title: Transcatheter aortic valve replacement: establishing a comprehensive program model for hybrid cardiac catheterization laboratories in the Department of Veterans Affairs.
abstract: Aortic valve disease, especially aortic stenosis, becomes progressively debilitating and carries a high mortality risk if it is categorized as severe and symptomatic (J Thorac Cardiovas Surg. 2012;144(3):e29-e84). In the past, the only treatment for aortic stenosis was surgical aortic valve replacement. Surgical treatment may require several hours of cardioplegia, and if the patient has comorbidities, such as renal failure or chronic obstructive pulmonary disease, their operative mortality percentage increases.In 2011, the US Food and Drug Administration approved the use of a transcatheter aortic valve replacement (TAVR) procedure for patients who were deemed high risk or inoperative for the routine surgical aortic valve replacement surgery. More than 20, 000 TAVRs have been performed in patients worldwide since 2002 when Dr Alain Cribier performed the first-in-man TAVR (Arch Cardiovasc Dis. 2012;105(3):145-152). The Edwards Lifesciences SAPIEN XT valve and the Medtronic CoreValve are commercially available.The clinical findings and economic statistic have supported the expansion of the TAVR procedure. However, there has been considerable controversy over where the procedure is to occur and who is directly responsible for directing the TAVR care. This debate has identified barriers to the implementation of a TAVR program. The operating rooms and a cardiac catheterization laboratory are underprepared for the hybrid valve replacement therapy. Because of the barriers identified, the Department of Veterans Affairs determined a need for a systematic approach to review the programs that applied for this structural heart disease program. A centralized team was developed to ensure room readiness and staff competency. The use of the Health Failure Mode and Effects Analysis can define high-risk clinical processes and conduct a hazard analysis. Worksheets can show potential failure modes and their probabilities, along with actions and outcome measures, team collaboration, extensive screening, and selection process. The TAVR program begins implementation with data entry with each case into CART-CL (Cardiovascular Assessment, Reporting and Tracking System for Cath Labs, Veteran Administration database for interventional cardiology procedures). If an untoward event occurs, within 24 hours the CART-CL Quality Assessment Team is activated to begin the review process. This provides real-time review and feedback to the local facility in an expeditious manner. Cardiac catheterization laboratories have been inundated with rapidly changing technological advances in the past decade. The era for structural heart repair is rapidly mobilizing from a surgical/operating room setting to a transcatheter/hybrid catheterization laboratory suite. The use of the new hybrid catheterization laboratories will continue to expand as the approval of future transcatheter therapies evolve. Editor's note: Due to the volume of important information presented in each table, only the first table is included in the print version of the article, however, all tables may be viewed in their entirety free of charge on the online version of this article: http://journals.lww.com/dccnjournal/pages/default.aspx.
authors.affiliation: Bernadette Speiser, MSN, CCRN, CMS, is the nurse manager of Jesse Brown Veterans Administration Hospital Cardiology Department, Chicago, Illinois. She completed her bachelor of science degree in nursing from Northeast Missouri State University in 1982 and a master of science degree in nursing from Ball State University in 1990; she received her Certified Critical Care Nurse in 1985 and Certified Medical Surgical Nursing in 2009. Cynthia Dutra-Brice, RN, is the manager of the Cardiac Catheterization/Electrophysiology Lab at the Veterans Affairs Health Care System in Palo Alto, California.
authors.forename: Bernadette
authors.initials: B
authors.lastname: Speiser
authors.forename: Cynthia
authors.initials: C
authors.lastname: Dutra-Brice
mesh_terms: D001024:Aortic Valve Stenosis / Q000601:surgery*; D002983:Clinical Competence; D006749:Hospital Design and Construction; D006801:Humans; D007318:Inservice Training; D010348:Patient Care Team / Q000458:organization & administration; D061214:Patient Safety; D065467:Transcatheter Aortic Valve Replacement / Q000592:standards*; D014481:United States; D014493:United States Department of Veterans Affairs