1. TAVR for the Treatment of Pure Native Aortic Valve Regurgitation
Thomas Pilgrim, MD
Anna Franzone, Raffaele Piccolo, George Siontis, Jonas Lanz, Stefan Stortecky, Fabien Praz, Eva Roost. René Vollenbroich, Stephan Windecker, Thomas Pilgrim JACC Cardiovasc Interv 2016;9(22):

2. Off-label use of TAVR devices
Bicuspid anatomy
Valve-in-valve
PVR
Aortic Regurgitation
MAC
MAC
TAC
Introduction
Methods
Results
Discussion

3. The Euro Heart Survey on Valvular Heart Disease
A prospective survey of patients with valvular heart disease in Europe
Iung B et al, Eur Heart J. 2003;24(13):
5001 adults with moderate to severe native VHD from 92 centres in 25 countries %
Introduction
Methods
Results
Discussion

4. Etiology of Native Aortic Regurgitation
Iung B et al, Eur Heart J. 2003;24(13):
n=369 %
Introduction
Methods
Results
Discussion

5. Rate of Surgery versus Conservative Management
Euro Heart Survey on Valvular Heart Disease
Iung B et al, Eur Heart J. 2003;24(13):
Reasons for conservative management:
regression of symptoms
end-stage disease
recent myocardial infarction
old age
chronic obstructive pulmonary disease
renal failure
short life expectancy %
Introduction
Methods
Results
Discussion

6. Technical Challenges of TAVR in Aortic Regurgitation
Absence of valvular calcification
Hypercontractility of the left ventricle, excessive stroke volume, dynamic regurgitant jet
Dilatation of the annulus/aortic root
Positioning
Anchoring
Residual AR
Introduction
Methods
Results
Discussion

7. Flow Diagram of Manuscript Selection According to PRISMA Statement
PROSPERO CRD
Eligibility
Patients with pure native AR
Reports of >5 patients
English language
Introduction
Methods
Results
Discussion

8. Main Clinical and Procedural Characteristics
ntotal = 237 patients
Age
Range years
Risk Assessment
EuroSCORE 15.3% %
STS-PROM 5.4% % n
Introduction
Methods
Results
Discussion

9. Access Routes an Devices Used
Prosthesis % %
CoreValve, J-valve, JenaValve, Direct Flow, Symetis Acurate
Edwards Sapien, Edwards Sapien XT
Introduction
Methods
Results
Discussion

10. Peri-procedural Outcome
Device success as reported in 7 studies: % %
Introduction
Methods
Results
Discussion

11. Individual and Pooled Event Rates for 30-Day Mortality after TAVR
This slides shows individual an pooled event rates for 30-day mortality after TAVR. We found a pooled event rate of 7% with considerable heterogeneity across reports with an I squared of 37%.
Introduction
Methods
Results
Discussion

12. Meta-Analysis of Secondary Endpoints
Introduction
Methods
Results
Discussion

13. The Jena Valve for the Treatment of Patients with AR
CE-approval for the treatment of AR
Three sizes:
23mm, 25mm and 27mm, covering aortic valve annuli from 21mm to 27mm.
Nitinol self-expanding stent with three feelers enabling positioning
commissures of the prosthesis positioned precisely on the commissures of the patients native valve
Porcine leaflets
Outer skirt
Introduction
Methods
Results
Discussion

14. Clinical Outcome of Patients treated with TAVR-Prostheses with an without CE-Mark for the Treatment of AR
Overall
n=237
Jena-Valve
n=51
Mortality
7% (95% CI 3-13%), I2 37%
11% (95% CI 0-30%), I2 52%
Major Bleeding
2% (95% CI 0-7%), I2 41%
4% (95% CI 0-13%), I2 0%
Major Vascular Complication
3% (95% CI 1-7%), I2 0%
PPM
11% (95% CI 5-19%), I2 50%
6% (95% CI 0-18%), I2 21%
Residual moderate to severe AR
9% (95% CI 0-28%), I2 90%
0% (95% CI 0-%), I2 0%
Introduction
Methods
Results
Discussion

15. Newer Generation Devices for the Treatment of AR
repositionability
selfpositioning
specific fixation mechanisms
Newer generation devices featuring repositionability, self-positioning and specific anchoring mechanisms have a potential to improve the performance of TAVR in patients with pure AR. In the following slides we will go through some of the devices
Introduction
Methods
Results
Discussion

16. The Symetis Acurate TA bioprosthesis for Patients with AR
Wendt D et al, JACC Cardiovasc Interv 2014;7:
8 patients, no death or stroke at 30 days, AR grade I+ or lower in all patients
selfpositioning
valve.
Introduction
Methods
Results
Discussion

17. The Direct Flow Valve for the Treatment of Patients with AR
repositionability
Three sizes: 25mm, 27mm , 29 mm
Metal-free double ring design
Polymer frame
Polyester cuff
Bovine tissue
Fully repositionable
Taramasso M. et al. Nat. Rev. Cardiol. 2014
Introduction
Methods
Results
Discussion

18. The LOTUS Valve for the Treatment of Patients with AR
repositionability
Wöhrle J et al, Catheter Cardiovasc Interv 2016;87(5):993-5
Introduction
Methods
Results
Discussion

19. The Helio Transcatheter Aortic Dock for Patients with AR
specific fixation
Barbanti M et al, EuroIntervention 2013;9 Suppl: S91-4
Introduction
Methods
Results
Discussion

20. The Engager Valve for the Treatment of Patients with AR
specific fixation
The transapical Engager System uses control arms designed to land in the sinus of valsalva, that secures a stable position throughout implantation.
Kiefer P et al, J Cardiovasc Surg 2014;147:e37-8
Introduction
Methods
Results
Discussion

21. Limitations Modest sample size Short duration of follow-up
Heterogeneity in terms of TAVR devices used, access, technique, and outcome definition
Publication bias
Incomplete data reporting
Introduction
Methods
Results
Discussion

22. Summary Challenges Strategy
Anatomy: Absence of calcification, Dilatation of the aortic root, dynamic regurgitant jet
Strategy
Oversizing; newer generation devices featuring repositionability, selfpositioning, and specific fixation mechanisms
Outcomes of TAVR for AR compared to TAVR for AS:
Embolisation, Migration, need for a second valve 
Residual moderate/severe AR 
Mortality 
PPM 
Vascular complications & bleeding 
Introduction
Methods
Results
Discussion