title: Clinical Durability of the CARMEDA BioActive Surface in EXCOR Ventricular Assist Device Pumps.
abstract: The durability of CBAS Heparin Surface on EXCOR pumps retrieved after clinical use for varying periods of time was studied by analyzing samples for surface heparin density and bioactivity. The mean time of clinical use of the investigated 14 EXCOR pumps was 178 days (range, 15-461 days). Mean heparin density was 3.1 ± 0.6 μg/cm² (range, 2.2-4.8 μg/cm²), and the measured mean heparin bioactivity was 14 ± 5 ρmol/cm² (range: 7-27 ρmol/cm²). There was no detectable degradation or loss of function of CBAS Heparin Surface over time. Samples from the housing and the membrane of the EXCOR pump showed no significant difference in heparin bioactivity or density. The CBAS Heparin Surface stays on the surface and remains bioactive on the EXCOR pump at least up until 1 year. This is an important demonstration of coating durability and supports the mid-term and long-term clinical use as bridge-to-heart transplantation or to myocardial recovery.
authors.affiliation: From the *Department of Cardiac Surgery, Heart and Lung Center, Helsinki University Hospital, Helsinki, Finland; †Department of Anesthesia and Intensive Care, Helsinki University Hospital, Helsinki, Finland; ‡Department of Cardiothoracic Surgery, Sahlgrenska University Hospital, Gothenburg, Sweden; §Division of Pediatric Cardiac Surgery, The Queen Silvia Children's Hospital, Gothenburg, Sweden; ¶Carmeda AB, Upplands Väsby, Sweden; and ‖Berlin Heart GmbH, Berlin, Germany.
authors.forename: Kalervo
authors.initials: K
authors.lastname: Werkkala
authors.forename: Janne J
authors.initials: JJ
authors.lastname: Jokinen
authors.forename: Leena
authors.initials: L
authors.lastname: Soininen
authors.forename: Göran
authors.initials: G
authors.lastname: Dellgren
authors.forename: Stefan
authors.initials: S
authors.lastname: Hallhagen
authors.forename: Fredrik
authors.initials: F
authors.lastname: Sundberg
authors.forename: Jonas
authors.initials: J
authors.lastname: Andersson
authors.forename: Lars I
authors.initials: LI
authors.lastname: Dahms
authors.forename: Nadine
authors.initials: N
authors.lastname: Jurrmann
authors.forename: Simon
authors.initials: S
authors.lastname: Ersel
mesh_terms: D004355:Drug Stability; D006353:Heart-Assist Devices; D006493:Heparin / Q000032:analysis*; D006801:Humans
chemical_list: D006493:Heparin