Universität zu Köln

Wilde, Nihal, Rogmann, Marc, Mauri, Victor ORCID: 0000-0003-2678-3501, Piayda, Kerstin, Schmitz, Marie-Therese ORCID: 0000-0003-1351-9381, Al-Kassou, Baravan, Shamekhi, Jasmin, Maier, Oliver, Sugiura, Atsushi, Weber, Marcel, Zimmer, Sebastian, Zeus, Tobias, Kelm, Malte, Adam, Matti, Baldus, Stephan, Nickenig, Georg, Veulemans, Verena and Sedaghat, Alexander (2022). Haemodynamic differences between two generations of a balloon-expandable transcatheter heart valve. Heart, 108 (18). S. 1479 - 1486. LONDON: BMJ PUBLISHING GROUP. ISSN 1468-201X

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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

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Wilde, Nihal UNSPECIFIED UNSPECIFIED UNSPECIFIED Rogmann, Marc UNSPECIFIED UNSPECIFIED UNSPECIFIED Mauri, Victor UNSPECIFIED orcid.org/0000-0003-2678-3501 UNSPECIFIED Piayda, Kerstin UNSPECIFIED UNSPECIFIED UNSPECIFIED Schmitz, Marie-Therese UNSPECIFIED orcid.org/0000-0003-1351-9381 UNSPECIFIED Al-Kassou, Baravan UNSPECIFIED UNSPECIFIED UNSPECIFIED Shamekhi, Jasmin UNSPECIFIED UNSPECIFIED UNSPECIFIED Maier, Oliver UNSPECIFIED UNSPECIFIED UNSPECIFIED Sugiura, Atsushi UNSPECIFIED UNSPECIFIED UNSPECIFIED Weber, Marcel UNSPECIFIED UNSPECIFIED UNSPECIFIED Zimmer, Sebastian UNSPECIFIED UNSPECIFIED UNSPECIFIED Zeus, Tobias UNSPECIFIED UNSPECIFIED UNSPECIFIED Kelm, Malte UNSPECIFIED UNSPECIFIED UNSPECIFIED Adam, Matti UNSPECIFIED UNSPECIFIED UNSPECIFIED Baldus, Stephan UNSPECIFIED UNSPECIFIED UNSPECIFIED Nickenig, Georg UNSPECIFIED UNSPECIFIED UNSPECIFIED Veulemans, Verena UNSPECIFIED UNSPECIFIED UNSPECIFIED Sedaghat, Alexander UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-678228
DOI:	10.1136/heartjnl-2021-320084
Journal or Publication Title:	Heart
Volume:	108
Number:	18
Page Range:	S. 1479 - 1486
Date:	2022
Publisher:	BMJ PUBLISHING GROUP
Place of Publication:	LONDON
ISSN:	1468-201X
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language SAPIEN 3; REPLACEMENT; XT; REGURGITATION; DEGENERATION; IMPLANTATION; INSIGHTS Multiple languages Cardiac & Cardiovascular Systems Multiple languages
URI:	http://kups.ub.uni-koeln.de/id/eprint/67822