Dataset Information

Effects of mechanical circulatory support devices in patients with acute myocardial infarction undergoing stent implantation: a systematic review and meta-analysis of randomised controlled trials.

ABSTRACT:

Objective

The survival benefit of using mechanical circulatory support (MCS) in patients with acute myocardial infarction (AMI) is still controversial. It is necessary to explore the impact on clinical outcomes of MCS in patients with AMI undergoing stenting.

Design

Systematic review and meta-analysis.

Data sources

Embase, Cochrane Library, Medline, PubMed, Web of Science, ClinicalTrials.gov and Clinicaltrialsregister.eu databases were searched from database inception to February 2021.

Eligibility criteria

Randomised clinical trials (RCTs) on MCS use in patients with AMI undergoing stent implantation were included.

Data extraction and synthesis

Data were extracted and summarised independently by two reviewers. Risk ratios (RRs) and 95% CIs were calculated for clinical outcomes according to random-effects model.

Results

Twelve studies of 1497 patients with AMI were included, nine studies including 1382 patients compared MCS with non-MCS, and three studies including 115 patients compared percutaneous ventricular assist devices (pVADs) versus intra-aortic balloon pump (IABP). Compared with non-MCS, MCS was not associated with short-term (within 30 days) (RR=0.90; 95% CI 0.57 to 1.41; I²=46.8%) and long-term (at least 6 months) (RR=0.82; 95% CI 0.57 to 1.17; I²=37.6%) mortality reductions. In the subset of patients without cardiogenic shock (CS) compared with non-MCS, the patients with IABP treatment significantly had decreased long-term mortality (RR=0.49; 95% CI 0.27 to 0.90; I²=0), but without the short-term mortality reductions (RR=0.51; 95% CI 0.22 to 1.19; I²=17.9%). While in the patients with CS, the patients with MCS did not benefit from the short-term (RR=1.09; 95% CI 0.67 to 1.79; I²=46.6%) or long-term (RR=1.00; 95% CI 0.75 to 1.33; I²=22.1%) survival. Moreover, the application of pVADs increased risk of bleeding (RR=1.86; 95% CI 1.15 to 3.00; I²=15.3%) compared with IABP treatment (RR=1.86; 95% CI 1.15 to 3.00; I²=15.3%).

Conclusions

In all patients with AMI undergoing stent implantation, the MCS use does not reduce all-cause mortality. Patients without CS can benefit from MCS regarding long-term survival, while patients with CS seem not.

SUBMITTER: Shi Y

PROVIDER: S-EPMC8245450 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:ImportanceMechanical circulatory support (MCS) devices, including intravascular microaxial left ventricular assist devices (LVADs) and intra-aortic balloon pumps (IABPs), are used in patients who undergo percutaneous coronary intervention (PCI) for acute myocardial infarction (AMI) complicated by cardiogenic shock despite limited evidence of their clinical benefit.ObjectiveTo examine trends in the use of MCS devices among patients who underwent PCI for AMI with cardiogenic shock, hospital-level use variation, and factors associated with use.Design, setting, and participantsThis cross-sectional study used the CathPCI and Chest Pain-MI Registries of the American College of Cardiology National Cardiovascular Data Registry. Patients who underwent PCI for AMI complicated by cardiogenic shock between October 1, 2015, and December 31, 2017, were identified from both registries. Data were analyzed from October 2018 to August 2020.ExposuresTherapies to provide hemodynamic support were categorized as intravascular microaxial LVAD, IABP, TandemHeart, extracorporeal membrane oxygenation, LVAD, other devices, combined IABP and intravascular microaxial LVAD, combined IABP and other device (defined as TandemHeart, extracorporeal membrane oxygenation, LVAD, or another MCS device), or medical therapy only.Main outcomes and measuresUse of MCS devices overall and specific MCS devices, including intravascular microaxial LVAD, at both patient and hospital levels and variables associated with use.ResultsAmong the 28 304 patients included in the study, the mean (SD) age was 65.4 (12.6) years and 18 968 were men (67.0%). The overall MCS device use was constant from the fourth quarter of 2015 to the fourth quarter of 2017, although use of intravascular microaxial LVADs significantly increased (from 4.1% to 9.8%; P < .001), whereas use of IABPs significantly decreased (from 34.8% to 30.0%; P < .001). A significant hospital-level variation in MCS device use was found. The median (interquartile range [IQR]) proportion of patients who received MCS devices was 42% (30%-54%), and the median proportion of patients who received intravascular microaxial LVADs was 1% (0%-10%). In multivariable analyses, cardiac arrest at first medical contact or during hospitalization (odds ratio [OR], 1.82; 95% CI, 1.58-2.09) and severe left main and/or proximal left anterior descending coronary artery stenosis (OR, 1.36; 95% CI, 1.20-1.54) were patient characteristics that were associated with higher odds of receiving intravascular microaxial LVADs only compared with IABPs only.Conclusions and relevanceThis study found that, among patients who underwent PCI for AMI complicated by cardiogenic shock, overall use of MCS devices was constant, and a 2.5-fold increase in intravascular microaxial LVAD use was found along with a corresponding decrease in IABP use and a significant hospital-level variation in MCS device use. These trends were observed despite limited clinical trial evidence of improved outcomes associated with device use.

