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Aortic Stenosis:

Interventional Choice for a 70-year old-

SAVR, TAVR or BAV?

Interventional Choice for a 90-year old-

SAVR, TAVR or BAV?

Samin K Sharma, MD, FACC, FSCAI

Director Clinical & Interventional Cardiology

Zena and Michael a Weiner Professor of Medicine

Mount Sinai Hospital, NY

Aortic Stenosis

Normal 3-4 cm2

AS: - mild >1.5 cm2

- moderate 1.0-1.5 cm2

- severe <1.0 cm2

- critical <0.7 cm2

Etiology: Congenital: unicuspid

bicuspid

tricuspid

Acquired: rheumatic

calcific

cholesterolemia

rheumatoid

Aortic valve area:

5% at 70 yrs

10% at 80 yrs

18% at 90 yrs

Ross J, Braunwald E. Circulation 1968; 38: 61-67.

Interventional Choices for AS:

SAVR TAVR BAV

Sapien

CoreValve

Summary of Recommendations for AS:

Choice of Surgical or Transcatheter Intervention

Nishimura et al., J Thorac Cardiovasc Surg 2014;148:e1

Summary of Recommendations for AS:

Choice of Surgical or Transcatheter Intervention

Nishimura et al., J Thorac Cardiovasc Surg 2014;148:e1

BAV may provide palliative symptomatic benefit in these pts

Symptomatic Severe Aortic Stenosis

ASSESSMENT: High Risk AVR Candidate

3105 Total Patients Screened

PARTNER US Trial: Study Design

High Risk TA

ASSESSMENT:

Transfemoral

Access

TAVR

Trans

Femoral

Surgical

AVR

High Risk TF

Primary Endpoint: All Cause Mortality (1 yr)

(Non-inferiority)

TAVI

Trans

Apical

Surgical

AVR

1:1 Randomization 1:1 Randomization

VS VS Standard

Therapy

(usually BAV)

ASSESSMENT:

Transfemoral

Access

Not In Study

TAVR

Trans

Femoral

Primary Endpoint: All Cause Mortality

over length of trial (Superiority)

1:1 Randomization

VS

Total = 1058 patients

2 Parallel Trials High-surgical risk Gp

STS >10% Cohort A n= 700 In-operable

Gp Cohort B n=358

Yes No

Leon et al, NEJM 2010;363:1597

PARTNER Trial Cohort B: Time-to-Event Analysis

of Key Endpoints During 2 Years Follow-up

Makkar et al., NEJM 2012;366:1696

Rate of Death From Any Cause Rate of Re-hospitalization

20%

5yrs

94%

71%

PARTNER Trial Cohort A: Time-to-Event

Curves for Primary Endpoints at 3-Yrs

Kodali et al., NEJM 2012;366:1686

Death from Any Cause,

Intention-to-Treat Population

Death from Any Cause,

As-Treated Population

CoreValve Pivotal Trials Study Design

CoreValve US Pivotal Trials

Extreme Risk (Inoperable; STS mortality/morbidity >50%)

High Risk

Incremental STS mortality >15%

Iliofemoral Access

for 18 Fr Sheath

CoreValve

Iliofemoral

CoreValve

Non-

Iliofemoral

Randomization 1:1

N=790

SAVR CoreValve

Versus Yes No

N=487 N=147 N=392 N=388

Presented in ACC 2014 Presented in TCT 2013

CoreValve Extreme Risk Study: Primary Endpoints

N= 487

Popma et al, TCT 2013; JACC May 2014

1 Year Mortality Major Stroke

CoreValve High Risk Pivotal trial: Primary

Endpoint-- 1 Year All-cause Mortality

19.1%

4.5%

Surgical (N= 357)

14.2%

P = 0.04 for superiority

3.3%

TAVR (N= 390)

0 1 2 3 4 5 6 7 8 9 10 11 12 Months Post-Procedure

All-c

au

se

Mo

rta

lity

(%

)

