title: Magnetic resonance imaging for cerebral lesions during minimal invasive mitral valve surgery: study protocol for a randomized controlled trial.
abstract: Recent data have highlighted a higher rate of neurological injuries in minimal invasive mitral valve surgery (MIMVS) compared with the standard sternotomy approach; therefore, the role of specific clamping techniques and perfusion strategies on the occurrence of this complication is a matter of discussion in the medical literature. The purpose of this trial is to prospectively evaluate major, minor and silent neurological events in patients undergoing right mini-thoracotomy mitral valve surgery using retrograde perfusion and an endoaortic clamp or a transthoracic clamp.
  
  
  
  A prospective, blinded, randomized controlled study on the rate of neurological embolizations during MIMVS started at the University of Turin in June 2014. Major, minor and silent neurological events are being investigated through standard neurological evaluation and magnetic resonance imaging assessment. The magnetic resonance imaging protocol includes conventional sequences for the morphological and quantitative assessment and nonconventional sequences for the white matter microstructural evaluation. Imaging studies are performed before surgery as baseline assessment and on the third postoperative day and, in patients who develop postoperative ischemic lesions, after 6 months.
  
  
  
  Despite recent concerns raised about the endoaortic setting with retrograde perfusion, we expect to show equivalence in terms of neurological events of this technique compared with the transthoracic clamp in a selected cohort of patients. With the first results expected in December 2016 the findings would be of help in confirming the efficacy and safety of MIMVS.
  
  
  
  ClinicalTrials.gov, Identifier: NCT02818166 . Registered on 8 February 2016 - trial retrospectively registered.
authors.affiliation: Department of Cardiovascular and Thoracic Surgery, University of Turin, Corso Bramante 88, 10126, Turin, Italy. cristina.barbero@unito.it.
authors.forename: Cristina
authors.initials: C
authors.lastname: Barbero
authors.affiliation: Department of Cardiovascular and Thoracic Surgery, University of Turin, Corso Bramante 88, 10126, Turin, Italy.
authors.forename: Davide
authors.initials: D
authors.lastname: Ricci
authors.affiliation: Department of Cardiovascular and Thoracic Surgery, University of Turin, Corso Bramante 88, 10126, Turin, Italy.
authors.forename: Erik
authors.initials: E
authors.lastname: Cura Stura
authors.affiliation: Department of Cardiovascular and Thoracic Surgery, University of Turin, Corso Bramante 88, 10126, Turin, Italy.
authors.forename: Augusto
authors.initials: A
authors.lastname: Pellegrini
authors.affiliation: Department of Cardiovascular and Thoracic Surgery, University of Turin, Corso Bramante 88, 10126, Turin, Italy.
authors.forename: Giovanni
authors.initials: G
authors.lastname: Marchetto
authors.affiliation: Department of Cardiovascular and Thoracic Surgery, University of Turin, Corso Bramante 88, 10126, Turin, Italy.
authors.forename: Suad
authors.initials: S
authors.lastname: ElQarra
authors.affiliation: Department of Cardiovascular and Thoracic Surgery, University of Turin, Corso Bramante 88, 10126, Turin, Italy.
authors.forename: Massimo
authors.initials: M
authors.lastname: Boffini
authors.affiliation: Department of Nuclear Medicine, University of Turin, Turin, Italy.
authors.forename: Roberto
authors.initials: R
authors.lastname: Passera
authors.affiliation: Department of Neuroradiology, University of Turin, Turin, Italy.
authors.forename: Maria Consuelo
authors.initials: MC
authors.lastname: Valentini
authors.affiliation: Department of Cardiovascular and Thoracic Surgery, University of Turin, Corso Bramante 88, 10126, Turin, Italy.
authors.forename: Mauro
authors.initials: M
authors.lastname: Rinaldi
mesh_terms: D000328:Adult; D000368:Aged; D001011:Aorta / Q000601:surgery; D058070:Asymptomatic Diseases; D006348:Cardiac Surgical Procedures / Q000009:adverse effects / Q000379:methods*; D002561:Cerebrovascular Disorders / Q000000981:diagnostic imaging* / Q000209:etiology; D002985:Clinical Protocols; D003250:Constriction; D005260:Female; D006801:Humans; D007558:Italy; D008279:Magnetic Resonance Imaging; D008297:Male; D008875:Middle Aged; D008943:Mitral Valve / Q000601:surgery*; D011237:Predictive Value of Tests; D011446:Prospective Studies; D012107:Research Design; D012307:Risk Factors; D013908:Thoracotomy / Q000009:adverse effects; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
keywords: Magnetic resonance; Minimal invasive surgery; Mitral valve; Stroke