St. John Hospital Treats First Patients as Part of National Non-Surgical Heart Valve Study
St. John Hospital & Medical Center: Detroit, St. John Providence Health System
Cardiac Care, Heart Care Network page
Tuesday, March 20, 2012
Contact: Brian Taylor, 586-753-0726.
St. John Hospital and Medical Center 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 40 hospitals in the United States. St. John Hospital will begin enrolling patients in the study this month. The first procedure is expected in late January.
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.
The procedures for the trial will be performed in St. John Hospital’s Gretchen C. Valade Hybrid Cardiovascular Operating Room. For more information about the trial, patients should call 855-988-2583.
St. John Hospital and Medical Center, 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.