According to the study, over the 20-year follow-up period, the Biocor valve was found to perform well on key measures of long-term performance including freedom from reoperation due to structural valve deterioration (the rate at which patients remain free from another operation related to degeneration that could affect the valve's proper functioning).
The study found that the Biocor valve's rate of freedom from reoperation for structural valve deterioration was 86.5 percent at 20 years compared to data reported for other tissue valves which have ranged from 52.9 to 67 percent (in 17 to 20 year follow-up studies).
"The excellent long-term durability found in the study confirms the results of other, earlier Biocor studies and shows that the Biocor valve has lower structural valve deterioration and reoperation rates than most other tissue valves that have been followed long-term," said the study's lead investigator, Walter Eichinger, M.D., of the German Heart Center in Munich, Germany.
The long-term performance of tissue heart valves is of growing importance as physicians seek solutions for younger patients with heart disease while seeking to avoid the need for re-operation. Physicians increasingly consider implanting tissue valves as studies demonstrate improved durability when compared to prior generation tissue valve designs.
While the excellent long-term performance of mechanical valves is well documented, patients who receive a mechanical valve must take anticoagulant (anti-clotting) medications for life. Patients who receive a tissue valve are typically not required to take anticoagulants as the risk of blood clots is less. Current European and U.S. clinical guidelines recommend tissue valves for patients 65 or older.
"Twenty-year studies such as this are of special importance in helping doctors advise patients concerning their individual risk after valve replacement," said Dr. Eichinger.
The Biocor valve study, which was sponsored by St. Jude Medical, consecutively enrolled 455 patients who received a St. Jude Medical Biocor tissue valve to replace their aortic valve at the German Heart Center Munich from Jan. 1985 through Dec. 1996. Follow-up occurred between 2003 and 2006. Following standardized follow-up methods, researchers received responses to a questionnaire or reviewed the medical records of 99.6 percent of the enrolled patients. The study population included equal numbers of patients younger and older than its mean age of 72.5 years.
"With this publication of Biocor valve 20-year data, physicians and their patients gain valuable information upon which to base critical heart valve choices," said Frank J. Callaghan, president of the St. Jude Medical Cardiovascular Division. "The data confirm that the Biocor valve provides industry-leading freedom from reoperation for structural valve deterioration. St. Jude Medical is committed to advancing tissue valve technology to further improve performance for patients and to simplify implant procedures for physicians."
St. Jude Medical is focused on helping physicians reduce risk by providing them with the tools and products they need to solve important clinical issues. To date, more than 145,000 St. Jude Medical stented porcine valves, including both the Biocor valve and Epic valve with Linx(TM) AC anticalcification treatment, have been implanted worldwide.
About St. Jude Medical
St. Jude Medical develops medical technology and services that focus on putting more control into the hands of those who treat cardiac, neurological and chronic pain patients worldwide. The company is dedicated to advancing the practice of medicine by reducing risk wherever possible and contributing to successful outcomes for every patient. Headquartered in St. Paul, Minn., St. Jude Medical employs more than 13,000 people worldwide and has five major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiac surgery, cardiology and neuromodulation. For more information, please visit www.sjm.com.
CONTACT: St. Jude Medical, Inc.
Angela Craig, 651-481-7789
Kathleen Janasz, 651-415-7042