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Objective: Endovascular therapy of lower extremity peripheral artery disease (PAD) is associated with higher complication rates and worse outcomes in women vs men. Although intravascular lithotripsy (IVL) has shown similarly favorable outcomes in men and women in calcified coronary arteries, there is no published safety and effectiveness data of peripheral IVL differentiated by sex. This study aims to evaluate sex-specific acute procedural safety and effectiveness following IVL treatment of calcified PAD., Methods: We performed a secondary analysis of the multicenter Disrupt PAD III Observational Study, which assessed short-term procedural outcomes of patients undergoing treatment of symptomatic calcified lower extremity PAD with the Shockwave peripheral IVL system. Adjudicated acute safety and efficacy outcomes were compared by sex using univariate analysis performed with the χ 2 test or Fisher exact test, as appropriate., Results: A total of 1262 patients (29.9% women) were included, with >85% having moderate to severe lesion calcification. Women were older (74 vs 71 years; P < .001), had lower ankle-brachial index (0.7 vs 0.8; P = .003), smaller reference vessel size (5.3 vs 5.6 mm; P = .009), and more severe stenosis at baseline vs men (82.3% vs 79.8%; P = .012). Rates of diabetes, renal insufficiency, chronic limb-threatening ischemia, lesion length, and atherectomy use were similar in both groups. Residual stenosis after IVL alone was significantly reduced in both groups. Final residual stenosis was 21.9% in women and 24.7% in men (P = .001). Serious angiographic complications were infrequent and similar in both groups (1.4% vs 0.6%; P = .21), with no abrupt vessel closure, distal embolization, or thrombotic events during any procedure., Conclusions: The use of IVL to treat calcified PAD in this observational registry demonstrated favorable acute safety and effectiveness in both women and men., Competing Interests: Disclosures S.N. reports consultant for Cardinal Health, Haemonetics, and Veryan Medical. K.M. reports speaker fees from Shockwave Medical and Penumbra Inc. S.S.M. reports speaker fees from Shockwave Medical. G.A. reports consultant for education and research for Shockwave Medical. N.W.S. reports research and educational grants from Bard, AngioDynamics, and Boston Scientific; consultant for Abbott, Shockwave Medical, and VentureMed Group; and speaker bureau for Janssen, Boehringer Ingelheim, Merck, Amgen, and Bayer. A.M. reports speaker fees from Shockwave Medical; and speaker and training fees from Abbott. P.S. reports institutional grant support from W.L. Gore, Boston Scientific, Contego Medical, Endologix, InspireMD, MicroMedical Solutions, Philips, and Shockwave Medical. B.B. reports speaker fees from Shockwave Medical. A.J.L. reports speaker fees from Shockwave Medical., (Copyright © 2023. Published by Elsevier Inc.)

Background: Coronary intravascular lithotripsy (IVL) has emerged as a novel technique for the treatment of severely calcified coronary lesions. We evaluated the mechanism and efficacy of IVL in facilitating optimal stent implantation in heavily calcified coronary lesions using intravascular ultrasound (IVUS)., Methods: Forty-six patients were initially enrolled as a part of the Disrupt CAD III study. Of these, 33 had pre-IVL, 24 had post-IVL, and 44 had post-stent IVUS evaluation. The final analysis was performed on 18 patients who had IVUS images interpretable at all three intervals. The primary endpoint was increase in minimum lumen area (MLA) from pre-IVL to post-IVL treatment to post-stenting., Results: Pre-IVL, MLA was 2.75 ± 0.84 mm 2 , percent area stenosis was 67.22 % ± 20.95 % with maximum calcium angle of 266.90° ± 78.30°, confirming severely calcified lesions. After IVL, MLA increased to 4.06 ± 1.41 mm 2 (p = 0.0003), percent area stenosis decreased to 54.80 % ± 25.71 % (p = 0.0009), and maximum calcium angle decreased to 239.40° ± 76.73° (p = 0.003). There was a further increase in MLA to 6.84 ± 2.18 mm 2 (p < 0.0001) and decrease in percent area stenosis to 30.33 % ± 35.08 % (p < 0.0001) post-stenting with minimum stent area of 6.99 ± 2.14 mm 2 . The success rate of stent delivery, implantation, and post-stent dilation was 100 % post-IVL., Conclusion: In this first study evaluating the mechanism of IVL using IVUS, the primary endpoint of increase in MLA from pre-IVL to post-IVL treatment to post-stenting was successfully achieved. Our study showed that the use of IVL-assisted percutaneous coronary intervention is associated with improved vessel compliance, facilitating optimal stent implantation in de novo severely calcified lesions., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: All others have no conflicts of interest to declare., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Objectives: The study sought to compare short-term outcomes in patients with femoropopliteal artery calcification receiving vessel preparation with intravascular lithotripsy (IVL) or percutaneous transluminal angioplasty (PTA) prior to drug-coated balloon (DCB) for symptomatic peripheral artery disease., Background: Endovascular treatment of calcified peripheral artery lesions is associated with suboptimal vessel expansion and increased complication risk. Although initial results from single-arm studies with IVL have been reported, comparative evidence from randomized trials is lacking for most devices in the