Flow‐Controlled Atherectomy Treatment for Severely Calcified Femoropopliteal Lesion; Seat Belt and Air Bag Technique

BACKGROUND: Distal embolization is a known risk during Jetstream atherectomy for severely calcified femoropopliteal lesions. AIM: This study aimed to evaluate the effectiveness of a novel "flow-controlled atherectomy treatment (FCAT)" using proximal protection to prevent distal embolization during Jetstream atherectomy, both in vitro and in vivo. METHODS: The study consisted of in vitro experiments and a retrospective, single-center clinical analysis. The clinical study included 18 patients with severely calcified femoropopliteal artery lesions. The FCAT procedural steps were as follows: (1) placing the Optimo catheter (Tokai Medical) proximal to the lesion, (2) inflating the occlusion balloon at the tip of the catheter to completely block antegrade flow, (3) after performing Jetstream atherectomy and subsequent balloon dilation of the lesion, manual aspiration was performed via the side port of the Optimo catheter, and (4) deflating the balloon and performing completion angiography. The primary endpoint was to investigate whether FCAT could prevent distal embolization in severely calcified lesions under both in vitro and in vivo conditions. RESULTS: In vitro experiments revealed no debris in the distal portion of artificial lesions following atherectomy under proximal protection, and debris was successfully captured via direct aspiration from the sheath and the Jetstream collection bag. In clinical cases, all procedures achieved initial success with embolus recovery via the Optimo catheter in each case and without any instances of distal embolization. CONCLUSION: Implementing proximal protection during Jetstream atherectomy may reduce the risk of distal embolization.