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Clinical Trial
. 2020 Dec;142(22):2095-2106.
doi: 10.1161/CIRCULATIONAHA.120.048792. Epub 2020 Oct 9.

Left Ventricular Unloading Is Associated With Lower Mortality in Patients With Cardiogenic Shock Treated With Venoarterial Extracorporeal Membrane Oxygenation: Results From an International, Multicenter Cohort Study

Benedikt Schrage  1   2 , Peter Moritz Becher  1   2 , Alexander Bernhardt  3   2 , Hiram Bezerra  4 , Stefan Blankenberg  1   2 , Stefan Brunner  5 , Pascal Colson  6 , Gaston Cudemus Deseda  7 , Salim Dabboura  1 , Dennis Eckner  8 , Matthias Eden  2   9 , Ingo Eitel  2   10 , Derk Frank  2   9 , Norbert Frey  2   9 , Masaki Funamoto  11 , Alina Goßling  1 , Tobias Graf  2   10 , Christian Hagl  12 , Paulus Kirchhof  1   2   13 , Danny Kupka  1   5 , Ulf Landmesser  14   15 , Jerry Lipinski  16 , Mathew Lopes  17 , Nicolas Majunke  18 , Octavian Maniuc  5   19 , Daniel McGrath  11 , Sven Möbius-Winkler  20 , David A Morrow  17 , Marc Mourad  6 , Curt Noel  2   9 , Peter Nordbeck  19 , Martin Orban, Federico Pappalardo  21   22 , Sandeep M Patel  23 , Matthias Pauschinger  8 , Vittorio Pazzanese  21 , Hermann Reichenspurner  3 , Marcus Sandri  18 , P Christian Schulze  20 , Robert H G Schwinger  24 , Jan-Malte Sinning  25 , Adem Aksoy  25 , Carsten Skurk  14   15 , Lukasz Szczanowicz  18 , Holger Thiele  18 , Franziska Tietz  18 , Anubodh Varshney  17 , Lukas Wechsler  24 , Dirk Westermann  2
Affiliations
Clinical Trial

Left Ventricular Unloading Is Associated With Lower Mortality in Patients With Cardiogenic Shock Treated With Venoarterial Extracorporeal Membrane Oxygenation: Results From an International, Multicenter Cohort Study

Benedikt Schrage et al. Circulation. 2020 Dec.

Abstract

Background: Venoarterial extracorporeal membrane oxygenation (VA-ECMO) is increasingly used to treat cardiogenic shock. However, VA-ECMO might hamper myocardial recovery. The Impella unloads the left ventricle. This study aimed to evaluate whether left ventricular unloading in patients with cardiogenic shock treated with VA-ECMO was associated with lower mortality.

Methods: Data from 686 consecutive patients with cardiogenic shock treated with VA-ECMO with or without left ventricular unloading using an Impella at 16 tertiary care centers in 4 countries were collected. The association between left ventricular unloading and 30-day mortality was assessed by Cox regression models in a 1:1 propensity score-matched cohort.

Results: Left ventricular unloading was used in 337 of the 686 patients (49%). After matching, 255 patients with left ventricular unloading were compared with 255 patients without left ventricular unloading. In the matched cohort, left ventricular unloading was associated with lower 30-day mortality (hazard ratio, 0.79 [95% CI, 0.63-0.98]; P=0.03) without differences in various subgroups. Complications occurred more frequently in patients with left ventricular unloading: severe bleeding in 98 (38.4%) versus 45 (17.9%), access site-related ischemia in 55 (21.6%) versus 31 (12.3%), abdominal compartment in 23 (9.4%) versus 9 (3.7%), and renal replacement therapy in 148 (58.5%) versus 99 (39.1%).

Conclusions: In this international, multicenter cohort study, left ventricular unloading was associated with lower mortality in patients with cardiogenic shock treated with VA-ECMO, despite higher complication rates. These findings support use of left ventricular unloading in patients with cardiogenic shock treated with VA-ECMO and call for further validation, ideally in a randomized, controlled trial.

Keywords: extracorporeal membrane oxygenation; shock, cardiogenic.

