Download Intervention Conceptual example of the “fusion map”

The Fluoro-less And Contrast-less
Peripheral Endovascular Intervention:
A Concept For The Future Today
Georges Ephrem MD, MSc, Joe F. Lau MD, PhD, FACC
and Perwaiz Meraj MD, FACC
Hofstra North Shore-LIJ School of Medicine at North Shore-LIJ
Health System, New York
Cardiovascular Innovation 2015
Georges Ephrem MD, MSc
I have no relevant financial relationships
Joe F. Lau MD, PhD, FACC
I have no relevant financial relationships
Perwaiz Meraj MD, FACC
I have no relevant financial relationships
Cardiovascular Innovation 2015
Background
• Endovascular revascularization increasingly
preferred option for occlusive atherosclerotic
lower extremity arterial disease
• Fluoroscopic guidance and radiopaque contrast
– Radiation exposure/fluoro time exposure a real
consideration especially in peripheral cases
– Limitations of CO2 imaging
– Problematic in patients with advanced renal
disease or contrast allergy
Background
National Council on Radiation Protection & Measurements (NCRP)
Ionizing Radiation Exposure
in US Population >600%
Increase over 25 years
Fluoroscopically guided diagnosis
and intervention accounts for only
12 % of exams, but 48% of radiation exposure (Bedetti G, et al. Br J Radiol,
2008)
Courtesy of Mark Seifert MD, FACC, FHRS, Phoenix, AZ
Background
• Occupational hazards for interventionalists
– 25% of interventionalists > age 60 no longer
performing invasive procedures due to back pain
– Incidence of orthopedic complaints > 50% in those
with over 15 years experience (42% spine, 28% hip,
knee or ankle)
– >30% reported missing work due to orthopedic pain
– Cardiologists utilize lead more than orthopedic
surgeons and were significantly more likely to report
pain or miss work days as a result
Goldstein, J. A., Balter, S., Cowley, M., Hodgson, J. and Klein, L. W. (2004), Occupational hazards of interventional cardiologists: Prevalence of orthopedic health problems in contemporary practice. Cathet. Cardiovasc. Intervent., 63: 407–411.
Courtesy of Mark Seifert MD, FACC, FHRS, Phoenix, AZ
Background
• ALARA recommendations from AHA 2014
Radiation Safety Statement (Circulation. 2014;130)
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Position patient as close as possible to image receptor
Maximize distance from x-ray tube to patient
Use collimation to minimize irradiated area
Lowest acceptable magnification, fluoroscopy dose rate
Lowest acceptable cine, DSA dose and pulse rates
Limit fluoroscopy to real time imaging guidance
Last image acquisition for review, hold or loop replay
Acquired loops in some cases may replace live fluoro
Courtesy of Mark Seifert MD, FACC, FHRS, Phoenix, AZ
Proposed Innovation
• We propose a fluoro-less and contrast-less
process for endovascular interventions:
– Diagnostic ultrasound imaging of the vessel using
volume rendering: GE’s LogiqE9 with LEA Mapping
and VNAV™ technology
– Wiring of the vessel/lesion and delivery of
angioplasty balloon +/- stent: MediGuide™
technology from St Jude Medical
– Characterization of lesion dimensions and
composition using the TVC Imaging System™ from
Infraredx
Vessel Mapping
• LOGIQ E9 Volume Navigation
– Sensor-tracked 2D transducer allows for
volumetric acquisition of entire length of vessel
– Volume location is acquired with respect to the
transmitter that creates the position tracking field
– This acquisition map is in addition co-registered to
the inguinal ligament of the patient
Vessel Mapping
Vessel Mapping
Original
VNAV™ Inside
No external bracket
No external cables
Only commercially available on abdominal curved linear probes today, but illustrates potential future
capability for peripheral vascular probes.
