Navigation Links
Minimally Invasive Heart Valve Therapy Improves Heart Function, Quality of Life for Mitral Regurgitation Patients
Date:3/14/2010

EVANSTON, Ill., March 14 /PRNewswire/ -- NorthShore University HealthSystem (NorthShore) interventional cardiologist, Ted Feldman, MD, presented data today at the American College of Cardiology annual scientific sessions from the EVEREST II trial (Endovascular Valve Edge-to-Edge REpair STudy) demonstrating the MitraClip, a novel, first-in-class catheter-based device,  is a safe and effective alternative to open heart surgery for select patients with mitral regurgitation.

"This is a major advancement in cardiac care," said Ted Feldman, MD, principal investigator of the trial and director of NorthShore's Cardiac Catheterization Laboratory where he became the first physician in the U.S. to use any method for non-surgical repair of leaking mitral valves. "It's the first catheter-based therapy for a mitral valve problem to complete a trial, and has transformed the lives of patients suffering from moderate to severe mitral regurgitation."

Over eight million people in the US and Europe have Mitral Regurgitation (MR), a condition in which the mitral valve leaflets do not seal tightly. This valvular defect allows blood to flow backward into the heart and is often referred to as a "leaking heart valve". The condition can cause shortness of breath, fatigue, coughing, heart palpitations, swollen feet or ankles and heart murmur.  If left untreated, MR's progressive nature could lead to heart failure, stroke, heart attack or death.  The MitraClip is designed to help these patients on a case-by-case basis, and is currently under review by the FDA.

Patients participating in the EVEREST II trial experienced improvements in heart function, quality of life and the ability to engage in normal physical activity.  "[Before the procedure] I had a hard time walking up the stairs. I would have to stop several times and sometimes sit down to catch my breath," said Beyna, an EVEREST II trial participant and NorthShore patient.  "Now it's different. I don't get out of breath and I can do the things I couldn't do before."

In Phase I of the trial, started in 2003, 107 patients had their mitral valves repaired with the MitraClip, a 4 mm-wide, polyester-covered device developed by Abbott Vascular, Inc. Under general anesthesia, the clip (or sometimes two) is inserted via catheter through an artery in the groin, threaded up to the heart and clamped to the mitral valve's two edges to hold them together. The heart beats normally during the procedure, and therefore does not require a heart-lung bypass machine.

The results of Phase II, announced today, are very promising. A one-year follow-up showed that only 9.6 percent of the 279 MitraClip patients had safety issues associated with the procedure vs. 57 percent of open-heart patients. In terms of effectiveness, 72.4 percent of MitraClip patients had successful reduction of MR vs. 87.8 of surgical patients. Importantly, patients treated with the MitraClip could still have traditional surgery if needed.  

About the EVEREST II Trial

The EVEREST II pivotal trial is a multi-center, randomized clinical trial of 279 patients with moderate-to-severe (3+) or severe (4+) mitral regurgitation who were candidates for mitral valve surgery. The mean age for patients was 68 years, and patients in the trial tended to have more co-morbidities, such as hypertension and congestive heart failure, than the average surgical patient as defined by the 2008 Society for Thoracic Surgery (STS) Database. Patients had at least moderate-to-severe functional or degenerative mitral regurgitation and were either symptomatic or asymptomatic with evidence of compromised left ventricular function, atrial fibrillation, or pulmonary hypertension. The echocardiography core laboratory at the University of California, San Francisco (UCSF) reviewed the trial's echocardiograms based on the American Society of Echocardiography (ASE) criteria for assessment of MR and left ventricular function.

About NorthShore University HealthSystem

Headquartered in Evanston, NorthShore University HealthSystem (NorthShore) is a comprehensive, fully integrated, healthcare delivery system that serves the Chicago Region.  The system includes four hospitals in Evanston, Glenview (Glenbrook Hospital), Highland Park and Skokie.  Further, NorthShore supports teaching and research as the principal teaching affiliate for the University of Chicago Pritzker School of Medicine.  The NorthShore Research Institute focuses on clinical and translational research, including leadership in outcomes research and clinical trials.  The NorthShore University HealthSystem Foundation is a leading philanthropic entity of NorthShore.  It raises charitable contributions, engages volunteer friends and invests in community partnerships.