Adams et al., N Engl J Med 2014;370:1790

CoreValve High-risk Pivotal Trial: 1-Year

Results

%

SAVR (n=357)

TAVR (n=390)

p=0.10

p=0.59

p=<0.001

p=0.004

p=0.03

p=<0.001

Adams et al., N Engl J Med 2014;370:1790

p=<0.001

Any stroke Major stroke AKI PPM Vasc MACCE Life-threatening/

compl disabling bleeding

159 86 70 44 31 15

163 91 71 46 31 15

Mean

Gra

die

nt

(mm

Hg

) V

alv

e A

rea (c

m²)

N =

EOA

Mean Gradient Error bars = ± 1 Std Dev

PARTNER Trial: Aortic Mean Gradient & Valve Area

0.0

0.5

1.0

1.5

2.0

0

10

20

30

40

50

ME

AN

GR

AD

IEN

T

(mg

) A

VA

(cm

2)

46±18

11.8±5.7 10±4.5 0.62±0.17

1.67±0.41 1.40±0.25

Baseline Post TAVR 5 Year

Mean Gradient Aortic Valve Area

Makkar et al., NEJM 2012;366:1696

Partner Trial Cohort B: TAVR for Inoperable

Severe Aortic Stenosis; Impact of Co-morbidities

What about Intermediate risk AS patients;

(defined as STS mortality risk of 4 to 8-10%)

Two Trials: PARTNER IIA (completed)

SURTAVI Trial (ongoing)

Severe AS Indication for AVR

Separate randomization for AS+CAD

Heart Team Discussion

• Europe: STS mortality risk score > 3% and < 8%

• US: STS mortality risk score > 4 and < 10%

Suitable for

Randomization 1:1 Randomization Non-randomization

Registries

TAVI AVR Control TAVI AVR

Medical

Management Primary Endpoint:

All cause Mortality

and Stroke at 2 yrs

CoreValve US Pivotal SURTAVI Trial: Design

Endpoint: All-cause Mortality at 2 yrs

VS

N = 1100

Yes No

N = 220

N = 220

VS

N = 1760

The PARTNER II Trial Study Design

The patient has the following:

CARDIAC STATUS NYHA Class IV

RISK FACTORS AND COMORBIDITIES History of CVA, previous CABG x4, chronic persistent A-Fib, s/p PPM Chronic Lung Disease/ COPD: Moderate FEV1: 1500cc %predicted: 55 Other: Frail, history of multiple GI bleeds, hyponatremia PREVIOUS CARDIAC INTERVENTIONS: CABG x4 in 1991, PCI x3 in remote and BAV in July 2013

Patient History

Age (years): 90

Gender: M

Height (ins): 72

Weight (Ibs): 160

Creatinine (mg) /dL: 1.03 Creatinine clearance (cc/min) : 60 BNP (pg/mL): 717 Coronary Art Disease: 3 Patent grafts Aortic Calcification: Severe

Echo Images: Annulus Measurement

22 Aortic annular size (mm)

0.41 Aortic valve area (cm2)

0.211 Aortic valve area index (cm2/m2)

48 Mean gradient (mmHg)

4.4 Peak velocity (m/sec)

52 LVEF (%)

Echo Image

CT Images: Annulus Measurements

CT Image

Ao Annulus mean diameter: 28.0 mm

32.6 x 23.4 Major x Minor aortic annulus diam

89.2 Aortic Annulus perimeter (28.4 x 3.14)

32.8 Max ascending Aorta diameter

35.8 – 39.3 Sinus of Valsalva diameter

23.5 – 30.5 Sinus of Valsalva height

29.5 – 30.9 Sinotubular Junction width (STJ)

(all in mm)

CT 3D Reconstructions



RISK FACTORS AND COMORBIDITIES History of CVA, previous CABG x4, chronic persistent A-Fib, s/p PPM Chronic Lung Disease/ COPD: Moderate FEV1: 1500cc %predicted: 55 Other: Frail, history of multiple GI bleeds, hyponatremia PREVIOUS CARDIAC INTERVENTIONS: CABG x4 in 1991, PCI x3 in remote and BAV in July 2013

