Fixing Failing Valves: Advancing Safer TVI for Heart Failure

Mitral regurgitation (MR) and tricuspid regurgitation (TR) are the most common valve diseases encountered in patients with heart failure (HF). Independent of heart failure severity, both conditions are linked to worse symptoms, poorer quality of life, and higher mortality. Transcatheter interventions with tested efficacy and safety are available to treat valve disease. However, the evidence is limited and inconclusive due to heterogeneity in patient characteristics, the dynamic nature of valve disease severity, the influence of heart failure treatments, including medications and devices, the small number of participants enrolled, and limitations in using patient-reported outcomes when studies are unblinded. The lack of consensus has led to varying degrees of acceptance by the clinical community, potentially limiting options for patient care.

A new paper published in Circulation reviews these limitations and proposes solutions to advance evidence generation for the safe and effective use of transcatheter treatment of valvular heart disease in heart failure patients. The authors advocate for closer collaboration among specialists in cardiology, cardiac surgery, and imaging to generate evidence that informs patient care. The paper also proposes solutions across a wide range of problems noted in designing trials for patients with secondary valvular heart disease and chronic HF.

The proposed solutions address problems such as heterogeneity of atrioventricular valvular heart disease, the use of guideline-directed medical therapy (GDMT), the size of the study group, and endpoints.

The paper notes that while surgery remains the standard, many patients are unable to withstand the procedure. However, alternatives like the less invasive transcatheter valve interventions (TVI), such as the MitraClip, have yielded mixed results in clinical trials due to variations in trial designs, patient types, and heart failure treatments.

The authors emphasize the need to optimize GDMT before considering TVI. The researchers also call for larger, better-designed trials with more precise patient selection to better understand the benefits and limitations of TVI.

The details of this study can be found here.