title: Comparison of sedation and general anaesthesia for transcatheter aortic valve implantation on cerebral oxygen saturation and neurocognitive outcome†.
abstract: BACKGROUND
  Transcatheter aortic valve implantation (TAVI) is a treatment strategy for patients with severe aortic stenosis. Although general anaesthesia (TAVI-GA) and sedation (TAVI-S) have previously been described for TAVI, the difference in safety and efficacy of both methods has not been studied in a randomized trial.
  
  
  METHODS
  The INSERT trial was a single centre, controlled parallel-group trial with balanced randomization. Sixty-six patients (68-94 yr) with acquired aortic stenosis undergoing transfemoral CoreValve™ were assigned to TAVI-GA or TAVI-S. Comparable operative risk was determined from risk-scores (EUROscore, STS-Score). Monitoring and anaesthetic drugs were standardized. Near-Infrared-Spectroscopy was used to monitor cerebral-oxymetry blinded. Primary outcome was the perioperative cumulative cerebral desaturation. As secondary outcomes, changes in neurocognitive function and respiratory and haemodynamic adverse events were evaluated.
  
  
  RESULTS
  Of 66 included patients, 62 (TAVI-GA: n=31, TAVI-S: n=31) were finally analysed. Baseline characteristics were comparable. In 24 patients (39%) cerebral desaturation was observed. Cumulative cerebral desaturation was comparable (TAVI-GA:(median [IQR]) (0[0/1308] s%) vs. TAVI-S:(0[0/276] s%); P=0.505) between the groups. Neurocognitive function did not change within and between groups. Adverse events were more frequently observed in TAVI-S patients (P<0.001). Bradypnoea (n=16, 52%) and the need for airway manoeuvres (n=11, 36%) or bag-mask-ventilation (n=6, 19%) were the most common respiratory adverse events.
  
  
  CONCLUSIONS
  Cerebral desaturation occurred in both patient groups, but there was no significant difference between the two groups. Based on primary outcome, both methods were shown to be comparable. Neurocognitive outcome was similar. The higher incidence of adverse events in the sedation group suggests a potential advantage of general anaesthesia.
  
  
  BACKGROUND
  NCT 01251328.
authors.affiliation: Institut für Anästhesiologie, Deutsches Herzzentrum München des Freistaates Bayern, Technische Universität München, Lazarettstr. 36, D-80636 Munich, Germany patrick.mayr@tum.de.
authors.forename: N P
authors.initials: NP
authors.lastname: Mayr
authors.affiliation: Institut für Medizinische Statistik und Epidemiologie, Klinikum Rechts der Isar, Technische Universität München, Ismaningerstr. 22, D-81675 Munich, Germany.
authors.forename: A
authors.initials: A
authors.lastname: Hapfelmeier
authors.affiliation: Institut für Anästhesiologie, Deutsches Herzzentrum München des Freistaates Bayern, Technische Universität München, Lazarettstr. 36, D-80636 Munich, Germany.
authors.forename: K
authors.initials: K
authors.lastname: Martin
authors.affiliation: Klinik und Poliklinik für Psychiatrie und Psychotherapie, Klinikum Rechts der Isar, Technische Universität München, Ismaningerstr. 22, D-81675 Munich, Germany.
authors.forename: A
authors.initials: A
authors.lastname: Kurz
authors.affiliation: Department of Anesthesia, Stanford University Medical Center, Stanford, California, 300 Pasteur Drive, MC 5640, Stanford, CA 94305, USA.
authors.forename: P
authors.initials: P
authors.lastname: van der Starre
authors.affiliation: Department of Anesthesiology and Intensive Therapy, University of Szeged, 6. Semmelweis st., 6725 Szeged, Hungary.
authors.forename: B
authors.initials: B
authors.lastname: Babik
authors.affiliation: Klinik für Herz- und Gefäßchirurgie, Deutsches Herzzentrum München des Freistaates Bayern, Technische Universität München, Lazarettstr. 36, D-80636 Munich, Germany.
authors.forename: D
authors.initials: D
authors.lastname: Mazzitelli
authors.affiliation: Klinik für Herz- und Gefäßchirurgie, Deutsches Herzzentrum München des Freistaates Bayern, Technische Universität München, Lazarettstr. 36, D-80636 Munich, Germany.
authors.forename: R
authors.initials: R
authors.lastname: Lange
authors.affiliation: Institut für Anästhesiologie, Deutsches Herzzentrum München des Freistaates Bayern, Technische Universität München, Lazarettstr. 36, D-80636 Munich, Germany.
authors.forename: G
authors.initials: G
authors.lastname: Wiesner
authors.affiliation: Institut für Anästhesiologie, Deutsches Herzzentrum München des Freistaates Bayern, Technische Universität München, Lazarettstr. 36, D-80636 Munich, Germany.
authors.forename: P
authors.initials: P
authors.lastname: Tassani-Prell
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000768:Anesthesia, General / Q000009:adverse effects*; D001021:Aortic Valve / Q000601:surgery; D001921:Brain / Q000187:drug effects* / Q000503:physiopathology; D003072:Cognition Disorders / Q000139:chemically induced*; D054810:Deep Sedation / Q000009:adverse effects*; D005260:Female; D006801:Humans; D008297:Male; D009483:Neuropsychological Tests / Q000706:statistics & numerical data; D010092:Oximetry / Q000706:statistics & numerical data; D010100:Oxygen / Q000097:blood*; D012307:Risk Factors; D013055:Spectrophotometry, Infrared; D065467:Transcatheter Aortic Valve Replacement; D016896:Treatment Outcome
chemical_list: D010100:Oxygen
keywords: anaesthesia; aortic valve stenosis; brain; deep sedation; general; hypoxia; transcatheter aortic valve implantation