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Who is a candidate for non-invasive aortic valve replacement?
Who is a candidate for non invasive aortic valve replacement? inclusions and exclusions?.
submitted by Barbara from Houston, Texas on 8/16/2011
by Texas Heart Institute cardiologist, Pranav Loyalka, MD
Currently the trials with aortic valve replacement have two groups of patients that are being considered.
• First are those who have been deemed by two surgeons to be EXTREME risk for surgery due to a variety of conditions.
• Second are those that are HIGH risk for complications for regular surgical valve replacement. The risk of not surviving had to be greater than 10%.
• The HIGH risk group then gets randomized to surgery or percutaneous approach. The EXTREME group gets just the percutaneous approach.
• If you contact us we can give you more details. Thank you.
by Texas Heart Institute cardiovascular surgeon, Joseph S. Coselli, MD
First of all, all non-invasive catheter-based aortic valve replacements are carried out currently for patients with severe aortic valvular stenosis based initially and primarily on echocardiography. We are currently involved in the Medtronic CoreValve Trial. Clearly, it has inclusions and exclusions. In addition to severe aortic valvular stenosis, the patients have to be at significant risk for surgery. Patients whose operative risk is on the low end of the spectrum go directly to surgery. Additionally, the patients must be symptomatic from the stenosis as based upon a Functional Class II or greater of the New York Heart Association Classification. Patients or their legal representative must be informed of the nature of the trial and agree to its provisions. Patients have to agree to return for all required postoperative follow-up visits.
Exclusions include patients who have had an acute myocardial infarction (heart attack) less than 30 days before the intended treatment. Patients who have had recent percutaneous coronary or peripheral vascular interventions and stents within 30 days for bare metal stents, and six months for drug eluting stents, are excluded. Patients with low white counts and low platelet counts or a history of bleeding are excluded. Patients with untreated clinically significant coronary artery disease requiring coronary artery bypass, of course, are not treated with an endovascular valve. In addition, patients with extremely poor hearts as measured by what we refer to as a left ventricular ejection fraction (<20%) based upon a resting echocardiogram are excluded. Patients with recent strokes or transient ischemic attacks, end-stage renal disease requiring dialysis, recent gastrointestinal bleeding, hypersensitivity to aspirin, heparin, nitinol, and contrast media are excluded. Patients with active aortic valve infection (endocarditis), or those who would refuse a blood transfusion are excluded.
Additionally, patients with a life expectancy of less than 1 year are excluded. Patients with severe dementia, who are currently participating in another drug or device trial, or have symptomatic blockages to their carotid arteries are excluded. Additionally, there are some specific anatomical issues. Patients have to have an adequate size to their aortic valve, not too big and not too small. Their other heart valves have to work reasonably well. Their aorta has to be of reasonable size and they cannot have a bicuspid or unicuspid aortic valve by echocardiography.
The clinical trial is also broken down into two separate groups. One is an Extreme High-Risk group. In this Extreme High-Risk group, the patients are not randomized. One cardiologist and two heart surgeons have to agree that the medical factors regarding these particular patients are such that they conclude that the probability of death or serious morbidity exceeds the probability of meaningful improvement and consequently these patients are not candidates for operative surgery. All of these patients, if accepted by the screening committee of the clinical trial go directly into the CoreValve treatment group.
The second group is considered High-Risk. These individuals are evaluated by one cardiologist and two heart surgeons and they agree that the predicted risk of operative mortality is greater than 15% at 30 days. These individuals are randomized, some going into open surgery and the others have the CoreValve inserted as a Transcatheter valve.
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Updated August 2011