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