Microaxial Flow Pump Use and Renal Outcomes in Infarct-Related Cardiogenic Shock: A Secondary Analysis of the DanGer Shock Trial.

Background: In DanGer Shock (the Danish-German Cardiogenic Shock trial), use of a microaxial flow pump (mAFP) in patients with ST-segment-elevation myocardial infarction-related cardiogenic shock led to lower all-cause mortality but higher rates of renal replacement therapy (RRT). In this prespecified analysis, rates and predictors of acute kidney injury (AKI) and RRT were assessed.
Methods: In this international, randomized, open-label, multicenter trial, 355 adult patients with ST-segment-elevation myocardial infarction-related cardiogenic shock were randomized to mAFP (n=179) or standard care alone (n=176). AKI was defined according to RIFLE criteria (Risk, Injury, Failure, Loss, and End-stage kidney disease) and assessed using logistic regression models. Use of RRT was assessed accounting for the competing risk of death using Fine-Gray subdistribution hazard models.
Results: AKI (RIFLE ≥1) was recorded in 110 patients (61%) in the mAFP group and 79 patients (45%) in the control group ( P <0.01); RRT was used in 75 (42%) and 47 (27%) patients, respectively ( P <0.01). About two-thirds of the RRTs were initiated within the first 24 hours from admission (n=48 [64%] in the mAFP group and n=31 [66%] in the control group). Occurrence of AKI and RRT were associated with higher 180-day mortality in both study arms. At 180 days, all patients alive were free of RRT. mAFP use was associated with higher rates of RRT, even when accounting for competing risk of death (subdistribution hazard, 1.67 [1.18-2.35]). This association was largely consistent among prespecified subgroups. Allocation to mAFP was associated with lower 180-day mortality irrespective of AKI or RRT ( P _interaction =0.84). Relevant predictors of AKI in both groups comprised reduced left ventricular ejection fraction, baseline kidney function, shock severity, bleeding events, and positive fluid balance. Predictors of AKI specific to mAFP were suction events, higher pump speed, and longer duration of support.
Conclusions: Shock severity, allocation to mAFP, and device-related complications were associated with an increased risk of AKI. AKI was generally associated with higher mortality, but the allocation to mAFP consistently led to lower mortality rates at 180 days irrespective of the occurrence of AKI with or without RRT initiation.
Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01633502.
Competing Interests: Dr Zweck reports a travel grant from Abiomed Inc. Dr Hassager reports institutional research grants from Novo Nordisk Foundation, Lundbeck Foundation, and Danish Heart Foundation outside the submitted work. Dr Beske has nothing to disclose. Dr Jensen reports unrestricted institutional research grants from Biosensors International Group and Biotronik. Dr Eiskjær reports institutional research grants from Novo Nordisk Foundation and Independent Research Fund Denmark and speaker fees from Novartis outside the submitted work. Dr Mangner received a research and an educational grant from Abiomed to his institution, outside the submitted work; an educational grant from Boston Scientific to his institution, outside the submitted work; and personal fees from Edwards Lifesciences, Medtronic, Biotronik, Novartis, Sanofi Genzyme, AstraZeneca, Pfizer, Daiichi Sankyo, Abbott, Abiomed, B. Braun, and Boston Scientific, outside the submitted work. Dr Polzin reports institutional research grants and personal speaker honoraria from Abiomed Inc. Dr Schulze reports grants from Boehringer Ingelheim, Abiomed Inc, Edwards Inc, Cytosorb Inc, and Boston Sci; consulting fees or honoraria from Bayer, Astra Zeneca, Daiichi Sankyo, Novartis, Actelion, Roche, Sanofi Aventis, Pharmacosmos, Medtronic, Thoratec, Boehringer Ingelheim, Heartware, Coronus, Abbott, Boston Scientific, St Jude Medical, Abiomed, and DGK; and trial committee work for Abbott and Abiomed. Dr Skurk reports speaker honoraria from Abiomed. Dr Nordbeck reports speaker honoraria from Abiomed, Bayer Healthcare, Boehringer Ingelheim, Daiichi Sankyo Europe GmbH, and Pfizer. Dr Clemmensen reports consultant fees from Acarix AB, is an investigator for Acarix AB and Bayer Healthcare, and is on End Point Review Committees for Boehringer Ingelheim and WGC, outside the submitted work. Dr Panoulas reports consultant fees, honoraria, and an educational grant from Abiomed J&J. Dr Zimmer reports speaking engagements and serves on the scientific advisory board for Abiomed. Dr Schäfer received honoraria from Abiomed, ZOLL Circulation, AstraZeneca, Amgen, BMS, Pfizer, Daiichi-Sankyo, Eli Lilly, and Boehringer Ingelheim, as well as an institutional grant from Abiomed and Daiichi-Sankyo. Dr Kelm reports grant support from Abbott Vascular, Abiomed, Amgen, B. Braun, Boston Scientific, Daiichi Sankyo, Mars, Edwards LifeSciences, Medtronic, Microvision Medical Holding B.V., Philips, and the German Research Foundation, and is on the Scientific Advisory Board for Mars. Dr Engstrøm reports speakers fees from Boston Scientific, Abbott, and Novo Nordisk, and advisory board fees from Novo Nordisk and Abbott; and has received educational grants from Novo Nordisk and The Danish Heart Foundation. Dr Holmvang received a travel grant from Boston Scientific. Drs Junker and Schmidt have nothing to disclose. Dr Terkelsen reports research grants from Novo Nordisk and Danish Heart Foundation not related to this topic; unrestricted research grants from Meril and Terumo not related to this topic; and lecture and proctor fees from Meril and Terumo not related to this topic. Dr Linke reports consultant and speaker honoraria from Abbott Laboratories, Abiomed, AstraZeneca, Bayer, Boehringer Ingelheim, Boston Scientific Corporation, Corvia, Daiichi Sankyo Europe GmbH, Edwards Lifesciences, Medtronic USA, Novartis, and Pfizer, and stock options for Picardia, Transverse Medical Inc. Dr Westenfeld is employed by Abiomed Inc. Dr Møller reports institutional research grants from Novo Nordik Foundation and Abiomed and serves as an advisor for Boston Scientific.