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Open Access 01-12-2021 | Aortic Valve Replacement | Study protocol

Impact of pre-existing comorbidities on outcomes of patients undergoing surgical aortic valve replacement – rationale and design of the international IMPACT registry

Authors: Farhad Bakhtiary, Ali El-Sayed Ahmad, Rüdiger Autschbach, Peter Benedikt, Nikolaos Bonaros, Michael Borger, Oliver Dewald, Richard Feyrer, Hans-Joachim Geißler, Jürg Grünenfelder, Ka Yan Lam, Rainer Leyh, Andreas Liebold, Markus Czesla, Arash Mehdiani, Francesco Pollari, Saad Salamate, Justus Strauch, Andreas Vötsch, Alberto Weber, Daniel Wendt, Beate Botta, Peter Bramlage, Andreas Zierer

Published in: Journal of Cardiothoracic Surgery | Issue 1/2021

Abstract

Background

Degenerative aortic valve disease accounts for 10–20% of all cardiac surgical procedures. The impact of pre-existing comorbidities on the outcome of patients undergoing surgical aortic valve replacement (SAVR) needs further research.

Methods

The IMPACT registry is a non-interventional, prospective, open-label, multicenter, international registry with a follow-up of 5 years to assess the impact of pre-existing comorbidities of patients undergoing SAVR with the INSPIRIS RESILIA aortic valve on outcomes. IMPACT will be conducted across 25 sites in Austria, Germany, The Netherlands and Switzerland and intends to enroll approximately 500 patients. Patients will be included if they are at least 18 years of age and are scheduled to undergo SAVR with the INSPIRIS RESILIA Aortic Valve with or without concomitant ascending aortic root replacement and/or coronary bypass surgery. The primary objective is to determine all-cause mortality at 1, 3, and 5 years post SAVR. Secondary objectives include cardiac-related and valve-related mortality and structural valve deterioration including hemodynamics and durability, valve performance and further clinical outcomes in the overall study population and in specific patient subgroups characterized by the presence of chronic kidney disease, hypertension, metabolic syndrome and/or chronic inflammation.

Discussion

IMPACT is a prospective, multicenter European registry, which will provide much-needed data on the impact of pre-existing comorbidities on patient outcomes and prosthetic valve performance, and in particular the performance of the INSPIRIS RESILIA, in a real-world setting. The findings of this study may help to support and expand appropriate patient selection for treatment with bioprostheses.

Trial registration

ClinicalTrials.gov identifier: NCT04053088.

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Title: Impact of pre-existing comorbidities on outcomes of patients undergoing surgical aortic valve replacement – rationale and design of the international IMPACT registry
Authors: Farhad Bakhtiary
Ali El-Sayed Ahmad
Rüdiger Autschbach
Peter Benedikt
Nikolaos Bonaros
Michael Borger
Oliver Dewald
Richard Feyrer
Hans-Joachim Geißler
Jürg Grünenfelder
Ka Yan Lam
Rainer Leyh
Andreas Liebold
Markus Czesla
Arash Mehdiani
Francesco Pollari
Saad Salamate
Justus Strauch
Andreas Vötsch
Alberto Weber
Daniel Wendt
Beate Botta
Peter Bramlage
Andreas Zierer
Publication date: 01-12-2021
Publisher: BioMed Central
Keywords: Aortic Valve Replacement
Aortic Valve Replacement
Aortic Valve Replacement
Published in: Journal of Cardiothoracic Surgery / Issue 1/2021
Electronic ISSN: 1749-8090
DOI: https://doi.org/10.1186/s13019-021-01434-w

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Impact of pre-existing comorbidities on outcomes of patients undergoing surgical aortic valve replacement – rationale and design of the international IMPACT registry

Abstract

Background

Methods

Discussion

Trial registration

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Methods

Discussion

Trial registration

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