TAVR Pearls
Addressing the Shortcomings of the
Current TAVR Generation
Moderator
Ted E. Feldman, MD
Director
Cardiac Catheterization Laboratory
Evanston Hospital
Evanston, Illinois
Panelists
Ian T. Meredith, MBBS, PhD
Professor of Cardiology and Medicine
Monash University
Director, MonashHeart
Monash Medical Centre
Southern Health
Melbourne, Australia
Nicolo Piazza, MD, PhD
Assistant Professor and Co-Director
Structural Heart Disease Program
McGill University Health Centre
Interventional Cardiology
German Heart Center Munich
Munich, Germany
Michael J. Reardon, MD
Professor of Cardiothoracic Surgery
The Methodist DeBakey Heart Center
Houston, Texas
TAVR Development
• Originally large delivery profiles: up to 25
French
• High rate of vascular complications (15%25%)
– Mortality rates at 30 days (10%-15%) were
then considered acceptable
• Now complication rates much lower
– Evolution of devices and careful patient
selection
Importance of Imaging
• Originally used 2-dimensional imaging
• 3-dimensional imaging has become key in
selecting valve size and placement
• Retrospective analyses comparing valve size
in patients based on echo vs estimation using
CT, approximately 50% of patients received
the incorrect size valvea
– Number of paravalvular leaks was tremendously
high
– Limited number of valve sizes available
Piazza N. JACC Cardiovasc Interv. In press.[2]
CTA Assessment of Aortic Valve
Annulus
Image courtesy of Ted E. Feldman, MD.
The Ice Cream Cone Analogy
..
Images courtesy of Ian T. Meredith, MBBS, PhD.
..
CTA Prediction of TAVR Working
Angle
Image courtesy of Ted E. Feldman, MD.
Repositioning and Retrievability
• A variety of second-generation devices are
repositionable and fully retrievable.
• A one-to-one connection is needed between
the handle outside the body and the
movement of the valve in situ.
REPRISE II
Aortic Regurgitation Over Time
Evaluable Echocardiograms, %
Combined
1.9
2.7
100%
100
Paravalvular
1
1
15.2%
12.5
15.5
17.9
80%
80
16.8
5.2
17
43.8
60%
60
40%
40
20.5
63.2
20.8
78.4
20%
20
20.5
5.2
0%
0
Baseline
(N
112)
n == 112
Meredith IT. TCT 2013.[3]
Discharge
(N
110)
n == 110
30 Days
(N
103)
n == 103
30 Days
(N
103)
n == 103
Severe
Moderate
Mild
Trace
None
Paravalvular Leak
Irregular annulus + concentric
valve = paravalvular leak
Images courtesy of Ian T. Meredith, MBBS, PhD.
Adaptive seal
REPRISE II
Conclusions
• Successful valve implantation and positioning in all
120 patients
• Primary device performance end point met
• Low mortality (4.2%) and disabling stroke (1.7%) at 30
days
• No embolization, ectopic valve deployment, or TAV-inTAV
• Negligible aortic regurgitation
• Clinical event rates consistent with those reported for
other valves
Meredith IT. TCT 2013.[3]
Abbreviations
2D = 2-dimensional
3D = 3-dimensional
CT = computed tomography
CTA = computed tomography angiogram
LV = left ventricular
TAVR = transcatheter aortic valve replacement
References
1. ClinicalTrials.gov. Safety and efficacy study of the Medtronic CoreValve® System in
the treatment of severe, symptomatic aortic stenosis in intermediate risk subjects who
need aortic valve replacement (SURTAVI). clinicaltrials.gov/show/NCT01586910.
Accessed December 1, 2013.
2. Piazza N. Erroneous measurement of the aortic annular diameter using 2dimensional echocardiography resulting in inappropriate CoreValve size selection: a
retrospective comparison with multislice computed tomography. JACC Cardiovasc
Interv. In press.
3. Meredith IT. REPRISE II: A prospective registry study of transcatheter aortic valve
replacement with a repositionable transcatheter heart valve in patients with severe
aortic stenosis. Presented at: Transcatheter Cardiovascular Therapeutics Meeting;
October 27-November 1, 2013; San Francisco, CA.
4. Sponga S, Perron J, Dagenais F, et al. Impact of residual regurgitation after aortic
valve replacement. Eur J Cardiothorac Surg. 2012;42:486-492.