Forum for Science, Industry and Business

Sponsored by:     3M 
Search our Site:

 

Percutaneous edge-to-edge mitral valve repair shows favorable preliminary results

08.11.2004


Cath lab procedure could replace major heart surgery in some patients



The Hospital of the University of Pennsylvania (HUP) is participating in a nationwide clinical trial of a new valve repair device that could replace major heart surgery in some patients. A tiny clip – delivered by a catheter and deployed in the heart to repair a malfunctioning and leaking mitral valve – is building a favorable safety and feasibility profile as the EVEREST Phase I clinical trial nears completion.

Severe mitral valve regurgitation (MR) is a debilitating condition that causes shortness of breath, fatigue and palpitations. In the United States, about 250,000 people develop significant MR each year, with almost 50,000 requiring surgery. The clip is designed to secure the valve’s leaflets near the center of the valve so that blood leakage is minimized and the heart pumps more efficiently. This new device could decrease a patient’s hospital stay, result in fewer complications, provide a quicker recovery time, and significantly reduce health care costs. "In my most recently treated patient, we utilized two clips to reduce his MR from severe to mild. It has been six months since his procedure, and he has no symptoms whatsoever," says Howard C. Herrmann, MD, Director of Interventional Cardiology & the Cardiac Catheterization Laboratory at Penn, and principal investigator for HUP’s component of the EVEREST Trial.


"The development and clinical evaluation of this device are paving the way for percutaneous, or through the skin, valve repair. We are at the beginning of an exciting new avenue in interventional cardiology. I have no doubt that in five or ten years, interventional cardiologists will be routinely treating valvular heart disease in many patients without cardiac surgery," adds Dr. Herrmann.

To date, a total of 24 patients who suffered from significant MR have received the clip as part of the EVEREST I clinical study under an FDA-approved investigational device exemption (IDE). The clip is a product of Evalve Inc., a medical device company, and the sponsor of the trial. Based on these promising results, a larger, Phase II safety and efficacy trial may be initiated later this year.

Dr. Herrmann presented an update of the trial’s findings today at the American Heart Association’s Scientific Sessions 2004 in New Orleans during a presentation entitled "Percutaneous Edge-to-Edge Mitral Valve Repair: Preliminary Results of the EVEREST- I Study." To be eligible for the investigational procedure, candidates must have moderate-to-severe or severe MR and be experiencing symptoms (fatigue, chest pain, shortness of breath); or, lacking these symptoms, they must have a weakened left ventricle (heart muscle).

Performed in the cardiac catheterization lab, the initial procedures have taken approximately two to four hours. Under full anesthesia, a catheter (a thin, flexible plastic tube) is introduced through the skin in the thigh area and guided through the femoral vein to the affected area of the heart. A smaller delivery catheter that holds the clip is slipped through this tube so that the clip can be guided into place and attached to the leaflets (the "swinging doors") of the mitral valve. Once the clip is attached, the delivery catheter is removed. The entire process is monitored by an echocardiogram. The hospital stay has generally been two nights; and most patients returned to normal activity within one week.

Other investigators contributing to this study are Ted Feldman, MD, Evanston Northwestern Healthcare System; Hal Wasserman, MD, Columbia University Medical Center; William Gray, MD, Swedish Medical Center, Seattle; Peter Block, MD, Emory University Hospital and Patrick Whitlow, MD, The Cleveland Clinic Foundation.

Ed Federico | EurekAlert!
Further information:
http://www.uphs.upenn.edu
http://www.evalveinc.com

More articles from Health and Medicine:

nachricht New antibody analysis accelerates rational vaccine design
09.08.2018 | Scripps Research Institute

nachricht Distrust of power influences choice of medical procedures
01.08.2018 | Johannes Gutenberg-Universität Mainz

All articles from Health and Medicine >>>

The most recent press releases about innovation >>>

Die letzten 5 Focus-News des innovations-reports im Überblick:

Im Focus: New interactive machine learning tool makes car designs more aerodynamic

Scientists develop first tool to use machine learning methods to compute flow around interactively designable 3D objects. Tool will be presented at this year’s prestigious SIGGRAPH conference.

When engineers or designers want to test the aerodynamic properties of the newly designed shape of a car, airplane, or other object, they would normally model...

Im Focus: Robots as 'pump attendants': TU Graz develops robot-controlled rapid charging system for e-vehicles

Researchers from TU Graz and their industry partners have unveiled a world first: the prototype of a robot-controlled, high-speed combined charging system (CCS) for electric vehicles that enables series charging of cars in various parking positions.

Global demand for electric vehicles is forecast to rise sharply: by 2025, the number of new vehicle registrations is expected to reach 25 million per year....

Im Focus: The “TRiC” to folding actin

Proteins must be folded correctly to fulfill their molecular functions in cells. Molecular assistants called chaperones help proteins exploit their inbuilt folding potential and reach the correct three-dimensional structure. Researchers at the Max Planck Institute of Biochemistry (MPIB) have demonstrated that actin, the most abundant protein in higher developed cells, does not have the inbuilt potential to fold and instead requires special assistance to fold into its active state. The chaperone TRiC uses a previously undescribed mechanism to perform actin folding. The study was recently published in the journal Cell.

Actin is the most abundant protein in highly developed cells and has diverse functions in processes like cell stabilization, cell division and muscle...

Im Focus: Lining up surprising behaviors of superconductor with one of the world's strongest magnets

Scientists have discovered that the electrical resistance of a copper-oxide compound depends on the magnetic field in a very unusual way -- a finding that could help direct the search for materials that can perfectly conduct electricity at room temperatur

What happens when really powerful magnets--capable of producing magnetic fields nearly two million times stronger than Earth's--are applied to materials that...

Im Focus: World record: Fastest 3-D tomographic images at BESSY II

The quality of materials often depends on the manufacturing process. In casting and welding, for example, the rate at which melts solidify and the resulting microstructure of the alloy is important. With metallic foams as well, it depends on exactly how the foaming process takes place. To understand these processes fully requires fast sensing capability. The fastest 3D tomographic images to date have now been achieved at the BESSY II X-ray source operated by the Helmholtz-Zentrum Berlin.

Dr. Francisco Garcia-Moreno and his team have designed a turntable that rotates ultra-stably about its axis at a constant rotational speed. This really depends...

All Focus news of the innovation-report >>>

Anzeige

Anzeige

VideoLinks
Industry & Economy
Event News

Within reach of the Universe

08.08.2018 | Event News

A journey through the history of microscopy – new exhibition opens at the MDC

27.07.2018 | Event News

2018 Work Research Conference

25.07.2018 | Event News

 
Latest News

'Building up' stretchable electronics to be as multipurpose as your smartphone

14.08.2018 | Information Technology

During HIV infection, antibody can block B cells from fighting pathogens

14.08.2018 | Life Sciences

First study on physical properties of giant cancer cells may inform new treatments

14.08.2018 | Life Sciences

VideoLinks
Science & Research
Overview of more VideoLinks >>>