Philipp Kahlert1, Heike Annelie Hildebrandt2, Polykarpos Christos Patsalis3, Fadi Al-Rashid4, Rolf Alexander Jánosi5, Felix Nensa6, Thomas Wilfried Schlosser7, Marc Schlamann8, Daniel Wendt9, Matthias Thielmann10, Eva Kottenberg11, Ulrich Frey12, Markus Neuhäuser13, Michael Forsting14, Heinz Günther Jakob15, Tienush Rassaf16, Jürgen Peters17, Gerd Heusch18, Petra Kleinbongard19. 1. Department of Cardiology and Vascular Medicine, West-German Heart and Vascular Center Essen, Universitätsklinikum Essen, Universität Duisburg-Essen, Germany. Electronic address: philipp.kahlert@uk-essen.de. 2. Department of Cardiology and Vascular Medicine, West-German Heart and Vascular Center Essen, Universitätsklinikum Essen, Universität Duisburg-Essen, Germany. Electronic address: heike.hildebrandt@uk-essen.de. 3. Department of Cardiology and Vascular Medicine, West-German Heart and Vascular Center Essen, Universitätsklinikum Essen, Universität Duisburg-Essen, Germany. Electronic address: polycarpos-christos.patsalis@uk-essen.de. 4. Department of Cardiology and Vascular Medicine, West-German Heart and Vascular Center Essen, Universitätsklinikum Essen, Universität Duisburg-Essen, Germany. Electronic address: fadi.al-rashid@uk-essen.de. 5. Department of Cardiology and Vascular Medicine, West-German Heart and Vascular Center Essen, Universitätsklinikum Essen, Universität Duisburg-Essen, Germany. Electronic address: alexander.janosi@uk-essen.de. 6. Institute for Diagnostic and Interventional Radiology and Neuroradiology, Universitätsklinikum Essen, Universität Duisburg-Essen, Germany. Electronic address: felix.nensa@uk-essen.de. 7. Institute for Diagnostic and Interventional Radiology and Neuroradiology, Universitätsklinikum Essen, Universität Duisburg-Essen, Germany. Electronic address: thomas.schlosser@uni-due.de. 8. Institute for Diagnostic and Interventional Radiology and Neuroradiology, Universitätsklinikum Essen, Universität Duisburg-Essen, Germany; Department of Neuroradiology, University Hospital Gießen, Gießen, Germany. Electronic address: marc.schlamann@radiol.med.uni-giessen.de. 9. Department of Thoracic and Cardiovascular Surgery, West-German Heart and Vascular Center Essen, Universitätsklinikum Essen, Universität Duisburg-Essen, Germany. Electronic address: daniel.wendt@uk-essen.de. 10. Department of Thoracic and Cardiovascular Surgery, West-German Heart and Vascular Center Essen, Universitätsklinikum Essen, Universität Duisburg-Essen, Germany. Electronic address: matthias.thielmann@uk-essen.de. 11. Klinik für Anästhesiologie und Intensivmedizin, Universitätsklinikum Essen, Universität Duisburg-Essen, Germany; Klinik für Anästhesiologie, Intensivmedizin und Schmerztherapie, Evangelisches Krankenhaus Mülheim, Germany. Electronic address: eva.kottenberg@evkmh.de. 12. Klinik für Anästhesiologie und Intensivmedizin, Universitätsklinikum Essen, Universität Duisburg-Essen, Germany. Electronic address: ulrich.frey@uk-essen.de. 13. Institute for Medical Informatics, Biometry, and Epidemiology, Universitätsklinikum Essen, Universität Duisburg-Essen, Germany; Department of Mathematics and Technology, Koblenz, University of Applied Science, Remagen, Germany. Electronic address: neuhaeuser@hs-koblenz.de. 14. Institute for Diagnostic and Interventional Radiology and Neuroradiology, Universitätsklinikum Essen, Universität Duisburg-Essen, Germany. Electronic address: michael.forsting@uk-essen.de. 15. Department of Thoracic and Cardiovascular Surgery, West-German Heart and Vascular Center Essen, Universitätsklinikum Essen, Universität Duisburg-Essen, Germany. Electronic address: heinz.jakob@uk-essen.de. 16. Department of Cardiology and Vascular Medicine, West-German Heart and Vascular Center Essen, Universitätsklinikum Essen, Universität Duisburg-Essen, Germany. Electronic address: tienush.rassaf@uk-essen.de. 17. Klinik für Anästhesiologie und Intensivmedizin, Universitätsklinikum Essen, Universität Duisburg-Essen, Germany. Electronic address: juergen.peters@uni-duisburg-essen.de. 18. Institute for Pathophysiology, West-German Heart and Vascular Center Essen, Universitätsklinikum Essen, Universität Duisburg-Essen, Germany. Electronic address: gerd.heusch@uk-essen.de. 19. Institute for Pathophysiology, West-German Heart and Vascular Center Essen, Universitätsklinikum Essen, Universität Duisburg-Essen, Germany. Electronic address: petra.kleinbongard@uk-essen.de.
