Methods:
This single-center prospective observational study was performed between
May 2013 and January 2016. A total of 50 consecutive patients indicated
to long-term LVAD implantation (48 HeartMate II VADs, 2 HeartMate 3
VADs; Abbott, Abbott Park, IL, USA) as a bridge to heart transplantation
were included (INTERMACS profiles: 2 - 19/50, 3 - 18/50, 4 - 13/50).
Exclusion criteria were active infection in 48 hours prior to the
surgery, known immune disorder, immunosuppressive drugs in medication
and previous short-term LVAD or extracorporeal membrane oxygenation.
Preoperative characteristics and baseline values before LVAD
implantation are summarized in table 1.
PCT and PSEP levels were assessed before the surgery and during the
post-operative period – on the first, second, 14thand 30th post-operative day (POD). PCT (reference
range <0.5 µg/L; intermediate precision <2.5%) was
measured on a Roche Cobas 6000 analyser (Roche Diagnostics, Rotkreuz,
Switzerland) with the Elecsys Brahms Procalcitonin kit (cat. no.
05056888; Roche Diagnostics, Mannheim, Germany). PSEP
(reference range 60-365 ng/L; total precision <5%) was
measured on a Mitsubishi Pathfast analyser using a Pathfast Presepsin
kit (cat. no. PF 1201-K; Mitsubishi Chemical Medience Corporation,
Tokyo, Japan).
The PCT and PSEP values were compared according to the presence of IC.
The definition of the IC was clinically relevant infection (i.e. single
positive urine culture without any other signs or symptoms of the
infection was excluded) confirmed by at least two physicians in regard
to the complete medical chart (sings, symptoms, body temperature, blood
samples, cultures, imaging methods etc.).
Values are presented as a median with interquartile range in µg/L (PCT)
or ng/L (PSEP). Statistical analysis using Mann-Whitney test with
Bonferroni correction was performed by MedCalc software (version
12.5.0.0) and a p value of 0.05 or less was considered
statistically significant. Study protocol has been approved by
institutional review board (IRB) and all patients gave written informed
consent.