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Figures

Figure 1.
Figure 1.
Kaplan-Meier curve of the unmatched study cohort. ECMELLA indicates Impella+extracorporeal membrane oxygenation; HR, hazard ratio; and VA-ECMO, venoarterial extracorporeal membrane oxygenation.
Figure 2.
Figure 2.
Kaplan-Meier curve of the matched study cohort. ECMELLA indicates Impella+extracorporeal membrane oxygenation; HR, hazard ratio; and VA-ECMO, venoarterial extracorporeal membrane oxygenation.
Figure 3.
Figure 3.
Association between ECMELLA use and 30-day all-cause mortality in prespecified subgroups. P interaction is 0.79 for age <52 years versus age 52 to 62 years, 0.95 for age <52 years versus age >62 years, and 0.82 for age 52 to 62 years versus age >62 years. P interaction is 0.23 for lactate <5 mmol/L versus 5 to 10.8 mmol/L, 0.20 for <5 mmol/L versus >10.8 mmol/L, and 0.90 for 5 to 10.8 mmol/L versus >10.8 mmol/L. P interaction is 0.55 for survival after venoarterial extracorporeal membrane oxygenation (SAVE) score >−6 versus −6 to −11, 0.99 for >−6 versus <−11, and 0.52 for −6 to −11 versus <−11. P interaction is 0.16 for Simplified Acute Physiology Score II (SAPS II) <52 versus −52 to 76, 0.21 for <52 versus >76, and 0.86 for 52 to 76 versus >76. AMI indicates acute myocardial infarction; CS, cardiogenic shock; ECMELLA, Impella+extracorporeal membrane oxygenation; eCPR, venoarterial extracorporeal membrane oxygenation–assisted cardiopulmonary resuscitation; HR, hazard ratio; NS, nonsignificant; and VA-ECMO, venoarterial extracorporeal membrane oxygenation.
Figure 4.
Figure 4.
Association between ECMELLA use and severe bleeding in prespecified subgroups. P interaction is 0.30 for age <52 years versus age 52 to 62 years, 0.11 for age <52 years versus age >62 years, and 0.50 for age 52 to 62 years versus age >62 years. P interaction is 0.21 for lactate <5 mmol/L versus 5 to 10.8 mmol/L, 0.77 for <5 mmol/L versus >10.8 mmol/L, and 0.32 for 5 to 10.8 mmol/L versus >10.8 mmol/L. P interaction is 0.74 for survival after venoarterial extracorporeal membrane oxygenation (SAVE) score >−6 versus −6 to −11, 0.72 for >−6 versus <−11, and 0.97 for −6 to −11 versus <−11. P interaction is 0.70 for Simplified Acute Physiology Score II (SAPS II) <52 versus −52 to 76, 0.67 for <52 versus >76, and 0.41 for 52 to 76 versus >76. AMI indicates acute myocardial infarction; CS, cardiogenic shock; ECMELLA, Impella+extracorporeal membrane oxygenation; eCPR, venoarterial extracorporeal membrane oxygenation–assisted cardiopulmonary resuscitation; OR, odds ratio; NS, nonsignificant; and VA-ECMO, venoarterial extracorporeal membrane oxygenation.
Figure 5.
Figure 5.
Association between ECMELLA use and intervention because of access site–related ischemia in prespecified subgroups. P interaction is 0.75 for age <52 years versus age 52 to 62 years, 0.95 for age <52 years versus age >62 years, and 0.82 for age 52 to 62 years versus age >62 years. P interaction is 0.62 for lactate <5 mmol/L versus 5 to 10.8 mmol/L, 0.52 for <5 mmol/L versus >10.8 mmol/L, and 0.23 for 5 to 10.8 mmol/L versus >10.8 mmol/L. P interaction is 0.58 for survival after venoarterial extracorporeal membrane oxygenation (SAVE) score >−6 versus −6 to −11, 0.51 for >−6 versus <−11, and 0.23 for −6 to −11 versus <−11. P interaction is 0.65 for Simplified Acute Physiology Score II (SAPS II) <52 versus −52 to 76, 0.64 for <52 versus >76, and 0.31 for 52 to 76 versus >76. AMI indicates acute myocardial infarction; CS, cardiogenic shock; ECMELLA, Impella+extracorporeal membrane oxygenation; eCPR, venoarterial extracorporeal membrane oxygenation–assisted cardiopulmonary resuscitation; NS, nonsignificant; OR, odds ratio; and VA-ECMO, venoarterial extracorporeal membrane oxygenation.
Figure 6.
Figure 6.
Kaplan-Meier curves for all-cause mortality in patients receiving ECMELLA treated with early LV unloading and delayed LV unloading versus matched patients treated with only VA-ECMO. A, Only patients receiving ECMELLA in whom the Impella was implanted before or within 2 hours after the VA-ECMO implantation were considered for the matching; eg, matching patients with early LV unloading versus patients treated with VA-ECMO only. B, Only patients receiving ECMELLA in whom the Impella was implanted >2 hours after the VA-ECMO implantation were considered; eg, matching patients with delayed LV unloading versus patients treated with VA-ECMO only. ECMELLA indicates Impella+extracorporeal membrane oxygenation; HR, hazard ratio; LV, left ventricular; and VA-ECMO, venoarterial extracorporeal membrane oxygenation.
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