Minimally Invasive
 Image-Guided Therapy:
Cardiovascular Applications
      Kendall R. Waters, PhD
          kendallw@svmii.com



              Presented on Mar. 4, 2010
        Triple Ring Technologies, Newark, CA
              MedTech Frontiers Series
               www.tripleringtech.com
Original Image from iStockPhoto.com




Minimally Invasive Surgery without Image Guidance is Surgery
Blindfolded
Animation from iStockPhoto.com




72 BPM, 100,000 Day, 2.5 Billion Lifetime
CVD: Affect over 86 Million Americans, Estimated direct and indirect
costs for 2010 are $500 Billion
A silhouette misses part of the picture

                              Pilobolus Video from YouTube.com




Pilobulus @ 2007 Oscars
Is the standard good enough?




                     Angiograms are Silhouettes

Contrast Angiography: Shadows hide some details
Is the standard good enough?




                      Poor Soft Tissue Contrast

X-Ray: Poor Tissue Contrast
Coronary heart disease is
                               the largest major killer

                                  Unable to predict
                                  which plaques will
                                lead to clinical events




                                Image from Northwest Houston Heart Center (www.houstonheartcenter.com)




CHD: Largest killer, >17M pts
$177B direct/indirect costs 2006
Unable to predict which plaques lead to events
Imaging inside the coronary arteries




                             Image from ShutterStock.com




Catheter-Based Imaging: Retrograde approach
Courtesy of Sean Madden, PhD, InfraReDx




Catheter-Based Imaging: Retrograde approach
Synthetic Aperture Array Catheter




                         Mechanically Rotating Catheter




Array Catheter: Ease of Use (No flushing required)
Mechanically Rotating Catheters (US, OCT, NIRS): Image Quality
The Watch Child of Vulnerable Plaques
                     Poster an artery get clogged
                Lipid-Rich
                    or
                Necrotic
                  Core
                  ~25%




                                                                          Thin Fibrous Cap
                             Courtesy of Geoff Vince, PhD, Volcano Corp
                                                                              <65 µm

Normal > Constrictive Remodeling > Core Development > Rupture >
Occlusion > MI
Thin Cap Fibroatheroma: Thin Cap + Necrotic Core Content
IVUS this a vulnerable plaque?
                   Is image ... or Hurricane Map




Zoomed View of a Diseased Vessel with Array Catheter
Modest Spatial Resolution > Poor Tissue Differentiation
Segmentation > Plaque Burden + Lumen Area > Advanced Analysis
Do advanced algorithms help?
                 Volcano VH-IVUSTM                BSC iMAP




                  Fibrosis      Necrotic Core   Necrotic   Fibrotic
                  Fibro-Fatty   Calcification   Lipidic    Calcified


VH-IVUS > Spectral Parameters > Statistical Classification > 4
Categories > Colorized
iMAP > Spectral Signatures > Statistics Classification > 4 Categories >
Colorized
PROSPECT Trial > Plaque Burden & Necrotic Core & Minimum Lumen
Area
Will emerging technologies
     find plaques that
 lead to clinical events?
OCT provides striking detail
                 Vulnerable ?




                       but has limited penetration
OCT > 15/30 um resolution > 1-2 mm penetration > Minimum Lumen
Area                    0')(.1'2+-
Plaque Characterization > Fibrous (Signal Rich Homogeneous) & Lipid
(Signal Poor with Diffuse Borders)
IVUS + OCT Combination
                          IVUS                                                                  OCT




                    Penetration                                         Fine Structural Detail
                     Courtesy of Dr. Brian Courtney MD and Brian Liang, Sunnybrook Health Sciences Centre,Toronto, CA




Sunnybrook + Colibri > IVUS + OCT > Penetration + Lumen Detail
Spectroscopy = Chemical Composition
                                   Pullback Distance




                    Angle

                            Limited Spatial Resolution
                                   Courtesy of Sean Madden, PhD, InfraReDx




