In Vitro Apheresis Port Compatibility Testing at UT ...€¦ · In Vitro Apheresis Port...
Transcript of In Vitro Apheresis Port Compatibility Testing at UT ...€¦ · In Vitro Apheresis Port...
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?
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
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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
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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)