More than 150,000 patients in the United States have severe ischemic coronary artery disease that is not treatable with standard coronary artery bypass surgery, coronary angioplasty or stenting. These patients are disabled due to symptoms of angina, shortness of breath, fatigue and lack of exercise tolerance. Angiogenesis (formation of new blood vessels) using laser therapy could be a promising modality to improve their quality of life.
Dr. Edward Diethrich and Dr. Nabil Dib have developed a research study to evaluate laser therapy for these patients who otherwise have no other option for treatment of their heart disease. The procedure, which is called transmyocardial laser revascularization (TMR), is an open chest surgery where Dr. Diethrich creates channels through the heart muscle using the laser directly in the area that is not receiving adequate blood flow. These channels will produce new blood flow to the diseased area of the heart.
Previous studies using TMR have shown promising results: 47% to 76 % of patients reported improvement in angina symptoms. Improvement in exercise and quality of life were also reported.
This study will utilize two new diagnostic systems in order to accurately measure improved blood flow and contractility (ability of the heart to pump blood). This will be obtained with the NOGA™ electromechanical cardiac mapping system and Doppler FloWire measurements of coronary blood flow.
A NOGA™ procedure is a newer sophisticated invasive diagnostic procedure performed in the catheterization laboratory. It will be used to assist in more accurate delivery of the laser therapy and evaluate its effectiveness. The patient will undergo NOGA™ electromechanical cardiac mapping prior to the TMR laser surgery. Dr. Dib will map the inner surface of the left ventricle by moving a catheter over it and collecting information from multiple points in the heart.
This data is used by the NOGA™ system to create a three dimensional, real-time dynamic reconstruction of the ventricle. The information can be utilized to accurately detect typical regions of scarred myocardium resulting from heart attack and detect regions of the heart that have decreased contractility, but preserved electrical activity.
The laser therapy can then be delivered to the specific region of the heart identified by the NOGA™. The patients will undergo repeat NOGA™ mapping three months after receiving the laser therapy, which will also provide more accurate data to assess the effectiveness of the laser therapy.
In addition to the NOGA™ mapping procedure, before and after TMR, Dr. Dib will measure the coronary blood flow using a doppler flow wire. This is also a new procedure, which provides more specific measurement of coronary blood flow and evaluate the effectiveness of the TMR procedure.
The patients will also receive standard diagnostic testing, including stress testing, echocardiogram and left heart catheterization. The data obtained from the NOGA and doppler flow wire will be compared to the standard tests.
Each of these procedures is currently FDA approved. For more information, please call Ann Campbell, RN, at (602) 266-2200 ext. 4404.
What is a NOGA™ Cardiac Mapping Procedure?
As a patient suffering from a known coronary artery disease, or a possibly ischemic heart disease, your attending physician has probably referred you for evaluation by a specialist. There are several non-invasive tests available to diagnose your problem. Based on your risk factors, history of heart problems and current symptoms, the cardiologist has probably begun with the simplest test and progressed to more sophisticated ones. Following these tests it was recommended that you undergo a cardiac catheterization, including a NOGA™ procedure. A NOGA™ procedure is a sophisticated invasive diagnostic procedure performed in the catheterization laboratory. The doctor maps the inner surface (endocardium) of the left ventricle by moving a special catheter over it and collecting information from multiple points. This data is used by the NOGA™ system to create a three dimensional real-time dynamic reconstruction of the ventricle. It is very important to discuss all the risks and benefits of cardiac catheterization with your cardiologist or physician before deciding to have this or any other procedure.
What Information Will the NOGA™ Procedure Provide?
