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Multicenter Study
. 2021 Mar 25;16(1):51.
doi: 10.1186/s13019-021-01434-w.

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

Farhad Bakhtiary  1 , Ali El-Sayed Ahmad  2 , Rüdiger Autschbach  3 , Peter Benedikt  4 , Nikolaos Bonaros  5 , Michael Borger  6 , Oliver Dewald  7 , Richard Feyrer  8 , Hans-Joachim Geißler  4 , Jürg Grünenfelder  9 , Ka Yan Lam  10 , Rainer Leyh  11 , Andreas Liebold  12 , Markus Czesla  13 , Arash Mehdiani  14 , Francesco Pollari  15 , Saad Salamate  2 , Justus Strauch  16 , Andreas Vötsch  17 , Alberto Weber  18 , Daniel Wendt  19 , Beate Botta  20 , Peter Bramlage  20 , Andreas Zierer  4
Affiliations
Multicenter Study

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

Farhad Bakhtiary et al. J Cardiothorac Surg. .

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 .

Keywords: Aortic valve disease; Comorbidities; Real-world setting; SAVR; Surgical aortic valve replacement.

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Conflict of interest statement

Farhad Bakhtiary has received lecture fees and/or research support from Edwards Lifesciences.

Ali El-Sayed Ahmad has nothing to disclose with regard to commercial support.

Rüdiger Autschbach has no conflict of interest to disclose.

Peter Benedikt has no conflict of interest to disclose.

Nikolaos Bonaros has received lecture fees and/or research support from Edwards Lifesciences.

Michael Borger has received lecture fees and/or research support from Edwards Lifesciences.

Oliver Dewald has no conflict of interest to disclose.

Richard Feyrer has received proctoring fees from Edwards Lifesciences.

Hans-Joachim Geißler has no conflict of interest to disclose.

Jürg Grünenfelder has no conflict of interest to disclose.

Ka Yan Lam has not conflict of interest to disclose.

Rainer Leyh has no conflict of interest to disclose.

Andreas Liebold has received lecture and proctoring fees from Edwards Lifesciences.

Markus Czesla has no conflict of interest to disclose.

Arash Mehdiani has no conflict of interest to disclose.

Francesco Pollari has no conflict of interest to disclose.

Saad Salamate has no conflict of interest to disclose.

Justus Strauch has received research funding from Edwards Lifesciences.

Andreas Vötsch has received lecture fees and is a proctor for Edwards Lifesciences.

Alberto Weber has no conflict of interest to disclose.

Daniel Wendt has no conflict of interest to disclose.

Beate Botta: her institution has received research support from Edwards Lifesciences.

Peter Bramlage has received lecture fees and/or research support from Edwards Lifesciences.

Andreas Zierer has received lecture fees and/or research support from Edwards Lifesciences.

The institutions of these and those of the remaining authors representing study centers have received patient inclusion-based funding.

References

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