Navigation Links
MitraClip Safely Relieves Symptoms in Patients With No Surgical Options
Date:5/6/2010

SAN DIEGO, May 6 /PRNewswire/ -- An innovative catheter-based procedure is providing relief to patients who suffer from shortness of breath and fluid overload as the result of a severely leaky heart valve, but who are too sick for open-chest surgery, according to a study presented today at the Society for Cardiovascular Angiography and Interventions (SCAI) 33rd Annual Scientific Sessions.

Data from the Endovascular Valve Edge-to-Edge REpair STudy (EVEREST II) High Risk Registry showed that, in patients who are not healthy enough to undergo surgery to repair a leaky mitral valve, use of the MitraClip valve repair system is safe and, in the majority of patients, effective in relieving symptoms that limit the ability to engage in day-to-day activities. There has never been a treatment option for this high-risk group of patients in the past.

"The MitraClip system is a first-in-class treatment and a remarkable innovation—the beginning of a very exciting era for treating valvular disease with minimally invasive devices," said Saibal Kar, M.D., FSCAI, director of interventional cardiac research at the Heart Institute, Cedars Sinai Medical Center, Los Angeles.

The mitral valve controls blood flow between the atrium (upper chamber) and the ventricle (lower chamber) on the left side of the heart. A leaky mitral valve, or mitral regurgitation, can develop when the valve flaps, or leaflets, do not close effectively. This can happen either because the valve flaps are scarred or defective, or because the heart has become enlarged, stretching the valve opening so much that the flaps no longer meet in the center.

Mitral regurgitation is the most common condition involving the valves of the heart. Of the 250,000 patients newly diagnosed with mitral regurgitation in the United States each year, only about 20 percent have surgery. The rest are either too high-risk or not yet sick enough for surgery.

The MitraClip is an investigational device that has not yet been approved by the FDA. During the procedure, the device is mounted on a catheter and advanced into the heart via a vein in the groin. The clip is centered directly across the center of the valve and the leaflets are clipped together in the middle, converting a leaky single orifice mitral valve into a competent double-orifice valve. The entire procedure is done on a beating heart using x- ray and ultrasound to guide the procedure.

For the study, interventional cardiologists recruited 78 patients with severe mitral regurgitation (classified as moderate-to-severe, or severe) who were considered to be at very high risk for surgery. The average age of patients was 77 years. All patients had congestive heart failure, and 90 percent were in New York Heart Association (NYHA) class III or IV, meaning they were experiencing marked limitation of physical activity or even shortness of breath while resting. Some 60 percent of patients had previously undergone cardiac surgery, 85 percent had coronary artery disease, 35 percent had chronic lung disease, and 23 percent had moderate-to-severe kidney failure. According to a formula developed by the Society of Thoracic Surgeons, the average predicted risk of surgery-related death was 18.2 percent.

The placement of the MitraClip was successful in 96 percent of patients, with no procedural deaths. Within the first 30-days, mortality was 7.7 percent, which was significantly lower than the predicted 18.2 percent surgical mortality (p=0.008) and not significantly different from the 8.3 percent mortality in a matched control group who were treated with medications alone. At 30-day follow-up, 75 percent of survivors were in NYHA class I or II, meaning no or only slight limitation in physical activity. Survival at one year was 75 percent, better than the 55 percent in the medication-only control group.

At one year, 74 percent of survivors who were treated with the MitraClip were still in NYHA class I or II and average heart function was improved by several measures. In addition, there was a 45 percent reduction in readmissions to the hospital for congestive heart failure. None of the patients in the study developed more severe symptoms, worse mitral regurgitation or underwent surgery within that time period.

Researchers concluded that treatment with the MitraClip valve repair system can be performed safely in high-risk patients and provides long-lasting relief of symptoms.

"Patients who couldn't walk across a room without being short of breath are now able to walk up a flight of stairs, go shopping, and exercise," said Dr. Kar. "The MitraClip procedure can be transformational for patients."

The study was sponsored by Evalve, Inc, which is now part of Abbott. Dr Kar received research grants from Evalve, Inc.

Dr. Kar will present the study "MitraClip® Therapy in the EVEREST II High Risk Registry: One Year Results" in an oral abstract session on Thursday, May 6, 2010, 10:45 a.m. to 11:00 a.m.

