CytoSorbents Corporation (CTSO)

[techxen]

40 patient retrospective study-Journal of Artificial Organs

Below is the abstract of a study which was published this past week in the Journal of Artificial Organs. Note the reductions in key measurements especially the 30 day mortality rate. I believe in the past the 28 day rate has been in the range of 60-78%.

Blood Purification With CytoSorb in Critically Ill Patients: Single-Center Preliminary Experience
Maria Grazia Calabrò, Daniela Febres, Gaia Recca, Rosalba Lembo, Evgeny Fominskiy, Anna Mara Scandroglio, Alberto Zangrillo, Federico Pappalardo
First published: 29 August 2018
https://doi.org/10.1111/aor.13327

Abstract

The CytoSorb adsorber, a blood purification therapy, is able to remove molecules in the 5–60 kDa range which comprises the majority of inflammatory mediators and some endogenous molecules. We aimed to evaluate CytoSorb therapy on clinical outcomes in critically ill patients. A retrospective case series study, from February 2016 to May 2017, was performed in 40 patients with multiple organ failure who received CytoSorb treatment. There were 28 patients with cardiogenic shock, 2 with septic shock, 9 with acute respiratory distress syndrome, and 1 with liver failure. Nineteen patients (47%) underwent extracorporeal membrane oxygenation, 11 (27%) had an intra-aortic balloon pump, 9 (22%) were implanted with Impella, 6 (15%) had a ventricular assist device, and 18 (45%) were treated with continuous veno-venous hemofiltration. After CytoSorb treatment, total bilirubin decreased from 11.6 ± 9.2 to 6.8 ± 5.1 mg/dL (P = 0.005), lactate from 12.1 ± 8.7 to 2.9 ± 2.5 mmol/L (P < 0.001), CPK from 2416 (670–8615) to 281 (44–2769) U/L (P <0.001) and LDH from 1230 (860–3157) to 787 (536–1148) U/L (P <0.001). The vasoactive-inotropic score after 48 h of treatment was reduced to 10 points, P = 0.009. Thirty-day mortality was 55% and ICU mortality was 52.5% at expected ICU mortality of 80%. Our study shows that CytoSorbTM treatment is effective in reducing bilirubin, lactate, CPK and LDH, in critically ill patients mainly due to cardiogenic shock. There is a need for randomized controlled trials to conclude on the potential benefits blood purification with CytoSorb in critically ill patients.
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The significant difference in the mortality rate vs expected in this study has been something I had a difficult time reconciling with what was reported in the MedTech briefing that NICE published in 2016 having "found no differences in 30 to 60 day mortality" for 43 patients. (https://www.nice.org.uk/advice/mib87/chapter/clinical-and-technical-evidence). This is one of the reasons in my opinion that there has been limited sales in the UK (not to mention the pricing of the filter and the lackluster activity from the previous distributor).