In a groundbreaking shift within cardiovascular interventional practice, Japan’s 2020 revision of the rotational atherectomy (RA) facility criteria marks a significant evolution in the accessibility and management of complex coronary artery disease. This regulatory amendment permits board-certified operators to perform RA in lower-volume hospitals, fundamentally expanding patient access to advanced coronary treatments without compromising procedural safety or outcomes.
Percutaneous coronary intervention (PCI) serves as an essential therapeutic modality for patients afflicted with obstructive coronary artery disease, aiming to restore optimal myocardial perfusion through mechanically resolving arterial blockages. Yet, when confronted with heavily calcified atherosclerotic plaques, traditional PCI faces technical challenges. These calcifications hinder proper stent expansion and apposition, compromising luminal gain and procedural efficacy. Rotational atherectomy—the use of a high-speed, diamond-tipped burr designed to selectively ablate calcific deposits—has become a pivotal adjunctive technique to modify lesion architecture prior to stent placement, thereby enhancing PCI success in heavily calcified lesions.
Historically, Japan’s Ministry of Health, Labour and Welfare alongside the Japanese Association of Cardiovascular Intervention and Therapeutics (CVIT) imposed stringent facility prerequisites for RA, restricting its use to high-volume training hospitals equipped with on-site surgical backup and annual PCI caseloads exceeding 200 procedures. This policy was predicated on ensuring operator proficiency and immediate surgical rescue capabilities, mitigating procedural risks associated with the complexity of RA.
However, as cardiovascular disease demographics evolve and the burden of calcified coronary lesions rises, it became imperative to reassess accessibility to RA. The 2020 regulatory adjustment dismantled volume-based restrictions, allowing certified PCI operators trained specifically in RA to perform the technique within smaller, non-training hospitals—even in the absence of on-site cardiac surgery. This paradigm shift intended to reduce geographic and institutional disparities, enabling a wider patient population to benefit from RA-facilitated PCI.
Dr. Tadao Aikawa and colleagues at Juntendo University spearheaded a nationwide examination of this policy impact, harnessing data from the expansive J-PCI registry comprising over 1.16 million procedures across 1,243 hospitals from 2019 to 2023. This quasi-experimental, difference-in-differences study uniquely bridges pre- and post-policy eras, offering robust insights into procedural utilization patterns and patient outcomes following facility criteria relaxation.
Quantitative analysis revealed a notable uptick in RA usage, from 4.2% of all PCI procedures in 2019 to 5.2% in 2023. This incremental rise underscores enhanced access to sophisticated calcium-modifying therapies, particularly in hospitals previously restricted by volume criteria. Importantly, outcome metrics such as in-hospital mortality and complication rates were closely scrutinized to assess safety implications in the context of broader RA deployment.
The study found that in-hospital mortality following PCI experienced only a modest elevation nationwide—from 1.6% to 1.9%—with comparable trends observed between training and non-training facilities. When considering a composite endpoint incorporating procedural complications, adverse event rates increased slightly in high-volume training centers (3.1% to 3.7%) but remained stable at approximately 3.3% in lower-volume, non-training establishments throughout the study period.
These findings poignantly suggest that the facility criteria revision did not detract from procedural safety or efficacy standards. Rather, the expanded eligibility facilitated equitable care by diminishing the necessity for patient referral to specialized centers, an important consideration for elderly or mobility-limited populations. Decentralizing access to RA thereby promotes more timely and inclusive coronary interventions tailored to patient needs.
The implications of this study resonate beyond Japanese borders, positioning this evidence-based regulatory reform as a potential global exemplar. By emphasizing operator competency and rigorous device-specific training over hospital procedural volume or surgical backup mandates alone, healthcare systems can optimize resource allocation while preserving patient safety. Such a model advocates for integrating procedural proficiency standards coupled with outcome surveillance to underpin policy modifications.
This work exemplifies the critical intersection of clinical innovation, population health management, and health policy. It illustrates that flexibility in facility usage criteria can harmonize with contemporary demands of personalized interventional cardiology without jeopardizing quality metrics. These insights pave the way for the thoughtful recalibration of procedural access criteria worldwide, ensuring more universal availability of cutting-edge therapies.
Dr. Aikawa’s team, collaborating with leading cardiovascular researchers both domestically and internationally, highlights the value of large-scale registry data and comparative effectiveness research in guiding policy decisions. Their findings also invite further longitudinal studies assessing long-term outcomes post-criteria revision and exploring patient-reported quality-of-life measures to holistically evaluate impact.
In summary, Japan’s 2020 regulatory revision on rotational atherectomy facility criteria successfully broadened the availability of specialized PCI techniques to a wider patient population. This expansion did not compromise safety or increase adverse events, challenging traditional paradigms that limited advanced interventions to high-volume centers. The study offers a compelling argument for evidence-driven policy reform embracing operator training and certification as cornerstones for safe RA implementation across diverse hospital settings.
Subject of Research: People
Article Title: Impact of Facility Criteria Revision for Rotational Atherectomy on Outcomes After PCI: A Quasi-Experimental Difference-in-Differences Study
News Publication Date: 13-Mar-2026
Web References:
- DOI link: 10.1016/j.jacadv.2026.102672
References:
Authors: Tadao Aikawa, Yuichiro Mori, Toshiki Kuno, Yoshihisa Miyamoto, Yuya Matsue, Shun Kohsaka, Kyohei Yamaji, Ken Kozuma, and Tohru Minamino.
Image Credits:
Tadao Aikawa from Juntendo University, Japan
Keywords: Cardiology, Medical specialties, Health and medicine, Diseases and disorders, Health care, Human health, Medical diagnosis, Cardiovascular disorders, Heart disease
