Objectives: Functional tricuspid regurgitation (FTR), secondary to left-sided heart disease may
lead to poor quality of life and increased long-term mortality. Annuloplasty with
different ring devices offers excellent treatment; however, the role of 3-dimensional
annuloplasty rings has not yet been determined. This prospective, multicenter, observational
study was designed to evaluate the clinical and functional outcome after concomitant
tricuspid valve (TV) repair with the rigid 3-dimensional Contour 3D™ annuloplasty ring (Medtronic, Minneapolis MN, USA).
Methods: From September 2011 to July 2015, 112 consecutive patients (mean age 70.9 ± 9.0 years)
were enrolled at 10 centers in Europe, Israel, and the United States. Inclusion criteria
were FTR ≥ moderate and/or tricuspid annular dilatation > 40 mm. 75.9% of the patients
presented with ≥ moderate TR. The mean tricuspid annular diameter was 41.2 ± 7.3 mm.
63.4% of the patients were in NYHA functional class III or IV. Two-dimensional echocardiography
was planned before surgery and at discharge. Echocardiographic and clinical follow-up
was completed 6 months after surgery.
Results: The most common concomitant procedure was mitral valve repair, which was performed
in 60 patients (53.6%). 30-day mortality was 0.9% (1 patient). There were 6 deaths
during follow-up (3 cardiac-related, 3 non-cardiac-related). Mean ring size implanted
was 30.4 ± 2.7. At 6-months follow-up 93.7% of the patients showed ≤ mild TR and 92.4%
of the patients were in NYHA functional class I or II. 6 months after surgery the
mean pressure gradient across the tricuspid valve was 2.1 ± 1.1 mm Hg, and the leaflet
coaptation length was 7.3 ± 3.5 mm. Multivariate analysis revealed that recurrent
TR (≥ moderate) at 6 months was associated with left ventricular dilatation (LVEDD > 70
mm) (p = 0.049). Tethering distance >7.6 mm was not a risk factor for recurrent (≥ moderate)
TR. A remodeling of the right ventricle was not observed. No ring dehiscence, endocarditis,
or TV-related reoperation occurred during follow-up.
Conclusion: TV repair with the Contour 3D annuloplasty ring shows an excellent reduction of TR
up to 6 months with low mean pressure gradients across the TV. There was a significant
shift from NYHA functional classes III/IV to I/II.