About SCAI

Headquartered in Washington, D.C., the Society for Cardiovascular Angiography and Interventions is a 4,000-member professional organization representing invasive and interventional cardiologists in approximately 70 nations. SCAI's mission is to promote excellence in invasive and interventional cardiovascular medicine through physician education and representation, and advancement of quality standards to enhance patient care. SCAI's annual meeting has become the leading venue for education, discussion, and debate about the latest developments in this dynamic medical specialty. SCAI's patient and physician education program, Seconds Count, offers comprehensive information about cardiovascular disease. For more information about SCAI and Seconds Count, visit www.scai.org or www.seconds-count.org.


'/>"/>
SOURCE Society for Cardiovascular Angiography and Interventions
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. New Data Shows Ongoing Benefits of Percutaneous MitraClip(R) Device for Patients With Mitral Regurgitation
2. MitraClip Device Preliminary Data Suggests Improved Heart Function and Relief from Heart Failure Symptoms in Functional Mitral Regurgitation Patients
3. First European Patients Treated With the Percutaneous MitraClip(R) System
4. Two-Year Follow-Up Data Demonstrates Preservation of Adequate Mitral Valve Area in Patients Treated with the MitraClip(R) System
5. First Swiss Patients Treated with the Percutaneous MitraClip(R) System
6. MitraClip(R) Therapy Data Shows Important Clinical Benefit in High Risk Patients With Functional Mitral Regurgitation at 12-Month Follow Up
7. MitraClip(R) Therapy Data Demonstrate Clinical Benefit in High-Risk Patients With Mitral Regurgitation
8. MitraClip(R) Therapy Introduced in Austria
9. New Data Demonstrates Abbotts Investigational MitraClip(R) System Has Potential to be a Valuable Treatment Option for Patients With Mitral Regurgitation, the Most Common Heart Valve Condition
10. New Topical Therapy Safely Treats Serious Skin Infections Without Systemic Side Effects
11. New Research Just Released: Women Can Now Safely Postpone Motherhood Until Time Is Right
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/12/2017)... SAN DIEGO , Oct. 12, 2017   Divoti ... Medical Alert Jewelry up to the standard of the latest FDA ... (Launched: June 2017). Anyone in need of Medical ID ... Divoti Medical Alert Jewelry are engraved in terms of the ... ...
(Date:10/11/2017)... , Oct. 11, 2017  Hill-Rom Holdings, Inc. ... Aspen Surgical facility in Las Piedras, Puerto ... scalpels and blades. ... that the facility sustained minor structural damage, temporary loss ... Maria. Repairs have been completed, manufacturing operations have resumed, ...
(Date:10/4/2017)... 2017  South Korean-based healthcare product Development Company I.M. ... on Kickstarter. The device will educate the user about ... better efficiency compared to the dated and pricey CPR ... efficacy of the compression for a more informed CPR ... to raise $5,000. ...
Breaking Medicine Technology:
(Date:10/13/2017)... ... ... “The Journey: From the Mountains to the Mission Field”: the story of a ... “The Journey: From the Mountains to the Mission Field” is the creation of published ... all ages and currently teaches a class of ladies at her church, which she ...
(Date:10/12/2017)... ... October 12, 2017 , ... Planet Fitness, one of the ... today its plans to open a flagship location in Covington, LA at 401 N. ... To Go store next to Office Depot in the Holiday Square shopping center. Its ...
(Date:10/12/2017)... (PRWEB) , ... October 12, 2017 , ... ... AccentCare, a leader in post-acute health care, have expanded their existing home health ... Home Health. , AccentCare has been operating a joint venture home health company ...
(Date:10/12/2017)... ... October 12, 2017 , ... Leading pediatric oncology experts at ... for the 49th Congress of the International Society of Paediatric Oncology (SIOP) ... Center for Cancer and Blood Disorders at Children’s National, and Stephen P. ...
(Date:10/12/2017)... ... October 12, 2017 , ... In the ... a year. In some states—like New York, New Jersey, Massachusetts, Texas, Virginia, Connecticut, ... retirement havens have extremely low property-tax rates, which contributes to the relatively lower ...
Breaking Medicine News(10 mins):