Clinical, echocardiographic outcomes and complications after transcatheter tricuspid valve replacement (TTVR): a systematic review and meta-analysis

Background Tricuspid regurgitation (TR) is a relatively frequent and under-treated condition, particularly in elderly and high-risk patients, whom this condition significantly decrease life expectancy and QoL on, considering the heavy consequences of surgical treatment and the high rate of procedure-related adverse events. Recently transcatheter tricuspid valve replacement (TTVR) has emerged as a promising alternative for patients unsuitable for traditional surgery or transcatheter edge-to-edge repair (T-TEER) due to high risk of complications. However, comprehensive data on its efficacy and safety remain limited. Aim To evaluate the clinical outcomes, echocardiographic impact and complication rates in a large contemporary cohort of patients undergoing orthotopic TTVR. Searching methods This metanalysis was conducted according to Cochrane Collaborations and Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statements. Searches were conducted up to 3 April 2025 in PubMed Central, Ovid EMBASE and Scopus databases, focusing on observational studies and RCTs that evaluated clinical and echocardiography impact on patients undergoing TTVR, as well as incidence of procedure-related adverse events. Results 13 studies published between 2020 and 2025 were analysed, including 12 observational study and 1 RCT, encompassing a total number of 827 patients. Primary outcomes included procedural success and incidence of all-cause mortality at the latest follow-up. Secondary outcomes were divided in safety outcomes, focusing on incidence of adverse events selected according to TVARC criteria, and efficacy outcomes, including TR reduction, as long as echocardiographic remodelling, and symptom improvement. Data were pooled using random-effects models. The average procedural success rate was 92.5%, with an all-cause mortality rate of 13.2% at a median 12-month follow-up (IQR 4.2-12.0). TTVR significantly improved NYHA class (RR 0.38), 6-minute walk distance (MD +99 m), and KCCQ score (MD +24.4). A marked reduction in severe or greater TR, RV dimensions, and pulmonary artery pressure was observed, without impact on LV and RV function but with significative impact on RV dimension. The most common adverse events were permanent pacemaker implantation (14.9%) and major bleeding (13.6%), while stroke, myocardial infarction, and device-related embolism were rare. Conclusions TTVR is a feasible and effective option for symptomatic TR patients at high surgical risk and unsuitable for T-TEER basing on anatomical or imaging limitations. It achieves significant symptomatic and hemodynamic improvement with an acceptable safety profile, being a useful tool to improve QoL and foavouring RV remodelling in a population not eligible for any other effective treatment.