Latest Review Date: February 2024

Category:  Surgery                                                     

POLICY:

Open transmyocardial laser revascularization may be considered medically necessary for individuals with class III or IV angina, who are not candidates for coronary artery bypass graft (CABG) 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 laser revascularization may be considered medically necessary as an adjunct to CABG in those individuals with documented areas of ischemic myocardium that are not amenable to surgical revascularization.

Open transmyocardial laser revascularization is considered investigational for all other indications.

Percutaneous transmyocardial laser revascularization is considered not medically necessary.

DESCRIPTION OR PROCEDURE OR SERVICE:

Transmyocardial revascularization (TMR), also known as transmyocardial laser revascularization, is a surgical technique that attempts to improve blood flow to ischemic heart muscle by creating direct channels from the left ventricle into the myocardium. TMR may be performed via a thoracotomy or percutaneous transmyocardial revascularization (PTMR).

Two populations of patients are candidates for transmyocardial revascularization (TMR): (1) those with ischemic heart disease and angina pectoris and (2) those undergoing percutaneous coronary intervention or coronary artery bypass surgery who do not achieve complete revascularization.

Transmyocardial Revascularization

TMR can be performed via a thoracotomy, with the patient under general anesthesia. Cardiopulmonary bypass is not required. A laser probe is placed on the surface of the myocardium, and 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, including port access procedures using novel robotic and thoracoscopic techniques.

Percutaneous TMR

TMR can also be performed percutaneously (percutaneous transmyocardial revascularization [PTMR]). PTMR (also called percutaneous myocardial channeling) is a catheter-based system using Holmium:YAG laser revascularization under fluoroscopic guidance. It is performed in Europe but is not currently approved by the U.S. Food and Drug Administration (FDA). PTMR is performed by interventional cardiologists who create myocardial channels with lasers positioned at the endocardial surface inside the left ventricle. Although less invasive than TMR, there are potential disadvantages to the PTMR approach. To minimize the possibility of cardiac tamponade, a potentially fatal condition in which the pericardium fills with blood, the myocardial channels created by PTMR are not as deep as those made by TMR. Also, positioning the laser under fluoroscopic guidance is less precise than the direct visual control of TMR. Less invasive (e.g., robotic) techniques for use of this procedure are also being studied.

KEY POINTS:

The most recent literature search was performed through January 3, 2024.

Summary

For individuals who have class III or IV angina refractory to medical treatment who receive TMR, the evidence includes several randomized controlled trials (RCTs). Relevant outcomes are disease-specific survival, symptoms, functional outcomes, health status measures, quality of life, treatment-related mortality, and treatment-related morbidity. The available RCTs have demonstrated that TMR may provide significant improvements in angina symptoms compared with optimal medical management, but not in survival outcomes or other objective outcomes. The unblinded design of the RCTs with subjective outcomes raises concern for bias. In addition, all of the studies of TMR were conducted in an era prior to the availability of drug-eluting stents, and some were notable for unexpectedly high mortality rates in the control groups. Although studies have not shown improvements in survival or significant increases in exercise duration, the improvement in symptoms represents a health outcome benefit for patients with class III or IV angina who are not candidates for revascularization, who are refractory to medical management, who have reversible ischemia, and who have a left ventricular ejection fraction greater than 30%. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have coronary artery disease and are undergoing coronary artery bypass graft with documented areas of ischemic myocardium that can not be surgically revascularized who receive TMR as adjunctive treatment, the evidence includes meta-analyses of RCTs. Relevant outcomes are overall survival, disease-specific survival, symptoms, morbid events, functional outcomes, health status measures, quality of life, treatment-related mortality, and treatment-related morbidity. Meta-analyses of these trials have reported an improvement in angina, but no improvement in mortality or other relevant outcomes. Similar to TMR as a stand-alone procedure, the unblinded design of the RCTs with subjective outcomes raises concern for bias, but the improvement suggests a health benefit to this patient population. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have class III or IV angina refractory to medical treatment who receive PTMR, the evidence includes a number of RCTs. Relevant outcomes are overall survival, disease-specific survival, symptoms, morbid events, functional outcomes, health status measures, quality of life, hospitalizations, treatment-related mortality, and treatment-related morbidity. Although PTMR is less invasive than TMR and some studies have shown improvements in angina symptoms and health-related quality of life, the available evidence is less robust in showing whether PTMR improves net health outcomes. Additionally, no U.S. Food and Drug Administration‒approved PTMR devices are available. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Practice Guidelines and Position Statements

