Degenerative mitral regurgitation occurs when the mitral valve prolapses, causing blood to leak back into the atrium every time the heart beats. The condition can be asymptomatic for many people, but for some it can cause a variety of issues, including fainting, pain, and shortness of breath.
Currently, open-heart surgery is considered to be the gold-standard treatment for degenerative mitral regurgitation, but the procedure is obviously highly invasive. The HARPOON system developed by Edwards Lifesciences aims to provide mitral valve repair through a small chest incision, with the procedure occuring while the heart is still beating.
The system is currently being tested for efficacy and safety in the RESTORE trial, and the company recently announced that the first patient in the trial has been treated using the system. Medgadget had the opportunity to speak with Daveen Chopra, Corporate Vice President, Surgical Structural Heart at Edwards Lifesciences, about the HARPOON system and the RESTORE trial.
See a video about the technology below:
Conn Hastings, Medgadget: Please give us an overview of degenerative mitral regurgitation.
Daveen Chopra, Edwards Lifesciences: Degenerative mitral valve regurgitation 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.
Medgadget: How is the condition currently treated?
Daveen Chopra: 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.
Medgadget: Please give us an overview of the HARPOON system, its advantages, and how it works.
Daveen Chopra: The HARPOON system is an investigational device in the US and CE Marked for Europe designed to repair the damaged mitral valve while the heart is beating. Unlike open-heart surgery, this minimally invasive procedure occurs through a small incision on the left side of the chest. This approach eliminates the need for a bypass machine to do the work of the heart and lungs while the heart is stopped for surgery. Using ultrasound technology called an echocardiogram (moving X-ray), the system replaces the leaflet’s chords, which allow the valve to open and close properly. The HARPOON system is designed for the surgeon to visualize the reduction of mitral regurgitation in real-time while the heart is beating under normal physiologic conditions.
Medgadget: Is it difficult to repair mitral valves using a minimally invasive approach? Does it require much training before a surgeon can use the HARPOON system?
Daveen Chopra: The difficulty of the repair varies by the actual case and patient. Like with any new treatment technology, training is important to ensure success of the procedure. We find that with some practice, surgeons quickly learn how to maneuver the HARPOON device. Since the procedure uses echocardiographic guidance, surgeons can see the result in real-time and ensure correct placement and tension of the chords before completing the procedure.
Medgadget: Please give us an overview of the ongoing RESTORE trial.
Daveen Chopra: The RESTORE trial will enroll up to 360 patients with severe degenerative mitral valve regurgitation who are at least 21 years of age and meet certain eligibility criteria based on their prior medical history, anatomy and disease progression. The trial will include up to 40 centers in the US and Canada and will take approximately two years to enroll. Once the trial is complete, we plan to submit the data to the FDA as part of the pre-market approval process.
Product info page: HARPOON system
Link: Edwards Lifesciences