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. 2024 Oct 18:15266028241283716.
doi: 10.1177/15266028241283716. Online ahead of print.

Intravascular Lithotripsy for Peripheral Artery Calcification: 30-Day Outcomes From the Disrupt PAD III Observational Study

Ehrin J Armstrong  1 , George Adams  2 , Peter A Soukas  3 , Sarang S Mangalmurti  4 , Nicolas W Shammas  5 , Anderson Mehrle  6 , Barry Bertolet  7 , William A Gray  8 , Gunnar Tepe  9 , Edward Y Woo  10 , James F McKinsey  11 , Andrew Holden  12 , Sahil A Parikh  13
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Free article

Intravascular Lithotripsy for Peripheral Artery Calcification: 30-Day Outcomes From the Disrupt PAD III Observational Study

Ehrin J Armstrong et al. J Endovasc Ther. .
Free article

Abstract

Purpose: Intravascular lithotripsy (IVL) has shown promising safety and effectiveness in calcified peripheral artery disease (PAD) in large trials and small real-world experiences. Real-world evidence from a larger cohort is lacking, so we aimed to evaluate the real-world acute performance of IVL in the treatment of calcified PAD.

Materials and methods: The Disrupt PAD III Observational Study (OS) is a prospective, multicenter, single-arm study. Patients with claudication or critical limb-threatening ischemia (CLTI) and at least moderate calcification were eligible. Independent predictors of procedural outcomes were assessed by multivariable analysis.

Results: Between November 2017 and June 2021 across 30 global sites, 1373 patients with 1677 lesions (1531, 91.3% core lab evaluable) were enrolled. Diameter stenosis and lesion length was 80.6±17.6% and 93.5±74.3 mm, respectively. Target vessels included femoropopliteal (61%), iliac (15.8%), common femoral (10.7%), and infrapopliteal arteries (12.8%). Lesion characteristics included 31.1% chronic total occlusions (CTOs) and 19.3% long lesions (≥15 cm). At final assessment, residual stenosis was 23.8±11.3%, with 0.9% serious angiographic complications, no abrupt closures, distal embolization, no flow, or thrombotic events. Independent predictors of ≤30% residual stenosis were lesion length ≥15 cm (odds ratio [OR]=0.384), female sex (OR=1.850), age ≤75 years (OR=1.625), IVL balloon to artery ratio ≥1.0 (OR=1.538), and CTO lesions (OR=0.638). Lesion length ≥15 cm (OR=16.076) was an independent predictor of procedural complications.

Conclusions: The Disrupt PAD III OS represents the largest assessment of IVL periprocedural outcomes in calcified PAD. It confirmed excellent procedural safety and effectiveness in complex lesions across multiple peripheral vascular beds.

Clinical impact: This final analysis of the PAD III OS represents the largest report of peripheral IVL utilization in daily clinical practice. The outcomes of this study indicate that previously reported procedural results in clinical trial settings can be translated to a broader patient population. Treatment with peripheral IVL in severely calcified stenotic lower limb lesions demonstrated consistent acute safety and stenosis reduction, even in complex patients across multiple vessel beds. In addition, the importance of proper IVL balloon sizing to achieve excellent acute stenosis reduction was confirmed by multivariate analysis.

Keywords: CLTI; calcified PAD; complex PAD; intravascular lithotripsy; severe calcium.

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Conflict of interest statement

Declaration of Conflicting InterestsThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: E.J.A. is a consultant to Abbott Vascular, BD Bard, Boston Scientific, Gore, Medtronic, Philips, and Shockwave Medical. S.A.P. receives institutional research support from Abbott Vascular, Boston Scientific, Shockwave Medical, TriReme Medical, Surmodics, Veryan Medical, MedAlliance, Concept Medical, and Acotec. He serves as an advisor to Abbott Vascular, Boston Scientific, BD, Cordis, Medtronic, Philips, and R3 Medical. He is a consultant to Terumo, Penumbra, Inari, and Canon and has equity in Advanced Nanotherapies, eFemoral, and Encompass Vascular. G.A. is a consultant and has education responsibilities for Shockwave Medical, Abbott Vascular, Phillips, and is CMO of Cordis. P.A.S. is a consultant to AngioSafe, Boston Scientific, Cordis, Endologix, Shockwave Medical, and W.L. Gore. He is on the Advisory Board of AngioSafe, Endologix, and Shockwave Medical. He receives institutional research support from Boston Scientific, Contego Medical, Endologix, MedAlliance, Micromedical Solutions, Philips, Reflow Medical, Shockwave Medical, SoundBite, and W.L. Gore. S.S.M. is a consultant for Shockwave Medical, Philips, Cardiovascular Systems Inc., and Medtronic. N.W.S. receives educational and research grants from Angiodynamics, Boston Scientific, Bard/BD, and Abbott and is an investigator on several Shockwave Medical studies. He is a consultant to Cardiovascular Systems, Inc, Abbott, Angiodynamics and Bard. A.M. is a consultant and trainer for Abbott, Phillips, and a speaker for Janssen. B.B. is a consultant and trainer for Medtronic Vascular, and a speaker for Shockwave Medical. W.A.G. is a consultant for Alucent, Boston Scientific Corporation, Edwards Lifesciences, efemoral, Medtronic, Phillips, W.L. Gore and Associates, Inc, and Shockwave Medical. He is performing contracted research for Boston Scientific Corporation, Edwards Lifesciences LLC, Medtronic, Phillips, and Shockwave Medical. G.T. is on the advisory board for BSC, Medtronic, and receives study support from B.Braun, Bold, BSC, Biotronic, Verian, Philips, and Shockwave Medical. E.Y.W. has no disclosures. J.F.M. has no disclosures. A.H. is a Medical Advisory Board Member for Medtronic, Gore, Philips, and Boston Scientific. He is a clinical investigator for Abbott, Bard-BD, Biotronik, Boston Scientific, Cagent, Cook, Efemoral, Endologix, Endospan, FluidX, Gore, Medtronic, Nectero, Philips, Reflow Medical, Shape Memory, Shockwave, Terumo, and TriReme. S.A.P. is a Clinical Trial Investigator for Abbott Vascular, Acotec, Boston Scientific, Concept Medical, MedAlliance, and Shockwave Medical. He is consulting or part of advisory boards for Abbott Vascular, Boston Scientific, Cordis, Medtronic, and Philips; receives grants or research support from Abbott Vascular, Shockwave Medical, Surmodics, and TriReme; conducts contracted research for Acotec, Concept Medical, and MedAlliance; a speaker for Inari, Penumbra, Shockwave Medical, and Teruma; and he is part of a DSMB for Boston Scientific.

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