On June 27, the ACC and the Society of Thoracic Surgeons (STS) released a societal overview of transcatheter valve therapy. The overview highlights the issues cardiology societies will face as they try to guide the process of rational dispersion of this very new and important technology. TAVR has been documented by the PARTNER trial to improve outcomes in patients with severe aortic stenosis who are inoperable. It has been found to significantly reduce mortality and composite endpoints at one year compared to medical therapy, including balloon aortic valvuloplasty.
The overview provides a 20,000-foot view of transcatheter valve therapy and raises a number of questions for practitioners, patients and government agencies on the appropriate treatment strategy for patients who could be eligible for this procedure. According to the paper, some of the most important questions include:
- How will this technology be regulated and by whom?
- Where will this technology be available and who will be able to perform it?
- What types of patients will be able to benefit from this technology?
- How will training be accomplished?
- How will this new technology be reimbursed?
The paper also underscores the importance of team-based care and complication management. Given the complexity of the procedure, patient selection will be extremely important and cardiologists, surgeons, hospitalists and others dealing with structural heart disease and heart failure will need to find a way to work together as a team. The paper also raises questions about data collection for long-term outcome assessment, comparative effectiveness research and cost-effectiveness analysis. The use of registries will be exceedingly important to document and optimize outcomes in patients as well as identify areas that need to be changed or improved.
The document is the first of a series of documents that will address the topic in a more detailed fashion. More specific documents on pre- and post-procedural issues and training and credentialing will be developed jointly by the ACCF, cardiovascular specialty societies, and thoracic surgery societies and released in the future. It’s important to note that many key milestones for the technology still need to be met – including FDA approval. TAVR is scheduled to be considered by an FDA panel on July 20, with the agency to make a decision following the results of that hearing.
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