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MP 7.01.54 Transmyocardial Revascularization

Medical Policy    
Section
Surgery 
Original Policy Date
5/30/97
Last Review Status/Date
Reviewed with literature search/8:2014
Issue
8:2014
  Return to Medical Policy Index

Disclaimer

Our medical policies are designed for informational purposes only and are not an authorization, or an explanation of benefits, or a contract.  Receipt of benefits is subject to satisfaction of all terms and conditions of the coverage.  Medical technology is constantly changing, and we reserve the right to review and update our policies periodically. 


 

Description

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 TMR (PTMR).

Several randomized controlled trials (RCTs) have demonstrated that TMR may provide significant improvements in angina symptoms compared with optimal medical management. While studies have not shown improvements in survival or significant increases in exercise duration, TMR may be considered medically necessary for patients with class III or IV angina, who are not candidates for coronary artery bypass graft (CABG) surgery or percutaneous transluminal coronary angioplasty (PTCA) surgery, based on improvement in symptoms. Candidates for TMR must also be refractory to medical management, have reversible ischemia, and left ventricular ejection fraction (LVEF) greater than 30%. TMR may also be considered medically necessary as an adjunct to CABG in those patients with documented areas of ischemic myocardium that are not amenable to surgical revascularization.

While 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 consistent in showing whether PTMR improves net health outcomes. Additionally, there is no U.S. Food and Drug Administration (FDA)‒approved PTMR device available. Therefore, PTMR is considered investigational. Studies on PTMR with longer follow-up and further data on safety, adverse events, and survival are needed.

Background

 

TMR is 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. Various port access procedures are being evaluated for TMR using novel robotic and thoracoscopic techniques.

TMR can also be performed by the percutaneous route (PTMR). PTMR (now being called percutaneous myocardial channeling) is a catheter-based system using Ho:YAG laser revascularization under fluoroscopic guidance. It is performed in Europe but is not currently approved by 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 (eg, robotic) techniques for use of this procedure are also being studied.

Open TMR has been investigated in 2 populations of patients: 1) patients with ischemic myocardium who are not candidates for other types of revascularization procedures, such as CABG or PTCA due to anatomic features of their coronary circulation; and 2) as an adjunct to CABG in patients with areas of ischemic myocardium that are not amenable to surgical revascularization. Other potential applications of TMR include its use as an adjunct to stem-cell based therapy.


Policy

Open transmyocardial laser revascularization may be considered medically necessary for patients 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
  • Documentation of reversible ischemia
  • Left ventricular ejection fraction greater than 30%
  • No evidence of recent myocardial infarction or unstable angina within the last 21 days
  • 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 patients with documented areas of ischemic myocardium that are not amenable to surgical revascularization.

Open transmyocardial laser revascularization is considered investigational for all other indications not meeting the above criteria.

Percutaneous transmyocardial laser revascularization is considered investigational.


Policy Guidelines 

CPT code 33140 (transmyocardial laser revascularization, separate procedure) describes transmyocardial laser revascularization performed as a stand-alone procedure.

CPT code 33141 (transmyocardial laser revascularization at the time of other open cardiac procedures), an add-on code introduced in 2001, 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 33400-33496, 33510-33536, and 33542.


Benefit Application
BlueCard/National Account Issues 

Bundling or multiple surgery guidelines should apply.


Rationale 

Regulatory Status

The Heart Laser™ received final FDA approval to market in 1998 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 amendable to direct coronary revascularization. The Eclipse TMR 2000™ received FDA approval for similar indications in July 1999. Neither device is approved for use as an adjunct to CABG. Use of either device for this purpose would be considered an off-label indication. PMA product code: MNO.

 This policy was originally created in 1997 and has been regularly updated with searches of the MEDLINE database. The most recent literature search was performed for the period of June 2013 through July 20,2014. Following is a summary of the key literature to date.


Open Transmyocardial Laser Revascularization

This portion of the policy is based in part on 2 TEC Assessments, a 1998 Assessment1 that focused on the use of open transmyocardial laser revascularization (TMR) as an alternative to inoperable coronary artery disease and a 2001 Assessment2 that focused on its use as an adjunct to coronary artery bypass surgery (CABG).


