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What causes mitral regurgitation? Mitral regurgitation (MR) is usually caused by conditions that damaged the mitral valve or weakened the heart muscle. Common causes of MR in adults are:
How does mitral regurgitation develop? Mitral regurgitation (MR) is usually caused by conditions or incidents that weaken or damage the heart's mitral valve. The most common causes of MR in adults are:
How common is mitral regurgitation? Chronic mitral regurgitation affects approximately 6% of women and 3% of men, but after 55 years of age, some degree of mitral regurgitation is found in almost 20% of men and women who undergo echocardiograms (also known as echo, and / or Doppler echocardiography) - an ultrasound test that produces an image of the heart and its valve functions. Return to top of page. What are the symptoms of mitral regurgitation? In order to assess the effects of MR, it is important to have regular health exams with your doctor to monitor your condition. The symptoms of MR vary, depending on the severity of a person's disease. Some people may never develop symptoms while other people may develop an enlarged left ventricle (because it is working harder to pump blood out to the body). Patients with severe chronic MR may have symptoms of congestive heart failure such as:
Return to top of page. What increases my risk of mitral regurgitation? There are several risk factors for mitral regurgitation (MR), which include:
When should I see a doctor?
If you believe you are experiencing symptoms (see Symptoms of Mitral Regurgitation), you should see your doctor immediately. Return to top of page. How will my doctor diagnose mitral regurgitation? To diagnose MR, your doctor needs to make several assessments. First, s/he will need to determine whether the MR has been present for a long time (chronic) or has developed/worsened recently (acute). Your doctor will need to assess the severity and check for any other complications or influencing conditions. To determine this, your doctor may:
Your doctor may also perform a physical exam: take your blood pressure, check your pulse, listen to your heart and lungs, and examine your feet and legs for signs of excess fluid. Additionally, your doctor may order tests to identify abnormal heart function. These tests include:
Return to top of page. What is an echocardiogram? An echocardiogram (also known as ECG, and / or Doppler echocardiography) is an ultrasound test that produces an image of the heart and its valves. Return to top of page. What other heart valve disease is there? The heart has four valves: the pulmonary valve, the aortic valve, the tricuspid valve, and the mitral valve. When functioning properly, the four heart valves ensure sure that blood always flows in a forward direction, without backward leakage. There are several types of heart valve disease: Valvular stenosis (narrowing of opening). This occurs when a heart valve opening is smaller than normal, due to stiff or fused leaflets (flaps). The narrowed opening causes the heart to work hard to pump blood through it. This increased exertion can lead to heart failure, or other heart problems. All four valve openings can become narrowed restricting blood flow). The conditions are called pulmonic stenosis, aortic stenosis, tricuspid stenosis and mitral stenosis. Valvular insufficiency. Also called regurgitation, incompetence or "leaky valve", this occurs when a valve does not close properly. If the valve does not seal, some blood will leak backwards across the valve. As the leak worsens, the heart has to work harder to make up for the leaky valve, and less blood may flow to the rest of the body. Depending on which valve is affected, the valvular insufficiency is called: pulmonary regurgitation, aortic regurgitation, tricuspid regurgitation or mitral regurgitation. Return to top of page. How is mitral regurgitation treated? Medical Treatment (MR), but there are medications that may be used to treat it's symptoms. For patients diagnosed with Grade 1 (mild) or Grade 2 (moderate) MR, ongoing monitoring of their MR condition, along with treatment of its symptoms, may be sufficient. Drugs that are used to treat symptoms of MR include:
For symptomatic patients diagnosed with either Grade 3 (moderate to severe) or Grade 4 (severe) MR, surgery is generally recommended. The American College of Cardiology and the American Heart Association also recommend mitral valve surgery (repair or replacement), if the patient's ejection fraction (the amount of blood pumped out of the left ventricle during each heartbeat) drops below 60%, or if the patients left ventricle is larger than 45 millimeters at rest if the patient has no symptoms. Mitral valve repair or replacement requires hospitalization and involves open-heart surgery, which usually lasts several hours. A patient is placed under general anesthesia for the entire operation. The heart surgeon makes an incision into the patient's chest. Blood is circulated through a heart-lung machine, which adds oxygen to the blood and maintains stable blood flow. The patient's heart is stopped to allow the physician to perform the surgery. The mitral valve is either removed and replaced with a replacement valve or repaired as described below. Mitral Valve Repair Mitral valve repair is usually preferable to mitral valve replacement. Mitral valve repair is accomplished using one or more of the following techniques:
