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Prosthetic Heart Valves - Tissue Valves News

Study: Tissue Heart Valves Seem Best for Middle-Aged Patients

Posted 13 Jan 2016 by Drugs.com

WEDNESDAY, Jan. 13, 2016 – Middle-aged heart valve replacement patients may have better outcomes if they receive valves made from animal tissue rather than metal, researchers report. The investigators analyzed 13 studies that compared metal and tissue valves in patients aged 40 to 70 who had aortic valve replacement. Heart valves are designed to allow blood to flow in only one direction through the heart. The two types of valves studied have different risks and benefits, the authors of the report explained. Metal (mechanical) valves last longer but are more likely to cause blood clots. So patients have to take blood-thinning drugs for the rest of their lives, which can increase the risk of major bleeding, the study authors said. Tissue (bioprosthetic) valves are less likely to cause blood clots, but they may need to be replaced at some point, the authors added. Fifteen years after ... Read more

Related support groups: Heart Disease, Prosthetic Heart Valves, Mitral Valve Prolapse, Prosthetic Heart Valves - Mechanical Valves, Mitral Insufficiency, Aortic Stenosis, Prosthetic Heart Valves - Tissue Valves, Mitral Stenosis, Aortic Insufficiency, Valvular Heart Disease

Heart Doctors May Have Hard Time Spotting Valve Problems

Posted 1 Sep 2015 by Drugs.com

TUESDAY, Sept. 1, 2015 – Heart specialists can't always identify heart valve problems through the sound of heart murmurs, but additional training improves their abilities, a new study shows. A heart murmur is an extra or unusual sound that occurs during a heartbeat, according to the U.S. National Heart, Lung, and Blood Institute (NHLBI). Some murmurs don't indicate a problem, but others can signal heart valve problems, the NHLBI says. The study included nearly 1,100 cardiologists who had their skills assessed at American College of Cardiology meetings from 2011 to 2014. They were asked to diagnose heart valve problems after listening to recordings of heart murmurs. The doctors failed to identify half of basic problems and one-third of advanced problems, the study found. The cardiologists then did extra training for both basic and advanced heart valve problems (90 minutes each). They ... Read more

Related support groups: Prosthetic Heart Valves, Mitral Valve Prolapse, Prosthetic Heart Valves - Mechanical Valves, Mitral Insufficiency, Aortic Stenosis, Prosthetic Heart Valves - Tissue Valves, Mitral Stenosis, Aortic Insufficiency, Valvular Heart Disease

Drug May Be Antidote to Bleeding Tied to Blood Thinner Pradaxa

Posted 22 Jun 2015 by Drugs.com

MONDAY, June 22, 2015 – The new blood thinner Pradaxa (dabigatran) is being widely used, but it comes with one serious drawback: rare but dangerous cases of sudden, uncontrolled bleeding in patients. Now, a new study finds than an experimental, injected drug called idarucizumab could be used to quickly stop that bleeding. "Idarucizumab completely reversed the anticoagulant [bleeding] effect of dabigatran within minutes," researchers say in a study published online June 22 in the New England Journal of Medicine. In recent years, new-generation blood thinners such as Pradaxa have been approved as more manageable alternatives to older drugs such as warfarin. Unlike warfarin, these drugs "do not require blood tests for monitoring... while offering similar results in terms of effectiveness," explained Dr. Kevin Marzo, chief of cardiology at Winthrop-University Hospital in Mineola, N.Y. ... Read more

Related support groups: Warfarin, Coumadin, Atrial Fibrillation, Pradaxa, Transient Ischemic Attack, Prosthetic Heart Valves, Prevention of Thromboembolism in Atrial Fibrillation, Prosthetic Heart Valves - Mechanical Valves, Atrial Flutter, Ischemic Stroke - Prophylaxis, Thrombotic/Thromboembolic Disorder, Thromboembolic Stroke Prophylaxis, Prosthetic Heart Valves - Tissue Valves, Jantoven, Dabigatran, Mitral Stenosis, Myocardial Infarction - Prophylaxis, Valvular Heart Disease, Iprivask, Anisindione

Improved Artificial Heart Valve Approved

Posted 17 Jun 2015 by Drugs.com

WEDNESDAY, June 17, 2015 – The newest version of the Sapien 3 Transcatheter Heart Valve has been approved by the U.S. Food and Drug Administration. The artificial valve is designed for people with a narrowed aortic valve, a condition that restricts blood flow from the heart to the aorta, the body's main artery. The product is sanctioned for people who are at high risk for death or serious complications from open-heart surgery to repair the narrowed valve, the FDA said in a news release. The newly approved device is the third-generation Sapien 3, originally approved in 2011. The newest version includes changes designed to minimize leakage, the FDA said. In people with aortic stenosis, the heart must work harder to pump blood through the narrowed opening. Symptoms can include fainting, chest pain, heart failure, irregular heartbeat and cardiac arrest. Possible side effects of the device ... Read more

Related support groups: Prosthetic Heart Valves, Mitral Valve Prolapse, Prosthetic Heart Valves - Mechanical Valves, Mitral Insufficiency, Aortic Stenosis, Prosthetic Heart Valves - Tissue Valves, Aortic Insufficiency, Valvular Heart Disease, Cardiothoracic Surgery

FDA Expands Approval for 'Valve in Valve' Aortic Replacement

Posted 31 Mar 2015 by Drugs.com

TUESDAY, March 31, 2015 – The U.S. Food and Drug Administration said Tuesday that use of the CoreValve "valve-in-valve" aortic replacement has been expanded to include people at extreme risk for serious complications of traditional open-heart surgery. The CoreValve System is designed for people who had a prior aortic valve replacement and are now in need of a second one, the FDA said in a news release. Some people whose own valves wear out have open-heart surgery to replace the original valve with one made of animal tissue. It's when that second valve needs replacing that the CoreValve product may be prescribed. The CoreValve valve is made of tissue from the heart of a pig. It's attached to a supportive metal frame of nickel-titanium alloy, the FDA said. Insertion is made via a catheter inserted into a leg artery, or via a small incision between the ribs. This removes the need for ... Read more