Open TMR in Patients With Inoperable Coronary Artery Disease
The 1998 TEC Assessment offered the following observations and conclusions1:

  • Results of randomized controlled clinical trials suggested that patients with refractory, nonoperable class III or IV angina respond well to TMR. Specifically, results of 1 trial reported that 86% of those assigned TMR were in angina class I or II at 12 months of follow-up compared with
    30% in the medical management group. In addition, a decline in the number of hospital admissions favored TMR. The data on morbidity and mortality were inconclusive but were in favor of an equivalent or lower mortality rate with TMR.


Patients enrolled in these trials were carefully selected to maximize the benefit of TMR. All patients had class III or IV angina that was refractory to medical management and objective evidence of reversible ischemia on exercise testing or perfusion scanning. In addition, a variety of exclusion criteria were used to minimize the risk of open thoracotomy. These exclusion criteria varied slightly among the trials and have evolved in response to recognition of high-risk subgroups among the initial randomized controlled trials (RCTs). In general, in patients with recent unstable angina or myocardial infarction (MI), an ejection fraction of less than 30% and severe comorbid illness were excluded from these trials.

The 3 unpublished RCTs cited in the original TEC Assessment1 have since appeared in the literature.3-5 Since then, 3 additional RCTs with similar design have been published. Schofield et al6 randomized 188 patients with refractory angina to TMR via a high-energy CO2 laser or medical management alone. At 12 months, 25% of the patients assigned to TMR improved by at least 2 Canadian Cardiovascular Society (CCS) anginal classes, compared with only 4% in the medical management group (p<0.001). There were no statistically significant differences in exercise duration, 12-minute walk distance, or radionucleotide perfusion. The number of patients improving by 2 or more angina classes was much less than in the 3 previously cited RCTs. There was 5% perioperative mortality for the TMR group and a lower overall
survival (OS) at 12 months (89% vs 96%, p=0.14), but this difference was not statistically significant.

Aaberge et al7 compared 50 patients randomized to pulsed CO2 laser TMR with 50 patients randomized to medical management. At 12 months, 39% of the patients assigned to TMR improved by at least 2 New York Heart Association (NYHA) anginal classes versus 0% in the medical management group (both the NYHA and CCS contain 4 anginal classes, but class 1 in the NYHA system allows no symptoms, potentially making a 2-class improvement more difficult to achieve). Exercise capacity was not improved by TMR. There was a 4% perioperative mortality rate with lower OS at 12 months (88% vs 92%, respectively, p=NS), but this difference was not statistically significant.

Jones et al8 randomized 86 patients with refractory angina to TMR with a Ho:YAG laser or to medical management. At 12 months, the TMR group had an average improvement of slightly more than 2 CCS anginal classes over the medical management group. The TMR group also had a significant improvement in exercise duration (490 vs 294 seconds, respectively, p<0.001). There was only 1 perioperative death in
the TMR group, but OS data were not provided.

Analysis of registry data evaluated outcomes of TMR in 661 patients who underwent TMR alone for refractory angina.9,10 This study reported that many patients undergoing TMR in clinical practice differed from those in the randomized trials, especially in regard to the presence of high-risk factors such as unstable angina or recent MI. Patients with unstable angina undergoing TMR had a 30-day mortality that was almost double that of patients without unstable angina (8.3% vs 4.3%, respectively, p<0.05), while patients with an MI in the last 21 days had a mortality risk that was more than double that of patients without recent MI (13.0% vs 5.4%, respectively, p<0.05). Finally, Allen et al reported on the 5-year results of his earlier trial,4 which demonstrated at 5 years that the significant anginal relief observed 12 months after sole therapy TMR was sustained long-term and continued to be superior to that observed for patients maintained on continued medical management alone.11

These additional studies support the conclusions of the TEC Assessment that TMR improves anginal symptoms in patients with refractory angina, compared with medical management, and confirm the need for careful selection of patients undergoing the procedure. These studies differ from the original 3 trials in that fewer patients improved by at least 2 anginal classes, suggesting that the magnitude of benefit may be less than in the first 3 trials. These trials do not provide conclusive evidence on whether TMR improves survival or exercise capacity. The data also reinforce that achieving beneficial outcomes of TMR depends on careful patient selection as follows:

  • Patients with class III or IV angina refractory to medical management
  • Documentation of reversible ischemia
  • Left ventricular ejection fraction (LVEF) greater than 30%
  • No evidence of recent MI or unstable angina within the last 21 days
  • No severe comorbid illness such as chronic obstructive pulmonary disease

