Diagnostic performance potential of periprocedural tissue … · Stage 1 Stage 2 Stage 3 Stage 4 15...
Transcript of Diagnostic performance potential of periprocedural tissue … · Stage 1 Stage 2 Stage 3 Stage 4 15...
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Diagnostic performance potential of periprocedural tissue oxygen monitoring
to assess functional success of endovascular revascularization
Marianne Brodmann
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Disclosure
Speaker name: Marianne Brodmann
.................................................................................
I have the following potential conflicts of interest to report:
X Consulting
Employment in industry
Stockholder of a healthcare company
Owner of a healthcare company
Other(s)
I do not have any potential conflict of interest
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• Lumee® Oxygen Platform is
designed to continuously monitor
tissue oxygen
• OMNIA is a study designed to
characterize the relationships
between revascularization
success, traditional
hemodynamics, and tissue
oxygen
• Interim OMNIA analysis reveals a
potential association between
tissue oxygen data and wound
improvement
LUMEE® OXYGEN PLATFORM
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Soft biocompatible hydrogel sensor injected into subcutaneous space
Fluorescence chemistry on hydrogel responds based on analyte concentration. Reader collects emissions and data sent to cloud.
Excitation light from surface reader reaches hydrogel in tissue.
HOW DOES LUMEE® OXYGEN WORK
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• Lumee® Oxygen provides continuous real-time tissue
oxygen at point location(s)
• Sensor placement can be uniformly specified or
customized to suit wound location or target of intervention
• Pilot analyses developing association between oxygen
dynamics and treatment outcome
• This talk develops strategies to interpret data from multiple
locations to provide guidance for optimal sensor
placement locations
HOW DO WE EXTRACT CLINICAL VALUE FROM MULTIPLE POINT MEASUREMENTS OF TISSUE OXYGEN DURING REVASCULARIZATION?
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• Enrolled CLI subjects (Rutherford 4 or 5) scheduled to undergo endovascular revascularization
• Prospective, single-arm, open-label, multicenter study. 35 subjects enrolled.
• Injected 3 Lumee® Oxygen sensors in the foot and 1 reference sensor in the upper arm
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Study Design Protocol Analysis
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OMNIA- OXYGEN MONITORING NEAR ISCHEMIC AREAS
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Study Design Protocol Analysis
• Lumee® measurements performed
during endovascular
revascularization (EVT) procedures
• Lumee® measurements also
performed during functional
assessment tests conducted before
and after revascularization, and at
follow-up visits over 12 months.
• Also sampled: arterial duplex, toe and ankle brachial index, WiFI scores,
wound characterization and
photographs.
Consent, Enrollment
Sensor
Injection
Intra-procedure monitoring
Long term monitoring
Pre-operative
Discharge
1 month
3 months
6 months
1-3 days
12 months
Revascularization
OMNIA- OXYGEN MONITORING NEAR ISCHEMIC AREAS
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Study Design Protocol Analysis
• Features of oxygen increase extracted from continuous Lumee®
data
• Wound healing assessed during follow-ups based on objective criteria
• Sensor locations considered in data interpretation
• Retrospective classification analysis determines potential diagnostic power of Lumee® Oxygen to predict success of EVT
Baseline Interventions End
Oxygen increase
Lum
ee
Oxyg
en
In
de
x [
-]
OMNIA- OXYGEN MONITORING NEAR ISCHEMIC AREAS
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Parameter Number
Rutherford IndexV 35
WIFI classificationStage 1Stage 2Stage 3Stage 4
15668
Wound LocationToes
MidfootHeel
Dorsal
30221
Parameter Mean +/-SD
Range
Age (years) 73.7 12 43 - 90
Parameter Mean +/- SD Range
Wound size [cm2]
1.9 2.7 0 – 13.7
ABI [-] 0.8 0.5 0 – 1.9
TBI [-] 0.3 0.2 0 - 1.4Parameter Number
GenderMale
Female278
DiabetesType 1Type 2
None
1277
RevascularizationEVT
Bypass332
Affected LimbRight
Left1718
Demographics Wound/Hemodynamics
at enrollment
Adverse Event Reporting
• 83 adverse events were reported
• 1 AE was described as “possibly related to study device” (swelling forefoot, most likely related to underlying disease); described as mild and resolved at follow-up.
