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):2308-2317

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

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):1231-43 5001 adults with moderate to severe native VHD from 92 centres in 25 countries % Introduction Methods Results Discussion

Etiology of Native Aortic Regurgitation Iung B et al, Eur Heart J. 2003;24(13):1231-43 n=369 % Introduction Methods Results Discussion

Rate of Surgery versus Conservative Management Euro Heart Survey on Valvular Heart Disease Iung B et al, Eur Heart J. 2003;24(13):1231-43 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

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

Flow Diagram of Manuscript Selection According to PRISMA Statement PROSPERO CRD42016038422 Eligibility Patients with pure native AR Reports of >5 patients English language Introduction Methods Results Discussion

Main Clinical and Procedural Characteristics ntotal = 237 patients Age Range 68 - 84 years Risk Assessment EuroSCORE 15.3% - 34.0% STS-PROM 5.4% - 13.1% n Introduction Methods Results Discussion

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

Peri-procedural Outcome Device success as reported in 7 studies: 74-100% % Introduction Methods Results Discussion

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

Meta-Analysis of Secondary Endpoints Introduction Methods Results Discussion

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 www.jenavalve.de Introduction Methods Results Discussion

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

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

The Symetis Acurate TA bioprosthesis for Patients with AR Wendt D et al, JACC Cardiovasc Interv 2014;7:1159-67 8 patients, no death or stroke at 30 days, AR grade I+ or lower in all patients selfpositioning valve. Introduction Methods Results Discussion

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

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

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

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. www.medtronic-engager.com Kiefer P et al, J Cardiovasc Surg 2014;147:e37-8 Introduction Methods Results Discussion

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

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