Microaxial Left Ventricular Assist Device in Cardiogenic Shock: A Systematic Review and Meta-Analysis

Abstract

Microaxial left ventricular assist devices (LVAD) are increasingly used to support patients with cardiogenic shock; however, outcome results are limited to single-center studies, registry data and select reviews. We conducted a systematic review and meta-analysis, searching three databases for relevant studies reporting on microaxial LVAD use in adults with cardiogenic shock. We conducted a random-effects meta-analysis (DerSimonian and Laird) based on short-term mortality (primary outcome), long-term mortality and device complications (secondary outcomes). We assessed the risk of bias and certainty of evidence using the Joanna Briggs Institute and the GRADE approaches, respectively. A total of 63 observational studies (3896 patients), 6 propensity-score matched (PSM) studies and 2 randomized controlled trials (RCTs) were included (384 patients). The pooled short-term mortality from observational studies was 46.5% (95%-CI: 42.7–50.3%); this was 48.9% (95%-CI: 43.8–54.1%) amongst PSM studies and RCTs. The pooled mortality at 90 days, 6 months and 1 year was 41.8%, 51.1% and 54.3%, respectively. Hemolysis and access-site bleeding were the most common complications, each with a pooled incidence of around 20%. The reported mortality rate of microaxial LVADs was not significantly lower than extracorporeal membrane oxygenation (ECMO) or intra-aortic balloon pumps (IABP). Current evidence does not suggest any mortality benefit when compared to ECMO or IABP.

Complications and Outcomes of Impella Treatment in Cardiogenic Shock Patients With and Without Acute Myocardial Infarction

“… 10 In the aforementioned meta‐analysis, short‐term mortality was also numerically higher in patients with AMI‐CS, without statistical significance (52.1% versus 42.0%, P =0.09). 14 In the present study, in‐hospital mortality was similar between the 2 groups (46.0% versus 43.9%, P =0.38). Therefore, it is likely that once a patient develops severe CS that needs the Impella treatment, complications and outcomes may be similar regardless of the indications (ie, AMI versus non‐AMI).…”

“… 13 A recent meta‐analysis focusing on clinical outcomes in patients with CS treated with the Impella demonstrated that in‐hospital or 30‐day mortality was 46.5% (95% CI, 42.7%–50.3%) in 63 observational studies (n=3896). 14 In this meta‐analysis, the incidence of access site bleeding, limb ischemia, and stroke were reported to be 25.8%, 6.1%, and 5.5%, respectively, with a large heterogeneity. 14 The present nationwide study with a large sample (n=2047) provides robust data on the incidence of in‐hospital complications and mortality, in which the risks may be higher in the elderly and obese and in those with previous cerebrovascular events and a critically ill presentation.…”

“… 14 In this meta‐analysis, the incidence of access site bleeding, limb ischemia, and stroke were reported to be 25.8%, 6.1%, and 5.5%, respectively, with a large heterogeneity. 14 The present nationwide study with a large sample (n=2047) provides robust data on the incidence of in‐hospital complications and mortality, in which the risks may be higher in the elderly and obese and in those with previous cerebrovascular events and a critically ill presentation. In addition to the high in‐hospital mortality, our results reinforce the high complication rate related to the Impella devices.…”

Differential utilization of Impella devices, extracorporeal membrane oxygenation, and combined therapies as escalation and de-escalation strategies

“… 1 The Impella devices have shown promise in improving haemodynamic parameters and end-organ function in patients with CS. 5 The axillary-implanted Impella 5.5 devices are more powerful and offer numerous benefits. However, the femoral-inserted devices (Impella CP) are established as primary therapy and provide powerful support and unloading.…”