Minimally Invasive Image Guided Therapy

Minimally InvasiveImage-Guided Therapy:

Cardiovascular ApplicationsKendall R. Waters, PhD

kendallw@svmii.com

Presented on Mar. 4, 2010Triple Ring Technologies, Newark, CA

MedTech Frontiers Serieswww.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 LifetimeCVD: 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

Angiograms are Silhouettes

Is the standard good enough?

Contrast Angiography: Shadows hide some details

Poor Soft Tissue Contrast

Is the standard good enough?

X-Ray: Poor Tissue Contrast

Unable to predict which plaques will

lead to clinical events

Coronary heart disease is the largest major killer

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

CHD: Largest killer, >17M pts$177B direct/indirect costs 2006Unable 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

Mechanically Rotating Catheter

Synthetic Aperture Array Catheter

Array Catheter: Ease of Use (No flushing required)Mechanically Rotating Catheters (US, OCT, NIRS): Image Quality

Watch an artery get cloggedThe Poster Child of Vulnerable Plaques

Thin Fibrous Cap<65 µm

Lipid-Richor

NecroticCore~25%

Courtesy of Geoff Vince, PhD, Volcano Corp

Normal > Constrictive Remodeling > Core Development > Rupture > Occlusion > MIThin Cap Fibroatheroma: Thin Cap + Necrotic Core Content

IVUS image ... or Hurricane MapIVUS image ...Is this a vulnerable plaque?

Zoomed View of a Diseased Vessel with Array CatheterModest Spatial Resolution > Poor Tissue DifferentiationSegmentation > Plaque Burden + Lumen Area > Advanced Analysis

Do advanced algorithms help?

Necrotic Fibrotic

Lipidic Calcified

BSC iMAPVolcano VH-IVUSTM

Fibro-Fatty Calcification

Necrotic CoreFibrosis

VH-IVUS > Spectral Parameters > Statistical Classification > 4 Categories > ColorizediMAP > Spectral Signatures > Statistics Classification > 4 Categories > ColorizedPROSPECT Trial > Plaque Burden & Necrotic Core & Minimum Lumen Area

Will emerging technologies find plaques that

lead to clinical events?

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OCT provides striking detail

Vulnerable ?

but has limited penetration

OCT > 15/30 um resolution > 1-2 mm penetration > Minimum Lumen AreaPlaque Characterization > Fibrous (Signal Rich Homogeneous) & Lipid (Signal Poor with Diffuse Borders)

IVUS OCT

Fine Structural Detail

IVUS + OCT Combination

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

Penetration

Sunnybrook + Colibri > IVUS + OCT > Penetration + Lumen Detail

Spectroscopy = Chemical Composition

Limited Spatial ResolutionCourtesy of Sean Madden, PhD, InfraReDx

Pullback Distance

Ang

le

NIRS > Spectroscopy = Chemical Composition > Lipid ContentLimited 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

Chemical Composition + Structural Detail

NIRS + IVUS Chemogram

IVUS Long View

NIRS + IVUS Combination

Courtesy of Sean Madden, PhD, InfraReDx

InfraReDx > NIRS + IVUS > Composition + Structure

Very Good Structural Detail

A Much Better (HD) IVUS

Better image quality. IVUS with near-optical resolution. Device simplicity.

Some valves become leaky

1% to 5 % mortality rateImage from Consultants in Cardiology (www.cicmd.com)

Can imaging help?

Soft Tissue Imaging

Image from the GE Healthcare Vivid Image Library

Soft Tissue StructureColor Flow > MVR Jets

Can imaging help?

Precision Guidance

Image from Siemens Ultrasound

PFO Closuremm Length Scale

Alignment of Delivery Catheter in LACan imaging help?

Real-Time 3D

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

Matrix Array Technology > RT3DCatheter > Transseptal > MV

Can imaging help?

Reduced X-Ray Dose

Procedure Length > X-Rays (Pt & Operator)US > Non-Ionizing > Reduce X-Ray Need

Image from ShutterStock.com

Imaging from inside the heart

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

HUDSON, ET AL.

Figure 1. Comparison of echocardiographic transducers. (A) ICEtransducer (AcuNav,TM Siemens, Mountain View, CA, USA). (B)Conventional two-dimensional multiplane TEE transducer. (C) 3Dmatrix array TEE (X7-2t, Philips, Andover, MA, USA) transducer.

Figure 6. 2D- and 3D-TEE guidance of percutaneous mitral valveballoon valvuloplasty. (A) 2D-TEE demonstrating a “hockey-stick”configuration of the anterior mitral valve leaflet (arrowhead) proto-typical of rheumatic mitral stenosis. (B) 3D volumetric reconstruc-tion of an en face view of the restricted mitral valve as viewed fromthe left atrium demonstrating a narrowed mitral orifice (arrow) andcommissural fusion (arrowheads). (C) 2D X-Plane view of the inter-atrial septum illustrating “septal tenting” (arrows) during transseptalpuncture. (D) Live 3D-TEE guidance of the Inoue balloon catheteracross the rheumatic mitral valve. (E) 3D-TEE view of Inoue ballooninflation across the rheumatic mitral valve. (F) 3D-TEE volumetricreconstruction demonstrating an enlarged mitral valve orifice (ar-row) and split commissure (arrowhead). LA = left atrium; LV = leftventricle; RA = right atrium; RV = right ventricle.

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Figure 4. Percutaneous ASD closure with an Amplatzer Septal Oc-cluder using 2D- and 3D-TEE guidance. (A) 2D-TEE suggesting asmall ASD (arrows). (B) Live 3D-TEE displaying an en face viewof the ASD (arrow) from the left atrium, revealing its oval shapewith a long-axis twice the short-axis dimension. (C) 3D volumetricreconstruction with color Doppler demonstrating left to right shunt-ing across the ASD (arrow). (D) Live 3D-TEE of an en face viewfollowing deployment of the left atrial disk of a 12 mm AmplatzerSeptal Occluder (arrowheads) with excellent visualization of thedelivery cable (arrow) through the ASD. (E) Live 3D-TEE demon-strating good positioning of ASD occluder following right atrialdisk (arrowheads) deployment. (F) 2D X-plane with color Dopplerdemonstrating final device positioning without evidence of residualshunting from two simultaneous planes of view. LA = left atrium;RA = right atrium; # = septum primum; ## = septum secundum.

540 Journal of Interventional Cardiology Vol. 21, No. 6, 2008

Image From Philips Healthcare (www.medical.philips.com) Image from Hudson et al., J Interv Cardiol 21(6) (2008).

Steerable > Matrix Array > Multi-plane

A Leaky Mitral Valve

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

Normal

Prolapse

Normal Leaflets > One-way FlowProlapse Leaflets > Leaky

We can visualize soft tissue and blood flow

Image from Philips Healthcare iE33 Echocardiography System Image Library

Philips xPlane > Biplane TEEMVR > 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 ChordPhotograph > Ruptured Chord

... and Roadmaps the Repair

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

Quantitative Analysis > 3D Visualization > Specific AreaRoadmap the Intervention

Image Guidance Devices are Expensive

Philips X7-2t Probe > Engineering Marvel > many $10Ks > outside CV systemAcuNav > ~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, MDTranscatheter 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 YouKendall R. Waters, PhD

kendallw@svmii.com