Patient History

Age (years): 90

Gender: M

Height (ins): 72

Weight (Ibs): 160

Risk Summary:

STS Score: 12% mortality

39% morbidity/mortality


Treatment of Choice in this 90 Yr old AS pt

?Re-BAV

?SAVR

?TAVR

TAVR because

- 12% STS risk score making him

high risk for conventional SAVR

• Pt underwent 31mm CoreValve via RFA

percutaneous approach (using 2 perclose

sutures) under conscious sedation.

460 NSTEMI patients

460 NSTEMI patients

20 not ramdomized


?Re-BAV

?SAVR

?TAVR

TAVR because

- 12% STS risk score making him

high risk for conventional SAVR

• Pt underwent 31mm CoreValve via RFA

percutaneous approach (using 2 perclose sutures)

under conscious sedation.

• No complications, out of CCU next day and

discharged on post TAVR day 5.



RISK FACTORS AND COMORBIDITIES History of CVA, previous CABG x4, chronic persistent A-Fib, s/p PPM

Chronic Lung Disease/ COPD: Severe FEV1: 500cc %predicted: 25 Other: Frail, history of multiple GI bleeds, hyponatremia PREVIOUS CARDIAC INTERVENTIONS: CABG x4 in 1991, PCI x3 in remote and BAV in July 2013

Patient History

Age (years): 90

Gender: M

Height (ins): 72

Weight (Ibs): 160

Risk Summary:

STS Score: 32% mortality

69% morbidity/mortality



?Re-BAV

?SAVR

?TAVR

Re-BAV because

- This pt with high comorbidity (FEV1 <500

cc) has extremely poor 1 year survival and

TAVR is unlikely to improve the long-term

survival

- BAV will provide palliative symptomatic

relief in these pts

The patient has the following: NYHA Class: III RISK FACTORS AND COMORBIDITIES previous CABG x4 in 2005, PAD Chronic Lung Disease/ COPD: Mild FEV1: 1900cc %predicted: 65 Other: No frailty PREVIOUS CARDIAC INTERVENTIONS PCI x2 last in 2/2013, recent cath showed patent all 3 grafts and patent PCI sites

Patient History Age (years): 71

Gender: M

Height (ins): 66

Weight (Ibs): 170

Creatinine (mg) /dL) 1.9 Creatinine clearance (cc/min) 30 BNP (pg/mL) 117 LVEF: 55% Aortic Calcification: Severe

Iliofemorals

The patient has the following: NYHA Class: III RISK FACTORS AND COMORBIDITIES previous CABG x4 in 2005, PAD Chronic Lung Disease/ COPD: Mild FEV1: 1900cc %predicted: 55 Other: No frailty PREVIOUS CARDIAC INTERVENTIONS PCI x2 last in 2/2013, recent cath showed patent all 3 grafts and patent PCI sites


Gender: M

Height (ins): 66

Weight (Ibs): 170

Risk Summary:

STS Score: 4.5% mortality

8.2% morbidity/mortality



?BAV

?SAVR

?TAVR

Pt was Randomized in the ongoing

Intermediate risk TAVR trial (SURTAVI)

because

- 4.5% STS risk score makes him ideal

for evaluation of TAVR vs. SAVR in

these intermediate risk AS pts

• Pt was randomized to SAVR and underwent

21mm Pericardial valve without complications.

