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Bicaval TricValve Implantation in Patients With Severe Symptomatic TR
Quick Takes
- Combining data from two small, prospective, nonblinded, nonrandomized, single-arm trials, caval valve implantation of the TricValve system in 44 patients was associated with 1-year improvements in at least some measure of QOL in 95% of patients.
- Echocardiography documented abolishment of hepatic vein backflow in a subset of patients and a small decrease in tricuspid annular diameter, with otherwise unchanged measures of right heart dimensions and function.
Study Questions:
What is the impact of caval implantation of the TricValve system on quality of life (QOL) outcomes at 1 year among patients with severe symptomatic tricuspid regurgitation (TR)?
Methods:
TRICUS (an early feasibility first-in-man study) and TRICUS EURO (a multicenter safety and efficacy study) were prospective, nonblinded, nonrandomized, single-arm trials representing the early-in-man experience with the TricValve system in patients with severe (grade ≥3 out of 5) TR despite optimal medical treatment and New York Heart Association (NYHA) functional class III or IV symptoms and significant caval backflow who were ineligible for surgery. Combining data from these two trials, the primary endpoint was improved QOL at 1 year based on clinical improvement in any one of: 1) Kansas City Cardiomyopathy Questionnaire (KCCQ-12) score increase ≥15 points, 2) improvement to NYHA class I-II, or 3) 6-minute walk test (6MWT) increase ≥40 m. Secondary endpoints included freedom from major adverse events, freedom from heart failure (HF) hospitalization or serious device-related adverse events, echocardiographic changes in right heart dimensions, improvement in echocardiographically measured venous congestion or N-terminal pro–B-type natriuretic peptide, or changes in renal or hepatic function.
Results:
A total of 44 patients were included (76.2 ± 7.5 years, 82% women); TRI-SCORE was 5.4 ± 1.2%. The primary endpoint of any measure of QOL improvement at 1 year was achieved in 42 patients (95%); with KCCQ-12 increase ≥15 points in 56% (p < 0.001 vs. baseline), NYHA class I-II in 62% (p < 0.001 vs. baseline), and a nonsignificant trend toward 6MWT increase ≥40 m in 40% (p = 0.28 vs. baseline). There were three deaths (7%) at 1 year (one cardiovascular) and the HF rehospitalization rate was 30%. Stent fracture, conduction system disturbances, or clinically significant leaflet thrombosis were not detected. Echocardiographic hepatic vein backflow decreased from 38 of 44 patients (86%) to 16 of 44 patients (36%); other than a small decrease in tricuspid annular diameter (41 ± 5 mm vs. 43 ± 6 mm at baseline, p = 0.01), other echocardiographic variables were unchanged.
Conclusions:
The authors conclude that caval valve implantation of the TricValve system was associated with 1-year clinical improvements in measures of QOL and relatively low mortality rates.
Perspective:
Anatomic factors can limit the feasibility of transcatheter tricuspid edge-to-edge repair, transcatheter tricuspid annuloplasty, and transcatheter tricuspid valve replacement. The TricValve system involves the transcatheter deployment of self-expanding nitinol stents with bovine pericardial leaflets in the superior and inferior vena cavae in an attempt to abolish backflow responsible for systemic venous congestion in patients with severe TR. This report adds 1-year safety and outcomes data to previously published reports of 30-day and 6-month outcomes with this system, and documents improvement in at least some measure of QOL in almost all patients accompanied by echocardiographic documentation of abolished hepatic vein backflow in a subset of patients. Pending data from larger trials, this system might prove to be another tool potentially useful in the transcatheter treatment of severe TR.
Clinical Topics: Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Interventions and Structural Heart Disease, Valvular Heart Disease
Keywords: Transcatheter Aortic Valve Replacement, Tricuspid Valve Insufficiency
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