St. John Hospital Selected for National Study of Non-Surgical Heart Valve Replacement
SJH&MC has been selected to take part in a clinical trial to evaluate a non-surgical alternative to open-heart surgery for patients with severe aortic stenosis, a common heart problem caused by an abnormal narrowing of the heart’s aortic valve.
The trial will evaluate Medtronic’s CoreValve System, a minimally invasive option for patients with symptomatic, severe aortic stenosis who are at high risk, or are ineligible, for open heart surgery.
The non-surgical valve replacement procedure, known as transcatheter aortic valve implantation, is similar to a heart catheterization and balloon angioplasty. An artificial aortic heart valve attached to a wire frame is guided by catheter (thin, flexible tube) to the heart. Once in the proper position in the heart, the wire frame expands, allowing the new aortic valve to open, deploying the new valve inside the diseased aortic valve without open-heart surgery or surgical removal of the patient’s original valve.
About 100,000 Americans, most of them over the age of 70, are diagnosed with severe aortic stenosis each year, but one-third of patients, because of age or frail health, are considered too high-risk for traditional surgery.
When the aortic valve narrows it does not open or close properly, making the heart work harder to pump blood throughout the body. Eventually, this extra work weakens the heart and limits the amount of blood it can pump, which may lead to heart failure and increased risk for sudden cardiac death.
The clinical trial will involve more than 1,300 patients at up to 44 hospitals in the United States. St. John Hospital will begin enrolling patients in the study this month. New clinical data presented recently at the European Society of Cardiology Congress 2011 demonstrated positive long-term performance for the CoreValve System.
The study monitored patients through four years – the longest follow-up in a published study of any transcatheter aortic valve implantation system to date – and found the CoreValve System maintained its structural integrity and led to positive clinical outcomes.
SJH&MC, a member of St. John Providence Health and the St. John Providence Heart and Vascular Care Center of Excellence, is involved in heart and vascular research and treatment, and home to the W. Warren Shelden Heart and Circulatory Center.
Interested patients should call 855-98-VALVE to speak with a cardiology nurse practitioner.
Surgeries will be performed in the Gretchen C. Valade Hybrid Cardiovascular Operating Room, which has amazing graphic displays to help surgeons. To demonstrate the quality of graphics available in the OR, above is a photo of another surgery performed in the center.