Abstract
Objective: To assess the cost-utility, budget impact, and feasibility of sutureless/rapid-deployment aortic valve replacement (SUAVR) compared with conventional aortic valve replacement (CAVR) in patients with aortic stenosis Methods: To assess the cost-utility analysis, a hybrid model between decision tree and Markov model was used to compare SUAVR and CAVR in patients with aortic stenosis, considering the societal perspective. Input parameters were obtained from several sources such as primary data collection from three hospitals (Chulalongkorn, Siriraj, Central Chest Institute of Thailand), e-Claim database from National Health Security Office, and literature review. The study outcomes were measured in terms of total life-year costs, life-years, and quality-adjusted life-years (QALY). All costs and outcomes were discounted at an annual rate of 3%. Incremental cost-effectiveness ratio (ICER) was estimated. One-way sensitivity analysis and probabilistic sensitivity analysis were also performed. Budget impact analysis was also conducted based on the data from literature review and epidemiological data in Thailand. The base-case analysis comparing scenario 1 (CAVR used only) versus scenario 2 (SUAVR and CAVR used) was assessed. A five-year period of annual budget in each scenario was reported. Net budget impact is the difference in the budget of two scenarios. Sensitivity analyses were also performed. The Feasibility test was conducted by in-depth interviewing heart surgeons and nurses. Several issues, patterns of healthcare services, resource management were prior set up for interview. Results: The base-case results of cost-utility analysis showed that patients undergoing SUAVR had total life-time cost of 1,733,355 THB, life-year of 6.19 years, and QALY of 4.95 years, while those undergoing CAVR had total life-time cost of 1,220,643 THB, life-year of 6.29 years, and QALY of 5.18 years. Therefore, SUAVR had higher total life-time cost, but gained less life-years and QALYs compared with CAVR. This indicated that SUAVR was not a cost-effective strategy. The sensitivity analysis showed that utility of patients undergoing CAVR or SUAVR had the impact on ICER. The base-case results of budget impact analysis showed that the average annual of scenario 1 and scenario 2 was equal to 579,881,017 THB and 613,767,528 THB, respectively. The net budget impact (NBI) was equal to 33,886,511 THB per year for substituting SUAVR for CAVR at the initial uptake rate of 4% and increased 0.5% in subsequent year. However, SUAVR group had lower hospitalization costs than CAVR group. The higher budget of using SUAVR stemmed from the costs of valve and material. The reduction in the cost of SUAVR valve would lead to the reduction in NBI. The results of feasibility study showed that SUAVR can be performed in all hospitals that service open heart surgery without the need for additional devices. Heart surgeons and nurses can also perform SUAVR by few trainings. Nowadays, hospitals with heart care center are available in various regions so that the referring system can be used for those who are in need. Specific indications or criteria should be clearly defined for patients with aortic stenosis who are qualified for SUAVR; for example, patients with minimally invasive surgery, patients with concomitant procedures, patients with calcification at aortic root or aortic cannulus, or patients undergoing redo surgery etc. Conclusion: The findings of the study indicated that SUAVR is not a cost-effective technology compared with CAVR. However, SUAVR shows benefits for some patient groups due to reduction in surgery time, days of hospitalization. It is necessary to justify SUAVR to be included the benefit package with clear specifications of accessibility for those who truly receive the benefits.
