update on the treatment of aortic stenosis – focus on tavr stenosis-sharaf.pdfupdate on the...

Update on the Treatment ofAortic Stenosis – Focus on TAVR

RIACC Primary Care SymposiumOctober 2nd, 2013

Barry Sharaf, M.D.Interim Director – RIH Cardiac Catheterization Laboratory

Associate Professor – Brown University School of Medicine

Disclosures

• I have no financial interests to disclose• If I did I probably would not have to be here

speaking to you

Treatment of Aortic Stenosis

• Natural history and Surgical treatment of aortic stenosis

• Risk Assessment – Characteristics of the high-surgical risk and inoperable patient

• PARTNER Trial• Screening for TAVR• Transcatheter Heart valve – Device Description• Outline of the TAVR Procedure• LS CVI TAVR Program Results• Present the case both for and against de-funding

Obamacare

Aortic Stenosis

Gross specimen of minimally diseased aortic valve (left) and severely stenotic aortic valve (right)

Images courtesy of Renu Virmani MD at the CVPath Institute

Survival after onset of symptoms is 50% at 2 years and 20% at 5 years

Aortic Stenosis Is Life Threatening and Progresses Rapidly Once Symptoms Develop

Study data demonstrate that early and late outcomes were similarly good in both symptomatic and asymptomatic patients

Aortic Valve Replacement is Tried and Trueand Greatly Improves Survival

Patient Survival AVR, No Symptoms

AVR, Symptoms

No AVR, No Symptoms

No AVR, Symptoms

Years

Results of AVR at RIH2000-2010

Total Number of Pts

1.2%

2%

480 pts

720 pts

2%3%

7%

5%

738 pts

Age

in Y

ears

• Multiple studies show at least 40% of SAS patients are not treated with an AVR

Many Patients With Severe Aortic StenosisRemain Under-treated

Prompt AVR Is Indicated in Almost All Severe Symptomatic AS Patients

• 2008 ACC/AHA Guidelines state:• In the absence of serious co-morbid conditions, aortic valve replacement (AVR) is indicated in virtually all symptomatic patients with severe AS

• Because of the risk of sudden death, AVR should be performed promptly after the onset of symptoms

• Age is not a contraindication for surgery





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Treatment for Aortic Stenosis

• However, there remain patients who are not good candidates for AVR:– Hostile chest (radiation, chest wall deformities)– Prior median sternotomies– Porcelain aorta– Co-morbidities such as severe lung and/or liver disease– Extreme surgical risk (STS predicted mortality/combined M&M)

– Dementia– Frailty

Risk Assessment – “Porcelain Aorta”

Risk AssessmentPulmonary Disease

• No absolute cutoffs but general guidelines include– FEV1 < 1.0 L (< 40% predicted)– DLCO < 30% (20%-40%)– Hypoxia/hypercarbia at rest (room air ABG)– Oxygen dependence– Severe pulmonary fibrosis with reduced DLCO

Risk AssessmentNeurologic Dysfunction

• Dementia– Difficult to grade but there are scales that are used – Clinical

Dementia Rating (CDR) scale– Who is too sick?

• Moderate dementia – TAVR• Severe dementia – medical therapy• Mild dementia – surgical AVR

15

Risk AssessmentFrailty

• Subjective assessment• Continuum from inoperable to futile (too sick

to consider treatment)• How can we determine if a patient is frail?

– “Eyeball” test– Gait speed (> 7 seconds)– Grip strength (< 18 kg)– Albumin level (< 3.5 mg/dl)– Katz ADLs (4/6 or less)

Risk AssessmentFrailtyPatient A Patient B

Same age and predicted risk (STS score)One passes the “eyeball” test – one does not

Mortality With Standard Therapy Is Worse Than With Certain Metastatic Cancers

* National Institutes of Health. National Cancer Institute. Surveillance Epidemiology and End Results. Cancer Stat Fact Sheets. http://seer.cancer.gov/statfacts/. Accessed November 16, 2010. † Using constant hazard ratio. Data on file, Edwards Lifesciences LLC. Analysis courtesy of Murat Tuczu.

Sur

viva

l, %

23

4

12

30 28

3 0

5

10

15

20

25

30

35

5-Year Survival

BreastCancer*

LungCancer*

ColorectalCancer*

ProstateCancer*

OvarianCancer*

SevereInoperable AS†





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Webb et al. Webb et al. CirculationCirculation 2006;113:8422006;113:842--850850

What is TAVR?What is TAVR?PercutaneousPercutaneous TTranscatheterranscatheter AAortic ortic VValve alve RReplacementeplacement

TAVR

Medical Medical ManagementManagement

PRIMARY ENDPOINTPRIMARY ENDPOINTAllAll--cause mortality (1 yr)cause mortality (1 yr)

NonNon--inferiorityinferiority

PARTNER Trial DesignSymptomatic Severe Aortic Symptomatic Severe Aortic StenosisStenosis

AssessmentAssessmentHigh Risk High Risk

AVR CandidateAVR CandidateYesYes NoNo

Cohort ACohort A Cohort BCohort BAssessmentAssessment

TransfemoralTransfemoral AccessAccessAssessmentAssessment

TransfemoralTransfemoral AccessAccess

Not in StudyNot in Study

vsvsTransTrans

FemoralFemoralTAVRTAVR

AVRAVRvsvs

TransTransApicalApicalTAVRTAVR

AVRAVR vsvsTransTrans

FemoralFemoralTAVRTAVR

PRIMARY ENDPOINTPRIMARY ENDPOINTAllAll--cause mortality (1 yr)cause mortality (1 yr)