Abstract
BACKGROUND:Remote ischemic preconditioning (RIPC) reduces myocardial injury and improves clinical outcome in patients undergoing coronary revascularization, but only in the absence of propofol-anesthesia. We investigated whether RIPC provides protection of heart, kidneys and brain and improves outcome in patients undergoing transfemoral transcatheter aortic valve implantation (TF-TAVI). METHODS:Patients undergoing TF-TAVI were randomized to receive RIPC (3cycles of 5min left upper arm ischemia and 5min reperfusion) or placebo. The primary endpoint was myocardial injury, reflected by the area under the curve for serum troponin I concentrations (AUC-TnI) over the first 72h. Secondary endpoints included the incidences of periprocedural myocardial infarction, delayed gadolinium enhancement on postprocedural cardiac MRI, acute kidney injury, periprocedural stroke, and the incidence and volume of new lesions on postprocedural cerebral MRI. All-cause and cardiovascular mortality and major adverse cardiac and cerebrovascular events (MACCE) were assessed over 1-year follow-up. A prespecified interim-analysis was performed after the last patient had completed 1-year follow-up (NCT02080299). RESULTS:100 consecutive patients were enrolled between September 2013 and June 2015. There were no significant between-group differences in the primary endpoint of peri-interventional myocardial injury (ratio RIPC/placebo AUC-TnI: 0.87, 95% CI: 0.57-1.34, p=0.53) or the secondary endpoints of cardiac, renal and cerebral impairment. There was no significant treatment effect in subgroup-analyses of patients undergoing cardiac or cerebral MRI. Mortality and MACCE did not differ. No RIPC-related adverse events were observed. CONCLUSIONS:RIPC did neither protect heart, kidneys and brain nor improve clinical outcome in patients undergoing TF-TAVI.
RCT Entities:
BACKGROUND: Remote ischemic preconditioning (RIPC) reduces myocardial injury and improves clinical outcome in patients undergoing coronary revascularization, but only in the absence of propofol-anesthesia. We investigated whether RIPC provides protection of heart, kidneys and brain and improves outcome in patients undergoing transfemoral transcatheter aortic valve implantation (TF-TAVI). METHODS:Patients undergoing TF-TAVI were randomized to receive RIPC (3cycles of 5min left upper arm ischemia and 5min reperfusion) or placebo. The primary endpoint was myocardial injury, reflected by the area under the curve for serum troponin I concentrations (AUC-TnI) over the first 72h. Secondary endpoints included the incidences of periprocedural myocardial infarction, delayed gadolinium enhancement on postprocedural cardiac MRI, acute kidney injury, periprocedural stroke, and the incidence and volume of new lesions on postprocedural cerebral MRI. All-cause and cardiovascular mortality and major adverse cardiac and cerebrovascular events (MACCE) were assessed over 1-year follow-up. A prespecified interim-analysis was performed after the last patient had completed 1-year follow-up (NCT02080299). RESULTS: 100 consecutive patients were enrolled between September 2013 and June 2015. There were no significant between-group differences in the primary endpoint of peri-interventional myocardial injury (ratio RIPC/placebo AUC-TnI: 0.87, 95% CI: 0.57-1.34, p=0.53) or the secondary endpoints of cardiac, renal and cerebral impairment. There was no significant treatment effect in subgroup-analyses of patients undergoing cardiac or cerebral MRI. Mortality and MACCE did not differ. No RIPC-related adverse events were observed. CONCLUSIONS: RIPC did neither protect heart, kidneys and brain nor improve clinical outcome in patients undergoing TF-TAVI.
Authors: Hans Erik Bøtker; Derek Hausenloy; Ioanna Andreadou; Salvatore Antonucci; Kerstin Boengler; Sean M Davidson; Soni Deshwal; Yvan Devaux; Fabio Di Lisa; Moises Di Sante; Panagiotis Efentakis; Saveria Femminò; David García-Dorado; Zoltán Giricz; Borja Ibanez; Efstathios Iliodromitis; Nina Kaludercic; Petra Kleinbongard; Markus Neuhäuser; Michel Ovize; Pasquale Pagliaro; Michael Rahbek-Schmidt; Marisol Ruiz-Meana; Klaus-Dieter Schlüter; Rainer Schulz; Andreas Skyschally; Catherine Wilder; Derek M Yellon; Peter Ferdinandy; Gerd Heusch Journal: Basic Res Cardiol Date: 2018-08-17 Impact factor: 17.165
Authors: Nilgün Gedik; Marcus Krüger; Matthias Thielmann; Eva Kottenberg; Andreas Skyschally; Ulrich H Frey; Elke Cario; Jürgen Peters; Heinz Jakob; Gerd Heusch; Petra Kleinbongard Journal: Sci Rep Date: 2017-08-09 Impact factor: 4.379
Authors: Mandy Flechsig; Tobias F Ruf; Willi Troeger; Stephan Wiedemann; Silvio Quick; Karim Ibrahim; Christian Pfluecke; Akram Youssef; Krunoslav M Sveric; Robert Winzer; Frank R Heinzel; Axel Linke; Ruth H Strasser; Kun Zhang; Felix M Heidrich Journal: J Clin Med Date: 2020-01-07 Impact factor: 4.241