d.MISTRAL

The results of the first experience in humans with the Mistral device (Mitralix, Yokneam, Israel) have recently been published [41]. This device consists of a spiral nitinol guide that grasps the tendinous cords, approximating them to the leaflets and thus increasing coaptation. This study included 7 patients with severe functional TR; one of them required two devices. No adverse events related to the procedure were recorded after 30 days, and a significant decrease in effective regurgitant orifice area (EROA), vena contracta and regurgitant volume was achieved, together with improved functional class.

### *3.1.2 Percutaneous annuloplasty devices*

As it has been explained above, the basic mechanism underlying functional TR is TVA dilatation, which mainly occurs in its anteroseptal diameter. TV annuloplasty is currently the surgical treatment of choice in this scenario. Based on this surgical technique, different percutaneous annuloplasty devices have been developed in recent years with the fundamental aim of reducing the annular dimensions and prevent further TVA dilatation. These devices can be classified into rings (CARDIOBAND, IRIS MILLIPEDE, DA VIGNI, TRAIPTA) or direct suture devices (TRIALIGN, TRICINCH, PASTA, MIA) (**Figure 3**).

#### a.CARDIOBAND

The CARDIOBAND (Edwards Lifesciences, Irvine, CA, USA) is an annuloplasty system consisting of an adjustable surgical-like Dacron ring that is im*Percutaneous Treatment of Tricuspid Regurgitation DOI: http://dx.doi.org/10.5772/intechopen.95799*

**Figure 3.**

*A: CARDIOBAND, B: Iris MILLIPEDE, C: TRIALIGN, D: TRICINCH, E: Pasta, F: TRAIPTA, G: Mia.*

planted on the atrial side of the tricuspid TVA and fixed with multiple anchors. Once the last anchoring has been placed, the device is cinched until enough TR reduction is achieved. The two-year results of the TRI-REPAIR study have recently been published. This trial evaluated the efficacy and safety of this system in 30 patients with symptomatic functional TR (83% in NYHA functional class III-IV) [42]. The procedure was successful in all patients and related to a significant reduction in TR (72% of the subjects presented TR ≤ moderate) and TVA dimension, and to an improvement in functional status (82% of the subjects were in NYHA class I-II), 6-minute walk distance and quality of life at 24-months follow-up. The Early Feasibility Study of CARDIOBAND included 22 patients with severe symptomatic TR in which this treatment was carried out [43]. The procedure success rate was 96%, with improvement of both the severity of TR and of the NYHA functional class.

#### b.IRIS MILLIPEDE

The IRIS transcatheter annuloplasty system (Boston Scientific, Marlborough, MA), is a complete semirigid ring that is placed in a supra-annular position and anchored through 7–9 screws. The ring can be adjusted to reduce the

TVA diameter and thus the severity of TR. Although this system was initially designed to be used in the mitral valve, Rogers et al. presented the results obtained in two patients that received this device in the tricuspid position in a combined procedure with the mitral valve annuloplasty [44]. For the TV treatment, only 7 of the 9 anchors were used in order to avoid the risk of atrioventricular block. The results in these patients were good showed no need for a pacemaker and a 40% reduction of the TVA size after 12 months, with no residual significant TR.
