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
Aortic valve disease, especially aortic stenosis (AS), is the most common valvular heart disease in the United States. As the disease becomes progressively debilitating, it carries a high mortality risk if categorized as severe and symptomatic.1 In fact, those who are medically untreated for severe AS have a mortality of about 50% in 2 years.2 In the past, the only definitive treatment for AS was surgical aortic valve replacement (SAVR), which usually requires several hours of cardioplegia. Many of these patients are elderly and are toting comorbidities such as renal failure, vascular and lung disease. The United States developed a system to calculate the surgical mortality risk based on comorbidities and the type of procedure the patient is undergoing. This system of scoring is called the Society of Thoracic Surgery. There is also a European equivalent predictor of surgical outcomes identified as the European EuroScore. Based on the score, the patient and surgeon may opt out of performing the operative event because of the high risk of death. This leaves patients who are considered high risk without surgical treatment options. Medical treatment does not prolong life; it offers palliative treatment.3 Patients are frequently readmitted with multiple hospitalizations over a 2- to 4-year period, until death transpires.
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 routine SAVR surgery. More than 20, 000 TAVRs have been performed in patients worldwide since 2002 when Dr Alain Cribier performed the first-in-man TAVR.4 The Edwards Lifesciences SAPIEN XT valve and the Medtronic CoreValve are commercially available. The SAPIEN XT valve consists of a bovine aortic trileaflet valve attached to a metallic scaffold (Figure 1). The CoreValve is constructed with a potentially larger orifice area with a noncircular annuli design option (Figure 2). The valves are manually crimped onto the inflation balloon and deployed once the valve is in the correct position. Currently, there are 2 valve sizes (23 and 25 mm) for the Edwards valve and 4 sizes (23, 26, 29, and 31 mm) for the Medtronic valve. For placement and delivery of the valves, an 18F to 24F sheath is required. Smaller sheath sizes are currently being investigated but are not US approved. The valves are delivered transfemorally via a percutaneous puncture or a vascular cut-down. If the patient has significant vascular disease, the valves can also be placed with a transapical or a direct aortic approach (Figure 3).
TRIALS AND STUDIES
The PARTNER (Placement of AoRTic TraNscath-etER) trial was the first randomized study to evaluate the placement of transcatheter aortic valves in humans within the United States.5 In the PARTNER B trial, 358 patients who were not considered suitable for surgery were randomized to either standard therapy or TAVR. Most strikingly, 1-year all-cause mortality was 50.7% for standard therapy versus 30.7% for TAVR (95% confidence interval, 0.4-0.74; P = .001).6 Economically, the PARTNER Trial Cohort B study identified a cost-effectiveness ratio of $32,170 per quality-adjusted life-year when the TAVR treatment was compared with medical management in patients with inoperable severe AS.7 In the CoreValve US Pivotal Trial 471, extreme-risk patients were selected. The outcomes at 12 months noted an all-cause mortality or major stroke at 25.5% (P = 0.0001).8 The CoreValve Trial also identified an improvement of a least 1 New York Heart Association class with 90% of the patients and a 60% improvement of 2 New York Heart Association classes by the first year after implantation.
The clinical findings and economic statistics have supported the expansion of the TAVR procedure. However, there has been considerable controversy over where the procedure is to take place and who is to direct the TAVR care. This debate has identified barriers to the implementation of a TAVR program.
CHALLENGES IN THE DEVELOPMENT OF A TAVR PROGRAM
The TAVR experience has left the cardiac catheterization laboratories (cath labs) underprepared for the hybrid operative experience. The cardiac cath labs are space confined and cannot accommodate the square footage necessary for a surgical open-heart experience. The laminar air flow and air exchanges are usually insufficient to meet the standards for an operative suite. Power may be limited and will not meet the electrical wattage requirements for all the additional equipment utilized for a TAVR procedure. The cath lab egress and room configuration do not offer an aseptic environment for the flow of staff and equipment in and out of the procedural suite, thus not meeting the Association of periOperative Registered Nurses Standards of Care. Even simple placement of electrodes must be an area of education (Figure 4-6).
