SPC365

Efficacy and Safety of Impella Versus Standard of Care in Cardiogenic Shock Secondary to Acute Myocardial Infarction: A Systematic Review

Session: SESSÃO DE POSTERS 35 - DOENÇAS CARDIOVASCULARES - CHOQUE CARDIOGÉNICO 1
Speaker: Gonçalo Terleira Batista

Congress: CPC 2025
Topic: E. Coronary Artery Disease, Acute Coronary Syndromes, Acute Cardiac Care
Theme: 14. Acute Cardiac Care
Subtheme: 14.3 Acute Cardiac Care – CCU, Intensive, and Critical Cardiovascular Care
Session Type: Cartazes
FP Number: ---
Authors: Gonçalo Terleira Batista; Dulce Iolanda Gonçalves; Ana L. Silva; Marian Rodrigues Simões; Tiana Pereira Dos Santos; Bernardo Resende; Mafalda Griné; Luisa Gomes Rocha; Tomás M. Carlos; Joana Delgado Silva; Lino Gonçalves

<p>*Gon&ccedil;alo Terleira Batista and&nbsp;Dulce Iolanda Gon&ccedil;alves&nbsp;share co-first authorship</p>

<p style="text-align:start"><span style="font-size:medium"><span style="font-family:Calibri,sans-serif"><span style="color:#000000"><strong><span style="font-size:14pt">Background: </span></strong><span style="font-size:16px">Cardiogenic shock (CS) remains associated with high mortality rates. The introduction of the microaxial pump device, commonly known as Impella, has introduced an innovative yet debated approach in this critical context. However, only a limited number of randomized controlled trials (RCT) have rigorously evaluated the efficacy of this device.</span></span></span></span></p>

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<p style="text-align:start"><span style="font-size:medium"><span style="font-family:Calibri,sans-serif"><span style="color:#000000"><strong><span style="font-size:14pt">Objective: </span></strong><span style="font-size:16px">To compare the Impella device with standard of care (SC) in patients with CS secondary to acute myocardial infarction (AMI).</span></span></span></span></p>

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<p style="text-align:start"><span style="font-size:medium"><span style="font-family:Calibri,sans-serif"><span style="color:#000000"><strong><span style="font-size:14pt">Methods</span></strong>: <span style="font-size:16px">A systematic review was conducted using PubMed, Embase, the Cochrane Central Register of Controlled Trials, and grey literature to identify observational and interventional studies published up to August 2024 that compared Impella to standard of care (SC). The primary endpoint was all-cause mortality. Secondary outcomes included major adverse cardiovascular events (MACE: death, myocardial infarction, or stroke), bleeding, renal replacement therapy and vascular complications. The Cochrane Risk of Bias tool was used to assess the quality of the studies, and data analysis was performed using RevMan 2.0.</span></span></span></span></p>

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<p style="text-align:start"><span style="font-size:medium"><span style="font-family:Calibri,sans-serif"><span style="color:#000000"><strong><span style="font-size:14pt">Results</span></strong>: <span style="font-size:16px">After initial screening, a total of five observational studies and one RCT were included, comprising 101,823 participants (14,163 in the Impella arm and 87,660 in the standard of care [SC] arm). Regarding all-cause mortality, a trend towards lower mortality was observed in the SC arm, though this difference was not statistically significant. Significant heterogeneity was noted between the included studies (57.7% vs. 45.1%; Odds Ratio [OR]: 1.35; 95% Confidence Interval [CI]: 0.95&ndash;1.92; p = 0.09; I&sup2; = 97%)&nbsp;</span></span></span></span><span style="font-size:16px">Similarly, for MACE the SC arm showed lower event rates than the Impella arm, but the difference remained statistically non-significant&nbsp;<span style="font-family:Calibri,sans-serif"><span style="color:#000000">&nbsp;(62.9% vs. 49.0%; OR: 1.47; 95% CI: 0.74&ndash;2.93; p = 0.27; I&sup2; = 98%). In contrast, the Impella arm showed significantly higher rates of bleeding (OR: 2.60; 95% CI: 2.04&ndash;3.31; p &lt; 0.001)&nbsp;</span></span>and a greater need for&nbsp;<span style="font-family:Calibri,sans-serif"><span style="color:#000000">renal replacement therapy (OR: 3.31; 95% CI: 2.16&ndash;5.07; p &lt; 0.001). No data were available to analyze vascular complications.</span></span></span></p>

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<p style="text-align:start"><span style="font-size:medium"><span style="font-family:Calibri,sans-serif"><span style="color:#000000"><strong>Conclusions</strong>: Although observational studies suggest a trend favoring standard of care (SC), conflicting results from the single included RCT highlight the need for further investigation. Large, rigorously conducted RCTs are essential to define the role of the Impella device in managing CS.</span></span></span></p>