Medical Policy

This document addresses transmyocardial revascularization.

Medically Necessary:

Open transmyocardial revascularization, also known as transmyocardial laser revascularization, is considered medically necessary for individuals with class III or class IV angina who are not candidates for coronary artery bypass graft surgery or percutaneous transluminal coronary angioplasty surgery who meet all of the following criteria:

• Presence of class III or IV angina refractory to medical management; and
• Documentation of reversible ischemia; and
• Left ventricular ejection fraction greater than 30%; and
• No evidence of recent myocardial infarction or unstable angina within the last 21 days; and
• No severe comorbid illness such as chronic obstructive pulmonary disease.

Open transmyocardial revascularization is considered medically necessary as an adjunct to coronary artery bypass graft in those individuals with documented areas of ischemic myocardium that are not amenable to surgical revascularization.

Investigational and Not Medically Necessary:

Percutaneous myocardial revascularization is considered investigational and not medically necessary.

All other uses of transmyocardial revascularization are considered investigational and not medically necessary.

Transmyocardial revascularization (TMR), also known as transmyocardial laser revascularization (TMLR) involves the use of a high-energy laser beam to create transmural channels in the heart to allow oxygenated left ventricular blood to directly perfuse ischemic myocardium. TMR can be performed using an open thoracotomy approach or using a percutaneous approach where the laser can be inserted through the femoral artery. Open and percutaneous TMR have been used in individuals with end-stage coronary artery disease (CAD) that is refractory to medical therapy and who are not suitable candidates for alternative surgical interventions. These are persons with stable class III or class IV angina, who have hypoperfused but viable myocardium, who have failed maximal medical management and are not amenable to traditional myocardial revascularization procedures, such as coronary artery bypass graft (CABG) and percutaneous transluminal coronary angioplasty (PTCA).

TMR has also been used in conjunction with CABG in some individuals with end-stage CAD that can be partially revascularized with CABG. The areas of ischemic myocardium not amenable to CABG are then treated by TMR, in conjunction with the standard CABG procedure. When performed in conjunction with CABG, an open approach is used.

A variety of randomized studies have consistently reported that open TMR, as a sole therapy in individuals with CAD who are not candidates for revascularization, is associated with a significant improvement in anginal symptoms. A meta-analysis of seven randomized trials involving 1053 participants concluded at 1 year follow-up, that TMR produced a significant improvement in anginal class but no improvement in survival (Liao, 2005). Since this large analytic review of the evidence, there has been limited published literature related to TMR procedures. However, the evidence continues to sufficiently demonstrate improved clinical outcomes in the subset of individuals with refractory angina who are not surgical candidates for traditional revascularization procedures.

One randomized, blinded trial evaluated the addition of open TMR to CABG. While there appeared to be a mortality benefit associated with combined TMR/CABG at 1 year (Allen, 2000), at 5 year follow-up survival was similar in both groups (Allen, 2004). However, the addition of TMR to CABG provided superior anginal relief compared to CABG alone.

A 2018 study by Konstanty-Kalandyk and colleagues reported on the 10-year survival rate of those who had CABG and TMR. In this retrospective review of charts there were 86 participants who had CABG due to disseminated coronary atherosclerosis and presence of angina. There were 77 participants who had both CABG and TMR while 9 participants had TMR only (due to technical issues during the CABG). The 46 participants who underwent CABG plus TMR on at least one heart wall were referred to as the combined therapy group. The remaining 40 participants did not receive combined treatment (received procedures on separate heart walls) and were referred to as the single therapy group. For the entire cohort, the overall mortality rate at 10 years was 31%. Median average survival was 137 months. In the single therapy group, the cumulative 10-year survival from cardiac death was 72.5% and freedom from cardiac death was 77.5%. In the combined therapy group, the survival from cardiac death was 78.3% and freedom from cardiac death was 80.4%.

In 2021, the American College of Cardiology (ACC), the American Heart Association (AHA), and Society for Cardiovascular Angiography and Interventions (SCAI) published a guideline for Coronary Artery Revascularization. This guideline replaces the previous 2011 guidelines for Coronary Artery Bypass Graft Surgery and Percutaneous Coronary Interventions. The 2021 guideline does not address transmyocardial revascularization.