Open TMR as an Adjunct to CABG
The 2001 TEC assessment offered the following observations and conclusions about 2 randomized single-blind trials that compared outcomes of patients who underwent CABG alone versus CABG plus TMR2:

  • While the smaller of the 2 trials, enrolling only 42 patients, showed a trend toward an improved perioperative mortality associated with TMR, this outcome was statistically significant in the second larger trial, enrolling 266 patients. In this trial, perioperative mortality decreased from 7.5% in the control group to 1.5% in the TMR group.
  • The scientific basis of the improvement in perioperative mortality is unknown, yet the randomized trial was well-designed and conducted at multiple institutions, which supported the conclusions.
  • There was no significant improvement in subjective symptoms and exercise tolerance, which were the inverse of prior findings evaluating TMR as sole therapy (see above).

A 2005 meta-analysis of 7 randomized trials by Liao et al, involving 1053 patients concluded, at 1-year follow-up, that TMR produced a significant improvement in angina class but no improvement in survival.12 In 2008, Campbell et al conducted a systematic review of TMR and percutaneous TMR (PTMR) for refractory angina pectoris.13 The authors evaluated 16 RCTs (10 TMR, 6 PTMR) and 13 nonrandomized studies (8 TMR, 5 PTMR), and concluded TMR and PTMR were not effective in treating refractory angina and did not improve objective measures of MI (ie, myocardial perfusion tests and LVEF) or 12-month survival. While subjective, patient-reported outcomes showed some improvement with TMR and PTMR, the review noted improvements in angina symptoms and exercise tolerance were lost or reduced when blinding of treatment occurred. The review found the mortality risks and risk of adverse events raised safety concerns. Additionally, the review also noted most studies were conducted in the United States on male patients, and, therefore, there is a lack of evidence on outcomes in wider populations. A 2009 Cochrane review of 7 studies of TMR noted that while improvement in angina was greater in treated patients than in control patients, 1-year mortality was similar between the groups, but 30-day mortality was greater in the TMR group.14 These authors concluded that there was insufficient evidence to determine whether the clinical benefits of TMR outweighed the potential risks.

Percutaneous Transmyocardial Revascularization
Although PTMR was designed as a less invasive alternative to TMR, no studies have directly compared the 2 procedures. The various differences between PTMR and TMR outlined here require that they be considered as distinct entities.

At the time of the original TEC Assessment,1 no outcome data on PTMR were available, although early observational data suggested that the symptomatic benefit of PTMR approached that seen with TMR.9 As noted earlier, in a 2008 systematic review, Campbell et al concluded PTMR was not an effective treatment for refractory angina pectoris.13 A 2010 meta-analysis by McGillion et al evaluated 7 RCTs to compare PTMR with maximally tolerated antianginal therapy management.15 A total of 1213 patients with CCS class III-IV refractory angina on optimal medical management were included in the trials analyzed.Exclusion criteria for the trials included recent MI, aortic stenosis, mechanical aortic valve, peripheral vascular disease precluding catheter insertion, LVEF less than 25% to 30%, and myocardial wall thickness in laser-targeted areas of less than 8 to 9 mm. All patients randomized to PTMR groups in the trials received low-dose holmium:YAG lasers except for 1 arm of 1 trial, which used a high-dose holmium:YAG laser. The high-dose laser arm was excluded from the primary analysis. Maximally tolerated antianginal therapy was not changed in any treatment group across the trials.

Data on 12-month outcomes from 5 of the trials examined were analyzed and demonstrated that PTMR significantly reduced angina symptoms by at least 2 CCS classes with a pooled odds ratio of 2.13 (95% confidence interval [CI], 1.22 to 3.73) (n=3 studies). PTMR also significantly improved self-reported, health-related quality of life (HRQOL), as measured by the Seattle Angina Questionnaire. In the areas of
angina frequency, standardized mean differences (SMD) were 0.29 (95% CI, 0.05 to 0.52), disease perception SMD was 0.37 (95% CI, 0.14 to 0.61), and physical limitations SMD was 0.29 (95% CI, 0.05 to 0.53) (n=2 studies). Significant differences were not found in patient-reported angina stability or treatment satisfaction. Nor were significant differences found in exercise duration or all-cause mortality.  dditionally, when a secondary analysis including the high-dose laser group from Leon et al,16 was performed, the differences in angina class, exercise duration, and HRQOL were no longer significant between treatment and control groups.

