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Vlinx Serial Server ManualUse this page to view details for the decision Memo for Transcatheter Mitral Valve Repair (TMVR) (CAG-00438N). The medical profession should play a central role in evaluating the evidence related to drugs, devices, and procedures for the detection, management, and prevention. Introduction. Since the first implantation of a transcatheter aortic valve in 2002 1 this new technology has reached world-wide acceptance as an alternative to. Original Article. Surgical or Transcatheter Aortic-Valve Replacement in Intermediate-Risk Patients. Reardon, M.D., Nicolas M. Van Mieghem, M.D., Ph.D. Aortic valve replacement (AVR) has been the mainstay of treatment of symptomatic severe aortic stenosis (AS). The role of transcatheter aortic valve implantation. ![]() Decision Memo for Transcatheter Mitral Valve Repair (TMVR) (CAG- 0. N)TO: Administrative File: (CAG- 0. N). FROM: Tamara Syrek Jensen, JD. Coverage and Analysis Group. Acting Director. Division of Medical and Surgical Services. Jyme Schafer, MD, MPH. Division of Medical and Surgical Services. Lori Paserchia, MD. Medical Officer. Division of Medical and Surgical Services. Lead Analyst. Division of Medical and Surgical Services. Rosemarie Hakim, Ph. D. Epidemiologist. Coverage and Analysis Group. SUBJECT: Final Decision Memorandum for Transcatheter Mitral Valve Repair (TMVR). DATE: August 7, 2. I. Final Decision. The Centers for Medicare & Medicaid Services (CMS) covers transcatheter mitral valve repair (TMVR) under Coverage with Evidence Development (CED) with the following conditions: A. TMVR is covered for the treatment of significant symptomatic degenerative mitral regurgitation when furnished according to an FDA approved indication and when all of the following conditions are met. TMVR must be furnished in a hospital with the appropriate infrastructure that includes but is not limited to: On- site active valvular heart disease surgical program with . Outlined below are institutional and operator requirements for performing TMVR. The hospital must have the following: A surgical program that performs . What is the long term (? What are the long term (. TMVR is covered for uses that are not expressly listed as an FDA approved indication when performed within a FDA- approved randomized controlled trial that fulfills all of the following. TMVR must be performed by an interventional cardiologist or a cardiac surgeon. What is the incidence of transient ischemic attacks (TIAs)? What is the incidence of major vascular events? What is the incidence of renal complications? What is the incidence of worsening mitral regurgitation? What is the patient’s post TMVR quality of life? What is the patient’s post TMVR functional capacity? C. The research study does not unjustifiably duplicate existing studies. The research study is sponsored by an organization or individual capable of executing the proposed study successfully. The research study is in compliance with all applicable Federal regulations concerning the protection of human subjects found in the Code of Federal Regulations (CFR) at 4. CFR Part 4. 6. If a study is regulated by the Food and Drug Administration (FDA), it also must be in compliance with 2. CFR Parts 5. 0 and 5. All aspects of the research study are conducted according to appropriate standards of scientific integrity. The research study has a written protocol that clearly addresses, or incorporates by reference; the standards listed as Medicare coverage requirements. Trials of all medical technologies measuring therapeutic outcomes as one of the objectives meet this standard only if the disease or condition being studied is life threatening as defined in 2. CFR . The clinical research studies and registries are registered on the www. Clinical. Trials. Registries are also registered in the Agency for Healthcare Quality (AHRQ) Registry of Patient Registries (Ro. PR). The research study protocol specifies the method and timing of public release of all prespecified outcomes to be measured including release of outcomes if outcomes are negative or study is terminated early. The results must include number started/completed, summary results for primary and secondary outcome measures, statistical analyses, and adverse events. Final results must be reported in a publicly accessibly manner; either in a peer- reviewed scientific journal (in print or on- line), in an on- line publicly accessible registry dedicated to the dissemination of clinical trial information such as Clinical. Trials. gov, or in journals willing to publish in abbreviated format (e. If the inclusion and exclusion criteria are expected to have a negative effect on the recruitment or retention of underrepresented populations, the protocol must discuss why these criteria are necessary. The research study protocol explicitly discusses how the results are or are not expected to be generalizable to the Medicare population to infer whether Medicare patients may benefit from the intervention. Consistent with section 1. Act, the Agency for Healthcare Research and Quality (AHRQ) supports clinical research studies that CMS determines meet the above- listed standards and address the above- listed research questions. The principal investigator must submit the complete study protocol, identify the relevant CMS research question(s) that will be addressed and cite the location of the detailed analysis plan for those questions in the protocol, plus provide a statement addressing how the study satisfies each of the standards of scientific integrity (a. The information will. CMS website. Background The following acronyms are used throughout this document. Food and Drug Administration. FDM - final decision memorandum. FMR - functional mitral regurgitation. GDMT – guideline determined medical therapy. GI – gastrointestinal HRR – high risk registry. HRS – high risk study. IVC – inferior vena cava. KCCQ – Kansas City Cardiomyopathy Questionnaire. LV- left ventricle. LVEF - left ventricular ejection fraction. MCS – Mental Component Summary. MELD – model for end stage liver disease. MI - myocardial infarction. MLHFQ – Minnesota Living with Heart Failure Questionnaire. MR - mitral regurgitation. MV - mitral valve. NCA - National Coverage Analysis NCD - National Coverage Decision. NCDR - National Cardiovascular Data Registry. NYHA - New York Heart Association. PCI – percutaneous coronary intervention. PSC – Physical Component Summary. PDM – proposed decision memorandum. PMA – FDA premarket approval. PR – prohibitive risk. Qo. L - Quality of Life. RCT - randomized controlled trial. Ro. PR - Registry of Patient Registries. SCAI - Society for Cardiovascular Angiography and Interventions. SSED – Summary of Safety and Effectiveness Data. STS - Society of Thoracic Surgeons. TA – technology assessment. TAVR – Transcatheter Aortic Valve Replacement. TEE – transesophageal echocardiography. TIA – transient ischemic attack. TMV – transcatheter mitral valve. TMVR - Transcatheter Mitral Valve Repair. TRAMI – transcatheter mitral valve interventions. U - unit. Mitral Regurgitation. Mitral regurgitation (MR) is the most common type of heart valve insufficiency in the United States. According to de Marchena (2. This causes the heart to work harder to pump blood through the body, and in turn, is accompanied by an increase in the size of the left ventricle, potentially leading to heart failure. MR also is often associated with irregular heartbeats, stroke, myocardial infarction (a. The natural history of MR varies. MR may present as acute and severe or it may progress over a period of time (Bonow 2. There are numerous causes of MR, including mitral valve prolapse, rheumatic heart disease, coronary artery disease, infective endocarditis, certain drugs and collagen vascular disease (Bonow 2. Additionally, there are two types of MR: 1) degenerative MR (DMR) or primary MR, which refers to leaflet abnormalities and 2) functional MR (FMR), or secondary MR, where the valve structure is normal, but the papillary muscles are displaced and the annulus is stretched. As Rosenhek (2. 01. Degenerative and functional mitral regurgitation (MR) constitute 2 separate disease entities. There are three surgical options available: 1) MV repair; 2) MV replacement with preservation of part or all of the mitral apparatus; and 3) MV replacement with removal of the mitral apparatus. However, patients with advanced age, LV dysfunction and comorbidities are deemed to be high risk surgical candidates and therefore surgery is often not presented as an option for these individuals (Bonow 2. 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