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

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.