title: Novel emboli protection system during cardiac surgery: a multi-center, randomized, clinical trial.
abstract: BACKGROUND
  Stroke is a major cause of morbidity and mortality during open-heart surgery. Up to 60% of intraoperative cerebral events are emboli induced. This randomized, controlled, multicenter trial is the first human study evaluating the safety and efficacy of a novel aortic cannula producing simultaneous forward flow and backward suction for extracting solid and gaseous emboli from the ascending aorta and aortic arch upon their intraoperative release.
  
  
  METHODS
  Sixty-six patients (25 females; 68±10 years) undergoing elective aortic valve replacement surgery, with or without coronary artery bypass graft surgery, were randomized to the use of the CardioGard (CardioGard Medical, Or-Yehuda, Israel) Emboli Protection cannula ("treatment") or a standard ("control") aortic cannula. The primary endpoint was the volume of new brain lesions measured by diffusion-weighted magnetic resonance imaging (DW-MRI), performed preoperatively and postoperatively. Device safety was investigated by comparisons of complications rate, namely neurologic events, stroke, renal insufficiency and death.
  
  
  RESULTS
  Of 66 patients (34 in the treatment group), 51 completed the presurgery and postsurgery MRI (27 in the treatment group). The volume of new brain lesion for the treatment group was (mean±standard error of the mean) 44.00±64.00 versus 126.56±28.74 mm3 in the control group (p=0.004). Of the treatment group, 41% demonstrated new postoperative lesions versus 66% in the control group (p=0.03). The complication rate was comparable in both groups.
  
  
  CONCLUSIONS
  The CardioGard cannula is safe and efficient in use during open-heart surgery. Efficacy was demonstrated by the removal of a substantial amount of emboli, a significant reduction in the volume of new brain lesions, and the percentage of patients experiencing new brain lesions.
authors.affiliation: Department of Cardiac Surgery, Rambam Health Care Campus, and Faculty of Medicine, Technion-Israel Institute of Technology, Haifa, Israel. Electronic address: g_bolotin@rambam.health.gov.il.
authors.forename: Gil
authors.initials: G
authors.lastname: Bolotin
authors.affiliation: University Clinic for Cardiovascular Surgery Inselspital, Bern, Switzerland.
authors.forename: Christoph Hans
authors.initials: CH
authors.lastname: Huber
authors.affiliation: Department of Cardiac Surgery, Rambam Health Care Campus, and Faculty of Medicine, Technion-Israel Institute of Technology, Haifa, Israel.
authors.forename: Liran
authors.initials: L
authors.lastname: Shani
authors.affiliation: Heart Center Leipzig, University of Leipzig, Leipzig, Germany.
authors.forename: Friedrich Wilhelm
authors.initials: FW
authors.lastname: Mohr
authors.affiliation: University Clinic for Cardiovascular Surgery Inselspital, Bern, Switzerland.
authors.forename: Thierry P
authors.initials: TP
authors.lastname: Carrel
authors.affiliation: Heart Center Leipzig, University of Leipzig, Leipzig, Germany.
authors.forename: Michael Andrew
authors.initials: MA
authors.lastname: Borger
authors.affiliation: University Hospital Zurich, Zurich, Switzerland.
authors.forename: Volkmar
authors.initials: V
authors.lastname: Falk
authors.affiliation: University of Oxford, Oxford, United Kingdom.
authors.forename: David
authors.initials: D
authors.lastname: Taggart
authors.affiliation: Department of Cardiac Surgery, Rambam Health Care Campus, and Faculty of Medicine, Technion-Israel Institute of Technology, Haifa, Israel.
authors.forename: Rony-Reuven
authors.initials: RR
authors.lastname: Nir
authors.affiliation: University Clinic for Cardiovascular Surgery Inselspital, Bern, Switzerland.
authors.forename: Lars
authors.initials: L
authors.lastname: Englberger
authors.affiliation: Heart Center Leipzig, University of Leipzig, Leipzig, Germany.
authors.forename: Joerg
authors.initials: J
authors.lastname: Seeburger
authors.affiliation: University Hospital Zurich, Zurich, Switzerland.
authors.forename: Etem
authors.initials: E
authors.lastname: Caliskan
authors.affiliation: University Hospital Zurich, Zurich, Switzerland.
authors.forename: Christoph Thomas
authors.initials: CT
authors.lastname: Starck
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001024:Aortic Valve Stenosis / Q000601:surgery; D038524:Diffusion Magnetic Resonance Imaging; D057505:Embolic Protection Devices; D004617:Embolism / Q000175:diagnosis / Q000453:epidemiology / Q000517:prevention & control*; D004867:Equipment Design; D005260:Female; D005500:Follow-Up Studies; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D016896:Treatment Outcome