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