Six-month Performance of a Three-Dimensional Annuloplasty Ring for Repair of Functional Tricuspid Regurgitation

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.

No conflict of interest has been declared by the author(s).