title: Does total implantability reduce infection with the use of a left ventricular assist device? The LionHeart experience in Europe.
abstract: BACKGROUND
  Infection is the leading cause of death for left ventricular assist device (LVAD) patients with end-stage heart failure. Decreased infection may be possible with fully implantable LVADs such as the LionHeart, which lacks percutaneous conduits (PCs), a common source of device-related infection (DRI). This sub-study reports infections with the LionHeart and compares these results with historic data from the REMATCH trial, bridge to recovery (BTR) and bridge-to-transplantation (BTT) studies.
  
  
  METHODS
  Twenty-three patients were implanted with the LionHeart LVAD and followed until death or heart transplant during a non-randomized, multicenter, European trial from October 1999 to April 2004. The nature and incidence of infection were analyzed and adjudicated to definitions similar to, or the same as, the REMATCH definitions.
  
  
  RESULTS
  The combined number of implant days was 7,980, with a mean of 347 days (median 112, range 17 to 1,259 days). Survival at 1 year was 39%, with 2-year survival at 22%. Seventy-four percent of patients developed one or more infections, with 30% developing sepsis, and 35% developing pump-pocket infections (PSIs). No patients developed pump-housing or inflow- or outflow-tract infections (PI). For comparison, the prevalence rates of sepsis, PSI and PI in REMATCH were 51%, 35% and 19%, respectively.
  
  
  CONCLUSIONS
  The patients in the European LionHeart Clinical Utility Baseline Study (CUBS) trial had less sepsis and less overall DRI compared with the REMATCH LVAD group. Therefore, the fully implanted device may cause less infection than PC devices during destination therapy (DT). Although lower for DT, these rates are still higher than for some BTT experiences. Areas for future improvement include miniaturization of controller/battery components to reduce wound complications related to pocket size, and installation of more modern lithium-ion batteries to decrease the need for re-operations due to battery end-of-life.
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: Amos
authors.initials: A
authors.lastname: Adelowo
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; D004867:Equipment Design; D006353:Heart-Assist Devices / Q000009:adverse effects*; D006801:Humans; D015994:Incidence; D017053:Infection Control / Q000379:methods*; D007239:Infections / Q000453:epidemiology / Q000209:etiology; D008875:Middle Aged; D019736:Prostheses and Implants / Q000009:adverse effects*; D018570:Risk Assessment; D018805:Sepsis / Q000209:etiology / Q000401:mortality; D016019:Survival Analysis