Percutaneous TMR was designed as a less invasive alternative to open TMR. Leon and colleagues published the results of a double-blind study that randomized 298 individuals with refractory angina to undergo percutaneous or sham TMR (Leon, 2005). Notably, myocardial “mapping” was obtained prior to the procedure to determine the electrical viability of treatment targets and to decide where to locate laser channels. The primary endpoint was the change in exercise duration from baseline to 6 months. At 6 months post-procedure, there were no significant differences in outcomes between the treatment groups and the placebo group, in part due to the pronounced placebo effect resulting in a 30% improvement in exercise duration and angina symptoms that was sustained for 12 months. This improvement was identical to that observed in the treatment arms. There was an increased rate of adverse clinical events associated with the laser treatment groups at 30 days. The authors note that blinded and unblinded randomized studies of percutaneous TMR have reported conflicting results, while the randomized studies of open TMR, all unblinded, have generally reported favorable results. Leon and colleagues suggest that a placebo effect may be responsible. There is insufficient evidence, to date, to demonstrate efficacy and the long-term outcomes of percutaneous TMR.

McGillion and colleagues (2010) reported a meta-analysis of percutaneous myocardial laser revascularization (PMLR) and maximal medical therapy versus maximal medical therapy alone for refractory angina. A total of five trials were included in the final assessment (two trials initially included were excluded due to poor methodological quality) with a summarization of 12-month outcomes. The meta-analysis revealed that PMLR did not significantly improve exercise performance, however different approaches were used during each study to measure exercise performance. The meta-analysis also showed no significant overall impact on all-cause mortality. The analyses showed promising results for angina, but further study is needed.

CAD occurs when the blood flow through one or more of the coronary arteries becomes inadequate, due to a combination of atherosclerotic plaques, clot formation, or inadequate perfusion of the myocardium. Typically, CAD is treated with medication, risk factor reduction, and surgery (CABG and/or PTCA). Although these techniques have been proven successful in many individuals with CAD, many people in the United States with incapacitating angina are not suitable candidates for these surgical procedures, due to failed prior procedures, diffuse coronary artery disease, distal stenoses, or very small coronary arteries.

Both open and percutaneous TMR are techniques that attempt to improve blood flow to ischemic heart muscle by using lasers to create channels into the left ventricle myocardium. How TMR reduces angina is still not fully understood. The laser may stimulate new blood vessels to grow, called angiogenesis, and it may also destroy nerve fibers to the heart, making people unable to feel their chest pain. The open procedure is done via a thoracotomy (incision through the ribs to access the heart) on a beating heart without the use of cardiopulmonary bypass. The surgeon uses a laser to drill a series of holes from the epicardium into the heart's pumping chamber. In some individuals, TMR is combined with bypass surgery. Using a femoral arterial approach, percutaneous myocardial revascularization uses a fiberoptic catheter to create channels in the myocardium. In contrast to open TMR, where the channels extend from the epicardium to the endocardium, in a percutaneous approach the channels are created from the endocardium to the epicardial surface.

Angina pectoris: Chest pain that is typically severe and crushing. The individual experiences a feeling of pressure and suffocation just behind the breastbone (the sternum) caused by an inadequate supply of oxygen to the heart muscle.

Canadian Cardiovascular Society Score (Campeau, 1976): This organization defines anginal classes as follows:

Class I:      Ordinary physical activity does not cause angina;
Class II:     Slight limitation of ordinary activity;
Class III:    Marked limitation of ordinary physical activity;
Class IV:    Inability to carry on physical activity without discomfort.

Myocardial ischemia: Inadequate blood supply (circulation) to a part of the heart due to blockage of the vessels supplying blood to the area.

The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

When services may be Medically Necessary when criteria are met:

When services are Investigational and Not Medically Necessary:
For the procedure and diagnosis codes listed above when criteria are not met or for all other diagnoses not listed; or when the code describes a procedure indicated in the Position Statement section as investigational and not medically necessary.

