Today was a big day for late-breaking clinical trials related to transcatheter aortic valve replacement (TAVR) at TCT 2011. Three separate trials addressed the following: PARTNER Cohort B Two-Year, PARTNER Cohort A Quality of Life, and PARTNER Cohort A Cost-Effectiveness.

In addition, results from the STACCATO trial were also released. This trial focused on implantation of the Edwards Sapien transcatheter aortic valve, which was recently given the green light by the Food and Drug Administration (FDA). The STACCATO trial was designed to include 200 relatively low-risk patients, but was halted after enrollment of 70 patients by the Data Safety and Monitoring Board. However, the trial results suggest that transapical TAVR in its current stage of development should be restricted to high-risk patients, and that use in patients who are otherwise good operative candidates may not be in the patient’s best interest. It must be remembered that we have not seen the final data, it has not been subjected to peer review, and the results must be considered in light of other data available. There are multiple issues to be considered including patient selection, operator experience as well as experience of the whole team.  This data provides the rationale of continuing to optimize strategies of care for these patients, with optimal selection and optimal procedural performance.

The results of these trials continue to underscore the necessity for specialty societies like the ACC and the Society of Thoracic Surgeons (STS), the FDA, the Centers for Medicare and Medicaid Services and industry to work together as we move forward with TAVR. Patient selection and provider training will be key. It also underscores the necessity of the new ACC/STS TVT Registry™ scheduled for release later this year. Backed by the registry expertise of the ACC’s NCDR^® and the STS National Database, the TVT Registry will serve as the main repository for clinical data related to TAVR and is positioned to capture outcomes data for expanded indications, additional devices and procedures that will likely emerge in the future. The goal of the registry is to link clinical and administrative claims data to assess early and longer term outcomes. The registry also forms the basis of a new platform that can be used for FDA post approval studies in future generations of transcatheter valve devices.

This is an exciting time for interventional medicine and as president of the ACC, I’m proud of the collaborative work we are doing to make sure that this transformational new therapy is appropriately used. Hopefully the lessons learned from TAVR will serve as a new paradigm for other devices and drugs developed in the future.

Keep up with all of the TCT 2011 coverage on CardioSource.org.

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