Intravascular ultrasound assessment of the effect of laser energy on the arterial wall during the treatment of femoro-popliteal lesions: a CliRpath excimer laser system to enlarge lumen openings (CELLO) registry study

Abstract

The CliRpath Excimer Laser System to Enlarge Lumen Openings (CELLO) registry included patients treated with modified excimer laser catheters for the endovascular treatment of peripheral artery disease affecting the superficial femoral artery (SFA) and proximal popliteal artery. The aim of this study was to assess, via intravascular ultrasound (IVUS) the dissections in the vessel wall following treatment with the laser catheters. IVUS grayscale images from the CELLO registry were systematically reviewed for dissections in the treated vessel segments by two investigators. Images from 33 patients; 66 pullbacks (1867 IVUS frames in 2 phases), were successfully matched frame-to-frame to evaluate identical segments of the treated vessels in the two phases; post-2 mm Turbo-Elite laser pilot channel creation and post Turbo-Booster laser atherectomy. Dissections were categorized as; (1) intimal, (2) medial, (3) intramural hematoma, and (4) adventitial according to the ACC Clinical Expert Consensus Document classification of dissections. An average of 57 frames was evaluated per pullback, giving a total of 3734 frames (1867 matched for pre-ablation (post channel creation) and post-ablation phases). Treatments with the modified Excimer laser catheters resulted in a significant increase in lumen area of 5.5 ± 3.2-mm2 (95% CI 4.3–6.8, p < 0.0001) and reduction in plaque plus media volume of −10.6 ± 36.0 mm3 (95% CI −25.8 to 4.6, p = 0.1619) whilst giving rise to mainly intramural hematoma formations post Turbo-Booster laser treatment in 55% of frames assessed and 24% medial dissections with less than 1% adventitial disruption. The Excimer laser based Turbo-Booster treatment of peripheral artery lesions resulted in significant plaque debulking and increased lumen diameter with negligible degree of adventitial layer injury.

Combined Use of Excimer Laser and High-Speed Rotational Atherectomy to Overcome a Severely Calcified Lesion in Endovascular Therapy

“…A randomized control trial demonstrated the superiority of ELA with PTA versus PTA alone for treating femoropopliteal ISR in mid-term (6-month freedom from target lesion revascularization; 73.5% versus 51.8%, p < 0.005) [10]. With respect to imaging, intravascular ultrasound assessment indicated that ELA of peripheral artery lesions resulted in significant plaque debulking and increased lumen diameter with negligible degree of adventitial layer injury [11]. Angioscopy assessment also visualized the ELA effect of vaporization of thrombi in femoropopliteal in-stent lesions [12].…”

A post-market, multi-vessel evaluation of the imaging of peripheral arteries for diagnostic purposeS comparing optical Coherence tomogrApy and iNtravascular ultrasound imaging (SCAN)

“…Use of such imaging can help form the treatment strategy, size the vessel so that the appropriate diameter of balloons or stents being placed is chosen, and guide and direct treatments such as angioplasty and atherectomy to minimize vessel wall injury [6,[27][28][29][30][31]. Intravascular imaging also permits assessment of tissue in the region of the procedure in order to determine whether further treatment is necessary to address regions with incomplete treatment or injury resulting from the treatment [30,32,33].…”

Cardiovascular imaging 2018 in the International Journal of Cardiovascular Imaging

“…The authors described adventitial layer disruption in < 1% of the 1867 post ablation frames assessed by IVUS, which resulted in a secondary patency of 100% at 6 and 12 months, despite a lower percentage of primary patency. Those are very promising results and results from RCT are welcomed [23].…”