Additional Information & Facts
Transmyocardial Laser Revascularization


Study Purpose
The purpose of this study is to determine the safety and effectiveness of the "Heart Laser" (a high powered carbon dioxide laser system) in creating laser channels in the beating heart to enhance myocardial perfusion in the presence of ischemia.


Study Design
This is an open label, randomized treatment protocol. St. Luke's Medical Center is one of the first approved sites and the location where the procedure originiated. Patients are randomized to TMLR or medical management.


Rationale
To develop a surgical technique that can relieve symptoms of angina in patients unable to withstand conventional coronary bypass surgery.


Objectives
To evaluate the use of the carbon dioxide laser to create channels in the myocardium in the beating heart as sole therapy for patients with coronary artery disease.

The objectives will have been met when improvement in patient function with respect to angina-related symptoms is observed during the follow-up period. Pre-operative baseline studies as well as follow-up examinations will be recorded and analyzed. Thallium stress testing, and relief of symptoms will be used as primary measurements of effectiveness.


Patient Population
The study will involve 50 evaluable adult patients, 21 years of age or older. Criteria include:

  • Patient does not respond to medical management and is not a candidate for other therapy.
  • Patients with any condition (cardiac or non-cardiac) which would make them a high risk for bypass surgery, such as those with prior difficulties with surgery, diabetes, or a history of stroke.
  • Diffuse disease, or disease in areas in which bypass is not feasible.
  • Early deterioration of previous bypass grafts.


Patient Selection

  • Viable muscle
  • Diffuse Disease
  • Inadequate response to medical/surgical therapies
  • Not a candidate for other therapy


Eligibility Criteria

  • Myocardial ischemia
  • Symptomatic coronary artery disease
  • Patients who are considered high risk for CABG
  • Poor response to current medical management
  • Poor response to previous surgery with evidence of graft closure
  • Ejection fraction >15%


Exlusion Criteria

  • Ejection fraction <15%
  • Current congestive heart failure
  • Those with other medical problems that would exclude anesthesia and thoracotomy


Example of a blocked coronary artery.
When a coronary artery becomes blocked, blood supply to
the myocardium is reduced. This results in the pain known
as angina. Prolonged or severe reduction of blood flow can
damage the muscle, resulting in a heart attack.
Pre-Operative Evaluation

  • Clinical status
  • MUGA
  • Echocardiogram
  • Stress test
  • Myocardial perfusion scan
  • Cardiac catheterization
    • Coronary artery status
    • Wall motion
    • Ejection fraction



Post-Operative Evaluation
To be done at 3, 6, 9, 12 months and then annually

  • Clinical status
  • MUGA
  • Echocardiogram
  • Cardilate Stress test
  • Myocardial perfusion scan (technetium)
  • Cardiac catheterization (annually only)
    • Coronary artery status
    • Wall motion
    • Ejection fraction


Prevention of angina and protection of the myocardium from infraction.
Channels created by the laser allow blood to flow from the
ventrical and provide nourishment to the heart muscle.
The flow is sufficient to prevent angina and protect the
myocardium from infraction.
Procedure

  • LV laser channels as sole therapy
    • Limited thoracotomy
    • Beating heart
    • Target area assessed and treated
    • Laser output triggered by EKG
  • LV laser channels in conjunction with CABG (non-randomized study)



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