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Original research
Haemodynamic differences between two generations of a balloon-expandable transcatheter heart valve
  1. Nihal Wilde1,
  2. Marc Rogmann1,
  3. Victor Mauri2,
  4. Kerstin Piayda3,
  5. Marie-Therese Schmitz4,
  6. Baravan Al-Kassou1,
  7. Jasmin Shamekhi1,
  8. Oliver Maier3,
  9. Atsushi Sugiura1,
  10. Marcel Weber1,
  11. Sebastian Zimmer1,
  12. Tobias Zeus3,
  13. Malte Kelm3,
  14. Matti Adam2,
  15. Stephan Baldus2,
  16. Georg Nickenig1,
  17. Verena Veulemans3,
  18. Alexander Sedaghat1
  1. 1Heart Centre Bonn, Department of Medicine II, University Hospital Bonn, Bonn, Germany
  2. 2Heart Centre Cologne, Department of Cardiology, University Hospital Cologne, Cologne, Germany
  3. 3Department of Cardiology, Pulmonology, and Angiology, University Hospital Düsseldorf, Düsseldorf, Germany
  4. 4Department of Medical Biometry, Informatics and Epidemiology, University Hospital Bonn, Bonn, Germany
  1. Correspondence to Dr Alexander Sedaghat, Heart Center Bonn, Department of Medicine II, Universitatsklinikum Bonn Medizinische Klinik II Innere Medizin Kardiologie Angiologie und Pneumologie, Bonn, Germany; alexander.sedaghat{at}ukbonn.de

Abstract

Objectives This study aimed to investigate early haemodynamic and clinical performance of the SAPIEN 3 Ultra (S3 Ultra) transcatheter heart valve (THV) system in comparison to its precursor, the SAPIEN 3 (S3). Previous studies have indicated potential haemodynamic differences between the S3 Ultra and S3. Such differences may impact clinical outcome after transcatheter aortic valve implantation (TAVI).

Methods Postprocedural haemodynamic performance and 30-day clinical outcome were compared in patients who underwent TAVI receiving either the S3 or the new S3 Ultra prostheses. Multivariable analysis and propensity score matching (PSM) were used to identify factors associated with higher mean transvalvular gradients.

Results We included 697 patients (S3 Ultra: n=314, S3: n=383) from the multicentre RhineHeart TAVI Registry. Patients receiving the S3 Ultra prosthesis showed significantly higher postprocedural mean transvalvular gradients (14.2±4.8 vs 10.2±4.4 mm Hg; p<0.01). Multivariable logistic regression analyses and additional PSM revealed the use of the S3 Ultra to be associated with higher postprocedural mean transvalvular gradients (p<0.01). 30-day clinical outcomes, such as mortality, myocardial infarction, permanent pacemaker implantation and vascular complications were comparable between the groups.

Conclusions The new S3 Ultra THV was associated with a higher postprocedural mean transvalvular gradient compared with the S3 system, while there was no difference in mortality or adverse clinical outcomes at 30 days. These echocardiographic differences will require long-term studies to assess the clinical relevance of this finding.

  • transcatheter aortic valve replacement
  • aortic valve stenosis
  • heart valve prosthesis
  • heart valve diseases

Data availability statement

Data are available on reasonable request.

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Footnotes

  • Twitter @KPiayda

  • NW and MR contributed equally.

  • Contributors NW, joint first author, submitting author, conceptualised, organised, analysed and interpreted data and drafted the work; performed the statistical analysis; wrote the draft of the manuscript. MR, joint first author, conceptualised, organised, analysed and interpreted data and drafted the work; performed the statistical analysis; wrote the draft of the manuscript. VM conceptualised, organised and analysed data from Cologne; wrote sections and interpreted. KP organised and analysed data from Duesseldorf; wrote sections and interpreted. M-TS performed the statistical analysis; wrote sections and interpreted. BA-K conceptualised, organised and analysed data from Bonn. JS conceptualised, organised and analysed data from Bonn; revised the manuscript critically for important intellectual content. OM conceptualised, organised and analysed data from Duesseldorf; wrote sections. ASu conceptualised, organised and analysed data; performed statistical analysis; wrote sections of the manuscript. MW organised and analysed data from Bonn; wrote sections and interpreted; drafted the work and revised critically for important intellectual content. SZ organised and analysed data from Bonn; wrote sections and interpreted; drafted the work and revised critically for important intellectual content. TZ organised and analysed data from Duesseldorf; wrote sections and interpreted. MK drafted the work and revised critically for important intellectual content; wrote and interpreted sections of the manuscript; made approval of the manuscript. MA organised and analysed data from Cologne; wrote sections and interpreted. SB drafted the work and revised critically for important intellectual content; made approval of the manuscript. GN drafted the work and revised critically for important intellectual content; wrote and interpreted sections of the manuscript; made final approval of the manuscript. VV drafted and designed the work and revised critically for important intellectual content; wrote and interpreted sections of the manuscript. ASe is the corresponding author, responsible for the overall content as the guarantor, drafted the work and revised critically for important intellectual content, wrote sections and made the final approval of the manuscript.

  • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

  • Competing interests MA received speakers’ honoraria from Medtronic. SB received research funding from Abbott Vascular and Edwards Lifesciences. GN has received research funding from Edwards Lifescienes and Medtronic and has received honoraria for lectures or advisory boards from Abbott, Edwards Lifesciences and Medtronic. VV and TZ have received consulting fees, travel expenses or study honoraria from Medtronic and Edwards Lifesciences. All other authors have nothing to disclose with regard to this project. All other authors declare that there is no conflict of interest regarding this manuscript.

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

  • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.

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