Intravascular Lithotripsy for Treatment of Calcified Lower Extremity Arterial Stenosis: Initial Analysis of the Disrupt PAD III Study

Abstract

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.

Keywords: acute gain; calcification; chronic total occlusion; common femoral artery; complication; iliac artery; infrapopliteal arteries; lithoplasty; lithotripsy; occlusion; peripheral artery disease; popliteal artery; stenosis; superficial femoral artery.

Conflict of interest statement

Declaration of Conflicting Interests: The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: George Adams reports receiving research support from Boston Scientific, CSI, Medtronic, and Volcano and is a consultant to Abbott, Bard, Cook, CSI, Shockwave Medical, and Volcano. Nicolas Shammas reports receiving research support from Boston Scientific, Bard, Phillips, Intact Vascular, and VentureMed Group and is an Advisory Board member or consultant to Intact Vascular, VentureMed Group, Boston Scientific, and Bard. Sahil Parikh is a consultant to Terumo, Meril Life Sciences, and eFemoral and an Advisory Board member for Abbott, Boston Scientific, Medtronic, Philips, and CSI. Ehrin Armstrong is a consultant to Abbott Vascular, Boston Scientific, Cardiovascular Systems, Gore Medical, Intact Vascular, Medtronic, Philips, PQ Bypass, and Shockwave Medical. Peter Soukas receives research support from C.R. Bard, Intact Vascular, PQ Bypass, Philips, Shockwave Medical, and Gore Medical. Gunnar Tepe receives research support from Braun, Biotronic, Bard, Gore Medical, Boston Scientific, Medtronic, Verian, Shockwave Medical, and Phillips and is on the Advisory Board for Medtronic and Phillips. William Gray is a consultant to Shockwave Medical.

Figures

Figure 1.

Example of core laboratory angiographic assessment of a treated lesion. DS, diameter stenosis; IVL, intravascular lithotripsy; PARC, Peripheral Academic Research Consortium; RVD, reference vessel diameter.

Figure 2.

Adjunctive therapy utilization across multiple vessels.

Figure 3.

Baseline and residual stenosis across subgroups.

Figure 4.

(A) Severe concentric calcification of a left superficial femoral artery (SFA) with 94.3% stenosis [reference vessel diameter (RVD) 4.95 mm]. (B) The lesion was treated with 180 pulses from a 6.5-mm intravascular lithotripsy (IVL) catheter, followed by drug-coated balloon (DCB) angioplasty. (C) The treatment achieved a 24.9% residual stenosis and 3.83-mm acute gain. (D) Severe eccentric calcification of a left SFA with an 88.7% ostial stenosis (RVD 6.83 mm) a second 80.4% mid SFA lesion (RVD 5.88 mm). (E) The lesions were treated with 210 pulses from a 7.0-mm IVL catheter, followed by DCB angioplasty. (F) Treatment achieved a 17.3% residual stenosis in the ostial SFA (4.91-mm acute gain) and a 19.3% residual stenosis (3.49-mm acute gain) in the mid-vessel lesion.

Figure 5.

Lesion complexity comparison between Disrupt PAD I/II and Disrupt PAD III Observational Study. (A) Peripheral arteries included and (B) complexity of lesions treated.