25-Year Study of Mechanical Heart Valve

A 25-year study of patients with implanted aortic or mitral mechanical heart valves has revealed low complication rates, according to a study published in the March 2005 issue of the Annals of Thoracic Surgery.

The study analyzed 4,480 patients from October 1977 to October 2002, who were implanted with mechanical heart valves from St. Jude Medical (St. Paul, MN, USA). The objective was to document patient survival and valve-related events or complications during the 25-year period. An independent database was created to study these patients. To ensure accuracy, clinical study documents from prior studies were crosschecked with the new data. These efforts resulted in 95% complete follow-up covering 32,190 patient years.

"In summary, this extensive experience demonstrates excellent function of the SJM valve in the mitral or aortic position. Valve-related events were low, most commonly caused by patient-related factors as opposed to the presence of a prosthetic valve. Valve-related mortality was low, and there have been no re-operations as a result of valve wear. The SJM valve can be recommended to patients as a prosthesis that will last their lifetime.”

St. Jude Medical has been a leading producer of mechanical heart valves since the company's founding in 1976. In November 2004, the company announced its 1.5 millionth mechanical valve implant in Iwate, Japan. "We are committed to continued advancements in our mechanical heart valve franchise, while we also broaden our portfolio of therapies and technologies to enhance surgeons' clinical practice and their patients' care,” remarked George J. Fazio, president of St. Jude Medical's Cardiac Surgery Division.