Overview of Aortic Stenosis and Transcatheter Aortic valve Replacement… · 2020-03-20 · All valve disease Mitral valve disease Aortic valve disease 0 2 4 6 8 10 12 14

Overview of Aortic Stenosis and Transcatheter Aortic valve Replacement/Implantation

(TAVR/TAVI)Gaurav R. Parikh, MD, MRCP(UK)

Interventional Cardiology

Aortic Stenosis• Restricted opening of the aortic valve

– Thickening and calcification of leaflets– Fusion of commissures (rheumatic)– Intrinsically narrowed orifice (congenital)

• When orifice is decreased by more than 50% it becomes flow-limiting Pressure gradient develops across valve LV hypertrophy maintains wall stress Eventual LV failure and coronary insufficiency

result in symptomatology

CDC PHIL #848

Aortic Stenosis

Pathophysiology of AS

Increasing Prevalence of Valvular Heart Disease with Age

0

2

4

6

8

10

12

14

75

Prev

alen

ce o

f mod

or s

ever

e VH

D (%

) All valve diseaseMitral valve diseaseAortic valve disease

0

2

4

6

8

10

12

14

75

Olmsted County, MN

Nkomo VT at al. Lancet 2006;368:1005-1011

Population-based Studies

Prevalence Moderate/Severe AS 2.4 % in Those Age >75

Clinical Presentation

• Classic symptoms:– Murmur– Dyspnea– Chest pain– Syncope– Heart Failure

Natural History of Aortic Stenosis

Age (years)

Surv

ival

(per

cent

)

Increasing obstruction,myocardial overload

Average Age Death

Latent Period

Symptoms

40 50 60 70 80

100

80

60

40

20

0

Chart1

40

50

60

70

80

as

Sheet1

4050607080

ar1001001001005548454240

as

Perc

ent

5 Year Survival: Metastatic Cancer

Mortality with Medical RxPerspectives

Courtesy Murat Tuzcu* Constant Hazard Model

3% *

SevereInoperable AS

Sheet1

0112233551315255354124146153367387832879

111111111111111111111

21

Percent

Breast2370

Lung5

Colorectal12

Prostate30

Ovarian28

Severe Inoperable AS3

Sheet1

Percent

23%

5%

12%

30%

28%

3% *

Chart1

0

1

1

2

2

3

3

5

5

13

15

25

53

54

124

146

153

367

387

832

879

Log EuroSCORE

30.65

1.51

8

2.61

17.89

3.54

Age

Baseline Age Distribution Data as of 23AUG2010

Age ClassFrequencyPercentCumulative Frequency

< 6061.70%6

60 - 69246.70%30

70 - 797721.50%107

80 - 8918050.30%287

>= 907119.80%358

Age

Age

Count

Baseline Age

Age (2)

