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Transcatheter Aortic ValveReplacement (TAVR)

Providence Heart and Vascular InstituteEric Kirker MD FACS, ABTSProvidence Valve CenterCo-Surgical DirectorOctober 20, 2012

Seldinger Technique

• Dr. Sven-Ivar Seldinger (1921-1998)• Swedish Radiologist• Introduced Technique in 1953

Structural Heart Therapy

• Surgery Based Techniques– Live real time direct visualization– Hands-on corrective therapy

• Imaging Based Techniques– Live real time indirect visualization– Tool based corrective therapy

• Hybrid Suite Concept• “Hybrid” Physician-surgical and interventional skills• Multidisciplinary TEAM

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Structural Heart HistoryBalloons, Stents, Valves• Vascular Disease

– PTA, thrombolysis, stents, embolization– Coronary Stents– Aortic Stent Grafts– Carotid Stents

• Congenital Heart Disease– Transseptal Left Heart– Balloon Atrial Septostomy– Coarctation of Aorta– Pulmonary Artery Stenosis– ASD, VSD

Structural Heart HistoryBalloons, Stents, Valves• Valvular Disease

– Valvuloplasty, BAV, MVP, PVP– Pulmonic Valve

• Medtronic Melody® (2010)– Aortic Valve

• Edwards SAPIEN®, RetroFlex3™ (2011)• Edwards SAPIEN XT®

• Medtronic CoreValve®

• St. Jude Medical Portico™

– Mitral Valve• Abbott MitraClip® System

Multiple Technologies• Edwards Sapien

– Commercial– Inoperable patients– Femoral only (for now)

• Edwards Sapien XT– Lower profile– In context of Partner II study

• Apical, transaortic, valve-in-valve

• E-Valve– Percutaneous mitral clip for

severe MR– Coapt Mitraclip study

• Medtronic Corevalve– Investigational – available at

Providence Sacred Heart,Spokane, WA

– Self-expanding– Providence Valve Center

has referred 4 patients

Available at Providence Valve Center

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7

Prevalence of Aortic Stenosis16.5 Million People in US

Over the Age of 652

7%PercentageDiagnosed withAortic Stenosis

Aortic stenosis is estimatedto be prevalent in up to 7%of the population over theage of 651

It is more likely to affectmen than women; 80% ofadults with symptomaticaortic stenosis are male3

Aortic Stenosis

Aortic Stenosis

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Aortic Stenosis Subtypes

• Congenital - before 6th decade– Bicuspid (1-2%), associated coarctation– Unicuspid (0.02%), infants, rarely adults

• Rheumatic - always associated with MV disease– Inflammatory– Commissure fusion

• Calcific, Senile - after 6th decade– No Fusion– Calcification– Atherosclerotic

Aortic StenosisSymptom Triad

• Angina• Dyspnea• Syncope

– All associated with exertion

Aortic StenosisPhysical Findings

• Murmur - crescendo, decrescendo• Upper sternal border• Radiates to carotids• Delayed carotid pulse• Diminished A2• S4

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Aortic StenosisPhysiology/Compensatory Mechanisms

• Pressure overload• Compensatory hypertrophy• Diminished coronary blood flow reserve• Increased LV diastolic pressure• Increased pulmonary pressure• Subendocardial ischemia• LV enlargement and systolic failure

1S.J. Lester et al., “The Natural History and Rate of Progression of Aortic Stenosis,” Chest 1998.2C.M. Otto, “Valve Disease: Timing of Aortic Valve Surgery,” Heart 200 Chart: Ross J Jr, Braunwald E. AorticStenosis. Circulation. 1968;38(Suppl 1):61-7.

