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
- 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
- Patients who otherwise have Class I indications for TMR but who have either
- Ejection fraction less than 30 percent with or without insertion of an intraaortic balloon pump. (Level of Evidence: C)
- Unstable angina/acute ischemia necessitating intravenous antianginal therapy. (Level of Evidence: B)
- Patients with Class II angina. (Level of Evidence: C)
Class III
- Patients without angina or with Class I angina. (Level of Evidence: C)
- Acute evolving myocardial infarction or recent transmural or nontransmural myocardial infarction. (Level of Evidence: C)
- 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)
- Uncontrolled ventricular or supraventricular tachyarrhythmias. (Level of Evidence: C)
- Decompensated congestive heart failure. (Level of Evidence: C)
Recommendations for TMR as an Adjunct to CABG
Class IIa
- 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
- 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