The new ACC valvular heart disease guidelines, released in 2020, recognize the expanding role of transcatheter aortic valve replacement (TAVR) and the intervention choices available for a patient with severe aortic stenosis. This focused update provides evidence-based recommendations to optimize care and management of patients with valvular heart disease, and highlights the expanding indications for this procedure, mostly as a direct result of multiple randomized controlled trials comparing TAVR and surgical aortic valve replacement (Otto, et al, 2020).
Advances in structural heart therapeutic modalities and interventional treatments have been evolving rapidly since TAVR was first approved by the U.S. Food and Drug Administration (FDA) in 2012. And since the expanded indication to low-risk patients in August 2019, there has been a paradigm shift from open surgical Aortic Valve Replacement (SAVR) to TAVR, based on research that shows similar clinical outcomes as good (if not better!) than standard open-heart surgical approach.
According to a report from the Society of Thoracic Surgeons (STS), since the low-surgical-risk indication approval in 2019, TAVR is now the dominant form of aortic valve replacement and exceeded all forms of SAVR in the U.S. for the first time. And according to the STS report, in addition to the steady rise in case volumes since 2011, there has also been a significant improvement in the quality of care over the last nine years. Other structural heart therapies like LAAC (left atrial appendage closure) and TMVR (transcatheter mitral valve repair and replacement) have also given cardiovascular programs the ability to extend and improve lives through a variety of minimally-invasive means.
As structural heart has increasingly become a top priority for many cardiovascular service lines, many realize that developing a successful program is not an easy task. Growing competition, pressure on margins, declining reimbursement, and increasing regulations that limit eligibility to implement and maintain a program can make developing a cost-effective and successful structural heart program challenging.
But starting a structural heart program will often allow hospitals the ability to recruit and retain top specialists who can bring more patients to the hospital. So as more patients opt for the minimally-invasive treatment option over traditional open heart surgery, more hospitals are pursuing structural heart service development, starting with TAVR as a cornerstone of the program.
Making the decision to start a structural heart program
Starting a structural heart program takes an in-depth and focused planning effort. These programs are complicated and involve multiple stakeholders, and require careful care coordination and an effective program leadership within a formalized structure for ongoing success. Building a successful structural heart program requires the following three key components as foundational building blocks:
- First and foremost, both a dedicated physician and administrative champion are necessary. The physician champion should possess the leadership skills to not only execute the program clinically and operationally, but also spearhead training/educational initiatives, advocate for the clinical aspects of the program, gain familiarity with the CMS criteria and regulatory requirements, and think strategically about growth. On the other hand, the administrative champion needs to be an experienced expert, adept at program development and the financial aspects of the service line.
- Dedicated team members are needed to drive the multifaceted processes of this complex service, and this team includes not only cardiac surgery and cardiology, but also clinical operations and nursing, care coordination, finance, marketing, and community outreach departments. The development of a care team with defined roles and responsibilities is an economical cost-effective strategy, and this approach fosters a collaborative effort between interventional cardiologists and cardiac surgeons as an essential element. This multidisciplinary team (MDT) should emphasize patient-centered care delivery, which in turn highlights the need for shared decision-making for patients, who tend to have multiple comorbidities and thereby have many requirements for pre- and post-procedural care (Nishimura, et al; 2019).
- A navigator can be a key role, as this person serves as a liaison between the surgeon and other physicians. Navigators may also lead initiatives to determine suitable patients as referrals, which are an important aspect to the future growth and sustainability of the program. Without referrals, any program would cease to flourish, regardless of market dynamics.
Additional required resources, which can limit or threaten a successful implementation, include commitments to training and education, appropriate staffing, case selection and screening, pre- and post-procedure protocols to handle complex patient needs, and financial resources.
Challenges and Benefits
Structural heart today has many moving parts and regulatory compliance is key among them for ensuring appropriate reimbursement. Missing, incomplete, or poor documentation can lead to decreased or no reimbursement. Creating templates for standardization and clinical pathways, regular meetings with abstractors and billing personnel, and understanding coding procedures are all integral to discovering opportunities for improvement.
Most programs report implants as the number one expense; therefore, cost containment and savings initiatives should be developed early in the program for a financially sustainable program. A study conducted by Luack, et. al. (2019) showed that significant cost savings can be achieved with the implementation of clinical pathways and other care coordination strategies such as length of stay initiatives, along with QA programs to monitor complications, which inevitably drive the costs of clinical care higher while reimbursement may remain the same.
