How To Test A Port For Apheresis

Transcription

1 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

2 Introduction UT Southwestern Medical Center, Dallas, Texas Over 600 beds Provide in- and outpatient apheresis services ~ 3,000 therapeutic apheresis procedures per year 2

3 Current Practice Apheresis procedures are performed utilizing PIVs, midlines, central lines, and vascular access ports The most common port used for our patients is the Vortex TM (Angiodynamics) Clinical practice allows a sustained flow rate of 60 ml/min with Vortex Port and a 16Ga non-coring needle 3

4 Current Practice 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 4

5 Study Objective & Design: Is There a Better Option? 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 5

6 Study Objective & Design: Is There a Better Option? 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 6

7 Port Chambers: Rounded vs Spherical Rounded Spherical 7

8 Sport Port 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) 8

9 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 noncoring needles Catheters were inserted into the 2-L bag with reconstituted whole blood Blood bag continuously mixed to ensure a homogenous solution Study Procedure

10 Study Procedure Apheresis machine pressure limits were set: Inlet -250 mmhg Return 400 mmhg Pressures at various flow rates were recorded 10

11 Results: Standard Vortex Trial Flow Rate (ml/min) Inlet Pressure (mmhg) Return Pressure (mmhg) Leaks, Damage, Occlusions Alarms Triggered None No None Yes (x2) None Yes (x3) *Alarms prevented running at 100 ml/min N/A N/A N/A Yes*

12 Results: Standard SportPort Trial Flow Rate (ml/min) Inlet Pressure (mmhg) Return Pressure (mmhg) Leaks, Damage, Occlusions Alarms Triggered None No None No None No None No None Yes (x2) 12

13 Inlet Pressure (mmhg) Results: Inlet Pressure vs. Flow Rate SportPort (Standard) Vortex Flow Rate (ml/min) 13

14 Return Pressure (mmhg) Results: Return Pressure vs. Flow Rate Flow Rate (ml/min) SportPort (Standard) Vortex 14

15 Results: Comparison of Inlet and Return Pressures Flow Rate (ml/min) Port Inlet Pressure (mmhg) -250mmHg Max % Difference Return Pressure (mmhg) 400mmHg Max SportPort TM % Vortex TM SportPort TM % Vortex TM SportPort TM % Vortex TM SportPort TM Vortex TM NO FLOW NO FLOW SportPort TM Vortex TM NO FLOW NO FLOW % Difference 55.9% 70.5% 57.0%

16 Present Day: Our In-Vivo Experience 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 16

17 Conclusion 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 17

18 Conclusion 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 18

19 Acknowledgements 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) UT Southwestern Dr. Ravi Sarode Dr. Karen Matevosyan Dr. Nicole DeSimone Dr. Sean Yates Norfolk Medical Michael Dalton Nitan Pheil Progressive Medical Brian Gaddy 19