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Updated: Nov 8, 2025
Utilizing Percutaneous Ventricular Assist Devices in Acute Myocardial Infarction Complicated by Cardiogenic Shock
Published on: June 12, 2021
Variability in reporting of key outcome predictors in acute myocardial infarction cardiogenic shock trials
Jeffrey M Tyler1, Christopher Brown1, Jacob Colin Jentzer2
1Interventional Cardiolgy at Scripps Clinic, Cedars Sinai Smidt Heart Institute, Los Angeles, California, USA.
Insights
Key mortality predictors for acute myocardial infarction patients with cardiogenic shock (AMICS) are often not reported in randomized controlled trials (RCTs). Standardizing data collection in AMICS trials is crucial for evaluating new therapies.
Area of Science:
- Cardiology
- Clinical Trials
- Critical Care Medicine
Background:
- Acute myocardial infarction with cardiogenic shock (AMICS) is a critical condition with significant mortality.
- Cardiac arrest (CA) and Society for Cardiovascular Angiography and Intervention (SCAI) shock classification are key mortality predictors in AMICS.
- Previous research highlights the prognostic importance of various variables in AMICS patients.
Purpose of the Study:
- To examine the reporting frequency of high-risk variables in published randomized controlled trials (RCTs) involving AMICS patients.
- To assess the consistency and completeness of data collection for prognostic factors in AMICS clinical trials.
- To identify gaps in reporting that may hinder the evaluation of novel therapeutic interventions for AMICS.
Main Methods:
- A systematic review of 15 randomized controlled trials (RCTs) enrolling 2,500 AMICS patients was conducted.
- Data on key prognostic variables including cardiac arrest (CA), neurologic status, hemodynamic parameters, lactate levels, mechanical ventilation, and mechanical circulatory support (MCS) were extracted.
- The prevalence and reporting rates of these variables were analyzed from primary manuscripts and supplementary data.
Main Results:
- Reporting frequency varied significantly for prognostic factors: neurologic status (0%), cause of death (33%), cardiac index/wedge pressure (47%), lactate (60%), LVEF (73%), CA (80%), MCS (80%), and mechanical ventilation (93%).
- Hypothermia was reported in 28% of trials with a prevalence of 33-75%.
- Wide variability in 30-day mortality (20-73%) was observed, potentially linked to inconsistent reporting of prognostic factors.
Conclusions:
- Essential predictors of outcome in AMICS patients are frequently underreported in seminal RCTs.
- Inconsistent data collection and reporting practices limit the comprehensive assessment of therapeutic efficacy in AMICS.
- Standardizing data collection and reporting in future AMICS trials is recommended to improve the evaluation of novel treatments.
Background:
Among acute myocardial infarction patients with cardiogenic shock (AMICS), a number of key variables predict mortality, including cardiac arrest (CA) and shock classification as proposed by Society for Cardiovascular Angiography and Intervention (SCAI). Given this prognostic importance, we examined the frequency of reporting of high risk variables in published randomized controlled trials (RCTs) of AMICS patients.
Methods:
We identified 15 RCTs enrolling 2,500 AMICS patients and then reviewed rates of CA, baseline neurologic status, right heart catheterization data, lactate levels, inotrope and vasopressor requirement, hypothermia, mechanical ventilation, left ventricular ejection fraction (LVEF), mechanical circulatory support, and specific cause of death based on the primary manuscript and Data in S1.
Results:
A total of 2,500 AMICS patients have been enrolled in 15 clinical trials over 21 years with only four trials enrolling >80 patients. The reporting frequency and range for key prognostic factors was: neurologic status (0% reported), hypothermia (28% reported, prevalence 33-75%), specific cause of death (33% reported), cardiac index and wedge pressure (47% reported, range 1.6-2.3 L min-1 m-2 and 15-24 mmHg), lactate (60% reported, range 4-7.7 mmol/L), LVEF (73% reported, range 25-45%), CA (80% reported, prevalence 0-92%), MCS (80% reported, prevalence 13-100%), and mechanical ventilation (93% reported, prevalence 35-100%). This variability was reflected in the 30-day mortality which ranged from 20-73%.
Conclusions:
In a comprehensive review of seminal RCTs in AMICS, important predictors of outcome were frequently not reported. Future efforts to standardize CS trial data collection and reporting may allow for better assessment of novel therapies for AMICS.
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