The number of hospitals providing TAVR could double in the US, due to recent changes to Medicare coverage rules. This IHPI brief outlines important policy considerations to help ensure optimal outcomes for patients.
For patients diagnosed with severe symptomatic aortic stenosis (AS), open-heart surgical replacement of the aortic valve (SAVR) was previously the only available definitive treatment to reduce symptoms and extend life. Over the past decade, transcatheter aortic valve replacement (TAVR) has emerged as a minimally invasive alternative to surgery. TAVR is now the primary therapy for inoperable patients and is rapidly replacing SAVR for patients at high or intermediate risk for surgery.1-4
Definition: the aortic valve is the gatekeeper that allows oxygenated blood to flow from the heart to the rest of the body. Narrowing of the aortic valve, called aortic stenosis (AS), disrupts this flow of blood, leading to episodes of chest pain, loss of consciousness, and heart failure.
Aortic stenosis in the U.S.
- 1 in 8 adults age 75 and older have moderate or severe AS.5-7
- 50% mortality rate within 2 years of severe symptomatic AS diagnosis if untreated.8-10
- 7-fold increase in the volume of TAVR procedures between 2012 and 2016.11
In 2019, the U.S. Food and Drug Administration approved TAVR for use in patients with severe symptomatic AS at low surgical risk.12 Consequently, the Centers for Medicare and Medicaid Services relaxed its national coverage rules, lowering cardiac surgical volume requirements in order to expand the number of hospitals providing the procedure.13
Takeaways from our research*
A University of Michigan research team studied hospitals that were not providing TAVR before the Medicare coverage changes, to assess how many of these hospitals may now meet the new surgical volume requirements and to describe their characteristics, using national Medicare data.
- The number of hospitals eligible to provide TAVR could double under new Medicare coverage rules.
- Sites newly eligible to provide TAVR are more likely to have fewer beds, be non-teaching hospitals, and treat less medically complex patients.
- Variation in the geographic distribution of TAVR hospitals persists, with limited access to TAVR in rural and safety net hospitals.
What are the implications for policy and practice?
As access to TAVR is expanded to new sites, important considerations remain in order to help ensure optimal outcomes for patients.
- TAVR-specific quality metrics are needed in order to monitor patient outcomes as access expands. Quality metrics should be evaluated to ensure that they are valid and reliable.
- The volume of TAVR procedures at the new and existing sites should be monitored, with special consideration around how to measure patient outcomes for sites with a low volume of TAVR procedures. Evidence shows that outcomes at low volume sites are worse on average, compared to high volume centers.14
- The location and characteristics of TAVR and non-TAVR hospitals should be monitored to help ensure that access is expanded in areas of need, rather than expanding further in existing markets.
- Continued tracking of case volume and quality for cardiovascular procedures outlined in national coverage requirements is needed to mitigate potential unintended effects.
*Access to Transcatheter Aortic Valve Replacement Under New Medicare Surgical Volume Requirements. Thompson MP, Brescia AA, Hou H, Pagani FD, Sukul D, Dimick, JB, Likosky DS. JAMA Cardiol. 2020 Apr 1;e200443. PMID: 32236500. doi:10.1001/jamacardio.2020.0443.
1 Transcatheter Aortic-Valve Implantation for Aortic Stenosis in Patients Who Cannot Undergo Surgery. Leon MB, Smith CR, Mack M, et al. N Engl J Med. 2010;363(17):1597-1607. PMID: 20961243. doi:10.1056/NEJMoa1008232.
2 Predictors of Poor Outcomes After Transcatheter Aortic Valve Replacement: Results From the PARTNER (Placement of Aortic Transcatheter Valve) Trial. Arnold SV, Reynolds MR, Lei Y, et al. Circulation. 2014;129(25):2682-2690. PMID: 24958751. doi:10.1161/CIRCULATIONAHA.113.007477.
3 Transcatheter Aortic-Valve Replacement with a Balloon-Expandable Valve in Low-Risk Patients. Mack MJ, Leon MB, Thourani VH, et al. N Engl J Med. 2019;380(18):1695-1705. PMID: 30883058. doi:10.1056/NEJMoa1814052.
4 Transcatheter Aortic-Valve Replacement with a Self-Expanding Valve in Low-Risk Patients. Popma JJ, Deeb GM, Yakubov SJ, et al. N Engl J Med. 2019;380(18):1706-1715. PMID: 30883053. doi:10.1056/NEJMoa1816885.
5 Burden of Valvular Heart Diseases: A Population-Based Study. Nkomo VT, Gardin JM, Skelton TN, Gottdiener JS, Scott CG, Enriquez-Sarano M. Lancet. 2006;368(9540):1005-1011. PMID: 16980116. doi:10.1016/S0140-6736(06)69208-8.
6 Prevalence of Aortic Valve Abnormalities in the Elderly: An Echocardiographic Study of a Random Population Sample. Lindroos M, Kupari M, Heikkila J, Tilvis R. J Am Coll Cardiol. 1993;21(5):1220-1225. PMID: 8459080. doi:10.1016/0735-1097(93)90249-Z.
7 The Evolving Epidemiology of Valvular Aortic Stenosis: The Tromsø Study. Eveborn GW, Schirmer H, Heggelund G, Lunde P, Rasmussen K. Heart. 2013;99(6):396-400. PMID: 22942293. doi:10.1136/heartjnl-2012-302265.
8 Aortic Stenosis. Ross J Jr, Braumwald E. Circulation. 1968;38(1 Suppl):61-67. PMID: 4894151. doi:10.1161/01.cir.38.1s5.v-61.
9 Prospective Study of Asymptomatic Valvular Aortic Stenosis. Otto CM, Burwash IG, Legget ME, et al. Circulation. 1997;95(9):2262-2270. PMID: 9142003. doi:10.1161/01.cir.95.9.2262.
10 2017 AHA/ACC Focused Update of the 2014 AHA/ACC Guideline for the Management of Patients with Valvular Heart Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Nishimura RA, Otto CM, Bonow RO, et al. J Am Coll Cardiol. 2017;70(2):252-289. PMID: 28315732. doi:10.1016/j.jacc.2017.03.011.
11 The Society of Thoracic Surgeons Adult Cardiac Surgery Database: 2018 Update on Outcomes and Quality. D’Agostino RS, Jacobs JP, Badhwar V, et al. Ann Thorac Surg. 2018;105(1):15-23. PMID: 29233331. doi:10.1016/j.athoracsur.2017.10.035.
12 Office of the Commissioner. FDA Expands Indication for Several Transcatheter Heart Valves to Patients at Low Risk for Death or Major Complications Associated with Open-Heart Surgery. U.S. Food and Drug Administration. https://www.fda.gov/news-events/press-announcements/fda-expands-indication-several-transcatheter-heart-valves-patients-low-risk-death-or-major. Published 2019. Accessed February 25, 2020.
13 Centers for Medicare and Medicaid Services. Decision Memo for Transcatheter Aortic Valve Replacement (TAVR) (CAG-00430R). Medicare Coverage Database. https://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=293. Published June 21, 2019. Accessed September 3, 2019.
14 Procedural Volume and Outcomes for Transcatheter Aortic-Valve Replacement. Vemulapalli S, Carroll J, Mack M, et al. N Engl J Med. 2019;380:2541-2550. PMID: 30946551. doi:10.1056/NEJMsa1901109.
RELATED ARTICLE: Medicare changes may increase access to TAVR
FOR MORE INFORMATION
Please contact Eileen Kostanecki, IHPI’s Director of Policy Engagement & External Relations, at firstname.lastname@example.org.