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 Organ-on-a-chip mimics heart's biomechanical properties
23.02.2017 | Vanderbilt University

nachricht Researchers identify cause of hereditary skeletal muscle disorder
22.02.2017 | Klinikum der Universität München

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: Breakthrough with a chain of gold atoms

In the field of nanoscience, an international team of physicists with participants from Konstanz has achieved a breakthrough in understanding heat transport

In the field of nanoscience, an international team of physicists with participants from Konstanz has achieved a breakthrough in understanding heat transport

Im Focus: DNA repair: a new letter in the cell alphabet

Results reveal how discoveries may be hidden in scientific “blind spots”

Cells need to repair damaged DNA in our genes to prevent the development of cancer and other diseases. Our cells therefore activate and send “repair-proteins”...

Im Focus: Dresdner scientists print tomorrow’s world

The Fraunhofer IWS Dresden and Technische Universität Dresden inaugurated their jointly operated Center for Additive Manufacturing Dresden (AMCD) with a festive ceremony on February 7, 2017. Scientists from various disciplines perform research on materials, additive manufacturing processes and innovative technologies, which build up components in a layer by layer process. This technology opens up new horizons for component design and combinations of functions. For example during fabrication, electrical conductors and sensors are already able to be additively manufactured into components. They provide information about stress conditions of a product during operation.

The 3D-printing technology, or additive manufacturing as it is often called, has long made the step out of scientific research laboratories into industrial...

Im Focus: Mimicking nature's cellular architectures via 3-D printing

Research offers new level of control over the structure of 3-D printed materials

Nature does amazing things with limited design materials. Grass, for example, can support its own weight, resist strong wind loads, and recover after being...

Im Focus: Three Magnetic States for Each Hole

Nanometer-scale magnetic perforated grids could create new possibilities for computing. Together with international colleagues, scientists from the Helmholtz Zentrum Dresden-Rossendorf (HZDR) have shown how a cobalt grid can be reliably programmed at room temperature. In addition they discovered that for every hole ("antidot") three magnetic states can be configured. The results have been published in the journal "Scientific Reports".

Physicist Dr. Rantej Bali from the HZDR, together with scientists from Singapore and Australia, designed a special grid structure in a thin layer of cobalt in...

All Focus news of the innovation-report >>>

Anzeige

Anzeige

Event News

Booth and panel discussion – The Lindau Nobel Laureate Meetings at the AAAS 2017 Annual Meeting

13.02.2017 | Event News

Complex Loading versus Hidden Reserves

10.02.2017 | Event News

International Conference on Crystal Growth in Freiburg

09.02.2017 | Event News

 
Latest News

From rocks in Colorado, evidence of a 'chaotic solar system'

23.02.2017 | Physics and Astronomy

'Quartz' crystals at the Earth's core power its magnetic field

23.02.2017 | Earth Sciences

Antimicrobial substances identified in Komodo dragon blood

23.02.2017 | Life Sciences

VideoLinks
B2B-VideoLinks
More VideoLinks >>>