Closure of the left atrial appendage: CLOSURE-AF vs. nationwide routine care in Germany

Background

The concept for left atrial appendage closure (LAAC) is appealing, as it potentially mitigates the stroke risk while reducing the bleeding risk compared to long-term anticoagulation. In Germany, favorable reimbursement of the procedure led to the common use of LAAC. However, the CLOSURE-AF trial, as an industry-independent randomized controlled multicenter trial showed that LAAC was not non-inferior as compared to best medical care in elderly high-risk patients. The trial was conducted in 46 high volume centers with substantial expertise in LAAC in Germany.

Purpose

To investigate the representativeness of the CLOSURE-AF trial population compared with patients undergoing LAAC in clinical routine using real-world data from the German healthcare system.

Methodology

We compared the characteristics and outcomes of patients enrolled in the the CLOSURE-AF trial with those of patients treated in clinical routine in Germany using data from the German DRG-Registry. Further we explored the centre volume and the associated patient characteristics and outcomes.

Results and Discussion

Key patient demographics of the CLOSURE-AF trial were similar to those treated in the German health care system (Table 1). Differences in CHA2DS2VASC score could be explained by an underreporting in secondary use data as ICD-Codes used for calculation are not relevant for reimbursement. Reported complications were lower in the Closure-AF LAAC intervention arm (Table 1).

In Germany, the number of centers performing LAAC rises (2016: N = 311, 2022; N = 419) and the yearly cases/centers decreases (2016 centers with less than 12 implantations/year: N = 159, 2022; N = 263). In 2022, there were 1608 LAAC-devices in hospitals implanted that were doing just one or less LAAC-cases per week. 105 centers (the lowest quartile) implant less than 4 devices per year (equals 290 patients receiving a device in centres of the lowest quartile). However, patient characteristics and outcome measurements were comparable in all size categories (Table 2).

Conclusion

Our report did not provide evidence that patient characteristics and outcomes in routine practice differ substantially to the data and patient characteristics reported from CLOSURE-AF. Furthermore there is a high number of low volume centres. From a healthcare system perspective LAAC may represent an area in which more selective use could enable a meaningful reallocation of resources.