Learning curve in pipeline embolization device: results from the pipeline embolization device in China post-market multicentre registry study

Abstract

Background: Intracranial aneurysms pose a significant health issue, affecting 3–5% of the adult population. The pipeline embolization device (PED) has emerged as a promising treatment for these lesions. This study aimed to investigate the impact of operator experience on complication and poor outcome rates, as well as the learning curve for PED. Methods: A total of 217 patients were consecutively enroled from four eligible centres and divided into three groups based on the number of procedures performed: group 1 (first 10 procedures), group 2 (11–20 procedures), and group 3(>20 procedures). Major complications include operation-related ischaemic or haemorrhagic events and mass effect deterioration. Poor outcome was defined as a modified Rankin Scale score greater than 2 at discharge. Cumulative summation (CUSUM) analysis was generated to assess the learning curve according to major complications and poor outcome. Results: The study found that major complications and poor outcomes occurred in 5.1% and 2.3% of cases, respectively. The rate of major complications decreased from 10.0% in group 1 to 2.9% in group 3 (P=0.053), while the rate of poor outcomes decreased from 7.5% in group 1 to 0.7% in group 3 (P=0.015). Multivariable regression analysis adjusted for covariates showed that operator experience was associated with a lower rate of poor outcomes (P=0.034). CUSUM analysis demonstrated that the learning curve for avoiding major complications and poor outcomes required 27 (mean=13) and 40 (mean=20) cases, respectively. Conclusions: These findings suggest that PED treatment requires a learning curve of 40 cases to achieve reproducibility regarding complications and functional results. Additionally, major complications and poor outcomes significantly decreases after the first 20 procedures. CUSUM analysis can serve as a useful tool for monitoring and assessing surgical performance.