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Prosthetic Heart Valves - Mechanical 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, Valvular Heart Disease, Aortic Insufficiency

Heart Valve Patients Who Manage Their Own Blood Thinners May Do Better

Posted 10 Nov 2015 by Drugs.com

TUESDAY, Nov. 10, 2015 – Patients with mechanical heart valves may benefit from managing their own blood thinners, a new study suggests. "There are several reasons that patients who self-manage treatment have better outcomes than those who follow standard management," said study leader Dr. Thomas Decker Christensen, from Aarhus University Hospital, in Denmark. "Self-management patients receive more detailed information about oral anticoagulation therapy; they also learn more about the influence that diet, infectious diseases, alcohol, and other drug interactions can have on their treatment than do patients receiving standard management," Christensen explained. "We believe that the majority of patients who have a mechanical heart valve inserted during surgery should be able to manage their oral anticoagulant therapy, and recommend this as the standard treatment approach for these ... Read more

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

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, Valvular Heart Disease, Aortic Insufficiency

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, Dabigatran, Jantoven, Mitral Stenosis, Myocardial Infarction - Prophylaxis, Valvular Heart Disease, Dicumarol, Acova

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, Valvular Heart Disease, Cardiothoracic Surgery, Aortic Insufficiency

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

Medical Implant Devices Skate Through Review Process, Studies Claim

Posted 30 Sep 2014 by Drugs.com

MONDAY, Sept. 29, 2014 – Every day, people receive medical implants – artificial valves, hip replacements, surgical mesh and the like – that may not have been rigorously tested before or after their approval by the U.S. Food and Drug Administration, two new studies contend. The studies – conducted by prominent nonprofit groups and published online Sept. 29 in JAMA Internal Medicine – lay the blame for inadequate medical device testing on lax oversight by the FDA. Manufacturers didn't submit any scientific evidence on the safety or effectiveness of 42 out of a sample of 50 new implants in their applications to the FDA, according to a review conducted by the nonprofit National Center for Health Research. The FDA cleared the implants for use in humans. "If you are a doctor who wants to know what the scientific evidence is that this device is safe and effective, there is no publicly ... Read more

Related support groups: Hip Replacement, Knee Joint Replacement, Prosthetic Heart Valves - Mechanical Valves

Blood Thinner Dangerous for Patients With Artificial Heart Valves, Study Finds

Posted 26 Sep 2013 by Drugs.com

THURSDAY, Sept. 26 – When used by patients with mechanical heart valves, the blood thinner Pradaxa raises the risk of both dangerous clots and bleeding around the heart, a new study says. The bottom line for lead researcher Dr. Frans Van de Werf, chairman of the department of cardiovascular medicine at the University Hospitals Leuven in Belgium, is "don't use Pradaxa in patients with a mechanical valve." In fact, the trial was halted early and the U.S. Food and Drug Administration subsequently issued a 'black box' warning that said this particular group of heart patients should not take Pradaxa because of an increased chance of a stroke or heart attack. Pradaxa (dabigatran) is a drug that prevents clotting. It has been approved as an alternative to warfarin for patients with an abnormal heartbeat called atrial fibrillation, the researchers noted. "It was hoped that a novel oral direct ... Read more

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

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

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