The patient has the following in 8/2013: NYHA Class: IV and CCS class III angina on presentation to OSH with TnI 1.2U and transferred for treatment RISK FACTORS AND COMORBIDITIES previous CABG x4 in 1999 Chronic Lung Disease/ COPD: None FEV1: 2250cc %predicted: 95 Other: No frality PREVIOUS CARDIAC INTERVENTIONS Recent cath showed patent all 4 grafts with 80% stenosis of SVG to OM, LVEF 55%


Gender: M

Height (ins): 68

Weight (Ibs): 162



Site Images of AV annulus

_23_ Aortic annular size (mm)

_0.6_ Aortic valve area (cm2)

__---_ Aortic valve area index (cm2/m2)

42.0_ Mean gradient (mmHg)

_4.2_ Peak velocity (m/sec)

__60_ LVEF (%)


Clinical Analyst’s Image

Ao Annulus mean diameter 26.1 mm

30.3 X 21.8_ Major x Minor aortic annulus diameter

82.9_ Aortic Annulus perimeter (26.4 x 3.14)

33.5 Max Ascending Aorta diameter

35.9 - 31.4 Sinus of Valsalva width

30.8-22.6 Sinus of Valsalva height (all in mm)

31.4 – 28.6 Sinotubular Junction width (STJ)

Hemodynamics: Baseline

460 NSTEMI patients

460 NSTEMI patients

20 not ramdomized

The patient has the following in 8/2013: NYHA Class: IV and CCS class III angina on presentation to OSH and transferred for treatment RISK FACTORS AND COMORBIDITIES previous CABG x4 in 1999 Chronic Lung Disease/ COPD: None FEV1: 2250cc %predicted: 95 Other: No frality PREVIOUS CARDIAC INTERVENTIONS Recent cath showed patent all 4 grafts with 80% stenosis of SVG to OM


Gender: M

Height (ins): 68

Weight (Ibs): 162


Risk Summary:

STS Score: 2.8% mortality



Presenting with CHF and NSTEMI/UA

?BAV+ PCI to SVG to OM

?SAVR+ CABG to OM

?TAVR+ PCI to SVG to OM

Pt was in CHF class IV and NSTEMI/unstable

angina. Had Heart Team discussion with CT

surgeon and recommended percutaneous

approach to stabilize the pt’s condition.


Presenting with CHF and NSTEMI/UA

?BAV+ PCI to SVG to OM

?SAVR+ CABG to OM

?TAVR+ PCI to SVG to OM

Pt was in CHF class IV and NSTEMI/unstable

angina. Had Heart Team discussion with CT

surgeon and recommended percutaneous

approach to stabilize the pt’s condition. Pt

then underwent BAV and BMS PCI to SVG to

OM. Did well and discharged home next day.


5 mths later for CHF Class III symptom

recurrence

?re-BAV

?SAVR

?TAVR

Pt had low STS risk (<4) score and

hence underwent conventional SAVR

using 23mm Pericardial valve without

any complications. No CABG needed

as BMS to SVG to OM was patent.

Risk Summary:

STS Score:

1.8% mortality


Algorithm for Management of Severe AS: SAVR vs TAVR

Severe AS

Symptoms

No Yes

No Yes

LVEF <50%

Physically active

No Yes

Exercise Test

ressure below baseline

No Yes

Presence of risk factors and

low/intermediate individual surgical

risk

No Yes

Re-evaluate in 6 months SAVR

Contraindication

for AVR

No Yes

High risk for AVR Short life expectancy

Serious Comorbidity

STS >50%

No Yes No Yes

TAVR or SAVR

TAVR Med Rx

? BAV

Severe AS

No Yes

No Yes

LVEF <50%

Physically active

No Yes

Exercise Test

Symptoms or fall in blood

pressure below baseline

No Yes

Presence of risk factors and

low/intermediate individual surgical risk

No Yes

Re-evaluate in 6 months SAVR

No Yes

Emerging TAVR Devices Involving Improved

Technologies, Potentially Minimizing PVL/AR after TAVR

TAVR in Evolution (2014+)

Future Clinical Indications

• Valve-in-valve for bio-prosthetic aortic valve failure

• Intermediate (moderate) risk AS patients

• Asymptomatic severe AS

• Low flow-low gradient AS – impedance mismatch

• Aortic insufficiency; difficult with current

generation which is dependent on calcified native

AV to anchor the prosthesis

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