Related support groups: Heart Disease, Prosthetic Heart Valves - Tissue Valves, Cardiothoracic Surgery, Aortic Insufficiency, Valvular Heart Disease

Study Compares Tissue-Based or Mechanical Replacement Heart Valves

Posted 3 Oct 2014 by Drugs.com

THURSDAY, Oct. 2, 2014 – When the heart's aortic valves cease to work properly, surgeons often use replacement valves to help restore proper cardiac function. Now a new study compares two leading types of aortic valve replacements, and finds they have similar performance in terms of long-term risk of stroke and death for patients. However, the study also found significant differences between the two types of devices when it came to rates of major bleeding and the need for another heart valve operation. According to background information from the researchers, each year in the United States about 50,000 people receive an aortic valve replacement. "Surgical aortic valve replacement is indicated for patients with symptoms of heart failure and a dysfunctional aortic valve, either too narrow or too leaky," explained one expert, Dr. Chad Kliger, a structural heart interventional cardiologist ... Read more

Related support groups: Prosthetic Heart Valves - Mechanical Valves, Prosthetic Heart Valves - Tissue Valves, Valvular Heart Disease

FDA: Don't Use Pradaxa Blood Thinner in Patients With Artificial Heart Valves

Posted 20 Dec 2012 by Drugs.com

THURSDAY, Dec. 20 – The blood thinner Pradaxa should not be used to prevent stroke or blood clots in patients with mechanical heart valves, the U.S. Food and Drug Administration said in a warning issued Wednesday. As the agency noted, a clinical trial in Europe was halted recently because patients taking Pradaxa (dabigatran) were more likely to suffer strokes, heart attacks and clots forming on their mechanical heart valves than patients who were taking the older blood thinner warfarin. Patients in the study who were taking Pradaxa also had more bleeding after valve surgery, the agency said. Doctors should immediately switch patients with a mechanical heart valve who are taking Pradaxa to another medication, the FDA said. The use of Pradaxa in patients with heart valve replacements made of natural biological tissue has not been evaluated and cannot be recommended, the agency added. The ... Read more

Related support groups: Pradaxa, Prosthetic Heart Valves, Prosthetic Heart Valves - Mechanical Valves, Prosthetic Heart Valves - Tissue Valves, Dabigatran

FDA Medwatch Alert: Pradaxa (dabigatran etexilate mesylate): Drug Safety Communication - Should Not Be Used in Patients with Mechanical Prosthetic Heart Valves

Posted 20 Dec 2012 by Drugs.com

ISSUE: The U.S. Food and Drug Administration (FDA) is informing health care professionals and the public that the blood thinner (anticoagulant) Pradaxa (dabigatran etexilate mesylate) should not be used to prevent stroke or blood clots (major thromboembolic events) in patients with mechanical heart valves, also known as mechanical prosthetic heart valves. A clinical trial in Europe (the RE-ALIGN trial)1 was recently stopped because Pradaxa users were more likely to experience strokes, heart attacks, and blood clots forming on the mechanical heart valves than were users of the anticoagulant warfarin. There was also more bleeding after valve surgery in the Pradaxa users than in the warfarin users. Pradaxa is not approved for patients with atrial fibrillation caused by heart valve problems.  FDA is requiring a contraindication (a warning against use) of Pradaxa in patients with mechanical ... Read more

Related support groups: Pradaxa, Prosthetic Heart Valves, Prosthetic Heart Valves - Mechanical Valves, Prosthetic Heart Valves - Tissue Valves, Dabigatran

Patient's Pulmonary Valve May Substitute for Donor Aortic Valve

Posted 4 Aug 2010 by Drugs.com

TUESDAY, Aug. 3 – Heart patients who need a new aortic valve are more likely to survive and have a better quality of life if a valve from their own pulmonary artery is used, instead of an aortic valve from a dead donor, new research has found. The aortic valve connects the left ventricle of the heart with the aorta, which is the body's main artery. The pulmonary valve connects the heart to the pulmonary artery, which carries blood from the heart to the lungs. In this study, 108 patients had their malfunctioning aortic valve replaced with their own pulmonary valve (autograft). Their pulmonary valve was then replaced with a pulmonary valve from a dead donor. Another 108 patients had their aortic valve replaced with an aortic valve from a dead donor (homograft). After 10 years, four patients in the autograft group and 15 patients in the homograft group had died. This means that patients ... Read more

Related support groups: Prosthetic Heart Valves - Tissue Valves

'Decellularized' Heart Valve Approved

Posted 7 Feb 2008 by Drugs.com

THURSDAY, Feb. 7 – The U.S. Food and Drug Administration has approved the first replacement heart valve from donated human tissue, in which the tissue's cells have been removed. Removing the tissue's cells and cellular debris is designed to lower the risk of an immune response from the body and subsequent tissue rejection, the FDA said in a statement. Cyrolife Inc's CyroValve SynerGraft pulmonary valve is designed for patients who need a replacement for a pulmonary valve because of disease, malformation or malfunction. The pulmonary valve directs blood flow from the heart's right ventricle to the lungs. Clinical studies compared results of 342 of the SynerGraft valves to 1,246 traditional valves. The FDA said it found that the new valves performed at least as well as the traditional ones. More information The FDA has more about this approval. Read more

Related support groups: Prosthetic Heart Valves - Tissue Valves

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warfarin, Coumadin, Jantoven