Comparative Evaluation of Sport Port

(Tidal Port) vs. Vortex Port for

Therapeutic Plasma Exchange in Vivo

Rebecca Dill, RN, Jennifer Wintz, RN, Shelli Chernesky, RN, Lisa

Dalton, RN, Sean G. Yates, MD, Nicole De Simone, MD, Ravi Sarode,

MD, Karen Matevosyan, MD

University Of Texas Southwestern Medical Center at Dallas

• UT Southwestern Medical Center

• Over 600 beds

• Provide in- and outpatient apheresis services

• 3,300 therapeutic apheresis procedures per year

Background

• Angiodynamics Vortex Ports single and double lumen have been

routinely utilized at our UT Southwestern Medical Center for

vascular access for extracorporeal photopheresis, RBC exchange

and, to a limited extend, Therapeutic Plasma Exchange (TPE)

• Its use for TPE has resulted in lower flow rates due to limited flow

capacity of the port

– Single-lumen 60 mL/min, dual-lumen 50 mL/min

• Long term use of Vortex port requires frequent use of

tissue plasminogen activator (tPA) due to sludge and fibrin

sheath formation in the chambers of the port

– likely due to the cylindrical design of the Vortex port chamber

Background

• In 2014 Sport/Tidal Port (Norfolk Medical, Skokie, IL) was evaluated at our institution through in vitro studies

• The study supported company’s claims that the Sport/Tidal Port was capable of supporting continuous flow rates up to 100 mL/min, suitable for TPE- Reported at 2015 ASFA annual meeting

• Additional claim by Norfolk Medical• the spherical design of the Sport/Tidal Port should significantly reduce

sludging

• Resulting in decreased tPA requirement

Background

Port Chambers: Rounded vs Spherical

6

Rounded Spherical

• Sport/Tidal Port has been used since April 2015

• The Sport/Tidal port was used for inlet, while peripheral vein

used for return

• Bilateral Single-lumen Vortex Ports served as control

• The purpose of the study was to evaluate the performance of

Sport/Tidal Port in vivo and compare its performance to that of

bilateral single-lumen Vortex ports in patients undergoing TPE

Purpose

• 40 procedures were evaluated on 10 patients

• Sport/Tidal Port - 26 procedures (5 patients)

• Vortex Port - 14 procedures (5 patients)

• 1-1.2 plasma volume TPE • 5% albumin or normal saline/albumin replacement

• COBE Spectra and Spectra Optia cell separators

Study Design

Patients Demographics

• All patients required long-term TPE

• Age, mean (range) - 51.7 (36-62)• Male (1)• Female (9)

• Diagnoses• Multiple sclerosis (6)

• Neuromyelitis optica(1)

• Myasthenia gravis (2)

• Chronic inflammatory demyelinating polyneuropathy (1)

• All TPE's were performed at the highest allowable alarm-free inlet rates

• Mann-Whitney U-test was used for comparative analysis

Methods

• Procedural parameters• Inlet volumes

• Inlet flow rates

• Total Procedure Time

• Pure Procedure Run Time (instrument clock time)

• Inlet pressure alarms

• Operator interventions including port flushing

• Use of tPA

Data Collected

Parameters SportPort (N=5)

Vortex Port (N=5)

p value

Total procedures, n=40 26 14

Inlet volume (mL), mean (SD) 3929 (+777) 4066 (+643)

Inlet flow rate (mL/min), mean (SD) 67.4 (+11.0) 56.1 (+10.2) 0.002

Pure procedure run time (min), mean (SD) 86.2 (+35.7) 122.9 (+35.7) 0.001

Total procedure time (min), mean (SD) 99.8 (+32.0) 136.2 (+33.5) 0.002

Inlet pressure alarms per procedure, n 1.7 5.1

tPA requirement, n (%) 1 (4.3%) 3 (21.4%)

Results

• Both ports exhibited slower than optimal inlet flow rates for TPE

• Sport/Tidal Port allowed a slightly faster Inlet flow rate (p value

0.002)

• Sustained flow rates approaching 100 mL/min observed in the in

vitro study, were not achievable

• Vortex Port had 3 times greater Inlet flow/pressure-related

alarms compared to the Sport/Tidal Port

Conclusion

• Pure Procedure Run Time and Total Procedure Time were

shorter with Sport /Tidal Port (respective p values 0.001 and

0.002)

• Sport/Tidal Port generated 3 times fewer inlet flow/pressure

related alarms compared to Vortex port

• Sport/Tidal Port required 3x fewer tPA treatment compared to

Vortex port (4.3% vs. 21.4%)

Conclusion

• These initial results suggest that the Sport/Tidal Port is the

fastest continuous implantable port on market suitable for TPE

• However, flow rates of 100 mL/min initially observed in in

vitro evaluation could not be achieved in vivo

• The significant improvement in the procedure time as well as

decreased need for interventions suggest that the Sport/Tidal

Port may be a favorable option over Vortex Port in the clinical

setting for TPE’s

Conclusion

• Study Limitations

• Due to the small sample size of patients and procedures

evaluated further study is needed to verify the superior

performance of the Sport/Tidal Port for TPE

• Due to the limitations, further research is needed for the role

Sport/Tidal port will play on Apheresis procedures other than

TPE’s

Conclusion

ApheresisTeam!