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.
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.
NIST scientists discover how to switch liver cancer cell growth from 2-D to 3-D structures
17.11.2017 | National Institute of Standards and Technology (NIST)
High speed video recording precisely measures blood cell velocity
15.11.2017 | ITMO University
The formation of stars in distant galaxies is still largely unexplored. For the first time, astron-omers at the University of Geneva have now been able to closely observe a star system six billion light-years away. In doing so, they are confirming earlier simulations made by the University of Zurich. One special effect is made possible by the multiple reflections of images that run through the cosmos like a snake.
Today, astronomers have a pretty accurate idea of how stars were formed in the recent cosmic past. But do these laws also apply to older galaxies? For around a...
Just because someone is smart and well-motivated doesn't mean he or she can learn the visual skills needed to excel at tasks like matching fingerprints, interpreting medical X-rays, keeping track of aircraft on radar displays or forensic face matching.
That is the implication of a new study which shows for the first time that there is a broad range of differences in people's visual ability and that these...
Computer Tomography (CT) is a standard procedure in hospitals, but so far, the technology has not been suitable for imaging extremely small objects. In PNAS, a team from the Technical University of Munich (TUM) describes a Nano-CT device that creates three-dimensional x-ray images at resolutions up to 100 nanometers. The first test application: Together with colleagues from the University of Kassel and Helmholtz-Zentrum Geesthacht the researchers analyzed the locomotory system of a velvet worm.
During a CT analysis, the object under investigation is x-rayed and a detector measures the respective amount of radiation absorbed from various angles....
The quantum world is fragile; error correction codes are needed to protect the information stored in a quantum object from the deteriorating effects of noise. Quantum physicists in Innsbruck have developed a protocol to pass quantum information between differently encoded building blocks of a future quantum computer, such as processors and memories. Scientists may use this protocol in the future to build a data bus for quantum computers. The researchers have published their work in the journal Nature Communications.
Future quantum computers will be able to solve problems where conventional computers fail today. We are still far away from any large-scale implementation,...
Pillared graphene would transfer heat better if the theoretical material had a few asymmetric junctions that caused wrinkles, according to Rice University...
15.11.2017 | Event News
15.11.2017 | Event News
30.10.2017 | Event News
20.11.2017 | Earth Sciences
20.11.2017 | Earth Sciences
20.11.2017 | Life Sciences