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New device provides alternative for open-heart surgery

Assoc. Pediatrics Prof. Scott Lim develops MitraClip, FDA approves non-invasive procedure

Assoc. Pediatrics Prof. Scott Lim and his research team at the Medical School have developed an innovative heart device — the MitraClip — which can be used to plug a leaking mitral valve in the heart without requiring invasive, open-heart surgery. The Food and Drug Administration approved the system for use last month.

With each heartbeat, the mitral valve of a human heart passes oxygenated blood from the left atrium downwards into the left ventricle. Two leaflets, or cusps, guard the valve and prevent blood from refluxing back into the atrium during a heartbeat. Sometimes, however, the leaflets of the valve don’t attach, causing blood to regurgitate upwards through the valve — this is the issue the MitraClip aims to correct.

“Often, the mitral valve leaflets are unattached at birth, and the issue of blood sloshing back and forth between the atrium and ventricle becomes acute as the person reaches adulthood and old age,” Lim said.

A leaking mitral valve poses serious health consequences. In the short term, a person can experience shortness of breath and fatigue. Long term, patients can experience heart failure.

“When blood is leaking back and forth, the heart is inefficient as it is not able to pump the normal volume of blood, therefore, the heart dilates and swells as it is forced to work harder and compensate for the blood lost through leaking, which may result in heart failure and ultimately death if the problem is not corrected,” Lim said.

Open-heart surgery is the traditional method used to seal the leak, but this procedure involves long recovery times and numerous other risks inherent with exposing the heart. With the MitraClip, the heart is never exposed — the device is attached to a catheter that is inserted into the femoral artery in the thigh. The catheter is then guided into the mitral valve of the heart and ultrasound technology is used to precisely place the clip over the leakage.

“Once the surgeon is satisfied with the placement of the clip, he or she simply detaches the catheter, and the clip is left to plug the leaky valve,” Lim said.

The MitraClip was designed last March, after which it went through a rigorous FDA approval process. Though open-heart surgery proved slightly better at fixing mitral leaks, Lim said this is likely only because the former procedure has existed since the mid-20th century, which has allowed surgeons to perfect the technique. But Lim’s recent study showed that in patients who would be unable to withstand open-heart surgery, such as the elderly, the MitraClip was a viable alternative.

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