Transcatheter Aortic Valve Replacement (TAVR): The Rapid Shift from Transformative Technology to Core Component of Distinctive Heart Programs

In a January 2011 article, I stated that “if TAVI continues to demonstrate improved quality of life and longevity compared to standard medical therapy or the more invasive, open surgical approach, then even the smallest of cath labs will need to be prepared for this disruptive technology to one day invade their space.”¹ At the time of that publication, there was a single valve device on the cusp of becoming commercially available and those in the cardiovascular industry were just becoming familiar with the technology as well engaging in trivial discussions such as debating the terminology: implant (TAVI) versus replacement (TAVR). It is hard to believe that only three years later, many heart programs are striving for innovative ways to initiate TAVR procedures, while those already offering the technology strive for greater efficiencies. It was also difficult to predict in 2011 that just three years later, so many heart programs would position TAVR procedures as a core component of a distinctive market position. 

As with any transformative technology, the growth of TAVR as a distinct clinical service was constrained by patient eligibility and internal programmatic factors. The Corazon team predicts that the number of TAVR-eligible patients will increase significantly as technology enhancements support more patient types and current restrictions that limit procedural candidates loosen. Currently, patients must be deemed ‘inoperable’ for standard aortic valve replacement (SAVR) using an open chest approach; thus, the TAVR cohort is often elderly, with multiple co-morbidities. Until recently, program growth may have been hindered by the availability of specialists to offer the procedure, though one of the most beneficial aspects of TAVR program development has been the forced collaboration between interventional cardiologists and cardiothoracic surgeons. In June 2012, new multi-societal guidelines were published, providing a roadmap for the operator and institutional requirements for programs performing the TAVR procedure.² These guidelines state that the “defining principle is that this effort is a joint institutionally-based activity for cardiologists and cardiac surgeons.”² In fact, the guidelines define programs offering TAVR with only one of these specialties represented as “fundamentally deficient”.² Corazon clients performing TAVR have described a revitalized sense of collaboration between their cardiologists and heart surgeons, with this cooperative approach filtering down into more scrutinized patient selection criteria for other heart therapies such as percutaneous coronary intervention (PCI) and coronary artery bypass graft surgery (CABG). 

Just a few years ago the Corazon team was educating clients on the potential benefits related to a catheter-based valve replacement device; now, we often assist with TAVR program development or re-engineering of an existing program. In order to achieve successful outcomes, the TAVR procedure cannot be isolated from other cardiovascular service line components such as the program service offerings, cardiovascular team, patient care protocols, and facility planning/design needs. Experience proves that building a TAVR program from the ground up usually requires a minimum of 10 months, though some programs have reported implementation times in as little as 8 months.³ 

The complexities associated with the procedure itself and the number of team members involved, including physician specialists, can greatly impact this timeline. Full implementation in less than 10 months assumes that the key medical specialists are already available and meet minimum credentialing requirements. Due to the physician dyad (interventional cardiologist and heart surgeon) that must champion this service, many programs deploy co-medical directors of the TAVR program so that each specialty is equally represented. 

Building the foundation: ensuring procedural volume

One of the most difficult tasks in these few short years has been transitioning the understanding of TAVR from a conceptual piece of technology to a core service offering of the heart program. As with any new(er) service, many factors need to be considered when predicting program size. The number of eligible patients remains constrained, as patients must be considered inoperable and deemed high risk, defined as a surgical mortality risk greater than 15%. 

Maine Medical Center’s TAVR program performed 53 procedures in one year, yielded from over 500 screenings for patients with suspected severe aortic stenosis.⁴ These numbers indicate that even though TAVR has developed rapidly, it is not a general replacement for SAVR in the general population. Most of our clients that perform over 100 TAVR procedures annually are large academic or quaternary centers that have robust surgical valve programs with an already large draw of patients with valvular disease. Defining a minimum patient volume has become a painful reality for resource-intensive services such as TAVR, due to both clinical competence and financial concerns. The volume required to remain viable will vary from program to program based on physician experience as well as the overhead resources (staffing, space, etc.) attributed to the program. 

