National indication document and aortic valve replacement landscape in the Netherlands

Since 2021, the Heart Teams of all Dutch 16 heart centres performing AVR procedures (SAVR and TAVI) have to base their decision for SAVR or TAVI in a specific patient upon the national indication document [8, 9]. This indication document defines which TAVI patients are eligible for reimbursement. The most prominent difference between the criteria in this indication document and the 2021 ESC/EACTS Guidelines for the management of valvular heart disease is that the latter recommends TAVI in patients aged ≥ 75 years [10], whereas the indication document only allows TAVI in patients < 80 years in case of significant comorbidity.

This analysis focused on the potential changes in the SAVR and TAVI landscape in the Netherlands after the implementation of the indication document. The total number of SAVR plus TAVI procedures and the SAVR/TAVI ratio did not differ in 2021 compared with 2019 and 2020. In addition, baseline characteristics for the TAVI cohort in 2021 did not differ from those in 2019 and 2020. One might therefore argue that the indication document did not change the landscape importantly. However, there are 2 important factors that should be taken into consideration.

First, the indication document might have dampened the potential increase in TAVI in 2021. In other words, without the indication document, what would have happened with the SAVR/TAVI ratio in 2021, after the publication of the new European guidelines in mid-2021? The new guidelines are based on trial data that were already available in 2019. We know that clinical experts generally adapt their practice rapidly, based on published results. In 2019 and 2020, the SAVR/TAVI ratio in the Netherlands was similar to that in 2021, which supports the notion that a potential effect in 2021 was not dampened by the indication document. If, in the most extreme case, all SAVR-treated patients in the age cohort 75–80 years in 2021 would instead have been treated with TAVI, this would have led to an annual increase of 477 TAVI procedures and the percentage of TAVI would have risen from 52 to 63% in 2021.

Second, the COVID-19 pandemic has affected hospital care, starting in March 2020. Did the pandemic create a potential bias with respect to this analysis? Rooijakkers and colleagues from the Radboud University Medical Centre in Nijmegen, the Netherlands showed the COVID-19 pandemic did not have an impact on TAVI patient characteristics and outcome [13]. In our analysis, we did not find arguments for a COVID-19 effect as the SAVR/TAVI ratios of 2018 (pre-COVID year) and 2020 (COVID year) did not differ, making a potential COVID effect less likely.

We analysed separate age cohorts in 2021 because of the discrepancy in age-based recommendations for TAVI between the European guidelines and the indication document (75 versus 80 years, respectively). Based on the criteria of the indication document, for the all age cohort, TAVI was more frequent in patients of older age (≥ 80 and ≥ 85 years), frail patients, patients with a reduced LVEF and those with previous cardiac surgery. These patients had a higher surgical risk profile with a higher risk of postoperative complications, making TAVI the preferred treatment. Rates of the variables ‘age ≥ 80 years’, ‘age ≥ 85 years’ and ‘reduced LVEF’ did not differ from 2018 through 2021. For the age group 75–80 years, similar findings were seen. This illustrates that consistent decisions have been made throughout the years and the indication document did not alter this.

Study limitation

The indication document was implemented by Heart Teams in 2021. To see its full effect on Heart Team decisions, adding another full year could provide more insight into the annual number of procedures of TAVI versus SAVR.

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