Balloon-Expandable Versus Self-Expanding Transcatheter Aortic Valve Replacement
Authors: Van Belle Eric , Vincent Flavien , Labreuche Julien , Auffret Vincent , Debry Nicolas , Lefèvre Thierry , Eltchaninoff Helene , Manigold Thibaut , Gilard Martine , Verhoye Jean-Phillipe , Himbert Dominique , Koning Rene , Collet Jean-Phillipe , Leprince Pascal , Teiger Emmanuel , Duhamel Alain , Cosenza Alessandro , Schurtz Guillaume , Porouchani Sina , Lattuca Benoit , Robin Emmanuel , Coisne Augustin , Modine Thomas , Richardson Marjorie , Joly Patrick , Rioufol Gilles , Ghostine Said , Bar Olivier , Amabile Nicolas , Champagnac Didier , Ohlmann Patrick , Meneveau Nicolas , Lhermusier Thibaut , Leroux Lionel , Leclercq Florence , Gandet Thomas , Pinaud Frédéric , Cuisset Thomas , Motreff Pascal , Souteyrand Géraud , Iung Bernard , Folliguet Thierry , Commeau Philippe , Cayla Guillaume , Bayet Gilles , Darremont Olivier , Spaulding Christian , Le Breton Hervé , Delhaye Cédric 
Published: November 2019

Background:
No randomized study powered to compare balloon expandable (BE) with self expanding (SE) transcatheter heart valves (THVs) on individual end points after transcatheter aortic valve replacement has been conducted to date.

Methods:
From January 2013 to December 2015, the FRANCE-TAVI nationwide registry (Registry of Aortic Valve Bioprostheses Established by Catheter) included 12 141 patients undergoing BE-THV (Edwards, n=8038) or SE-THV (Medtronic, n=4103) for treatment of native aortic stenosis. Long term mortality status was available in all patients (median 20 months; interquartile range, 14 to 30). Patients treated with BE-THV (n=3910) were successfully matched 1:1 with 3910 patients treated with SE-THV by using propensity score (25 clinical, anatomical, and procedural variables) and by date of the procedure (within 3 months). The first coprimary outcome was ≥ moderate occurrence of paravalvular regurgitation or in-hospital mortality, or both. The second coprimary outcome was 2-year all-cause mortality.

Results:

In propensity–matched analyses, the incidence of the first coprimary outcome was higher with SE-THV (19.8%) compared with BE-THV (11.9%; relative risk, 1.68 [95% CI, 1.46–1.91];
P
<0.0001). Each component of the outcome was also higher in patients receiving SE-THV: ≥ moderate paravalvular regurgitation (15.5% versus 8.3%; relative risk, 1.90 [95% CI, 1.63–2.22];
P
<0.0001) and in hospital mortality (5.6% versus 4.2%; relative risk, 1.34 [95% CI, 1.07–1.66];
P
=0.01). During follow up, all cause mortality occurred in 899 patients treated with SE-THV (2-year mortality, 29.8%) and in 801 patients treated with BE-THV (2-year mortality, 26.6%; hazard ratio, 1.17 [95% CI, 1.06–1.29];
P
=0.003). Similar results were found using inverse probability of treatment weighting using propensity score analysis.

Conclusion:
The present study suggests that use of SE-THV was associated with a higher risk of paravalvular regurgitation and higher in-hospital and 2-year mortality compared with use of BE-THV. These data strongly support the need for a randomized trial sufficiently powered to compare the latest generation of SE-THV and BE-THV.

Clinical Trial Registration:

https://www.clinicaltrials.gov
. Unique identifier: NCT01777828.