Download Soul Mate Real Time, Non-Invasive Heart Data

Soul Mate
Real Time, Non-Invasive Heart Data
Anthony Sierra
Christine Cherop
Onyebuchi Udozorh
Outline
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Physiology and pathophysiology of the condition to be treated
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Prior treatments/therapies
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Therapeutic procedures-complete protocols
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Cost and Coverage
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Expected post-therapy improvement
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Expected post-therapy complications
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Why is Soul Mate the best choice?
Physiology and Pathophysiology: Heart
Failure and Transplant Rejection
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Heart transplants are typically performed on patients with end-stage heart
failure or patients with severe coronary heart disease
Heart failure occurs when the heart is incapable of maintaining a cardiac
output that is adequate to meet metabolic requirements and accommodate
venous return.
Coronary heart disease is caused by plaque building up along the inner
walls of the arteries, making the arteries narrower hence restricting blood
flow to the heart
After a heart transplant, a patient returns to the hospital for regular
checkups and remains on immunosuppressants for the rest of his/her life
Acute and chronic allograft rejections are the most significant factors
limiting heart transplants
Regular monitoring is required to detect rejection, and is normally done by
regular biopsy that is later replaced by AlloMap Molecular Expression
Testing, a gene expression blood test
The first three are complications that could
lead to heart failure, the last diagram is the
heart transplant procedure
Prior Treatments/Therapies
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Endomyocardial biopsies with examination of structural
damage or increased levels of T cells
Identification of patient symptoms of potential rejection
Traditional pacemakers/defibrillators without additional
detection function
Monitoring the heart, posttransplant
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The functional state of the heart can be
closely monitored by the heart's electrical
activity
Analysis of intramyocardial
electrocardiography (IMEG) is considered
sensitive and specific for allograft rejection
The peak to peak amplitude (PPA) of the
unipolar IMEG has been shown sensitive to
a variety of alterations in myocardial
physiology
Soul Mate-
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Soul mate, an Implantable Heart Transplant rejection
monitor is based on a new technology- Cardiac
Rejection Device that senses naturally occurring
electrical activity of the heart and automatically applies
electrical stimulation treatment if needed
The device is still on trial, and TransWorld hopes to get
FDA approval at the end of the trial Phase
This is the second generation of the Soul Mate. The first
version, designed for patients following a heart
transplant, is being marketed in Europe.
How it works
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The components of the Soul Mate Heart Transplant
Monitoring system,
Horai T et al. Circulation; 2009, 120:S185- S190
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Nine IMEG parameters recorded
The Cardiac Rejection Monitoring
Device (CRD), non-invasively
implanted under the skin, records
IMEG through standard 3 leads at
programmable times in either
bipolar or unipolar configurations.
1 lead is placed on the epicardial
surface of the right ventricle and
the other two on the left ventricle
Information of 9 IMEG parameters
from QRS complexes are
recorded and later analyzed
Onelife wand is held over the
Cardiac Rejection Monitoring
Device to transfer data
Data transferred to Home Call Box
through the wireless bluetooth
connection
Data is then sent automatically to
the Central Monitoring Centre for
analysis
Costs and Coverage
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No current costs/insurance coverage
information on Soul Mate
Current pacemaker and surgery cost:
Dependent on type of pacemaker, length of
stay, location
~ $19,651 total in Ohio, $28,348 in Western
United States (without insurance)
Covered by Medicare and private insurance:
costs between 2.5-4k
Expected Post-Therapy
Improvements
"This device would potentially reduce the number of biopsies needed and result in earlier detection
and treatment of rejection. It is possible that the device could actually replace EMB and allow
vastly more frequent allograft rejection assessment that would assist the clinician with day-to-day,
evidence-based adjustments of complicated and toxic immunosuppression cocktails. Furthermore,
using the transtelephonic measurements could be beneficial for patients who can be monitored at
great distances from the transplant center. There is a potential that the Soul Mate system would
offer a method for less invasive and more effective management of HTx patients"- Horiai etal
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Horai et.al found that Soulmate, when used in Cannine
models, has the potential to non-invasively detect
allograft rejection and reduce the number of biopsies.
Expected Post-Therapy
Complications
Due to still being in development phase, we are
unable to find concrete information on
expected post-therapy complications.
However, based on complications with the
typical pacemaker and surgery in general, we
can infer a variety of potential complications:
• Lead Displacement
• Tissue Scarring
• Heating of the Cardiac Tissue
• Fibrosis
• "Twiddler's Syndrome"
• Infection (Surgical Site)
Why Is the Soul Mate the Best
Choice?
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The Soul Mate can detect allograft rejection earlier than the typical
methods.
Non-invasive
Reduces the number of endomyocardial biopsies needed for
detection, and could actually replace biopsies
Very accurate
Allows for 24/7 monitoring in and out of the hospital- cutting costs
arising from unnecessary doctors visits
Pacemaker or defibrillator capabilities
Prolong morbidity free survival
Reference
"Cost of a Pacemaker." CostHelper. CostHelper, Inc.,
n.d. Web. 29 Apr. 2013.
Horai et al. "Novel Implantable Device to Detect
Cardiac Allograft Rejection." Circulation 120 (2009): 185190. AHAJournals. Web. 29 Apr. 2013.
Thomas, Jennifer. "Cardiac device maker Transworld
to launch $25M clinical trial." Charlotte Business Journal.
American City Business Journals, 23 Mar. 2012. Web.
29 Apr. 2013.