Farhad Bakhtiary1, Ali El-Sayed Ahmad2, Rüdiger Autschbach3, Peter Benedikt4, Nikolaos Bonaros5, Michael Borger6, Oliver Dewald7, Richard Feyrer8, Hans-Joachim Geißler4, Jürg Grünenfelder9, Ka Yan Lam10, Rainer Leyh11, Andreas Liebold12, Markus Czesla13, Arash Mehdiani14, Francesco Pollari15, Saad Salamate2, Justus Strauch16, Andreas Vötsch17, Alberto Weber18, Daniel Wendt19, Beate Botta20, Peter Bramlage20, Andreas Zierer4. 1. Division of Cardiac Surgery, Heart Center Siegburg-Wuppertal, University Witten-Herdecke, Ringstr. 49, 53721, Siegburg, Germany. farhad.bakhtiary@helios-gesundheit.de. 2. Division of Cardiac Surgery, Heart Center Siegburg-Wuppertal, University Witten-Herdecke, Ringstr. 49, 53721, Siegburg, Germany. 3. University Hospital RWTH Aachen, Aachen, Germany. 4. Kepler University Hospital Linz, Linz; and Hospital Wels-Grieskirchen, Wels, Austria. 5. Medical University of Innsbruck, Innsbruck, Austria. 6. University Hospital Leipzig, Leipzig, Germany. 7. University Hospital Oldenburg, Oldenburg, Germany. 8. Bundeswehrzentralkrankenhaus, Koblenz, Germany. 9. Heart Clinic Hirslanden, Zurich, Switzerland. 10. Catharina Hospital Eindhoven, Eindhoven, The Netherlands. 11. University Hospital Wuerzburg, Wuerzburg, Germany. 12. University Hospital Ulm, Ulm, Germany. 13. Hospital Passau, Passau, Germany. 14. University Hospital Duesseldorf, Duesseldorf, Germany. 15. Cardiac Surgery, Klinikum Nürnberg - Paracelsus Medical University, Nuremberg, Germany. 16. University Hospital Bergmannsheil, Bochum, Germany. 17. Department of Cardiovascular and Endovascular Surgery, Paracelsus Medical University, Salzburg, Austria. 18. Heart Center Hirslanden, Zurich, Switzerland. 19. Essen University Hospital, Essen, Germany. 20. Institute for Pharmacology and Preventive Medicine, Cloppenburg, Germany.
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 .
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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