Appeal type: Experimental/Investigational
Decision: Overturned

Cardiac/Circulatory Problems/Heart Problem/Right Heart Failure
Treatment: Transcatheter tricuspid valve implantation (TTVI)/replacement with prosthetic valve and inpatient stay
The health plan denied the requested Transcatheter tricuspid valve implantation (TTVI)/replacement with prosthetic valve and inpatient stay as not medically necessary. The health plan's determination is overturned.

This case involves a male with chronic kidney disease, atrial flutter, ventricular septal defect (VSD) and tricuspid valve endocarditis status post ventricular septal defect repair with bioprosthetic tricuspid valve replacement. The patient has developed progressive severe bioprosthetic tricuspid valve regurgitation with stenosis resulting in symptomatic right heart failure. Review of his transesophageal echocardiogram report demonstrated severe bioprosthetic tricuspid valve stenosis with moderate regurgitation. The patient has been deemed to be at high risk for surgical tricuspid valve repair/replacement (TVR) with redo sternotomy and the patient declined surgical TVR. The patient's treating cardiologist has recommended transcatheter tricuspid valve in valve replacement (SAPIEN VIV) for the treatment of this patient's severe bioprosthetic tricuspid valve dysfunction. The patient's health plan has denied coverage for transcatheter tricuspid valve in valve replacement due to lack of medical necessity since the proposed treatment is believed to be investigational and experimental.
The medical necessity for a transcatheter valve implantation (TTVI)/replacement with prosthetic valve is at issue.

I recommend that the health plan's determination be overturned, in whole, and that coverage be granted for transcatheter tricuspid valve and valve replacement for the treatment of severe bioprosthetic tricuspid valve dysfunction in this case. Transcatheter tricuspid valve in valve replacement is a safer alternative to redo surgical TVR in this case and will result in improvement in heart failure symptoms and quality of life for this patient.

Yes, according to the patient's pre-operative evaluation and results of his cardiac testing in the context of his high surgical risk of redo TVR, transcatheter tricuspid valve in valve replacement for this patient will be an effective treatment to improve the patient's symptoms, quality of life, and survival compared to his current treatment approach with medical therapy. In addition, the patient's records indicate that he is failing medical therapy and manifesting signs of worsening right heart failure which will ultimately result in progressive multiorgan dysfunction and mortality unless addressed with transcatheter tricuspid valve in valve replacement. Based on the currently available published medical literature on the success and cardiovascular outcomes of patients treated with transcatheter valve in valve replacement for severe tricuspid valve prosthesis dysfunction, the transcatheter valve in valve procedure has shown in multiple studies to be safe and result in significant improvement of valvular hemodynamics, heart failure symptoms, and quality of life. [1-3] Given the clinical benefits of transcatheter tricuspid valve in valve replacement and that it is a safer alternative for this patient, I strongly believe that transcatheter tricuspid valve in valve replacement is a good choice to effectively treat this patient's severe bioprosthetic tricuspid valve dysfunction.