Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Aortic stenosis
Treatment: 33361 - Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; percutaneous femoral artery approach

The health plan should not cover the 33361 - transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; percutaneous femoral artery approach.

The patient is a male. He presented with hx (history) of progressive dyspnea on exertion with evidence of aortic stenosis (AS) on echocardiogram. He had medical history of hypertension, diabetes, hyperlipidemia and CVA (cerebrovascular accident). Outpatient echocardiogram revealed normal LV (left ventricle) function and valve area of 1.1 cm2. 

The patient underwent evaluation for valve replacement, including cardiac catheterization which revealed two-vessel CAD (coronary artery disease), proximal LAD (left anterior descending) and proximal circ. These significant lesions were successfully stented. A gradient across the valve of 12 mm Hg and normal LV function was determined to be present.  

Two weeks after discharge, the patient had a syncope episode, which was treated with hydration and then he was discharged.  He underwent a successful TAVR (transcatheter aortic valve replacement). Post TAVR, echocardiogram show peak gradient of 12 and valve area of 2.0. Patient was discharged on standard post TAVR medications.

The 33361 - transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; percutaneous femoral artery approach is not likely to be more beneficial.

In this case, indications for aortic valve replacement, either percutaneous or surgical, were not met. Indications for aortic valve replacement both in the literature and community practice are as follows:

"The following recommendations for aortic valve replacement apply to patients with severe high-gradient AS (criteria include maximum aortic jet velocity over >=4 m/s or mean transvalvular pressure gradient >=40 mmHg) 

For patients with severe high-gradient AS who have symptoms by history or on exercise testing (stage D1), we recommend aortic valve replacement. Valve replacement should be performed promptly after the onset of symptoms.

For asymptomatic patients with severe high-gradient AS (stage C2) and LVEF [left ventricle ejection fraction] <50 percent, we suggest aortic valve replacement.

For patients with severe high-gradient AS (stage C or D) when undergoing other cardiac surgery, we suggest aortic valve replacement.

For asymptomatic patients with very severe AS (stage C1 and maximum aortic velocity >=4.5 m/s) and low surgical or TAVI [transcatheter aortic valve implantation] procedural risk, we suggest aortic valve replacement.

For asymptomatic patients with severe AS (stage C1) and decreased exercise tolerance or fall in systemic blood pressure with exercise, we suggest aortic valve replacement."

While this patient did exhibit dyspnea on exertion, its etiology could have been ischemic due to multivessel CAD. There is no evidence of dyspnea after revascularization. The aortic valve showed moderate reduction in valve area and a low gradient in patient with normal LV function. (The gradient post TAVR remained 12 mm Hg). 

The patient did not have evidence of severe high gradient AS, very severe AS, or severe AS with demonstrable exercise intolerance.

The patient should have been evaluated post PCI (percutaneous coronary intervention) to determine if symptomatic criteria were met, as the AS was not severe by echo or gradient, and LV function normal.

If criteria had been met, TAVR would be considered acceptable for AVR (aortic valve replacement) in this clinical situation. However, no evidence that criteria for AVR were present in the medical records.