Transcatheter Aortic Valve Replacement

TAVRPaul Gordon, MD

Associate Prof of Medicine, Brown UniversityDirector, Cardiac Catheterization Laboratory

The Miriam Hospital

Disclosures: none

Symptomatic Aortic Stenosis is Rapidly Symptomatic Aortic Stenosis is Rapidly Progressive and Life ThreateningProgressive and Life Threatening

0

20

40

60

80

100

40 50 60 70 80Age (years)Age (years)

Sur

viva

l (pe

rcen

t)S

urvi

val (

perc

ent) Increasing obstruction,Increasing obstruction,

myocardial overloadmyocardial overload

Average Age DeathAverage Age Death

Latent PeriodLatent Period

SymptomsSymptoms

4040 5050 6060 7070 8080

from Ross and Braunwald,from Ross and Braunwald, Circulation Circulation 1968;38:V1968;38:V--6161

100100

8080

6060

4040

2020

00

•• Survival after onset of symptoms is 50% at 2 years and 20% at 5 Survival after onset of symptoms is 50% at 2 years and 20% at 5 yearsyears•• Surgical intervention for severe aortic stenosis should be perfoSurgical intervention for severe aortic stenosis should be performed rmed

promptly once even minor symptoms occurpromptly once even minor symptoms occur

Years

Patient Survival3

Aortic Valve Replacement Greatly Improves Survival

Prompt AVR Is Indicated in Almost All Severe Symptomatic AS Patients

2008 ACC/AHA Guidelines state:

In the absence of serious comorbid 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

Treatment for Aortic Stenosis• Only treatment for aortic stenosis that improves

survival is aortic valve replacement• Risk of surgical AVR is low even in the very elderly• However, there remain patients who are not

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

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

Percutaneous Transcatheter Aortic Valve ReplacementPercutaneous Transcatheter Aortic Valve Replacement

TAVR

Medical Medical Management Management

ControlControl

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

NonNon--inferiorityinferiority

2 Trials2 TrialsIndividually PoweredIndividually Powered

(Cohorts A & B)(Cohorts A & B)

PARTNER Trial DesignFully enrolled: published 2 year outcomes for both cohorts

Symptomatic Severe Aortic StenosisSymptomatic Severe Aortic Stenosis

AssessmentAssessmentHigh Risk High Risk

AVR CandidateAVR CandidateYesYes NoNo

Cohort ACohort A Cohort BCohort B

AssessmentAssessmentTransfemoral AccessTransfemoral Access

AssessmentAssessmentTransfemoral AccessTransfemoral Access

Not in StudyNot in Study

vsvsTransTrans

FemoralFemoral

Cohort A TFCohort A TF

AVRAVRControlControl vsvs

TransTransApicalApical

AVRAVRControlControl vsvs

TransTransFemoralFemoral

1:1 Randomization1:1 Randomization

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

SuperioritySuperiority

YesYesYesYes NoNo

Cohort A TACohort A TA

1:1 Randomization1:1 Randomization

NoNo

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

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

Total = 1,052 ptsTotal = 1,052 pts

Cohort B: inoperable patients with combined morbidity/mortality risk > 50%Transfemoral TAVR access onlyBAV with standard medical therapy in nearly 80% of control patients

Absolute Reduction in Mortality Absolute Reduction in Mortality Continues to Diverge at 2 YearsContinues to Diverge at 2 Years

> 30% Absolute Reduction in > 30% Absolute Reduction in Cardiovascular MortalityCardiovascular Mortality

> 35% Reduction in Repeat > 35% Reduction in Repeat HospitalizationHospitalization

Higher Incidence of StrokeHigher Incidence of Stroke

Mortality or StrokeMortality or Stroke

Higher Incidence of Major Vascular Higher Incidence of Major Vascular ComplicationsComplications

TAVR - Current StatusOver 40,000 implants outside of US over last

5 yearsSuccess rates >95% in absence of MACEFDA approval in November 2011:

inoperable patients with severe AS2 cardiac surgeons

transfemoral access onlyNearly 3000 commercial cases in US since

approvalIntense resource utilizationSuccess of program dependent on team

approach

Multidisciplinary in all aspects:• Patient selection

– TTE/TEE– CT angiography

• Procedure planning• Patient treatment• Post-operative care

Patient-Focused Multidisciplinary Heart Team Approach

Only ~1 in 5 patients refered for TAVR are candidates

•Some are surgical candidates for AVR•Inadequate iliofemoral access (aortic valvuloplasty)

•Large 22 and 24F sheaths require >7-8 mm arteries

•“futility”

Hybrid OR

patient

A

I

I

CS

EValveprep

perfusionist P

SN

V

CL

CL

CL

IABP

RT

C

coordinator

X-ray

Current Investigational Technology

Sapien XT + NovaFlex Delivery SystemCore valve

18F

Transapical TAVER

(PARTNERS II Trial)

COHORT A

Predicted operative mortality ≥ 15% (STS mortality ≥ 10%)

Summary• In patients with symptomatic aortic stenosis:

– Surgical AVR is the prefered treatment– TAVR is an alternative option in inoperable

patients who have adequate iliofemoral access• Coming 4th quarter 2012

– Transapical TAVR will be an option for high/extreme risk surgical patients or inoperable patients where femoral access is not possible

– Transfemoral TAVR will be an alternative option for select extreme/high risk surgical patients who have adequate femoral access