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Prosthetic Heart Valves Blog

Related terms: Aortic Valve Replacement, Mitral Valve Replacement, Tricuspid Valve Replacement, Pulmonary Valve Replacement, Heart Valve Replacement

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

Approval Expanded for Sapien Artificial Heart Valve

Posted 22 Oct 2012 by Drugs.com

MONDAY, Oct. 22 – U.S. Food and Drug Administration approval for the Sapien Transcatheter Heart Valve has been expanded to include additional people with aortic valve stenosis, the medical term for a narrowing of the aortic valve that prevents the valve from functioning properly. The new approval sanctions the artificial valve for patients who are at above-average risk of complications from valve surgery, including the possibility of death, the agency said Friday in a news release. The valve was first approved in 2011. The device is implanted without opening the chest. It is compressed and placed into a delivery catheter that's inserted through an artery in the leg and is threaded to the site of the diseased valve. The replacement valve should not be implanted in people who cannot tolerate anti-clotting therapies, the FDA warned. Device maker Edwards Lifesciences Corp, based in Irvine, ... Read more

Related support groups: Prosthetic Heart Valves, Valvular Heart Disease

Less Invasive Heart Valve Replacement Works for Elderly: Study

Posted 2 May 2012 by Drugs.com

WEDNESDAY, May 2 – For elderly patients with a heart valve disease known as aortic stenosis, a procedure called a transcatheter aortic-valve implantation appears safe and effective, French researchers say. Transcatheter aortic-valve implantation is a less invasive way of replacing the heart's aortic valve than traditional open-heart surgery. The procedure involves passing a replacement valve through a leg or shoulder artery and advancing it until it reaches the aortic valve, taking its place. The U.S. Food and Drug Administration approved the technique in 2011. "Surgical aortic valve replacement is the definitive therapy for severe symptomatic aortic stenosis," said study co-author Dr. Martine Gilard, of the department of cardiology at Brest University Hospital in France. And transcatheter aortic-valve implantation "is a new therapeutic option for these patients," he said. The U.S. ... Read more

Related support groups: Prosthetic Heart Valves, Aortic Stenosis, Valvular Heart Disease

Minimally Invasive Heart-Valve Procedure Shows Promise: Study

Posted 3 Apr 2011 by Drugs.com

SUNDAY, April 3 – An experimental, minimally invasive procedure to place a new valve in a damaged heart is as good as conventional open-heart surgery, although it comes with a higher risk of stroke, researchers reported Sunday. Transcatheter aortic valve implantation (TAVI) involves snaking a valve into position in the heart via an artery in the leg or directly through a tiny incision into the left ventricle of the heart, similar to a balloon angioplasty procedure to clear clogged arteries. The collapsible heart valve, called the Edwards SAPIEN valve, is made by Edwards Lifesciences Corporation, which sponsored the study. According to Dr. Paul Teirstein, an interventional cardiologist with Scripps Health in San Diego and a study author, the full procedure could cost up to $50,000 – about the same as traditional aortic valve replacement surgery. The device is not yet approved by the ... Read more

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Prosthetic Heart Valves - Mechanical Valves, Prosthetic Heart Valves - Tissue Valves, Valvular Heart Disease

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