Aortic Stenosis isLifeThreatening

Survival after onset ofsymptoms is50% at two yearsand 20% at five years1

“Surgical intervention [forsevere AS] should beperformed promptly onceeven…minor symptomsoccur”2

Valve Gradient

Gradient (mmHg) Area (cm2) CO (L/min)

2 3.0 5.0

11 2.5 5.0

16 1.25 5.0

25 1.0 5.0

45 0.75 5.0

70 0.6 5.0

100 0.5 5.0

20Yrs

5 Yrs

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• Studies show at least 40% of SAS patients are not treated with an AVR9-15

Addressing a Serious Unmet Need

0102030405060708090

100

0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15

Sur

viva

l, %

AVR, no Sx

AVR, Sx

No AVR, no Sx

No AVR, Sx

Aortic Valve ReplacementGreatly Improves Survival

Years

5 year survival of breast cancer, lung cancer, prostate cancer, ovariancancer and severe inoperable aortic stenosis

Sobering Perspective

5-Year Survival8

Surv

ival,

%

BreastCancer

LungCancer

ColorectalCancer

ProstateCancer

OvarianCancer

SevereInoperable AS*

*Using constant hazard ratio. Data on file, Edwards Lifesciences LLC. Analysis courtesy of Murat Tuczu, MD, Cleveland Clinic

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ASE GuidelinesECHO is Gold Standard

Providence Valve Center June 1,2011

• Options for Aortic Stenosis Patients• Transcatheter Valve Technology• Required Multidisciplinary Evaluation• Continued Growth of PHVI• Research Potential• Stature in Valve Disease Therapies• Other Valve Therapies

Transcatheter Aortic ValveImplantation/Replacement(TAVI/TAVR)

• First available in 2002 (Alain Cribier)• Rapid growth throughout the world for thetreatment of severe AS in patients who areat high surgical risk (~ 40,000)• “Additional” ~ 25% of cases in Germany• 2007-2009 Placement of AoRTicTraNscathetER Valve Trial (PARTNER TRIAL)

• November 2, 2011 FDA approval ofEdwards SAPIEN® with theRetroFlex3™(21-24Fr) for commercialrelease

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PARTNER Study Sites

IntermountainMedical CenterSalt Lake City, UT

EmoryUniversityAtlanta, GA

Univ. of MiamiMiami, FL

Univ. of VirginiaCharlottesville, VA

St. Luke’s HospitalKansas City, MO

Barnes-Jewish HospitalSt. Louis, MO

MedicalCity Dallas

Dallas, TX

St. Paul's HospitalVancouver, Canada

Univ. of WashingtonSeattle, WA

Mayo ClinicRochester, MN

StanfordUniversityPalo Alto, CA

Hospital LavalQuebec City,

Canada

Ochsner FoundationNew Orleans, LA

Scripps ClinicLa Jolla, CA

Cedars-SinaiMedical CenterLos Angeles, CA

Cleveland ClinicCleveland, OH

Columbia UniversityCornell UniversityNew York, NY

WashingtonHosp. CenterWash., DC

Univ. of PennPhila., PA

Brigham & Women’sMass GeneralBoston, MA

Northwestern Univ.Chicago, IL

Toronto Gen.Hospital

Toronto, Canada

Evanston Hospital

Leipzig Heart CenterLeipzig, Germany

n = 1,057 patients26 investigator sites22 USA, 3 Canada, 1 Germany

PHVI

TAVR Program Overview

• First TAVR in Oregon– February 1st, 2012

• First Oregon PARTNER II TAVR-TF– April 5th, 2012

• First Oregon PARTNER II TAVR-TA– August 21st, 2012

• Excellent multidisciplinary collaborationof multiple physicians, staff (eg. Echo,peripheralist, anesthesia, etc)

Patient Screening Physician Partnership Procedural Training

High Quality Imaging

Providence Valve CenterAn Integrated Approach

Multidisciplinary Treatment

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Providence Valve CenterMultidisciplinary Team• Interventional Cardiology

– Caulfield, Hodson, Korngold• Cardiac Imaging

– Walsh, Rahimtoola, Wilson– Zinck, Warfel

• Cardiac Surgery– Swanson, Kirker

• CV Anesthesia– Kelly

• Nurse Coordinator– Marla Craft

• Administrative Assistant– Kristina Wilson

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Providence Valve CenterExperience To Date September 2012

