New Light on the ‘Forsaken Valve’

Tricuspid regurgitation is frequent and mostly secondary to right ventricle and tricuspid annulus dilation. Tricuspid regurgitation has been associated to mortality increase, even though historically the importance of this valve has been disregarded compared to the other three.

Tricuspid surgical repair has seen good results, but it is mostly done in the context of another valve repair. Isolated tricuspid valve repair is rare and involves risks due to comorbidities such as right ventricle dysfunction, pulmonary hypertension and prior heart surgery.

The FORMA system (Edwards Lifesciences, Irvine, California) is a device that provides a surface for the coaptation of the valve’s native leaflets by reducing the regurgitant orifice.

Also Read: “Tricuspid Valve Repair with MitraClip”.

The work included 18 patients receiving this new device in three different centers, and achieved procedural success in 16 (89%). Failed procedures involved right ventricle perforation that required surgery, or device dislocation.

At one year, there were no deaths, significant arrhythmia, device infection or device dislocation. In all 14 patients with successful implantation at one year follow up, there was significant functional class improvement and an 84 meter increase in the 6 minute walk test.

Also Read: “VIVA post-market study: More Evidence for the “Valve-in-Valve Technique”.

The echocardiogram showed a reduction of prior-procedure severe tricuspid regurgitation to moderate or less in 69% of patients at 30 days and in 46% of patients at one year. Tricuspid annulus and right ventricle diameter also saw a reduction at one year (from 45.7 ± 4.8 mm to 42.1 ± 4.4 mm, p=0.004 and from 54 ± 5.3 mm to 49.9 ± 4.3 mm, p=0.02, respectively).

Conclusion

FORMA device implantation in high risk patients with severe tricuspid regurgitation is feasible and has shown good safety outcomes at mid-term. At one year, despite variable reduction in tricuspid regurgitation grade, there was significant clinical improvement and ventricular diameter reduction.

Editorial Comment

The main contribution of this study is the significant clinical improvement driven by tricuspid regurgitation reduction and diameter improvement at one year. This favorable trend lead to shorter hospitalization periods for cardiac failure. Improvement can be standardized by reducing right atrial filling pressure and increasing right ventricle demand.  

The most modest echocardiograms did not correlate with the clinical or hemodynamic outcomes, which could be due to the measuring techniques used once the device was in place.

Original Title: Transcatheter Tricuspid Valve Repair with a New Transcatheter Coaptation System for the Treatment of Severe Tricuspid Regurgitation. 1-Year Clinical and Echocardiographic Results.

Reference: Gidon Perlman et al. J Am Coll Cardiol Intv 2017. Article in press.

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