The U.S. Food and Drug Administration (FDA) has granted an investigational device exemption (IDE) to the American College of Cardiology (ACC) and The Society of Thoracic Surgeons (STS) to conduct a study assessing alternative access approaches for transcatheter aortic valve replacement (TAVR).
Currently, only the transfemoral approach to TAVR using the Edwards SAPIEN valve and, in some cases, the transapical approach have been approved in the U.S. However, an estimated one out of four patients are not eligible for this approach due to inadequate vessel size, vessel disease and/or other anatomical considerations. The IDE – the first-ever filed for by either organization – will assess the safety and effectiveness of alternative access approaches (i.e. axillary, transapical, transaortic, subclavian/axillary) in these patients with severe aortic stenosis who are inoperable or extreme risk patients where transfemoral insertion is contraindicated.
"The goal behind the study is to expand the field and extend the benefits of TAVR to broader patient groups," said former ACC President David Holmes, Jr., MD, MACC. "This should be a model for specialty societies, industry and federal regulators aligning efforts to ensure appropriate patient access to a new technology in a cost-effective and evidence-based way."
The ACC and STS worked closely with the FDA, the Centers for Medicare and Medicaid Services and Edwards Lifesciences to develop the trial, which will be tracked using the STS/ACC TVT Registry™. As part of the trial, patients not eligible for aortic valve surgery will receive TAVR through transapical, transaortic, and other non transfemoral approaches. These data will be compared to those of patients in the original PARTNER Cohort A trial who received TAVR through the transapical approach.
"The approval of the IDE represents the next step in the collaboration between the professional societies, CMS, the FDA and our medical device manufacturers," said former STS President Michael Mack, MD, FACC. "The process required all parties to be flexible and innovative while navigating these 'uncharted waters.' This is an iterative process that we hope will allow the safe and timely introduction of new medical device technology to our patients."
"The beauty of using the STS/ACC TVT Registry is that we can continue to gain a truly complete picture of the risks and benefits of different approaches to TAVR," said Holmes. "Having the data in one place means we can conduct further data analysis for outcome assessment, fulfill regulatory mandates, and potentially identify and implement additional new proposals and protocols to make TAVR accessible to more patients."
Moving forward, the STS and ACC are working closely with Edwards Lifesciences to secure funding so that the study can begin. Both societies are also working to gain FDA approval to perform two additional studies examining the role of alternative approaches in high-risk patients who are eligible for surgery and valve-in-valve TAVR procedures, respectively. In addition, Holmes notes that collaborations with other international registries have also been initiated.
"We have learned much about TAVR since its approval a little more than a year ago," said Holmes. "The continued application of new, more advanced technology, the presentation and publication of new trial data, and more optimal matching of devices and patients moving forward will allow even greater utilization of the attributes of this transformational technology in years to come."