Right Catheter. Right Patient. Right Technique.
Every Choice Matters
NexSite HD Catheter
John R. Ross, Sr., MD
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DISCLOSURE
Consultant: Marvao Medical Devices
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CHRONIC CATHETER DESIGN EVOLUTION
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CHRONIC CATHETER DESIGN EVOLUTION
Ease of Placement
Sustainable Flow
Flow Capability
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CHRONIC CATHETER DESIGN EVOLUTION
Shaft Design:
• Double Barrel Shotgun
• Mahurkar ‘Double D’
• Schon /Tesio
• 16F
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CHRONIC CATHETER DESIGN EVOLUTION
Tip Design:
• Step
• Spilt
• Symmetrical
Shaft Design:
• Double Barrel Shotgun
• Mahurkar ‘Double D’
• Schon /Tesio
• 16F
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CHRONIC CATHETER DESIGN EVOLUTION
Hub Design:
• ‘One Piece’ Ante-grade Insertion
• ‘Modular’ Retrograde Insertion
Tip Design:
• Step
• Spilt
• Symmetrical
Shaft Design:
• Double Barrel Shotgun
• Mahurkar ‘Double D’
• Schon /Tesio
• 16F
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CATHETER DESIGN: TIP GEOMETRY
STEP
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SPLIT
SYMETRICAL TWO TIPS
TIP SELECTION: ATRIUM MORPHOLOGY/GEOMETRY
Long Tubular
Small Globular
Normal
Triangular
Complex
Large Atrium
Catheter tips are available to suite every Right Atrium geometry!!
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TIP SELECTION: ATRIUM MORPHOLOGY/GEOMETRY
Long Tubular
Small Globular
Normal
Triangular
Complex
Large Atrium
Catheter tips are available to suite every Right Atrium geometry!!
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EASE OF USE: RETROGRADE PLACEMENT
CATHETER TIP IS PLACED IN ATRIUM FIRST, THEN TUNNELLED
FROM VENOTOMY SITE TO THE EXIT SITE
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COMPLICATION: TECHNIQUE
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COMPLICATION: TECHNIQUE
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IS THIS A COMPLICATION?
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COMPLICATION: EXIT SITE POSITIONING
KINK AT EXIT SITE!!
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COMPLICATION: EXIT SITE INFECTION
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COMPLICATION: EXIT SITE INFECTION
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COMPLICATION: EXIT SITE INFECTION
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CHRONIC CATHETER DESIGN EVOLUTION
Ease of Placement
Sustainable Flow
Flow Capability
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CHRONIC CATHETER DESIGN EVOLUTION
Ease of Placement
Sustainable Flow
Flow Capability
Cuff Design unchanged
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Conventional Cuff Design: Provides anchoring and pathogen barrier
INFECTION: REPORTED CRBSI RATE
1.6
5.5
K/DOQI Reported CRBSI Range 1
0.0
1.0
2.0
3.0
4.0
5.0
6.0
7.0
CRBSI events / 1000 catheter days
1- NFK K/DOQI Clinical Practice Guidelines, 2006 Update
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INFECTION: REPORTED CRBSI RATE
1.6
5.5
K/DOQI Reported CRBSI Range 1
0.4
1.8
CRBSI using Anti-biotic Exit Site Management 2
0.0
1.0
2.0
3.0
4.0
5.0
6.0
7.0
CRBSI events / 1000 catheter days
1- NFK K/DOQI Clinical Practice Guidelines, 2006 Update
2- Rabindranath et al NDT Dec 2009; 24(12) 3763 – 74
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INFECTION: CATHETER BASED ESM TECHNOLOGY
NexSite HD
The only HD catheter that provides Exit Site Management Technology
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CHRONIC CATHETER DESIGN EVOLUTION: NEXSITE
CVC Exit Site
CVC Cuff
CONVENTIONAL CATHETER
Provides minimal tissue ingrowth surface area
Allows Exit Site and tunnel to be colonized
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CHRONIC CATHETER DESIGN EVOLUTION: NEXSITE
CVC Exit Site
NexSite
CVC Cuff
CONVENTIONAL CATHETER
NexSiteTM CATHETER
Provides minimal tissue ingrowth surface area
Provides maximum tissue ingrowth surface area
Allows Exit Site and tunnel to be colonized
Skin healing blocks Exit Site colonization
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NEXSITE PLACEMENT: MAKE VENOTOMY - LANDMARK
Patient’s Head
