In Vitro Apheresis Port Compatibility Testing at UT

Southwestern Medical Center

Jennifer Peterson BSN, BS, RN, CMSRN Michael Dalton, Natan Pheil, Brian Gaddy,

Karen Matevosyan MD and Ravi Sarode MD

Introduction

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• UT Southwestern Medical Center, Dallas, Texas

• Over 600 beds

• Provide in- and outpatient apheresis services

• ~ 3,000 therapeutic apheresis procedures per year

Current Practice

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Apheresis procedures are performed utilizing PIVs, midlines, central lines, and vascular access ports

The most common port used for our patients is the VortexTM (Angiodynamics)

Clinical practice allows a sustained flow rate of 60 mL/min with Vortex Port and a 16Ga non-coring needle

Current Practice

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Spectra Optia capabilities

– Flow rate: 140 mL/min

– Maximum pressure limits

Inlet -250 mmHg

Return 400 mmHg

Despite proper port heparinization, tPA is often needed to clear ports of sludge or debris build-up in port chamber

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Vortex port has a rounded chamber with a tangential outlet, which creates a swirling flow

Has better flow characteristics than conventional cylindrical chamber ports of similar size

Available as single-lumen and double-lumen

It allows for a flow rate of 60 mL/min when using a 16Ga non-coring needle

At UT Southwestern, Vortex ports are used for apheresis procedures with lower flow rate requirements, such as RBC exchange and extracorporeal photopheresis

Requires periodic Rx with tPA to eliminate sludge which forms over time within the chamber

Study Objective & Design: Is There a Better Option?

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SportPort is a new port from Norfolk Medical Products, Inc that was approved by FDA in 2011

It offers a unique spherical internal chamber with no corners, an outlet at the chamber floor, connected to the polyurethane catheter

SportPort with 9F catheter is expected to provide flow rates up to 100 ml/min

Available only as a single-lumen

Potential advantages

- decreased sludge formation

- decreased need for tPA Rx

- improved flow rate characteristics

Study Objective & Design: Is There a Better Option?

Port Chambers: Rounded vs Spherical

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Rounded Spherical

Sport Port

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SportPort has not been tested clinically for continuous flow applications, such as apheresis procedures

We compared side by side ex-vivo performances of:

– Angiodynamics Vortex™ (rounded shape – standard profile)

–9F Polyurethane catheter from Norfolk attached

– Norfolk Medical SportPort™, 9F Polyurethane (spherical shape – standard profile)

Study Procedure

Expired donor RBC units (3), reconstituted with NS to Hct 40%, in the 2-L bag, were used to simulate a patient

Inlet and return lines of TPE disposable kit connected to the ports via 16Ga non-coring needles

Catheters were inserted into the 2-L bag with reconstituted whole blood

Blood bag continuously mixed to ensure a homogenous solution

Study Procedure

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Apheresis machine pressure limits were set:

– Inlet -250 mmHg

– Return 400 mmHg

– Pressures at various flow rates were recorded

Results: Standard Vortex

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*Alarms prevented running at 100 mL/min

Trial Flow Rate (mL/min)

Inlet Pressure (mmHg)

Return Pressure (mmHg)

Leaks, Damage,

Occlusions

Alarms Triggered

1 70 -201 159 None No

2 80 -196 179 None Yes (x2)

3 90 -225 223 None Yes (x3)

4 100 N/A N/A N/A Yes*

Results: Standard SportPort

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Trial Flow Rate (mL/min)

Inlet Pressure (mmHg)

Return Pressure (mmHg)

Leaks, Damage,

Occlusions

Alarms Triggered

1

70 -125 102 None No

2 80 -146 105 None No

3 90 -173 142 None No

4 100 -204 160 None No

5 110 -206 168 None Yes (x2)

Results: Inlet Pressure vs. Flow Rate

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-250

-225

-200

-175

-150

-125

-100

-75

-50

-25

0

0 20 40 60 80 100 120

Inle

t P

ress

ure

(m

mH

g)

Flow Rate (mL/min)

SportPort (Standard)

Vortex

Results: Return Pressure vs. Flow Rate

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0

25

50

75

100

125

150

175

200

225

250

0 20 40 60 80 100 120

Re

turn

Pre

ssu

re (

mm

Hg)

Flow Rate (mL/min)

SportPort (Standard)

Vortex

Results: Comparison of Inlet and Return Pressures

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Flow Rate (mL/min)

Port Inlet Pressure

(mmHg) -250mmHg Max

% Difference Return Pressure

(mmHg) 400mmHg Max

% Difference

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SportPortTM -125 60.8%

102 55.9%

VortexTM -201 159

80

SportPortTM -146 34.2%

105 70.5%

VortexTM -196 179

90

SportPortTM -173 30.1%

142 57.0%

VortexTM -225 223

100

SportPortTM -204 -

160 -

VortexTM NO FLOW NO FLOW

110

SportPortTM -206 -

168 -

VortexTM NO FLOW NO FLOW

Present Day: Our In-Vivo Experience

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SportPort approved for use at UT Southwestern on March 3, 2015

Since then 2 patients have had unilateral SportPorts implanted: one MS patient, one CIDP patient

– First port implanted on April 1, 2015

First patient underwent a total of 5 inpatient procedures over a course of 2 weeks

Has since had 2 weekly outpatient procedures

No tPA required thus far

Conclusion

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The ex vivo study has allowed for comparative analysis of flow rate capabilities between ports

SportPort demonstrated superior flow characteristics when compared to Vortex SmartPort

Lower inlet pressures

Faster flow rate

Shortened procedure time

Potentially reduced sludge formation and, thus, decreased need for tPA

Conclusion

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More in vivo case assessments are necessary to determine/describe the flow characteristics of the SportPort, as well as the potential for sludge formation and requirements for tPA

All apheresis patients that need ports from now on will have a SportPort placed

Look forward to gathering additional data over the next year and returning to give you an update at the next ASFA conference

Acknowledgements

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UT Southwestern Dr. Ravi Sarode Dr. Karen Matevosyan Dr. Nicole DeSimone Dr. Sean Yates Norfolk Medical Michael Dalton Nitan Pheil Progressive Medical Brian Gaddy

UT Southwestern Tomas Armendariz BSN, RN Anthony Barnes RN Emelita Bennett BSN, RN, CCRN Joanne Dawson BSN, RN Rebecca Dill RN Edward George RN Martin Macias BSN, RN Giovanni Torti BSN, RN Kyle Souter BSN, RN Laura Strunk RN Jennifer Wintz BSN, RN Betty Doggett AT (ASCP) Nellie Session-Augustine AT (ASCP)