Edwards Lifesciences has announced that the first patient has been treated in the RESTORE clinical trial, which will evaluate the safety and effectiveness of the investigational Harpoon Beating Heart Mitral Valve Repair System in the USA and Canada. The Harpoon system is used to treat severe degenerative mitral valve regurgitation. The procedure took place at the University of Maryland Medical Center, Baltimore, USA.
Degenerative Mitral Valve Regurgitation (MR)
Degenerative mitral valve regurgitation (MR) is a type of heart disease. It’s commonly caused by mitral valve prolapse, a condition in which the valve’s two flap-like leaflets and supporting string-like structures (chords) attached to the leaflet edges are too stretchy and may even break.
When the heart contracts, one of the leaflets may bulge (prolapse) backward into the heart’s left atrium and prevent the mitral valve from closing correctly. This causes regurgitation, which occurs when blood leaks backward into the left atrium with each heartbeat.
The patient may experience chest pain, fatigue, shortness of breath, lightheadedness or fainting, though the majority of patients do not experience any symptoms at all.
The treatment depends on how far the disease has progressed. Open-heart surgery to repair the valve is the most common and the gold standard, though there are also less invasive options for those too sick to have surgery.
“Symptomatic patients with severe degenerative mitral valve regurgitation can experience limitations in their day-to-day life ranging from reduced physical activity to more serious complications,” said Vinod Thourani, national principal investigator of the RESTORE trial and Marcus Chief of Cardiovascular Surgery for Piedmont Healthcare. “Utilising less invasive approaches, we can potentially reduce the need for traditional open-heart surgery and the hardships associated with a patient’s healing and recovery process.”
The Harpoon system, which was developed by researchers at the University of Maryland Heart and Vascular Center, requires only a small incision to repair the mitral valve.
The procedure is conducted while the heart is still beating, eliminating the need for a heart bypass machine to do the work of the heart and lungs while the heart is stopped for surgery.
The RESTORE clinical trial is an investigational device exempt study that will enrol and follow up to 360 patients who need mitral valve repair surgery due to severe degenerative mitral valve regurgitation.
Degenerative mitral valve regurgitation is commonly caused by mitral valve prolapse, which prevents the valve from closing properly and causes blood to leak backwards as the heart contracts. The condition is associated with cardiovascular issues such as chest pain, shortness of breath and fatigue. In the most serious cases, it can lead to heart failure.
Harpoon Device Details
The Harpoon Mitral Valve Repair System (H-MVRS) is designed to treat degenerative mitral regurgitation (MR), the most common type of heart valve disorder. In mitral regurgitation (MR), a leaky valve lets blood travel in the wrong direction on the left side of the heart, causing shortness of breath, fluid retention, irregular heartbeats and fatigue.
Mitral regurgitation (MR) develops when the small fibrous cords that open and close the valve’s flaps, known as leaflets, are broken or stretched, preventing them from closing tightly and causing the leaflets to bulge or prolapse upward toward the left atrium.
The natural cords connect the valve flaps to muscles inside the heart that contract to close the mitral valve, which gets its name because its two flaps resemble a bishop’s mitre.
The device anchors artificial cords on the flaps to take the place of the natural cords. The artificial cords are made of expanded polytetrafluoroethylene (ePTFE), a polymer commonly used as sutures in cardiac surgery.
Surgeons insert the device into the beating heart through a tiny opening in the ribcage and, using echocardiographic imaging, guide it to the surface of the defective mitral flaps.
When the surgeon determines the optimal placement for an artificial cord, the device is actuated and a specially designed needle makes a tiny hole and sends the cord material through the flap. The needle is then withdrawn and the cord of ePTFE is tightened to form a double-helical knot to hold it in place.
The sequence is repeated for the desired number of knots (usually four to six). The other end of the cord is adjusted for optimum length and tied to the outside layer of the heart, the epicardium.