SuperioritySuperiority

YesYesYesYes NoNo NoNo

N=491N=491 N=203N=203

N=694N=694 N=358N=358

Total = 1,052 ptsTotal = 1,052 pts

Cohort B Cohort B –– InoperableInoperableAbsolute Reduction in Mortality Continues to Diverge at 2 YearsAbsolute Reduction in Mortality Continues to Diverge at 2 Years

Cohort B Cohort B –– InoperableInoperableHigher Incidence of StrokeHigher Incidence of Stroke

Cohort A Cohort A –– Operable But High RiskOperable But High Risk

TAVR – Current Indications• Initial Approval in 2011- Inoperable patients from a transfemoral

approach (Cohort B)• Last Winter - expanded access to Cohort A patients

– Transfemoral or Transapical access for patients identified as High-Risk for AVR

– Predicted STS mortality ≥ 8%– Surgical mortality ≥ 15% (2 surgeons)

• Just Last Week - high‐risk and inoperable patients with severe symptomatic aortic stenosiswithout limitations on the delivery approach





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Patient Screening Involves a Stepwise Approach

Confirm severe and symptomatic native aortic valve

stenosis

independent evaluation by

interventionalistand two cardiac

surgeons

Evaluate the aortic valvularcomplex using

echocardiography

Evaluate the peripheral

vasculature and aortic valvularcomplex using

MDCT*

Coronary angiography to rule out concomitant

severe CAD

44 553311 22

28

Eligibility Suitability

*

Imaging – Echocardiography

Gold StandardConfirm Severe Aortic Stenosis and Suitability for TAVR

29

CT Angiogram - Annulus Diameter and Area

• Assess

• Size

• Tortuosity

• Calcification

31

CT Angiography - Peripheral Vessels

•Surgical AVR – For patients who are

suitable for open-chest aortic valve replacement

•TAVR – For high-risk and

inoperable patients

•Medical Management and BAV– For patients not suitable for

invasive procedures– Bridge in decompensated

patients– Test for significance of

symptoms relative to AS

Devising a Treatment Plan –A Collaborative Process

Additional testing completed

Patient with severe aortic

stenosisidentified by

referring physician

Patient referred to

TAVR valve clinic

Multidisciplinary review & treatment decision by TAVR

Heart Team*

Treatment decision discussed with

referring physicianUltimate treatment

choice is a collaborative

decision between ALL physicians,

patient, and patient’s family

Ultimate treatment choice is a

collaborative decision between ALL physicians,

patient, and patient’s family

32

LS CVI TAVR Physician Team• Frank Sellke – Chief of Cardiothoracic Surgery, RIH-TMH

• Arun Singh – Cardiothoracic Surgery

• Afshin Ehsan – Cardiothoracic Surgery

• Paul Gordon – Director of TMH Cath Lab

• Barry Sharaf – Interim Director of RIH Cath Lab

• Athena Poppas – Director of RIH Echocardiography

• Phil Stockwell – Non-invasive Cardiology

• Andy Maslow – Director of Cardiac Anesthesia, RIH-TMH

• Herb Chen – Cardiac Anesthesia

• Manuel Garcia-Toca – Vascular Surgery

• Mike Atalay – Diagnostic Imaging, Director – Cardiac CT





Obamacare

35

Transcatheter Heart ValveBalloon Expandable Design

TAVR Procedure - BAV

Valve Deployment –Trans-femoral

Valve Deployment –Trans-apical

TEE Assessment - Para-valvular Leak





Obamacare

Lifespan CVI TAVR Program• Clinic ½ day / week

• Patients seen by Interventionalist and 2 Surgeons• Facilitate testing• > 200 patients screened since March, 2012

• Weekly meetings• Case presentations• Imaging Review• Administrative Issues

• LS CVI Administrative Support• Nick Dominick

• Cardiac Catheterization Laboratory Support• Kathy Lally, Lynn Soito, Joe Morgado, Tony Rodrigues

• Program Manager• Nancy Kelly - For Referrals - 444-3316

• Paula Ziobro – Administrative Assistant

Lifespan CVI TAVR Program - Results• N = 54• Mean age - 85 (range 68-98)

(collectively 4584 years of life)• 28 Males and 26 Females• 34 Trans-Femoral and 20 Trans-Apical

• Procedural success rate = 100%• No peri-procedural MI, emergency AVR or death• 1 peri-procedural embolic CVA

• N = 9 deaths (3 within 30 days) • In-hospital survival = 94%• 1 Year Survival = 75%

Treatment of Aortic Stenosis - Conclusions• Symptomatic patients with severe aortic stenosis have a very high

2-year mortality• Surgical aortic valve replacement is an effective and safe

procedure for most patients “Tried and True”• Transcatheter aortic valve replacement is an effective and safe

alternative for many of those patients who are inoperable or high risk for surgery

• Case selection with thorough screening is the key to achieving the best outcomes

• Technology is currently “1st Generation” with evolving refinements and indications

• TAVR Program is a huge commitment– Personnel and Resources– Time and $

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