Age

Percent of Patients

Baseline Age

STS



< 70308.40%30

70 - 74246.70%54

75 - 795314.80%107

80 - 847922.10%186

85 - 8910128.20%287

90 - 944913.70%336

>= 95226.10%358

STS

Age

Count

Baseline Age

EuroSCORE

Age

Percent of Patients

Baseline Age

STS v Euro Data

Baseline STS Data as of 23AUG2010

STS ClassFrequencyPercentCumulative Frequency

0 - 4.94011.20%40

5.0 - 9.99426.30%134

10.0 - 14.913337.30%267

15.0 - 19.96819.00%335

>= 20226.20%357

STS v Euro Data

Age

Count

Baseline STS

STS by Site

Age

Percent of Patients

Baseline STS

Baseline EuroSCORE Data as of 23AUG2010

EuroSCORE ClassFrequencyPercentCumulative Frequency

0 - 9.95515.40%55

10.0 - 19.98523.70%140

20.0 - 29.97220.10%212

30.0 - 39.95415.10%266

40.0 - 49.93710.30%303

50.0 - 59.9359.80%338

>= 60205.60%358

Age

Count

Baseline log EuroSCORE

Age

Percent of Patients


STS vs EuroSCORE 23AUG2010

Subject name or identifierDayLog EuroSCORE

030.650112233551315255354124146153367387832879

11.51

18

22.61

217.89

33.54

3

5

5

13

15

25

53

54

124

146

153

367

387

832

879

r = .4720

Log EuroSCORE

STS Risk Score

log EuroSCORE

STS v. EuroSCORE

Day

STS By Site 23AUG2010

SiteNMean STS

Pooled35711.53

Barnes1210.27

Mass General210.85

Cedars Sinai3612.24

Cleveland Clinic4510.33

Columbia3313.90

Dallas2112.47

Emory4212.03

Evanston810.71

Evanston Northwestern39.67

Laval47.73

Leipzig216.10

Mayo710.79

Miami1511.81

Northwestern59.12

Pennsylvania2114.20

Scripps813.50

StLukes513.66

Stanford613.82

Toronto27.05

UWashington87.75

Vancouver228.06

WHC5011.04

Mean STS

Mean STS by Site

Sheet1

0112233551315255354124146153367387832879

111111111111111111111

21

Percent

Breast2370

Lung5

Colorectal12

Prostate30

Ovarian28

Severe Inoperable AS3

Sheet1

Percent

23%

5%

12%

30%

28%

3% *

Chart1

0

1

1

2

2

3

3

5

5

13

15

25

53

54

124

146

153

367

387

832

879

Log EuroSCORE

30.65

1.51

8

2.61

17.89

3.54

Age



< 6061.70%6

60 - 69246.70%30

70 - 797721.50%107

80 - 8918050.30%287

>= 907119.80%358

Age

Age

Count

Baseline Age

Age (2)

Age

Percent of Patients

Baseline Age

STS



< 70308.40%30

70 - 74246.70%54

75 - 795314.80%107

80 - 847922.10%186

85 - 8910128.20%287

90 - 944913.70%336

>= 95226.10%358

STS

Age

Count

Baseline Age

EuroSCORE

Age

Percent of Patients

Baseline Age

STS v Euro Data

Baseline STS Data as of 23AUG2010

STS ClassFrequencyPercentCumulative Frequency

0 - 4.94011.20%40

5.0 - 9.99426.30%134

10.0 - 14.913337.30%267

15.0 - 19.96819.00%335

>= 20226.20%357

STS v Euro Data

Age

Count

Baseline STS

STS by Site

Age

Percent of Patients

Baseline STS

Baseline EuroSCORE Data as of 23AUG2010

EuroSCORE ClassFrequencyPercentCumulative Frequency

0 - 9.95515.40%55

10.0 - 19.98523.70%140

20.0 - 29.97220.10%212

30.0 - 39.95415.10%266

40.0 - 49.93710.30%303

50.0 - 59.9359.80%338

>= 60205.60%358

Age

Count


Age

Percent of Patients


STS vs EuroSCORE 23AUG2010

Subject name or identifierDayLog EuroSCORE

030.650112233551315255354124146153367387832879

11.51

18

22.61

217.89

33.54

3

5

5

13

15

25

53

54

124

146

153

367

387

832

879

r = .4720

Log EuroSCORE

STS Risk Score

log EuroSCORE

STS v. EuroSCORE

Day

STS By Site 23AUG2010

SiteNMean STS

Pooled35711.53

Barnes1210.27

Mass General210.85

Cedars Sinai3612.24

Cleveland Clinic4510.33

Columbia3313.90

Dallas2112.47

Emory4212.03

Evanston810.71

Evanston Northwestern39.67

Laval47.73

Leipzig216.10

Mayo710.79

Miami1511.81

Northwestern59.12

Pennsylvania2114.20

Scripps813.50

StLukes513.66

Stanford613.82

Toronto27.05

UWashington87.75

Vancouver228.06

WHC5011.04

Mean STS

Mean STS by Site

Therapeutic Options• Mechanical problem = Mechanical solution

• No medical therapy effective in delaying progression or altering outcome of AS

• Surgical AVR:– Mechanical vs Bioprosthetic

• Transcatheter therapy: – BAV and TAVR

At Least 30% of Patients with Severe Symptomatic AS are “Untreated”!

5968 70

4052

6955

41 3230

6048

3145

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Bouma1999

Iung* 2004

Pellikka2005

Charlson2006

Bach 2009

Spokane Vannan

Severe Symptomatic Aortic StenosisPercent of Cardiology Patients Treated

1. Bouma B J et al. To operate or not on elderly patients with aortic stenosis: the decision and its consequences. Heart 1999;82:143-1482. Iung B et al. A prospective survey of patients with valvular heart disease in Europe: The Euro Heart Survey on Valvular Heart Disease. European Heart Journal

2003;24:1231-1243 (*includes both Aortic Stenosis and Mitral Regurgitation patients)3. Pellikka, Sarano et al. Outcome of 622 Adults with Asymptomatic, Hemodynamically Significant Aortic Stenosis During Prolonged Follow-Up. Circulation 20054. Charlson E et al. Decision-making and outcomes in severe symptomatic aortic stenosis. J Heart Valve Dis2006;15:312-321

AVRNo AVR

Unmet Clinical Need

NO ONE Likes Surgery (of any kind)!

