The use of transcatheter aortic valve replacement (TAVR) as an alternative to surgical aortic valve replacement (SAVR) has grown rapidly in recent years. The evidence base for its use has also grown and is now quite extensive. With randomized controlled trials comprising over 7,000 patients in the United States and a raft of publications in top journals, TAVR is now considered just as effective as SAVR for certain populations. There are currently 587 sites in the U.S. performing TAVR, up from just 156 in 2012.1
In July 2018, four cardiology societies—the American Association for Thoracic Surgery (AATS), the American College of Cardiology (ACC), the Society for Cardiovascular Angiography and Interventions (SCAI), and the Society of Thoracic Surgeons (STS)—released a new expert consensus statement on operator and institutional requirements for TAVR. This new document is intended to provide support and guidance for centers that perform TAVR throughout the U.S.2
This is the first update TAVR requirements since 2012, and was much-needed, as the number of programs offering TAVR has rapidly increased since then. What’s more, the Centers for Medicare & Medicaid Services (CMS) has not updated their national coverage determination (NCD) for TAVR since 2012. In July, CMS convened a panel of the Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) to discuss updating the NCD, which will be completed by the summer of 2019. The panel used the newly updated consensus statement in their discussions and the document will very likely play a big role in the final NCD released next year. So practices may find that these new guidelines will influence what CMS will reimburse for the TAVR procedure.3
What do the new guidelines say and what do they mean for TAVR centers?
Change in focus from volume to quality
Although the new guidelines shift the focus away from measuring the performance of centers by using only the volume of procedures performed,4 they still recommend that existing TAVR programs meet certain requirements. Specifically, at least 50 TAVRs per year, or 100 over two years, and at least 30 SAVRs over one year, or 60 over two years. This is an increase from the current NCD that specifies 20 annual TAVRs. However, the writing committee includes the caveat that they are not recommending that programs that do not meet those volume guidelines should close, but should evaluate whether they are within national benchmarks for quality of care.
Beyond number of procedures performed, centers must now track a number of other quality metrics focused on morbidity, mortality, and quality of life at certain time points post-TAVR. They also recommend that centers implement a quality assessment and improvement process including active participation in a registry, quarterly meetings of the multidisciplinary team, and documentation of appropriate-use criteria in the patient selection process.
The issue of the relevance of procedural volume to patient outcomes has been a matter of lively debate, with several papers and opinions being published by experts in recent months that discuss the relationship between quality and volume as well as whether a focus on the number of procedures performed limits access to TAVR for patients in rural or underserved areas.5,6,7,8 Those in favor of volume requirements say that recent studies support a correlation between volume and patient outcomes. Experts who are opposed to volume requirements cite patient access as their main concern, including whether smaller centers might in fact yield high-quality outcomes with lower volume. The new consensus statement aimed to balance the need for patient access to TAVR with the latest evidence on competency and quality outcomes.
Two-surgeon sign-off requirement dropped
Just days before MEDCAC convened last summer, several TAVR expert physicians penned an editorial, questioning the current requirement that two surgeons must examine a patient and sign off before TAVR is approved. The authors asserted that this requirement was a major barrier for patients to receiving timely care.9
The 2018 guidelines align with this opinion. The expert consensus statement requires only one cardiac surgeon at the TAVR center to evaluate the patient face-to-face. A second physician on the heart team must also evaluate the patient, but they do not need to be a cardiac surgeon—a general cardiologist or interventionist will suffice.
Requirements for establishing a new program
The 2018 update substantially changes the recommendations for what hospitals must do before launching a new TAVR program. While they have lowered the number of SAVR procedures that must have been performed in the year prior, hospitals must now have a trained TAVR operator on their heart team. This operator, who must be either a cardiothoracic surgeon or an interventionalist, should have at least 100 transfemoral TAVR procedures under their belt, with at least 50 of those as the primary operator. The TAVR operator must spend at least 50 percent of their active practice time with the TAVR program. If this TAVR operator is a surgeon, the other team physician must be an interventional cardiologist.
The multidisciplinary heart team also needs to include a cardiac surgeon who has performed at least 100 SAVRs over their lifetime or 50 SAVRs over two years, with at least 20 of those in the previous year. This cardiac surgeon also must spend at least half their active practice time with the TAVR program.
Anticipating the updated TAVR NCD
While the expert consensus statement provides recommendations and guidelines for TAVR centers, everyone is still watching and waiting for the new TAVR NCD to be released by CMS in June of 2019. The MEDCAC panel that convened last summer was somewhat split when considering the need for volume requirements for TAVR and what type of requirements those should be. They discussed the potential harm of limiting access by requiring a certain volume of procedures, but also the need to maintain high-quality outcomes via consistent experience.
Physicians will have to wait and see how CMS implements the new society consensus statement in their final update to the NCD, but practices can begin to implement the new guidelines in the meantime.
1. The Evolution of TAVR from a High Risk Procedure to Standard of Care. Cardiology Today’s Intervention. https://www.healio.com/cardiac-vascular-intervention/transcatheter-aortic-valve-replacement/news/print/cardiology-today-intervention/%7B3e1ce456-ca82-4688-a352-42990cc31606%7D/the-evolution-of-tavr-from-a-high-risk-procedure-to-standard-of-care Last accessed January 10, 2019.
2. 2018 AATS/ACC/SCAI/STS Expert Consensus Systems of Care Document: Operator and Institutional Recommendations and Requirements for Transcatheter Aortic Valve Replacement. Journal of the American College of Cardiology. http://www.onlinejacc.org/content/early/2018/06/20/j.jacc.2018.07.002?_ga=2.149407094.1184132970.1532054744-1546805590.1489634869 Last accessed January 10, 2019.
3. TAVR Program Requirements Are Changing, Are You Ready? Advisory Board: Cardiovascular Rounds. https://www.advisory.com/research/cardiovascular-roundtable/cardiovascular-rounds/2018/08/tavr Last accessed January 10, 2019.
4. Updated TAVR Consensus Statement Keeps Volume Requirements but Shifts Focus to Quality. TCTMD. https://www.tctmd.com/news/updated-tavr-consensus-statement-keeps-volume-requirements-shifts-focus-quality Last accessed January 10, 2019.
5. Assuring High Quality for Transcatheter Aortic Valve Replacement While Achieving Adequate Patient Access: What’s the Controversy? Cardiovascular Revascularization Medicine. https://www.sciencedirect.com/science/article/pii/S1553838918305013?via%3Dihub Last accessed January 10, 2019.
6. Volume and the Ever-Increasing Standard of Quality Heart Valve Care. https://www.sciencedirect.com/science/article/pii/S1936879818323008?via%3Dihub Last accessed January 10, 2019.
7. Transcatheter Aortic Valve Replacement in the Era of Quality Assessment: Crossing the Quality Chasm. https://www.ahajournals.org/doi/pdf/10.1161/CIRCOUTCOMES.118.005233 Circulation and Cardiovascular Quality Outcomes. Last accessed January 10, 2019.
8. Has a New Determinant of Transcatheter Aortic Valve Replacement Outcomes Been Identified? https://jamanetwork.com/journals/jamacardiology/fullarticle/2715809?utm_campaign=articlePDF&utm_medium=articlePDFlink&utm_source=articlePDF&utm_content=jamacardio.2018.4170 JAMA Cardiology. Last accessed January 10, 2019.
9. Is Two Better Than One? Re‐evaluating the Surgical Approval Process for TAVR. Catheterization Cardiovascular Interventions. https://onlinelibrary.wiley.com/doi/full/10.1002/ccd.27666 Last accessed January 10, 2019.