Transcatheter Aortic Valve Replacement with the Latest-Iteration Self-Expanding or Balloon-Expandable Valves: The Multicenter OPERA-TAVI Registry.

Costa, Giuliano; Saia, Francesco; Pilgrim, Thomas; Abdel-Wahab, Mohamed; Garot, Philippe; Valvo, Roberto; Gandolfo, Caterina; Branca, Luca; Latib, Azeem; Santos, Ignacio Amat; Mylotte, Darren; De Marco, Federico; De Backer, Ole; Franco, Luis Nombela; Akodad, Mariama; Mazzapicchi, Alessandro; Tomii, Daijiro; Laforgia, Pietro; Cannata, Stefano; Fiorina, Claudia; ... (2022). Transcatheter Aortic Valve Replacement with the Latest-Iteration Self-Expanding or Balloon-Expandable Valves: The Multicenter OPERA-TAVI Registry. JACC. Cardiovascular Interventions, 15(23), pp. 2398-2407. Elsevier 10.1016/j.jcin.2022.08.057

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The latest iterations of devices for transcatheter aortic valve replacement (TAVR) have brought refinements to further improve patient outcomes.


This study sought to compare early outcomes of patients undergoing TAVR with the self-expanding (SE) Evolut PRO/PRO+ or balloon-expandable (BE) Sapien 3 ULTRA devices.


The OPERA-TAVI registry collected data from 14 high-volume centers worldwide on patients undergoing TAVR with SE or BE devices. After excluding patients who were not eligible to both devices, patients were compared using 1:1 propensity score matching. The primary efficacy and safety outcomes were VARC-3 device success and early safety, respectively.


Among 2,241 patients eligible for the present analysis, 683 pairs of patients were matched. The primary efficacy outcome did not differ between patients receiving SE or BE transcatheter aortic valves (SE: 87.4% vs BE: 85.9%; P = 0.47), but BE device recipients showed a higher rate of the primary safety outcome (SE: 69.1% vs BE: 82.6%; P < 0.01). This finding was driven by the higher rates of permanent pacemaker implantation (PPI) (SE: 17.9% vs BE: 10.1%; P < 0.01) and disabling stroke (SE: 2.3% vs BE: 0.7%; P = 0.03) in SE device recipients. On post-TAVR echocardiography, the rate of moderate-to-severe paravalvular regurgitation was similar between groups (SE: 3.2% vs BE: 2.3%; P = 0.41), whereas lower mean transvalvular gradients were observed in the SE cohort (median SE: 7.0 vs BE: 12.0 mm Hg; P < 0.01).


The OPERA-TAVI registry showed that SE and BE devices had comparable VARC-3 device success rates, but the BE device had a higher rate of early safety. The higher PPI and disabling stroke rates in SE device recipients drove this composite endpoint.

Item Type:

Journal Article (Original Article)


04 Faculty of Medicine > Department of Cardiovascular Disorders (DHGE) > Clinic of Cardiology

UniBE Contributor:

Pilgrim, Thomas, Tomii, Daijiro


600 Technology > 610 Medicine & health








Pubmed Import

Date Deposited:

21 Sep 2022 09:53

Last Modified:

10 Dec 2022 00:13

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Uncontrolled Keywords:

Balloon-expandable Self-expanding TAVR VARC-3 comparison outcomes




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