NIRS > Spectroscopy = Chemical Composition > Lipid Content
Limited Penetration and Resolution
“This is the first device that can help assess the chemical makeup of
coronary artery plaques and help doctors identify those of particular
concern.” -- FDA
NIRS + IVUS Combination
                    NIRS + IVUS                           Chemogram




                                                     IVUS Long View
                 Chemical Composition + Structural Detail
                              Courtesy of Sean Madden, PhD, InfraReDx




InfraReDx > NIRS + IVUS > Composition + Structure
A Much Better (HD) IVUS




                         Very Good Structural Detail


Better image quality. IVUS with near-optical resolution. Device simplicity.
Some valves become leaky




1% to 5 % mortality rate
    Image from Consultants in Cardiology (www.cicmd.com)
Can imaging help?


                        Soft Tissue Imaging




                         Image from the GE Healthcare Vivid Image Library




Soft Tissue Structure
Color Flow > MVR Jets
Can imaging help?


                  Precision Guidance




                      Image from Siemens Ultrasound




PFO Closure
mm Length Scale
Alignment of Delivery Catheter in LA
                         Can imaging help?


                               Real-Time 3D




                          Image from presentation by J. D. Carroll, MD at TCT 2009




Matrix Array Technology > RT3D
Catheter > Transseptal > MV
Can imaging help?


                        Reduced X-Ray Dose




Procedure Length > X-Rays (Pt & Operator)
US > Non-Ionizing > Reduce X-Ray Need
Imaging from inside the heart




                              Image from ShutterStock.com




Access > Right Side > IVC & SVC
Image from Hao and Hongo, EPLab Digest 5(4) (2005). (www.eplabdigest.com)




AcuNav > Steerable > 8-10F > 5-10MHz
Imaging from the esophagus




Access > Eso > Proximity
Imaging from the esophagus




 Images from Toronto General Hospital Department of Anesthesia and Pain Management
Figure 6. 2D- and 3D-TEE guidance of percutan
                                                                                                                                                     balloon valvuloplasty. (A) 2D-TEE demonstrating
                 Image From Philips Healthcare (www.medical.philips.com)                  Image from Hudson et al., J Interv Cardiol 21(6) (2008).
                                                                                                                                                     configuration of the anterior mitral valve leaflet (a
                                                                                                                                                     typical of rheumatic mitral stenosis. (B) 3D volum
                                                                      Figure 1. Comparison of echocardiographic transducers. (A) ICE
                                                                                                                                                     tion of an en face view of the restricted mitral valv
Steerable > Matrix Array > Multi-plane                                transducer (AcuNav,TM Siemens, Mountain View, CA, USA). (B)
                                                                      Conventional two-dimensional multiplane TEE transducer. (C) 3D
                                                                                                                                                     the left atrium demonstrating a narrowed mitral o
                                                                                                                                                     commissural fusion (arrowheads). (C) 2D X-Plane
                                                                      matrix array TEE (X7-2t, Philips, Andover, MA, USA) transducer.
                                                                                                                                                     atrial septum illustrating “septal tenting” (arrows) d
                                                                                                                                                     puncture. (D) Live 3D-TEE guidance of the Inoue
                                                                                                                                                     across the rheumatic mitral valve. (E) 3D-TEE view
                                                                                                                                                     inflation across the rheumatic mitral valve. (F) 3D
                                                                                                                                                     reconstruction demonstrating an enlarged mitral
                                                                                                                                                     row) and split commissure (arrowhead). LA = left
                                                                                                                                                     ventricle; RA = right atrium; RV = right ventricle




                                                                                                                                                     ←−−−−−−−−−−−−−−
                                                                                                                                                      −−−−−−−−−−−−−−