One of the more challenging elements for TAVR programs involves the physician experience criteria that have been set as the minimum credentialing standard. Interventional cardiologists aspiring to perform TAVR procedures should have 100 structural heart procedures performed in their lifetime or 30 left-sided structural procedures per year, of which 60% must be balloon aortic valvuloplasties.² Conversely, the heart surgeon should have 50 total aortic valve replacements (AVR) per year, of which at least 10 must be considered high risk.² In the realm of interventional cardiology, structural heart disease treatments are considered among the most difficult procedures to perform (often associated with higher-level [more advanced] privileging criteria) with a much lower volume of cases when compared to coronary work. Therefore, it is not surprising that many institutions struggle to have access to an adequately skilled cardiologist. Similarly, valve surgery performance has been one of the cornerstones for gauging the expertise of cardiac surgeons, as the number of valve procedures performed by cardiac surgeons across the country is just a fraction of the total open heart (mainly CABG) case volume. 

It is also not surprising that programs offering TAVR, including those with case volumes of less than 100 TAVRs per year, have experienced growth in other cardiac procedures, which can add significant contributions to the overall cardiovascular service line. For example, computerized tomography scan (CT) testing is being used routinely in the pre- and post-procedure work ups of TAVR patients. Most of these programs have elevated their cardiac CT and echocardiography capabilities in order to meet the demands for standard cardiac diagnostic testing protocols throughout the valve patient’s continuum of care. 

With TAVR, there will also be an increase in cardiac catheterization, as well as increased angioplasty (PCI) procedures. PCI procedures typically rise in number, because coronary flow must be optimized to function effectively. TAVR patients are not routinely placed on a cardiopulmonary bypass pump and the heart must have completely stable intrinsic functions. Finally, traditional SAVR procedures normally increase at TAVR facilities due to the smaller number of patients being directed away from valve disease screening processes because they were once deemed too sick for any further therapies. After TAVR is initiated, Corazon recommends a thorough evaluation of the resources that have supported the existing SAVR services, as these patients usually exhibit the longest length-of-stay among all cardiac surgical patients. 

TAVR program needs

In the 2011 article, I provided a side-by-side comparison of programmatic needs for TAVR versus SAVR. This comparison required a crystal ball of sorts in order to hypothesize the likely physician operators, the facility needs, and some intra-procedural requirements.¹ Given the rapid industry shift that allows even smaller regional community hospitals the opportunity to offer TAVR services, the future has arrived, and many common program implications are being uncovered. 

One of the initial challenges can be the immediate availability and interest of both an interventional cardiologist and heart surgeon to lead the program and maintain availability during the procedure. A unique requirement for the procedure and for Medicare reimbursement is that the cardiologist and surgeon must both be physically present during the TAVR procedure. Often, Corazon meets with both groups of physicians to provide guidance regarding the ‘presence’ requirement, because it is mandatory that both physician skill sets are immediately available during the TAVR procedure. Currently, surgeons are transferring their intraoperative surgical skills to the interventional cardiologists, and the cardiologists are transferring their catheter-based skills to the surgeons, and we suspect that this requirement of dual physician operators may become less restrictive in the near future. 

Fortunately the intra-procedural phase of TAVR does not usually place a heavy burden on the procedure/operating room schedule. In fact, most skilled operators are able to perform the TAVR procedure in 2 to 3 hours. It is with the post-operative management of these patients that facilities have the most difficulty conforming to a best-practice standard. Managing patients who are often [erroneously] viewed as ‘simple’ valve surgery patients in a new way can be challenging even for experienced hospital staff. Corazon is aware of programs outside of the United States that consistently discharge TAVR patients in three days or less. And, these same programs also post excellent results in terms of readmissions or other complications often associated with early discharge. Our client database currently reveals an average length-of-stay (LOS) closer to five days. 

Many tools are available to assist with the implementation of a TAVR program, such as the TAVR clinical guidelines that have been developed through a consensus of the American Association for Thoracic Surgery, American College of Cardiology Foundation, Society for Cardiovascular Angiography and Interventions, and the Society of Thoracic Surgeons.² However, there are no readily available tools for the development of patient pathways/protocols that expedite safe care practices for TAVR, particularly in the post-procedure phase. Most often, these tools must be created by the TAVR program personnel through a collaborative approach with the key medical and hospital staff. This effort can be time-consuming and should be led by one champion to oversee the process. 

