Optics in in Cardiology April 21, 2018 I did it for the - - PowerPoint PPT Presentation
Optics in in Cardiology April 21, 2018 I did it for the patients>>: My journey from academia to industry and back to academia Dr. James Mller Brigham and Womens Hospital Boston, MA Conflict of Interest CEO, SpectraWAVE, Inc,
Brigham and Womens’ Hospital Boston, MA
Conflict of Interest CEO, SpectraWAVE, Inc, which is building a combination OCT-Spectroscopy Catheter
Photoelectric effect 1921 Nobel Prize in Physics PTCA
1915- 2015
Lipid-core Plaques +1.2 Million Heart Attacks Per Year in US and Complicate Stenting
5
Muller, Tofler, Stone Circulation, 1989 Introduction of the “Vulnerable Plaque” concept
A “Vulnerable” Nuclear Weapon
200 400 600 800 1000 1200 1400 1600 1800
1985 1990 1995 2000 2005 2010 2012
"Vulnerable Plaque" and "Case-Crossover" Citations per year
(Google Scholar) Vulnerable Plaque Case Cross-over
= 14,221
= 6,259 Case-crossover , Maclure, Mittleman, 1990
VP, 1989
Other Applications of the Case-Crossover Method
Exposure Outcome Result Odds Ratio Air Pollution Mortality from COPD in Barcelona 1.1 Anger MI in Stockholm 9.0 Air Pollution Mortality in Seoul 1.02 Air Pollution Mortality in Philadelphia 1.05 Benzodiazepine Auto accident 1.6 (not for SSRI) Family Quarrel Childhood accident 2.6
1100 1200 1300 1400 1500 1600 1700 1800 1900
Cholesterol Cholesteryl Linoleate Cholesteryl Oleate Collagen Cholesterol Cholesteryl Linoleate Cholesteryl Oleate Collagen
1.0 0.8 0.6 0.4 0.2
wavelength absorbance
Diffuse Reflectance NIR Spectroscopy to Identify Chemical Composition of Unknown Substances
Absorbance
Spectroscopy in 1998
40 mm 36 mm 26 mm 20 mm
Chemogram Findings in a Coronary Autopsy Specimen: Comparision with Histology
14
15
Fibrotic / Calcified Plaque Lipid-Rich Plaque
Lumen Lumen
NIRS and IVUS Combined Catheter
Sheath IVUS Transducer Catheter Core Tip Fiber Optics NIRS Mirrors NIRS Image (Chemogram) IVUS Image Structure Composition
Confidential 16
Intravascular Coronary Diagnostics Using Light and Sound to Image Coronary Arteries
1999
Founded by
17 2008
FDA Approval Spectroscopy used to image coronary arteries
2010
FDA Approval Dual modality Spectroscopy/IVUS Catheter
TVC Imaging System
algorithms
(PBR) Device
TVC Insight Catheter
2012 Commercial Launch
Courtesy Dr. Ryan Madder, TCT 2012
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The Myth of the “Vulnerable Plaque” Transitioning From a Focus on Individual Lesions to Atherosclerotic Disease Burden for Coronary Artery Disease Risk Assessment
Armin Arbab-Zadeh, MD, PHD,* Valentin Fuster, MD, PHD: JACC 2015
Peter Libby and Gerard Pasterkamp, EHJ, March 2015
The Vulnerable Plaque Hype-pothesis
Steve Nissen, MD, CRT Meeting
Soon, the Data will Speak
Identification of Vulnerable Patients by NIRS Schuurman, Oemrawsingh et al EHJ, 2018
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1500 PCI patients with ACS or SA with NIRS-IVUS imaging of 2 or more vessels Max 4 mm LCBI >250 for 100% FU Max 4 mm LCBI ≤ 250 for 50% FU 2 year MACE from a new lesion at patient and coronary segment level
PI, Europe, Dr. Carlo Di Mario
Results TCT Sept, 2018
PROSPECT 2 Study
PROSPECT / ABSORB RCT
“PROSPECT 2” 600 Patients
“ABSORB”
180 pts > 70% Plaque Burden,Non-Flow -Limiting
900 ACS Patients Undergoing PCI
GDMT Only
90 Patients
BVS Scaffold +
GDMT 90 Patients
Assess Treatment Effect in Sub-set with LCP
No LCP LCP No LCP LCP NIRS/IVUS Predicts MACE BVS Scaffold
100 200 300 400 500 600 700 800 900 1000 5 10 15 20 25 30 35
Max 4mm LCBI 3-Year Event Rate (%)
(21.3%) (15%) (16.2%) (16.3%) (13%) (7.6%) (5%) (3.1%) (1.3%) (1.3%) Distribution of LCBI from COLOR:
213 150 162 163 130 76 50 31 13 13 Estimate of Evaluable Events (116): 4 5 8 18 27 21 15 10 4 4 Event Rate Prospect 1 (17%) (34%)
LCBI 974 LCBI 68
Possible Outcome of LRP Study: Risk that a 30 mm coronary segment with a given 4 mm Max LCBI will produce a MACE event in 3 years. Estimate only.