American College of Cardiology Foundation/American Heart Association et al

In 2012, guidelines for stable ischemic heart disease were developed by the American College of Cardiology Foundation/American Heart Association (ACCF/AHA) Task Force on Practice Guidelines, and the American College of Physicians, American Association for Thoracic Surgery, Preventive Cardiovascular Nurses Association, Society for Cardiovascular Angiography and Interventions, and Society of Thoracic Surgeons. As an alternative therapy for “relief of symptoms in patients with refractory angina ... transmyocardial revascularization (TMR) may be considered for relief of refractory angina in patients with SIHD” (Class IIb recommendation, level of evidence B; benefit greater than risk, evidence less well-established). These guidelines indicate TMR may be considered as an alternative therapy for refractory angina in patients with stable ischemic heart disease. In 2017, the AHA and 7 other cardiovascular medical associations released guidelines for appropriate use criteria for coronary revascularization in patients with SIHD, but there was no mention of TMR. The 2012 SIHD guidelines were updated in 2023 to guidelines for the management of patients with chronic coronary disease. Based on a thorough review of the available evidence, the 2023 writing committee decided a recommendation related to TMR is no longer warranted, and did not reaffirm the 2b recommendation from 2012.

In 2011, the American College of Cardiology and the American Heart Association published guidelines for coronary artery bypass surgery (CABG) and percutaneous artery intervention.  These guidelines both indicated that TMR may be performed as an adjunct to CABG on viable ischemic myocardium that is perfused by arteries not amenable to grafting (class IIb, level of evidence B: benefit greater than risk, evidence less well-established). These guidelines were consolidated and updated in 2021 as a guideline for coronary artery revascularization. This guideline did not mention the use of TMR or percutaneous TMR (PTMR) explicitly.

National Institute for Health and Care Excellence

In 2009, the National Institute for Health and Care Excellence (NICE) issued guidance on TMR and PTMR based on a 2008 systematic review by Campbell et al. The NICE guidance on TMR states:

“Current evidence on transmyocardial laser revascularization for refractory angina pectoris shows no efficacy, based on objective measurements of myocardial function and survival. Current evidence on safety suggests that the procedure may pose unacceptable risk. Therefore, this procedure should not be used.”

The 2009 NICE guidance for PTMR states:

“Current evidence on percutaneous laser revascularization for refractory angina pectoris shows no efficacy and suggests that the procedure may pose unacceptable safety risks.”

U.S. Preventive Services Task Force Recommendations

Not applicable.

KEY WORDS:

TMR, PTMR, Transmyocardial Revascularization, Percutaneous Transmyocardial Revascularization, cardiac ischemia, ischemia, angina

APPROVED BY GOVERNING BODIES:

In 1998, the Heart Laser™ was approved by the U.S. Food and Drug Administration (FDA) through the premarket approval process for the treatment of patients with stable class III or IV angina refractory to medical treatment and secondary to objectively demonstrated coronary artery atherosclerosis not amenable to direct coronary revascularization. In 1999, the Eclipse TMR 2000™ was approved by FDA through the premarket approval process for similar indications. Neither device is approved for use as an adjunct to coronary artery bypass graft. Use of either device for this purpose would be considered an off-label indication.

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits.  Group-specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply.

FEP:  Special benefit consideration may apply.  Refer to member’s benefit plan.  

CURRENT CODING:

CPT Codes:

*This code describes TMLR performed as a stand-alone procedure.

**This code describes the use of transmyocardial laser revascularization as an adjunct to other open cardiac procedures. Therefore this code will be used in conjunction with codes 33390 – 33391, 33405-33410, 33510-33536.

REFERENCES:

1. Aaberge L, Nordstrand K, Dragsund M, et al. Transmyocardial revascularization with CO2 laser in patients with refractory angina pectoris. Clinical results from the Norwegian randomized trial. J Am Coll Cardiol. Apr 2000;35(5):1170-1177.
2. Allen KB, Dowling RD, Angell WW, et al. Transmyocardial revascularization: 5-year follow-up of a prospective, randomized multicenter trial. Ann Thorac Surg. Apr 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. Mar 2000;119(3):540-549.
4. Allen KB, Dowling RD, Fudge TL, et al. Comparison of transmyocardial revascularization with medical therapy in patients with refractory angina. N Engl J Med. Sep 30 1999;341(14):1029-1036.
5. Blue Cross Blue Shield Association Technology Evaluation Center (TEC). Transmyocardial revascularization for the treatment of coronary artery disease. TEC Assessments 1998; Volume 13, Tab 23.
6. Blue Cross Blue Shield Association Technology Evaluation Center (TEC). TMR as an adjunct to CABG surgery for the treatment of coronary artery disease. TEC Assessments 2001; Volume 16, Tab 1.
7. Bridges CR, Horvath KA, Nugent WC, et al. The Society of Thoracic Surgeons practice guideline series: transmyocardial laser revascularization. Ann Thorac Surg. Apr 2004;77(4):1494-1502.
8. Briones E, Lacalle JR, Marin I. Transmyocardial laser revascularization versus medical therapy for refractory angina. Cochrane Database Syst Rev. 2009(1):CD003712.
9. Briones E, Lacalle JR, Marin-Leon I, et al. Transmyocardial laser revascularization versus medical therapy for refractory angina. Cochrane database of systematic reviews. Feb 27 2015(2):CD003712.
10. Burkhoff D, Schmidt S, Schulman SP, et al. Transmyocardial laser revascularisation compared with continued medical therapy for treatment of refractory angina pectoris: a prospective randomised trial. ATLANTIC Investigators. Angina Treatments-Lasers and Normal Therapies in Comparison. Lancet. Sep 11 1999;354(9182):885-890.
11. Campbell F MJ, FitzGerald P, et. al. Systematic review of the efficacy and safety of transmyocardial and percutaneous laser revascularisation for refractory angina pectoris. November 2008; //www.nice.org.uk/guidance/ipg302/documents/systematic-review-of-the-efficacy-and-safety-of-transmyocardial-and-percutaneous-laser-revascularisation-for-refractory-angina-pectoris2.
12. Fihn SD, Gardin JM, Abrams J, et al. 2012 ACCF/AHA/ACP/AATS/PCNA/SCAI/STS Guideline for the diagnosis and management of patients with stable ischemic heart disease: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines, and the American College of Physicians, American Association for Thoracic Surgery, Preventive Cardiovascular Nurses Association, Society for Cardiovascular Angiography and Interventions, and Society of Thoracic Surgeons. J Am Coll Cardiol. Dec 18 2012;60(24):e44-e164.
13. Frazier OH, March RJ, Horvath KA. Transmyocardial revascularization with a carbon dioxide laser in patients with end-stage coronary artery disease. N Engl J Med. Sep 30 1999;341(14):1021-1028.
14. Hillis LD, Smith PK, Anderson JL, et al. 2011 ACCF/AHA Guideline for Coronary Artery Bypass Graft Surgery. A report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Developed in collaboration with the American Association for Thoracic Surgery, Society of Cardiovascular Anesthesiologists, and Society of Thoracic Surgeons. J Am Coll Cardiol. Dec 6 2011;58(24):e123-210.
15. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
16. Jones JW, Schmidt SE, Richman BW, et al. Holmium:YAG laser transmyocardial revascularization relieves angina and improves functional status. Ann Thorac Surg. Jun 1999;67(6):1596-1601; discussion 1601-1592.
17. Laham RJ, Simons M. Transmyocardial laser revascularization for management of refractory angina. In: Saperia GM, ed. UpToDate. Waltham, MA: UpToDate Inc; 2017.
18. 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. Circulation. Jan 18 2022; 145(3): e18-e114.
19. 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. Journal of the American College of Cardiology. Nov 15 2005;46(10):1812-1819.
20. Levine GN, Bates ER, Blankenship JC, et al. 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention. A report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines and the Society for Cardiovascular Angiography and Interventions. J Am Coll Cardiol. Dec 6 2011;58(24):e44-122.
21. Liao L, Sarria-Santamera A, Matchar DB, et al. Meta-analysis of survival and relief of angina pectoris after transmyocardial revascularization. Am J Cardiol. May 15 2005;95(10):1243-1245.
22. 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.
23. National Institute for Health and Clinical Excellence. Percutaneous laser revascularisation for refractory angina pectoris. Interventional procedure guidance 302. May 2009; //publications.nice.org.uk/percutaneous-laser-revascularisation-for-refractory-angina-pectoris-ipg302. Accessed December 2020.
24. National Institute for Health and Clinical Excellence. Transmyocardial laser revascularisation for refractory angina pectoris. Interventional procedure guidance 301. May 2009; //publications.nice.org.uk/transmyocardial-laser-revascularisation-for-refractory-angina-pectoris-ipg301. Accessed December 2020.
25. Oesterle SN, Sanborn TA, Ali N, et al. Percutaneous transmyocardial laser revascularisation for severe angina: the PACIFIC randomised trial. Potential Class Improvement From Intramyocardial Channels. Lancet. Nov 18 2000;356(9243):1705-1710.
26. Patel MR, Calhoon JH, Dehmer GJ, et al. ACC/AATS/AHA/ASE/ASNC/SCAI/SCCT/STS 2017 Appropriate Use Criteria for Coronary Revascularization in Patients With Stable Ischemic Heart Disease : A Report of the American College of Cardiology Appropriate Use Criteria Task Force, American Association for Thoracic Surgery, American Heart Association, American Society of Echocardiography, American Society of Nuclear Cardiology, Society for Cardiovascular Angiography and Interventions, Society of Cardiovascular Computed Tomography, and Society of Thoracic Surgeons. J Nucl Cardiol. Oct 2017; 24(5): 1759-1792.
27. Peterson ED, Kaul P, Kaczmarek RG, et al. From controlled trials to clinical practice: monitoring transmyocardial revascularization use and outcomes. J Am Coll Cardiol. Nov 5 2003;42(9):1611-1616.
28. Saririan M, Eisenberg MJ. Myocardial laser revascularization for the treatment of end-stage coronary artery disease. J Am Coll Cardiol. Jan 15 2003;41(2):173-183.
29. Schofield PM, Sharples LD, Caine N, et al. Transmyocardial laser revascularisation in patients with refractory angina: a randomised controlled trial. Lancet. Feb 13 1999;353(9152):519-524.
30. 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. May 15 2002;39(10):1581-1587.
31. Virani SS, Newby LK, Arnold SV, et al. 2023 AHA/ACC/ACCP/ASPC/NLA/PCNA Guideline for the management of patients with chronic coronary disease: A report of the American Heart Association/American College of Cardiology Joint Committee on Clinical Practice Guidelines. Circulation. Aug 29 2023; 148(9): e9-e119.

