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Temporary mechanical circulatory support in infarct-related cardiogenic shock: an individual patient data meta-analysis of randomised trials with 6-month follow-up

2024; Elsevier BV; Volume: 404; Issue: 10457 Linguagem: Inglês

10.1016/s0140-6736(24)01448-x

1474-547X

Holger Thiele, Jacob Eifer Møller, José P.S. Henriques, Margriet Bogerd, Melchior Seyfarth, Daniel Burkhoff, Petr Ošťádal, Richard Rokyta, Jan Bělohlávek, Steffen Maßberg, Marcus Flather, Matthias Hochadel, Steffen Schneider, Steffen Desch, Anne Freund, Hans Eiskjær, Norman Mangner, Janine Pöss, Amin Polzin, P. Christian Schulze, Carsten Skurk, Uwe Zeymer, Christian Hassager, Daniel Burkhoff, Howard Cohen, Corinna Brunckhorst, William W. O’Neill, Hölger Thiele, Peter Sick, Enno Boudriot, Klaus-Werner Diederich, Rainer Hambrecht, Josef Niebauer, Gerhard Schüler, Melchior Seyfarth, Dirk Sibbing, Iris Bauer, Georg Fröhlich, Lorenz Bott‐Flügel, Robert A. Byrne, Josef Dirschinger, Adnan Kastrati, Albert Schömig, Dagmar M. Ouweneel, Erlend Eriksen, Krischan D. Sjauw, Ivo M. van Dongen, Alexander Hirsch, Erik Jerome Stene Packer, M. Marie Vis, Joanna J. Wykrzykowska, Karel T. Koch, Jan Baan, Robbert J. de Winter, Jan J. Piek, Wim K. Lagrand, Bas A.J.M. de Mol, Jan G.P. Tijssen, José P.S. Henriques, Jacob Eifer Møller, Thomas Engstrøm, Lisette Okkels Jensen, Hans Eiskjær, Norman Mangner, Amin Polzin, P. Christian Schulze, Carsten Skurk, Peter Nordbeck, Peter Clemmensen, Vasileios Panoulas, Sebastian Zimmer, Andreas Schäfer, Nikos Werner, Martin Frydland, Lene Holmvang, Jesper Kjærgaard, Rikke Sørensen, Jacob Lønborg, Matias Greve, Evald Høj Christiansen, Axel Linke, Felix Woitek, Ralf Westenfeld, S Moebius-Winkler, Kristian Wachtell, Hanne Berg Ravn, Jens Flensted Lassen, Søren Boesgaard, Oke Gerke, Christian Hassager, Korbinian Lackermair, Stefan Brunner, Mathias Orban, Sven Peterß, Martin Orban, Hans Theiß, Bruno Hüber, Gerd Juchem, F. Born, Anne‐Laure Boulesteix, Axel Bauer, Maximilian Pichlmaier, Jörg Hausleiter, Steffen Maßberg, Christian Hagl, S. Guenther, Petr Ošťádal, Richard Rokyta, Jiří Karásek, Andreas Krüger, Dagmar Vondraková, Marek Janotka, Jan Naar, Jana Šmalcová, Markéta Hubatová, Milan Hromadk, Štefan Volovár, Miroslava Seyfrydova, Jiří Jarkovský, Michal Svoboda, Aleš Linhart, Jan Bělohlávek, Amerjeet Banning, Manel Sabaté, Martin Orban, Jay Gracey, Teresa López‐Sobrino, Steffen Maßberg, Adnan Kastrati, Kris Bogaerts, Tom Adriaenssens, Colin Berry, Andrejs Ērglis, Steven Haine, Truls Myrmel, Sameer Patel, Irene Buera, Alessandro Sionís, Victòria Vilalta, Hakeem Yusuff, Christiaan Vrints, David Adlam, Marcus Flather, Anthony Gershlick, Holger Thiele, Uwe Zeymer, İbrahim Akın, Michael Behnes, Tienush Rassaf, Amir-Abbas Mahabadi, Ralf Lehmann, Ingo Eitel, Tobias Graf, Tim Seidler, Andreas Schuster, Carsten Skurk, Daniel Duerschmied, Peter Clemmensen, Marcus Hennersdorf, Stephan Fichtlscherer, Ingo Voigt, Melchior Seyfarth, Stefan John, Sebastian Ewen, Axel Linke, Eike Tigges, Peter Nordbeck, Leonhard Bruch, Christian Jung, Jutta Franz, Philipp Lauten, Tomaž Goslar, Hans‐Josef Feistritzer, Janine Pöss, Eva Kirchhof, Taoufik Ouarrak, Steffen Schneider, Steffen Desch, Anne Freund,

Cardiac Arrest and Resuscitation

SummaryBackgroundPercutaneous active mechanical circulatory support (MCS) devices are being increasingly used in the treatment of acute myocardial infarction-related cardiogenic shock (AMICS) despite conflicting evidence regarding their effect on mortality. We aimed to ascertain the effect of early routine active percutaneous MCS versus control treatment on 6-month all-cause mortality in patients with AMICS.MethodsIn this individual patient data meta-analysis, randomised controlled trials of potential interest were identified, without language restriction, by querying the electronic databases MEDLINE via PubMed, Cochrane Central Register of Controlled Trials, and Embase, as well as ClinicalTrials.gov, up to Jan 26, 2024. All randomised trials with 6-month mortality data comparing early routine active MCS (directly in the catheterisation laboratory after randomisation) versus control in patients with AMICS were included. The primary outcome was 6-month all-cause mortality in patients with AMICS treated with early routine active percutaneous MCS versus control, with a focus on device type (loading, such as venoarterial extracorporeal membrane oxygenation [VA-ECMO] vs unloading) and patient selection. Hazard ratios (HRs) of the primary outcome measure were calculated using Cox regression models. This study is registered with PROSPERO, CRD42024504295.FindingsNine reports of randomised controlled trials (n=1114 patients) were evaluated in detail. Overall, four randomised controlled trials (n=611 patients) compared VA-ECMO with a control treatment and five randomised controlled trials (n=503 patients) compared left ventricular unloading devices with a control treatment. Two randomised controlled trials also included patients who did not have AMICS, who were excluded (55 patients [44 who were treated with VA-ECMO and 11 who were treated with a left ventricular unloading device]). The median patient age was 65 years (IQR 57–73); 845 (79·9%) of 1058 patients with data were male and 213 (20·1%) were female. No significant benefit of early unselected MCS use on 6-month mortality was noted (HR 0·87 [95% CI 0·74–1·03]; p=0·10). No significant differences were observed for left ventricular unloading devices versus control (0·80 [0·62–1·02]; p=0·075), and loading devices also had no effect on mortality (0·93 [0·75–1·17]; p=0·55). Patients with ST-elevation cardiogenic shock without risk of hypoxic brain injury had a reduction in mortality with MCS use (0·77 [0·61–0·97]; p=0·024). Major bleeding (odds ratio 2·64 [95% CI 1·91–3·65]) and vascular complications (4·43 [2·37–8·26]) were more frequent with MCS use than with control.InterpretationThe use of active MCS devices in patients with AMICS did not reduce 6-month mortality (regardless of the device used) and increased major bleeding and vascular complications. However, patients with ST-elevation cardiogenic shock without risk of hypoxic brain injury had a reduction in mortality after MCS use. Therefore, the use of MCS should be restricted to certain patients only.FundingThe Heart Center Leipzig at Leipzig University and the Foundation Institut für Herzinfarktforschung.