Abstract

Introduction: Mechanical support devices such as the Impella are increasingly used to support patients with acute myocardial infarction complicated by cardiogenic shock (AMICS) with observational evidence suggesting earlier use improves survival. However, complications associated with Impella including significant bleeding, hemolysis, vascular injury, limb ischemia and stroke are recognized but poorly quantified in this population outside of a small randomized experience. Methods: We performed a systematic MEDLINE search to select studies where Impella devices were used in AMICS. Pooled estimates of complications and study heterogeneity were calculated. Results: We included ten studies published between 2014 and 2020 with a total of 1037 patients. The median duration of Impella support ranged from 24 hours to 4.6 days. Overall survival to discharge or 30 days was 50% (range 36 % - 66%). Bleeding requiring transfusion occurred in 19.6% (95% confidence interval [CI], 15.2% - 24.8%) and hemolysis in 12.0% (95% CI, 9.0 -15.9%). Both analyses had significant study heterogeneity. Less common were vascular complications requiring surgery in 6.3% (95% CI, 2.8 - 10.2%), bleeding requiring intervention occurred in 4.8% (95% CI, 3.3% - 6.8%), limb ischemia in 4.3% (95% CI, 2.7% - 6.6%) and stroke 2.8% (95% CI, 1.8-4.3%). Two studies did not find significant differences in complication rates comparing Impella use before or after PCI. Conclusions: Use of Impella in AMICS is associated with significant morbidity. Real-world complication rates are however reassuringly similar to rates in the randomized experience. With increasing early use of Impella devices in acute MI complicated by CS, clinicians should be aware of these risks to allow for implant optimization, appropriate patient selection, and surveillance for complications. Further investigations are needed to understand clinical correlates of these complication rates.

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