title: Neurologic events with a totally implantable left ventricular assist device: European LionHeart Clinical Utility Baseline Study (CUBS).
abstract: BACKGROUND
  Neurologic events such as thromboembolic and hemorrhagic strokes are common complications of mechanical circulatory support. We report the neurologic events observed in patients treated for end-stage heart failure with the implantable, pulsatile LionHeart left ventricular assist device (LVAD). This sub-study was part of the LionHeart European Clinical Utility Baseline Study (CUBS).
  
  
  METHODS
  Twenty-three male patients were implanted with the LionHeart LVAD in a non-randomized, observational study. Neurologic events were classified into three categories: (1) transient ischemic attacks (TIAs); (2) strokes, including cerebrovascular accidents (CVAs) and intracranial bleeding (ICB); and (3) "other," including hypoperfusion, coma and brain death. Neurologic injuries were also categorized as transient/reversible or permanent/disabling.
  
  
  RESULTS
  Thirteen of 23 patients (57%) had a total of 30 neurologic events. Eight patients (35%) had 18 TIAs. Eight patients (35%) also had a stroke, either CVA (n = 5, 22%) or ICB (n = 3, 13%), and 5 of these patients (22%) also had 12 TIAs. Three patients (13%) had 4 "other" neurologic events. Ten patients (43%) had transient/reversible neurologic deficits and 10 (43%) had permanent/disabling events. One patient (4%) had intracranial bleeding as a primary cause of death (anti-coagulation-related hemorrhage). The combined incidence of neurologic events was 1.37 events/patient-year. The incidences of transient and permanent events were 0.91 and 0.46 event/patient-year, respectively.
  
  
  CONCLUSIONS
  Neurologic events caused morbidity in the CUBS trial, with infrequent mortality. These results are similar to previous experiences with destination therapy and underscore the need for improvements in LVAD design, patient selection and patient management to reduce the incidence of neurologic events.
authors.affiliation: Heart and Vascular Institute, Milton S. Hershey Medical Center, Pennsylvania State University College of Medicine, Hershey, Pennsylvania 17033-0850, USA. wpae@psu.edu
authors.forename: Walter E
authors.initials: WE
authors.lastname: Pae
authors.forename: John M
authors.initials: JM
authors.lastname: Connell
authors.forename: John P
authors.initials: JP
authors.lastname: Boehmer
authors.forename: Reiner
authors.initials: R
authors.lastname: Korfer
authors.forename: Aly
authors.initials: A
authors.lastname: El-Banayosy
authors.forename: Roland
authors.initials: R
authors.lastname: Hetzer
authors.forename: Mario
authors.initials: M
authors.lastname: Vigano
authors.forename: Alain
authors.initials: A
authors.lastname: Pavie
mesh_terms: D000368:Aged; D005500:Follow-Up Studies; D005602:France / Q000453:epidemiology; D006333:Heart Failure / Q000628:therapy*; D006353:Heart-Assist Devices / Q000009:adverse effects*; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D011379:Prognosis; D011446:Prospective Studies; D012307:Risk Factors; D020521:Stroke / Q000453:epidemiology / Q000209:etiology*