TAVR is Here! - TriStar Health

Current Status of Percutaneous
Aortic Valve Replacement: TAVR is
Here!
John A Riddick
Centennial Heart

What is TAVR?
• Transcatheter Aortic Valve Replacement
• TAVI - Implantation
• Percutaneous AVR or Perc AVR
• Approaches:
– Femoral
– Transapical
– Transaortic
– Subclavian

Who gets a TAVR
• Severe , symptomatic aortic stenosis
• Inoperable – The U.S. became the 43 rd country
to have commercially available TAVR when the
FDA approved Edwards SAPIEN Balloon
Expandable valve on November 2 nd , 2011
• CMS/Medicare evaluating TAVR currently for a
NCD to determine insurance coverage

How do we get a Valve in through the
leg?

The Partner Trial – Cohort B
September 22, 2010 on NEJM.org

Objectives
• To evaluate the clinical outcomes of the
Edwards SAPIEN transcatheter heart valve
(THV) compared to standard therapy at 2
years in “inoperable” patients with severe
symptomatic native aortic valve stenosis
• To assess valve hemodynamic performance
using echocardiography
• To perform analyses to better define the
impact of comorbidities on outcomes
7

Aortic Stenosis

Aortic Stenosis Is Life-Threatening and
Progresses Rapidly 1
• Survival after onset of symptoms is 50% at 2 years and 20% at 5 years 2
• Surgical intervention for severe aortic stenosis should be performed promptly once
even minor symptoms occur 2

Undertreatment Is Profound

A New Era Begins
• There has been tremendous interest in
transcatheter aortic valve replacement (TAVR)
since the first procedure in 2002
• Since then, patient selection, operator skills,
and technology have improved
• There was a requirement for clinical data to
evaluate TAVR compared with current
standard therapies

TA, transapical; TF, transfemoral.
Rigorous Study Design

Rigorous Study Protocols

Strict Site Selection
St. Paul's Hospital
Vancouver, Canada
Univ. of Washington
Seattle, WA
Hospital Laval
Quebec City,
Canada
Stanford
University
Stanford, CA
Cedars-Sinai Medical Center
Los Angeles, CA
Scripps Clinic
La Jolla, CA
Mayo Clinic
Rochester, MN
Northwestern Univ.
Chicago, IL
Barnes-Jewish Hospital
St. Louis, MO
St. Luke’s Hospital
Kansas City, MO
Evanston Hospital
Chicago, IL
Cleveland Clinic
Cleveland, OH
Toronto Gen.
Hospital
Toronto, Canada
Univ. of Penn
Phila., PA
Washington
Hosp. Center
Wash., DC
Mass. General
Boston, MA
Columbia University
New York, NY
Medical
City Dallas
Dallas, TX
Emory University
Atlanta, GA
Leipzig Heart Center
Leipzig, Germany
n = 358 Cohort B patients
22 Cohort B investigator sites
18 USA, 3 Canada, 1 Germany
Univ. of Miami
Miami, FL

The PARTNER Trial Cohort B
Study Devices
Edwards SAPIEN Transcatheter
Heart Valve
RetroFlex 3
Introducer Sheath Set
RetroFlex 3
Delivery System
Crimper
RetroFlex
Balloon Catheter
RetroFlex Dilator Kit
Atrion
Inflation Devices

Stringent Patient Screening
Screening Methodology
• Screening including clinical evaluation, echocardiography
(+ TEE as needed), full catheterization and angiography
(including coronaries), and vascular access assessment
• Case screening logs
(screen failure rate > 70% at most sites)
• Case review webcast presentations
(twice per week when necessary for expedited reviews)
for cohort assignment and treatment strategy discussions
(every patient enrolled)
• Treatment goal: within 2 weeks of randomization

