New clinical trial to test promising U-M heart valve reconstruction operation for patients with serious heart failure

Heart failure patients once thought too sick for most surgery - and facing an 80 percent chance of dying within a year if they don't receive a heart transplant - may now have a chance to have their ailing hearts repaired, in the first clinical trial of a promising surgical procedure developed at the University of Michigan Health System.

The surgery repairs the valve that controls the flow of blood between two of the damaged heart's chambers. Its pioneer, Steven F. Bolling, M.D., professor in the Cardiac Surgery Section of the U-M Surgery Department, and his colleagues have reported dramatic survival improvements in 118 pilot patients operated on during the past four years.

Over 80 percent survived the first year, and 70 percent were still alive after two years, compared with a 20 percent one-year survival for similar patients on medication alone.

Called mitral valve reconstruction, the operation is similar to a kind of surgery that is routinely performed on heart patients with less serious conditions. But for patients with the two most severe forms of heart failure - an estimated 30 percent of the 4.6 million Americans with all forms of heart failure - the surgery may make a heart transplant unnecessary.

The only other surgical option for such patients, which removes a portion of the heart muscle, results in the operating-room deaths of 60 percent of patients who undergo it. Only one heart failure patient at U-M has died during the mitral valve reconstruction procedure. Initial results have been published in The Journal of Thoracic and Cardiovascular Surgery and presented at the American Heart Association's annual meeting.

Surgeons at U-M and nationwide will now test the surgery combined with conventional medical treatment against medical treatment alone in a multi-center trial named PREMIUM, short for Prospective Randomized Evaluation of Mitral Intervention started at the University of Michigan.

The study is supported by Baxter Healt

Contact: Kara Gavin
University of Michigan

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