TAVR – Current LandscapeEdwards SAPIEN 3

Balloon ExpandableMedtronic CoreValve Evolut

Self Expanding

• Intermediate-, high- and extreme-risk

• Valve-in-valve

Edwards LifesciencesApproved Nov 2011

Medtronic CoreValveApproved Jan 2014

First Generation Devices

The TAVR Revolution

TAVR and SAVR* ProceduresIn the TVT Registry and STS ACSD*

* SAVR= isolated surgical aortic valve replacement; ACSD=Adult Cardiac Surgery DatabaseSource: STS/ACC TVT Registry Database as of Oct 18, 2016; STS ACSD 2015 Annual Report

4,6019,173

16,358

22,444 23,85628,778 30,665 29,810 29,462

05,000

10,00015,00020,00025,00030,00035,000

2012 2013 2014 2015 2016 ytd

TAVRs (TVT Registry) SAVRs (ACSD)

Chart1

20122012

20132013

20142014

20152015

2016 ytd2016 ytd

TAVRs (TVT Registry)

SAVRs (ACSD)

4601

28778

9173

30665

16358

29810

22444

29462

23856

Sheet1

TAVRs (TVT Registry)SAVRs (ACSD)

20124,60128,778

20139,17330,665

201416,35829,810

201522,44429,462

2016 ytd23,856

To resize chart data range, drag lower right corner of range.

TAVR now accounts for 41% of all AV replacements

FY2015 MedPAR, all cases on file regardless of IPPS status

U. S. Medicare AV Cases in 2016

SAVR Tissue

SAVR Mech

TF TAVR

TA TAVR

Chart1

SAVR Tissue

SAVR Mech

TF TAVR

TA TAVR

Cases

35599

13418

20996

1816

Sheet1

Cases

SAVR Tissue35599

SAVR Mech13418

TF TAVR2099671829

TA TAVR1816

TAVR Sites in US = 477 and counting

Alaska: 1Hawaii: 1

2014 AHA/ACC Guideline

Class 1 recommendation: Patients with severe VHD should be evaluated by a multidisciplinary Heart Valve Team when intervention is considered.

Risk Assessment: Beyond The Risk Scores• STS risk score provides a reasonable preliminary estimate of risk for the majority

of patients

• The STS score fails to account for many important factors affecting surgical risk– Porcelain aorta– Chest wall radiation or deformity (hostile chest)– Previous sternotomy with adhesion of IMAs to chest wall– Severely compromised respiratory function– Severe liver disease– Severe pulmonary hypertension– Dementia and/or severe cerebrovascular disease– Frailty: “eyeball” test vs objective assessment

• Clinical judgment of experienced operators plays a key role in assessment of surgical risk status

Classic TAVR Patient #1o 68 y.o. maleo Recurrent CHF admissions

Clinical History

Systolic Heart Failure Severe low gradient low flow AS

CABG x 4 - 2005 HTN

Stent to RCA graft x2 (1/4/17) ICD

Ischemic cardiomyopathy Hyperlipidemia

EF 20 – 25%

Risk determination: o Intermediate risk based on STS score of 6%o Severe Pulmonary hypertension – 77/32 (48)mmHgo Severe biventricular dysfunctiono Redo sternotomy

Classic TAVR Patient #2

90 year old female

Severe AS with reduced EF of 35% now with CHF symptoms

History: Severe AS HyperlipidemiaPPM 6/14 Left hip fx with fixationCHF Extremely HOH

Patient factors :

*Independent for ADLs*Lives with daughter and son-in-law*Enjoys going out to dinner, casino, knitting, and frequent trips to the river.* Has been dx with AS for several years, but was asymptomatic until

recently, and would now like treatment.* 1/31/17 Admitted from ER with SOB, trop 0.52, 0.59.

