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Pertinent Disclosure Information: Equity Interest: BioStar Ventures, BOD of KONA, Embrellae Consulting : Boston Scientific, Abbott Labs, Medtronic, Covidien I will discuss off label, investigational use of product in this lecture
David Corteville, MD, FACC No Disclosures
Louis A. Cannon, MD, FCCP, FACA, FSCAI, FACC, FACP
Disclosures
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4
Hypertension
TAVR
Atrial Fibrillation BioAbsorbable Stents
$$$$
Bo
sto
n S
cien
tifi
c’s
Bio
abso
rbab
le S
ten
t Te
chn
olo
gies
“Leave Nothing Behind”
Bioabsorbable Metal Stent (Magnesium)
Absorbed within ~6 months
Bioabsorbable Polymer Stent
(PLLA)
Absorbed within +24 months
Bioabsorbable Polymer Stent
(Tyrosine-derived Polycarbonate)
Absorbed within +24 months
Bioabsorbable Metal Stent
(Iron)
Absorbed within +24 months
CAUTION: Under Development. Not for sale. Data on file. Under investigation and not FDA approved.
LAA Orifice – diameter 10 – 40 mm
• Develops during the third week of gestation
• Highest Level of ANP in body
• May have an effect on LA/LV filling
• Variable Size and Shape
• (40) with two or more lobes
Left Atrial
Appendage
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• Frame: Nitinol (shape memory) – Accommodates most LAA anatomy
– Barbs engage the LAA tissue
• Fabric Cap: Polyethyl terephthalate (PET) Fabric – Prevents harmful emboli from exiting
Barbs
160 µ PET fabric
• Device Sizes:
– 21, 24, 27, 30 and 33 mm
– Diameter is measured across face of
device
– Device Length = Device Diameter
– STUBBY DEVICE NOW AVAILABLE
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• Affects 1 in 3 adults globally
• $30B market worldwide for HTN medications
• 25% of HTN pts are uncontrolled despite multiple meds
• Recent data support the feasibility of treating HTN via:
• Ablation of the renal sympathetic nerves
• Electrical stimulation or activation of the baroreceptors
near the carotid sinuses
• Renal denervation helps other conditions
Source: www.ncbi.nlm.nih.gov/pmc/articles/PMC2560860, World Hypertension Report 2005-2010 Published 03/11/2005
Boy Dressed as Girl + Hypertension
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o Single largest contributor to death worldwide
o Every 20/10 mmHg increase in BP correlates 2x 10-year cardiovascular mortality
o Dramatically increases risk of stroke, heart attack, heart failure, & CKDz
o Only half of all treated hypertensives are controlled to established BP targets
o High prevalence:
• Affects 1 in 3 adults
• 1B people worldwide 1.6 B by 2025
35% Treated & Controlled
30% Untreated
35% Treated but Uncontrolled
Chobanian et al. Hypertension. 2003;42(6):1206–1252.
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Hypertrophy
Arrhythmia
Oxygen Consumption
Vasoconstriction
Atherosclerosis
Insulin
Resistance
Renal Afferent
Nerves
↑ Renin Release RAAS activation
↑ Sodium Retention
↓ Renal Blood Flow
Sleep Disturbances
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• Standard interventional technique
• 4-6 two-minute treatments per artery
• Proprietary RF Generator − Automated
− Low-power
− Built-in safety algorithms
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Property of KONA Medical. Proprietary and Confidential. 2011
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Non-Invasive System
Doppler Targeting of Renal Arteries
Property of KONA Medical. Proprietary and Confidential. 2011
Edwards Lifesciences
Medtronic CoreValve
Current Generation Devices
TAVR Arrives
>50,000 patients treated thru 2012
in >500 interventional centers
around the world!
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You Need
Surgery
Are you taking your
medicine
No reason to
crack your
chest, you need TAVR
independent
• 2000 “you‟re crazy, reckless idiots; won‟t get it
funded; can‟t work and will kill patients; interventionalists
are the leaches of medicine ”
• 2005 “you‟re merely irresponsible; procedure is too
complicated; but, possibly in inoperable patients only”
• 2010 “you‟re a visionary; breakthrough procedure which
is easily generalizable; „better than sex‟ (PST); will
transform therapy for most AS patients!”
Perspectives over time…
TAVR - Now
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Rules of Engagement
TAVR – The Early Years
Surgery
TAVR
Rules of Engagement
TAVR - Now
TAVR
SURGERY
From the beginning it is about our
patients! AS is a devastating dz and
the integration of selective TAVR with
surgery will improve effective therapy
for more patients in the future!