When services are also Investigational and Not Medically Necessary:

Peer Reviewed Publications:

1. Aaberge L, Rootwelt K, Blomhoff S, et al. Continued symptomatic improvement three to five years after transmyocardial revascularization with CO(2) laser: a late clinical follow-up of the Norwegian randomized trial with transmyocardial revascularization. J Am Coll Cardiol. 2002; 39(10):1588-1593.
2. Allen KB, Dowling RD, Angell WW, et al. Transmyocardial revascularization: 5-year follow-up of a prospective randomized multicenter trial. Ann Thorac Surg. 2004; 77(4):1228-1234.
3. Allen KB, Dowling RD, DelRossi AJ, et al. Transmyocardial laser revascularization combined with coronary artery bypass grafting: a multicenter, blinded, prospective, randomized, controlled trial. J Thorac Cardiovasc Surg. 2000; 119(3):540-549.
4. Allen GS. Mid-term results after thoracoscopic transmyocardial laser revascularization. Ann Thorac Surg. 2005; 80(2):553-558.
5. Horvath KA. Results of prospective randomized controlled trials of transmyocardial laser revascularization. Heart Surg Forum. 2002; 5(1):33-39; discussion 39-40.
6. Iwanski J, Knapp SM, Avery R, et al. Clinical outcomes meta-analysis: Measuring subendocardial perfusion and efficacy of transmyocardial laser revascularization with nuclear imaging. J Cardiothorac Surg. 2017; 12(1):37.
7. Konstanty-Kalandyk J, Piątek J, Kędziora A, et al. Ten-year follow-up after combined coronary artery bypass grafting and transmyocardial laser revascularization in patients with disseminated coronary atherosclerosis. Lasers in medical science. 2018; 33(7):1527-1535.
8. Leon MB, Kornowski R, Downey WE, et al. A blinded randomized placebo-controlled trial of percutaneous laser myocardial revascularization to improve angina symptoms in patients with severe coronary disease. J Am Coll Cardiol. 2005; 46(10):1812-1819.
9. Liao L, Sarria-Santamera A, Matchar DB, et al. Meta-analysis of survival and relief of angina pectoris after transmyocardial revascularization. Am J Cardiol. 2005; 95(10):1243-1245.
10. McGillion M, Cook A, Victor JC, et al. Effectiveness of percutaneous laser revascularization therapy for refractory angina. Vasc Health Risk Manag. 2010; 6:735-747.
11. Salem M, Rotevatn S, Stavnes S, et al. Usefulness and safety of percutaneous myocardial laser revascularization for refractory angina pectoris. Am J Cardiol. 2004; 93(9):1086-1091.
12. Saririan M, Eisenberg MJ. Myocardial laser revascularization for the treatment of end-stage coronary artery disease. J Am Coll Cardiol. 2003; 41(2):173-183.
13. Stone GW, Teirstein PS, Rubenstein R, et al. A prospective, multicenter, randomized trial of percutaneous transmyocardial laser revascularization in patients with nonrecanalizable chronic total occlusions. J Am Coll Cardiol. 2002; 39(10):1581-1587.
14. Whitlow PL, DeMaio SJ, Perin EC, et al. One-year results of percutaneous myocardial revascularization for refractory angina pectoris. Am J Cardiol. 2003; 91(11):1342-1346.

Government Agency, Medical Society, and Other Authoritative Publications:

1. Briones E, Lacalle JR, Marin-Leon I, Rueda JR. Transmyocardial laser revascularization compared to medical therapy for refractory angina. Cochrane Database Syst Rev. 2015;(2):CD003712.
2. Campeau L. Letter: Grading of angina pectoris. Circulation. 1976; 54(3):522-523.
3. Centers for Medicare and Medicaid Services. National Coverage Determination. Available at: https://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=120&ncdver=1&DocID=20.6&from2=index_chapter_list.asp&list_type=&bc=gAAAABAAAAAA&. Accessed on April 12, 2023.
   • Transmyocardial Revascularization (TMR). NCD #20.6. Effective July 1, 1999.
4. Fraker TD Jr, Fihn SD, Gibbons RJ, et al. 2007 chronic angina focused update of the ACC/AHA 2002 Guidelines for the management of patients with chronic stable angina: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines Writing Group to develop the focused update of the 2002 Guidelines for the management of patients with chronic stable angina. Circulation. 2007; 116(23):2762-2772.
5. Lawton JS, Tamis-Holland JE, Bangalore S, et al. 2021 ACC/AHA/SCAI Guideline for coronary artery revascularization: a report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Journal of the American College of Cardiology, 2022: 79(2):e21-e129.

1. American Heart Association. Available at https://www.heart.org/en/. Accessed on April 12, 2023.
2. Medline Plus. Available at: http://www.nlm.nih.gov/medlineplus/. Accessed on April 12, 2023

Percutaneous Transmyocardial Laser Revascularization
Transmyocardial Laser Revascularization
Transmyocardial Revascularization

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