Valvular Heart Disease Interventional Trials From 2000 to 2024: A Systematic Review

Valvular heart disease (VHD) is a growing contributor to global cardiovascular morbidity, especially in aging populations. As transcatheter therapies expand, assessing enrollment trends and demographic representation is essential for equitable, generalizable evidence.

The purpose of this study was to evaluate temporal trends in trial characteristics and demographic representation, particularly age and sex, in VHD interventional trials from 2000 to 2024.

We conducted a systematic review on VHD intervention trials indexed in PubMed between 2000 and 2024. Trials involving percutaneous or surgical interventions across aortic, mitral, tricuspid, and pulmonic valves were included. Descriptive and nonparametric statistics were used to assess trends in enrollment size, participant demographics, valve type, intervention modality, and trial scope.

A total of 487 trials with 87,412 participants were included; 44.9% were women. Median trial size (z = 4.98; P < 0.01) and participant age (z = 10.08; P < 0.01) increased over time. Trials involving percutaneous (11% to 45%), bioprosthetic (22% to 53%), aortic valve (27% to 62%), and multinational (2% to 16%) interventions increased. Female enrollment did not improve significantly (z = -0.48; P = 0.63) but was higher in mitral (58.9%) and tricuspid (59%) trials, and more common in percutaneous (52%) than surgical (41.7%) studies. A positive correlation was observed between participant age and female representation (ρ = 0.196; P < 0.01).

VHD trials have expanded in scale and scope with increased trial-level mean age. However, persistent sex disparities and demographic variability highlight the need for more inclusive trial designs to guide equitable valve therapy.