Expert consensus document on TAVR issued
MedWire News: US experts have issued a consensus document on transcatheter aortic-valve replacement (TAVR).
The new recommendations are jointly developed by the American Heart Association, American College of Cardiology (ACC) Foundation, American Association for Thoracic Surgery, Society for Cardiovascular Angiography and Interventions, and the Society of Thoracic Surgeons.
The document comes in the wake of the recent approval of the first transcatheter aortic valve in the USA in November 2011, which the authors say "represents a fundamental change in the management of aortic valvular heart disease" by presenting an alternative approach to traditional surgical AVR in carefully selected patients.
In the statement, lead author David Holmes (Mayo Clinic, Rochester, Minnesota) and colleagues stress the importance of team-based approach to patient care. This should mainly be centered on the primary cardiologist, cardiovascular surgeon, and the interventional cardiologist, but also includes cardiac anesthesiologists, heart failure specialists, structural heart disease physicians, imaging specialists, and the nursing care team, as well as patients and their families.
The team also outlines the criteria for TAVR patient selection, pointing out that the procedure is recommended in patients with prohibitive surgical risk (defined as an estimated 50% or greater risk for mortality or irreversible morbidity at 30 days). The procedure is also considered as a reasonable alternative to surgical AVR in patients at high surgical risk.
However, TAVR is not recommended for patients with an acceptable surgical risk for conventional surgical AVR, those with a known bicuspid aortic valve, failing bioprosthetic aortic valve, severe mitral annular calcification or severe mitral regurgitation, moderate valvular aortic stenosis, or severe aortic regurgitation and subaortic stenosis.
The authors advise that screening protocols, including imaging data on aortic stenosis, ventricular function, and assessment for cognitive impairment, should be part of every TAVR evaluation.
All centers performing TAVR should be experienced with structural heart disease, and all operating physicians must be experienced in using transapical, transarterial, and alternative arterial approaches for TAVR, they add.
Measures for procedural performance and postprocedural care are also highlighted in the document, and the authors suggest participation in national TAVR registries to evaluate the risks, benefits, and changes in patient selection criteria, procedural performance, and device iteration.
The Centers for Medicare & Medicaid Services have since announced the opening of a national coverage analysis for TAVR devices in response to a request from the ACC and the Society for Thoracic Surgeons, with a view to issuing a final decision in the summer.
The expert consensus document is published in the Journal of the American College of Cardiology.
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By Piriya Mahendra