Mitral Valve Replacement For patients with a hard, calcified annulus (mitral valve base) or widespread damage to the mitral valve and its surrounding tissue, replacement of the mitral valve is usually recommended. The damaged mitral valve is replaced with a mechanical (plastic or metal) valve, or a bio-prosthetic valve (either from a human cadaver, or from pig or cow tissue). The damaged mitral valve is removed and the replacement valve is sewn into place. Mechanical mitral valves have greater durability than tissue or bio-prosthetic valves, but patients who receive them must take medications which thin the blood and reduce the likelihood of blood clotting (anticoagulants) on a permanent basis. However, there are risks associated with these medications, which include increased risk of bleeding, drop in level of blood cells, dizziness, headache, stroke, etc. Return to top of page. Will I need any medication? See - How is mitral regurgitation treated? Patients who undergo mitral valve surgery will require medication. Often, antibiotics are prescribed, in order to minimize the risk of surgical infection. Usually in cases of mitral valve replacement, anticoagulants (blood-thinning drugs) are required, in order to reduce the risk of blood clotting and the potential for stroke (a rupture or obstruction of a blood vessel of the brain that can cause loss of consciousness, sensation, and voluntary motion). Return to top of page. Will I need surgery? If patients are diagnosed with either Grade 3 (moderate to severe) or Grade 4 (severe) mitral regurgitation (MR), surgery may be required to repair or replace the mitral valve. Your physician will be able to recommend the appropriate treatment. Return to top of page. What should I ask if surgery is recommended?
Return to top of page. Living with Mitral Regurgitation Can I exercise with mitral regurgitation? If diagnosed with mitral regurgitation, you should consult your doctor about safe health habits, including exercise and nutrition. Return to top of page. Should I have special concerns about antibiotics? Many people use and benefit from taking antibiotics. However, in some cases, and with certain antibiotics, some people develop side effects or allergic reactions. To learn more about antibiotics, you should ask your doctor about which specific medications are prescribed to you, so that you can learn more about it. Return to top of page. What are the risks associated with surgery for mitral regurgitation? Mitral valve repair or replacement requires hospitalization and involves open-heart surgery, which usually lasts several hours or more. A patient is placed under general anesthesia for the entire operation. The heart surgeon makes an incision into the patient's chest. Blood is circulated through a heart-lung machine, which adds oxygen to the blood and maintains stable blood flow. The patient's heart is stopped to facilitate the surgery. The mitral valve is either removed and replaced with a prosthetic (artificial) heart valve or repaired. Return to top of page. Is mitral regurgitation fatal? If left untreated, mitral regurgitation (MR) can result in death, in some cases. If you believe you are experiencing symptoms (please refer to Causes and Symptoms of MR) of MR, you should consult your doctor. Return to top of page. Where else can I learn about mitral regurgitation? Medline Plus http://www.nlm.nih.gov/medlineplus/ency/article/000176.htm Mayo Clinic.com http://www.mayoclinic.com/invoke.cfm?id=DS00421 Web MD http://my.webmd.com/hw/heart_disease/aa143445.asp http://my.webmd.com/hw/heart_disease/aa143456.asp CNN.com Health http://www.cnn.com/HEALTH/library/DS/00421.html Heart Center Online http://www.heartcenteronline.com/The_Heart_Valve_Center.html?WT.srch=1 Peace Health http://www.peacehealth.org/kbase/topic/special/aa143442/sec1.htm Return to top of page. EVEREST II Clinical Trial What is a clinical trial? A clinical trial is a research study that tests new drugs, medical devices or other instruments, or medical procedure procedures or drugs on people. Return to top of page. What is the EVEREST II clinical trial? EVEREST II is an ongoing Phase II FDA approved clinical research study to assess the safety and efficacy (or effectiveness) of the Evalve PMR system for patients diagnosed with Grade 