Purpose: to report up to 6 months follow-up results from the first 30 patients included in the study designed to assess safety, feasibility and efficacy in the treatment of functional tricuspid regurgitation (FTR).
Methods: Between October 2016 and July 2017, thirty patients with severe symptomatic FTR were enrolled among 9 participating sites in Europe. All patients were screened by the heart teams of the local sites and underwent thorough pre-procedural echocardiography and cardiac computed tomography evaluation. Echocardiographic data were assessed by an independent core lab.
Results: Mean patient age was 75.2 years, 73.3% were females, 23.3% had ischemic heart disease and the mean EuroSCORE II was 4.1%. At baseline, 83.3% of patients were in NYHA functional class III-IV and LVEF was 57.5%. Successful access, deployment and positioning was achieved in 100% of the patients. There were two deaths at one month follow-up. Implant size adjustment resulted in an average reduction of septolateral tricuspid annular diameter of 16.5% (4.43±0.44cm to 3.7±0.45cm; p<0.01) at discharge.
Thirty-day follow-up is available for 28 patients. 82.2% of patients were in NYHA class I-II. Echocardiography compared to baseline showed reduction in PISA EROA of 51% (from 0.79±0.5 cm2 to 0.39±0.3 cm2, p<0.001) and a 28% reduction in mean vena contracta (from 1.25±0.4 cm to 0.9±0.4 cm, p<0.001).
Six month follow-up is currently available for 22 patients. 85.7% of patients were in NYHA class I-II. Compared to baseline, there was a significant improvement in 6 minute walk test from 278.4 m to 327.4 m, (p<0.05), and a decrease in the occurrence of peripheral edema from 76% to 48% (p=0.06). Echocardiography showed significant reduction in PISA EROA of 48% (from 0.73±0.5 cm2 to 0.38±0.2 cm2, p<0.05) and a 27% reduction in mean vena contracta (from 1.1±0.3 cm to 0.8±0.3 cm, p<0.001).
Conclusions: Outcomes up to 6-months suggest feasibility and safety of transcatheter tricuspid repair with the Cardioband Tricuspid System in patients with symptomatic TR. Significant annular reduction and reduction of tricuspid regurgitation was observed despite treating a large proportion of patients with "torrential" TR at baseline. The study is ongoing and further follow-up data are warranted to validate the initial promising results.