Test Of Slogan That Reshapes Enlarged, Leaky Love Valve Shows Intriguing Early Results
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An innovative device that acts commensurate a sash to reshape an enlarged, leaky heart valve is providing a minimally invasive treatment option for patients who are as well sick for open-heart surgery. According to a Late-Breaking Clinical Evaluation presented at the Society for Cardiovascular Angiography and Interventions (SCAI) 32nd Annual Scientific Sessions, the CARILLON Mitral Edge Method safely treated leaky mitral valves yet 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) glance at besides showed that after treatment, patients experienced less shortness of breath and reported a better aspect of life.
"This system is an dangerous new preference for patients and represents a expressive improvement over medical management, the now criterion 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 bona fide light and can be performed in under an hour. This is exigent for these patients, who are generally very sick."
The AMADEUS discover 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 emotions muscle. As the feelings 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 completion is shortness of breath, exceptionally during physical activity.
To implant the CARILLON Mitral Contour System, the interventional cardiologist punctures the jugular vein in the neck and threads a miniature tube, or catheter, into the coronary sinus and then the bulky cardiac vein, a affection vein that passes near the mitral valve. The CARILLON device consists of two anchors connected by a shaping ribbon, fictional 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 put in grouping to restore the natural shape of the mitral valve and bring the valve flaps together. The moment 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 scan involved 48 patients with moderate-to-severe functional mitral regurgitation, an enlarged heart, reduced cardiac pumping ability, heart failure, and limited manipulate capacity. Researchers were able to implant the CARILLON device in 30 patients. In this group, echocardiography confirmed the improvement in mitral valve work after both 1 and 6 months. For example, the customary manual 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<0.001). Similarly, the sample size of the leaky opening between the mitral valve flaps was reduced from 0.25 cm2 before the procedure to 0.17 cm2 after 1 and 6 months (p<0.001).
In the 18 patients who could not be treated with the CARILLON device, the heart's veins were very 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 imaginable 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, on the contrary all of the blood vessels healed on their own. In three patients, abnormal lab tests hinted that the heart muscle might hold been injured, however further controversy showed no problems.
"These are besides intriguing clinical results that, I hope, will create enthusiasm among interventional cardiologists," Dr. Siminiak said. "This step might become a appropriate breakthrough for a broad battery of patients who really have had no other treatment option."
Dr. Siminiak is continuing to follow-up patients to cinch if the improvements in mitral valve function are long-lasting.
With these results, AMADEUS has demonstrated the safety of this coronary sinus nearing and provided early feasibility facts on the efficacy of the device in reducing functional mitral regurgitation and improving patient servicing and genius of life. Researchers have begun discussions with the FDA concerning investigational device exemption status for the CARILLON Mitral Borderline System. Whether approved, this would enable a pivotal randomized clinical proof to be launched later this year. The Carillon Mitral Contour Process was recently granted CE Point approval, which allows the device to be sold in Europe.
The AMADEUS interpret was funded by Cardiac Dimensions, the manufacturer of the CARILLON Mitral Border System. Dr. Siminiak was reimbursed for the costs of the announce nevertheless receives no other financial foothold from the company.
Kathy Boyd David
Community for Cardiovascular Angiography and Interventions
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