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NEXSITE PLACEMENT: FORM POCKET AND EXIT SITE
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NEXSITE PLACEMENT: ASSEMBLE AND TUNNEL DEVICE
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NEXSITE PLACEMENT: ADVANCE CATHETER INTO SVC
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NEXSITE PLACEMENT: POSITION TIP AND FLUORO
NexSite
Longer catheter cuff length provides some adjustability
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NEXSITE PLACEMENT: SUTURE POCKET CLOSED
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NEXSITE HEALING: 27 DAYS AFTER PLACEMENT
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DISC REMOVAL: PEEL OUT OF EXIT SITE
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CLINICAL EXPERIENCE
Retrospective Analysis of first 20 NexSite HD patients
Patient Profile (n=20):
• Avg Age: 66 years (29 to 83)
• Gender: 9/20 were Male
• Access Site: 90% RIJ /10% Femoral
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CLINICAL EXPERIENCE
Retrospective Analysis of first 20 NexSite HD patients
Patient Profile (n=20):
• Avg Age: 66 years (29 to 83)
• Gender: 9/20 were Male
• Access Site: 90% RIJ /10% Femoral
5 Patients excluded from CRBSI analysis:
• 2 patients may have had remote infections at time of implant
• 2 catheters developed low flow rates within first week of use
• NexSite was exchanged for a conventional HD catheter
• 1 Patient moved out of state and was lost to follow-up
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CLINICAL EXPERIENCE
Results (as of May 1, 2014)
100% technical success for placement
100% technical success for removal
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CLINICAL EXPERIENCE
Results (as of May 1, 2014)
100% technical success for placement
100% technical success for removal
15 patients and 1715 catheter days accrued to date:
• 6 patients had device removed once fistula had healed
• 5 patients continuing to receive therapy
• 1 patient developed skin erosion adjacent to NexSite DISC
• Device exchanged 105 days after implant
• 1 Patient died on day 15 (non catheter related)
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CLINICAL EXPERIENCE
Results (as of May 1, 2014)
100% technical success for placement
100% technical success for removal
15 patients and 1715 catheter days accrued to date:
• 6 patients had device removed once fistula had healed
• 5 patients continuing to receive therapy
• 1 patient developed skin erosion adjacent to NexSite DISC
• Device exchanged 105 days after implant
• 1 Patient died on day 15 (non catheter related)
Removal for infection:
• 1 confirmed Exit Site infection
• Device removed 180 days after implant
• 1 suspected CRBSI event
• Device removed 189 days after implant
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NEXSITE: OBSERVED CRBSI RATE (5/1/14)
1.6
5.5
K/DOQI Reported CRBSI Range 1
0.4
1.8
CRBSI using Anti-biotic Exit Site Management 2
0.6
0.0
1.0
NexSite HD Catheter CRBSI (First in Human study)
2.0
3.0
4.0
5.0
6.0
7.0
CRBSI events / 1000 catheter days
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1- NFK K/DOQI Clinical Practice Guidelines, 2006 Update
2- Rabindranath et al NDT Dec 2009; 24(12) 3763 - 74
3- Ross VASA 2014
CLINICAL EXPERIENCE
Conclusions:
1- NexSite is capable of providing reliable vascular access
•
•
Step tip design is currently available
Split tip and Symmetrical tip configurations are in development
2 - Pocket formation is similar to oncology port process
•
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Adds <10 minutes to placement procedure
CLINICAL EXPERIENCE
Conclusions:
1- NexSite is capable of providing reliable vascular access
•
•
Step tip design is currently available
Split tip and Symmetrical tip configurations are in development
2 - Pocket formation is similar to oncology port process
•
Adds <10 minutes to placement procedure
3 - Device removal is simple because the cuff is at ‘the surface’
•
•
No need to find and dissect cuff within tunnel
DISC can be peeled out of exit site
4 - Observed complication rate is low in this small study
•
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More clinical study across multiple sites is needed
Right Catheter. Right Patient. Right Technique.
Every Choice Matters
THANK YOU!
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