Economic Outcomes of Transcatheter Versus Surgical Aortic Valve Replacement in Patients with Severe Aortic Stenosis and Low Surgical Risk: Results from the PARTNER 3 Trial.

Autor:	Galper BZ; Mid-Atlantic Permanente Medical Group, McLean, VA (B.Z.G.)., Chinnakondepalli KM; Saint-Luke's Mid America Heart Institute, Kansas City, MO (K.M.C., K.W., E.A.M.)., Wang K; Saint-Luke's Mid America Heart Institute, Kansas City, MO (K.M.C., K.W., E.A.M.)., Magnuson EA; Saint-Luke's Mid America Heart Institute, Kansas City, MO (K.M.C., K.W., E.A.M.)., Lu M; Edwards Lifesciences, Irvine, CA (M.L.)., Thourani VH; Piedmont Heart Institute, Atlanta, GA (V.H.T.)., Kodali S; New York-Presbyterian/Columbia University Irving Medical Center, New York (S. Kodali, C.R.S., M.B.L.)., Makkar R; Cedars-Sinai Medical Center, Los Angeles, CA (R.M.)., Herrmann HC; University of Pennsylvania, Philadelphia (H.C.H.)., Kapadia S; Cleveland Clinic, OH (S. Kapadia)., Williams M; NYU-Langone Medical Center, New York, NY (M.W.)., Webb J; St. Paul's Hospital, Vancouver, BC, Canada (J.W.)., Smith CR; New York-Presbyterian/Columbia University Irving Medical Center, New York (S. Kodali, C.R.S., M.B.L.)., Mack MJ; Baylor Scott & White Health, Plano, TX (M.J.M.)., Leon MB; New York-Presbyterian/Columbia University Irving Medical Center, New York (S. Kodali, C.R.S., M.B.L.).; Cardiovascular Research Foundation, New York, NY (M.B.L., D.J.C.)., Cohen DJ; Cardiovascular Research Foundation, New York, NY (M.B.L., D.J.C.).; St. Francis Hospital, Roslyn, NY (D.J.C.).
Jazyk:	angličtina
Zdroj:	Circulation [Circulation] 2023 May 23; Vol. 147 (21), pp. 1594-1605. Date of Electronic Publication: 2023 May 08.
DOI:	10.1161/CIRCULATIONAHA.122.062481
Abstrakt:	Background: In patients with severe symptomatic aortic stenosis at low surgical risk, transfemoral transcatheter aortic valve replacement (TAVR) with the SAPIEN 3 valve has been shown to reduce the composite of death, stroke, or rehospitalization at 2-year follow-up compared with surgical aortic valve replacement (SAVR). Whether TAVR is cost-effective compared with SAVR for low-risk patients remains uncertain. Methods: Between 2016 and 2017, 1000 low-risk patients with aortic stenosis were randomly assigned to TAVR with the SAPIEN 3 valve or SAVR in the PARTNER 3 trial (Placement of Aortic Transcatheter Valves). Of these patients, 929 underwent valve replacement, were enrolled in the United States, and were included in the economic substudy. Procedural costs were estimated using measured resource use. Other costs were determined by linkage with Medicare claims or by regression models when linkage was not feasible. Health utilities were estimated using the EuroQOL 5-item questionnaire. With the use of a Markov model informed by in-trial data, lifetime cost-effectiveness from the perspective of the US health care system was estimated in terms of cost per quality-adjusted life-year gained. Results: Although procedural costs were nearly $19 000 higher with TAVR, total index hospitalization costs were only $591 more with TAVR compared with SAVR. Follow-up costs were lower with TAVR such that TAVR led to 2-year cost savings of $2030/patient compared with SAVR (95% CI, -$6222 to $1816) and a gain of 0.05 quality-adjusted life-years (95% CI, -0.003 to 0.102). In our base-case analysis, TAVR was projected to be an economically dominant strategy with a 95% probability that the incremental cost-effectiveness ratio for TAVR would be <$50 000/quality-adjusted life-year gained (consistent with high economic value from a US health care perspective). These findings were sensitive to differences in long-term survival, however, such that a modest long-term survival advantage with SAVR would render SAVR cost-effective (although not cost saving) compared with TAVR. Conclusions: For patients with severe aortic stenosis and low surgical risk similar to those enrolled in the PARTNER 3 trial, transfemoral TAVR with the SAPIEN 3 valve is cost saving compared with SAVR at 2 years and is projected to be economically attractive in the long run as long as there are no substantial differences in late death between the 2 strategies. Long-term follow-up will be critical to ultimately determine the preferred treatment strategy for low-risk patients from both a clinical and economic perspective. Competing Interests: Disclosures Dr Lu is an employee of Edwards Lifesciences. Dr Thourani has received grants from Edwards Lifesciences, consulting fees from Atricure, Abbott, Boston Scientific, Artivion, Shockwave, and Edwards Lifesciences, and holds equity in Dasi Simulations. Dr Kodali reports institutional research grants from Edwards Lifesciences, Medtronic, and Abbott; consulting fees from Abbott, Admedus, and Meril Lifesciences; and equity options from Biotrace Medical and Thubrikar Aortic Valve Inc. Dr Makkar reports grant support/research contract from Edwards Lifesciences, St. Jude Medical, and consultant fee/honoraria/speaker’s bureau from Abbott Vascular, Cordis Corporation, Medtronic. Dr Herrmann reports institutional research funding from Abbott Vascular, Ancora, Boston Scientific, Edwards Lifesciences, and Medtronic; consultant fees from Abbott Vascular, Edwards Lifesciences, Medtronic; and equity in Microinterventional Devices. Dr Williams has received consulting fees from Edwards Lifesciences. Dr Webb has received consulting fees from Edwards Lifesciences. Dr Mack served as coprimary investigator for the PARTNER Trial (Placement of Aortic Transcatheter Valves) for Edwards Lifesciences and COAPT trial (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation [The COAPT Trial] and COAPT CAS [COAPT]) for Abbott; served as study chair for the APOLLO trial (Transcatheter Mitral Valve Replacement With the Medtronic Intrepid TMVR System in Patients With Severe Symptomatic Mitral Regurgitation) for Medtronic (all activities unpaid). Dr Leon serves on the PARTNER Trial Executive Committee, Edwards Lifesciences (nonpaid), and reports institutional research grants and being a nonpaid advisor for Abbott, Boston Scientific, Medtronic, and Sinomed; and holds equity in Medinol. Dr Cohen reports research grant support from Abbott, Boston Scientific, Edwards Lifesciences, Medtronic and consulting fees from Abbott, Boston Scientific, Edwards Lifesciences, and Medtronic. The other authors have nothing to disclose.
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