This meta-analysis suggests that PTMR may have benefits similar to open TMR, but the conclusions are limited by several factors. Although 7 studies were included in the review, the results for each individual outcome were based on only 2 or 3 studies. The findings of outcome benefits on combined analysis were not robust, as the addition of a third treatment arm from 1 trial eliminated the significant findings.
Sensitivity analysis was not performed by study quality, presence of blinding, or the presence of a sham placebo, factors that may have been able to determine whether group differences reported in some of the trials were due to a treatment effect versus a placebo/nonspecific effect. The authors identified a need for further studies to evaluate adverse events, disease-specific mortality, laser dosages, and the underlying mechanisms of PTMR.

The following is an example of 2 published RCTs included in the McGillion et al meta-analysis15 previously discussed, which compared PTMR with medical management. In the PACIFIC trial,17 Oesterle et al compared PTMR (n=110) with medical management (n=111) in patients with refractory angina. Several patients in both the PTMR group (n=10) and the medical management group (n=14) received percutaneous transluminal coronary angioplasty (PTCA), CABG, or TMR within the 12-month follow-up period. When these patients were included in an analysis at 12 months, 46% in the PTMR group improved by at least 2 CCS anginal classes, compared with 11% in the medical management group. However, a subsequent masked assessment of anginal scores revealed that 28% of the improvement was attributable to investigator bias. When the patients who received an additional procedure were excluded, there was still an 82.5-second improvement in exercise duration in the PTMR group over the medical management group. There were more deaths at 12 months in the PTMR group, but the difference was not statistically significant (8 vs 3, p=0.21).

In the second published RCT,18 Stone et al studied 141 patients with refractory angina and 1 or more chronic total occlusions (CTOs) in territories with reversible ischemia. This study group was derived from a larger group of patients in whom PTCA of a CTO was attempted. If PTCA was not possible, the patients were immediately randomized to PTMR (n=71) or to a sham PTMR procedure followed by medical  management (n=70). At 6 months, 49% of the patients assigned to PTMR improved by at least 2 CCS classes versus 37% in the sham group. This difference was not statistically significant (p=0.33). There was a small increase in exercise duration (64 vs 52 seconds) in the PTMR group over the sham group that was also not statistically significant (p=0.73). There was no difference in mortality at 6 months (8.6% vs 8.8%, p=NS). The authors concluded that the similar degree of benefit in the sham group compared with the PTMR group suggests that  mprovement from PTMR may be largely due to a placebo effect.

Ongoing and Unpublished Clinical Trials

An online search of ClinicalTrials.gov on July 20, 2014, found 2 small cohort trials on TMR: with bone marrow aspirate concentrate (NCT01285297) and with bone marrow stromal stem cells (NCT01557543). A registry study on TMR is also ongoing (NCT01827319). No PTMR trials were identified. A study of TMR with cardiac magnetic resonance imaging evaluation (NCT01287910) was terminated.

Summary of Evidence

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 percutaneously.

Several randomized controlled trials (RCTs) have demonstrated that TMR may provide significant improvements in angina symptoms compared with optimal medical management. While studies have not shown improvements in survival or significant increases in exercise duration, TMR may be considered medically necessary for patients with class III or IV angina, who are not candidates for coronary artery bypass graft (CABG) surgery or percutaneous transluminal coronary angioplasty (PTCA) surgery, based on improvement in symptoms. Candidates for TMR must also be refractory to medical management, have reversible ischemia, and left ventricular ejection fraction greater than 30%. TMR may also be considered medically necessary as an adjunct to CABG in those patients with documented areas of ischemic myocardium that are not amenable to surgical revascularization.

While percutaneous TMR (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 consistent in showing whether PTMR improves net health outcomes. Additionally, there is no U.S. Food and Drug Administration (FDA) approved PTMR device available. Therefore, PTMR is considered investigational. Studies on PTMR with longer follow-up and further data on safety, adverse events, and survival are needed.

