Evaluating Transcatheter Valve Replacement in Tricuspid Regurgitation: Complexities and Limitations of Existing Models

OBJECTIVES: Surgical interventions are recommended for severe tricuspid regurgitation (TR) unresponsive to medical treatment. However, isolated tricuspid valve surgery carries high in-hospital mortality, leaving many severe symptomatic TR patients untreated.

Many studies like TRISCEND, have evaluated the impact of transcatheter valve replacement (TVR) which offer safer treatment options for these untreated patients. Assessing TVR's clinical impact is challenging due to diverse disease causes, associations with valve abnormalities, pulmonary hypertension, ventricular dysfunction, and other underlying conditions.

Our objective was to review cost-effectiveness models (CEM) of TVR devices considering the complexity of TR and its relationship with the causes and severity of the disease.

METHODS: We conducted a literature review using PubMED/MEDLINE and reviewed NICE and HAS efficiency submissions on TVR’s CEM specifically in TR.

We excluded secondary TR development (e.g., after cardiac surgeries) to maintain study relevance.

RESULTS: Our review identified only two CEMs evaluating TVR in TR. Both used decision trees based on NYHA state progression.

Shore et al. assessed PASCAL system CE, allocating patients among NYHA states based on the COAPT trial data. They assumed no progression after two years. Adverse events beyond 30 days, such as stroke or myocardial infarction, were not included. Despite being a primary endpoint in COAPT, re-hospitalization, making it impossible to estimate associated survival or disutility.

Kurnaz et al. modeled the TriClip system’ CE assigning specific mortality rates and treatment costs to NYHA states. The model lacked specific OS data and assumed NYHA improvement would lower mortality rate. Quality of life related to disease progression, adverse events, and reinterventions wasn't considered.

CONCLUSIONS: Existing CEMs evaluating TVR's impact on TR are limited, failing to incorporate disease complexity, specific survival data, significant adverse events like stroke or myocardial infection, and quality of life implications. As such, they cannot sufficiently characterize the added value of TVR compared to surgery.