The TAVR coordinator

In Corazon’s experience, many TAVR facilities report that they underestimated the resources required to adequately work up patients pre-procedure. Due to the fact that the target patient population is elderly with multiple co-morbidities, these patients require a great deal of pre-operative testing and education to ensure they are medically optimized prior to the procedure. This can be a monumental task requiring the precision of an expert air traffic controller, especially since the patients in this demographic can be at the greatest risk of falling outside of standard medical processes. In Corazon’s experience, the most successful TAVR programs have a dedicated TAVR coordinator at the helm.

Often, comparisons are made between the TAVR coordinator and the nurse navigator roles that are being deployed for other types of cardiac patient management (i.e., congestive heart failure). We believe that the TAVR coordinator will be most effective if the individual has an advanced clinical skill set to assist with patient assessments and administrative responsibilities, which include coordinating referrals with physician specialists. A mid-level provider, such as a nurse practitioner or physician assistant already experienced in the care of patients with valvular disease, is optimal in this role. The TAVR coordinator must also have an advanced understanding of patient selection criteria, the TAVR procedure, and the typical patient care pathway as they serve as the educational link for the patient and families, as well as directly coordinate patient flow for the physicians. 

The organization and coordination skills integral to the TAVR coordinator position should not be underestimated. Most valve patients have been dealing with a chronic condition or symptoms related to their valvular disease, and a valve clinic outreach model is highly effective for this chronic population. One of the most common models today also has the TAVR coordinator leading or co-leading the valve clinic with another mid-level or nurse provider. Lastly, no clinical service would be deemed complete without outcomes reporting. Thus, one of the final items of the TAVR coordinator’s responsibilities must be to ensure the accurate collection and submission of patient data.

Measuring TAVR program outcomes

Heart programs must continually demonstrate that newer and disruptive technologies like TAVR, particularly with the rapid widespread adoption, have a distinctive benefit for patients. Centers for Medicare & Medicaid Services (CMS) has issued the national coverage determination (NCD) requiring that hospitals must participate in a national TAVR registry in order to meet patient outcomes tracking.⁵ The American College of Cardiology (ACC) and Society of Thoracic Surgeons (STS) have jointly created the STS/ACC TVT (transcatheter valve therapy) Registry. The STS/ACC TVT Registry is accessed and reported to in an identical manner as the ACC-National Cardiovascular Data Registry (NCDR), which with most cath lab personnel are already familiar. Furthermore, the STS/ACC TVT Registry satisfies the requirements of the CMS/NCD. All TAVR programs in the Corazon client database use this tool, which will help prevent payment denials from CMS.

The individual metrics that should be tracked for TAVR programs are not that unique in comparison to other key heart program metrics. Mortality and major complications (such as stroke) should be the first indicators that any TAVR program places under intense scrutiny. These key indicators are the most directly linked to ultimate patient benefit and will likely become publically available. Therefore, mortality and complications should always be reported to the TAVR team on a regular basis. Perhaps the greatest benefit of the TAVR procedure is its minimally invasive approach, which should directly correlate with decreased LOS compared to traditional SAVR patients. Monitoring and treatment of complications related to surgical access sites are one of the strongest linkages to LOS. Also, Corazon urges our clientele to monitor labor and supplies for TAVR cases compared to SAVR cases, though this can be difficult in institutions that lack fully detailed cost accounting systems. 

TAVR is a distinctive component of heart programs

It is evident that TAVR therapy has quickly evolved from a mere technological device to a differentiating service offering for distinctive heart programs. Hospitals often struggle with the resources required to provide TAVR services in a standard and efficient manner. Thus, TAVR will no doubt continue to impact facilities with its requirements for physician manpower, facility, staffing, and other operational needs as the future of this evolving technology unfolds. Evaluating TAVR program components such as a proper growth plan, various program needs including physicians and personnel, the role of the TAVR coordinator, and outcomes management is absolutely essential, especially because minimally invasive approaches to structural heart disease, including TAVR and other options, are no doubt going to grow now, in the near future, and beyond.

