Josephine Herndon, 77, of Rochester Hills was the first patient at Beaumont Hospital, Royal Oak, to receive the MitraClip system, a device under FDA-review that repairs the mitral valve of the heart without open-heart surgery. 

Herndon, participating in a study to evaluate the effectiveness of the MitraClip, underwent the procedure April 30 and was released from the hospital less than 48 hours later.  At her 30-day follow-up visit she reported a significant improvement in her symptoms of fatigue and shortness of breath. 

“I’ve been feeling much, much better,” Herndon said from her home.  “I still have a little trouble breathing.  But I’m doing my own housework now.  I’m really happy I did it.”

Herndon suffers from mitral valve regurgitation, a condition that an estimated 4 million Americans share.  Approximately 250,000 people are newly diagnosed with the condition each year. In these patients, the leaflets or flaps of the mitral valve (the valve separating the left atrium and left ventricle) do not close properly. Blood then leaks backward through the valve with each heartbeat, causing the heart to work harder to circulate blood.

“Mitral valve regurgitation is a pretty common type of heart disease that we have treated until now with open heart surgery,” said Dr. George Hanzel, Beaumont’s director of valvular and congenital heart disease and principal investigator for the study.  “We’re always trying to find ways to treat patients less invasively.”

MitraClip insertion is a nonsurgical procedure that takes approximately two hours to perform. During the procedure, a catheter is inserted through the patient’s skin in the groin area and is guided through the femoral vein to the affected area of the heart. The clip is then guided into place and attached to the leaflets of the mitral valve. Once the clip is properly placed and securely attached, it is deployed and the catheter removed. The entire process is monitored with echocardiography.

“The results of the first patient are very encouraging,” said Dr. Hanzel.  “This device could potentially be an alternative treatment for some patients with mitral valve regurgitation.” 

According to Dr. Hanzel, recovery time with the MitraClip is significantly less than with open-heart surgery.  With the clip, patients are back to regular activity within 5 to 7 days, versus 6 weeks with open-heart surgery.

“The big question is durability,” said Dr. Hanzel, “how it will hold up five to 10 years from now compared to open-heart surgery.”

Beaumont is one of about 40 centers in North America evaluating the safety and effectiveness of the MitraClip procedure. The system is made by Evalve Inc. of Menlo Park, Calif. Participants in the study are randomized to receive the catheter-based repair with the MitraClip device or traditional open-heart valve repair or replacement.

Final results from the study will be available this fall or winter.

Approved for use already in Europe, Dr. Hanzel said the MitraClip could be available to the general U.S. population possibly within two years, if deemed safe and effective.

Beaumont is Michigan’s, and one of the nation’s, most experienced providers of heart care, ranking 12th on the U.S. News & World Report 2007 list of the “Top 50” hospitals for heart and heart surgery.  For more information visit Beaumont’s Cardiology page on the Web at www.beaumonthospitals.com/cardiology.