Practice Guidelines and Position Statements

In 2012, guidelines for stable ischemic heart disease were developed through a collaborative effort 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.19 These guidelines indicate TMR may be considered as an alternative therapy for refractory angina in patients with stable ischemic heart disease (class IIb, Level of evidence B: benefit greater than risk, evidence less well-established).

The American College of Cardiology/American Heart Association published guidelines for CABG20 and percutaneous artery intervention.21 The most recent 2011 versions of these guidelines both indicate that TMR may be performed as an adjunct to CABG on viable ischemic myocardium that is perfused by arteries that are not amenable to grafting (class IIb, level of evidence B: benefit greater than risk, evidence less well-established).

In 2004 (reaffirmed in 2009), the Society of Thoracic Surgeons published recommendations regarding open TMR; the recommendations do not discuss the percutaneous approach although it is noted to be less promising than open TMR.22 Class I recommendations were defined as conditions for which there is evidence or general agreement that a given procedure or treatment is useful and effective. There was 1
class I recommendation for TMR as solo therapy as follows:

“Patients with an ejection fraction greater than 0.30 and CCS class III or IV angina that is refractory to maximal medical therapy. These patients should have reversible ischemia of the left ventricular free wall and coronary artery disease corresponding to the regions of myocardial ischemia. In all regions of the myocardium, the coronary disease must not be amendable to CABG or percutaneous transluminal angioplasty either as a result of (1) severe diffuse disease, (2) lack of suitable targets for complete revascularization, or (3) lack of suitable conduits for complete revascularization.”

This recommendation was based on data derived from multiple RCTs. There were no class I recommendations for TMR combined with CABG. There was 1 class IIa recommendation, which defined conditions for which there is conflicting evidence or a divergence of opinion but for which the weight of evidence or opinion is in favor of usefulness or efficacy. The class IIa recommendation is as follows:

“Patients with angina (Class I-IV) in whom CABG is the standard of care who also have at least one accessible and viable ischemic region with demonstrable coronary artery disease that cannot be bypassed either because of (1) severe diffuse disease, (2) lack of suitable targets for complete revascularization, or (3) lack of suitable conduits for complete revascularization.”

This recommendation was based on data derived from a single randomized trial23 and data from a Society of Thoracic Surgeons National Cardiac Database.9 These 2 class I and class IIa recommendations are essentially consistent with the indications considered medically necessary in this policy for open TMR.

In 2009, the National Institute for Health and Clinical Excellence (NICE) issued guidance on TMR24 and PTMR25 based on a 2008 systematic review by Campbell et al, noted earlier.13 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

TMR and PTMR are not preventive services.

Medicare National Coverage

The Centers for Medicare and Medicare Services cover TMR as a late or last resort for patients with severe (CCS classification classes III or IV) angina (stable or unstable), which has been found refractory to standard medical therapy, including drug therapy at the maximum tolerated or maximum safe dosages.26 In addition, the angina symptoms must be caused by areas of the heart not amenable to surgical therapies such as PTCA, stenting, coronary atherectomy or coronary bypass. Coverage is further limited to those uses of the laser to perform the procedure which have been approved by FDA for the purpose for which they are being used.

Patients would have to meet the following additional selection guidelines: an ejection fraction of 25% or greater; have areas of viable ischemic myocardium (as demonstrated by diagnostic study) which are not capable of being revascularized by direct coronary intervention; and have been stabilized, or have had maximal efforts to stabilize acute conditions such as severe ventricular arrhythmias, decompensated congestive heart failure, or acute MI.

References: 

