Impact of Facility Criteria Revision for Rotational Atherectomy on Outcomes After PCI

BACKGROUND: In April 2020, the facility criteria for using rotational atherectomy (RA) during percutaneous coronary intervention (PCI) were updated in Japan. Board-certified PCI operators are now permitted to perform RA during PCI in low-volume hospitals (<200 PCIs/y) without on-site surgical backup (ie, nontraining facilities). OBJECTIVES: This study investigated the impact of the 2020 RA facility criteria revision on in-hospital PCI outcomes in nontraining facilities. METHODS: The authors conducted a retrospective, time-series analysis of patients who underwent PCI in Japan using the J-PCI (Japanese Percutaneous Coronary Intervention) registry, which covers over 90% of all PCIs performed in Japan. Using a quasi-experimental difference-in-differences analysis, the authors compared changes in PCI outcomes between training and nontraining facilities before (2019-2020) and after (2021-2023) the 2020 RA facility criteria revision. The primary outcome was in-hospital mortality after PCI. RESULTS: Among the 1,161,862 PCIs performed in 1,243 hospitals from 2019 to 2023, the rate of RA use during PCI increased from 4.2% in 2019 to 5.2% in 2023. Of the 1,181 hospitals performing PCI in 2023, 400 (33.9%) had never performed RA. Difference-in-differences regression analyses revealed a slight upward trend in in-hospital mortality in both training (1.6% to 1.9%) and nontraining (1.7% to 1.9%) facilities after the facility criteria revision. However, these trends did not differ significantly between the 2 groups (adjusted P = 0.55 for interaction [facility × time]). CONCLUSIONS: The 2020 RA facility criteria revision in Japan did not significantly increase in-hospital mortality after PCI in low-volume, nontraining facilities without on-site surgical backup that were newly accredited for RA use after the revision.