title: No protection of heart, kidneys and brain by remote ischemic preconditioning before transfemoral transcatheter aortic valve implantation: Interim-analysis of a randomized single-blinded, placebo-controlled, single-center trial.
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.
authors.affiliation: 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.
authors.forename: Philipp
authors.initials: P
authors.lastname: Kahlert
authors.affiliation: 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.
authors.forename: Heike Annelie
authors.initials: HA
authors.lastname: Hildebrandt
authors.affiliation: 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.
authors.forename: Polykarpos Christos
authors.initials: PC
authors.lastname: Patsalis
authors.affiliation: 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.
authors.forename: Fadi
authors.initials: F
authors.lastname: Al-Rashid
authors.affiliation: 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.
authors.forename: Rolf Alexander
authors.initials: RA
authors.lastname: Jánosi
authors.affiliation: Institute for Diagnostic and Interventional Radiology and Neuroradiology, Universitätsklinikum Essen, Universität Duisburg-Essen, Germany. Electronic address: felix.nensa@uk-essen.de.
authors.forename: Felix
authors.initials: F
authors.lastname: Nensa
authors.affiliation: Institute for Diagnostic and Interventional Radiology and Neuroradiology, Universitätsklinikum Essen, Universität Duisburg-Essen, Germany. Electronic address: thomas.schlosser@uni-due.de.
authors.forename: Thomas Wilfried
authors.initials: TW
authors.lastname: Schlosser
authors.affiliation: 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.
authors.forename: Marc
authors.initials: M
authors.lastname: Schlamann
authors.affiliation: 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.
authors.forename: Daniel
authors.initials: D
authors.lastname: Wendt
authors.affiliation: 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.
authors.forename: Matthias
authors.initials: M
authors.lastname: Thielmann
authors.affiliation: 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.
authors.forename: Eva
authors.initials: E
authors.lastname: Kottenberg
authors.affiliation: Klinik für Anästhesiologie und Intensivmedizin, Universitätsklinikum Essen, Universität Duisburg-Essen, Germany. Electronic address: ulrich.frey@uk-essen.de.
authors.forename: Ulrich
authors.initials: U
authors.lastname: Frey
authors.affiliation: 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.
authors.forename: Markus
authors.initials: M
authors.lastname: Neuhäuser
authors.affiliation: Institute for Diagnostic and Interventional Radiology and Neuroradiology, Universitätsklinikum Essen, Universität Duisburg-Essen, Germany. Electronic address: michael.forsting@uk-essen.de.
authors.forename: Michael
authors.initials: M
authors.lastname: Forsting
authors.affiliation: 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.
authors.forename: Heinz Günther
authors.initials: HG
authors.lastname: Jakob
authors.affiliation: 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.
authors.forename: Tienush
authors.initials: T
authors.lastname: Rassaf
authors.affiliation: Klinik für Anästhesiologie und Intensivmedizin, Universitätsklinikum Essen, Universität Duisburg-Essen, Germany. Electronic address: juergen.peters@uni-duisburg-essen.de.
authors.forename: Jürgen
authors.initials: J
authors.lastname: Peters
authors.affiliation: Institute for Pathophysiology, West-German Heart and Vascular Center Essen, Universitätsklinikum Essen, Universität Duisburg-Essen, Germany. Electronic address: gerd.heusch@uk-essen.de.
authors.forename: Gerd
authors.initials: G
authors.lastname: Heusch
authors.affiliation: Institute for Pathophysiology, West-German Heart and Vascular Center Essen, Universitätsklinikum Essen, Universität Duisburg-Essen, Germany. Electronic address: petra.kleinbongard@uk-essen.de.
authors.forename: Petra
authors.initials: P
authors.lastname: Kleinbongard
mesh_terms: D058186:Acute Kidney Injury / Q000453:epidemiology / Q000209:etiology / Q000517:prevention & control*; D000368:Aged; D001024:Aortic Valve Stenosis / Q000601:surgery*; D001921:Brain; D002406:Catheterization, Peripheral / Q000379:methods; D017558:Elective Surgical Procedures; D005260:Female; D005263:Femoral Artery; D005500:Follow-Up Studies; D005858:Germany / Q000453:epidemiology; D006321:Heart; D006801:Humans; D015994:Incidence; D019157:Ischemic Preconditioning, Myocardial / Q000379:methods*; D007668:Kidney; D019028:Magnetic Resonance Imaging, Cine; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000453:epidemiology / Q000209:etiology / Q000517:prevention & control*; D011300:Preoperative Care / Q000379:methods; D011446:Prospective Studies; D016037:Single-Blind Method; D020521:Stroke / Q000453:epidemiology / Q000209:etiology / Q000517:prevention & control*; D015996:Survival Rate / Q000639:trends; D065467:Transcatheter Aortic Valve Replacement / Q000009:adverse effects*; D019564:Unnecessary Procedures
keywords: Brain; Cardioprotection; Heart; Kidney; RIPC; TAVI