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Transcatheter Aortic Valve Replacement: Current and Future Devices: How do They
Work, Eligibility, Review of Data
Jonathan J. Passeri, M.D.
Co-Director, Heart Valve Program
Director, Interventional Echocardiography
Echo Florida 2013
Disclosures
• Edwards LifeSciences
Current and Future Devices
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Transcatheter Aortic Valve Replacement
• Anderson et al, 1992
– Swine model
• Bonhoeffer et al, 2000
– First human use of stent mounted bioprosthesis for pulmonary valve regurgitation
• Cribier et al, 2002
– First-in-man percutaneous aortic valve implantation
– Antegrade transvenous delivery
• Webb et al, 2006
– Retrograde via femoral artery
– Also transapical LV delivery
Transcatheter Valve Technology
• April 23, 2002
• First Heart Valve Replacement Without Open Heart Surgery
• SOURCE: Percutaneous Valve Technologies, Inc. (PVT) Experimental Device Developed By Percutaneous Valve Technologies May Provide Alternative to Open Heart Surgery In the United States
• “The 57 year old male patient that received the aortic valve procedure had a failing heart and was refused for surgery by three surgical teams because of his deteriorating condition and complicated vascular disease,” said Dr. Alain Cribier. “Lacking any other clinical solution for this patient, the PVT valve was a life saving technology. We are pleased to be the world's first clinical site to utilize this device.”
SAPIEN Transcatheter Heart Valve
Collapsed Expanded 26 mm 23 mm
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Percutaneous Aortic Valve
Implantation Via Antegrade Approach
Balloon valvuloplasty followed by
stented valve deployment during rapid
ventricular pacing
Cribier et al, JACC 2004;43:698-703
Webb et al. Circulation 2006; 113:842-850
Transfemoral Retrograde Approach for
Transcatheter Aortic Valve Replacement
Alternative Mode of Transcatheter
Deployment: Transapical Antegrade
Approach
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Direct Aortic Approach
Sapien THV and Delivery systems
Edwards SAPIEN THV 23 and 26 mm valves
RetroFlex 22 and 24 F sheaths
Ascendra 24 and 26 F sheaths
The Next Generation: SAPIEN XT THV
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NovaFlex Delivery System
CoreValve
Sapien and CoreValve
Edwards Sapien CoreValve
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CoreValve
Emerging Transcatheter Heart Valves
a | Direct Flow Medical® valve (Direct Flow Medical, Santa Rosa, CA, USA).
b | HLT valve (Heart Leaflet Technologies, Maple Grove, MN, USA). c | Innovare valve (Braile Biomedical, São José do Rio Preto, Brazil).
d | JenaValve® (JenaValve Technology, Munich, Germany).
e | Portico® valve (St-Jude Medical, St Paul, MN, USA). f | Sadra® Lotus Medical valve (Boston Scientific SciMed Inc, Maple Grove, MN, USA).
g | Symetis® Accurate valve (Symetis SA, Lausanne, Switzerland).
h | Engager® valve (Medtronic Inc., Minneapolis, MN, USA).
Rodés-Cabau, J. (2011) Transcatheter aortic valve implantation: current and future approaches
Nat. Rev. Cardiol. doi:10.1038/nrcardio.2011.164
Who is Eligible?
• Medical Eligibility
• Anatomic Eligibility
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N = 179
N = 358 Inoperable
Standard
Therapy
ASSESSMENT:
Transfemoral
Access
Not In Study
TF TAVR
Primary Endpoint: All-Cause Mortality
Over Length of Trial (Superiority) Co-Primary Endpoint: Composite of All-Cause Mortality
and Repeat Hospitalization (Superiority)
1:1 Randomization
VS
Yes No
N = 179
TF TAVR AVR
Primary Endpoint: All-Cause Mortality at 1 yr
(Non-inferiority)
TA TAVR AVR VS
VS
N = 248 N = 104 N = 103 N = 244
PARTNER Study Design
Symptomatic Severe Aortic Stenosis
ASSESSMENT: High-Risk AVR Candidate
3,105 Total Patients Screened
Total = 1,057 patients
2 Parallel Trials: Individually Powered
N = 699 High Risk
ASSESSMENT:
Transfemoral
Access
Transapical (TA) Transfemoral (TF)
1:1 Randomization 1:1 Randomization
Yes No
N = 179
N = 358 Inoperable
Standard
Therapy
ASSESSMENT:
Transfemoral
Access
Not In Study
TF TAVR
Primary Endpoint: All-Cause Mortality
Over Length of Trial (Superiority) Co-Primary Endpoint: Composite of All-Cause Mortality
and Repeat Hospitalization (Superiority)
1:1 Randomization
VS
Yes No
N = 179
PARTNER Study Design: Inoperable
Patients
Symptomatic Severe Aortic Stenosis
ASSESSMENT: High-Risk AVR Candidate
3,105 Total Patients Screened
Inclusion Criteria: Inoperable Group
• Severe Aortic Stenosis: Echo-derived AVA < 0.8 cm2 (or AVA index < 0.5 cm2/m2) and mean AVG > 40 mm Hg or peak jet velocity > 4.0 m/sec.
