Peri-procedural and 6-month outcomes of rotational atherectomy for highly calcified femoropopliteal lesions from Japanese postmarketing surveillance

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PURPOSE: To evaluate the peri-procedural and 6-month outcomes of the Jetstream rotational atherectomy system in treating severely calcified femoropopliteal lesions in a Japanese population under postmarketing surveillance (PMS). MATERIALS AND METHODS: This prospective observational PMS included 154 patients (161 procedures) treated at 20 Japanese centers between September 2022 and March 2023. Eligible lesions were ≥ 70% stenosed and severely calcified. Procedural success was defined as no bailout stenting or bypass. Lesion success required ≤ 30% residual stenosis, no Grade C or higher dissection, no perforation requiring treatment, and no significant flow reduction. Six-month follow-up included duplex ultrasound, Ankle-Brachial Index, and Rutherford category assessment. RESULTS: Patients had a mean age of 74.3 years; 74.7% had diabetes while 44.8% were currently on dialysis. Most lesions were in the superficial femoral artery with a mean length of 80.0 mm. Lesions were severely calcified (99.4%), and 33.3% of patients had chronic limb threatening ischemia at baseline. Procedural and lesion success rates were 98.8% and 96.6%, respectively. Distal embolization occurred in 5.8% of procedures. At 6 months, primary patency was 87.5%, freedom from TLR was 98.8%, and 87.1% of patients showed hemodynamic improvement without reintervention. All-cause mortality was 7.8% at 6-months post procedure. CONCLUSION: The Jetstream atherectomy system demonstrated high procedural and lesion success with acceptable complication rates in complex, calcified femoropopliteal lesions. These findings support its use in combination with drug-coated balloons in real-world Japanese clinical practice. LEVEL OF EVIDENCE: Level 3a, Nonrandomized postmarket surveillance.

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