• TAVR -20 (23 through October)– Commercial - 7– PARTNER II - 13

• TF - 9• TA - 4

• SAVR - 42– PARTNER II - 6– PH&S - 36

• Referred to CoreValve in Spokane: 4– Treated - 1

• Referred to other centers: 3 (IMHC, Swedish)*As of July 2012

Data Source: PATS STS Adult Cardiac Surgery Registry ,S.Fine, RHVDS 7-2-12

PVC Opens

Symptomatic Severe Aortic StenosisSymptomatic Severe Aortic Stenosis

ASSESSMENT: High Risk AVR Candidate3105 Total Patients Screened

ASSESSMENT: High Risk AVR Candidate3105 Total Patients Screened

PARTNER Study Design

High Risk TAHigh Risk TA

ASSESSMENT:Transfemoral Access

ASSESSMENT:Transfemoral Access

TAVITrans

femoral

TAVITrans

femoral

SurgicalAVR

SurgicalAVR

High Risk TFHigh Risk TF

Primary Endpoint: All Cause Mortality (1 yr)(Non-inferiority)

Primary Endpoint: All Cause Mortality (1 yr)(Non-inferiority)

TAVITransapical

TAVITransapical

SurgicalAVR

SurgicalAVR

1:1 Randomization1:1 Randomization1:1 Randomization1:1 Randomization

VSVS

StandardTherapy

(usually BAV)

StandardTherapy

(usually BAV)

ASSESSMENT:Transfemoral Access

ASSESSMENT:Transfemoral Access

Not In StudyNot In Study

TAVITrans

femoral

TAVITrans

femoral

Primary Endpoint: All Cause Mortality overlength of trial (Superiority)

Primary Endpoint: All Cause Mortality overlength of trial (Superiority)

1:1 Randomization1:1 Randomization

VS

Total = 1058 patientsTotal = 1058 patients2 Parallel Trials:

Individually Powered2 Parallel Trials:

Individually PoweredHigh RiskHigh Riskn= 700n= 700 InoperableInoperable n=358n=358

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GENERAL CLINICALINDICATIONS FOR TAVR

• Age > 75• Severe and symptomatic aortic stenosis• Moderate to high surgical risk

– PARTNER I and Commerical, STS >10%– PARTNER II, STS >4%

• Exceptions– Porcelain Aorta– Hostile Chest– Severe Pulmonary Disease– Midline LIMA/RIMA– Frailty– Severe Pulmonary Hypertension– Dementia– Cirrhosis– Severe Cerebral Vascular Disease

PARTNER Patient Population

• Severe symptomatic aortic stenosis• AVA of < 0.8 cm2

AND• Either mean AV gradient of > 40 mm Hg• Or peak aortic-jet velocity of > 4.0 m/sec

• All the patients had NYHA class II, III, or IVsymptoms

Cohort B

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Cohort B Down Side at 1 yearTAVI vs Control

• All Stroke/TIA 10.6 vs 4.5%

• Vascular Complications– All 32.4 vs 7.3%– Major 16.8 vs 2.2%– Major bleeding 22.3 vs 11.2%

Cohort A

Published CostEffectiveness Estimates

$0

$50

$100

$150

$200

$250

$300

aspirin MIprevention

rosuvastatinhigh-CRP

ICD primprev

CRT-D v.medical Rx

dabigatranAF

PARTNERCohort B

AF ablationvs. AAD

dialysis PCI stableCAD

LVADdestination

Rx

Dolla

rs p

er L

ife Y

ear o

rQAL

Y ($

thou

sand

s)

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Case Study• 83 yo female rancher, Eastern OR• Persistent AF (on dibagitran)• CRI, eGFR 56 ml/min, Cr 0.95• Moderate to severe TR• Referred to CV surgeon by PCP

for surgery eval for severe AS

GENERALNON-INDICATIONS FOR TAVR

• Age < 70• Refusal of surgery• Life expectancy < 1 yr

CLINICAL DECISION PROCESS

• Confirm Severe AS• Symptomatic• Risk Assessment• Technical feasibility

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TAVR WORK UP• Calculate risk scores• Frailty Assessment• TTE or TEE

