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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) – – – – – – – – 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 • • • • 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