This is the current release of the guideline.

Chronic, severe angina

Treatment

Cardiology
Thoracic Surgery

Physicians

• To assist physicians and other health care providers in clinical decision-making by describing a range of generally acceptable approaches for the diagnosis, management, or prevention of specific diseases or conditions
• To present a clinical guideline with specific recommendations for the selection of patients for Transmyocardial Laser Revascularization (TMR)

• Patients whose coronary anatomy precludes complete revascularization by either coronary artery bypass graft (CABG) or percutaneous catheter intervention (PCI)
• Patients in whom complete revascularization may be achieved with CABG but for whom the risk/benefit ratio of CABG is prohibitive

Transmyocardial laser revascularization (TLR):

• as sole therapy
• as an adjunct to coronary artery bypass graft (CABG)

• Symptoms (e.g., angina)
• Function (e.g., exercise capacity)
• Survival
• Mortality
• Morbidity

Hand-searches of Published Literature (Primary Sources)
Hand-searches of Published Literature (Secondary Sources)
Searches of Electronic Databases
Searches of Unpublished Data

Reviewed articles were obtained through a search of the MedLine database (1966-present), the National Center for Biotechnology Information (NCBI), PubMed database (using keywords including "TMR," "laser," "revascularization," "transmyocardial," "TMLR," "PMR," and "DMR" as well as subject headings to which these terms were mapped and logical combinations of these sets). Using the same databases, searches were performed by author for investigators active in the field. Additional references were obtained through direct communication with investigators. Selected manuscripts cited in the references were also reviewed.

Not stated

Weighting According to a Rating Scheme (Scheme Given)

Level of Evidence

Level A: Data derived from multiple randomized clinical trials

Level B: Data derived from a single randomized trial or from several nonrandomized trials

Level C: Consensus expert opinion

Systematic Review with Evidence Tables

Not stated

Expert Consensus

Not stated

Classification of Recommendations

Class I: Conditions for which there is evidence and/or general agreement that a given procedure or treatment is useful and effective

Class II: Conditions for which there is conflicting evidence and/or a divergence of opinion about the usefulness/efficacy of a procedure or treatment

II.a.: Weight of evidence/opinion is in favor of usefulness/efficacy

II.b.: Usefulness/efficacy is less well established by evidence or opinion

Class III: Conditions for which there is evidence and/or general agreement that the procedure/treatment is not useful and in some cases may be harmful

A formal cost analysis was not performed and published cost analyses were not reviewed.

Peer Review

Not stated

The levels of evidence (A-C) and classification of recommendations (I-III) are defined at the end of the "Major Recommendations" field.

Recommendations for Transmyocardial Laser Revascularization (TMR) as Sole Therapy

Class I

1. Patients with an ejection fraction greater than 30% and Canadian Cardiovascular 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 region of myocardial ischemia. In all regions of the myocardium, the coronary disease must not be amenable to coronary artery bypass graft (CABG) or percutaneous transluminal coronary angioplasty (PTCA), either due to a) severe diffuse disease, b) lack of suitable targets for complete revascularization, c) lack of suitable conduits for complete revascularization. (Level of Evidence: A)

Class IIB

1. Patients who otherwise have Class I indications for TMR but who have either
   1. Ejection fraction less than 30 percent with or without insertion of an intraaortic balloon pump. (Level of Evidence: C)
   2. Unstable angina/acute ischemia necessitating intravenous antianginal therapy. (Level of Evidence: B)
   3. Patients with Class II angina. (Level of Evidence: C)

Class III

1. Patients without angina or with Class I angina. (Level of Evidence: C)
2. Acute evolving myocardial infarction or recent transmural or nontransmural myocardial infarction. (Level of Evidence: C)
3. Cardiogenic shock defined as a systolic blood pressure less than 80 mm/Hg or a cardiac index of less than 1.8L/min/m2. (Level of Evidence: C)
4. Uncontrolled ventricular or supraventricular tachyarrhythmias. (Level of Evidence: C)
5. Decompensated congestive heart failure. (Level of Evidence: C)

Recommendations for TMR as an Adjunct to CABG

Class IIa

1. 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 which cannot be bypassed, either due to a) severe diffuse disease, b) lack of suitable targets for complete revascularization, or c) lack of suitable conduits for complete revascularization. (Level of Evidence: B)

Class IIb

1. Patients without angina in whom CABG is the standard of care who also have at least one accessible and viable ischemic region with demonstrable coronary artery disease which cannot be bypassed, either due to a) severe diffuse disease, b) lack of suitable targets for complete revascularization, or c) lack of suitable conduits for complete revascularization. (Level of Evidence: C)

Class III

Patients in whom CABG is not the standard of care (Level of Evidence: C)

Definitions

Level of Evidence

Level A: Data derived from multiple randomized clinical trials

Level B: Data derived from a single randomized trial or from several nonrandomized trials

Level C: Consensus expert opinion

Classification of Recommendations

Class I: Conditions for which there is evidence and/or general agreement that a given procedure or treatment is useful and effective

Class II: Conditions for which there is conflicting evidence and/or a divergence of opinion about the usefulness/efficacy of a procedure or treatment

II.a.: Weight of evidence/opinion is in favor of usefulness/efficacy

II.b.: Usefulness/efficacy is less well established by evidence or opinion

Class III: Conditions for which there is evidence and/or general agreement that the procedure/treatment is not useful and in some cases may be harmful

None provided

The type of evidence supporting the recommendations is specifically stated for each recommendation (see 'Major Recommendations' field).

• Assist physicians and other health care providers in clinical decision-making regarding selection of patients for Transmyocardial Laser Revascularization (TMR)
• Reduce angina symptoms
• Improve quality of life

Morbidity and mortality

Subgroup Most Likely to Experience Harms

Patients at highest risk for morbidity and mortality following transmyocardial laser revascularization (TMR) include patients with unstable angina, global myocardial ischemia, and diminished left ventricular function.

These guidelines should not be considered inclusive of all proper methods of care or exclusive of other methods of care reasonably directed at obtaining the same results. Moreover, these guidelines are subject to change over time, without notice. The ultimate judgment regarding the care of a particular patient must be made by the physician in light of the individual circumstances presented by the patient.

An implementation strategy was not provided.

Getting Better

Effectiveness

Not applicable: The guideline was not adapted from another source.

2003

Society of Thoracic Surgeons - Medical Specialty Society

Society of Thoracic Surgeons

Workforce on Evidence-Based Medicine

Workforce Members: Charles R. Bridges, MD (TMR Taskforce Chair), ScD; Keith A. Horvath, MD; William C. Nugent, M.D; David M. Shahian, MD; Constance K. Haan, MD; Richard J. Shemin, MD; Keith B. Allen, MD; Fred H. Edwards, MD

Not stated

This is the current release of the guideline.

None available

None available

This NGC summary was completed by ECRI on March 30, 2005. The information was verified by the guideline developer on May 3, 2005.

© 2003 The Society of Thoracic Surgeons
The Society of Thoracic Surgeons Practice Guidelines may be printed or downloaded for individual and personal use only. Guidelines may not be reproduced in any print or electronic publication or offered for sale or distribution in any format without the express written permission of the Society of thoracic Surgeons.