POLICY HISTORY:

Medical Policy Panel, September 2015

Medical Policy Group, September 2015 (4):  Informational policy created around current procedures and coverage criteria already in effect.

Medical Policy Administration Committee, September 2015

Medical Policy Panel, February 2016

Medical Policy Group, February 2016 (4): Updates to Key Points.  No change to policy statement.

Medical Policy Panel, February 2017

Medical Policy Group, February 2017 (4): Updates to Key Points and References.  No change to policy statement.

Medical Policy Panel, February 2018

Medical Policy Group, February 2018 (4): Updates to Key Points, Key Words, Current Coding and References.  No change to policy statements.

Medical Policy Panel, February 2019

Medical Policy Group, February 2019 (4): Updates to Description and Key Points. No change to policy statements.

Medical Policy Panel, February 2020

Medical Policy Group, February 2020 (4): Updates to References. No change to policy statements.

Medical Policy Panel, February 2021

Medical Policy Group, February 2021 (4): Updates to Key Points.  No change to policy statements.

Medical Policy Panel, February 2022

Medical Policy Group, February 2022 (4): Updates to Key Points, Approved by Governing Bodies, and References.  No change to policy statements.

Medical Policy Panel, February 2023

Medical Policy Group, February 2023 (4): Updates to Key Points and Benefit Application.  No change to policy statement.

Medical Policy Panel, February 2024

Medical Policy Group, February 2024 (4): Updates to Key Points and References.  No change to policy statements.

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and

4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.