• Cardiac Symptoms: NYHA Functional Class II or greater
• Inoperable: Predicted risk of death or serious irreversible morbidity must exceed 50%
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Transfemoral Transapical
TAVR: Transfemoral Delivery
All Cause Mortality (ITT)
All
Ca
use
Mo
rta
lity (%
)
Months
Standard Rx
TAVR
∆ at 2 yr = 24.7% NNT = 4.0 pts
68.0%
43.3%
∆ at 1 yr = 20.0% NNT = 5.0 pts
50.7%
30.7%
Numbers at Risk
TAVR 179 138 124 110 83 47 14
Standard Rx 179 121 85 62 42 19 5
HR [95% CI] = 0.57 [0.44, 0.75]
p (log rank) < 0.0001
FDA Approval
November 2, 2011:
Edwards SAPIEN THV via Transfemoral Delivery
approved by FDA for Inoperable patients
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Who is Eligible?
• Medical Eligibility
– Symptomatic Severe Calcific Aortic Stenosis
• Inoperable in estimation of two cardiac surgeons
• Implantation route via FDA labeling
TF TAVR AVR
Primary Endpoint: All-Cause Mortality at 1 yr
(Non-inferiority)
TA TAVR AVR VS
VS
N = 248 N = 104 N = 103 N = 244
PARTNER Study Design: High Risk
Surgical Group
Symptomatic Severe Aortic Stenosis
ASSESSMENT: High-Risk AVR Candidate
3,105 Total Patients Screened
N = 699 High Risk
ASSESSMENT:
Transfemoral
Access
Transapical (TA) Transfemoral (TF)
1:1 Randomization 1:1 Randomization
Yes No
Inclusion Criteria: High-Risk Surgical
Group
• Severe Aortic Stenosis: Echo-derived AVA < 0.8 cm2 (or AVA index < 0.5 cm2/m2) and mean AVG > 40 mm Hg or peak jet velocity > 4.0 m/sec.
• Cardiac Symptoms: NYHA Functional Class II or greater
• High Surgical Risk: Predicted risk of operative mortality ≥ 15% (determined by site surgeon and cardiologist); guideline = STS score ≥ 10
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Transfemoral Transapical
TAVR:
Transfemoral or Transapical Delivery
ACC 2012: All-Cause Mortality at 2 Years
Kodali SK et al. N Engl J Med 2012;366:1686-1695.
Who is Eligible?
• Medical Eligibility
– Symptomatic Severe Aortic Stenosis
• Inoperable in estimation of two cardiac surgeons
• Implantation route via FDA labeling
• High risk surgical candidates soon to come?
• Meets eligibility for ongoing clinical trial (PARTNER
II, CoreValve U.S. Pivotal)
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Medical Eligibility: Contraindications and
Cautions
• Non-calcified aortic valve
• Bicuspid aortic valve
• Severe aortic regurgitation
• Severe mitral regurgitation
• Poor prognosis from non-cardiac disease (advanced
malignancy, very severe COPD
Transcatheter Aortic Valve Replacement: Outcomes of
Patients With Moderate or Severe Mitral Regurgitation
J Am Coll Cardiol. 2012;59(23):2068-2074. doi:10.1016/j.jacc.2012.02.020
Kaplan-Meier Curves for All-Cause Mortality in Patients With Mild or Less, Moderate, and Severe MR at Baseline
Survival in patients with mild or less, moderate, and severe mitral regurgitation (MR) at baseline was 92.5%, 86.5%, and 83.7% at 30 days; 79.0%, 76.2%, and 64.5% at 1 year; and 66.2%, 67.9%, and 58.5% at 2 years, respectively. TAVR = transcatheter aortic va lve
replacement.
Source XT: Improvement in Mitral
Regurgitation
Presented by H Baumgartner PCR London Valves 2012
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Medical Eligibility: Areas of Uncertainty
• Understanding Frailty
• Mild or Moderate Dementia
• End-Stage Renal Disease
• Low-gradient Aortic Stenosis (without contractile reserve)
• Very Low Ejection Fraction
Anatomic Eligibility
• Aortic valve morphology
• Annulus size
• Determining route of vascular access for implantation
– Not always about vessel size
– Minimize risk of stroke and vascular complications
• LVOT and aortic root anatomy/pathology
– HOCM
– Narrowed and circumferentially calcified STJ
Relation of Paravalvular Aortic Regurgitation to All-Cause Mortality in the TAVR As-Treated Population.
Kodali SK et al. N Engl J Med 2012;366:1686-1695.
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CTA
Bicuspid Aortic Valve
Bicuspid Aortic Valve: TAVR
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Bicuspid Aortic Valve: TAVR
How to Assess Eligibility
• Comprehensive medical evaluation
• Echocardiogram
• CTA
• Cardiac catheterization
• Transesophageal echocardiography
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