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Economic Implications of Transcatheter Aortic Valve Replacement in Patients at Intermediate Surgical Risk

2016; Lippincott Williams & Wilkins; Volume: 134; Issue: 19 Linguagem: Inglês

10.1161/circulationaha.116.021962

1524-4539

Matthew R. Reynolds, Suzanne J. Baron, David J. Cohen,

Cardiac pacing and defibrillation studies

HomeCirculationVol. 134, No. 19Economic Implications of Transcatheter Aortic Valve Replacement in Patients at Intermediate Surgical Risk Free AccessResearch ArticlePDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissions ShareShare onFacebookTwitterLinked InMendeleyReddit Jump toFree AccessResearch ArticlePDF/EPUBEconomic Implications of Transcatheter Aortic Valve Replacement in Patients at Intermediate Surgical Risk Matthew R. Reynolds, MD, MSc, Suzanne J. Baron, MD, MSc and David J. Cohen, MD, MSc Matthew R. ReynoldsMatthew R. Reynolds From Harvard Clinical Research Institute, Boston, MA, and Lahey Hospital & Medical Center, Burlington, MA (M.R.R.); and Saint Luke's Mid America Heart Institute, University of Missouri-Kansas City (S.J.B., D.J.C.). , Suzanne J. BaronSuzanne J. Baron From Harvard Clinical Research Institute, Boston, MA, and Lahey Hospital & Medical Center, Burlington, MA (M.R.R.); and Saint Luke's Mid America Heart Institute, University of Missouri-Kansas City (S.J.B., D.J.C.). and David J. CohenDavid J. Cohen From Harvard Clinical Research Institute, Boston, MA, and Lahey Hospital & Medical Center, Burlington, MA (M.R.R.); and Saint Luke's Mid America Heart Institute, University of Missouri-Kansas City (S.J.B., D.J.C.). Originally published8 Nov 2016https://doi.org/10.1161/CIRCULATIONAHA.116.021962Circulation. 2016;134:1416–1418IntroductionPopulation aging and other factors are propelling healthcare spending on a perpetually increasing trajectory. More than ever, we must carefully assess the economic impact of adopting new medical technologies into clinical practice. Recently, transcatheter aortic valve replacement (TAVR) has emerged as a remarkable advance in the treatment of aortic stenosis. Studies have shown that TAVR in patients with aortic stenosis at extreme and high surgical risk provides good economic, as well as, clinical value.1–3 As the role of TAVR is now considered for intermediate-risk patients, questions about value must be asked and answered again.To understand the cost-effectiveness of TAVR in intermediate-risk patients, it is helpful to consider the lessons learned in higher-risk patients. First, it is apparent that the major offsets for the increased technology cost of TAVR in comparison with surgical aortic valve replacement (SAVR) are decreased hospital length of stay (LOS) and a reduced need for postacute rehabilitation services. With TAVR prices currently in excess of $30 000 per device in the United States (in comparison with ≈$5000 per surgical valve), reductions in LOS must be quite large for TAVR to pay for itself. If the costs of TAVR are higher than SAVR, the cost-effectiveness of TAVR from a societal perspective is strongly affected by the presence or absence of a mortality benefit with TAVR. In the absence of a survival difference, the advantages of TAVR relative to SAVR consist primarily of faster recovery, avoidance of certain complications, and improved quality of life, which is transient. In health economic terms, these benefits result in only small ( $10 000 per patient), then ICERs are quite high and unfavorable in the absence of a survival difference.Download figureDownload PowerPointFigure. Schematic diagram demonstrating the hypothetical relationship between postprocedure length of stay, mortality benefit, and the cost-effectiveness of TAVR for intermediate-risk patients. ICER indicates incremental cost-effectiveness ratio; LOS, length of stay; SAVR, surgical aortic valve replacement; and TAVR, transcatheter aortic valve replacement.An additional consideration in the assessment of TAVR cost-effectiveness is the impact of access site. Although TAVR via nontransfemoral (TF) access may be preferred to SAVR in some circumstances, available data from randomized trials have failed to demonstrate any clear advantage of non-TF TAVR over SAVR in either high- or intermediate-risk patients. Furthermore, the reductions in LOS with non-TF TAVR relative to SAVR have been small. The net result is that the cost-effectiveness of TAVR relative to SAVR has been generally favorable for patients eligible for TF access, but less so for patients only suitable for non-TF approaches.Another factor that influences the cost-effectiveness of TAVR is the healthcare system in which the procedure is performed. Indeed, cost-effectiveness estimates for TAVR outside the United States have been much less favorable than those from US-based analyses. This is partly because hospital