Expanded access to rotational atherectomy maintains safety in PCI procedures

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."

Tadao Aikawa, Assistant Professor, 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.