• Kendrick A Shunk, Jeffrey Zimmet, Brian Cason, Bernadette Speiser, and Elaine E Tseng.
• Division of Cardiology, San Francisco Veterans Affairs (VA) Medical Center, San Francisco, California.
• JAMA Surg. 2015 Mar 1;150(3):216-22.

ImportanceTranscatheter aortic valve replacement (TAVR) revolutionized the treatment of aortic stenosis. Developing a TAVR program with a custom-built hybrid operating room (HOR) outside the surgical operating room area poses unique challenges in Veterans Affairs (VA) institutions.ObjectiveTo present the process by which the San Francisco VA Medical Center developed a VA-approved TAVR program, in which an HOR exists in a cardiac catheterization laboratory, as a guideline for future programs.Design, Setting, And ParticipantsRetrospective review of each required approval process for developing an HOR in a cardiac catheterization laboratory in a VA designated for complex surgery. Participants included San Francisco VA Medical Center health care professionals and individuals responsible for new program initiation in VA institutions.ExposuresExternal reviews by industry vendors, the VA Central Office, and the Office for Construction, Facilities, and Management and an internal Healthcare Failure Mode and Effect Analysis.Main Outcomes And MeasuresThe timeline for each process.ResultsDeveloping a TAVR program required vetting and approval from industry vendors, who provided training and expertise. Architectural plans for construction of the HOR began in 2010-2011, followed by approval from Edwards Lifesciences, Inc, in 2012 and fundamentals training on February 8 and 9, 2013. Following a pilot launch of the first VA TAVR program at the Houston VA Medical Center, subsequent programs were required to submit a plan to the VA Central Office for proposed restructuring of their clinical programs. After the San Francisco VA Medical Center proposal submission on February 3, 2013, a site visit consisting of a National Chief of Catheterization Laboratory Managers, a cardiac surgeon, and an interventional cardiologist with TAVR experience was conducted on April 12, 2013. During construction, HOR plans were inspected by the Office for Construction, Facilities, and Management followed by on-site inspection on August 8, 2013, to assess the adequacy of the HOR, newly built restricted corridors, equipment storage areas, and altered staff and patient flow patterns. Last, a Healthcare Failure Mode and Effect Analysis was performed to mitigate any negative effects of the HOR not being colocated in the surgical operating room area. Approval was then granted on November 13, 2013. Our first 10 TAVR cases were successfully completed as of April 2, 2014.Conclusions And RelevanceThe primary factor for development of a successful TAVR program is integration of the heart valve team. Particular adaptations to the cardiac catheterization laboratory environment are required to accommodate an uncompromised HOR in which cardiac and vascular surgeons can be as comfortable as their interventional cardiology colleagues.

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