Efficacy and safety of intravascular lithotripsy for the treatment of peripheral arterial disease: An individual patient-level pooled data analysis

Abstract

Background: Peripheral arterial disease (PAD) is one of the most common manifestations of atherosclerotic disease worldwide. Peripheral arterial calcification reduces acute success and long-term patency of endovascular therapy for PAD. Several calcium modification devices are available for use in peripheral interventions. Outcomes after peripheral intravascular lithotripsy (IVL), a novel approach using pulsatile sonic waves to treat luminal and medial calcium in patients with PAD, have not been extensively characterized. Therefore, we sought to perform an individual patient-level data (IPD) pooled analysis of available studies to evaluate the efficacy and safety of IVL in the treatment of PAD.

Methods and results: We pooled IPD, including baseline and procedural variables, from five prospective studies which assessed IVL in the treatment of patients with extensive peripheral artery calcification. Final postprocedural percent diameter stenosis (%DS) and procedural angiographic complications were assessed by independent core laboratory. Efficacy endpoints were analyzed using linear mixed effects models and safety endpoints were tabulated overall and by vascular bed. Among 336 patients who underwent endovascular revascularization with use of IVL, there was a significant reduction between pre-procedural and final %DS of 55.1% (95% confidence interval 53.3-57.0%, p < .0001). Core-laboratory assessed lesion-level complications, including flow-limiting dissections (Types D-F), vessel perforation, distal embolization, thrombus, abrupt closure, and no reflow, occurred in 4/328 (1.22%) of treated lesions.

Conclusions: The present IPD of five prospective studies, marking the largest analysis to date evaluating the use of IVL in significantly calcified PAD lesions, demonstrates this treatment strategy to be both effective and safe.

Keywords: endovascular intervention; peripheral arterial disease; peripheral intervention; vascular calcification.

Conflict of interest statement

Dr Mena‐Hurtado is a consultant for Abbott, Boston Scientific, Cardinal Health, Cook, Medtronic, and Bard. Dr Garcia reports grants/research support from Abbott and Covidien/Medtronic; Nonfinancial consulting relationships with Covidien/Medtronic, Boston Scientific, and Abbott; Equity in Arsenal, Primacea, TissueGen, CV Ingenuity, Spirox, Scion Cardiovascular, Syntervention, Essential Medical, Transit Medical, and Orchestra Medical; and Ownership/Founder of Innovation Vascular Partners. Dr Parikh reports institutional grants/research support from Abbott Vascular, Shockwave Medical, TriReme Medical, Sumodics, Silk Road, Medical, and the NIH; consulting fees from Terumo and Abiomed; and Advisory Board participation for Abbott, Medtronic, Boston Scientific, CSI, and Philips. The other authors have nothing to disclose.

© 2020 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals, Inc.

Figures

Figure 1

Representative images before and after IVL. Significant occlusion in right superficial femoral artery with baseline RVD of 5.1 mm, 100% diameter stenosis, severe PARC calcification (a), lesion treatment with intra‐vascular lithotripsy (b), post‐IVL catheter angiographic assessment demonstrates 22.6% diameter stenosis and acute gain of 4.2 mm (c), and final angiographic assessment demonstrates 23.1% diameter stenosis, acute gain of 3.9 mm, and no evidence of complications (d). PARC, Peripheral Academic Research Consortium; RVD, reference vessel diameter

Figure 2

Improvements in clinical measures of PAD. Box plots comparing median [interquartile range] of pre‐procedural (0.71 [0.57–0.85]) and post‐IVL (0.98 [0.98–1.08]) in the 88 patients from the PAD I and II studies with ABI assessment on discharge are presented in panel (a). Lower, middle, and upper hinges of the box correspond to the 25th, 50th, and 75th percentiles, respectively. The upper whisker extends from the hinge to the largest value no further than 1.5 times the interquartile range of the hinge. The lower whisker extends from the hinge to the smallest value at most 1.5 times interquartile range of the hinge. Raw data are individually plotted as circles. Proportion of patients by Rutherford category before and after IVL therapy in the 77 patients with Rutherford class assessment from the PAD I and II studies on discharge are presented in panel (b)

Figure 3

Efficacy and safety of IVL therapy. Longitudinal linear mixed effect regression models comparing baseline, post‐IVL, and final percent diameter stenosis measurements are presented in panel (a). Final percent diameter stenosis by study and pooled estimate values are presented in panel (b). Final percent diameter stenosis by key clinical subgroups, including age, sex, diabetes mellitus, renal insufficiency, chronic total occlusion, severe calcification by Yale and PARC definitions, calcium distribution, vascular bed, poor distal runoff (≤1 vessel), high‐risk Rutherford categories 4‐6, and use of adjunctive lesion modification therapies are presented in panel (c). Rates of dissection by vascular bed (iliac, common femoral, superficial femoral, popliteal, infrapopliteal) after intervention are presented in panel (d). CI, confidence interval; DS, diameter stenosis; PARC, Peripheral Academic Research Consortium