Open-heart surgery is risky and can take patients months to recover from. Researchers at the University of Maryland Medical Center have developed a device that eliminates the need for such surgery for those suffering degenerative mitral regurgitation (MR). Not only does the device reduce time spent on the operating table, but it could eventually see patients heading home from hospital the day after a heart operation.
Degenerative mitral regurgitation is a common heart valve disorder that affects around eight million people in the US alone. It is caused by a leaky heart valve, in which the small cords that control the valve's flaps are broken or stretched and cause blood to flow in the wrong direction. To repair the valve, invasive open-heart surgery is carried out to replace the small cords in a procedure that requires surgical skill and experience.
The Harpoon TSD-5 device built by Harpoon Medical of Baltimore is based on technology developed by the University of Maryland Medical Center and makes the job easier for surgeons and safer and less intrusive for patients.
The device looks a spray attachment for a garden hose with a long needle on the end of it. It enters the heart through a small puncture in the patient's ribcage that's guided to the damaged flaps through echocardiographic imaging. The device can install artificial cord material through the damaged flap while the heart is still beating – so a heart-lung bypass machine isn't required – and tie a knot to keep the cord in place through an automated process. The cords can also be adjusted as the heart beats to achieve the optimum length.
In the first clinical study of the device, funded by Harpoon Medical, surgeons used the Harpoon TSD-5 to implant artificial cords in 11 patients in Poland. The team says three or four cords are required in most cases. All 11 patients showed a reduction in MR following their successful implants and remained stable for the next 30 days.
"We think this approach is applicable to probably three-quarters of patients with degenerative disease, which is the number one reason why people come to the operating room for surgery for mitral valve regurgitation," says James Gammie, a professor and chief of cardiac surgery at the University of Maryland School of Medicine who served as the principle investigator for the study. "We think this is a safer approach than open heart surgery. We think the safety profile is going to be better and, ultimately, people will be able to go home from the hospital the next day."
The results of the study were published in the journal Circulation.