Purpose: Tricuspid regurgitation (TR) is a frequent comorbidity in patients with advanced heart failure and associated with high morbidity and mortality. As surgical repair carries a high risk for postoperative complications in these patients, innovative interventional therapies of TR are an unmet clinical need. The aim of this study was to evaluate the impact of caval valve implantation (CVI) on exercise capacity compared to optimal medical therapy (OMT).
Methods: 28 patients with severe symptomatic TR (mean age 75.6±8.4 years) were selected based on clinical and anatomic suitability criteria and randomized to OMT (n=14) or implantation of a balloon-expandable Edwards Sapien XT into the inferior vena cava (n=14). Primary endpoint was maximal oxygen uptake after three months. Secondary endpoints included six minute walk test, NYHA class, NTproBNP levels, right heart function, unscheduled hospitalization for heart failure progression, and quality of life as assessed by the Minnesota Living with Heart Failure Questionnaire (MLHFQ). Safety was evaluated according to the VARC-2 criteria.
Results: The change from baseline of maximal oxygen uptake did not differ significantly between the OMT and CVI groups (-0.1±1.7 ml/kg/min vs. -1.0±1.4 ml/kg/min, p=0.352). CVI patients showed significant improvement of NYHA class (-0.6±0.5, p=0.025) and quality of life (MLHFQ -19.9±12.2, p=0.004). Compared to the control group, however, there were no significant differences regarding the changes from baseline of NYHA class, six minute walk test, NTproBNP, right heart function, hospitalizations, and quality of life between both groups. Four periprocedural complications (one tamponade, three valve dislocations) occurred in the CVI group resulting in conversion to surgery.
Conclusion: Implantation of a ballon-expandable transcatheter valve into the inferior vena cava did not result in a superior functional outcome compared to OMT and was associated with a high rate of periprocedural complications. Further studies with dedicated devices may be needed to identify patient subgroups who may benefit from the procedure.