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Vol.:(0123456789)Lasers in Medical Science (2025) 40:4 https://doi.org/10.1007/s10103-024-04216-7ORIGINAL ARTICLEPercutaneous photoacoustic debulking of infra?inguinal atherosclerotic disease? early European experience with a novel, solid?state, pulsed ?wave, ultraviolet 355 nm laserWac?aw Kuczmik 1  · Grzegorz Oszkinis 2  · ?ukasz Kruszyna 2  · Micha? Goran Stanisi? 2  · Wojciech Zelawski 1  · Jacek Kostecki 1  · David Planer 3  · Luis R Leon Jr. 4  · Yossi Muncher 5  · Oshrat Cohen 5  · On Topaz 6Received: 22 May 2024 / Accepted: 16 October 2024 / Published online: 2 January 2025 © The Author(s) 2024AbstractThe broad spectrum of clinical manifestations caused by peripheral arterial disease [PAD] and the morphologic heterogeneity of associated atherosclerotic lesions present a considerable management challenge. Endovascular interventions are recognized an ef f ective treatment for PAD. Within this revascularization strategy the role of atherectomy debulking modalities continue to evolve. Accordingly, the study herein assessed the ef f i cacy and safety of a novel, solid state, Nd: YAG pulsed-wave [355 nm wavelength] laser atherectomy in the treatment of symptomatic infra-inguinal PAD. The EX-PAD-01 study, a prospective, single-arm, open label trial enrolled 50 patients (38 males, 12 females; mean age 64 years] with symptomatic peripheral arte-rial disease, who underwent percutaneous revascularization with a novel, solid state, pulsed-wave [355 nm wavelength] laser atherectomy followed with adjunct treatment. The Ankle-brachial index [ABI], Rutherford classif i cation for chronic limb ischemia and the walking impairment questionnaire [WIQ] were used for assessment of the index clinical condition of the enrolled patients, for post procedure evaluation and during follow-up. Accordingly, the patients were followed for 12-months with repeated direct physician contact visits. Fifty-three atherosclerotic stenoses (51 femoropopliteal, 2 tibial) with a mean length of 7.4 cm. (ranged 1cm to 25cm) were treated. There were 79% occlusions, and 61% containing moderate-to-severe calcif i cations. The pre-procedure stenosis was 95.3 ± 10.3%, the Rutherford classif i cation for chronic limb ischemia [CLI] was 2.90 ± 0.54 ranging between 2–4 and the WIQ 34.6 ± 8.62. Technical success was achieved in 52 of the 53 (98%) target lesions. Following laser debulking the baseline stenosis was reduced from 95.3 ± 10.3% to 61.3 ± 25.5% [ [p < 0.0001] and with adjunct balloon/stenting to fi nal of 14.0 ± 14.0% [p < 0.0001]. Embolic protection devices were utilized in 6 [12%] patients. At 30-day post procedure evaluation the ABI increased from baseline of 0.57 ± 0.14 to 0.94 ± 0.14 [p < 0.0001] and no major adverse ef f ects or device adverse ef f ects were detected. At 6 months follow -up the ABI was 0.84 ± 0.20% (p < 0.0001 vs. initial) and at 1 year follow-up 0.79 ± 0.16 (P = 0.0001 vs. initial) without major adverse events. Out of 46 [92%] patients who reached the 12 months follow-up mark, 2 [4.3%] experienced clinically driven target lesion revasculariza-tion. Sustained clinical benef i t for up to 12 months post procedure was demonstrated through documentation of statistically signif i cant decrease of Rutherford CLI class as well as concomitant improvement in WIQ score and an increase of ABI value. The primary patency rate, as def i ned by peak systolic velocity ratio (PSVR) of < 2.5m/second was 95.7% (22 of 23) and 81.8% (18 of 22) at 6 months and 12 months, respectively. In an early European clinical experience with a series of 50 patients with symptomatic peripheral arterial disease, the novel Nd: YAG solid state, pulsed- wave 355nm cardiovascular laser atherectomy device provided ef f ective and safe revascularization treatment. Follow-up at 6 and 12 months, respectively, substantiate the ef f i cacy, safety prof i le and clinical merits of this novel laser. Thus, this device is useful in the management of select patients with symptomatic infra-inguinal atherosclerotic lesions.Clinical Trial Registration: Clinical trials.gov number: NTC02556255.Keywords Laser · 355nm · Debulking · Atherectomy · Plaque · Vaporization · Peripheral artery disease · Calcif i cation · Chronic limb ischemiaExtended author information available on the last page of the article