                                                                                                                                                     Figure 4. Percutaneous ASD closure with an Amp
                                                                                                                                                     cluder using 2D- and 3D-TEE guidance. (A) 2D-T
                                                                                                                                                     small ASD (arrows). (B) Live 3D-TEE displaying
                                                                                                                                                     of the ASD (arrow) from the left atrium, reveali
                                                                                                                                                     with a long-axis twice the short-axis dimension. (
                                                                                                                                                     reconstruction with color Doppler demonstrating l
                                                                                                                                                     ing across the ASD (arrow). (D) Live 3D-TEE of
                                                                                                                                                     following deployment of the left atrial disk of a 1
                                                                                                                                                     Septal Occluder (arrowheads) with excellent vis
                                                                                                                                                     delivery cable (arrow) through the ASD. (E) Live
                                                                                                                                                     strating good positioning of ASD occluder follo
A Leaky Mitral Valve
                                                                                        Normal




                                                                                                    Prolapse




                    Image from Weill Cornell Medical College, Cardiothoracic Surgery (www.cornellheartsurgery.org)




Normal Leaflets > One-way Flow
Prolapse Leaflets > Leaky
We can visualize soft tissue and blood flow




                         Image from Philips Healthcare iE33 Echocardiography System Image Library




Philips xPlane > Biplane TEE
MVR > Mixing of Reds and Blues = Regurgitation
3D Imaging Provides Stunning Detail ...

                        3D TEE                    Photograph during Surgery




                             Images from Ma et al., Chinese Med J 121(20) (2008).




RT3D > Inferior View > Ruptured Chord
Photograph > Ruptured Chord
... and Roadmaps the Repair




                            Images from Ma et al., Chinese Med J 121(20) (2008).




Quantitative Analysis > 3D Visualization > Specific Area
Roadmap the Intervention
Image Guidance Devices are Expensive




Philips X7-2t Probe > Engineering Marvel > many $10Ks > outside CV
system
AcuNav > ~10 yrs old > $2500 disposable > Certified Resterilization
A Cardiologist ... and a Cast of Thousands




                             Images from iStockPhoto.com and ShutterStock.com




Complexity > Echo > Anasthesia > Surgeons
“Structural Heart Disease Interventions
       are to Cardiac Ultrasound

                    what

Percutaneous Coronary Interventions
were to X-Ray Coronary Angiography.”


                             John D. Carroll, MD
  Transcatheter Cardiovascular Therapeutics 2009
Acknowledgements
               All my colleagues at SVMI


Sean Madden, PhD!                                 InfraReDx, Boston, MA
Geoff Vince, PhD!                     Volcano Corporation, San Diego, CA
Brian Courtney, MD !   Sunnybrook Health Science Center,Toronto, Canada
Chris Daft, PhD!                  Siemens Ultrasound, Mountain View, CA
Thank You
Kendall R. Waters, PhD
   kendallw@svmii.com

