The ACC and the Society of Thoracic Surgeons (STS) earlier today released a societal overview of transcatheter valve therapy (TVT). The overview highlights the issues that will be faced as cardiology and surgical societies try to guide the process of rational dispersion of this very new and important technology. Transcatheter aortic valve replacement (TAVR), one form of TVT, 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 for specific patient populations, including balloon aortic valvuloplasty.

The overview makes several key points:

1. Use of team-based care will be critical to TVT success. The therapy cannot revolve around just surgery and cardiology, but must involve interventionalists, echocardiographers, hospitalists and others who deal with structural heart disease and heart failure.
2. Providers performing TVT must be very skilled and well-educated in the field. The devices can substantially improve outcomes, but there are potential side effects that may be very significant and clinically important.
3. Randomized trials have included only patients with severe aortic stenosis who are at very high risk for conventional aortic valve replacement, or patients who are not surgical candidates because of a variety of comorbidities.  Accordingly, we do not have randomized trials on other patient groups. For this reason, patient selection is critically important.
4. Efforts need to be focused on evaluation of data on the outcomes of patients both in the hospital and for longer-term follow up. Understanding outcomes will be important in identifying areas that need to be modified or improved. The use of registries will be exceedingly important to complete this task.

The document provides a 20,000-foot view of TVT, and 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 also important to note that many key milestones for the technology must 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.

TVT technology has the potential to be transformational for the field of cardiology and thoracic surgery. However, this transformation will not happen overnight. It’s going to be a long road with many hurdles.

Additional Resources:

• 10 Points to Remember on the ACC, STS Position Statement on TVT
  
• PARTNER Cohort A: TAVI vs. Surgical AVR
• PARTNER Cohort B: Transfemoral TAVI vs. Medical Management

UPDATED: 6/28/11

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