TAVR-Update

[Pages:67]TAVR-Update

Andrzej Boguszewski MD, FACC, FSCAI Vice Chairman, Cardiology Mid-Michigan Health Associate Professor Michigan State University, Central Michigan University

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Disclosure

Chiesi Pharma- Consultant

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Objectives

Review where TAVR is now Current Challenges TAVR Updates

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Background

Aortic valve stenosis

? 15,000 deaths per year in North America ? 85,000 valve procedures ? AVR is indicated for severe AS and either symptoms

or LV dysfunction ? Over 500 TAVR programs open

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2017

40th Anniversary of PCI

? September 1977

15th Anniversary of TAVR

? April 2002

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Two TAVR Options

? Edwards Sapien Valve

? Cobalt Chromium frameballoon expandable (bovine)

? More Aortic Regurg, less AV block/PPM

? Better for severe bulky calcification.

? Medtronic CoreValve

? Nitinol Frame-self expanding

? Less Aortic Regurg, More heart block/PPM

PARTNER Study Design

Symptomatic Severe Aortic Stenosis

Cohort A

ASSESSMENT: High-Risk AVR Candidate 3,105 Total Patients Screened

Cohort B

N = 699

High Risk

Total = 1,057 patients

2 Parallel Trials: Inoperable N = 358

Individually Powered

ASSESSMENT:

Yes

Transfemoral

No

Access

ASSESSMENT:

Transfemoral Access

Transfemoral (TF)

Transapical (TA)

Yes

No

1:1 Randomization

N = 244

N = 248

1:1 Randomization

N = 104

N = 103

TF TAVR VS

AVR

TA TAVR VS

AVR

Primary Endpoint: All-Cause Mortality at 1 yr (Non-inferiority)

1:1 Randomization

Not In Study

N = 179

TF TAVR VS

N = 179

Standard Therapy

Primary Endpoint: All-Cause Mortality Over Length of Trial (Superiority)

Co-Primary Endpoint: Composite of All-Cause Mortality and Repeat Hospitalization (Superiority)

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