TAVR Candidate Risk Determination: *High Risk Candidate based on STS score of 13*Frailty

Workup for TAVR

• Transthoracic echocardiogram• Cardiac catheterization• MDCT gated CT scan of heart, abd pelvis• Risk assessment (STS score, technical issues)• Frailty assessment• Heart Team meeting

Workup - Echocardiogram

Workup- Cardiac catheterization

Retrospective Gated MDCT– Annulus Sizing

ExampleExample

26

Retrospective Gated MDCT– Annulus Sizing

[Comments]

ExampleExample

InteleViewer Series#: InteleViewer Image #:


27

Retrospective Gated MDCT

Example Example


28

Access Vessels on CT Angiogram

Workup for TAVR

• Transthoracic echocardiogram• Cardiac catheterization• MDCT gated CT scan of heart, abd pelvis• Risk assessment (STS score, technical issues)• Frailty assessment• Heart Team meeting

TAVR Procedure& Hospital Course

Done in Cardiac Catheterization Lab / Hybrid OR General Anesthesia/moderate sedation Both Interventional Cardiologist and Cardiac

surgery in the roomBoth groins accessed

14 - 16 French for catheter for valve (arterial) Temporary pacer (venous) & Pigtail (arterial)

Percutaneous arterial access and closurePatient extubated in cathlab on table Patient to CICU for < 12-24 hrsLOS: 2 or 3 days

31

S/p Successful Trans-femoral TAVR Sapien 3 Valve

#1• Tolerated procedure well• Extubated next day• Was able to get diuresed

and now tolerate HF meds• Discharged Home after 7

days• Has not had any more CHF

admission • Able to walk > 30 min upon

DC

#2• Tolerated procedure well• Extubated on table• Ambulating next day• Discharged home within 48

hours• Continues to do well

Building the Evidence for TAVR

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

0 12 24 36 48Al

l-Cau

se M

orta

lity

TAVR

SAVR

HR [95% CI] =1.03 [0.85, 1.24]

p (log rank) = 0.76

69.3%

69.8%

30.7%

50.8%71.8%

93.6%Standard Rx (n = 179)TAVR (n = 179)

All-C

ause

Mor

talit

y (%

)

PARTNER Cohort B PARTNER Cohort A

PARTNER trial established that TAVR improves survival in extreme risk patients with AS and is an alternative to surgery in high risk patients

Key points to remember Enrollment started in 2007 - Chi-Square

Log-Rank29.77861

PARTNER: Inoperable Cohort

Is TAVR Superior to Surgery?The evidence builds…

Smith, ACC 2016

TAVR in 2018New performance benchmarks

for high-risk AS patients (@ 30 days)

All-cause mortality < 3%

Major (disabling) strokes < 3%

Major vascular complications < 5%

Major bleeding complications

Discharge Instructions Highlights

47

• Cardiology follow-up 4 – 5 days, 30 days, 1 year

• Aspirin 81 mg daily and Plavix 75 mg daily x 3-6 months

• Standard Post Cath precautions

• Antibiotics prophylaxis prior to dental work

The Future of TAVR?• Multiple valve choices

• How many do we need?• Different learning curves• How do we choose?

• Expanding indications• Bicuspid valves• Valve in valve• Lower risk patients• Moderate AS• Asymptomatic patients

• Minimalist approach will grow• Evolving role of heart team

NOTION

US COREVALVEPARTNER

SURTAVIPARTNER II

Overview of Aortic Stenosis and Transcatheter Aortic valve Replacement/Implantation (TAVR/TAVI)Aortic StenosisSlide Number 3Pathophysiology of ASIncreasing Prevalence of �Valvular Heart Disease with AgeClinical PresentationNatural History of Aortic StenosisSlide Number 8Therapeutic OptionsAt Least 30% of Patients with Severe Symptomatic AS are “Untreated”!Slide Number 11Slide Number 12TAVR – Current LandscapeSlide Number 14TAVR and SAVR* Procedures�In the TVT Registry and STS ACSD*�U. S. Medicare AV Cases in 2016TAVR Sites in US = 477 and counting�Slide Number 182014 AHA/ACC GuidelineRisk Assessment: Beyond The Risk ScoresClassic TAVR Patient #1Classic TAVR Patient #2Workup for TAVRWorkup - EchocardiogramWorkup- Cardiac catheterizationSlide Number 26Slide Number 27Slide Number 28Access Vessels on CT AngiogramWorkup for TAVRTAVR Procedure�& Hospital CourseSlide Number 32Slide Number 33S/p Successful Trans-femoral TAVR Sapien 3 ValveSlide Number 35Building the Evidence for TAVRPARTNER: Inoperable CohortSlide Number 38Slide Number 39Slide Number 40Slide Number 41Slide Number 42Slide Number 43Slide Number 44Slide Number 45Slide Number 46Discharge Instructions HighlightsThe Future of TAVR?

Overview of Aortic Stenosis and Transcatheter Aortic valve Replacement… · 2020-03-20 · All valve disease Mitral valve disease Aortic valve disease 0 2 4 6 8 10 12 14

Documents