Aortic Aortic StenosisStenosis -- 20112011
Steven F. Bolling, M.D.Steven F. Bolling, M.D.Professor of Cardiac SurgeryProfessor of Cardiac Surgery
University of MichiganUniversity of Michigan
Aortic SurgeryAortic Surgery
Aortic Stenosis
EB CT EB CT -- Ca++ everywhere !Ca++ everywhere !
100,000 USA + 100,000 OUS
High-risk patients ≈ 25%
“Non operable candidates” ≈ 30%
Surgery for Aortic Stenosis
Buckberg et al. Congestive heart failure: Treat the disease, not the symptom—Return to normalcy J. Thorac. Cardiovasc. Surg. 2001;121: 628-637.
Risk of Late Death following myocardial infarction
Survival vs. ESVI
Geometry of Heart FailureGeometry of Heart Failure
LVLV dilation in ASdilation in AS is progressive is progressive
Risk of death = Risk of death = LV size & volume :LV size & volume :
-- predicts mortality predicts mortality > LVEF> LVEF
Geometry of Heart FailureGeometry of Heart Failure
Surgery for Heart Failure – AS
Patients “followed to death”Severe LV dysfunctionLow transvalvular gradient
role of Dobutamine echo ?
YearsYears
Surv
ival
(%)
Surv
ival
(%)
41%41%±±9%9%
56%56%±±5%5%
70%70%±±3%3%
45%45%±±3%3%
34%34%±±6%6%
P<0.0001P<0.0001100
80
60
40
Low EF <35Low EF <35%%MedEF 35%MedEF 35%--50%50%Nl EF Nl EF ≥≥50%50%
20
0
2121±±9%9%
4141±±5%5%
5656±±4%4%
0 2 4 6 8 10 12 14 16 18 20
AVR with low EFSurvival
ChalikiChaliki et al: Circ 2002et al: Circ 2002
157 patients (68 AVR; 89 med)
AVA < 0.75 cm2
LVEF < 35%
Mean AV gradient < 30 mmHg
Surgery for Heart Failure – AS
Pereira JJ et. al. Survival after aortic valve replacement for severe aortic stenosis with low transvalvular gradients and severe left ventricular dysfunction. JACC2002;39:1356-1363.
Pereira JJ et. al. Survival after aortic valve replacement for severe aortic stenosis with low transvalvular gradients and severe left ventricular dysfunction. JACC2002;39:1356-1363.
Surgery for Heart Failure – ASAll Patients Propensity-matched Patients
Group I (respond) Group II (non) (n=32) n=24
Δ LVEF .12 (.07-.13) .03 (.02-.05)Δ CI% 49 (42-74) 24 (18-37)Δ AVA% 17 (8-29) 5 (-3 – 8)Δ MPG% 38 (31-45) 20 (14-30)
Monin et al. Aortic stenosis with severe left ventricular dysfunction and low transvalvular pressure gradients: Risk stratification by low-dose dobutamine echocardiography JACC 2001;37:2101-2107
Surgery for Heart Failure – ASDobutamine echo
Monin et al. Aortic stenosis with severe left ventricular dysfunction and low transvalvularpressure gradients: Risk stratification by low-dose dobutamine echocardiography JACC2001;37:2101-2107
Surgery for Heart Failure – AS
70
60
50
40
30
20
0Pre-op Post-op Pre-op Post-op
LoEF(EF <35%)
Nl EF(EF ≥50%)
P<0.06
10
29±6%
35±14%
58±7% 56±10%EF
%Ejection Fraction
LV systolic and diastolic dimensionsalso get better….geometry is improved !
AVR and Low EF
Acceptable mortality and morbidity
Long-term survival without CHF
Improvement in EF
Never “too late” in AS ?
Valve problem makes heart bad !
AVR : 2011
Ross Prima or Freestyle
Ross procedure…sorry – NO!
State of the Art State of the Art -- 19791979
What you want to drive What you want to drive –– 2011 !2011 !
Current Valves
• Tissue valves : better– Improved hemodynamics– Improved durability
• Proven 20 years of data• Addition of anti-Ca
– Improved ease of implant
1997 2001 2005 20100%
20%
40%
60%
80%
100%
Perc
ent o
f Tot
al V
alve
s Tissue
Mechanical
U.S.