days, the main cost offset for TAVR, are less costly in other countries. Moreover, the acceptable ICER threshold (which is ≈$50 000/quality-adjusted life-year in the United States) is generally lower in environments where healthcare spending is substantially less than in the United States. This has resulted in more pricing pressure on TAVR devices (aided by the availability of multiple TAVR systems), and more selective reimbursement schemes, as well, in some less affluent countries.Recently, clinical outcomes were reported from the PARTNER 2A trial (Placement of Aortic Transcatheter Valve), the first randomized trial comparing TAVR with SAVR for intermediate-risk patients,4 and so we can begin to speculate on the cost-effectiveness of TAVR in this population. PARTNER 2A demonstrated noninferiority between TAVR and SAVR on the primary end point (a composite of mortality or disabling stroke). In the TF cohort, there was a trend toward reduced mortality at 2 years (14.2 versus 17.2%, P=0.11). Furthermore, median LOS was 6 days for TAVR and 9 days for SAVR in the full study population.4 These results suggest that TAVR was probably not cost neutral relative to SAVR in the trial, and that the cost-effectiveness of TAVR would therefore depend on the precise incremental costs of TAVR as well as the magnitude of observed and projected survival and quality-of-life differences.It is clear, however, that the evaluation of cost-effectiveness in intermediate-risk patients will have to look beyond PARTNER 2A. Concurrently with the release of the PARTNER 2A results, investigators also reported results from a similar patient group treated with the third-generation SAPIEN 3 valve.5 In this nonrandomized, propensity score–adjusted comparison, the SAPIEN 3 cohort had lower rates of stroke and death in comparison with patients treated with either TAVR or SAVR in PARTNER 2A and a reduction in median LOS of 5 days in comparison with SAVR. Notwithstanding the limitations of nonrandomized studies, the available results from the SAPIEN 3 study suggest that TAVR may provide both high clinical and economic values in intermediate-risk patients, but final conclusions will require the completion of rigorous analysis. In addition to the aforementioned issues, this analysis may need to consider the issue of long-term valve durability. Most high-risk patients with aortic stenosis are elderly and, thus far, it has appeared unlikely that long-term valve performance would affect cost-effectiveness. Whether this is also true for younger, lower-risk patients is not yet known.As with most real advances in health care, current data suggest that, although the benefits of TAVR come at a price, these costs may be well justified. TAVR is a fast-moving field, with rapid improvements not only in technology, but also in patient selection, intraprocedural care, and avoidance of complications. The compelling clinical benefits of TAVR now demonstrated in intermediate-risk patients demand strong consideration for appropriate patients, particularly those suitable for TF access. Just as previous data have suggested that TAVR is cost-effective in high-risk patients, preliminary data suggest that the health economic story of TAVR in intermediate-risk patients is likely to have a similar ending.DisclosuresDr Reynolds: Edwards Lifesciences (consulting income); Medtronic (consulting income); Dr Baron: Edwards Lifesciences (consulting income); St. Jude Medical (consulting income); and Dr Cohen: Edwards Lifesciences, Medtronic, Boston Scientific (research grant support); Edwards Lifesciences and Medtronic (consulting income).FootnotesThe opinions in this article are not necessarily those of the editors or of the American Heart Association.Circulation is available at http://circ.ahajournals.org.Correspondence to: David J. Cohen, MD, MSc, Saint Luke's Mid America Heart Institute, University of Missouri-Kansas City School of Medicine, 4401 Wornall Rd, Kansas City, MO 64111. E-mail [email protected]References1. Reynolds MR, Lei Y, Wang K, Chinnakondepalli K, Vilain KA, Magnuson EA, Galper BZ, Meduri CU, Arnold SV, Baron SJ, Reardon MJ, Adams DH, Popma JJ, Cohen DJ; CoreValve US High Risk Pivotal Trial Investigators. Cost-effectiveness of transcatheter aortic valve replacement with a self-expanding prosthesis versus surgical aortic valve replacement.J Am Coll Cardiol. 2016; 67:29–38. doi: 10.1016/j.jacc.2015.10.046.CrossrefMedlineGoogle Scholar2. Reynolds MR, Magnuson EA, Lei Y, Wang K, Vilain K, Li H, Walczak J, Pinto DS, Thourani VH, Svensson LG, Mack MJ, Miller DC, Satler LE, Bavaria J, Smith CR, Leon MB, Cohen DJ; PARTNER Investigators. Cost-effectiveness of transcatheter aortic valve replacement compared with surgical aortic valve replacement in high-risk patients with severe aortic stenosis: results of the PARTNER (Placement of Aortic Transcatheter Valves) trial (Cohort A).J Am Coll Cardiol. 