Medtronic’s CE mark approved CoreValve System, delivered via subclavian access, achieved excellent procedural success rates and low in-hospital complication rates, according to a multi-center study.
Medtronic said CoreValve is designed to provide a non-surgical valve replacement option for patients with severe aortic stenosis who are at high or prohibitive risk for open-heart surgery.
The new approach is used primarily for people whose femoral arteries are too narrow or are compromised due to disease.
The multi-center study evaluated 132 consecutive subclavian patients in Italy and found positive patient outcomes, despite patients in the subclavian group being sicker than patients in the femoral access group (based on EuroSCORE and rates of peripheral artery disease, coronary artery disease, prior stroke and prior heart attacks).
Azienda Ospedaliero-Universitaria Pisana head and Cardiology associate professor Sonia Petronio said the subclavian approach is a feasible and safe option for transcatheter aortic-valve implantation (TAVI), providing excellent procedural success and low in-hospital complication rates.
"In our opinion, this approach should be considered a valid alternative not only in patients with the impossibility of a femoral approach, but also in patients with a difficult femoral approach with high risk of vascular complications," Petronio said.
The Medtronic CoreValve System is currently limited to investigational use in the US, and the subclavian approach is being evaluated in the Medtronic CoreValve US Pivotal Trial.