Navigation Links
FDA OKs Heart Valve That Does Not Require Open-Heart Surgery
Date:11/3/2011

THURSDAY, Nov. 3 (HealthDay News) -- The first artificial heart valve that can be implanted without open-heart surgery has been approved by the U.S. Food and Drug Administration.

The Sapien Transcatheter Heart Valve is designed to replace an aortic heart valve damaged by senile aortic valve stenosis, a progressive and age-related illness caused by calcium deposits that cause the valve to narrow.

One expert called the advent of the device "a revolutionary breakthrough" in terms of expanding access for sick or frail patients.

"This new approach to valve replacement is designed for the elderly and the highest risk patients who are inoperable -- or nearly inoperable -- by conventional criteria," said Dr. Gregory Crooke, assistant director of cardiothoracic surgery at Maimonides Medical Center in New York City, which is already offering the device to select patients. "As has been shown in trials, it should greatly improve the survival and quality of life for this cohort of patients," he said.

In aortic stenosis, the heart has to work harder to pump sufficient amounts of blood through the narrowed valve opening. This eventually causes the heart to weaken, leading to problems such as fainting, chest pain, heart failure, irregular heart rhythms, or cardiac arrest.

More than half of patients with symptoms of senile aortic valve stenosis die within two years. Open-heart surgery to replace the diseased valve can restore blood flow, but the procedure is too dangerous for some patients, the FDA noted in a news release.

The new artificial valve -- made of cow tissue and polyester supported with a stainless steel mesh -- provides an option for these patients. The valve is compressed into the end of a catheter that's inserted into a femoral artery (large artery in the thigh) and threaded to the site of the diseased valve. The artificial valve is then released from the catheter and expanded with a balloon. The valve is immediately functional, according to information in the FDA news release.

The FDA's approval of the valve is based on a study of 365 patients with the condition who weren't eligible for open-heart surgery. Half of the patients received the artificial valve while the other patients received alternative treatments, such as one that enlarges the aortic valve opening by stretching it with a balloon.

Patients who received the new valve did have eight times as many vascular and bleeding complications and 2.5 times more strokes than those who did not receive the valve. However, patients who received the valve were also more likely to be alive one year after surgery than those who received an alternative treatment -- 69 percent versus 50 percent, respectively, the investigators found.

The most common serious side effects associated with the artificial valve and its implantation include death, stroke, perforation of blood vessels or ventricular or valvular structures in the heart, significant bleeding, leaks around the new valve, and damage to the heart's conduction system, which is responsible for a consistent and healthy heart beat.

Another cardiologist called the device's approval "important news."

"Often these patients are elderly with numerous other medical ailments that make standard aortic valve surgery too risky to perform," said Dr. James Slater, director of the Cardiac Catheterization Lab at NYU Langone Medical Center in New York City. "Medical [drug] therapy is generally not effective and the availability of a therapy that is less invasive and traumatic than standard surgery is an important advance," he added.

Slater also hopes that "further improvements in these devices will decrease the rate of complications and that further investigations will allow this therapy to be available to a wider range of patients with this disease."

California-based Edwards Lifescience, which makes the new valve, says it will continue to evaluate patient outcomes through a national registry.

The FDA approved the Sapien Transcatheter Heart Valve for patients who are not eligible for open-heart surgery, but it is not approved for those who can be treated by open-heart surgery. The agency also said that patients with congenital heart valve abnormalities, masses or an infection in their hearts, or those who cannot tolerate anticoagulation/antiplatelet therapy should not receive the new valve.

The valve's product label says a heart surgeon should be involved in determining if a patient is a suitable candidate for the artificial valve.

More information

The U.S. National Heart, Lung, and Blood Institute has more about heart valve problems.

-- Robert Preidt

SOURCES: U.S. Food and Drug Administration, news release, Nov. 2, 2011; Gregory Crooke, MD, assistant director, cardiothoracic surgery, Maimonides Medical Center, New York City; James Slater, M.D., director, Cardiac Catheterization Lab, NYU Langone Medical Center, New York City


'/>"/>
Copyright©2010 ScoutNews,LLC.
All rights reserved  

Related medicine news :

1. ICU Patients at Risk for Rare Heart Rhythm Problem
2. Cook With Love This Valentines Day With Heart-Smart Recipes
3. Study finds racial gaps continue in heart disease awareness
4. Highmark Foundation Awards $120,000 to the American Heart Association
5. Womens Heart Disease Awareness Still Lacking
6. American Heart Association Rapid Access Journal Report: Study Finds Racial Gaps Continue in Heart Disease Awareness, Low Knowledge of Heart Attack Warning Signs Among Women
7. Migraine Linked to Increased Heart Attack Risk
8. PERSONALABS Offers Discounted Healthy Heart Online Blood Tests in February
9. Compound shows promise against intractable heart failure
10. New American Heart Association Survey Finds Heart Disease and Stroke Patients Face Significant Barriers in Obtaining Quality, Affordable Care
11. Ex-President Clinton Undergoes Heart Procedure
Post Your Comments:
*Name:
*Comment:
*Email:
Related Image:
FDA OKs Heart Valve That Does Not Require Open-Heart Surgery
(Date:4/24/2017)... ... , ... Today, Bright Pink , a national non-profit organization focusing on the prevention and ... , Bright Pink is proud to announce Katie Thiede as their new Chief Executive Officer. ... as Chairman of the Board and launched a national search to find a visionary ...
(Date:4/24/2017)... ... April 24, 2017 , ... Sean Fay is the undisputed king of ... Juiceman Juicer, and the George Foreman Grill (which sold more than 100 million units ... last 25 years. , Now, due to changes in the broadcast media landscape, the ...
(Date:4/24/2017)... ... April 24, 2017 , ... The John P. McGovern Museum of ... anyone, anywhere to track their cognitive health, and share results with their physicians. Members ... health on the museum's website. , BrainCheck founder, Dr. David Eagleman, formerly at Baylor ...
(Date:4/24/2017)... ... 2017 , ... The world-class designers of Happy Gadget Alert ... lifesaving device for the everyday use of parents worldwide. It is a lightweight, ... a child’s vital signs, and detect unusual symptoms or physical patterns. This innovative ...
(Date:4/24/2017)... ... April 24, 2017 , ... Salus Telehealth, Inc. ... company’s VideoMedicine mobile platform has launched Quick Care, a new service offering on-demand ... Care provides patients with the option to request and begin a consultation with ...
Breaking Medicine News(10 mins):
(Date:4/19/2017)... April 19, 2017 Global Surgical Drainage Device ... tubes used to remove excess liquid and air. The ... urine, bile or lymph. Surgical drains are used in ... as orthopedics surgery, cardiovascular surgery, neurosurgery, plastic surgery etc. ... to prevent accumulation of fluid e.g. blood or pus. ...
(Date:4/19/2017)... , April 19, 2017 ... stimulate an immune response in pets such as ... products are of various types such as Attenuated ... Toxoid Vaccines, DNA Vaccines and Recombinant Vaccines. Attenuated ... as virus or bacteria, which have been weakend ...
(Date:4/18/2017)... Cogentix Medical, Inc. (NASDAQ: CGNT), a global ... and Gynecology markets with innovative and proprietary products, will ... 31, 2017 after the market close on Tuesday, May ... a conference call and webcast to discuss its financial ... at 4:30 p.m. Eastern Time (3:30 p.m. Central Time). ...
Breaking Medicine Technology: