Cost-Effectiveness and Clinical Outcome of Transcatheter Versus Sutureless Aortic Valve Replacement
DOI:
https://doi.org/10.1532/hsf.5445Keywords:
cost-effectiveness, transcatheter aortic valve implantation, sutureless aortic valve replacementAbstract
Background: Sutureless aortic valve replacement (SU-AVR) and transcatheter aortic valve implantation (TAVI) are becoming increasingly common. The aim of this study is to compare the clinical outcome and cost-effectiveness of the two methods. Methods: In this study, cross-sectional retrospective data were collected on 327 patients who underwent SU-AVR (n = 168) and TAVI (n = 159). Homogeneous groups were provided by the “propensity score matching" method, and 61 patients from the SU-AVR group and 53 patients from the TAVI group were included in the study sample. Results: The two groups did not have statistically different death rates, complications after surgery, lengths of hospital stays, or visits to the intensive care unit. It is stated that the SU-AVR method provides an additional 1.14 Quality-Adjusted Life Year (QALY) compared to the TAVI method. The TAVI was more expensive than the SU-AVR in our study, but the difference was not statistically significant ($40,520.62 vs. $38,405.62, p > 0.05). For SU-AVR, the most expensive factor was the length of stay in the intensive care unit; for TAVI, it was arrhythmia, bleeding, and renal failure. Conclusions: These bioprostheses are safe and effective treatments for valve stenosis. Clinical outcomes were similar between the two groups. Therefore, clinicians may find it difficult to determine an effective treatment strategy. According to the evaluation made in terms of cost-effectiveness, it was found that the SU-AVR method gave a higher QALY at a lower cost compared to the TAVI method. However, this result is not statistically significant.
References
Lorenzoni V, Barbieri G, Saia F, Meucci F, Martinelli GL, Cerillo AG, et al. The cost-effectiveness of transcatheter aortic valve implantation: exploring the Italian National Health System perspective and different patient risk groups. The European Journal of Health Economics. 2021; 22: 1349–1363.
Johnston LE, Downs EA, Hawkins RB, Quader MA, Speir AM, Rich JB, et al. Outcomes for Low-Risk Surgical Aortic Valve Replacement: A Benchmark for Aortic Valve Technology. The Annals of Thoracic Surgery. 2017; 104: 1282–1288.
Leon MB, Smith CR, Mack M, Miller DC, Moses JW, Svensson LG, et al. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. The New England Journal of Medicine. 2010; 363: 1597–1607.
Otto CM, Nishimura RA, Bonow RO, Carabello BA, Erwin JP 3rd, Gentile F, et al. 2020 ACC/AHA Guideline for the Management of Patients With Valvular Heart Disease: Executive Summary: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Journal of the American College of Cardiology. 2021; 77: 450–500.
Falk V, Baumgartner H, Bax JJ, De Bonis M, Hamm C, Holm PJ, et al. 2017 ESC/EACTS Guidelines for the management of valvular heart disease. European Journal of Cardio-Thoracic Surgery. 2017; 52: 616–664.
D'Onofrio A, Rizzoli G, Messina A, Alfieri O, Lorusso R, Salizzoni S, et al. Conventional surgery, sutureless valves, and transapical aortic valve replacement: what is the best option for patients with aortic valve stenosis? A multicenter, propensity-matched analysis. The Journal of Thoracic and Cardiovascular Surgery. 2013; 146: 1065–1071.
Weinstein MC, Stason WB. Foundations of cost-effectiveness analysis for health and medical practices. The New England Journal of Medicine. 1977; 296: 716–721.
Doubilet P, Weinstein MC, McNeil BJ. Use and misuse of the term “cost effective" in medicine. The New England Journal of Medicine. 1986; 314: 253–256.
Çelik M, Milojevic MM, Durko AP, Oei FBS, Bogers AJJC, Mahtab EAF. Mortality in low-risk patients with aortic stenosis undergoing transcatheter or surgical aortic valve replacement: a reconstructed individual patient data meta-analysis. Interactive Cardiovascular and Thoracic Surgery. 2020; 31: 587–594.
Sanders GD, Neumann PJ, Basu A, Brock DW, Feeny D, Krahn M, et al. Recommendations for Conduct, Methodological Practices, and Reporting of Cost-effectiveness Analyses: Second Panel on Cost-Effectiveness in Health and Medicine. The Journal of the American Medical Association. 2016; 316: 1093–1103.
Nashef SA, Roques F, Sharples LD, Nilsson J, Smith C, Goldstone AR, et al. EuroSCORE II. European Journal of Cardio-thoracic Surgery. 2012; 41: 734–745.
Risk calculator. Online STS Adult Cardiac Surgery Risk Calculator: New Version. 2023. Available at: http://riskcalc.sts.org/stswebriskcalc/calculate (Accessed: 26 April 2022).
1999 World Health Organization-International Society of Hypertension Guidelines for the Management of Hypertension. Guidelines Subcommittee. Journal of Hypertension. 1999; 17: 151–183.
Mevzuat Bilgi Sistemi. Sosyal Güvenlik Kurumu Sağlık Uygulama Tebliği. 2013. Available at: https://www.mevzuat.gov.tr/mevzuat?MevzuatNo=17229&MevzuatTur=9&MevzuatTertip=5 (Accessed: 26 April 2022).
OECD Data. Purchasing power parities (PPP) Exchange Rates. 2022. Available at: https://data.oecd.org/conversion/purchasing-power-parities-ppp.htm#indicator-chart (Accessed: 26 April 2022).
Povero M, Miceli A, Pradelli L, Ferrarini M, Pinciroli M, Glauber M. Cost-utility of surgical sutureless bioprostheses vs TAVI in aortic valve replacement for patients at intermediate and high surgical risk. ClinicoEconomics and Outcomes Research. 2018; 10: 733–745.
Austin PC. An Introduction to Propensity Score Methods for Reducing the Effects of Confounding in Observational Studies. Multivariate Behavioral Research. 2011; 46: 399–424.
Muneretto C, Solinas M, Folliguet T, Di Bartolomeo R, Repossini A, Laborde F, et al. Sutureless versus transcatheter aortic valves in elderly patients with aortic stenosis at intermediate risk: A multi-institutional study. The Journal of Thoracic and Cardiovascular Surgery. 2022; 163: 925–935.e5.
Shinn SH, Altarabsheh SE, Deo SV, Sabik JH, Markowitz AH, Park SJ. A Systemic Review and Meta-Analysis of Sutureless Aortic Valve Replacement Versus Transcatheter Aortic Valve Implantation. The Annals of Thoracic Surgery. 2018; 106: 924–929.
Santarpino G, Pfeiffer S, Jessl J, Dell'Aquila A, Vogt F, von Wardenburg C, et al. Clinical Outcome and Cost Analysis of Sutureless Versus Transcatheter Aortic Valve Implantation With Propensity Score Matching Analysis. The American Journal of Cardiology. 2015; 116: 1737–1743.
Indraratna P, Ang SC, Gada H, Yan TD, Manganas C, Bannon P, et al. Systematic review of the cost-effectiveness of transcatheter aortic valve implantation. The Journal of Thoracic and Cardiovascular Surgery. 2014; 148: 509–514.
Osnabrugge RLJ, Kappetein AP, Reynolds MR, Cohen DJ. Cost-effectiveness of transcatheter valvular interventions: economic challenges. EuroIntervention. 2013; 9: S48–S54.
Kodera S, Kiyosue A, Ando J, Komuro I. Cost effectiveness of transcatheter aortic valve implantation in patients with aortic stenosis in Japan. Journal of Cardiology. 2018; 71: 223–229.
Ailawadi G, LaPar DJ, Speir AM, Ghanta RK, Yarboro LT, Crosby IK, et al. Contemporary Costs Associated With Transcatheter Aortic Valve Replacement: A Propensity-Matched Cost Analysis. The Annals of Thoracic Surgery. 2016; 101: 154–161.
D'Onofrio A, Messina A, Lorusso R, Alfieri OR, Fusari M, Rubino P, et al. Sutureless aortic valve replacement as an alternative treatment for patients belonging to the “gray zone" between transcatheter aortic valve implantation and conventional surgery: a propensity-matched, multicenter analysis. The Journal of Thoracic and Cardiovascular Surgery. 2012; 144: 1010–1016.
Arnold SV, Lei Y, Reynolds MR, Magnuson EA, Suri RM, Tuzcu EM, et al. Costs of periprocedural complications in patients treated with transcatheter aortic valve replacement: results from the Placement of Aortic Transcatheter Valve trial. Circulation. Cardiovascular Interventions. 2014; 7: 829–836.
Cockburn J, Dooley M, de Belder A, Trivedi U, Hildick-Smith D. A comparison between surgical risk scores for predicting outcome in patients undergoing transcatheter aortic valve implantation. The Journal of Cardiovascular Surgery. 2017; 58: 467–472.
Butchart EG, Gohlke-Bärwolf C, Antunes MJ, Tornos P, De Caterina R, Cormier B, et al. Recommendations for the management of patients after heart valve surgery. European Heart Journal. 2005; 26: 2463–2471.
Hyman MC, Vemulapalli S, Szeto WY, Stebbins A, Patel PA, Matsouaka RA, et al. Conscious Sedation Versus General Anesthesia for Transcatheter Aortic Valve Replacement: Insights from the National Cardiovascular Data Registry Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry. Circulation. 2017; 136: 2132–2140.
Pollari F, Santarpino G, Dell'Aquila AM, Gazdag L, Alnahas H, Vogt F, et al. Better short-term outcome by using sutureless valves: a propensity-matched score analysis. The Annals of Thoracic Surgery. 2014; 98: 611–617.
Tam DY, Hughes A, Fremes SE, Youn S, Hancock-Howard RL, Coyte PC, et al. A cost-utility analysis of transcatheter versus surgical aortic valve replacement for the treatment of aortic stenosis in the population with intermediate surgical risk. The Journal of Thoracic and Cardiovascular Surgery. 2018; 155: 1978–1988.e1.
Sangaraju S, Cox I, Dalrymple-Hay M, Lloyd C, Suresh V, Riches T, et al. Effect of procedural refinement of transfemoral transcatheter aortic valve implantation on outcomes and costs: a single-centre retrospective study. Open Heart. 2019; 6: e001064.
Petronio AS, Capranzano P, Barbato E, Piazza N, Baumbach A, Haude M, et al. Current status of transcatheter valve therapy in Europe: results from an EAPCI survey. EuroIntervention. 2016; 12: 890–895.
Crisp N. What would a sustainable health and care system look like? British Medical Journal. 2017; 358: j3895.
Yacoub MH, Takkenberg JJM. Will heart valve tissue engineering change the world? Nature Clinical Practice. Cardiovascular Medicine. 2005; 2: 60–61.
Karnon J, Brennan A, Akehurst R. A critique and impact analysis of decision modeling assumptions. Medical Decision Making. 2007; 27: 491–499.
Mack MJ, Leon MB, Thourani VH, Makkar R, Kodali SK, Russo M, et al. Transcatheter Aortic-Valve Replacement with a Balloon-Expandable Valve in Low-Risk Patients. The New England Journal of Medicine. 2019; 380: 1695–1705.
