Transmyocardial Revascularization (TMR) for the Treatment of Coronary Artery Disease
DESCRIPTION
Transmyocardial revascularization (TMR), also known as transmyocardial laser revascularization (TMLR) is a technique that is used in an effort to improve blood flow to ischemic heart muscle. This is done via the creation of direct channels from the left ventricle into the myocardium. TMR is performed via a thoracotomy, with the individual under anesthesia. Cardiopulmonary bypass is not required. A laser probe is placed on the surface of the myocardium. While the heart is in diastole, the laser is discharged to create a channel through the myocardium into the left ventricle. Less invasive approaches to TMR are also being studied.
Open TMR has been investigated in two populations of individuals. The first is in individuals with ischemic myocardium who, due to anatomical features of their coronary circulation, are not candidates for other types of revascularization procedures (e.g., coronary artery bypass graft [CABG] surgery, or percutaneous transluminal coronary angioplasty [PTCA]). The second is the usage of open TMR as an adjunct to coronary artery bypass grafting in individuals that have areas of ischemic myocardium which are not amenable to surgical revascularization.
POLICY
Open transmyocardial revascularization for the treatment of ischemic myocardium is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Percutaneous transmyocardial revascularization for the treatment of ischemic myocardium is considered investigational.
Any device utilized for this procedure must have FDA approval specific to the indication, otherwise it will be considered investigational.
MEDICAL APPROPRIATENESS
Open transmyocardial revascularization is considered medically appropriate if ALL of the following criteria are met:
The individual has stable class III or IV angina that is refractory to medical treatment
The ejection fraction is greater than 30%
There is confirmation that the myocardium is re-perfusable
The individual has ANY ONE of the following:
Unsuitable coronary anatomy (i.e., diffuse vascular disease, small coronary arteries, and/or distal obstruction) for coronary artery bypass graft surgery or percutaneous transluminal coronary angioplasty
Documented unsuitable coronary anatomy in areas of the myocardium so that TMR is used as an adjunct to surgical revascularization
ADDITIONAL INFORMATION
Few controlled studies were found in the published literature regarding the efficacy or safety of percutaneous TMR or provide comparisons to open TMR. There is no FDA approved device for percutaneous TMR. The current literature supports the policy as stated.
SOURCES
American College of Cardiology. (2004). ACC/AHA 2004 guideline update for coronary artery bypass graft surgery: summary article. Retrieved March 6, 2009 from http://www.acc.org/qualityandscience/clinical/guidelines/cabg/index.pdf.
American College of Cardiology. (2009). ACC/AHA 2009 Appropriateness Criteria for Coronary Revascularization. Retrieved March 6, 2009 from. http://content.onlinejacc.org/cgi/reprint/53/6/530.pdf.
BlueCross BlueShield Association. Medical Policy Reference Manual. (10:2008). Transmyocardial revascularization (7.01.54). Retrieved March 5, 2009 from BlueWeb.
Complete Guide to Medicare Coverage Issues [Computer software]. (2008, November). Transmyocardial Revascularization (TMR) for Treatment of Severe Angina (NCD 20.6, p. 2-7). The Ingenix Complete Guide to Medicare Coverage Issues. `
Hayes. Medical Technology Directory. (2006, January). Myocardial Laser Revascularization. Retrieved March 6, 2009 from http://www.hayesinc.com/hayes/. (73 articles and/ or guidelines reviewed)
ECRI Institute. Health Technology Assessment Information Service. Target database. (2002, November. Percutaneous myocardial laser revascularization (PMR) for palliation of intractable angina. Retrieved April 27, 2005 from ECRI HTAIS. (19 articles and/ or guidelines reviewed)
ECRI Institute. Health Technology Assessment Information Service. Target database. (2001, May). Surgical transmyocardial laser revascularization (TMR) for palliation of intractable angina. Retrieved April 27, 2005 from ECRI HTAIS. (35 articles and/ or guidelines reviewed)
ECRI Institute. Health Technology Assessment Information Service. Windows on Medical Technology™. (2001, April). Surgical transmyocardial laser revascularization for the palliation of intractable angina. Retrieved April 27, 2005 from ECRI HTAIS. (80 articles and/ or guidelines reviewed)
Technology Evaluation Center. (1999, February). Transmyocardial revascularization for the treatment of coronary artery disease (Vol. 13, No. 23). Chicago: BlueCross BlueShield Association.(42 articles and/ or guidelines reviewed)
Technology Evaluation Center. (2001, May). TMR as an adjunct to CABG surgery for the treatment of coronary artery disease (Vol. 16, No. 1). Chicago: BlueCross BlueShield Association.(50 articles and/ or guidelines reviewed)
The Society of Thoracic Surgeons. (2004, January). Practice guideline series: Transmyocardial laser revascularization. Retrieved April 27, 2005 from http://ats.ctsnetjournals.org/cgi/content/full/77/4/1494.
ORIGINAL EFFECTIVE DATE: 5/1/2000
MOST RECENT REVIEW DATE: 4/9/2009
ID_BT
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
This document has been classified as public information.