Minimally Invasive Image Guided Therapy

  • 1.
    Minimally Invasive Image-GuidedTherapy: Cardiovascular Applications Kendall R. Waters, PhD [email protected] Presented on Mar. 4, 2010 Triple Ring Technologies, Newark, CA MedTech Frontiers Series www.tripleringtech.com
  • 2.
    Original Image fromiStockPhoto.com Minimally Invasive Surgery without Image Guidance is Surgery Blindfolded
  • 3.
    Animation from iStockPhoto.com 72BPM, 100,000 Day, 2.5 Billion Lifetime CVD: Affect over 86 Million Americans, Estimated direct and indirect costs for 2010 are $500 Billion
  • 4.
    A silhouette missespart of the picture Pilobolus Video from YouTube.com Pilobulus @ 2007 Oscars
  • 5.
    Is the standardgood enough? Angiograms are Silhouettes Contrast Angiography: Shadows hide some details
  • 6.
    Is the standardgood enough? Poor Soft Tissue Contrast X-Ray: Poor Tissue Contrast
  • 7.
    Coronary heart diseaseis the largest major killer Unable to predict which plaques will lead to clinical events Image from Northwest Houston Heart Center (www.houstonheartcenter.com) CHD: Largest killer, >17M pts $177B direct/indirect costs 2006 Unable to predict which plaques lead to events
  • 8.
    Imaging inside thecoronary arteries Image from ShutterStock.com Catheter-Based Imaging: Retrograde approach
  • 9.
    Courtesy of SeanMadden, PhD, InfraReDx Catheter-Based Imaging: Retrograde approach
  • 10.
    Synthetic Aperture ArrayCatheter Mechanically Rotating Catheter Array Catheter: Ease of Use (No flushing required) Mechanically Rotating Catheters (US, OCT, NIRS): Image Quality
  • 11.
    The Watch Childof Vulnerable Plaques Poster an artery get clogged Lipid-Rich or Necrotic Core ~25% Thin Fibrous Cap Courtesy of Geoff Vince, PhD, Volcano Corp <65 µm Normal > Constrictive Remodeling > Core Development > Rupture > Occlusion > MI Thin Cap Fibroatheroma: Thin Cap + Necrotic Core Content
  • 12.
    IVUS this avulnerable plaque? Is image ... or Hurricane Map Zoomed View of a Diseased Vessel with Array Catheter Modest Spatial Resolution > Poor Tissue Differentiation Segmentation > Plaque Burden + Lumen Area > Advanced Analysis
  • 13.
    Do advanced algorithmshelp? Volcano VH-IVUSTM BSC iMAP Fibrosis Necrotic Core Necrotic Fibrotic Fibro-Fatty Calcification Lipidic Calcified VH-IVUS > Spectral Parameters > Statistical Classification > 4 Categories > Colorized iMAP > Spectral Signatures > Statistics Classification > 4 Categories > Colorized PROSPECT Trial > Plaque Burden & Necrotic Core & Minimum Lumen Area
  • 14.
    Will emerging technologies find plaques that lead to clinical events?
  • 15.
    OCT provides strikingdetail Vulnerable ? but has limited penetration OCT > 15/30 um resolution > 1-2 mm penetration > Minimum Lumen Area 0')(.1'2+- Plaque Characterization > Fibrous (Signal Rich Homogeneous) & Lipid (Signal Poor with Diffuse Borders)
  • 16.
    IVUS + OCTCombination IVUS OCT Penetration Fine Structural Detail Courtesy of Dr. Brian Courtney MD and Brian Liang, Sunnybrook Health Sciences Centre,Toronto, CA Sunnybrook + Colibri > IVUS + OCT > Penetration + Lumen Detail
  • 17.
    Spectroscopy = ChemicalComposition Pullback Distance Angle Limited Spatial Resolution Courtesy of Sean Madden, PhD, InfraReDx NIRS > Spectroscopy = Chemical Composition > Lipid Content Limited Penetration and Resolution “This is the first device that can help assess the chemical makeup of coronary artery plaques and help doctors identify those of particular concern.” -- FDA
  • 18.
    NIRS + IVUSCombination NIRS + IVUS Chemogram IVUS Long View Chemical Composition + Structural Detail Courtesy of Sean Madden, PhD, InfraReDx InfraReDx > NIRS + IVUS > Composition + Structure
  • 19.
    A Much Better(HD) IVUS Very Good Structural Detail Better image quality. IVUS with near-optical resolution. Device simplicity.
  • 20.
    Some valves becomeleaky 1% to 5 % mortality rate Image from Consultants in Cardiology (www.cicmd.com)
  • 21.
    Can imaging help? Soft Tissue Imaging Image from the GE Healthcare Vivid Image Library Soft Tissue Structure Color Flow > MVR Jets
  • 22.