Ross is a Senior Vice President at Corazon, Inc., offering consulting, recruitment, interim management, and IT solutions for hospitals and practices in the heart, vascular, neuro, and orthopedics specialties. To learn more, call (412) 364-8200 or visit www.corazoninc.com. To reach the author, email rswanson@corazoninc.com

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What Do You Think? A Follow-up

In the January 2014 issue, CLD featured a discussion question submitted by Marshall Ritchey, MS, MBS, RCIS, CPFT, a cath lab manager. His question focused on whether STEMI patients — if stable and not in great distress — should be slid over from the cath lab exam table to the stretcher by staff or whether a patient should scoot themselves.

CLD received one additional answer, below…

Todd: Making a patient scoot or slide does increase the work of the heart.
In patients with ANY symptom or sign, or active complaint, I agree that they should be moved. Maybe if it was Tom Brady, LeBron James or someone in great shape, I might consider it…maybe… just for a second.
Asking someone to move when they have any symptoms is risky medically, risky ethically, risky politically, and risky to your patient survey process. DO NO HARM!
The challenge here is to find out WHY staff feel they need to have the patient move on their own. 

…And then we checked in with Mr. Ritchey on his final lab policy decision:

Thank you to all who participated in this discussion and for your support! Better safe than sorry. We will slide all STEMI patients. 

Respectfully yours,

Marshall Ritchey, Manager, Cardiac Cath Lab

Piedmont Medical Center, Rock Hill, South Carolina

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Want more CMEs/CEUs? Check out these two previous TAVR articles:

Focusing on Each Patient: TAVR Care Protocols at Long Island Jewish Medical Center

Planning and Developing a Successful TAVR Program at Maine Medical Center: Economic, Program, and Procedural Considerations

References

1. Swanson R. A paradigm shift in the treatment of valvular heart disease: transcatheter aortic valve implantation (TAVI). Cath Lab Digest 2011: 19(1). Available online at https://www.cathlabdigest.com/articles/Paradigm-Shift-Treatment-Valvular-Heart-Disease-Transcatheter-Aortic-Valve-Implantation-TAV. Accessed February 18, 2014.
2. Tommaso CL, Bolman RM 3rd, Feldman T, Bavaria J, Acker MA, Aldea G, Cameron DE, Dean LS, Fullerton D, Hijazi ZM, Horlick E, Miller DC, Moon MR, Ringel R, Ruiz CE, Trento A, Weiner BH, Zahn EM; American Association for Thoracic Surgery; Society for Cardiovascular Angiography and Interventions; American College of Cardiology Foundation; Society of Thoracic Surgeons. Multisociety (AATS, ACCF, SCAI, and STS) expert consensus statement: operator and institutional requirements for transcatheter valve repair and replacement, part 1: transcatheter aortic valve replacement. J Thorac Cardiovasc Surg. 2012 Jun;143(6):1254-63. doi: 10.1016/j.jtcvs.2012.03.002. 
3. Mihelis E, Lam J. Focusing on each patient: TAVR care protocols at Long Island Jewish Medical Center. Cath Lab Digest. 2013 Dec; 21(12). Available online at https://www.cathlabdigest.com/articles/Focusing-Each-Patient-TAVR-Care-Protocols-Long-Island-Jewish-Medical-Center. Accessed February 18, 2014.
4. Butzel D, Berg CM, Black K. Planning and developing a successful TAVR program at Maine Medical Center: economic, program, and procedural considerations. Cath Lab Digest. 2013 Nov; 21(11). Available online at https://www.cathlabdigest.com/articles/Planning-Developing-Successful-TAVR-Program-Maine-Medical-Center-Economic-Program-Procedura. Accessed February 18, 2014. 
5. CMS releases official national coverage determination for TAVR. STS/ACC TVT Registry. Available online at https://www.ncdr.com/TVT/Home/NewsAnnouncement.aspx. Accessed February 2, 2014.