3 (moderate to severe) or Grade 4 (severe) MR. Study participants will be required to have a number of follow-up visits and evaluations including ultrasound studies over the course of at least a 24-month period following treatment. These follow up visits are intended to monitor the outcome of the procedure. EVEREST II consists of a randomized arm and a high risk registry arm. EVEREST II Randomized Arm This study arm compares the Evalve PMR procedure to the current standard of care, mitral valve surgery. To ensure that the results are unbiased, participants will be randomly assigned to either the Evalve PMR procedure or to surgery, in a "two-to-one" ratio. This means that two out of 3 of trial participants will undergo the Evalve PMR procedure and one out of 3 of trial participants will undergo mitral valve surgery. Initiated in late 2005, this arm will enroll approximately 300 patients. EVEREST II High Risk Registry Arm This study arm is a registry for patients who are considered to be at high risk of not surviving surgery. High risk patients enrolled in the registry will not be randomized and will undergo the Evalve PMR procedure. Initiated in February 2007, the registry will be limited to 70 patients and will be closed once enrollment is complete. Return to top of page. What are the objectives of the EVEREST II clinical trial? See What is the EVEREST II Clinical Trial. Return to top of page. Who is sponsoring the EVEREST II clinical trial? Evalve is sponsoring clinical trials in order to secure regulatory approval from the FDA (Food and Drug Administration). Enrollment in the EVEREST I (Endovascular Valve Edge-to-Edge REpair STudy) research study was successfully completed in February of 2006. This FDA approved Phase I study was designed to evaluate the feasibility of the MitraClip device. Enrollment in the EVEREST II research study is ongoing. See What is the EVEREST II Clinical Trial. Evalve was incorporated in 1999 to design, develop, manufacture and market innovative devices to enable percutaneous repair of cardiac valves. The company's initial products are intended to reduce the risks, trauma and costs associated with current open, arrested heart surgical options. The company's present development and clinical efforts are focused on mitral valve repair. Return to top of page. Which hospitals are participating in the EVEREST II clinical trial? The EVEREST II study will take place in several medical centers located throughout the Am I eligible for participating in the EVEREST II clinical trial? To find out whether you may qualify for EVEREST II, please call toll-free: 1-877-MY-MR-FIX / (877)-696-7349. Click here to link to the EVEREST II Call Center. All information provided to the call center is kept confidential and used only for the purposes of determining eligibility to participate in this study. Alternatively, you can contact an investigational site in your area. (Click here) to view an interactive map of the investigational sites. The EVEREST II trial investigators are seeking to enroll patients who have been diagnosed with Grade 3 (moderate to severe) or Grade 4 (severe) mitral regurgitation (MR), who are seeking treatment for their condition and who:
How long will the EVEREST II trial last? EVEREST II trial participants will participate in a number of associated tests, procedures and follow-up visits over the course of a 24-month period, starting in early 2005. Return to top of page. How will patient safety be monitored in the EVEREST II trial? The rights and safety of clinical trial patients are protected in several important ways. First, every clinical trial must be designed and conducted with the approval and oversight of an Institutional Review Board (IRB) or ethics committee. The IRB is comprised of both physicians and lay people, and is responsible for reviewing and assessing the clinical trial's protocols (e.g., detailed plans), in order to protect patients' rights and safety. Equally important, prospective clinical trial participants are required to sign an "informed consent" form, which provides detailed information regarding the purpose and objectives of the clinical trial, the risks involved in the trial, and potential effects and risks of the trial on patients. All trial participants have the right to leave the trial whenever they wish. A Data Safety Monitoring Board (DSMB) is set up to assure patient safety as well. A DSMB is a group of experts who meet periodically to review accumulated information (data) gathered from participants in clinical trials with the purpose of protecting
A DSMB is made up of people external to the study group. The members of the Board
How can I learn more about the EVEREST II trial? To learn more about the EVEREST II clinical trial, please visit www.evalveinc.com or contact one of the research sites.
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