Key Lesson
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– Direct Flow
– Sadra
– St. Jude
– AorTx
– HLT
– EndoTech
– ABPS PercValve
TAVR:
SAPIEN Valve and CoreValve
Bates E R Circulation 2011;124:355-359 Copyright © American Heart Association
Timing of Surgical Evaluation May Be Short
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Timing of Surgical Evaluation Improves With Collaboration
Goal: provide centralized assessment and Rx options for complex valve disorders.
InterDisciplinary
Especially for possible TAVR PTS
Goal: maximize quality pt testing, surgical scoring, cardiology and cardiac surgery evaluation, the same day
Goal: Minimize travel, maximize quality and outcomes –many of our pts travel great distances
• TAVR is intended for use in sx pts with severe calcific AS requiring AVR who are high risk for open chest surgery due to comorbid conditions or inoperable pts .
• Defining high-risk surgical pts is not simple. A Society of Thoracic Surgeons (STS) risk score > 10 or EuroSCORE > 20 are most often used to define high risk.
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• Only 20% of patients who are referred for TAVR
are actually candidates. Most will be medical
mgmt or surgical treatment.
• Exhaustive testing:dental evaluation, carotid
studies, surface echo, TEE, CT scan of
chest/abd/pelvis, rt/lt heart cath and valve clinic
appointment.
• Finding the right patient for the procedure is
actually very difficult and can be frustrating for
patients and families.
• Traditional Surgery
• Minimally Invasive Surgery
• Hybrid Procedure (minimally invasive
valve surgery with simultaneous PCI)
• Balloon Aortic Valvuloplasty
• TAVR
Transcatheter Aortic Valve Replacement (TAVR) Hybrid OR
Multidisciplinary Team
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The
Heart Team
TAVR - 2012
Sponsor Clinical Research
Protocols Clinical Research Staff
Cath Lab
Anesthesia
Echo Operating Room
Perfusion
Interventional Cardiology CT Surgery
Advanced Imaging
Referral Sources
Institutional Support
Clinical Staff Cath Lab/OR
Cardiac Critical Care Units Telemetry/Cardiac Units
Consultants
Administrative Staff
Dedicated Valve Program Staff RN/NP/PA
Patients &
Families
McLaren Bay Region, Bay City
McLaren Flint, Flint
McLaren Northern Michigan, Petoskey
McLaren Greater Lansing, Lansing
McLaren Macomb, Mount Clemens
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Cath Lab OR
Hybrid Cath Lab/OR
Multi-Disciplinary Collaboration
D QALY (TAVR - AVR)
D 1
-yr
co
st
(TA
VR
– A
VR
)
TAVR
Economically
Dominant
$50,000 per
QALY
Complete Population
Cobolt Frame & New Leaflet Geometry Tissue Attachment
.0109 .0217 .0187 .0210 .0196 .0177 .0156 .0189 .0171 .0182 .0121
.0193 .0136 .0189 .0173 .0118 .0189 .0261 .0247 .0212 .0231 .0235 .0205 .0208 .0177 .0166 .0149 .0153 .0170 .0155
.0111 .0138 .0187 .0204 .0144 .0141 .0250 .0244 .0189 .0187 .0214 .0204 .0208 .0187 .0135 .0140 .0150 .0150 .0134
.0113 .0115 .0162 .0218 .0184 .0139 .0256 .0292 .0194 .0164 .0186 .0211 .0217 .0169 .0144 .0115 .0118 .0135 .0117
.0130 .0111 .0133 .0198 .0225 .0167 .0259 .0343 .0268 .0179 .0195 .0181 .0253 .0163 .0144 .0118 .0112 .0115 .0050
.0136 .0104 .0124 .0154 .0243 .0178 .0237 .0372 .0337 .0231 .0180 .0138 .0200 .0145 .0127 .0132 .0116 .0109 .0104
.0119 .0208 .0369 .0330 .0272 .0210 .0108 .0302 .0134 .0115 .0133 .0119 .0135 .0110
.0122 .0100 .0110 .0128 .0113 .0136 .0110
.0113 .0110 .0084 .0117
Leaflet Matching
& ThermaFix
Finite Element
Analysis
Partially
Closed
Design Sapien XT
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June 2012 ACA Sustained
“Law of the Land”
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Physician Perspective
Emotional Upheaval
• Loss of Control
• Anxiety over Unknown
• Lack of Prestige
• Stallions as Employees
• Decreased Income
• Public Scrutiny
• Loss of Trust
Business Upheaval
• Employed Physician Model
– Interesting JV‟s
– Creative Money Pools
– Gainsharing
– Incentive alignment
• Cath Lab Changes
– Out/Pt PCI
– Radial cases
– Structural Heart Dz
• Government
– P4P
– Risk Sharing
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© 2010 Boston Scientific or its affiliates. All rights reserved. 90568837 JAN10 52
According to practice guidelines (such as InterQual or
Milliman), non-urgent PTCA with stent placement and
transvenously placed ICDs can be safely performed in
the hospital outpatient department. If there is a
medical justification for the procedure to be
performed in the inpatient setting, the physician must
issue clear admission orders (“admit to hospital” vs.