0%
20%
40%
60%
80%
100%
Tissue
Mechanical
Perc
ent o
f Tot
al V
alve
s
Rest of World
1997 2001 2005 20101997 2001 2005 20100%
20%
40%
60%
80%
100%
Perc
ent o
f Tot
al V
alve
s Tissue
Mechanical
U.S.
1997 2001 2005 20100%
20%
40%
60%
80%
100%
Perc
ent o
f Tot
al V
alve
s Tissue
Mechanical
U.S.
0%
20%
40%
60%
80%
100%
Tissue
Mechanical
Perc
ent o
f Tot
al V
alve
s
Rest of World
1997 2001 2005 20100%
20%
40%
60%
80%
100%
Tissue
Mechanical
Perc
ent o
f Tot
al V
alve
s
Rest of World
1997 2001 2005 2010
Shift in Valve Prostheses :Mechanical Tissue
Critical AS : 40 Critical AS : 40 -- 60 %60 %““UnderoperatedUnderoperated””
Other approaches :Other approaches :Far end of bell curveFar end of bell curveincreased catchmentincreased catchment
Aortic Surgery and CHFAortic Surgery and CHF
Minimally Invasive Surgical Approaches
Circ 2006;114:591Circ 2006;114:591--596.596.
••High risk surgical High risk surgical candidates without candidates without adequate femoral accessadequate femoral access
••Trans ApicalTrans Apical••Beating Heart SurgeryBeating Heart Surgery
AorticAortic SutureSuture--lessless‘‘Drop inDrop in’’ ValvesValves
Percutaneous Valves
Fantastic advance … Entire future - ?? !
TAVI for Aortic Stenosis
50% patient adoption by 2014…
TAVI B - “inoperable”
TAVR
Control
Difference in In-Trial Life Expectancy= 0.49 years
Based on data available as of 28SEP2010
Projected Survival
Life Expectancy (undiscounted)
TAVR: 3.11 yearsControl: 1.23 yearsDifference: 1.88 years
TAVI A “HIGH RISK”
699 ptsSTS 12%
.
TAVI A “High Risk”for Aortic Stenosis
.
TAVI for Aortic Stenosis# 2 reason won’t :
FDA
.
Longevity? - Crush loaded !
5000 implants pAVR - K-M (12-Mo))Survival Distribution Function
0.00
0.25
0.50
0.75
1.00
Time to death until 360 jours after procedure (Days)
0 50 100 150 200 250 300 350 400
Legend: Product-Limit Estimate CurveCensored Observations
One-Year Total All Mortality Rate = 28.4%
Time to death until 360 days after procedure
Post-procedure Days
YearsYears
Surv
ival
(%)
Surv
ival
(%)
41%41%±±9%9%
56%56%±±5%5%
70%70%±±3%3%
45%45%±±3%3%
34%34%±±6%6%
P<0.0001P<0.0001100
80
60
40
Low EF <35Low EF <35%%MedEF 35%MedEF 35%--50%50%Nl EF Nl EF ≥≥50%50%
20
0
2121±±9%9%
4141±±5%5%
5656±±4%4%
0 2 4 6 8 10 12 14 16 18 20
AVR for all EF30 % mortality low EF @ 5-10 years !!
ChalikiChaliki et al: Circ 2002et al: Circ 2002
TAVI for Aortic Stenosis# 1 reason won’t :
$$$$
.
$50,000 per LY$50,000 per LY
ΔCost = $79,837 Δ LE = 1.59 years
ICER = $50,212/LYG
ΔCost = $79,837 Δ LE = 1.59 years
ICER = $50,212/LYG
$100,000 per LY$100,000 per LY
Cost-Effectiveness of TAVR
$$$ AnalysesIncremental
Costs (TAVR – Control)
Incremental Life Years
(TAVR – Control)
ICER($/LY)
Base Case $79,837 1.59 50,212
QALYs $79,837 1.29 61,889*
QALYs assuming no QOL improvement $79,837 0.96 83,163*
Exclude non-CV costs $53,837 1.59 33,860
Study device = $20,000 $69,390 1.59 43,642
Study device = $40,000 $90,284 1.59 56,782
Exclude BAV costs $82,623 1.59 51,964
* $/QALY
Find ASFind ASFix AS!Fix AS!
……any way you can!any way you can!
Aortic Surgery 2011Aortic Surgery 2011
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