presence of heavy calcification., Methods: The Disrupt PAD III (Shockwave Medical Peripheral Lithoplasty System Study for PAD) randomized trial enrolled patients with moderate or severe calcification in a femoropopliteal artery who underwent vessel preparation with IVL or PTA prior to DCB or stenting. The primary endpoint was core lab-adjudicated procedural success (residual stenosis ≤30% without flow-limiting dissection) prior to DCB or stenting., Results: In patients receiving IVL (n = 153) or PTA (n = 153), procedural success was greater in the IVL group (65.8% vs. 50.4%; p = 0.01) and the percentage of lesions with residual stenosis ≤30% (66.4% vs. 51.9%; p = 0.02) was greater in the IVL group, while flow-limiting dissections occurred more frequently in the PTA group (1.4% vs. 6.8%; p = 0.03). Post-dilatation (5.2% vs. 17.0%; p = 0.001) and stent placement (4.6% vs. 18.3%; p < 0.001) were also greater in the PTA group. The rates of major adverse events (IVL: 0% vs. PTA: 1.3%; p = 0.16) and clinically driven target lesion revascularization (IVL: 0.7% vs. PTA: 0.7%; p = 1.0) at 30 days were comparable between groups., Conclusions: IVL is an effective vessel preparation strategy that facilitates definitive endovascular treatment in calcified femoropopliteal arteries in patients with peripheral artery disease. (Shockwave Medical Peripheral Lithoplasty System Study for PAD [Disrupt PAD III]; NCT02923193)., Competing Interests: Funding Support and Author Disclosures Shockwave Medical (Santa Clara, California) provided financial support for this research. Dr. Tepe has served on the advisory board for B. Braun, BSC, and Medtronic; and has received study support by Bayer Health Care, B. Braun, Biotronik, Bard, BSC, Gore, Medtronic, Verian, and Shockwave Medical. Dr. Brodmann has served on the advisory board for Medtronic, BD Bard, Philipps Spectranetics, Intact Vascular, Boston Scientific, Biotronik, Shockwave Medical, Cagent, Profusa, and Bayer Healthcare. Dr. Werner has received honoraria from Philips, Boston Scientific, Trireme Medical, and Shockwave Medical. Dr. Bachinsky has received research grant support and is a consultant for Abbott Vascular, Boston Scientific, BD Bard Vascular, Medtronic, and Shockwave Medical. Dr. Holden has served on the advisory board for Medtronic, Boston Scientific, Gore Medical, Philips, Shockwave Medical, Abbott, Intact Vascular, and Cagent; and has served as a Clinical investigator for Reflow Medical, LimFlow, Surmodics, and Shape Memory. Dr. Zeller has received honoraria from Abbott Vascular, BIBA Medical, Biotronik, Boston Scientific, Cook Medical, Efemoral Medical, W.L. Gore and Associates, Medtronic, Philips-Spectranetics, Shockwave, and Veryan; has served as a consultant for Boston Scientific, CSI, W.L. Gore and Associates, Medtronic, Veryan, Intact Vascular, Shockwave, Bayer, and Vesper Medical; has received institutional research grant, clinical trial, or drug study funds from Bard Peripheral Vascular, Veryan, Biotronik, Cook Medical, W.L. Gore and Associates, Medtronic, Philips, Terumo, TriReme, Shockwave, Med Alliance, Intact Vascular, B. Braun, CSI, Boston Scientific, University of Jena, Pluristem, Philips, and PQ Bypass; and holds common stock from QT Medical. Dr. Mangalmurti has served as a consultant for Shockwave Medical, Philips, Cardiovascular Systems, and Medtronic. Dr. Nolte-Ernsting has received honoraria from Medtronic, Biotronik, and Penumbra; and has served on advisory boards of Shockwave Medical, Medtronic, and W.L. Gore and Associates. Dr. Scheinert has received institutional research support from Shockwave Medical. Dr. Gray has served as a consultant for and received institutional research support from Shockwave Medical. Dr. Bertolet has reported that he has no relationships relevant to the contents of this paper to disclose., (Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Purpose: To evaluate the performance of peripheral intravascular lithotripsy (IVL) in a real-world setting during endovascular treatment of multilevel calcified peripheral artery disease (PAD). Materials and Methods: The Disrupt PAD III Observational Study ( ClinicalTrials.gov identifier NCT02923193) is a prospective, nonrandomized, multicenter, single-arm observational study assessing the acute safety and effectiveness of the Shockwave Peripheral IVL System for the treatment of calcified, stenotic lower limb arteries. Patients were eligible if they had claudication or chronic limb-threatening ischemia and moderate or severe arterial calcification. Between November 2017 and August 2018, 200 patients (mean age 72.5±8.7 years; 148 men) were enrolled across 18 sites and followed through hospital discharge. Results: In the 220 target lesions, IVL was more commonly used in combination with other balloon-based technologies (53.8%) and less often with concomitant atherectomy or stenting (19.8% and 29.9%, respectively). There was a 3.4-mm average acute gain at the end of procedure; the final mean residual stenosis was 23.6%. Angiographic complications were rare, with only 2 type D dissections and a single perforation following drug-coated balloon inflation (unrelated to the IVL procedure). There was no abrupt closure, distal embolization, no reflow, or thrombotic event. Conclusion: Use of peripheral IVL to treat severely calcified, stenotic PAD in a real-world study demonstrated low residual stenosis, high acute gain, and a low rate of complications despite the complexity of disease.