  1. Blue Cross Blue Shield Association Technology Evaluation Center (TEC). Transmyocardial revascularization for the treatment of coronary artery disease. TEC Assessments 1998; Volune 13, Tab 23.
  2. 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.
  3. 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. PMID 10502591
  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. PMID 10502592
  5. 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. PMID 10489946
  6. 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. PMID 10028979
  7. 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. PMID 10758957
  8. 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. PMID 10391261
  9. 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. PMID 14607448
  10. 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. PMID 12535804
  11. 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. PMID 15063241
  12. 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. PMID 15878002
  13. 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;http://www.nice.org.uk/guidance/ipg302. Accessed June, 2014.
  14. Briones E, Lacalle JR, Marin I. Transmyocardial laser revascularization versus medical therapy for refractory angina. Cochrane Database Syst Rev. 2009(1):CD003712. PMID 19160223
  15. 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. PMID 20859544
  16. 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. PMID 16286164
  17. 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. PMID 11095257
  18. 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. PMID 12020483
  19. 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. PMID 23182125
  20. 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. PMID 22070836
  21. 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. PMID 22070834
  22. 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. PMID 15063304 
  23. 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. PMID 10694615
  24. National Institute for Health and Clinical Excellence. Transmyocardial laser revascularisation for refractory angina pectoris. Interventional procedure guidance 301. May 2009;
    http://publications.nice.org.uk/transmyocardial-laser-revascularisation-for-refractory-angina-pectoris-ipg301.
    Accessed June, 2014.
  25. National Institute for Health and Clinical Excellence. Percutaneous laser revascularisation for refractory angina pectoris. Interventional procedure guidance 302. May 2009; http://www.nice.org.uk/guidance/ipg302. Accessed June, 2014.
  26. Centers for Medicare and Medicaid Services. National Coverage Determination for Transmyocardial Revascularization (20.6). July 1, 1999(100-3).   

Codes

Number

Description

CPT  33140  Transmyocardial laser revascularization, by thoracotomy (separate procedure) 
  33141  Transmyocardial laser revascularization, performed at the time of other open cardiac procedures (List separately in addition to code for primary procedure) 
ICD-9 Procedure  36.31  Open chest transmyocardial revascularization 
  36.32  Other transmyocardial revascularization (percutaneous) 
  36.33 Endoscopic transmyocardial revascularization
  36.34 Percutaneous transmyocardial revascularization
ICD-9 Diagnosis 411.1 Intermediate coronary syndrome (including unstable angina) 
  413.0-413.9 Angina pectoris code range
  414.00–414.07 Coronary atherosclerosis code range 
   414.8-414.9 Chronic ischemic heart disease code range
HCPCS  No Code   
ICD-10-CM (effective 10/1/15) I20.0-I20.9 Intermediate coronary syndrome code range  
  I25.10-125.119 Angina pectoris code range  
   I25.89 Other forms of chronic ischemic heart disease  
   125.9 Chronic ischemic heart disease  
ICD-10 PCS (effective 10/1/15)    ICD-10-PCS codes are only used for inpatient services.  
   02QA4ZZ Surgical, repair, heart, percutaneous endoscopic, no device  
   02QC4ZZ Surgical, repair, heart, left, percutaneous endoscopic, no device  
   02QB4ZZ Surgical, repair, heart, right, percutaneous endoscopic, no device  
   02QA3ZZ Surgical, repair, heart, percutaneous, no device  
   02QC3ZZ Surgical, repair, heart, left, percutaneous, no device  
   02QA3ZZ Surgical, repair, heart, right, percutaneous, no device 
Type of Service  Surgery 
Place of Service  Inpatient 

Index

Revascularization, Transmyocardial
Transmyocardial Laser Revascularization
Transmyocardial Revascularization for the Treatment of Coronary Artery Disease


Policy History

 

Date Action Reason
5/30/97 Add to Surgery section New policy
03/15/99 Replace policy Policy revised and changed; referenced TEC Assessment
11/01/99 Replace policy New CPT code; policy unchanged
05/31/01 Replace policy Policy revised; policy statement changed
10/9/03 Replace policy Policy revised; new policy statement added re: PTMR
12/17/03 Replace policy Policy revised; literature updated with new registry publication
03/15/05 Replace policy Policy updated with literature review; no change in policy statement. Reference numbers 13–15 added
07/20/06 Replace policy Policy updated; no change in policy statements. Description section expanded to include new, less-invasive approaches. References 16 and 17 added
09/18/07 Replace policy Policy updated; no change in policy statements. Reference number 18 added.
10/07/08 Replace policy  Policy updated; reference number 19 added. No change in policy statements 
8/11/11 Replace policy Policy updated with literature review; reference numbers 13, 15 and 20-24 added. No change in policy statements
08/09/12 Replace policy Policy updated with literature review; reference number 21 added. No change in policy statements
8/08/13 Replace policy Policy updated with literature review through June 2013; references 18-20 added and previous references 20-22 deleted. No change in policy statements
8/14/14 Replace policy Policy updated with literature review through July 20, 2014. Policy statement added indicating open TMR is considered investigational for all other indications not meeting the medical necessity criteria.