Project description:BackgroundAs health care markets in the United States have become increasingly consolidated, the role of market concentration on physician treatment behavior remains unclear. In cardiology, specifically, there has been evolving treatment of acute myocardial infarction complicated by cardiogenic shock (AMI-CS) with increasing use of mechanical circulatory support (MCS). However, there remains wide variation in it use. The role of market concentration in the utilization of MCS in AMI-CS is unknown. We examined the use of MCS in AMI-CS and its effect on outcomes between competitive and concentrated markets.Methods and resultsWe used the National Inpatient Sample to query patients admitted with AMI-CS between 2003 and 2009. The primary study outcome was the use of mechanical circulatory support. The primary study exposure was market concentration, measured using the Herfindahl-Hirschman Index, which was used to classify markets as unconcentrated (competitive), moderately concentrated, and highly concentrated. Baseline characteristics, procedures, and outcomes were compared for patients in differently concentrated markets. Multivariable logistic regression was used to examine the association between HHI and use of MCS.ResultsThere were 32,406 hospitalizations for patients admitted with AMI-CS. Patients in unconcentrated markets were more likely to receive MCS than in highly concentrated markets (unconcentrated 46.8% [5087/10,873], moderately concentrated 44.9% [2933/6526], and high concentrated 44.5% [6676/15,007], p < 0.01). Multivariable regression showed that patients in more concentrated markets had decreased use of MCS in patients in later years of the study period (2009, OR 0.64, 95% CI 0.44-0.94, p = 0.02), with no effect in earlier years. There was no significant difference in in-hospital mortality.ConclusionMultivariable analysis did not show an association with market concentration and use of MCS in AMI-CS. However, subgroup analysis did show that competitive hospital markets were associated with more frequent use of MCS in AMI-CS as frequency of utilization increased over time. Further studies are needed to evaluate the effect of hospital market consolidation on the use of MCS and outcomes in AMI-CS.

Project description:BackgroundPercutaneous mechanical circulatory support devices (pMCSDs) are increasingly used on the assumption (but without solid proof) that their use will improve prognosis. A meta-analysis was undertaken according to the PRISMA guidelines to evaluate the benefits of pMCSDs in patients undergoing high-risk percutaneous coronary intervention (hr-PCI).MethodsWe searched PubMed, EMbase, Cochrane Library, Clinical Trial.gov, and other databases to identify eligible studies. Relative risks (RRs) and 95% confidence intervals (CIs) were calculated for 30-day and 6-month all-cause mortality rates, reinfarction, and other adverse events using a random effect model.ResultsSixteen randomized controlled trials (RCTs) were included in this study. In the pooled analysis, intra-aortic balloon pump (IABP) was not associated with a decrease in 30-day and 6-month all-cause mortality (RR 1.01 95% CI 0.61-1.66; RR 0.88 95% CI 0.66-1.17), reinfarction (RR 0.89 95% CI 0.69-1.14), stroke/transient ischemic attack (TIA) (RR 1.75 95% CI 0.47-6.42), heart failure (HF) (RR 0.54 95% CI 0.11-2.66), repeat revascularization (RR 0.73 95% CI 0.25-2.10), embolization (RR 3.00 95% CI 0.13-71.61), or arrhythmia (RR 2.81 95% CI 0.30-26.11). Compared with IABP, left ventricular assist devices (LVADs) were not associated with a decrease in 30-day and 6-month all-cause mortality (RR 0.96 95% CI 0.71-1.29; RR 1.23 95% CI 0.88-1.72), reinfarction (RR 0.98 95% CI 0.68-1.42), stroke/TIA (RR 0.45 95% CI 0.1-1.95), acute kidney injury (AKI) (RR 0.83 95% CI 0.38-1.80), or arrhythmia (RR 1.52 95% CI 0.71-3.27), but LVADs were associated with a decrease in repeat revascularization (RR 0.26 95% CI 0.08-0.83). However, LVADs significantly increased the risk of bleeding compared with IABP (RR 2.85 95% CI 1.72-4.73).ConclusionsNeither LVADs nor IABP improves short or long-term survival in hr-PCI patients. LVADs are more likely to reduce repeat revascularization after PCI, but to increase the risk of bleeding events than IABP.

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