Careful Patient Selection
• Select inclusion criteria
• Severe symptomatic native aortic valve stenosis (aortic valve area < 0.8
cm 2 , mean gradient > 40 mm Hg, or peak aortic jet velocity > 4.0 m/s)
• Predicted risk of mortality or irreversible morbidity > 50% as determined
by 2 cardiothoracic surgeons and a cardiologist
• Select exclusion criteria
• Left ventricular ejection fraction (LVEF) < 20%
• Severe (> 3+) mitral regurgitation (MR) or aortic regurgitation (AR)
• Untreated coronary disease (CAD) requiring revascularization
• Serum creatinine > 3.0 mg/dL or hemodialysis
• Recent myocardial infarction (1 month), stroke, or transient ischemic
attack (6 months)
• Life expectancy < 12 months

An Elderly and Highly Symptomatic
Population
.

25% of Patients Had an STS Score ≥ 15 and 37% of
Patients Had an STS Score < 10

Patients Had Multiple Severe
Comorbidities

Key Insights for Cohort B
• Standard therapy is failing these patients with
severe symptomatic native aortic valve
stenosis
– TAVR with Edwards SAPIEN THV delivers:
• Superior survival rate
• Reduction in symptoms and restoration of quality of life
• Improvement in hemodynamics
• Sustained valve performance

Standard Therapy Is Failing These
Patients
Standard therapy, including balloon aortic
valvuloplasty (BAV), did not alter the dismal
natural history of patients with severe
symptomatic native aortic valve stenosis
• All-cause and cardiovascular mortality at 2
years were 68.0% and 62.4%, respectively

Absolute Reduction in Mortality
Continues to Diverge at 2 Years

30% Absolute Reduction in
Cardiovascular Mortality

35% Reduction in Repeat
Hospitalization

Error bars = ± 1 Std Dev
Reduced Mean Gradient

Error bars = ± 1 Std Dev
Increased Valve Area

Significant Improvement
in 6-Minute Walk Test

KCCQ Subscales

Higher Incidence of Stroke
30

Mortality or Stroke
31

Higher Incidence of Major Vascular
Complications
32

Higher Incidence of Major Bleeding
* Major bleeding is defined as an event that causes death; causes a hospitalization or prolongs hospitalization; requires pericardiocentesis or an open and/or endovascular
procedure for repair or hemostasis; causes permanent disability (eg, blindness, paralysis, hearing loss); or requires transfusion of > 3 units of blood within a 24-hour period.

New Pacemaker Implantation

Paravalvular Regurgitation
Slightly Improved Over Time

Conclusions
At 2 years, in patients with severe symptomatic native aortic
valve stenosis who were not suitable candidates for surgery:
• Treatment with the Edwards SAPIEN THV remained superior
to standard therapy with incremental benefit from 1 to 2
years, reducing the rates of mortality and repeat
hospitalization
• Treatment with the Edwards SAPIEN THV improved NYHA
functional status and decreased class III/IV symptoms
compared to standard therapy

Conclusions
• There were significantly more strokes in patients
treated with the Edwards SAPIEN THV than in
patients who received standard therapy
• After 30 days, differences in stroke frequency were largely
due to increased hemorrhagic strokes in patients treated
with the Edwards SAPIEN THV
• Patients treated with the Edwards SAPIEN THV
also had a higher incidence of major vascular
complications and major bleeding than standard
therapy patients

Clinical Implications
• Two-year data continue to support the role of
treatment with the Edwards SAPIEN THV as the
standard of care for patients with severe
symptomatic native aortic valve stenosis who are
not surgical candidates
• The ultimate value of the Edwards SAPIEN
THV in “inoperable” patients will depend on
careful selection of patients who are not surgical
candidates, and yet do not have extreme
comorbidities that overwhelm the benefits and
render the intervention futile

March 26 th 2012

What’s next
• High Risk surgical patients (operative
candidates) – FDA likely begin approval
process this summer
• Core Valve self-expanding percutaneous AVR
(CoreValve U.S. Pivotal Trial)
• 18 F Edwards Sapient XT Valve (Partner II trial -
US)
• 16 F Edwards eSheath expandable system
(European studies)

TAVR: A novel, hybrid approach

One Call…
855-900-VALVE