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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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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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Author notes

  1. Ariel Finkelstein and Arie Steinvil contributed equally to this paper.

Authors and Affiliations

  1. The Cardiology Department, Tel Aviv Sourasky Medical Center, Israel, Affiliated to the Sackler School of Medicine, Tel Aviv University, 6 Weizmann Street, 62439, Tel Aviv, Israel

    Ariel Finkelstein, Arie Steinvil, Zach Rozenbaum, Amir Halkin & Shmuel Banai

  2. Leviev Heart Center, Chaim Sheba Medical Center, Ramat Gan, Israel, Affiliated to the Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel

    Israel Barbash, Victor Guetta & Amit Segev

  3. The Cardiology Department, Hadassah Medical Center, Jerusalem, Affiliated to the Hebrew University of Jerusalem, Jerusalem, Israel

    Haim Danenberg

  4. The Cardiology Department, Rabin Medical Center, Petach Tikva, Israel, Affiliated to the Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel

    Katia Orvin, Hana Vaknin Assa, Abid Assali & Ran Kornowski

Authors
  1. Ariel Finkelstein
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  2. Arie Steinvil
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Corresponding author

Correspondence to Arie Steinvil.

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Conflict of interest

Dr. Ariel Finkelstein receives proctor fees from Medtronic and Edwards Lifesciences. None of the other authors have a conflict of interest to declare.

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Finkelstein, A., Steinvil, A., Rozenbaum, Z. et al. Efficacy and safety of new-generation transcatheter aortic valves: insights from the Israeli transcatheter aortic valve replacement registry. Clin Res Cardiol 108, 430–437 (2019). https://doi.org/10.1007/s00392-018-1372-6

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  • DOI: https://doi.org/10.1007/s00392-018-1372-6

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