Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Tricuspid regurgitation.
Treatment: TTVR (transcatheter tricuspid valve repair) with TriClip implantation.

The insurer denied the TTVR with TriClip implantation.  The denial is upheld.

The patient is a female with severe, symptomatic, tricuspid regurgitation (TR). She was referred for TTVR  (transcatheter tricuspid valve repair) with TriClip implantation.

No, the health plan should not cover the TTVR (transcatheter tricuspid valve repair) with TriClip implantation.

Devices for transcatheter tricuspid valve repair (TriClip and PASCAL) are approved for use in Europe but are investigational in the United States. Studies have investigated the efficacy of treating TR (tricuspid regurgitation) with transcatheter approaches similar to those used for mitral valve disease with either a clip on the valve leaflets or an annular remodeling device. These approaches require advanced imaging modalities for patient selection and procedural guidance. The six-month safety and performance of a transcatheter tricuspid valve reconstruction system in 30 patients with moderate to severe secondary TR (tricuspid regurgitation) showed technical success in all patients with an average 9 percent reduction in annular diameter and significant reduction in regurgitant severity (although still in the severe range after the procedure)]. At six-month follow-up there were three deaths (10 percent) with 88 percent of survivors in NYHA (New York Heart Association) Class I or II.

No, the TTVR (transcatheter tricuspid valve repair) with TriClip implantation is not more beneficial.

Severe tricuspid regurgitation (TR) is an independent predictor of mortality even in patients with other cardiovascular conditions.

In symptomatic patients with severe TR (tricuspid regurgitation), management includes evaluation and treatment of the underlying cause(s), which often includes other cardiovascular disorders, particularly mitral valve disease and/or left ventricular systolic dysfunction (heart failure [HF] with reduced ejection fraction).

In symptomatic patients with severe TR (tricuspid regurgitation), diuretics are indicated to treat volume overload and congestion. However, many patients with severe TR (tricuspid regurgitation) have refractory peripheral edema unresponsive to medical management.

Treatment of the causes of pulmonary hypertension (such as HF [heart failure], mitral stenosis, and chronic thromboembolic pulmonary disease) can result in improvement in secondary TR (tricuspid regurgitation).

Patients with primary TR (tricuspid regurgitation) who have normal right ventricular (RV) systolic function, a right atrial pressure less than 20 mmHg (millimeters of mercury) , and normal RV (right ventricle) systolic pressure can participate in all competitive sports, regardless of TR (tricuspid regurgitation) severity.

Management of symptomatic TR (tricuspid regurgitation) associated with a pacer lead is problematic; TR (tricuspid regurgitation) often persists after lead removal.

For patients with severe primary TR (tricuspid regurgitation) undergoing surgery for left-sided (eg, mitral) valve disease, tricuspid surgery is recommended (Grade 1C).

For patients with mild, moderate, or greater secondary TR (tricuspid regurgitation) who are undergoing left-sided valve surgery, we suggest concomitant tricuspid valve repair if there is either tricuspid annular dilation (diameter on transthoracic echocardiogram of > [greater than] 40 millimeters) or prior evidence of right HF (heart failure) (Grade 2C).

Tricuspid valve surgery is suggested for symptomatic patients with severe primary TR (tricuspid regurgitation) despite medical therapy without severe RV (right ventricle) systolic dysfunction (Grade 2C).

When feasible, tricuspid valve repair is generally preferred to tricuspid valve replacement. However, repair is associated with significant risk of recurrent TR (tricuspid regurgitation).

A bioprosthetic valve is preferred over a mechanical prosthetic in the tricuspid position due to the high risk of right-sided mechanical valve thrombosis. Transcatheter approaches to treatment of TR (tricuspid regurgitation) are investigational.