Safety and Feasibility of Intravascular Lithotripsy for Treatment of Below-the-Knee Arterial Stenoses

Abstract

Purpose: To evaluate the safety and feasibility of treating calcified infrapopliteal stenoses using an intravascular lithotripsy (IVL) system. Methods: The Disrupt BTK study was a prospective, nonrandomized, multicenter, feasibility, and safety trial that enrolled 20 patients (mean age 79.0±9.6 years; 14 men) at 3 participating sites (ClinicalTrials.gov identifier NCT02911623). Fifteen patients had Rutherford category 5 ischemia, and all patients had moderate to severe below-the-knee arterial calcification. Patients were treated with the Shockwave Medical Peripheral IVL System and followed for 30 days. The primary safety endpoint was a composite of major adverse events through 30 days defined as death, myocardial infarction, need for emergency surgical revascularization of the target limb, or amputation of the target limb. The primary effectiveness outcome was acute reduction in the percent diameter stenosis. Results: IVL catheter delivery was successful in 19 patients. The composite of major adverse events at 30 days was 0%. The acute reduction in percent diameter stenosis of target lesions was 46.5%. All patients achieved residual diameter stenosis ≤50%. Vascular complications were minimal with only 1 type B dissection reported and 2 stents placed. None of the subjects experienced thrombus formation, abrupt closure, distal embolization, or perforation. There were no device-related complications. Conclusion: The early results of this pilot study demonstrated that calcified, stenotic infrapopliteal arteries can be safely and successfully treated with intravascular lithotripsy.

A Case of Stent Under-Expansion due to Calcified Plaque Treated with Shockwave Lithoplasty

“…The Lithoplasty system received FDA approval in 2016, and has been available in Europe since 2015. To date, it is employed for the treatment of calcified lesion in various vascular districts such as coronary, iliac, femoral, popliteal, infra-popliteal, and renal arteries [4, 5]. The novelty highlighted in our paper is about the use of the lithoplasty system to treat stent under-expansion due to calcified plaque.…”

Intravascular iliac artery lithotripsy to enable transfemoral thoracic endovascular aortic repair

“…The use of this technology for the treatment of peripheral arterial disease has recently been reported in the Disrupt BTK and Disrupt PADII studies. 8,9 In these studies, intravascular lithotripsy was demonstrated to be safe with minimal vessel injury and an average increase in vessel diameter of 3.0 mm. No perforation, distal embolization, or no-reflow phenomena were reported.…”

“…6 Intravascular lithotripsy, based on the principle of calcium disruption by sonic pressure waves first used in urology, has been introduced as a new method for calcified plaque modification in coronary and peripheral arteries. [7][8][9] In this case report, we report as the first the use of intravascular lithotripsy to enable transfemoral TEVAR in a patient with small caliber iliac arteries and circumferential calcified plaques.…”

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

“…The present analysis evaluates IPD from a pooled database of prospective studies of the Shockwave IVL device. The studies included in the present analysis are DISRUPT PAD I, II, III, BTK, and CFA . IPD for these studies were provided by the study sponsor (Shockwave Medical).…”

“…Representative case images before and after IVL therapy in a severely calcified right superficial femoral artery lesion are presented (Figure ). However, to date, this device has only been evaluated in small‐to‐intermediate sized nonrandomized studies . Therefore, we sought to perform an individual patient‐level data (IPD) pooled meta‐analysis of available IVL trials to assess the efficacy and safety of this technique in the treatment of moderately‐to‐severely calcified PAD lesions.…”