NOGA™ maps are unique in that they provide your doctor with a simultaneous assessment of the electrical and mechanical properties of the heart muscle (myocardium). This information can be utilized to accurately detect typical regions of scarred myocardium resulting from myocardial infarction. Moreover, one can detect regions of hibernating myocardium (muscle that has been damaged) characterized by decreased contractility but preserved electrical activity. The physician thus receives complete quantitative cardiac electromechanical information in a single cath-lab procedure, as opposed to current methods of acquiring data via a series of different tests and imaging modalities. It is very important to discuss all the risks and benefits of cardiac catheterization with your cardiologist or physician before deciding to have this or any other procedure.
How Will I Benefit from a NOGA™ Procedure?
Your interventional cardiologist's clinical decision can be facilitated by the diagnostic NOGA™ map findings. For instance, it is of utmost importance to accurately identify a particular viable area in your heart supplied by a specific stenosed coronary artery. Viable myocardium will benefit greatly from revascularization (for example, PTCA or CABG surgery). This can be accomplished in the cath-lab by acquiring a NOGA™ map. Based on the data gathered by the NOGA™ system, your cardiologist will decide on the best treatment for your stenosis. It is very important to discuss all the risks and benefits of cardiac catheterization with your cardiologist or physician before deciding to have this or any other procedure.
Are There any Risks Involved in the NOGA™ Procedure?
A NOGA™ procedure is very similar to a standard cardiac catheterization and is considered a minimally invasive procedure. NOGA™ mapping utilizes a novel technology based on ultra-low magnetic fields that are biologically harmless. As with any minimally invasive procedure, cardiac catheterization presents risks such as physical injury or even death, though this is rare. It is very important to discuss all the risks and benefits of cardiac catheterization with your cardiologist or physician before deciding to have this or any other procedure.
Is the NOGA™ Procedure Safe?
The NOGA™ system has undergone thorough investigation and has been cleared to be marketed in the United States, Europe and other countries worldwide. More than a thousand procedures have already been performed worldwide and the procedure is considered to be very safe. As an invasive procedure there are naturally associated risks, as with any catheterization procedure; however, the NOGA™ system and Biosense Webster catheter used in the procedure were specifically designed to minimize these risks. You have the right to ask your cardiologist for a full explanation before signing your consent to undergo cardiac catheterization with a diagnostic NOGA™ procedure
Are There any Prerequisites for a NOGA™ Procedure?
Almost all patients who are considered suitable candidates for standard cardiac catheterization can safely undergo a NOGA™ procedure. Your physician is aware of the contraindications and will consider NOGA™ mapping only if you meet the criteria. You might be instructed to stop taking certain drugs prior to hospitalization. Note that performing a NOGA™ procedure is ultimately the clinical decision of your cardiologist.
What Will I Feel During and Following the Procedure?
Similar to standard cardiac catheterization local anesthesia is applied at the site where the catheter is inserted. General anesthesia is usually not required. Thus, you will remain conscious, but you should not experience any pain, though you may feel some discomfort or a burning sensation when the catheter is initially introduced into a vein.Since you will be lying on your back throughout the procedure you may even be able to view your own heart on the computer screen as the CARTO™ map is acquired and analyzed. Following the procedure you may be required to stay in bed until the morning after and you may feel slight discomfort at the catheter insertion site
When Will I Be Discharged?
If there are no complications the patient is typically discharged from the hospital the day after a successful procedure. A follow up echocardiography study is routinely performed prior to discharge. Your referring physician will receive a full report of your NOGA™ procedure including representative color-coded maps and electromechanical assessment.
More than 150,000 patients in the United States have severe ischemic coronary artery disease that is not treatable with standard coronary artery bypass surgery, coronary angioplasty or stenting. These patients are disabled due to symptoms of angina, shortness of breath, fatigue and lack of exercise tolerance. Angiogenesis (formation of new blood vessels) using laser therapy could be a promising modality to improve their quality of life.
This study will utilize two new diagnostic systems in order to accurately measure improved blood flow and contractility (ability of the heart to pump blood). This will be obtained with the NOGA™ electromechanical cardiac mapping system and Doppler FloWire measurements of coronary blood flow.