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FDA Decision Expands Access to Sapien Valve
Utilizing registry data in its decision-making, the FDA has removed references to specific access points for the Sapien transcatheter valve, making it available for inoperable patients with aortic stenosis in the United States who are in need of an alternate access route.
The impact of this decision may go beyond the field of transcatheter valves, however, as the use of registry data represents a new paradigm for the FDA, researchers, registry sponsors and the medical device industry, according to an FDA press release.
"We believe this approach can be used with future well-designed device registries to speed patient access to important, well-evaluated therapies," Jeffrey Shuren, MD, director of the FDA's Center for Devices and Radiological Health, said in the release.
Jeffrey Shuren
The decision to expand access to the Sapien valve was based on a submission for a labeling change by the manufacturer (Edwards Lifesciences), which included data from the Transcatheter Valve Therapy (TVT) Registry in the United States and European registries along with data from FDA-approved clinical studies and peer-reviewed journals. According to the press release, the submitted data featured several thousand procedures performed on patients using an alternative access point and found no evidence that the device has a different benefit-risk profile based on access route.
In the release, Shuren said that medical device registries like the TVT Registry not only play an important role in the agency’s post-market surveillance system, but also collect robust and timely data that can be used to identify additional patient populations that benefit from the therapy.
The Sapien valve had previously been approved for implantation via the transfemoral and transapical access routes. Edwards Lifesciences plans to continue to use data from the TVT Registry to study short- and long-term patient outcomes of transcatheter valve procedures using alternative access sites.
Perspective
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This decision is good news for patients and surgeons/interventionalists. This primarily opens up the transaortic (TAO) route of access for commercial Sapien implantation. Many physicians prefer the TAO route over transapical insertion for patients with peripheral vascular disease that precludes the transfemoral approach, particularly if they are less experienced with transapical access. The TAO approach may also be better for patients with significant lung disease or left ventricular dysfunction. More options mean more choices and hopefully better results for our patients. In addition, the novel use of the TVT registry to support this labeling change may provide a new pathway for other future potential approvals, including valve-in-valve and mitral implantations.
Perspective
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At the University of Miami, before the national coverage determination was issued, we performed a number of transaortic (TAO) TAVRs and found that these procedures were easier for the team and the patient: The recovery time was faster with less pain; the time in critical care was shorter; and the learning curve was shorter for the team. We published our experience in the Journal of American College of Cardiology earlier this year; however, we had to stop doing the TAO approach because CMS would not reimburse for the procedure, limiting us to transapical and transfemoral and unfortunately these two access approaches do not allow you to treat all patients that require TAVR, especially those with poor lungs, low ejection fraction and peripheral vascular disease. So these restrictions imposed to physicians on the way they can practice have been problematic.
In addition, the TAO approach is a relatively simple procedure for CV surgeons. All TAO procedures entail performing a small thoracotomy, exposing the aorta and cannulating it with a sheath, a routine operation for CV surgeons. We then deliver and deploy the valve working as a team. So this expanded access of TAVR is very good news for patients and physicians because now physicians can individualize the approach to the particular patient.
In terms of the registry component, it is extremely important because as TAVR matures in the United States, we need to have a picture of what’s going on. The National Cardiovascular Data Registry and the professional societies are doing a fantastic job at tracking outcomes and patterns of treatment. Hopefully, we will gain valuable insight in the future as we collect more information and, ultimately, be able to pinpoint best practices to optimize clinical outcomes.