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  • Early versus newer generation devices for transcatheter aortic valve implantation in routine clinical practice: a propensity score matched analysis

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Aortic and vascular disease
Original research article
Early versus newer generation devices for transcatheter aortic valve implantation in routine clinical practice: a propensity score matched analysis
  1. Thomas Pilgrim1,
  2. Joe K T Lee1,
  3. Crochan J O’Sullivan2,
  4. Stefan Stortecky1,
  5. Sara Ariotti1,
  6. Anna Franzone1,
  7. Jonas Lanz1,
  8. Dik Heg3,
  9. Masahiko Asami1,
  10. Fabien Praz1,
  11. George C M Siontis1,
  12. René Vollenbroich1,
  13. Lorenz Räber1,
  14. Marco Valgimigli1,
  15. Eva Roost4 and
  16. Stephan Windecker1
  1. 1 Department of Cardiology, University of Bern, Bern, Switzerland
  2. 2 Triemlispital, Zurich, Switzerland
  3. 3 Clinical Trials Unit, University of Bern, Bern, Switzerland
  4. 4 Department of Cardiovascular Surgery, University of Bern, Bern, Switzerland
  1. Correspondence to Dr Thomas Pilgrim; thomas.pilgrim{at}insel.ch

Abstract

Aim Contemporary data comparing early versus newer generation transcatheter heart valve (THV) devices in routine clinical practice are lacking. We sought to compare the safety and efficacy of early versus newer generation THVs in unselected patients undergoing transcatheter aortic valve implantation (TAVI).

Methods and results We performed a propensity score matched analysis of patients undergoing transfemoral TAVI at a single centre with early versus newer generation devices between 2007 and 2016. Patients were matched for balloon-expandable versus self-expandable valves and Society of Thoracic Surgeons score. The primary end point was the Valve Academic Research Consortium (VARC)-2 early safety composite end point at 30 days. Among the 391 matched pairs, no differences between early (21.2%) and newer generation (20.8%) THVs regarding the early safety composite end point (HR 0.98, 95% CI 0.72 to 1.33, P=0.88) were observed. The rates of valve embolisation (0.8% vs 4.2%, P=0.005), bleeding events (24.8% vs 32.0%, P=0.028) and moderate-to-severe paravalvular regurgitation (PVR) (3.1% vs 12.1%, P<0.001) were lower among patients receiving newer generation devices. Conversely, patients treated with early generation THVs less frequently experienced annulus rupture (0% vs 2.0%, P=0.008).

Conclusion Newer compared with early generation THV devices were associated with a lower rate of valve embolisation, PVR and bleeding events.

  • valvular disease
  • aortic valve disease

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

https://doi.org/10.1136/openhrt-2017-000695

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    Footnotes

    • Funding TP has received research grants to the institution from Edwards Lifesciences, Symetis, and Biotronik. SW has received research grants to the institution from Bravo, Boston Scientific and Terumo. LR has received research grants to the institution from Abbott Vascular. All other authors have nothing to disclose.

    • Competing interests None declared.

    • Patient consent Obtained.

    • Ethics approval Cantonal Ethics Committee of Bern.

    • Provenance and peer review Not commissioned; externally peer reviewed.