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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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55

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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

57

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58

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