Multisociety Consensus Document Offers Guidance for TAVR
January 31, 2012—A multisociety expert consensus document from the American College of Cardiology Foundation (ACCF), the American Association for Thoracic Surgery (AATS), the Society for Cardiovascular Angiography and Interventions (SCAI), and the Society of Thoracic Surgeons (STS) was published to provide guidance on the use of transcatheter aortic valve replacement (TAVR) to treat patients with aortic valvular stenosis.
The 2012 ACCF/AATS/SCAI/STS Expert Consensus Document on TAVR is endorsed by a dozen leading medical societies. It is available online ahead of print in the Journal of the American College of Cardiology. The writing committee was led by Chair David R. Holmes Jr, MD; Vice Chair Michael J. Mack, MD; and Vice Chair Sanjay Kaul, MD.
Dr. Holmes, who is President of the ACC, commented, "This is a new, transformational technology for our patients. We have never had this type of an approach before; it's not like another balloon catheter. As this technology is introduced into practice, detailed and agreed upon protocols are needed to ensure we achieve optimal clinical results. This consensus document provides the field with clear recommendations and guidance for its use."
The new report is a detailed follow-up to the joint position statement from the ACC and STS released in late 2011. It examines the current state of the evidence, offers steps to facilitate integration of TAVR into the mix of available therapeutic options for select patients, and outlines how it should best be used and how to appropriately select patients to optimize clinical outcomes and encourage responsible application of this promising technology. The US Food and Drug Administration approved TAVR with the Edwards Sapien transcatheter aortic heart valve (Edwards Lifesciences, Irvine, CA) in November 2011.
According to the writing committee, TAVR represents a fundamental change in the management of aortic valvular heart disease by offering an alternative to traditional surgical aortic valve replacement in carefully selected patients. Its implementation into the flow of patient care is complex and involves consideration of several key factors such as clinical site selection, operator and team training and experience, patient selection and evaluation, procedural performance and complication management, and postprocedural care. Therefore, guidance is urgently needed to ensure it is smoothly integrated into clinical practice and followed to achieve real-world benefits and minimize risks to patients.
"Our goal in crafting this expert consensus document is to provide a clear roadmap for the use of TAVR as it reaches patients across the United States," stated Dr. Mack, who is President of STS. "TAVR innovation is a major advance in treating aortic stenosis and sick, elderly patients should have access to this new treatment so they can resume normal, active lives. These guidelines are a coordinated effort from the cardiovascular community to help ensure the appropriate use of TAVR therapy for optimum patient safety."
The consensus document outlines key recommendations for the success introduction of TAVR therapy. The recommendations provide detailed criteria on careful patient selection; a team-based approach given the complexity of procedure coupled with the high-risk profile of suitable patients, many of whom have extensive comorbid conditions that require ongoing management; specialized heart centers and physician expertise in treating valve disorders, which includes the use of proctors as needed to serve on the heart care team during the first few cases, as well as proper facilities (hybrid operating rooms or modified catheterization labs); TAVR screening tests to inform treatment decisions; enhanced patient and family education in the risk and benefits of this procedure; and ongoing evaluation and participation in national TAVR registry to assess real world outcomes
Clinical use of TAVR, its continued evolution, and outcomes will be evaluated in the new STS/ACC Transcatheter Valve Therapy (TVT) registry, which will further inform future recommendations on application of this technology. The societies noted that an estimated 45,000 patients have received TAVR worldwide. Multiple single and multicenter registries, as well as a single randomized trial, have documented favorable outcomes using a wide spectrum of endpoints including survival, symptom status, quality of life, and need for repeat hospitalization.
The writing committee cautioned that TAVR is not for everyone and stress that more data are needed to ascertain the risk-benefit ratio before using this approach in certain groups. At present, and as outlined in the consensus document, TAVR is not recommended in adults who have an acceptable surgical risk for conventional surgical AVR, known bicuspid aortic valve, severe mitral annular calcification or severe mitral regurgitation, moderate aortic stenosis, and other conditions such as severe AR and subaortic stenosis.