Mitral valve regurgitation (MVR) is the most prevalent form of heart valve disease.

Transcatheter Mitral Valve Repair/Replacement (TMVR) is a minimally invasive procedure that uses catheter-based technology that emulates surgical annuloplasty and edge-to-edge repair of regurgitant mitral valves. TMVR is performed on a beating heart with no cardiopulmonary bypass.  

TMVR with a device approved by the United States (U.S.) Food and Drug Administration (FDA) for use in mitral valve repair may be considered medically necessary when individual meets ALL of the following criteria:

• Symptomatic primary mitral valve regurgitation:
  • New York Heart Association (NYHA) Class III to IV with severe primary mitral regurgitation (stage D) (see tables below); and
• Individual is considered prohibitive high risk for surgery; and
• Has failed optimal guideline directed medical therapy for heart failure; and
• Has favorable anatomy for the procedure as well as a reasonable life expectancy.

TMVR with a device approved by the U.S. FDA may be considered medically necessary for individuals with heart failure and moderate-to-severe or severe symptomatic secondary mitral regurgitation despite the use of maximally tolerated guideline-directed medical therapy.

• Moderate to severe or severe MR may be determined by EITHER:
  • Grade 3+ (moderate) or 4+ (severe) MR confirmed by echocardiography; or
  • New York Heart Association (NYHA) functional class II, III, or IVa (ambulatory) despite the use of stable maximal doses of guideline-directed medical therapy and cardiac resynchronization therapy (if appropriate) administered in accordance with guidelines of professional societies.

TMVR for repair of a degenerated bio-prosthetic valve (valve-in-valve) with a device approved by U.S. FDA may be considered medically necessary when ALL of the following criteria are met:

• The individual has a failed (i.e., stenosed, insufficient, and/or combined) previous surgical bio-prosthetic mitral valve; and
• At the discretion of the Heart Team specialists, the individual is EITHER:
  • Not a operable candidate for open surgery; or
  • Is an operable candidate but at high risk for open surgery (i.e. STS score of 8% or higher or have an expected mortality risk of 15% or greater for open surgery).

TMVR not meeting the criteria as indicated in this policy is considered experimental/investigational and therefore, non-covered because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature.

Requirements:

The Professional Team must meet ALL of the following requirements:

• Both a cardiothoracic surgeon experienced in mitral valve surgery and a cardiologist experienced in mitral valve disease; and
• Each interventional cardiologist performs greater than 50 structural procedures per year including atrial septal defects (ASD), patent foramen ovale (PFO) and trans-septal punctures; and
• Interventional cardiologist(s) must receive prior suitable training on the devices to be used; and
• The interventional cardiologist(s) must be board-certified in interventional cardiology or board-certified/eligible in pediatric cardiology or similar boards from outside the United States; and
• The cardiothoracic surgeon(s) must be board-certified in thoracic surgery or similar foreign equivalent.

TMVR must be performed by an interventional cardiologist or a cardiothoracic surgeon. Interventional cardiologist(s) and cardiothoracic surgeon(s) may jointly participate in the intra-operative technical aspects of TMVR as appropriate.

The Facility must meet ALL of the following requirements:

• On-site active valvular heart disease surgical program with greater than or equal to two (2) hospital-based cardiothoracic surgeons experienced in valvular surgery; and
• A surgical program that performs greater than or equal to 25 total mitral valve surgical procedures for severe mitral regurgitation (MR) per year of which at least 10 must be mitral valve repairs; and
• An interventional cardiology program that performs greater than or equal to 1000 catheterizations per year, including greater than or equal to 400 percutaneous coronary interventions (PCIs) per year, with acceptable outcomes for conventional procedures compared to National Cardiovascular Data Registry (NCDR) benchmarks; and
• Cardiac catheterization laboratory or hybrid operating room/catheterization laboratory equipped with a fixed radiographic imaging system with flat-panel fluoroscopy offering catheterization laboratory-quality imaging; and
• Post-procedure intensive care facility with personnel experienced in managing individuals who have undergone open-heart valve procedures.

New York Heart Association (NYHA) Classification of Heart Failure

Stages of Secondary Mitral Regurgitation (MR)