TAVR Pearls Addressing the Shortcomings of the Current TAVR Generation

TAVR Pearls

Addressing the Shortcomings of the Current TAVR Generation

ModeratorTed E. Feldman, MDDirectorCardiac Catheterization Laboratory Evanston HospitalEvanston, Illinois

Panelists Ian T. Meredith, MBBS, PhDProfessor of Cardiology and MedicineMonash UniversityDirector, MonashHeartMonash Medical CentreSouthern HealthMelbourne, Australia

Nicolo Piazza, MD, PhDAssistant Professor and Co-Director Structural Heart Disease Program McGill University Health Centre Interventional CardiologyGerman Heart Center MunichMunich, Germany

Michael J. Reardon, MD Professor of Cardiothoracic Surgery The Methodist DeBakey Heart CenterHouston, 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.

Baseline (N = 112)

Discharge (N = 110)

30 Days (N = 103)

30 Days (N = 103)

0%

20%

40%

60%

80%

100%

20.5

63.2

5.2

78.420.5

17

20.8

5.2

43.8

17.916.8

15.512.5

1.9 1 12.7

SevereModerateMildTraceNone

REPRISE II Aortic Regurgitation Over Time

Eval

uabl

e Ec

hoca

rdio

gram

s, %

Combined Paravalvular

15.2%100

80

60

40

20

0

Meredith IT. TCT 2013.[3]

n = 112 n = 110 n = 103 n = 103

Paravalvular Leak

Irregular annulus + concentric valve = paravalvular leak Adaptive seal

Images courtesy of Ian T. Meredith, MBBS, PhD.

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-in-

TAV • Negligible aortic regurgitation • Clinical event rates consistent with those reported for

other valves

Meredith IT. TCT 2013.[3]

Abbreviations2D = 2-dimensional3D = 3-dimensionalCT = computed tomographyCTA = computed tomography angiogram LV = left ventricularTAVR = transcatheter aortic valve replacement

References1. 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 2-dimensional 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.