The operating rooms (ORs) also are ill prepared to perform TAVR without additional investments into hemodynamic equipment, fluoroscopy equipment, a radiation-protective environment, and trained personnel in coronary care. Many ORs and hybrid rooms are also space challenged. Most existing hybrid OR rooms were built on a vascular platform instead of an open-heart platform, thus a reduced room size and underprepared for an SAVR experience.
Because of the barriers identified, the Department of Veterans Affairs determined a need for a systematic approach to review facilities that applied to perform TAVR procedures. This process would ensure room readiness, staff competency, team collaboration, an extensive screening, and selection plan for optimal patient selection.
A national TAVR Review Team was developed composed of a cardiology nurse consultant/cardiology nurse manager, a TAVR-trained interventional cardiologist, a TAVR-trained cardiothoracic surgeon, and the TAVR-specialized National Architectural Engineer. This team begins the process of reviewing the architectural plans and work collaboratively with the individual Veteran Administration (VA) facilities to ensure the environmental requirements are sufficient. A major consideration is the structural environment. The National Architectural Engineer has numerous consultations with the local architects, project engineers, and imaging modality companies. The team works on a one-on-one basis with the cardiothoracic surgeons, interventional cardiologists, the cath lab team, the intensive care unit staff, and OR personnel. Once the site is prepared for the start-up of their program, an on-site evaluation is completed. The review team meets with the local multidisciplinary TAVR team. The local team members present their individualized process for the care of the TAVR clients within their hospital. Facility policies and procedures are reviewed. The entire TAVR client’s procedural data are captured in the VA CART-CL (Cardiovascular Assessment, Reporting and Tracking System for Cath Labs). This system provides real-time reviews and quality matrixes at a national level.
From the experience gleaned from the TAVR reviews, a successful TAVR team ensures the input of a variety of disciplines. The TAVR team shares data in an electronic medical record with check-off sheets to ensure all testing has been sufficiently completed. Also, the team has multiple meetings to collectively determine a treatment plan for the patient. It is imperative that effective communication, both written and verbal, is present within the team. The collective team is a major component in the success of the program. The TAVR coordinator safeguards the patient’s readiness for the procedure.
THE TAVR COLLABORATIVE TEAM
The TAVR collaborative team is composed of the following:
2 experienced TAVR cardiovascular surgeons
2 experienced TAVR interventional cardiologists
TAVR imaging specialists—radiologist-trained for TAVI/TAVR and computed tomography imaging
2 cardiac anesthesiologists
heart failure cardiologist specialists
peripheral vascular surgeons
trained intensive care unit staff who are used to dealing with large sheaths and open-heart-surgery patients
Social Services personnel
cath lab–trained staff
representatives from supply and distribution
representatives from pharmacy
representatives from biomedical engineering
representatives from information technology
representatives from billing and coding
representatives from laboratory services
One of the most difficult challenges has been determining the procedural location. A paradigm shift has begun to emerge relocating the TAVR procedure from an operative suite to the cardiac cath lab. The requirement for a hybrid-type suite is necessary for the TAVR experience; however, the suite can be located physically in the OR, cardiac catheterization, or interventional radiology laboratory. The ORs have already noted a demand for this type of hybrid suite. In 2010, it was estimated that 34% of all facilities had at least 1 hybrid OR, and 18% will have an additional 2 or more.9
The relocation of the hybrid suite to the cardiology department has created a challenging work environment. There must be a platform of care established meeting the Association of periOperative Registered Nurses Standards for Operative Procedures. Building or reconfiguring a hybrid cath lab takes significant planning on the part of the facility. Construction costs in designing and building a hybrid suite range from $2 million to $4 million.10 About 24% of hybrid cardiac cath labs are refurbished from a standard cath lab, and 15% are new construction.11
The physical design of the hybrid lab is not the only consideration in play. For the retrofitted cath lab, space is often sacrificed, and the workflow of personnel is altered. The development of room layouts showing the exact placement of specified equipment and personnel must be implemented. The hybrid cath lab must be able to quickly transform to fit the clinical situation at hand. For example, the room must be ready to transition from a percutaneous TAVR to an open chest SAVR at a moment’s notice. This is accomplished with extremely detailed instructions of how and who will be responsible for the adjustment of the equipment and their respective rolls. The staff must be trained and perform “mock” drills on the most common complications that occur with TAVR in order to identify gaps in the procedural process. It is extremely important that all staff members are acutely aware of their job in these critical clinical events, to provide optimum care to the patient in crisis (Table 1).