Although building the business case for a structural heart program can be challenging, and the cost of the valve implants and suitable procedural space may be costly or prohibitive, the return on investment (ROI) is not necessarily based on the increase in ancillary growth and downstream revenue, such as increases in surgical valve volumes. And while it is important to understand the overall program margin, it can also be challenging because the methodology for cost and revenue calculations is often varied in hospital systems. Despite the complexity, hospital leaders must understand costs, manage expenses, and be able to calculate the financial halo effect and bottom line impact of the program. A review of the financials can help to form the basic planning framework to explore the addition or expansion of a structural heart program.
For more information on implementing a structural heart or TAVR program, sign up for our webinar March 30, 2021 titled “Options and Opportunity: Does a Structural Heart Program Make Sense for Your Organization?”
- Catherine M. Otto, Rick A. Nishimura, Robert O. Bonow, Blase A. Carabello, John P. Erwin, Federico Gentile, Hani Jneid, Eric V. Krieger, Michael Mack, Christopher McLeod, Patrick T. O’Gara, Vera H. Rigolin, Thoralf M. Sundt, Annemarie Thompson, and Christopher Toly. 2020 ACC/AHA Guideline for the Management of Patients With Valvular Heart Disease: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. J Am Coll Cardiology. Dec 17, 2020. Epublished DOI: 10.1016/j.jacc.2020.11.018
- Raj R. Makkar, Vinod H. Thourani, Michael J. Mack, et al. Five-Year Outcomes of Transcatheter or Surgical Aortic-Valve Replacement. New England Journal of Medicine. Published online Jan. 29, 2020. DOI: 10.1056/NEJMoa1910555.
- Natalie Morrison, TAVR Use Exceeds That of SAVR in US in 2019, Outcomes Continue to Improve. Accessed online on December 7, 2020 at https://www.crtonline.org/news-detail/tavr-use-exceeds-that-of-savr-in-us-in-2019-outcom
- Nishimura RA, O’Gara PT, Bavaria JE, Brindis RG, Carroll JD, Kavinsky CJ, Lindman BR, Linderbaum JA, Little SH, Mack MJ, Mauri L, Miranda WR, Shahian DM, Sundt TM 3rd. 2018 AATS/ACC/ASE/SCAI/STS expert consensus systems of care document: a proposal to optimize care for patients with valvular heart disease: a joint report of the American Association for Thoracic Surgery, American College of Cardiology, American Society of Echocardiography, Society for Cardiovascular Angiography and Interventions, and Society of Thoracic Surgeons. J Am Coll Cardiol 2019;72:2609-35.
- Bavaria JE, Tommaso CL, Brindis RG, Carroll JD, Deeb GM, Feldman TE, Gleason TG, Horlick EM, Kavinsky CJ, Kumbhani DJ, Miller DC, Seals AA, Shahian DM, Shemin RJ, Sundt TM III, Thourani VH. 2018 AATS/ACC/SCAI/STS Expert Consensus Systems of Care Document: operator and institutional recommendations and requirements for transcatheter aortic valve replacement. Ann Thorac Surg 2019;107:650–684.
- Structural heart program survey. 2018.
- Sandra B. Lauck, Suzanne J. Baron, Janarthanan Sathananthan, Dale Murdoch, John G. Webb, Philippe Genereux, Susheel K. Kodali, Matthew Reynolds, Christin Thompson, Seth Clancy, Vinod H. Thourani, David A. Wood & David J. Cohen (2019) Exploring the Reduction in Hospitalization Costs Associated with Next-Day Discharge following Transfemoral Transcatheter Aortic Valve Replacement in the United States, Structural Heart, 3:5, 423-430, DOI: 10.1080/24748706.2019.1634854
- Carroll J, Mack M, Vemulapalli S, et al. STS-ACC TVT Registry of Transcatheter Aortic Valve Replacement. J Am Coll Cardiol 2020;76:2492-516.
- CMS Finalizes Updates to Coverage Policy for Transcatheter Aortic Valve Replacement (TAVR). July 2019, Accessed online January 4, 2021 at CMS website at: https://www.cms.gov/medicare-coverage-database/details/nca-tracking-sheet.aspx?NCAId=293
- STS News, Winter 2021 Accessed online at: https://www.sts.org/publications/sts-news/tavr-surges-past-surgery-us-avr-treatment-volume