Forum for Science, Industry and Business

Sponsored by:     3M 
Search our Site:

 

Intriguing early results for device that reshapes enlarged, leaky heart valve

11.05.2009
A fast, simple treatment option for patients too sick for surgery?

An innovative device that acts like a belt to reshape an enlarged, leaky heart valve is providing a minimally invasive treatment option for patients who are too sick for open-heart surgery.

According to a Late-Breaking Clinical Trial presented today at the Society for Cardiovascular Angiography and Interventions (SCAI) 32nd Annual Scientific Sessions, the CARILLON Mitral Contour System safely treated leaky mitral valves even in patients with moderate-to-severe heart failure, and was effective in reducing the backward flow of blood from the left ventricle to the left atrium.

The CARILLON Mitral Annuloplasty Device European Union Study (AMADEUS) study also showed that after treatment, patients experienced less shortness of breath and reported a better quality of life.

"This system is an exciting new option for patients and represents a significant improvement over medical management, the current standard of care," said Tomasz Siminiak, MD, PhD, a professor of cardiology at Poznan University of Medical Sciences, Cardiac and Rehabilitation Hospital Kowanowko, Kowanowko, Poland. "The CARILLON procedure is very simple and can be performed in under an hour. This is important for these patients, who are generally very sick."

The AMADEUS study focused on patients with functional mitral regurgitation. This type of leaky valve develops when the heart becomes abnormally enlarged after a heart attack or some other illness that damages the heart muscle. As the heart gets bigger, the valve opening stretches and the valve flaps, or leaflets, no longer come together to form a tight seal. As a result, when the heart contracts, some of the blood in the left ventricle is propelled backward through the leaky valve into the left atrium, instead of being circulated to the rest of the body. The result is shortness of breath, especially during physical activity.

To implant the CARILLON Mitral Contour System, the interventional cardiologist punctures the jugular vein in the neck and threads a slender tube, or catheter, into the coronary sinus and then the great cardiac vein, a heart vein that passes near the mitral valve. The CARILLON device consists of two anchors connected by a shaping ribbon, made of nitinol, which conforms to the natural contours of the veins.

The device is passed through the catheter and into the great cardiac vein. One of the anchors is locked in place in order to restore the natural shape of the mitral valve and bring the valve flaps together. The second anchor is then locked in place. Imaging studies are used to confirm that the leaky valve is closing properly, and the implant is released. If the results are not satisfactory, the interventional cardiologist can recapture the system.

The AMADEUS study was primarily designed to test the feasibility and safety of the CARILLON system for the repair of leaky mitral valves. The study involved 48 patients with moderate-to-severe functional mitral regurgitation, an enlarged heart, reduced cardiac pumping ability, heart failure, and limited exercise capacity. Researchers were able to implant the CARILLON device in 30 patients. In this group, echocardiography confirmed the improvement in mitral valve function after both 1 and 6 months. For example, the average volume of blood propelled backward through the mitral valve fell from 35 mL before the procedure to 23 mL after 1 month and 24 mL after 6 months (p

In the 18 patients who could not be treated with the CARILLON device, the heart's veins were too small, the device did not adequately reduce the backflow of blood through the mitral valve, or the device pressed on nearby coronary arteries and reduced blood flow to the heart muscle. However, when the coronary arteries are squeezed in this way, it is possible to successfully reposition the device almost half of the time, Dr. Siminiak said.

One patient died as a result of kidney failure, which was related to toxicity from the contrast dye used during interventional procedures. Three patients suffered an access-related puncture of the cardiac vein, but all of the blood vessels healed on their own. In three patients, abnormal lab tests hinted that the heart muscle might have been injured, but further investigation showed no problems.

"These are very intriguing clinical results that, I hope, will create enthusiasm among interventional cardiologists," Dr. Siminiak said. "This system might become a true breakthrough for a large group of patients who really have had no other treatment option."

Dr. Siminiak is continuing to follow-up patients to determine whether the improvements in mitral valve function are long-lasting.

