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FDA Approvals Expand Access to TAVR for Inoperable, High-Risk Patients
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The FDA has approved the second-generation Sapien XT transcatheter valve for the treatment of high-risk and inoperable patients with severe aortic stenosis and has also expanded the indication of the CoreValve for the treatment of high-risk patients.
The Sapien XT valve (Edwards Lifesciences) features a lower-profile system compared with the first-generation Sapien valve, which has been available in the United States for both high-risk and inoperable patients since October 2012. The new valve also includes a 29-mm valve size for patients with a large native annulus, allowing for the treatment of more patients.
In addition to the XT valve, the NovaFlex+ transfemoral delivery system with a low-profile 16F expandable sheath (eSheath) and the Ascendra+ transapical and transaortic delivery systems will also be immediately available for patients at leading CV centers in the country, according to a press release.
For the CoreValve (Medtronic), the FDA approval of the expanded indication applies to its entire platform, including the 23-mm, 26-mm, 29-mm and 31-mm valve sizes, which can all be delivered through its 18F delivery system. The self-expanding frame provides controlled deployment, which permits the accurate placement of the valve inside a patient’s original valve, while conforming the implant to the native annulus.
Perspective
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Faisal G. Bakaeen, MD
The news about the expansion of the CoreValve label to treat high-risk surgical patients and the approval of the Sapien XT valve is certainly welcome by US physicians. Now, there are more options available to treat patients with severe aortic stenosis who are at significant risk for traditional surgical aortic valve replacement. In addition, the vascular complication rates are likely to decrease and there will be a wider use of total percutaneous transfemoral approaches with the XT generation compared with the original Sapien model.
In general, what we are witnessing now is one of many steps toward having TAVR technology amenable to a wider pool of patients with different aortic annular and vascular access dimensions and anatomies. Future steps will be defined by lower profile delivery systems and smarter valves that will improve outcomes and reduce complications, including paravalvular leaks.
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