Medical Failure Medical Success Early Financial Success Ardian Connor Medical The Promised Land Early Financial Failure Infraredx?
(Definite early financial failure, medical
pending)
SpectraWAVE, Inc.
SpectraWAVE -- Combined OCT-Spectroscopy system
Uemura et al, Acta Cardiologia Sinica, 2014; Fard A, and Tearney GJ; Opt Express, 2013
OCT Provides:
Lipid
LUMEN Suspected Vulnerable plaque
Spectroscopy
Automated identification
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Circadian Rhythm
Triggers of CV Events 1987 Vulnerable Plaque Concept, 1989 NIRS 2008 NIRS-IVUS 2010 Prediction Trials Start 2014 Gill Heart, KY, 1998 Infraredx, Inc Founded Treatment Trials 2018 & Patient Care SpectraWAVE, Inc OCT-NIRS 2017 Industry Academia Academia
Academia
Positive
Patient care encourages research Teaching and research focus
Negative
Difficult to stay funded Pressure to see patients quickly
Industry
Positive
Focused drive to commercialization and wide use of a product Funding less difficult than in academia
Negative
For start-up, constant need to raise funds Assumed to be pitching for commercial reason
Prevention of Nuclear War – A Long and Winding Road
35
Exchange Student To Moscow 1967 US USSR Health Cooperation 1972 Summit Mtg International Physicians for Prevention of Nuclear War Wins Nobel Peace Prize 1985 Co-Founder IPPNW,1980 Co-Founder NKaUS Physicians for Prevention of Nuclear War 2018
Frank book On Nukes ICAN Wins Nobel Peace Prize 2017
Nuclear Activism Cardiology Only Nuclear Activism
Ambassador Ri of the United Nations – Responsible for DPRK Relations with the United States 14 April 2018
The International Campaign to Abolish Nuclear Weapons (ICAN) is a coalition of non-governmental organizations in one hundred countries promoting adherence to and implementation of the United Nations nuclear weapon ban treaty. This landmark global agreement was adopted in New York on 7 July 2017. Awarded the 2017 Nobel Peace Prize Annual Meeting, 22 April, 2018 Geneva, Switzerland
Harvard Medical School
Eugene Braunwald, MD Calum MacRae, MD, Ph.D Jim Kirshenbaum, MD John Parrish, MD Farouc Jaffer, MD Sam Goldhaber, MD Gary Tearney, MD, Ph.D Brett Bouma, Ph. D Peter Stone, MD Geoffrey Tofler, MD Stephan Willich, MD Murray Mittleman, MD Malcom MacLure, Ph.D Kevin Croce, MD Ron Blankstein, MD Tom Brady, MD Ahmed Tawakol, MD
Clinical Trial Colleagues
David Erlinge, MD Gregg Stone, MD John Ambrose, MD Rob Wilensky MD Jim Goldstein MD Ron Waksman, MD Sergio Waxman, MD Takashi Akasaka, MD Yasunori Ueda, MD Carlo DiMario,MD Francesco Prati, MD Antonio Columbo, MD Gary Mintz MD Akiko Maehara, MD Lorenz Rabe, MD Wolfgang Koenig, MD Renu Virmani, MD Ryan Madder, MD James Ware, Ph.D
InfraReDx/Nipro Inc
Sean Madden, Ph.D Steve Sum, Ph.D Michael Hendricks, MS Priti Shah Jay Caplan Craig Gardner, Ph.D Ed Hull, Ph.D
Erasmus Medical Center
Ton van der Steen, Ph.D Patrick Serruys, MD Evelyn Regar, MD Gijs van Soest, Ph.D Rohit Oemrawsingh, MD Yoshinobu Onuma, MD Jurgen Ligthart Eric BoersmaPh.D Bob McNeil Ph.D Bill Priest Bill Holland Bill Marquard Ken Jones Jack Gill, PhD Sano San Ujihara San