Vessel Mapping
Vessel Mapping
Vessel Mapping
Vessel Mapping
Vessel Mapping
• The LOGIQ E9 ultrasound system
– Embedded with a 3D Guidance driveBAY™ tracker
from Ascension Technology Corporation
– Magnetic tracking systems determine the position
of moveable sensors relative to a fixed transmitter
within a defined operating volume
• US rendering converted to volume rendering
through transformation matrix allowing for
coregistration with the MediGuide™ dataset
Vessel Mapping
Reference Sensor
Needle Tracking
In-plane
Out-of-plane
Navigating The Vessel
• MediGuide™ Technology
– Location of device-based sensors in 3D space
using a low-powered electromagnetic field
– Overlay MediGuide Enabled™ devices on the
corresponding pre-obtained image
• Reduction of the duration of live X-ray during a
procedure
– Automatic adjustment for changes in heart rate,
respiratory motion and patient movement
Navigating The Vessel
• MediGuide™ Technology
– Accurately tracks catheter position and
orientation within 1 mm and 1 degree
– Provides biplane visualization with uniplane
equipment
– Adds additional perspective and improves
workflow during catheter navigation
– Has already been validated in electrophysiology
procedures
Navigating The Vessel
Navigating The Vessel
Conceptual example of the “fusion map”
Baseline ultrasound-generated map
Live navigation of MediGuide™-enabled
guidewire and/or catheter
Lesion Dimensions And Composition
• The TVC Imaging System™
– Near infrared spectroscopy (NIRS) with
intravascular ultrasound (IVUS)
– Clearly displays key details of the lesion
• Location, length, and degree of stenosis
• Confirmation of proper stent placement
– Technical specifications
• IVUS axial resolution of 40-45 µm
• Linear registration of IVUS to NIRS -0.7± 0.2 mm
• Diameter and area measures accurate within 5%
Lesion Dimensions And Composition
• TVC Composite™ Image
– A co-registered image
– Appears immediately on both the high-definition
physician and operator monitors
• Integrating and co-registering the Chemogram
with IVUS provides critical information to
operators during the procedure
Lesion Dimensions And Composition
Intervention
• Using the results of TVC Imaging System™, the
lesion is demarcated on the “fusion map”
• The balloon is delivered to the lesion site using
the MediGuide™ system
• Balloon expansion is guided by the previously
obtained lesion diameter via TVC Imaging™
• Stenting is performed in a similar fashion
• Post stenting evaluation is performed by TVC
Imaging™
Intervention
Conceptual example of the “fusion map”
Baseline ultrasound-generated map
“Wiring”
Intervention
Conceptual example of the “fusion map”
Baseline ultrasound-generated map
Acquiring NIRS information
Intervention
Conceptual example of the “fusion map”
Baseline ultrasound-generated map
Acquiring NIRS information
Intervention
Conceptual example of the “fusion map”
Baseline ultrasound-generated map
Deploying the balloon
Intervention
Conceptual example of the “fusion map”
Baseline ultrasound-generated map
Angioplasty
Intervention
Conceptual example of the “fusion map”
Baseline ultrasound-generated map
Retracting the balloon
Intervention
Conceptual example of the “fusion map”
Baseline ultrasound-generated map
Acquiring NIRS information post intervention
Intervention
Conceptual example of the “fusion map”
Baseline ultrasound-generated map
Acquiring NIRS information post intervention
Intervention
Conceptual example of the “fusion map”
Baseline ultrasound-generated map
Color Doppler post intervention acquisition
Prospects
• At North Shore-Long Island Jewish
– 1,000 peripheral angiograms yearly
• 400 interventions
– 49,000 cc of contrast used
– 15,100 minutes of fluoro time
• Potential with the proposed innovation
– 0 cc of contrast
– 0 minutes of fluoro time
– No lead garment
Limitations
• Only conceptual at this point
• Image acquisition limited to large to mediumsized superficial vessels
– SFA, proximal popliteal artery before Hunter’s canal
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Tortuous vessels +/- significant calcific disease
Body habitus
Impact on procedure duration and cost
Learning curve +/- US tech at bedside
Current Efforts
• Fluoro and contrast reduction in EP procedures
• Fluoro and contrast reduction in coronary and
peripheral interventions
• IVUS-only coronary PCI after fluoro- and
contrast-guided diagnostic catheterization
Conclusion
• An endovascular peripheral intervention is
possible without fluoroscopy or contrast
• The prospects in renal function preservation
and radiation avoidance for both patients and
operators are extremely attractive
• The next step is to take this innovative idea to
the “proof of concept” stage
• Translation to other realms remains to be
explored
Acknowledgments
We gratefully acknowledge:
• Infraredx
• Michael Hendricks
• Shelly Sanderson
• General Electric
• Michael Washburn
• William Zang
• St Jude Medical
• Brad Campbell
• Amit Cohen
Thank you
Making lead aprons history!
Cardiovascular Innovation 2015