Saturday, December 8, 2018

CPT 0345T, 0483T, 0484T, 33418, 33419 - Transcatheter Mitral Valve Repair

Code Description CPT

0345T Transcatheter mitral valve repair percutaneous approach via the coronary sinus

0483T Transcatheter mitral valve implantation/replacement (TMVI) with prosthetic valve; percutaneous approach, including transseptal puncture, when performed (new code effective 1/1/18)

0484T Transcatheter mitral valve implantation/replacement (TMVI) with prosthetic valve; transthoracic exposure (eg, thoracotomy, transapical) (new code effective 1/1/18)

33418 Transcatheter mitral valve repair, percutaneous approach, including transseptal puncture when performed; initial prosthesis

33419 Transcatheter mitral valve repair, percutaneous approach, including transseptal puncture when performed; additional prosthesis(es) during same session (List separately in addition to code for primary procedure)
 

Transcatheter Mitral Valve Repair

Introduction


The heart has four chambers, two upper and two lower. The mitral valve is between the upper and lower left chambers. After blood has been pumped from the upper left chamber to the lower left chamber, the mitral valve closes. The mitral valve is made up of small pieces of tissue called leaflets. If the leaflets don’t close properly when the left lower chamber pumps blood out to the body some of the blood can leak back into the upper left chamber. This is known as mitral valve regurgitation. Medication can be used to help manage the symptoms of mitral valve regurgitation. Open heart surgery is a treatment option. If a person is too sick for surgery, a nonsurgical procedure may be used to place a clip to close the leaky mitral valve. In this procedure, a long, hollow tube (a catheter) is threaded through a specific vein into the heart. The catheter then becomes the pathway for getting the clip to the mitral valve. Imaging is used to make sure the device is correctly placed. This policy describes when transcatheter mitral valve repair is considered medically necessary.

Note: The Introduction section is for your general knowledge and is not to be taken as policy coverage criteria. The rest of the policy uses specific words and concepts familiar to medical professionals. It is intended for providers. A provider can be a person, such as a doctor, nurse, psychologist, or dentist. A provider also can be a place where medical care is given, like a hospital, clinic, or lab. This policy informs them about when a service may be covered.

Policy Coverage Criteria Service Medical Necessity Transcatheter mitral valve repair (eg, MitraClip® Clip Delivery System)

Transcatheter mitral valve repair using a device approved by the U.S. Food and Drug Administration for use in mitral valve repair may be considered medically necessary for patients with symptomatic, primary mitral regurgitation who are considered at prohibitive risk for open surgery. Prohibitive risk for open mitral valve repair surgery may be determined based on:


* The documented presence of a Society for Thoracic Surgeons predicted mortality risk of 12% or greater AND/OR

* The documented presence of a logistic EuroSCORE of 20% or greater

Transcatheter mitral valve repair is considered investigational in all other situations.

Documentation Requirements

The patient’s medical records submitted for review for all conditions should document that medical necessity criteria are met. The record should include the following:
* Name of the Food and Drug Administration (FDA) approved device to be used
* Documentation that patient has symptomatic primary mitral regurgitation AND
* Patient is at greater risk for open mitral valve repair surgery based on:
o The documented presence of a Society for Thoracic Surgeons predicted mortality risk of 12% or greater AND/OR
o The documented presence of a logistic EuroSCORE of 20% or greater


Related Information

Indications for Use


The FDA summary of safety and effectiveness data (SSED) from 2013 states the indications for use below: The MitraClip Clip Delivery System is indicated for the percutaneous reduction of significant symptomatic mitral regurgitation (MR of 3+ or greater) due to primary abnormality of the mitral apparatus [degenerative MR] in patients who have been determined to be at prohibitive risk for mitral valve surgery by a heart team that includes a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in mitral valve disease, and in whom existing comorbidities would not preclude the expected benefit from reduction of the mitral regurgitation.12

Repair Device

MitraClip® Clip Delivery System has the U.S. Food and Drug Administration (FDA) approval for the treatment of severe symptomatic degenerative mitral regurgitation (see Regulatory Status).


Evidence Review Description

Transcatheter mitral valve repair (TMVR) is an alternative to surgical therapy for mitral regurgitation (MR). MR is a common valvular heart disease that can result from a primary structural abnormality of the mitral valve (MV) complex or a secondary dilatation of an anatomically normal MV due to a dilated left ventricle caused by ischemic or dilated cardiomyopathy. Surgical therapy may be underutilized, particularly in patients with multiple comorbidities, suggesting that there is an unmet need for less invasive procedures for MV repair. One device, MitraClip, has approval from the U.S. Food and Drug Administration for the treatment of severe symptomatic MR due to a primary abnormality of the MV (primary MR) in patients considered at prohibitive risk for surgery.

Background

Mitral Regurgitation

Epidemiology and Classification


Mitral regurgitation (MR) is the second most common valvular heart disease, occurring in 7% of  people older than age 75 years and accounting for 24% of all patients with valvular heart disease.1-2

Patients with MR generally fall into 2 categories — primary (also called degenerative) and secondary (also called functional) MR. Primary MR results from a primary structural abnormality in the valve, which causes it to leak. This leak may result from a floppy leaflet (called prolapse) or a ruptured cord that caused the leaflet to detach partially (called flail).3 Because the primary cause is a structural abnormality, most cases of primary MR are surgically corrected. In contrast, secondary MR results from left ventricular dilatation due to ischemic or dilated cardiomyopathy. This causes the mitral value (MV) leaflets not to coapt or meet in the center.4 Because the valves are structurally normal in secondary MR, correcting the dilated left ventricular using medical therapy is the primary treatment strategy used in the United States.

MR severity is classified as mild, moderate, or severe disease on the basis of echocardiographic and/or angiographic findings (1+, 2+, and 3-4+ angiographic grade, respectively). MR with accompanying valvular incompetence leads to left ventricular volume overload with secondary ventricular remodeling, myocardial dysfunction, and left heart failure. Clinical signs and symptoms of dyspnea and orthopnea may also present in patients with valvular dysfunction.4 Standard Management

Medical Management

Medical management has a primary role in secondary MR. Patients with chronic secondary MR  should receive standard therapy for heart failure with reduced ejection fraction; standardmanagement includes angiotensin converting enzyme inhibitor (or angiotensin II receptor blocker or angiotensin receptor-neprilysin inhibitor), *-blocker and mineralocorticoid receptor antagonist, and diuretic therapy as needed to treat volume overload.3,4

Surgical Management

In symptomatic patients with primary MR, surgery is the main therapy. In most cases, MV repair is preferred over replacement, as long as the valve is suitable for repair and personnel with appropriate surgical expertise are available. The American College of Cardiology and the American Heart Association have issued joint guidelines for the surgical management of MV, which are outlined in Table 1.3

Table 1. Guidelines on Mitral Value Surgery Recommendation COR LOE

MV surgery is recommended for the symptomatic patient with acute severe MR. I B
MV surgery is beneficial for patients with chronic severe MR and NYHA functional class II, III, or IV symptoms in the absence of severe LV dysfunction (severe LV dysfunction is defined as ejection fraction less than 0.30) and/or end-systolic dimension greater than 55 mm. I B
MV surgery is beneficial for asymptomatic patients with chronic severe MR and mild-tomoderate
LV dysfunction, ejection fraction 0.30 to 0.60, and/or end systolic dimension greater than or equal to 40 mm. I B
MV repair is recommended over MV replacement in the majority of patients with severe chronic
MR who require surgery, and patients should be referred to surgical centers experienced in MV I C

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