Characteristics, adverse event reporting and completeness of intervention description in short-term mechanical circulatory support trials: an observational study

Short-term mechanical circulatory support (MCS) devices are increasingly used in cardiogenic shock and high-risk cardiac interventions (1), yet robust evidence synthesis is hindered by heterogeneous study designs, incomplete intervention reporting, and inconsistent safety data. Template for Intervention Description and Replication (TIDieR) checklist was introduced to enhance reporting of non-pharmacological interventions (2), but adherence in invasive cardiology trials remains low (3). This study systematically evaluates registered short-term MCS trials, focusing on intervention descriptions and adverse event (AE) reporting across registries and peer-reviewed literature.

This cross-sectional study analysed MCS device trials registered on ClinicalTrials.gov (searched 6 Feb 2025) and their corresponding publications (searched 25 Feb 2025). Two authors independently screened and extracted data, with third-author arbitration. Completeness of intervention reporting was assessed using the 12-item TIDieR checklist, while adverse events, including mortality, severe AEs (SAE) and other AEs (OAE) were extracted from registries and publications. Data were summarized using descriptive statistics. Categorical variables were presented as counts or percentages and continuous variables as means or medians with interquartile ranges (IQR). Statistical significance was set at p<0.05.

The search retrieved 3,671 records; after screening, 85 trials were included, with 33 corresponding publications identified. Most trials investigated MCS in coronary artery disease (n=30), 35.3%) and heart failure (n=22, 25.9%), were randomized (n=60, 70.6%), open label (n=63, 74.1%), and conducted at or with grants of academic institutions (n=60, 70.6%) (Table 1). Cardiopulmonary bypass machine (n=23, 27.1%), extracorporeal membrane oxygenation (n=21, 24.7%), and Impella® device (n=12, 14.1%) were most frequently studied. Registry protocols reported a median of 4.5/10 TIDieR items, most commonly naming, background, device type, and location, while procedural details and provider characteristics were rarely reported. Publications reported more items (median of 7.0/12 TIDieR items), but key procedural and provider details remained incomplete (Table 2). Out of 33 registry items with matching publications, only 11 (33.3%) had reported results in the Clinicaltrials.gov. SAEs were reported in all registry items. In 9 corresponding publications, number of SAEs was different from the ones reported in Clinicaltrials.gov (p=0.0348). There were no differences observed for OAEs and overall mortality.

Reporting of short-term MCS trials remains incomplete and inconsistent between registries and publications. Improved adherence to TIDieR and standardized adverse event reporting are essential to enhance transparency, comparability, and evidence synthesis in invasive cardiology.Table 1  Table 2