Clinical impact of atherectomy with multimodal embolic protection for severely calcified femoropopliteal lesions
D Yoshii, T Tsujimura, Y Hata, Y Okina, T Toyoshima, H Minamiguchi, Y Ichibori, K Nakamoto, N Mori, T Kanda, H Tsutsui, M Matsumura, S Nakawatase, S Okamoto, O IidaAbstract
Background
Severely calcified femoropopliteal (FP) lesions remain challenging in endovascular therapy (EVT). Although atherectomy is an effective treatment modality, distal embolization is not completely avoided, even with embolic protection device utilization.
Purpose
This study aimed to evaluate the impact of different embolic protection strategies for preventing distal embolization during atherectomy in severely calcified FP lesions.
Methods
This multicenter, retrospective study included 184 limbs (CLTI: 35.9%, lesion length: 148.8±103.0mm, PACCS grade 4: 60.9%) in 144 peripheral artery disease patients (age: 75.4 years, male: 69.6%, diabetes mellitus: 65.8%, hemodialysis: 44.0%) with FP lesions treated by the JETSTREAM® atherectomy system between September 2022 and November 2025. Patients were classified into four phases reflecting the stepwise intensification of embolic protection strategies: Phase 1 (n=30, April 2023-June 2023), no protection; Phase 2 (n=73, July 2023-May 2024), single protection using an embolic protection device (EPD) alone; Phase 3 (n=50, June 2024-April 2025), double protection consisting of proximal protection using an Optimo catheter® in addition to single protection with EPD; and Phase 4 (n=31, May 2025-), triple protection consisting of flow reversal induced by an artery-vein pressure gradient in addition to double protection. The outcome measure was the incidence of distal embolization, defined as angiographically observed slow-flow phenomenon or loss of runoff vessels. Odds ratios were calculated using univariate logistic regression analysis with the no-protection group as the reference. A multivariable logistic regression analysis was performed to identify independent predictors of distal embolization.
Results
There were no significant differences in patient or lesion characteristics among the four groups. Distal embolization occurred in 16.8% of limbs. Using the no protection group as the reference, the triple protection group had the lowest odds ratio (OR, 0.42; 95% confidence interval [CI], 0.21-0.87; P=0.019) for distal embolization risk reduction. Multivariable analysis identified chronic limb-threatening ischemia as an independent risk factor for distal embolization (OR, 2.96; 95% CI, 1.30–6.73; P=0.009), whereas the triple protection was a significantly associated with reduced risk of distal embolization (OR, 0.12; 95% CI, 0.01-0.95; P=0.045).
Conclusions
The current study revealed that distal embolization is a substantial complication during atherectomy for severely calcified FP lesions, and triple protection is an effective strategy to reduce distal embolization.Distal Embolization by Preventive StrategyFor image description, please refer to the figure legend and surrounding text.