PowerPoint Presentation (PDF) - Perfusion.com

The Role of Technology and Clinical Practice:
Emboli Monitoring
Ben Komorowski,
Clinical Specialist
Terumo Cardiovascular Systems

“If only we could
remove the blood
from her body by
bypassing her lungs,
and oxygenate it,
then return it to her
heart, we could
almost certainly save
her life.”
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Perfusion Advances
‣ Heart Lung Machines
‣ Oxygenators
‣ Arterial Pumps
‣ Arterial Filters
‣ Safety System Integration
‣ Smaller Circuits
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Perfusion Safety
‣ Serious Injury/Death 1:1000
Kurusz M, Conti VR, Arens JF, Brown JP, Faulkner SC, Manning JV Jr.
Perfusion accident survey.
Proc Am Acad Cardiovasc Perfuion 1986;7:57-65.
‣ Serious Injury/Death 1:1288
Jenkins OF, Morris R, Simpson JM. Australasian perfusion incident
survey. Perfusion 1997;12:279-
288.
‣Serious Injury/Death 1: 1482
Mejak BL, Stammers AH, Rauch E, Vang S, Viessman T. A retrospective
study on perfusion accidents
and safety devices. Perfusion 2000;15:51-61.
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Gross Air
‣ Efforts to eliminate gross
highlyhl
successful.
air have been
‣ In the 1970s, the incidence of gross air
embolism was one in every 2500 cases.
‣ By the 1990s, the incidence had fallen to
once in every 30,000000 cases.
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Micro Air
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“The idea that
something is easily
forgotten or
dismissed as
unimportant if it is
not in our direct
view”
“Out of sight out of
mind”
“Some things we need to
see (sight) inorderto
remember (mind); they
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are”

Mechanism of Microbubble Tissue
Damage

Mechanism of Microbubble Tissue
Damage
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Mechanism of Microbubble Tissue
Damage
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Saving the Heart Can Sometimes es Mean Losing
the Memory September 19, 2000
Mental Decline Is Linked to Heart Bypass
Surgery February 8, 2001
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Terumoʼs Monitoring
History
‣Terumo has a long 25 year history of being a
monitoring company for perfusion.
‣1978: Sarns released the first air bubble detector
with heart lung machine
‣Level sensors
‣1981: CDI
‣2002: Spencer Technologies and Terumo developed
a strategic partnership.
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Terumoʼs Monitoring
History
‣Terumo has a long 25 year history of being a
monitoring company for perfusion.
‣1978: Sarns released first air bubble detector with
heart lung machine
‣Level sensors
‣1981: CDI
‣2002: Spencer Technologies and Terumo developed
a strategic partnership.
‣2007: Luna and Terumo Marketing Alliance
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Enhancing
the
Standards of
Care
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EDAC Quantifier
Only FDA-cleared device for on-pump microemboli monitoring
‣ EDAC uses a short pulsed ultrasonic strobe, which is missile tracking
technology developed for the defense industry.
‣ Count rate > 1000 per second
‣ Sensitive to gaseous emboli 10 microns and up
‣ Sizes gaseous microemboli (10-10001000 microns)
‣ Simultaneous detection with 3 channels
‣ emboli tracks, count and load displayed in real time
‣ export size histograms and summary data
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EDAC Applications: Lab to
OR
‣Prior to FDA clearance:
‣Lab use
‣Post FDA clearance:
‣Changing perfusion techniques
‣Over occlusion
‣Drug adminstration
‣Perfusionist interventions
‣Circuit design differences
‣Various i sources of micro emboli (venous, venting,
suction, manifold manipulations)
‣Clinical outcome data
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Should We Be Using EDAC
On Every Case?
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I Already Have an “ABD”, Isn’t That
Enough?
‣ Current Air Bubble Detectors are Most Effective for
Sensing and Responding to Macro Air – (Visible)
‣ Typical ABD Practice is a Single Point of Information.
Sometimes, Not Enough to Diagnose Where Air is
Originating From
‣ So, a Second Multi-Channel Technology Permitting
surveillance and action at critical points in the CPB
Circuit Makes Sense!
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“Terumo, “Ray, people perfusion will come will come Ray. They'll Terumo. turn They'll up your call
your driveway salesnot people knowing notforknowing sure whyfor they're sure doing why
they're it. Theyʼll doing pass it. over Theyʼll money passwithout over money even without thinking
even aboutthinking it: for its about money it: they for its have money and peace they have they
and lack.”
the ability to monitor GME they lack.”
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Summarize
Industry Role
Clinicians Role
• What the field of wants
• Cost effective
• Promotes safety
• Easy to use
• Small footprint
• Research
• Research
• Research
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Thank You
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