title: Drive-line infections and sepsis in patients receiving the HVAD system as a left ventricular assist device.
abstract: BACKGROUND
  Drive-line infections and sepsis lead to significant morbidity and even mortality in patients with ventricular assist devices (VADs). The HeartWare HVAD system is unique compared with other VAD systems in that it has a thin, flexible drive-line and is implanted directly into the pericardial space without the need for a pump pocket. We reviewed 332 patients receiving the HVAD in the pivotal ADVANCE Bridge to Transplant (BTT) trial and Continued Access Protocol (CAP) to determine the incidence of drive-line infections and sepsis.
  
  
  METHODS
  Summary statistics of outcomes and Kaplan-Meier freedom-from-event analyses were performed. The Cochran-Mantel-Haenszel test for homogeneity was used to determine whether there was any site effect on rates of either drive-line exit-site or sepsis infections.
  
  
  RESULTS
  Drive-line exit-site infections occurred in 16.9% (56 of 332) of patients (0.25 event per patient-year [EPPY]). These infections were primarily treated with antibiotics and most occurred >30 days post-implant (88%, or 66 of 75 drive-line infections). Sepsis occurred in 17.2% (57 of 332) of patients (0.23 EPPY), and sepsis events occurred more frequently >30 days post-implant (86%, or 60 of 70 sepsis events). Of patients with sepsis, 17.5% (10 of 57) died due to sepsis-related neurologic events (7 of 10) and multisystem organ failure (2 of 10) and cardiopulmonary failure (1 of 10), whereas there were no deaths related to drive-line infections. In addition, 17.5% (10 of 57) of patients had a stroke event while under treatment for sepsis (7 hemorrhagic and 3 ischemic strokes), and 3.5% (2 of 57 patients with sepsis) had a device exchange for VAD thrombus (4 days before and 1 day after sepsis diagnosis). Patients with drive-line infections or sepsis had a larger body mass index compared to those without infection (29.4 vs 27.6 kg/m(2), p = 0.015), and were more frequently diabetic (43.7% vs 31.2%, p = 0.034). Although there was no negative impact on survival in patients with drive-line exit-site infections, there was a trend for reduced survival in patients with sepsis events when compared to those patients without sepsis.
  
  
  CONCLUSIONS
  The incidence of drive-line infection and sepsis was low in patients receiving the HVAD pump. Despite a trend toward reduced survival in patients with sepsis events, the overall survival of patients with either drive-line infections or sepsis was excellent.
authors.affiliation: Department of Cardiovascular and Cardiac Surgery, University of Minnesota, Minneapolis, Minnesota. Electronic address: johnx008@umn.edu.
authors.forename: Ranjit
authors.initials: R
authors.lastname: John
authors.affiliation: Division of Cardiovascular Medicine, University of Michigan, Ann Arbor, Michigan.
authors.forename: Keith D
authors.initials: KD
authors.lastname: Aaronson
authors.affiliation: Division of Cardiothoracic Surgery, Pennsylvania State University, Hershey, Pennsylvania.
authors.forename: Walter E
authors.initials: WE
authors.lastname: Pae
authors.affiliation: Division of Cardiovascular Surgery, University of Pennsylvania, Philadelphia, Pennsylvania.
authors.forename: Michael A
authors.initials: MA
authors.lastname: Acker
authors.affiliation: Department of Clinical Affairs, HeartWare, Inc., Framingham, Massachusetts.
authors.forename: David R
authors.initials: DR
authors.lastname: Hathaway
authors.affiliation: Department of Clinical Affairs, HeartWare, Inc., Framingham, Massachusetts.
authors.forename: Kevin B
authors.initials: KB
authors.lastname: Najarian
authors.affiliation: Thoracic and Cardiovascular Surgery Division, University of Louisville, Louisville, Kentucky.
authors.forename: Mark S
authors.initials: MS
authors.lastname: Slaughter
mesh_terms: D000328:Adult; D000368:Aged; D000900:Anti-Bacterial Agents / Q000627:therapeutic use; D004866:Equipment Contamination; D004867:Equipment Design; D005260:Female; D005500:Follow-Up Studies; D006333:Heart Failure / Q000628:therapy*; D006353:Heart-Assist Devices / Q000145:classification* / Q000382:microbiology*; D006801:Humans; D015994:Incidence; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies; D018805:Sepsis / Q000188:drug therapy / Q000453:epidemiology* / Q000401:mortality; D016896:Treatment Outcome
chemical_list: D000900:Anti-Bacterial Agents
keywords: drive-line infection; heart failure; infection; mechanical support; sepsis