Early experience with coronary debulking devices in a newcomer facility after introducing revised facility criteria in Japan.

Coronary debulking devices are essential in obtaining optimal results in percutaneous coronary intervention (PCI) for severely calcified lesions. However, since the introduction of these devices in Japan, the presence of full-time cardiovascular surgeons in their own facilities has been an essential condition (on-site surgical back-up) as the facility criteria for their use. The criteria were revised in April 2020, making their implementation possible at our hospital. Between May 2020 and January 2022, we administered PCIs using rotational atherectomy (RA) for 33 lesions in 28 patients and orbital atherectomy system (OAS) for 36 lesions in 27 patients. The most preferred strategy in our hospital is OAS via the distal radial approach using a 6Fr Glide sheath or RA via the femoral approach using a 7Fr sheath. The percentages of usable imaging modality as an initial device without lesion modification were 57.1 and 66.7% in the RA and OAS groups, respectively. In the RA procedure, 1.5- and 2.0-mm Rota burrs were more frequently adopted for the initial and second sessions, respectively. In the OAS procedure, the debulking was always initiated at a low speed. Nineteen of the 27 patients underwent additional high-speed debulking. Pre-procedural quantitative coronary angiographic analysis revealed that the minimal lumen diameter was significantly smaller in the RA than in the OAS group. Debulking procedures were successful in all patients excluding two instances of procedure-related complications in the RA group, one of which was coronary perforation safely treated via covered stent deployment without any resulting hemodynamic instability. Our early experience with coronary debulking devices with off-site surgical back-up clearly reveals the safety and feasibility of this procedure in a newcomer facility.