2012; 60:2683–2692. doi: 10.1016/j.jacc.2012.09.018.CrossrefMedlineGoogle Scholar3. Reynolds MR, Magnuson EA, Wang K, Lei Y, Vilain K, Walczak J, Kodali SK, Lasala JM, O'Neill WW, Davidson CJ, Smith CR, Leon MB, Cohen DJ; PARTNER Investigators. Cost-effectiveness of transcatheter aortic valve replacement compared with standard care among inoperable patients with severe aortic stenosis: results from the Placement of Aortic Transcatheter Valves (PARTNER) trial (Cohort B).Circulation. 2012; 125:1102–1109. doi: 10.1161/CIRCULATIONAHA.111.054072.LinkGoogle Scholar4. Leon MB, Smith CR, Mack MJ, Makkar RR, Svensson LG, Kodali SK, Thourani VH, Tuzcu EM, Miller DC, Herrmann HC, Doshi D, Cohen DJ, Pichard AD, Kapadia S, Dewey T, Babaliaros V, Szeto WY, Williams MR, Kereiakes D, Zajarias A, Greason KL, Whisenant BK, Hodson RW, Moses JW, Trento A, Brown DL, Fearon WF, Pibarot P, Hahn RT, Jaber WA, Anderson WN, Alu MC, Webb JG; PARTNER 2 Investigators. Transcatheter or surgical aortic-valve replacement in intermediate-risk patients.N Engl J Med. 2016; 374:1609–1620. doi: 10.1056/NEJMoa1514616.CrossrefMedlineGoogle Scholar5. Thourani VH, Kodali S, Makkar RR, Herrmann HC, Williams M, Babaliaros V, Smalling R, Lim S, Malaisrie SC, Kapadia S, Szeto WY, Greason KL, Kereiakes D, Ailawadi G, Whisenant BK, Devireddy C, Leipsic J, Hahn RT, Pibarot P, Weissman NJ, Jaber WA, Cohen DJ, Suri R, Tuzcu EM, Svensson LG, Webb JG, Moses JW, Mack MJ, Miller DC, Smith CR, Alu MC, Parvataneni R, D'Agostino RB, Leon MB. Transcatheter aortic valve replacement versus surgical valve replacement in intermediate-risk patients: a propensity score analysis.Lancet. 2016; 387:2218–2225. doi: 10.1016/S0140-6736(16)30073-3.CrossrefMedlineGoogle Scholar Previous Back to top Next FiguresReferencesRelatedDetailsCited By Fontes-Carvalho R, Guerreiro C, Oliveira E and Braga P (2020) Present and future economic impact of transcatheter aortic valve replacement on the Portuguese national healthcare system, Revista Portuguesa de Cardiologia, 10.1016/j.repc.2020.02.013, 39:9, (479-488), Online publication date: 1-Sep-2020. Fontes-Carvalho R, Guerreiro C, Oliveira E and Braga P (2020) Present and future economic impact of transcatheter aortic valve replacement on the Portuguese national healthcare system, Revista Portuguesa de Cardiologia (English Edition), 10.1016/j.repce.2020.02.014, 39:9, (479-488), Online publication date: 1-Sep-2020. Lauck S, Baron S, Sathananthan J, Murdoch D, Webb J, Genereux P, Kodali S, Reynolds M, Thompson C, Clancy S, Thourani V, Wood D and Cohen D (2019) Exploring the Reduction in Hospitalization Costs Associated with Next-Day Discharge following Transfemoral Transcatheter Aortic Valve Replacement in the United States, Structural Heart, 10.1080/24748706.2019.1634854, 3:5, (423-430), Online publication date: 1-Sep-2019. Khera S, Kolte D, Deo S, Kalra A, Gupta T, Abbott D, Kleiman N, Bhatt D, Fonarow G, Khalique O, Kodali S, Leon M and Elmariah S (2019) Derivation and external validation of a simple risk tool to predict 30-day hospital readmissions after transcatheter aortic valve replacement, EuroIntervention, 10.4244/EIJ-D-18-00954, 15:2, (155-163), Online publication date: 1-Jun-2019. Durko A, Osnabrugge R, Van Mieghem N, Milojevic M, Mylotte D, Nkomo V and Pieter Kappetein A (2018) Annual number of candidates for transcatheter aortic valve implantation per country: current estimates and future projections, European Heart Journal, 10.1093/eurheartj/ehy107, 39:28, (2635-2642), Online publication date: 21-Jul-2018. Durko A, Osnabrugge R and Kappetein A (2018) Long-term outlook for transcatheter aortic valve replacement, Trends in Cardiovascular Medicine, 10.1016/j.tcm.2017.08.004, 28:3, (174-183), Online publication date: 1-Apr-2018. Mokhles M, Huygens S and Takkenberg J (2018) The Risk in Avoiding Risk: Optimizing Decision Making in Structural Heart Disease Interventions, Structural Heart, 10.1080/24748706.2017.1407466, 2:1, (30-36), Online publication date: 1-Jan-2018. Voigtländer L and Seiffert M (2018) Expanding TAVI to Low and Intermediate Risk Patients, Frontiers in Cardiovascular Medicine, 10.3389/fcvm.2018.00092, 5 Stähli B, Reinthaler M, Leistner D, Landmesser U and Lauten A (2018) Transcatheter Aortic Valve Replacement and Concomitant Mitral Regurgitation, Frontiers in Cardiovascular Medicine, 10.3389/fcvm.2018.00074, 5 November 8, 2016Vol 134, Issue 19 Advertisement Article InformationMetrics © 2016 American Heart Association, Inc.https://doi.org/10.1161/CIRCULATIONAHA.116.021962PMID: 27821418 Originally publishedNovember 8, 2016 Keywordstranscatheter aortic valve implantationaortic valve stenosiscost effectivenesscost-benefit analysisPDF download Advertisement SubjectsAortic Valve Replacement/Transcatheter Aortic Valve ImplantationCost-Effectiveness