Excellent Procedural Success with Subclavian Approach Using Medtronic’s CoreValve in Patients with Compromised Peripheral Vasculature.
Medtronic, Inc. announced new data presented today on the safety and effectiveness of Medtronic’s CoreValve system via a novel, subclavian approach. The data reported procedural success of 100 percent; 24-hour survival of 100 percent; and 30-day survival of 89 percent. The available 30-day analysis also demonstrated clinical improvement in heart failure symptoms with 76 percent of the patients gaining at least a one-stage NYHA class and one-third improving by at least two stages.
Medtronic’s market-leading CoreValve system was designed to allow the implant of a replacement heart valve in patients with aortic stenosis who are at high or prohibitive surgical risk. The system enables a catheter-based implant via a peripheral blood vessel, traditionally the femoral artery. A significant subset of patients, however, have compromised peripheral arteries, which prevents the use of the femoral approach. Uniquely, the delivery system of the CoreValve device is small enough to allow an alternative approach via the subclavian artery beneath the collar bone.
“The combination of unique valve design and controlled deliverability have contributed to the tremendous success of the Medtronic CoreValve system using the femoral approach,” said John Liddicoat M.D., vice president and general manager of the CardioVascular Structural Heart division at Medtronic. “These new data suggest that a subclavian artery approach could address yet another under-served patient population. We are committed to gather the necessary clinical experience and evidence to support the routine use of a subclavian approach in those for whom a femoral approach is not possible.”
The data presented today at the PCR interventional cardiology meeting in Barcelona reported on data from 74 patients for whom subclavian access was used within the CoreValve Extended Evaluation Registry, an observational study which closed in January 2009. The average age of the patients was 81.4. Moreover, the average Logistic EuroSCORE (a measure which predicts risk of procedural mortality based upon patient status) was notably high at 28.4%.