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01-04-2019 | Original Paper

Efficacy and safety of new-generation transcatheter aortic valves: insights from the Israeli transcatheter aortic valve replacement registry

Authors: Ariel Finkelstein, Arie Steinvil, Zach Rozenbaum, Amir Halkin, Shmuel Banai, Israel Barbash, Victor Guetta, Amit Segev, Haim Danenberg, Katia Orvin, Hana Vaknin Assa, Abid Assali, Ran Kornowski

Published in: Clinical Research in Cardiology | Issue 4/2019

Abstract

Aim

To compare procedural outcomes of transcatheter aortic valve replacement (TAVR) patients treated with new-generation valves.

Methods

We performed a retrospective analysis on an Israeli multicenter registry comprised of four tertiary centers, comparing patient outcomes implanted with the Edwards SAPIEN S3 (ES3) vs. the Medtronic Evolut R (MER) valves.

Results

The study population included 735 patients (ES3 n = 223; MER n = 512). The use of MER was significantly associated (p < 0.05) with higher rates of post-dilatation (35% vs. 10%), and the need for a second valve (2.7% vs. 0.5%). Procedural device success was comparable between groups (97% vs. 98%, p = 0.76); however, moderate angiographic paravalvular leak was higher (3.3% vs. 0.5%, p = 0.027) for MER vs. ES3, respectively. As compared to MER, 1 month echocardiography revealed higher peak and mean aortic valve gradients for ES3 (12/6 vs. 17/10 mmHg, p < 0.001, respectively). While the safety outcome at 1 month was lower for MER (8.8% vs. 13.9%, p = 0.035), similar 1-month, 1-year, and 3-year all-cause mortality were observed (1.9% vs. 1.3%; 8% vs. 8.5%, and 9.7 vs. 10.3%, for MER vs. ES3, respectively). In a propensity score matching analysis, there was no difference in major outcomes between the groups, including device success and the 1 month safety outcome.

Conclusion

Although favorable efficacy and safety clinical outcomes were observed in this large contemporary registry for both new-generation devices used, some procedural and post-procedural outcomes differ significantly between the two valves.

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Title: Efficacy and safety of new-generation transcatheter aortic valves: insights from the Israeli transcatheter aortic valve replacement registry
Authors: Ariel Finkelstein
Arie Steinvil
Zach Rozenbaum
Amir Halkin
Shmuel Banai
Israel Barbash
Victor Guetta
Amit Segev
Haim Danenberg
Katia Orvin
Hana Vaknin Assa
Abid Assali
Ran Kornowski
Publication date: 01-04-2019
Publisher: Springer Berlin Heidelberg
Published in: Clinical Research in Cardiology / Issue 4/2019
Print ISSN: 1861-0684
Electronic ISSN: 1861-0692
DOI: https://doi.org/10.1007/s00392-018-1372-6

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Efficacy and safety of new-generation transcatheter aortic valves: insights from the Israeli transcatheter aortic valve replacement registry

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Conclusion

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