    Can imaging help? Precision Guidance Image from Siemens Ultrasound PFO Closure mm Length Scale
  • 23.
    Alignment of DeliveryCatheter in LA Can imaging help? Real-Time 3D Image from presentation by J. D. Carroll, MD at TCT 2009 Matrix Array Technology > RT3D Catheter > Transseptal > MV
  • 24.
    Can imaging help? Reduced X-Ray Dose Procedure Length > X-Rays (Pt & Operator) US > Non-Ionizing > Reduce X-Ray Need
  • 25.
    Imaging from insidethe heart Image from ShutterStock.com Access > Right Side > IVC & SVC
  • 26.
    Image from Haoand Hongo, EPLab Digest 5(4) (2005). (www.eplabdigest.com) AcuNav > Steerable > 8-10F > 5-10MHz
  • 27.
    Imaging from theesophagus Access > Eso > Proximity
  • 28.
    Imaging from theesophagus Images from Toronto General Hospital Department of Anesthesia and Pain Management
  • 29.
    Figure 6. 2D-and 3D-TEE guidance of percutan balloon valvuloplasty. (A) 2D-TEE demonstrating Image From Philips Healthcare (www.medical.philips.com) Image from Hudson et al., J Interv Cardiol 21(6) (2008). configuration of the anterior mitral valve leaflet (a typical of rheumatic mitral stenosis. (B) 3D volum Figure 1. Comparison of echocardiographic transducers. (A) ICE tion of an en face view of the restricted mitral valv Steerable > Matrix Array > Multi-plane transducer (AcuNav,TM Siemens, Mountain View, CA, USA). (B) Conventional two-dimensional multiplane TEE transducer. (C) 3D the left atrium demonstrating a narrowed mitral o commissural fusion (arrowheads). (C) 2D X-Plane matrix array TEE (X7-2t, Philips, Andover, MA, USA) transducer. atrial septum illustrating “septal tenting” (arrows) d puncture. (D) Live 3D-TEE guidance of the Inoue across the rheumatic mitral valve. (E) 3D-TEE view inflation across the rheumatic mitral valve. (F) 3D reconstruction demonstrating an enlarged mitral row) and split commissure (arrowhead). LA = left ventricle; RA = right atrium; RV = right ventricle ←−−−−−−−−−−−−−− −−−−−−−−−−−−−− Figure 4. Percutaneous ASD closure with an Amp cluder using 2D- and 3D-TEE guidance. (A) 2D-T small ASD (arrows). (B) Live 3D-TEE displaying of the ASD (arrow) from the left atrium, reveali with a long-axis twice the short-axis dimension. ( reconstruction with color Doppler demonstrating l ing across the ASD (arrow). (D) Live 3D-TEE of following deployment of the left atrial disk of a 1 Septal Occluder (arrowheads) with excellent vis delivery cable (arrow) through the ASD. (E) Live strating good positioning of ASD occluder follo
  • 30.
    A Leaky MitralValve Normal Prolapse Image from Weill Cornell Medical College, Cardiothoracic Surgery (www.cornellheartsurgery.org) Normal Leaflets > One-way Flow Prolapse Leaflets > Leaky
  • 31.
    We can visualizesoft tissue and blood flow Image from Philips Healthcare iE33 Echocardiography System Image Library Philips xPlane > Biplane TEE MVR > Mixing of Reds and Blues = Regurgitation
  • 32.
    3D Imaging ProvidesStunning Detail ... 3D TEE Photograph during Surgery Images from Ma et al., Chinese Med J 121(20) (2008). RT3D > Inferior View > Ruptured Chord Photograph > Ruptured Chord
  • 33.
    ... and Roadmapsthe Repair Images from Ma et al., Chinese Med J 121(20) (2008). Quantitative Analysis > 3D Visualization > Specific Area Roadmap the Intervention
  • 34.
    Image Guidance Devicesare Expensive Philips X7-2t Probe > Engineering Marvel > many $10Ks > outside CV system AcuNav > ~10 yrs old > $2500 disposable > Certified Resterilization
  • 35.
    A Cardiologist ...and a Cast of Thousands Images from iStockPhoto.com and ShutterStock.com Complexity > Echo > Anasthesia > Surgeons
  • 36.
    “Structural Heart DiseaseInterventions are to Cardiac Ultrasound what Percutaneous Coronary Interventions were to X-Ray Coronary Angiography.” John D. Carroll, MD Transcatheter Cardiovascular Therapeutics 2009
  • 37.
    Acknowledgements All my colleagues at SVMI Sean Madden, PhD! InfraReDx, Boston, MA Geoff Vince, PhD! Volcano Corporation, San Diego, CA Brian Courtney, MD ! Sunnybrook Health Science Center,Toronto, Canada Chris Daft, PhD! Siemens Ultrasound, Mountain View, CA
  • 38.