Policy revision expands access to rotational atherectomy without compromising PCI outcomes
Percutaneous coronary intervention (PCI) is a standard treatment for significant coronary artery disease. Cardiologists use a catheter to place a stent that opens up the blockage and restores blood flow to the heart. However, dense, calcified atherosclerotic plaque can prevent proper placement or unfolding of stents, resulting in reduced blood flow to the heart even after PCI. Rotational atherectomy (RA) is a specialized technique used to modify heavily calcified plaque before stent placement. A conical burr ablates the calcified plaque, creating space for the stent. RA is a recommended treatment for heavily calcified lesions during PCI.
Until 2020, facility criteria established by the Japanese Ministry of Health, Labour and Welfare and the Japanese Association of Cardiovascular Intervention and Therapeutics (CVIT) required that RA be performed only at high-volume training centers. These facilities were required to perform ≥200 PCI procedures per year and had on-site surgical backup. However, in April 2020, the facility criteria were revised. Under the new policy, board-certified PCI operators who completed device-specific training were permitted to perform RA at low-volume hospitals (defined as <200 PCIs per year), even without on-site cardiac surgery.
“While there has been concern that expanding RA use in these newly accredited non-training facilities could increase PCI-related complications, the impact of the 2020 RA facility criteria revision on overall PCI outcomes in Japan has yet to be verified,” says Assistant Professor Tadao Aikawa of the Department of Cardiovascular Biology and Medicine, Juntendo University Graduate School of Medicine.
Dr. Aikawa led a research study to understand the impact of the new RA regulations. This effort was supported by Dr. Yuichiro Mori of Kyoto University Graduate School of Medicine, Dr. Toshiki Kuno of the Beth Israel Deaconess Medical Center, Harvard Medical School, and members of the Japanese Association of CVIT Scientific Committee. Their findings will be published in an upcoming edition of the journal JACC: Advances.
The team analyzed data from the nationwide J-PCI registry, covering more than 1.16 million PCI procedures performed at 1,243 hospitals across Japan between 2019 and 2023, spanning the period before and after the facility criteria revision. They found that RA use increased from 4.2% of all PCIs in 2019 to 5.2% in 2023, indicating expanded access to calcium-modification therapy.
Importantly, the expansion of RA eligibility to low-volume, non-training hospitals did not result in a disproportionate increase in mortality or complications compared with training centers. In-hospital mortality after PCI rose modestly nationwide—from 1.6% in 2019 to 1.9% in 2023—in both training and non-training facilities. When post-procedural complications were included, adverse event rates increased slightly in training hospitals (from 3.1% to 3.7%) but remained stable at 3.3% in non-training facilities throughout the study period.
These findings suggest that the 2020 facility criteria revision for RA did not compromise the safety of PCI. Patients can receive RA without referral to a high-volume training hospital, thus reducing geographical disparities in care. Greater access to RA makes PCI more effective for a broad range of patients, especially those who may be older or have mobility issues.
“These findings provide a model for evidence-based device policy reform. Regulators can safely relax facility restrictions when operator competency and training standards are enforced,” says Dr. Aikawa.
The study aims to inspire countries worldwide to adopt evidence-based policies that expand access to cutting-edge treatments—without sacrificing patient safety.
About Dr. Tadao Aikawa
Tadao Aikawa MD, PhD, FACC, FESC, is an Assistant Professor at Department of Cardiovascular Biology and Medicine at the Juntendo University Graduate School of Medicine. Dr. Aikawa practices as a consultant cardiologist at Juntendo University Hospitals, specializing in the clinical management of heart failure and cardiomyopathies, cardiovascular imaging, and catheter-based coronary interventions. He is board-certified by the Japanese Society of Internal Medicine, the Japanese Circulation Society, the Japanese Society of Nuclear Medicine, and the Japanese Society of Cardiovascular Intervention and Therapeutics, and is a fellow of multiple professional societies including the American College of Cardiology (FACC) and the European Society of Cardiology (FESC).
Dr. Aikawa’s research focuses on coronary artery disease, cardiomyopathies, and noninvasive cardiovascular imaging. He has authored more than 130 publications in these fields. Dr. Aikawa has received numerous awards for his contributions to cardiovascular research, including the Hokkaido Science and Technology Encouragement Award (Governor’s Award), the JSNC Award from the Japanese Society of Nuclear Cardiology, and multiple Young Investigator Awards from various Japanese cardiovascular societies. He has also received international reviewer awards from the European Society of Cardiology and the Journal of the American Heart Association.
Reference
Authors: Tadao Aikawaa, Yuichiro Morib, Toshiki Kunoc, Yoshihisa Miyamotod, Yuya Matsuea, Shun Kohsakae,f, Kyohei Yamajig, Ken Kozumah, and Tohru Minaminoa
DOI: https://doi.org/10.1016/j.jacadv.2026.102672
Affiliations:
a Department of Cardiovascular Biology and Medicine, Juntendo University Graduate School of Medicine, Tokyo, Japan
b Department of Human Health Sciences, Kyoto University Graduate School of Medicine, Kyoto, Japan
c Division of Cardiology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA
d Department of Real-World Evidence, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan
e Department of Cardiology, Keio University School of Medicine, Tokyo, Japan
f Department of Health Data Science, Yokohama City University Graduate School of Data Science, Yokohama, Japan
g Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine, Kyoto, Japan
h Department of Internal Medicine, Division of Cardiology, Teikyo University School of Medicine, Tokyo, Japan
History of Juntendo University
Juntendo was originally founded in 1838 as a Dutch School of Medicine at a time when Western medical education was not yet embedded as a normal part of Japanese society. With the creation of Juntendo, the founders hoped to create a place where people could come together with the shared goal of helping society through the powers of medical education and practices. Their aspirations led to the establishment of Juntendo Hospital, the first private hospital in Japan. Through the years the institution's experience and perspective as an institution of higher education and a place of clinical practice has enabled Juntendo University to play an integral role in the shaping of Japanese medical education and practices. Along the way the focus of the institution has also expanded, now consisting of nine undergraduate programs and six graduate programs, the university specializes in the fields of health science, health and sports science, nursing health care and sciences, and international liberal arts, as well as medicine. Today, Juntendo University continues to pursue innovative approaches to international level education and research with the goal of applying the results to society.
Mission Statement
The mission of Juntendo University is to strive for advances in society through education, research, and healthcare, guided by the motto “Jin – I exist as you exist” and the principle of “Fudan Zenshin - Continuously Moving Forward”. The spirit of “Jin”, which is the ideal of all those who gather at Juntendo University, entails being kind and considerate of others. The principle of “Fudan Zenshin” conveys the belief of the founders that education and research activities will only flourish in an environment of free competition. Our academic environment enables us to educate outstanding students to become healthcare professionals whom patients can believe in, scientists who can make innovative discoveries and inventions, and global citizens who are ready to serve society.
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