Thomas Bochaton1, Laure Huot2, Meyer Elbaz3, Clement Delmas3, Nadia Aissaoui4, Fadi Farhat5, Nathan Mewton6, Eric Bonnefoy7. 1. Department of Intensive Cardiac Care, Hôpital Louis Pradel, Hospices Civils de Lyon, 59, boulevard Pinel, 69677 Bron, France. 2. Cellule Innovation, Hospices Civils de Lyon, 69677 Bron, France. 3. Department of Cardiology, Hôpital Rangueil, CHU de Toulouse, 31400 Toulouse, France. 4. Department of Intensive Care, Hôpital Européen Georges Pompidou, AP-HP, 75015 Paris, France. 5. Department of Cardiac Surgery, Hôpital Louis Pradel, Hospices Civils de Lyon, 69677 Bron, France. 6. Centre d'Investigation Clinique, Hôpital Louis Pradel, Hospices Civils de Lyon, 69677 Bron, France. 7. Department of Intensive Cardiac Care, Hôpital Louis Pradel, Hospices Civils de Lyon, 59, boulevard Pinel, 69677 Bron, France. Electronic address: eric.bonnefoy-cudraz@univ-lyon1.fr.
Abstract
BACKGROUND: Percutaneous assist devices may be used as a bridge to recovery in patients with acute myocardial infarction complicated by cardiogenic shock (CS-AMI). AIM: To test the hypothesis that the Impella®LP5.0 pump (Abiomed Europe GmbH, Aachen, Germany) provides haemodynamic benefits and improves left ventricular ejection fraction (LVEF) in patients with CS-AMI already managed with an intra-aortic balloon pump (IABP). METHODS: This was a prospective randomized study. The primary endpoint was change in cardiac power index (CPI) from baseline to 12hours after implantation, measured with a Swan-Ganz catheter. Secondary endpoints included LVEF at 30 days. RESULTS:Fifteen patients with CS-AMI were randomized; 12 were available for primary endpoint analysis (IABP group, n=6; Impella LP5.0+IABP group, n=6). Baseline characteristics were similar in both groups. Change in CPI after 12hours was not significantly different between the two groups (IABP group: ΔCPI=0.08±0.08W/m2; Impella LP5.0+IABP group: ΔCPI=-0.02±0.25W/m2; P=0.4). There was no significant change from baseline CPI in either group over 96hours, and no difference in CPI between groups at each timepoint. In the Impella LP5.0+IABP group, the part of the CPI provided by the native heart decreased from 0.37±0.10 to 0.10±0.20 (P=0.01). LVEF was similar at baseline (29.7%±8.4% and 29.3%±6.7%) and 1 month (40.6%±12.5% and 38.6%±14.4%) in the IABP and Impella LP5.0+IABP groups, respectively. Adverse events, especially major bleeding, were common, and occurred mainly in the Impella LP5.0+IABP group. CONCLUSIONS: In patients with CS-AMI stabilized by initial treatment with inotropes and an IABP, the Impella LP5.0 did not provide additional haemodynamic support or improvement in LVEF at 1 month; its use in this setting might be futile and possibly harmful.
RCT Entities:
BACKGROUND: Percutaneous assist devices may be used as a bridge to recovery in patients with acute myocardial infarction complicated by cardiogenic shock (CS-AMI). AIM: To test the hypothesis that the Impella® LP5.0 pump (Abiomed Europe GmbH, Aachen, Germany) provides haemodynamic benefits and improves left ventricular ejection fraction (LVEF) in patients with CS-AMI already managed with an intra-aortic balloon pump (IABP). METHODS: This was a prospective randomized study. The primary endpoint was change in cardiac power index (CPI) from baseline to 12hours after implantation, measured with a Swan-Ganz catheter. Secondary endpoints included LVEF at 30 days. RESULTS: Fifteen patients with CS-AMI were randomized; 12 were available for primary endpoint analysis (IABP group, n=6; Impella LP5.0+IABP group, n=6). Baseline characteristics were similar in both groups. Change in CPI after 12hours was not significantly different between the two groups (IABP group: ΔCPI=0.08±0.08W/m2; Impella LP5.0+IABP group: ΔCPI=-0.02±0.25W/m2; P=0.4). There was no significant change from baseline CPI in either group over 96hours, and no difference in CPI between groups at each timepoint. In the Impella LP5.0+IABP group, the part of the CPI provided by the native heart decreased from 0.37±0.10 to 0.10±0.20 (P=0.01). LVEF was similar at baseline (29.7%±8.4% and 29.3%±6.7%) and 1 month (40.6%±12.5% and 38.6%±14.4%) in the IABP and Impella LP5.0+IABP groups, respectively. Adverse events, especially major bleeding, were common, and occurred mainly in the Impella LP5.0+IABP group. CONCLUSIONS: In patients with CS-AMI stabilized by initial treatment with inotropes and an IABP, the Impella LP5.0 did not provide additional haemodynamic support or improvement in LVEF at 1 month; its use in this setting might be futile and possibly harmful.
Authors: Bernhard Wernly; Mina Karami; Annemarie E Engström; Stephan Windecker; Lukas Hunziker; Thomas F Lüscher; Jose P Henriques; Markus W Ferrari; Stephan Binnebößel; Maryna Masyuk; David Niederseer; Peter Abel; Georg Fuernau; Marcus Franz; Malte Kelm; Mathias C Busch; Stephan B Felix; Holger Thiele; Alexander Lauten; Christian Jung Journal: ESC Heart Fail Date: 2021-02-09