SOURCE NorthShore University HealthSystem

Back to top
'/>"/>
SOURCE NorthShore University HealthSystem
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. New Study Proves That Minimally Invasive Aneurysm Treatment Yields Successful Long-Term Results
2. New Minimally Invasive Breast Reconstructive Procedure for Breast Cancer Patients - Actively Recruiting Participants for Clinical Study
3. Minimally Invasive Treatment Reduces Shoulder Pain From Tendonitis
4. Positive Results Published Using AtriCure Minimally Invasive Products
5. Edwards Lifesciences Announces First Implants in U.S. Study of Minimally-Invasive Pulmonic Valve
6. New Minimally Invasive Surgical Procedure Restores Quality of Life in Patients With Potentially Debilitating Spinal Condition
7. New Study Offers More Than a Decade of Evidence for Minimally-Invasive Surgery to Treat Female Incontinence
8. Wrist Access Safer, Easier for Many Patients Undergoing Minimally Invasive Treatment of Blocked Heart Arteries
9. IlluminOss Medical Announces First Human Case Utilizing a Unique, New, Minimally Invasive Technology for Fracture Repair is Performed at Medical Hospital del Trabajadar in Santiago, Chile
10. Gallbladder Removal Through Vagina Offers Minimally Invasive Alternative
11. Cardiogenesis Announces Presentation of its PHOENIX(R) Combination TMR Plus Stem Cell Delivery System at the International Society of Minimally Invasive Cardiothoracic Surgeons (ISMICS) Annual Meeting
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/19/2017)... 19, 2017 Pfizer joins ... Milner Therapeutics Consortium   Major research ... Cambridge   The Milner Therapeutics ... ) as a partner to the Milner Therapeutics Consortium. ... the efficient transfer of materials between industry and academia ...
(Date:1/19/2017)... , Jan. 18, 2017  ViewRay, Inc. (Nasdaq: ... first and only clinical MRI-guided radiation therapy system, announced ... of approximately $26.1 million through a private placement ... Management led the financing and was joined by ... LLC and Kearny Venture Partners, and an additional ...
(Date:1/19/2017)... 18, 2017 The Academy of Managed ... Administration (FDA) for its release today of draft ... decision makers can proactively share clinical and economic ... as emerging therapies awaiting FDA approval. ... that AMCP developed during two multi-stakeholder meetings last ...
Breaking Medicine Technology:
(Date:1/19/2017)... ... January 19, 2017 , ... Next week after January 20th, the fear ... political games that circumvent health needs of over 30 million. Many interviews with Dr. ... and needs government public servants were suppose to prioritize. Interviews provided below. ...
(Date:1/19/2017)... ... January 19, 2017 , ... WhoHaha , a digital ... the American Heart Association (AHA) to produce a three-part video series that uses humor ... as part of the launch of AHA’s Healthy For Good™ movement, which is designed ...
(Date:1/19/2017)... ... 19, 2017 , ... Dr. Andrew Lian-Jie Li ... trained Mohs and cosmetic surgeon. After extensive dermatology research training at the National ... in internal medicine at the Emory University and dermatology training at the University ...
(Date:1/19/2017)... Beach, CA (PRWEB) , ... January 19, 2017 ... ... Oral Health, is now offering treatments for patients with sleep apnea and TMJ ... consequences for dental and physical health. Dr. Rassouli provides personalized care to reduce ...
(Date:1/19/2017)... ... January 19, 2017 , ... Rountree Brady Insurance Agency, ... communities throughout eastern Georgia, is embarking on a charity effort to raise awareness ... more Americans every year than anything else, yet risk factors associated with heart ...
Breaking Medicine News(10 mins):