In 2011, the FDA approved transcatheter aortic valve replacement (TAVR) for transfemoral use in symptomatic patients with severe aortic stenosis who are not considered candidates for surgery. On behalf of the Society for Cardiovascular Angiography and Interventions, the American College of Cardiology Foundation, the American Association for Thoracic Surgery, and the Society of Thoracic Surgeons, my colleagues and I collaborated to develop an expert consensus document on TAVR. The document, published in a 2012 issue of Journal of the American College of Cardiology, is intended to inform physicians on the most appropriate use of TAVR based on available evidence.
The consensus document does not recommend universal use of TAVR because the technology is still being investigated. Instead, we recommend that hospitals eligible to perform TAVR should initially be limited to those that are currently performing an average of at least one aortic valve replacement per week. This means that the 400 busiest cardiac surgery programs would be able to access this technology in the first 2 years following FDA approval. After monitoring outcomes, use of TAVR could be expanded or restricted depending on success and failure rates.
A Team Approach to TAVR
It’s recommended that territorial and specialty-based decisions on treatment with TAVR be avoided by utilizing a heart team approach. This team should include a surgeon, interventional cardiologist, cardiac anesthesiologist, and an imaging specialist. Allied health professionals—including social workers, nutritionists, and physician assistants— should also be involved. Data from the PARTNER trial, which was the initial regulatory trial for TAVR conducted in the United States, indicate that use of heart team approaches may enhance outcomes.
“It’s recommended that territorial and specialty-based decisions on treatment with TAVR be avoided by utilizing a heart team approach.”
Patient Selection for TAVR
Among patients with prohibitive surgical risk, the consensus statement recommends that TAVR be used in individuals with severe, symptomatic, calcific stenosis of a trileaflet aortic valve who have aortic and vascular anatomy suitable for TAVR and a predicted survival of more than 1 year. On the other hand, TAVR is not recommended in adults who have known bicuspid aortic valve, an acceptable surgical risk for conventional surgical aortic valve replacement, moderate aortic stenosis, or severe aortic regurgitation, among other factors.
The Tip of the Iceberg
Since there is only a small sample of recent trial successes with TAVR, clinical trials are ongoing to explore whether indications for the procedure can be expanded. More research is also looking into the potential for using TAVR via alternate routes of access, including transapical and direct aortic approaches. The consensus statement is only the beginning until future studies better define the role of TAVR. Other TAVR devices are currently being investigated in the U.S. and other countries, meaning there’s potential for more options to hit the market. For now, the consensus statement can help ensure the appropriate use of TAVR therapy for optimum patient safety based on available data and devices.
Readings & Resources (click to view)
Holmes D, Mack M, Kaul S. 2012 ACCF/AATS/SCAI/STS expert consensus document on transcatheter aortic valve replacement. J Am Coll Cardiol. 2012;59:1200-1254.
Holmes D, Mack M. Transcatheter valve therapy a professional society overview from the American College of Cardiology Foundation and the Society of Thoracic Surgeons. J Am Coll Cardiol. 2011;58:445-455.
Carabello B, Paulus W. Aortic stenosis. Lancet. 2009;373:956-966.
Leon M, Smith C, Mack M, et al. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med. 2010;363:1597-1607.
Baumgartner H, Hung J, Bermejo J, et al. Echocardiographic assessment of valve stenosis: EAE/ASE recommendations for clinical practice. J Am Soc Echocardiogr. 2009;22:1-23.
Adams D, Chikwe J, Filsoufi F, et al. The year in cardiovascular surgery. J Am Coll Cardiol. 2011;57:1425-1444.
Rodes-Cabau J, Webb J, Cheung A, et al. Transcatheter aortic valve implantation for the treatment of severe symptomatic aortic stenosis in patients at very high or prohibitive surgical risk: acute and late outcomes of the multicenter Canadian experience. J Am Coll Cardiol. 2010;55:1080-1090.