:

• Advance the needle slowly with the beveled • Any manipulation may traumatize the vessel cutting edge up facing the top of the vessel

• Do not rotate the axis

intima

For deep, hard to palpate AVGs:

• Immediately rotate the axis of the needle 180o

• Advance needle slowly with the beveled

• Rotating the axis avoids traumatizing the top of the intima

• Prevents the needle tip from entering the backside of the graft materialy

cutting edge down facing the bottom of the vessel

• This should only be utilized when the graft back-wall location is difficult to determine and the risk of continuing needle advancement into the back-wall is high


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AVG Cannulation Needle Handling

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Technique Rationale

• Pressing the needle shaft flat against the skin moves the tip from the desired position within the vessel lumen• Tape the needle at the angle insertion

• Remove the needle at the angle of insertion

• Never apply pressure before the needle is

within the vessel lumen

• Any needle manipulation may traumatize the vessel intimaNever apply pressure before the needle is

completely removed

• Avoid pressing the cutting edge of the needle into the intima when applying pressure for hemodialysisy


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Additional Considerations For H RO™ D i C l tiHeRO™ Device Cannulation

S l 3 i h f h i i i iStay at least 3 inches from the connector incision site

Never puncture the outflow componentoutflow component

Tourniquet may be beneficial to dilate graft

Hemostasis post dialysis should be achieved using digital Hemostasis post dialysis should be achieved using digital pressure rather than fistula clamps

Remove bridging catheter following successful


g g gHeRO™ device cannulation

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HeRO™ Healthcare Economics

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The Catheter Problem: Hi h C t t th H lth S t 1High Cost to the Healthcare System1

Bacteremia/septicemia is a significant complication Bacteremia/septicemia is a significant complication requiring hospital admission in hemodialysis patients

$23,451 is the mean cost of a catheter-related bacteremia hospitalization

• 17 day mean length of stay

• MRSA bacteremia associated with longer stays and higher costs

1Ramanathan V., Chiu, E.J., Thomas, J.T., Khan, A., Dolson, G.M., Darouicher, R.O. Healthcare Costs Associated with Hemodialysis


Catheter-Related Infections: A Single-Center Experience. Infection Control Hospital Epidemiology. 2007 May; 28(5):606-9.

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Potential Healthcare Savingsg

HeRO™ Device TDC Costs HeRO Device Costs2 HeRO™ Device Savings

Implant Procedure $1,4661 $4,006 ($2,540)

Maintenance Procedures (yearly) $4,256 $6,307 ($2,051)

Bacteremia Hospitalization (yearly)1 $19,699 $5,991 $13,708(yearly)1 $ , $ , $ ,

Total $25,421 $16,304 $9,117

1 R th V Chi E J Th J T Kh A D l G M D i h R O H lth C t A i t d ith

• Converting 20,000 catheter patients to HeRO™ devices could result in a potential healthcare system savings of ~$182 million


1 Ramanathan V., Chiu, E.J., Thomas, J.T., Khan, A., Dolson, G.M., Darouicher, R.O. Healthcare Costs Associated with Hemodialysis Catheter-Related Infections: A Single-Center Experience. Infect Control Hosp Epidemiology. 2007 May; 28(5):606-9.2 Economic analysis on file at Hemosphere, Inc.

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Identifying HeRO™ Device Candidates

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HeRO™ Device CandidatesHeRO Device Candidates

HeRO™ is ideally suited for the large and HeRO is ideally suited for the large and rapidly growing number of hemodialysis patients who are:p

• Catheter-dependent

A hi th t d d• Approaching catheter-dependency

• Failing an existing fistula or graft due to venous outflow obstruction or central venous stenosisoutflow obstruction or central venous stenosis


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HeRO™ Candidate Selection Criteria HeRO Candidate Selection Criteria

Follow KDOQI guidelines for vessel mapping to evaluate Follow KDOQI guidelines for vessel mapping to evaluate patient qualifiers necessary for HeRO™ device placement

Necessary Patient Qualifiers:

> 3 mm brachial artery

Adequate cardiac function (ejection fraction > 20%)

Systolic BP > 100 mmHg

Infection free

Without ipsilateral PM/IADC


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Introducing HeRO™ Into Your Access Programg

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What Will HeRO™ Do For Your Patients d Y V l A P ? and Your Vascular Access Program?

Positively impact the overall health and quality of life Positively impact the overall health and quality of life for your access-challenged patients

• Significantly reduce catheter-related bacteremia

• Improve adequacy of dialysis over catheters

• Reduce complications experienced with a catheter

Lower your percentage of catheter-dependent patients

Simplify staffing patterns related to care of catheter p y g ppatients


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What Happens Now?What Happens Now?

Review your current Review your current catheter-dependent patients to determine li ibilit

Access Coordinator/Hemodialysis

C t eligibility

Work with your HeRO™ representative to assist in

Coordinator/Nephrologist

Referral

Center Patients

representative to assist in educating the nephrologists and vascular surgeons

Vascular Access Surgeon


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Summary of HeRO™ Device MManagement

The HeRO™ device is the only long-term, peripheral AV access The HeRO device is the only long term, peripheral AV access

option for patients with venous outflow obstruction

Employ strict infection control procedures as per CDC dialysis Employ strict infection control procedures as per CDC dialysis

precautions to keep HeRO™ patients free from the risks of

infection

Keep in mind this patient population may require longer than 14

days for tissue to graft incorporation

Timely removal of the bridging TDC following successful HeRO™

device incorporation will likely decrease the risk of catheter-


related infections

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The HeRO as I see it!The HeRO as I see it!

HeRO is not for everybody but it might be just the right HeRO is not for everybody but it might be just the right device for that patient who has:

• Good brachial flow

• Compromised venous outflow

• No other peripheral access options

AND …………………………………………………………


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R b Remember -It’s Always about what is best for the individualPatient!Patient!


References and Resources

Dinwiddie, L.C. (2008). Vascular access for hemodialysis. In C.Dinwiddie, L.C. (2008). Vascular access for hemodialysis. In C. Counts (Ed.), Core Curriculum for Nephrology Nursing (5th ed). Pgs 735-764. ANNA, Pitman, NJ, PA.

National Kidney Foundation KDOQI Clinical Practice Guidelines forNational Kidney Foundation. KDOQI Clinical Practice Guidelines for Vascular Access: update 2006. (2006) American Journal of Kidney Diseases, 48(1), S176-S307.

Burrows Hudson S & Prowant B (2005) Nephrology nursingBurrows-Hudson S., & Prowant, B. (2005). Nephrology nursing standards of practice and guidelines for care. Pitman, NJ: American Nephrology Nurses Association.

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Questions & AnswersQuestions & Answers

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Documents

The HeRO™ Vascular Access Device: A New Solution for · PDF fileInventors of the HeRO™ Vascular Access Device The HeRO™ Vascular Access Device: A New Solution for the AV Access-