Natural aortic valves are subject to a great deal of physical stress. After decades, they can become stenosed or incompetent, but the prostheses that replace them end up being subjected to the same forces. Artificial valves have lifetimes as well, but by the time they fail the patients are older and more fragile, which means highly invasive procedures to replace the valves are not an option often anymore.
Medtronic just received European regulatory approval to begin offering its CoreValve transcatheter aortic valve replacement (TAVR) system as a correction over failing bioprosthetic valves in patients that would otherwise not be eligible for surgery.
Some details from Medtronic about the study that led to the clearance:
Results from the largest global VIV registry, published in Circulation in November (Transcatheter Aortic Valve Replacement for Degenerative Bioprosthetic Surgical Valves: Results from the Global Valve-in-Valve Registry), showed the VIV approach resulted in considerable hemodynamic (blood flow) improvements, including a decrease in valve gradients (blood flow resistance). Positive procedural outcomes were maintained at 1-year follow-up (with 89 percent survival at one year), which was comparable with other non-VIV TAVI studies.
The Global VIV registry evaluated the safety and efficacy of the VIV approach in 202 patients at 38 sites in Europe, North America, Australia, New Zealand and the Middle East,1 with 124 patients receiving the CoreValve System. In the study, the CoreValve System demonstrated superior hemodynamic outcomes and high procedural success rates (96.8 percent).
The valve-in-valve procedure, in which the CoreValve System is placed inside the degenerated surgical aortic valve through a low-profile, 18Fr delivery catheter, is approved for use with all four CoreValve sizes (23mm, 26mm, 29mm and 31mm), as well as three delivery approaches (transfemoral, subclavian and direct aortic access).
Flashbacks: CoreValve Evolut 23mm Transcatheter Aortic Valve Green Lighted in Europe; Medtronic Receives CE Marking for its 31mm CoreValve Percutaneous Aortic Valve; Subclavian Approach Proves Successful in Implanting Medtronic’s CoreValve System; Subclavian Approach for CoreValve Transcatheter Aortic Replacement Gets European OK; Medtronic’s CoreValve Clinical Trial Receives FDA Approval; Medtronic’s CoreValve Transcatheter Aortic Valve Replacement System Performs Well in Trial