Aortic stenosis (AS) is a severe disease that causes heart failure and sudden death (1, 2). A retrospective survey conducted in China showed that the prevalence of AS was 0.16% in inpatients younger than 65 years old and that it was 0.41 and 0.56% in those aged 65–74 and over 75 years old (3). Another study conducted in China found that 0.39–0.66% of outpatients aged over 65 years who received echocardiography were diagnosed with severe AS (4). As the Chinese population is entering an aging society, the burden of AS is increasing.

Surgical aortic valve replacement (SAVR) has always been the optimal treatment for patients with AS across different risk stratifications (5, 6). However, several important clinical studies regarding transcatheter aortic valve replacement (TAVR) (7–10) have demonstrated the efficacy and safety of TAVR all over the world (11, 12). It is estimated that more than 306,000 patients with AS have undergone TAVR in the United States (13). The number of patients AS who have undergone TAVR in China is much lower but is increasing at a fast rate.

In patients with AS who are at intermediate risk for surgery, it has been demonstrated that TAVR has similar efficacy as that of SAVR (9). The 2021 European Society of Cardiology (ESC) guidelines for valvular heart disease recommended that SAVR and TAVR are both first-line treatments for patients at intermediate-risk (6). In clinical practice, whether a treatment can be widely used depends not only on its effectiveness but also on whether it is cost-effective. The collective purchase policy launched by the Chinese govenment allows only cost-effective drugs or medical devices to be widely used in Chinese hospitals, but an economic evaluation comparing TAVR versus SAVR is lacking. Thus, the present study aimed to investigate the cost-effectiveness of TAVR compared to SAVR among Chinese patients at intermediate-risk.

The periprocedural complication incidence, transition probabilities, utilities, and costs are listed in Tables 1, 2. The range, distribution, and sources are also displayed in Tables 1, 2. All the analyses were performed based on the above data.

To the best of our knowledge, the present study is the first to investigate the cost-effectiveness of TAVR vs. SAVR in Chinese patients with AS. We found that in the intermediate surgical risk population, TAVR is not currently cost-effective in China, and TAVR could be cost-effective only when the TAVR device cost is decreased to 29,766 USD. Thus, if the TAVR device cost is lowered to 26,794 USD, TAVR would be highly cost-effective.

Some studies have reported that TAVR is cost-effective in their countries (16–19). However, in the present study, we concluded that TAVR is not currently cost-effective in China due to several reasons. First, the costs of the TAVR device vary among different regions, ranging from 17,268 USD to 45,526 USD (20, 21). In Canada, the cost is 17,268 USD, but the cost is approximately 45,526 USD in China, resulting in an ICER of 170,056 USD/QALY, which is higher than the per capita GDP in China. However, if we adopted the Canadian TAVR device cost in our analysis, the cost of TAVR would be less but the effect would not change. Second, as China is the largest developing country, the per capita GDP is only 12,500 USD, which is lower than that in the United States, Canada, Australia, and Japan, which may cause a lower threshold of WTP. The ICER of 170,056 USD/QALY may be accepted in the United States and Australia with a per capita GDP of more than 60,000 USD, but it cannot be currently accepted in China. Third, there is a difference in the composition of surgical costs between China and other countries. In China, the TAVR device costs account for over 90% of the overall costs, and the proportion of device costs is much higher in China than in other countries (21). In the USA, the proportion of the TAVR device costs is less than 65% of the total costs, and in Australia and Canada (20, 22), the proportion of the TAVR device costs is lower than 60%. The unique situation in China leads to the fact that TAVR is not currently cost-effective in China.

Compared to SAVR, TAVR achieves similar clinical outcomes (7–9). In inoperative patients, TAVR may significantly reduce mortality and other outcomes (23), but in patients with high risk or intermediate risk, the published clinical trials have indicated that TAVR displays similar efficacy to that of SAVR (7, 14). The improvement of TAVR versus SAVR may lie in the relief of symptoms, indicating that patients who underwent TAVR may achieve higher utilities than those who received SAVR, especially in the periprocedural period (24). In the PARTNER 2 study, the periprocedural mortality is 6.1% in the TAVR group versus 8.0% in the SAVR group, but these differences are not statistically significant. When the follow-up period is extended to 5 years, the mortalities in TAVR and SAVR groups are 47.9 and 43.4%, respectively (9, 14). A previous meta-analysis conducted by our team has also demonstrated that TAVR has similar efficacy to that of SAVR regardless of the follow-up period (10). A similar efficacy but higher costs may suggest that TAVR is not cost-effective in China. In addition, the durability of TAVR should be investigated. However, studies thus far have shown that TAVR is safe. The durability of SAVR needs to be evaluated for at least 10 years of follow-up (25), but the longest reported follow-up period of TAVR is only 6 years (26).

One-way sensitive analysis showed that the costs of the TAVR device had the largest impact on the ICER. The PSA showed that TAVR was cost-effective only with a 5% probability. These results indicated that under current costs, TAVR is not cost-effective. The scenario analysis showed that when the costs of the TAVR device are decreased to 29,766 USD, the TAVR could be cost-effective. If the costs of TAVR are lowered to 26,794 USD, TAVR would be highly cost-effective. The Chinese government has launched a collective purchase project, which requires that only cost-effective drugs or medical devices can be used in public hospitals in China, indicating that only drugs or medical devices listed in the collective purchase can be widely used in China at present (27). The present study demonstrated that TAVR could be cost-effective only when the costs are lowered to 29,766 USD. Importantly, the present study provided a viewpoint for TAVR from the Chinese health care system payer’s perspective.

The present study had several limitations. First, the cardiovascular mortality in our study was derived from the PARTNER 2 study with only a few Chinese patients included in the study. The cardiovascular mortality in Chinese patients who underwent TAVR may be slightly different from that in the PARTNER 2 study. Second, the simulation period in our study was 5 years, which was consistent with the PARTNER 2 study, but some studies have shown that a longer follow-up period may allow the TAVR to be cost-effective. Third, the data in our study were transformed from a published article. The inability to access the raw data limited our further analysis. Last, the present study was performed based on a published study rather than real-world data in China. Thus, real patient-level data may be more appropriate, indicating that additional studies based on the Chinese population are needed.

Transcatheter aortic valve replacement is not currently cost-effective in China. However, TAVR could be cost-effective with a reduction of costs to 29,766 USD, which is approximately 65% of the current price.

The original contributions presented in the study are included in the article/supplementary material, further inquiries can be directed to the corresponding author/s.

LQ and CZ came up with the idea and designed the protocol. WZ and YL synthesized the data and drafted the manuscript. YL and HW participated in the data collection and data analysis. All authors approved the final version of the manuscript.

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

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