With these results, AMADEUS has demonstrated the safety of this coronary sinus approach and provided early feasibility data on the efficacy of the device in reducing functional mitral regurgitation and improving patient function and quality of life. Researchers have begun discussions with the FDA concerning investigational device exemption status for the CARILLON Mitral Contour System. If approved, this would enable a pivotal randomized clinical trial to be launched later this year. The Carillon Mitral Contour System was recently granted CE Mark approval, which allows the device to be sold in Europe.

The AMADEUS study was funded by Cardiac Dimensions, the manufacturer of the CARILLON Mitral Contour System. Dr. Siminiak was reimbursed for the costs of the study but receives no other financial support from the company.

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 more than 60 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.

Kathy Boyd David | EurekAlert!
Further information:
http://www.scai.org
http://www.seconds-count.org

More articles from Health and Medicine:

nachricht TSRI researchers develop new method to 'fingerprint' HIV
29.03.2017 | Scripps Research Institute

nachricht Periodic ventilation keeps more pollen out than tilted-open windows
29.03.2017 | Technische 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: A Challenging European Research Project to Develop New Tiny Microscopes

The Institute of Semiconductor Technology and the Institute of Physical and Theoretical Chemistry, both members of the Laboratory for Emerging Nanometrology (LENA), at Technische Universität Braunschweig are partners in a new European research project entitled ChipScope, which aims to develop a completely new and extremely small optical microscope capable of observing the interior of living cells in real time. A consortium of 7 partners from 5 countries will tackle this issue with very ambitious objectives during a four-year research program.

To demonstrate the usefulness of this new scientific tool, at the end of the project the developed chip-sized microscope will be used to observe in real-time...

Im Focus: Giant Magnetic Fields in the Universe

Astronomers from Bonn and Tautenburg in Thuringia (Germany) used the 100-m radio telescope at Effelsberg to observe several galaxy clusters. At the edges of these large accumulations of dark matter, stellar systems (galaxies), hot gas, and charged particles, they found magnetic fields that are exceptionally ordered over distances of many million light years. This makes them the most extended magnetic fields in the universe known so far.

The results will be published on March 22 in the journal „Astronomy & Astrophysics“.

Galaxy clusters are the largest gravitationally bound structures in the universe. With a typical extent of about 10 million light years, i.e. 100 times the...

Im Focus: Tracing down linear ubiquitination

Researchers at the Goethe University Frankfurt, together with partners from the University of Tübingen in Germany and Queen Mary University as well as Francis Crick Institute from London (UK) have developed a novel technology to decipher the secret ubiquitin code.

Ubiquitin is a small protein that can be linked to other cellular proteins, thereby controlling and modulating their functions. The attachment occurs in many...

Im Focus: Perovskite edges can be tuned for optoelectronic performance

Layered 2D material improves efficiency for solar cells and LEDs

In the eternal search for next generation high-efficiency solar cells and LEDs, scientists at Los Alamos National Laboratory and their partners are creating...

Im Focus: Polymer-coated silicon nanosheets as alternative to graphene: A perfect team for nanoelectronics

Silicon nanosheets are thin, two-dimensional layers with exceptional optoelectronic properties very similar to those of graphene. Albeit, the nanosheets are less stable. Now researchers at the Technical University of Munich (TUM) have, for the first time ever, produced a composite material combining silicon nanosheets and a polymer that is both UV-resistant and easy to process. This brings the scientists a significant step closer to industrial applications like flexible displays and photosensors.

Silicon nanosheets are thin, two-dimensional layers with exceptional optoelectronic properties very similar to those of graphene. Albeit, the nanosheets are...

All Focus news of the innovation-report >>>

Anzeige

Anzeige

Event News

International Land Use Symposium ILUS 2017: Call for Abstracts and Registration open

20.03.2017 | Event News

CONNECT 2017: International congress on connective tissue

14.03.2017 | Event News

ICTM Conference: Turbine Construction between Big Data and Additive Manufacturing

07.03.2017 | Event News

 
Latest News

Researchers shoot for success with simulations of laser pulse-material interactions

29.03.2017 | Materials Sciences

Igniting a solar flare in the corona with lower-atmosphere kindling

29.03.2017 | Physics and Astronomy

As sea level rises, much of Honolulu and Waikiki vulnerable to groundwater inundation

29.03.2017 | Earth Sciences

VideoLinks
B2B-VideoLinks
More VideoLinks >>>