ENROLLMENT SUMMARY
• 35 subjects enrolled• 2 subjects did not undergo endovascular
revascularization• 3 subjects lost to follow up• 2 subjects withdrew consent• 3 subjects excluded based on sensor
location• 1 subject excluded based on angiography
Enrollment / Analysis
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QUANTIFICATION OF OXYGEN INCREASES DURING EVT
Therapeutic interventions
Rolling Baseline
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LO
I in
cre
ase d
uring E
VT
Medial Dorsal Lateral
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LUMEE® MEASUREMENTS AT MEDIAL LOCATION ON THE FOOT PROVIDES STRONGEST PREDICTIVE POWER
Metrics Medial Dorsal Lateral
N 24 23 24
Sensitivity 76 56 65
Specificity 71 56 56
PPV 87 77 79
NPV 56 40 40
Fisher’s Exact
0.04 0.34 0.3
Diagnostic Odds Ratio
8.1 2.2 2.4
*Exploratory retrospective classification analysis, including cross-validation
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LO
I in
cre
ase d
uring E
VT
Average
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ANALYZING OXYGEN DATA ACROSS MULTIPLE SENSOR LOCATIONS PROVIDES STRONGER PREDICTIVE POWER THAN SELECTING LOCATION CLOSEST TO WOUND
Metrics Average Maximum Closest to Wound
N 24 24 22
Sensitivity 76 76 67
Specificity 71 71 71
PPV 87 87 83
NPV 56 56 50
Fisher’s Exact
0.04 0.04 0.11
Diagnostic Odds Ratio
8.1 8.1 5.0MaximalClosest to
Wound
*Exploratory retrospective classification analysis, including cross-validation
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ASSAYING TISSUE OXYGEN FROM LOCATIONS OF INTEREST
PROVIDES SUPERIOR PREDICTIVE POWER COMPARED TO TBI
Metrics TBI LumeeClosest to Wound
LumeeMedial Location
LumeeAverage or Maximum
N 26 22 24 24
Sensitivity 47 67 76 76
Specificity 86 71 71 71
Fisher’s Exact 0.14 0.11 0.04 0.04
Diagnostic Odds Ratio
5.4 5.0 8.1 8.1
*Exploratory retrospective classification analysis, including cross-validation
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• OMNIA has integrated Lumee® Oxygen into EVT to continuously monitor tissue oxygen in 33 subjects.
• Tissue oxygen data collected from 3 Lumee® Oxygen sensors at specified locations on the foot (i.e. medial, dorsal, lateral).
• Point assessments of tissue oxygen from the medial location on the foot were stronger predictors of treatment outcome than other locations
• Assessment of tissue oxygen from multiple locations, or based on angiosomalmaps, may be better than selecting a location proximal to the wound
• Ongoing research considering link between measurement locations, wound location, and angiosome targeted by interventions.
SUMMARY
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ABOUT LUMEE® OXYGEN PLATFORM
• Wired platform: CE Mark in September 2016
• Wireless platform: CE Mark January 2020
• Indications for use:
“The Lumee® Oxygen Platform is an
adjunct instrument intended for continuous
and long-term monitoring of the oxygen in
the subcutaneous tissue in the upper
extremity, shoulder, or lower extremity. It is
indicated for use in patients with potential
acute and/or chronic changes in tissue
oxygen levels who may benefit from
monitoring. It should not be used as the
sole basis for diagnosis or therapy.”
• More information can be found at
Profusa.com
Lumee® App
Lumee® Patch Lumee® PenLumee® Oxygen
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Diagnostic performance potential of periprocedural tissue oxygen monitoring
to assess functional success of endovascular revascularization
Marianne Brodmann