– TEE routine part of procedure• CTA chest, abdomen, pelvis - “TAVR protocol”

– Gated– Beta-blockade issues– Contrast issues

• Coronary angio, right heart cath• PFTs, pulmonary consult• Carotid US

PVC- FacilitatedTAVR Work-up

COMMENTS•If any “NO” then considerMultidisciplinary Consult (MC)first.•If patient is likely SAVR, considerRHC/Cor first then MC beforeCTA or refer to surgeon.•If patient likely TAVR or P2, doRHC/Cor and CTA before MC.•All have an accurate STS.•All have a MC.•All are reviewed atMultidisciplinary Conference.•9/5/2012

Clinical Exam?NYHA II-IV?

Qualifying Echoor DSE?

STS>4%?

All Yes

DictateCompleteConsult

Order work up

MultidisciplinaryConsult

CTA

RHC/CorMultidisciplinaryConference

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RN Clinic Assessment

• Frailty Assessment– 15 foot timed walk

test– Grip Strength– ADL score– Albumin

• Mental Function– MMSE: mini mental

status exam

• Patient and Familymotivation andexpectations

• Quality of Life

• Social Support

• Decision MakingSupport

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ç

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LVOT 2.01 cmAnnulus 2.22 cm

Potential Recommendations:Routine Valve Surgical ValveReplacement• Aortic• Mitral, tricuspid

Percutaneous Valve Replacement• Edwards Sapien (Aortic)• Evalve Mitraclip (Mitral)

Continued Medical Therapy• Consider balloon valvuloplasty• Consider Connections consult• Continued Observation

CM 1/27/17

CATH

3/12/12

RA 10PA 44/19/31PCWP 16CO/CI3.17/1.71 (TD)2.62/1.41 (est Fick)

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CM 1/27/17

STJ 28.8Sinus 32.5Annulus 22.1

LCA height 15.5LC cusp 13.3

CM 1/27/17

11.12 x 13.82

CM 1/27/17

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RCF

REI

RCI

6.85 x 8.76 7.08 x 7.66 7.48 x 11.84

LEILCFLCI

6.31 x 8.20 6.46 x 6.96 6.35 x 9.13

Attention to detailTIMEOUTS 1,2,3

• JCAHO Timeout?• System rebooted?• Defibrillator• Conversion checklist• CPB plan

– Commercial: pt wishes (y/n)– Femoral vs. chest

• Valvuloplasty balloon• Pacer capture

• Particular concerns– Renal failure– CAD– Echo findings– Arrhythmia– Peripheral access

• If transfemoral:– Sheath sewn in?– Aortic occlusion balloon

• Valve prepped/checked• Valve positioning plan

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Trans-apical Approach

Post Operative Care

• #1 ….this is an AVR!• Potential Complications

– Vascular Access complications– Stroke– AV block– Acute MI– Acute Renal failure

TAVR patient withaortic stenosis

Incontinence

Osteoarthritis+/- joint replacement

Balance problems/immobility

Polypharmacy

Chronicbenzodiazepine

use

Alcohol dependence

Malnutrition

Renal insufficiency

Deconditioning

Depression

Constipation

Living alone

Inappropriatehousing

Lack of socialsupport

Courtesy C. Galte NP(F), MSNSt. Paul’s Hospital

Cognitive decline/dementia

CVA, PVD, CHF, COPD

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What I tell my patients

• Without surgery or TAVR ~50% mortality in 1-3 years• Calculate and discuss STS score• TAVI risks vary

– 5-10% risk of dying in first 30 days– 20-30% risk of dying in one year– Most deaths after 30 days are non-cardiac

• ~30% are pulmonary deaths– 10% risk of stroke in non-operable group– Stroke risk may be lower with surgery in high risk operable

group (5.5% TAVI vs 2.4% AVR)– 20-30% major vascular/bleeding complications

• We don’t know how long these valves will last– 5 year experience looks good

valvecenter@providence.org

THANK YOU