STAFF TRAINING AND COMPETENCY
The valve companies provide extensive training with online didactic courses and clinical courses at the local facilities. Comprehensive orientation and competency evaluations must be completed for each member of the team (Table 2). Proctoring for the physician team is a mandatory requirement. The TAVR procedure incorporates multiple disciplines, an array of equipment, and overlapping responsibilities that require precise planning and well-thought-out choreography. Mock setups, dress rehearsals, and postprocedure huddles refine process and enhanceteam cohesiveness. This all contributes to positive procedural outcomes. Because of the cross-coverage of the OR and cardiology staff, a combined effort to understand the variety of roles involved is a necessary component of the educational process.
PATIENT SAFETY FOR HIGH-RISK PROCEDURES
The use of the Health Failure Mode and Effects Analysis can define high-risk clinical processes and provide a hazard analysis. Worksheets can show potential failure modes and their probabilities along with actions and outcome measures (Tables 3-5). The Joint Commission Standard LD .04.04.05 states “a safety program integrates safety priorities into all process, functions, and services within the hospital, including patient care, support, and contract services.”12 The proactive risk assessment can correct process problems and reduce the likelihood of experiencing an adverse event. Proactive risk assessments are also useful for analyzing new processes before they are implemented. These processes need to be designed with a focus on quality and reliability to achieve desired outcomes and protect patients. The local Health Failure Mode and Effects Analysis can assist in the review of the processes for the TAVR experience to ensure safe patient outcomes. This is a requirement for the program to be approved in the VA system.
Once the team has completed the physical and clinical assessment of the TAVR program, a formal summary is provided to review the areas of adequacy and areas for improvement. Once all the issues have been resolved, a formal approval is provided. If an untoward event occurs, within 24 hours the CART-CL Quality Assessment Team is activated to begin a review process. This provides real-time review and feedback to the local facility in an expeditious manner. This is a superior review process compared with a retrospective chart review. The quality review is completed by VA experts in the field throughout the United States, providing an unbiased audit.
The TAVR procedure has proven to be cost-effective and adds years of quality to a patient’s life. The expansion of structural heart disease treatment in this hybrid environment is likely to expand incredibly in the next few years. The St Jude Portico Valve (Figure 7) is not approved in the US market but is under investigation abroad, as is the Medtronic Melody Transcatheter Pulmonic Valve (Figure 8). Also, the transcatheter delivery of the Abbott MitraClip (Figure 9) for severe Mitral Regurgitation (MR) and the Boston Scientific WATCHMAN Left Atrial Appendage Closure Device (Figure 10) is utilized to reduce the risk of stroke in patients with atrial fibrillation. All of these new technologies are likely to be performed in a cardiac cath lab.
Cardiac cath labs have been inundated with rapidly changing technological advances in the past decade. The era for structural heart repair is rapidly mobilizing from a surgical/OR setting to a transcatheter/hybrid cath lab. The use of the new hybrid cath labs will continue to expand as the approval of future transcatheter therapies evolves. The Department of Veterans Affairs TAVR team is methodically approaching this technological evolution with foresight by setting the groundwork and ensuring the proper elements are in place to support the infrastructure required for a successful TAVR program and other structural heart programs on the horizon.
The authors thank the TAVR team in the Department of Veterans Affairs.
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