“place in observation”) and the medical justification
must be clearly and accurately documented in the
patient’s medical record.
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Source: © 2009 The Advisory Board Company 19295C. Cardiovascular Roundtable research and analysis.
• Closure device utilization
• Case time changes morning intervention and afternoon valves
• Home care
• Hospitality Houses
• More scheduled interventions rather than cath possibles..
• Hydration and contrast utilization CIN
• IVUS and FFR push ?? To ensure appropriateness and
adequacy of deployment
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• Outcomes-focused reimbursement will materially risks to revenue
growth
• Operating efficiency will drive future inpatient profitability (not growth)
• Bundling/ reimbursement innovations will ↓↓specialty care profitability
• PCP: focus on coordination, chronic dz mgmt and population health
• Total cost management will supplant fee-for-service incentives
• Providers will maintain tighter and fewer affiliations
• M&A strategy will focus increasingly on functional integration
• Info-driven care (not IT adoption) will be a competitive differentiator
• Consumer-driven health care will be driven (further) to the margins
• New regulatory frameworks and entities will emerge
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59
60
Source: Online survey conducted by the Market Intelligence team of the American College of Cardiology between October 31 and November 17, 2009.
801 ACC members working in the U.S. participated, of which 387 work in private practice.
Published, Cardiology December 2009 issue, Volume 38, Number 12, Page 5
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Hospital Perspective
Benefits of hospital-employed physicians:
• Enhance capacity to achieve quality goals (leverage)
• Increase/maintain procedural volume (control site of procedure)
• Potential for financial alignment (gain sharing, negotiation)
• “Lock up” specialists
• Reduce competition
Overarching Elements of Legislation
– Coverage Expansion Through Exchanges & Medicaid
– Multiple Insurance Reforms
– Medicare Payment Cuts to Providers
– Taxes on Health Industries
– Increased Medicare Taxes on Upper-Income Filers
– New Comparative Effectiveness Research Institute
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– More insured patients - 19M by 2014, 32M by 2019
– Numerous pilots & payment reforms to align incentives and coordinate care
between physicians and hospitals
– Bonus payments for maintaining board certification & reporting quality measures
– Shift toward paying for value, less on paying for services
– Extends work and practice expense geographic floors and adjustments under MD
fee schedule
Sweeping Changes For Physicians
– New Independent Payment Advisory Board
• Recommendations on Medicare savings automatically take effect unless specifically blocked by Congress (starts in 2015)
– Center for Medicare and Medicaid Innovation within CMS • $10B allocated to test new ways of paying providers and delivering health care to
reduce Medicare and Medicaid spending
– HHS to implement “Physician Compare” website
– Amends physician “feedback” program on resource use, will give MDs data on their utilization compared to peers
And More Sweeping Changes . . .
WE can help you
live longer
Medicines Are Part of
the Plan I Have a Team
Member that Can Make you Feel Better
independent
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• Pay for what you do
• Pay for each piece
• Privacy for you and Pt
• Appropriate:
o Art of Medicine
• Independent Physicians
• Premium to Specialize
• Med Society Fraternities
• Pay for a diagnosis
• Pre-pay for team continuum
• Public reporting for phys’s
• Appropriate:
o Art of Law and Science
• Employed Physicians
• Push to Primary o Extreme Specialist Shortage < Decade
• Med Society Empowerment
• Staff Anchoring
• Specialized Unit Control
• Symptom to Diagnosis
• General Hospitals
• Physicians Drive 1 Care
• LifeStyle
• “Cardiology”
• Separate Trainining o Cardiac Surg & Cardiology
• Silo Protection
• Cross Training
• Shared Dz Rx Centers
• Genetic Propensity Scores
• Specialization or Extinction
• Caregivers Become Primary
• STEMI Call
• Integrated Training Pro o Structural, Vascular, EP, CI, PVI,
Endograft, Imaging
• DX Centered Training: o Combined Programs
• Silo Dissolution
• Federal Incentives for IT Adoption
• A Growing Demand for Data
• Increased Pressure to Monitor Margins
• Need to Prepare for New Payment Models
– Access to Comprehensive CV Data
– Improved Service Line Performance
– Prepare for Next Generation Payments
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• Disruption of Typical Care: Geographic, Economic, Practice
• New tech will have a huge impact for our pts
• Actually, Very Exciting and Dynamic Times
• Upcoming Modalities – DES that is temporary
– HTN Rx that avoids medicines and side effects
– Invasive Non-Invasive Modalities
– TAVR
Think differently No One owns the field –
• but we all own responsibility for optimum care
Thank You